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[null,null,"This Excel workbook contains the Evidence Map  on \nAN ANALYSIS OF PRO INSTRUMENTS USED TO ASSESS FATIGUE "]
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[null,null,"How this Evidence Map was generated"]
[null,null,"We searched heoro.com on the 5th December 2017 with the following field settings:"]
[null,null,"Disease: Fatigue AND Study type: PRO Instruments"]
[null,null,"The search identified a total of 341 relevant abstracts published since 1960, which were  segmented with the following standard heoro.com fields:"]
[null,null,null,"Locations - the geographical setting of the study, or, where this is unknown, the authors' location."]
[null,null,null,"Disease - the type of disease exhibited by the study population"]
[null,null,null,"Interventions - the interventions evaluated in the study, if any."]
[null,null,null,"PRO tools - the PRO intruments that were cited in the title or abstract."]
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[null,null,"In addition the following publication date segmentations are used:"]
[null,null,null,"1960 to 1999, 2000 to 2004, 2005 to 2009, 2010 to 2014, 2015 to 2018"]
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[null,null,"All data in this Evidence Map is taken from the heoro.com database"]
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[null,null,"Details of the PubMed search strategy used to populate the heoro.com database can be found here."]
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[null,null,"Contact us:"]
[null,null,"Address: Crystallise Ltd. Unit 21, Thames Enterpise Centre, Thames Industrial Park, East Tilbury, Essex, UK RM18 8RH"]
[null,null,"Tel: +44 (0)1375 488020"]
[null,null,"Email: alison.martin@crystallise.com"]

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[{"$f":"COUNT(A2:A988)","v":341},"Full citation","DOI","Authors","Title","Abstract","Citation","Locations","Year","Diseases","Interventions","PROtools","Subpopulations","Study types","Study methodologies","LocationsTags","SubpopulationsTags","DiseaseTags","InterventionsTags","StudytypesTags","StudyMethodologyTags","PROtoolTags","DateBand","C1","C2","C3","C4","C5"]
[1,"Aadahl,M.,et al. (2002). \"Fatigue and physical function after orthotopic liver transplantation.\" Liver Transpl 8(3): 251-259.",null,"Aadahl,M.,et al.","Fatigue and physical function after orthotopic liver transplantation","Over the last two decades,orthotopic liver transplantation (OLT) has become an established treatment for acute and chronic liver failure. OLT impacts not only on survival,but also on health-related quality of life. This study was undertaken to describe the self-rated health of Danish liver transplant recipients,compare their self-rated health against that of the general population,and to investigate associations between sex,age,diagnosis,time after OLT,and postoperative physical function and fatigue. All adult surviving liver transplant recipients who underwent OLT in Copenhagen,Denmark,from 1990 to 1998 (n = 154) were contacted by mail and asked to complete a self-administered questionnaire. The questionnaire contained the 36-Item Short Form Health Survey,the Multidimensional Fatigue Inventory,the Hospital Anxiety and Depression Scale,and questions on marital status,education,and work. The response rate was 84.4% (n = 130). Liver transplant recipients reported poorer self-rated health than the general population in physical,but not in mental,health areas. One health aspect,fatigue,was investigated in great detail. This study found that liver transplant recipients experienced physical,rather than mental,fatigue. Diagnosis was found to be a predictor of postoperative physical function and fatigue because patients with an alcoholic or cryptogenic cirrhosis background had significantly poorer physical function and experienced more physical fatigue than liver transplant recipients with other diagnoses. Work status and survival time after OLT had significant effects on postoperative physical function and fatigue. Working and having undergone transplantation 4 to 5 years previously were associated with significantly better physical function and less physical fatigue than not working and having undergone transplantation 1 to 3 years previously. This study suggests that liver transplant recipients experience physical,rather than mental,impairment and fatigue and that diagnosis,work status,and survival time after OLT are associated with physical function and fatigue.","Aadahl,M.,et al. (2002). \"Fatigue and physical function after orthotopic liver transplantation.\" Liver Transpl 8(3): 251-259.","Denmark",2002,"Liver Disease","Surgery","MFI"]
[2,"Abernethy,A. P.,et al. (2010). \"Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.\" J Pain Symptom Manage 40(4): 545-558.",null,"Abernethy,A. P.,et al.","Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients","CONTEXT: The Patient Care Monitor (PCM) is a review of systems survey delivered by means of an electronic patient-reported outcomes (ePRO) data capture system that uses wireless tablet computers. Although the PCM 1.0 is validated,the updated PCM 2.0 has not been validated nor tested in the academic setting. OBJECTIVES: To validate and test the PCM 2.0 in three cancer populations. METHODS: Two hundred seventy-five individuals participated in three clinical trials enrolling breast (n=65),gastrointestinal (n=113),and lung (n=97) cancer patients. Internal consistency was evaluated using Cronbach's alpha coefficients calculated for six PCM subscales (general physical symptoms,treatment side effects,distress,despair,impaired performance,and impaired ambulation) and a Quality-of-Life Index. Construct validity was evaluated through Pearson's correlation between PCM subscales and subscales of the Functional Assessment of Cancer Therapy--General (FACT-G),the M.D. Anderson Symptom Inventory (MDASI),and the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F). The participants had the following characteristics: mean age was 58 years (standard deviation: 11),52% were females,79% were whites,17% were blacks,62% had no college degree,and 78% had metastatic or recurrent disease. RESULTS: Raw and normalized scores for PCM 2.0 subscales were internally consistent across study cohorts. PCM 2.0 subscales correlated significantly (P<0.05) with the corresponding subscales on FACT-G,MDASI,and FACIT-F,with the exception of FACT-G social well-being,particularly for the lung cancer population. These correlations demonstrated construct validity. PCM 2.0 results followed expected patterns by cancer etiology. Prior reports demonstrate patient satisfaction with PCM 2.0. CONCLUSION: Within three unique academic oncology populations,PCM 2.0 is a valid ePRO instrument for assessing symptoms with seven patient-centered subscale or index domains.","Abernethy,A. P.,et al. (2010). \"Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.\" J Pain Symptom Manage 40(4): 545-558.","USA",2010,"Cancer","None","FACIT-F"]
[3,"Alsen,P.,et al. (2010). \"Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life.\" J Cardiovasc Nurs 25(2): E1-e10.",null,"Alsen,P.,et al.","Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life","BACKGROUND AND RESEARCH OBJECTIVE: : Health-related quality of life (HRQoL) is impaired in patients after a myocardial infarction (MI),and fatigue and depression are common health complaints among these patients. Patients' own beliefs about their illness (illness perceptions) influence health behavior and health outcomes. The aim of the present study was to examine illness perception and its association with self-reported HRQoL,fatigue,and emotional distress among patients with MI. SUBJECTS AND METHODS: : The sample consisted of 204 patients who had had MI and who completed the questionnaires during the first week in the hospital and 4 months after the MI. The questionnaires used were the Illness Perception Questionnaire,Multidimensional Fatigue Inventory,Hospital Anxiety and Depression Scale,and the Short Form Health Survey (SF-36). RESULTS: : Patient's illness perception changed over time from a more acute to a more chronic perception of illness,and beliefs in personal and treatment control of MI had decreased. Furthermore,these negative beliefs were associated with worse experiences of fatigue and lowered HRQoL. CONCLUSIONS: : Patients' illness perceptions influence health outcomes after an MI. Supporting MI patients in increasing their perception of personal control could be a primary nursing strategy in rehabilitation programs aimed at facilitating health behavior,decreasing experiences of fatigue,and increasing HRQoL.","Alsen,P.,et al. (2010). \"Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life.\" J Cardiovasc Nurs 25(2): E1-e10.","Sweden",2010,"CVD","None","MFI"]
[4,"Amato,M. P.,et al. (2001). \"Quality of life in multiple sclerosis: the impact of depression,fatigue and disability.\" Mult Scler 7(5): 340-344.",null,"Amato,M. P.,et al.","Quality of life in multiple sclerosis: the impact of depression,fatigue and disability","This study deals with the assessment of quality of life and its main clinical and demographical determinants in a clinical series of 103 patients with multiple sclerosis (MS) (37 men; 66 women; mean age 44.89 years; mean disease duration 12.40 years; mean EDSS score 4.07). We used the MSQOL-54 inventory,a disease-specific instrument recently validated in an Italian population. Each patient underwent a complete clinical assessment,including that of disability status (Expanded Disability Status Scale),cognitive function (Mini Mental State Examination),depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Severity Scale). In terms of Pearson's correlations,there was a moderate inverse relationship between disability level and the MSQOL-54 physical composite score,and a moderate to strong inverse correlation between depression or fatigue severity and both the physical and mental composite scores. In a stepwise linear regression analysis,depression,fatigue and disability level were confirmed to be significant and independent predictors of quality of life. Quality of life instruments can help to provide a broader measure of the disease impact and to develop a care program tailored to the patient's needs.","Amato,M. P.,et al. (2001). \"Quality of life in multiple sclerosis: the impact of depression,fatigue and disability.\" Mult Scler 7(5): 340-344.","Italy",2001,"Neurological","None","FSS"]
[5,"Ameringer,S.,et al. (2016). \"Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.\" Nurs Res 65(4): 279-289.",null,"Ameringer,S.,et al.","Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations","BACKGROUND: The need for reliable,valid tools to measure patient-reported outcomes (PROs) is critical both for research and for evaluating treatment effects in practice. The Patient-Reported Outcomes Measurement Information System Fatigue-Short Form v1.0-Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations. OBJECTIVES: The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations. METHODS: Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia,sickle cell disease,cardiometabolic risk,pregnancy,and healthy controls were used. Reliability was estimated using Cronbach's alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson's correlations between scores from the PROMIS F-SF,the Multidimensional Fatigue Symptom Inventory-Short Form,and the Brief Fatigue Inventory. Discriminant validity was evaluated by examining Pearson's correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SF scores in the clinical samples to healthy controls. RESULTS: Reliability of PROMIS F-SF scores was adequate across samples,ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups,correlations with scores on the Multidimensional Fatigue Symptom Inventory-Short Form and Brief Fatigue Inventory ranged from .60 to .85. Correlations of the PROMIS F-SF with measures of stress and depressive mood were moderate to strong,ranging from .37 to .64. PROMIS F-SF scores were significantly higher in clinical samples compared to healthy controls. DISCUSSION: Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis.","Ameringer,S.,et al. (2016). \"Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.\" Nurs Res 65(4): 279-289.","USA",2016,"Musculoskeletal,Hematological,Various","None","PROMIS-F,MFI,BFI"]
[6,"Andela,C. D.,et al. (2016). \"The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary.\" Pituitary 19(3): 293-302.",null,"Andela,C. D.,et al.","The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary","BACKGROUND: Patients report persisting impairment in quality of life (QoL) after treatment for pituitary disease. At present,there is no questionnaire to assess (a) whether patients with pituitary disease are bothered by these consequences,and (b) their needs for support. OBJECTIVE: To develop and validate a disease-specific questionnaire for patients with pituitary disease which incorporates patient perceived bother related to the consequences of the disease,and their needs for support. METHODS: Items for the Leiden Bother and Needs Questionnaire for patients with pituitary disease (LBNQ-Pituitary) were formulated based on results of a recent focus group study (n = 49 items). 337 patients completed the LBNQ-Pituitary and six validated QoL questionnaires (EuroQoL-5D,SF-36,MFI-20,HADS,AcroQol,CushingQoL). Construct validity was examined by exploratory factor analysis. Reliabilities of the subscales were calculated with Cronbach's alphas,and concurrent validity was assessed by calculating Spearman's correlations between the LBNQ-Pituitary and the other measures. RESULTS: Factor analyses produced five subscales (i.e.,mood problems,negative illness perceptions,issues in sexual functioning,physical and cognitive complaints,issues in social functioning) containing a total of 26 items. All factors were found to be reliable (Cronbach's alphas all >/=.765),and the correlations between the dimensions of the LBNQ-Pituitary and other questionnaires (all P </= .0001) demonstrated convergent validity. CONCLUSIONS: The LBNQ-Pituitary can be used to assess the degree to which patients are bothered by the consequences of the pituitary disease,as well as their needs for support. It could also facilitate an efficient assessment of patients' needs for support in clinical practice. We postulate that paying attention to needs for support will lead to optimal patient care (e.g.,improvement in psychosocial care),and positively affect QoL.","Andela,C. D.,et al. (2016). \"The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary.\" Pituitary 19(3): 293-302.","Netherlands",2016,"Endocrine","None","MFI"]
[7,"Appels,A.,et al. (2006). \"Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial.\" J Psychosom Res 61(1): 1-7; discussion 9-10.",null,"Appels,A.,et al.","Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial","OBJECTIVES: The EXhaustion Intervention Trial investigated the effect of a behavioural intervention programme on exhaustion,health-related quality of life (HRQL),depression,anxiety,hostility,and anginal complaints in angioplasty patients who felt exhausted after percutaneous coronary intervention (PCI). METHODS: Seven hundred ten patients were randomized into an intervention group and a usual care control group. The group intervention focused on stressors leading to exhaustion and on support of recovery. HRQL (measured by the MacNew questionnaire),exhaustion [measured by the Maastricht Questionnaire and the Maastricht Interview Vital Exhaustion (MIVE)],anxiety (measured by the State-Trait Inventory),and depression (measured by the structured clinical interview for DSM-IV) were assessed at intake and at 6 and 18 months. Presence of anginal complaints was assessed at 18 months. RESULTS: The intervention had a significant beneficial effect on all psychological factors except hostility and on the presence of anginal complaints. The effect of the intervention on exhaustion,as assessed by the MIVE,was modified by a previous history of coronary artery disease (CAD). Gender modified the effect of the intervention on exhaustion and on anxiety,the strongest effect being observed in women. CONCLUSIONS: The behavioural intervention improved HRQL and related psychological factors. Somatic comorbidity and a history of CAD limited the effect of the intervention.","Appels,A.,et al. (2006). \"Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial.\" J Psychosom Res 61(1): 1-7; discussion 9-10.","Netherlands",2006,"CVD","Psychobehavioural","Maastricht questionnaire,MIVE"]
[8,"Arora,S.,et al. (2006). \"Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.\" J Gastroenterol Hepatol 21(2): 406-412.",null,"Arora,S.,et al.","Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life","BACKGROUND: Peginterferon alpha-2a (40 kDa) plus ribavirin is equally effective in chronic hepatitis C patients with normal or elevated alanine aminotransferase (ALT) values. This analysis,in patients with normal ALT levels,compared health-related quality of life (HRQoL) measurements between untreated control patients and treated patients grouped by virological response. HRQoL in the present population was also compared with HRQoL in patients with elevated ALT levels,observed in a previous study. METHODS: A total of 491 patients with persistently normal ALT levels were randomized to peginterferon alpha-2a (40 kDa)/ribavirin for 24 (group A) or 48 weeks (group B) or no treatment for 72 weeks (group C). Quality of life was assessed with valid instruments (self-administered Short Form (SF)-36 Health Survey and Fatigue Severity Scale). RESULTS: In groups A and B,patients with sustained virological responses after combination therapy had significantly better quality of life and less fatigue than patients without sustained responses. Differences were significant for five SF-36 domains,the SF-36 Physical Component score and both Fatigue Severity Scale scores. Viral clearance was not observed in any untreated patients (group C). Comparison with data from elevated ALT patients revealed little difference in baseline quality of life,although normal ALT patients had significantly higher scores related to mental health than elevated ALT patients. CONCLUSIONS: Eradication of HCV with peginterferon alpha-2a (40 kDa) plus ribavirin is associated with better quality of life and less fatigue in normal ALT patients. These patient benefits,coupled with the high probability of eradicating HCV,should be considered in making decisions about treating this population.","Arora,S.,et al. (2006). \"Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.\" J Gastroenterol Hepatol 21(2): 406-412.","USA",2006,"Infectious Disease","Other Drugs","FSS"]
[9,"Arriens,C.,et al. (2015). \"Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus.\" Nutr J 14: 82.",null,"Arriens,C.,et al.","Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus","INTRODUCTION: A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus (SLE) found reduction of antioxidants and substrates for energy generation. These metabolic alterations may underlie one of the most common features of SLE--fatigue. The metabolomic studies also noted reduced omega-3 fatty acids,which are powerful anti- oxidants. This deficiency may be causally related to oxidative stress,inflammation,disease activity,and fatigue in SLE. Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies. The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue,quality of life,and disease activity as part of a randomized clinical trial. METHODS: Fifty SLE patients recruited in outpatient clinics were randomized 1:1 to fish oil supplementation or olive oil placebo,and blinded to their treatment group. At baseline and after 6 months of treatment,RAND Short Form-36 (RAND SF-36),Fatigue Severity Scale (FSS),SLE Disease Activity Index (SLEDAI),and Physician Global Assessment (PGA) were completed; serum was also collected for soluble mediator analysis. RESULTS: Thirty-two patients completed the study. PGA improved significantly in the fish oil group compared with the placebo group (p = 0.015). The RAND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends (p = 0.092 and 0.070). No clear difference was seen in FSS and SLEDAI (p = 0.350 and p = 0.417). Erythrocyte sedimentation rate and serum IL-12 were reduced (p = 0.008 and p = 0.058); while serum IL-13 was increased by fish oil supplementation (p = 0.033). CONCLUSIONS: In this randomized,placebo-controlled 6-month trial,SLE patients randomized to fish oil supplementation demonstrated improvement in their PGA,RAND SF-36,and some circulating inflammatory markers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).","Arriens,C.,et al. (2015). \"Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus.\" Nutr J 14: 82.","USA",2015,"Inflamatory Systemic Disease","Complementary","FSS"]
[10,"Auret,K. A.,et al. (2009). \"A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer.\" J Pain Symptom Manage 37(4): 613-621.",null,"Auret,K. A.,et al.","A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer","Fatigue is very common in patients with cancer. Current guidelines suggest that psychostimulants are \"reasonable to consider for severe fatigue.\" This randomized,double-blind,placebo-controlled trial investigated the hypothesis that dexamphetamine in fatigued patients with advanced cancer would produce a clinically significant improvement with minimal side effects. Fifty patients with advanced cancer,who were receiving palliative care,were randomized to dexamphetamine 10mg twice daily or placebo for eight days. Effectiveness was assessed using the Brief Fatigue Inventory and the McGill Quality-of-Life Questionnaire. The side effects were recorded. The results were analyzed on an intention-to-treat basis. The baseline demographics,fatigue levels,and quality-of-life scores were similar between the two arms. Patients were elderly,had impaired performance status (Eastern Cooperative Oncology Group score=3),and were taking a range of neurologically active medications. Thirty-nine patients completed the trial. There was a transient improvement in the fatigue levels on day 2,but no significant difference in fatigue (P=0.267) or quality of life (P=0.579) by the end of the study. Statistical modeling did not reveal any significant predictors of response to dexamphetamine. These results suggest that dexamphetamine 20mg daily,although well tolerated,does not significantly improve fatigue or quality of life in patients with advanced cancer,as measured by the selected instruments.","Auret,K. A.,et al. (2009). \"A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer.\" J Pain Symptom Manage 37(4): 613-621.","Australia",2009,"Cancer","Other Drugs","BFI"]
[11,"Bae,S. C.,et al. (2013). \"Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis.\" BMC Musculoskelet Disord 14: 13.",null,"Bae,S. C.,et al.","Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis","BACKGROUND: Patient reported outcomes (PROs) are especially useful in assessing treatments for rheumatoid arthritis (RA) since they measure dimensions of health-related quality of life that cannot be captured using strictly objective physiological measures. The aim of this study was to compare the effects of combination etanercept and methotrexate (ETN + MTX) versus combination synthetic disease modifying antirheumatic drugs (DMARDs) and methotrexate (DMARD + MTX) on PRO measures among RA patients from the Asia-Pacific region,a population not widely studied to date. Patients with established moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate were studied. METHODS: Patients were randomized to either ETN + MTX (N = 197) or DMARD + MTX (N = 103) in an open-label,active-comparator,multicenter study,with PRO measures designed as prospective secondary endpoints. The Health Assessment Questionnaire (HAQ),Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue),Medical Outcomes Short Form-36 Health Survey (SF-36),Hospital Anxiety and Depression Scale (HADS) and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) were used. RESULTS: Significantly greater improvements were noted for the ETN + MTX group at week16 for HAQ mean scores and for proportion of patients achieving HAQ score </= 0.5,compared to patients in the DMARD + MTX group. SF-36 Summary Scores for physical and mental components and for 6 of 8 health domains showed significantly greater improvements at week16 for the ETN + MTX group; only scores for physical functioning and role-emotional domains did not differ significantly between the two treatment arms. Greater improvements at week16 were noted for the ETN + MTX group for FACIT-Fatigue,HADS,and WPAI:GH mean scores. CONCLUSION: Combination therapy using ETN + MTX demonstrated superior improvements using a comprehensive set of PRO measures,compared to combination therapy with usual standard of care DMARDs plus MTX in patients with established rheumatoid arthritis from the Asia-Pacific region. TRIAL REGISTRATION: clintrials.gov # NCT00422227.","Bae,S. C.,et al. (2013). \"Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis.\" BMC Musculoskelet Disord 14: 13.","Korea",2013,"Musculoskeletal","Etanercept,Other Drugs","FACIT-F"]
[12,"Bansi,J.,et al. (2013). \"Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue.\" J Neurol 260(12): 2993-3001.",null,"Bansi,J.,et al.","Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue","The influences of exercise on cytokine response,health-related quality of life (HR-QoL),and fatigue are important aspects of MS rehabilitation. Physical exercises performed within these programs are often practiced in water,but the effects of immersion have not been investigated. To investigate the influences of short-term immune responses and cardiorespiratory fitness on HR-QoL and fatigue during 3 weeks endurance training conducted on a cycle-ergometer or an aquatic-bike. Randomized controlled clinical trial in 60 MS patients. HR-QoL,fatigue,cardiorespiratory fitness,and short-term immune changes (serum concentrations in response to cardiopulmonary exercise test) of brain-derived neurotrophic factor (BDNF),nerve growth factor (NGF),interleukin-6,and the soluble receptor of IL-6 (sIL-6R) were determined at the beginning and end of 3 weeks of training intervention. Subjects performed daily 30 min training at 60 % of their VO2peak. SF-36 total (p = 0.031),physical (p = 0.004),and mental health (p = 0.057) scores show time effects within both groups. Between-group effects were shown for FSMC total (p = 0.040) and motor function score (p = 0.041). MFIS physical fatigue showed time effects (p = 0.008) for both groups. Linear regression models showed relationships between short-term immune responses and cardiorespiratory fitness with HR-QoL and fatigue after the intervention. This study indicates beneficial effects of endurance training independent of the training setting. Short-term immune adaptations and cardiorespiratory fitness have the potential to influence HR-QoL and fatigue in persons with MS. The specific immune responses of immersion to exercise need further clarification.","Bansi,J.,et al. (2013). \"Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue.\" J Neurol 260(12): 2993-3001.","Switzerland",2013,"Neurological","Psychobehavioural","MFI"]
[13,"Barak,Y. and A. Achiron (2006). \"Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project.\" J Neurol Sci 245(1-2): 73-76.",null,"Barak,Y. and A. Achiron","Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project","BACKGROUND: Multiple sclerosis (MS) patients commonly suffer from fatigue and define it as one of their most disabling symptom profoundly disrupting their lives. However,the relationship of fatigue to cognitive functions and its impact on quality of life have not been widely studied. AIM: To define (1) \"cognitive fatigue\",(2) survey its frequency and (3) characterize severity and impact on quality of life in MS patients in the first 10 years of the disease. METHODS: A two-wave design was utilized to enrich the studied population in subjects whose fatigue is significant. In the first wave,fatigue was measured by the self-reported fatigue severity scale (FSS) in randomly selected MS patients from our computerized database. Patients responding to the 9th item of the FSS i.e.,\"Fatigue interferes with my work,family,or social life\" by a grade of 3 or higher (of 7) were further assessed (wave two) by the fatigue impact scale (FIS) and the RAYS quality of life questionnaire. RESULTS: Of the 259 patients that completed the first-wave screening,158 patients (61%,118 females,mean age 41.1+/-9.2 years,mean disease duration 6.2+/-5.5 years) satisfied the additional criterion and were defined to suffer from significant fatigue. The great majority of these patients-91.7%-had a relapsing-remitting disease course,mean FIS score was 77+/-25.9 and their mean EDSS was 2.9+/-2.6. Fatigue was reported to occur most of the day in 30.9% of patients,persist in 69% for more than 1 year,and in 59.8%,it was reported not to be associated with effort. No correlations were found between age,gender,disease duration or neurological disability and FIS cognitive subscale score. Significant correlations were found between the FIS cognitive subscale score and the three domains (physical,psychological and social-familial) of the RAYS quality of life questionnaire (p<0.001). CONCLUSIONS: Cognitive fatigue was found in more than half of MS patients in the first decade from onset that were particularly selected for significant fatigue in their lives. This aspect of fatigue correlated with all quality of life domains and especially with psychological everyday tasks.","Barak,Y. and A. Achiron (2006). \"Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project.\" J Neurol Sci 245(1-2): 73-76.","Israel",2006,"Neurological","None","FSS"]
[14,"Battaglini,C. L.,et al. (2009). \"The effects of an exercise program in leukemia patients.\" Integr Cancer Ther 8(2): 130-138.",null,"Battaglini,C. L.,et al.","The effects of an exercise program in leukemia patients","PURPOSE: To examine the feasibility of administering an in-hospital exercise program to acute leukemia patients undergoing chemotherapy. A secondary purpose explored the impact of exercise on selected physiological,psychological,and inflammatory markers. METHODS: Ten patients,aged 18 to 50 years,diagnosed with acute leukemia or newly relapsed were assessed for body weight,height,body composition (skinfolds),cardiorespiratory endurance (total minutes on bicycle ergometer at 60% heart rate reserve),dynamic muscular endurance (Rocky Mountain Cancer Rehabilitation Institute protocol),fatigue (Revised Piper Fatigue Scale),depression (Center for Epidemiologic Studies Depression scale,National Institute of Mental Health questionnaire),and quality of life (Functional Assessment of Cancer Therapy-General) at baseline (within 3 days of diagnosis) and at the end of induction phase of treatment. Blood draws were taken at baseline,midpoint,and at the end of induction for analyses of inflammatory markers (Linco Luminex assay). Combined aerobic and strength training exercises were administered 3 times per week,twice daily,for 30 minutes. Paired-samples t-tests were used for the analyses of physiological and psychological parameters. One-way repeated measures analysis of variance was used for the analyses of inflammatory markers. RESULTS: Significant improvements in cardiorespiratory endurance (P = .009,baseline 8.9 +/- 8.8 minutes,postexercise intervention 17 +/- 14.3 minutes) with significant reductions in total fatigue scores (P = .009,baseline 4.6 +/- 1.7,postexercise intervention 1.8 +/- 1.6) and depression scores (P = .023,baseline 19 +/- 11.5,postexercise intervention 12 +/- 8.2) were observed. Marginally significant decrease in interleukin-6 (IL-6; P = .059) with no significant changes in IL-10 (P = .223) or interferon-gamma (P = .882) were observed. CONCLUSION: Administration of exercise to acute leukemia patients undergoing treatment is feasible. The exercise protocol used increased cardiovascular endurance,reduced fatigue and depression scores,and maintained quality of life. Although no significant change in inflammation was observed,a trend demonstrating a reduction in IL-6 and an increase in IL-10 warrants further investigation.","Battaglini,C. L.,et al. (2009). \"The effects of an exercise program in leukemia patients.\" Integr Cancer Ther 8(2): 130-138.","USA",2009,"Cancer","Psychobehavioural","PFS"]
[15,"Beckerman,H.,et al. (2013). \"The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme.\" Trials 14: 250.",null,"Beckerman,H.,et al.","The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme","BACKGROUND: TREFAMS is an acronym for TReating FAtigue in Multiple Sclerosis,while ACE refers to the rehabilitation treatment methods under study,that is,Aerobic training,Cognitive behavioural therapy,and Energy conservation management. The TREFAMS-ACE research programme consists of four studies and has two main objectives: (1) to assess the effectiveness of three different rehabilitation treatment strategies in reducing fatigue and improving societal participation in patients with MS; and (2) to study the neurobiological mechanisms of action that underlie treatment effects and MS-related fatigue in general. METHODS/DESIGN: Ambulatory patients (n = 270) suffering from MS-related fatigue will be recruited to three single-blinded randomised clinical trials (RCTs). In each RCT,90 patients will be randomly allocated to the trial-specific intervention or to a low-intensity intervention that is the same for all RCTs. This low-intensity intervention consists of three individual consultations with a specialised MS-nurse. The trial-specific interventions are Aerobic Training,Cognitive Behavioural Therapy,and Energy Conservation Management. These interventions consist of 12 individual therapist-supervised sessions with additional intervention-specific home exercises. The therapy period lasts 16 weeks. All RCTs have the same design and the same primary outcome measures: fatigue - measured with the Checklist Individual Strength,and participation - measured with the Impact on Participation and Autonomy questionnaire. Outcomes will be assessed 1 week prior to,and at 0,8,16,26 and 52 weeks after randomisation. The assessors will be blinded to allocation. Pro- and anti-inflammatory cytokines in serum,salivary cortisol,physical fitness,physical activity,coping,self-efficacy,illness cognitions and other determinants will be longitudinally measured in order to study the neurobiological mechanisms of action. DISCUSSION: The TREFAMS-ACE programme is unique in its aim to assess the effectiveness of three rehabilitation treatments. The programme will provide important insights regarding the most effective treatment for MS-related fatigue and the mechanisms that underlie treatment response. A major strength of the programme is that the design involves three almost identical RCTs,enabling a close comparison of the treatment strategies and a strong overall meta-analysis. The results will also support clinical practice guidelines for the treatment of MS-related fatigue. TRIAL REGISTRATIONS: Current Controlled Trials ISRCTN69520623,ISRCTN58583714,and ISRCTN82353628.","Beckerman,H.,et al. (2013). \"The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme.\" Trials 14: 250.","Netherlands",2013,"Neurological","Psychobehavioural","CIS-F"]
[16,"Bedaiwi,M.,et al. (2015). \"Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort.\" J Rheumatol 42(12): 2354-2360.",null,"Bedaiwi,M.,et al.","Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort","OBJECTIVE: In this study,we aimed to address the prevalence of fatigue,its associated factors,and the effect of tumor necrosis factor inhibitors (TNFi) on this subgroup of patients in a large axial spondyloarthritis (axSpA) cohort. METHODS: The study included 681 patients [ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA)]. The Fatigue Severity Scale (FSS) and the Bath AS Disease Activity Index question 1 (BASDAI Q1) indices were used for fatigue assessment. Severe fatigue was defined as an FSS >/= 4 or a BASDAI Q1 >/= 5. Disease activity,function,and quality of life (QoL) measures were recorded. Patients who had been treated with TNFi were identified,and baseline and followup data were analyzed. RESULTS: Of the cohort,67.3% had severe fatigue,and the prevalence was similar between AS (67.2%) and nr-axSpA (68.2%). Severely fatigued patients tended to have higher disease activity scores,increased acute-phase proteins,and decreased QoL measures. TNFi therapy was associated with improvement in disease activity,and although this treatment led to significantly decreased fatigue scores,this reduction was not optimal in the majority of patients with 80% continuing to have severe fatigue according to their posttreatment scores. Health Assessment Questionnaire,mean scores of BASDAI Q5 and Q6,and BASDAI enthesitis were independent predictors of fatigue severity. CONCLUSION: Fatigue is a common symptom in axSpA,and the burden of fatigue among patients with nr-axSpA is similar to that seen in AS. While biologics are effective in improving disease activity,their effect on fatigue is more limited. In axSpA,fatigue remains unresponsive to TNFi in nearly 80% of patients.","Bedaiwi,M.,et al. (2015). \"Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort.\" J Rheumatol 42(12): 2354-2360.","Canada",2015,"Musculoskeletal","None","FSS"]
[17,"Bello-Haas,V. D.,et al. (2007). \"A randomized controlled trial of resistance exercise in individuals with ALS.\" Neurology 68(23): 2003-2007.",null,"Bello-Haas,V. D.,et al.","A randomized controlled trial of resistance exercise in individuals with ALS","OBJECTIVE: To determine the effects of resistance exercise on function,fatigue,and quality of life in individuals with ALS. METHODS: Subjects with a diagnosis of clinically definite,probable,or laboratory-supported ALS,forced vital capacity (FVC) of 90% predicted or greater,and an ALS Functional Rating Scale (ALSFRS) score of 30 or greater were randomly assigned to a resistance exercise group that received a home exercise program consisting of daily stretching and resistance exercises three times weekly or to a usual care group,who performed only the daily stretching exercises. ALSFRS,the Fatigue Severity Scale (FSS),and Short Form-36 (SF-36) were completed at baseline and monthly for 6 months. FVC and maximum voluntary isometric contraction (MVIC) were monitored monthly throughout the study. RESULTS: Of 33 subjects screened,27 were randomly assigned (resistance = 13; usual care = 14). Eight resistance exercise subjects and 10 usual care subjects completed the trial. At 6 months,the resistance exercise group had significantly higher ALSFRS and SF-36 physical function subscale scores. No adverse events related to the intervention occurred,MVIC and FVC indicated no negative effects,and less decline in leg strength measured by MVIC was found in the resistance exercise group. CONCLUSION: Our study,although small,showed that the resistance exercise group had significantly better function,as measured by total ALS Functional Rating Scale and upper and lower extremity subscale scores,and quality of life without adverse effects as compared with subjects receiving usual care.","Bello-Haas,V. D.,et al. (2007). \"A randomized controlled trial of resistance exercise in individuals with ALS.\" Neurology 68(23): 2003-2007.","Canada",2007,"Neurological","Psychobehavioural","FSS"]
[18,"Berger,A. M.,et al. (2009). \"Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens.\" Oncol Nurs Forum 36(5): 563-570.",null,"Berger,A. M.,et al.","Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens","PURPOSE/OBJECTIVES: To examine the relationships among fatigue and physical and mental quality of life (QOL) and different adjuvant chemotherapy regimens in patients with stage I-IIIA breast cancer prior to,during,and after treatment. DESIGN: Longitudinal,descriptive design embedded in a randomized,clinical trial. SETTING: Outpatient oncology clinics in the midwestern United States. SAMPLE: 196 postoperative women,mean age of 52 years,receiving anthracycline-based chemotherapy regimens: dose-dense taxane,dose-standard taxane,or dose-standard without taxane. METHODS: The Piper Fatigue Scale and Medical Outcomes Study SF-36(R) (v.2) Survey were completed 48 hours prior to treatment 1,at treatments 4 and 8,and 30 days after the final treatment. MAIN RESEARCH VARIABLES: Fatigue,adjuvant chemotherapy regimen,and QOL. FINDINGS: Fatigue and mental QOL changed significantly over time for all regimens,but the patterns of change did not differ based on regimen. Physical QOL changed significantly over time for all regimens,and the pattern of change differed based on whether taxanes were received. Higher fatigue was correlated with lower physical and mental QOL prior to and 30 days after the final treatment,regardless of regimen. CONCLUSIONS: Women who receive taxanes are at higher risk for lower physical QOL over time. Higher fatigue was associated with lower QOL regardless of the chemotherapy regimens. IMPLICATIONS FOR NURSING: Clinicians should screen patients for fatigue and assess for contributing factors at clinic visits. Methods to integrate evidence-based fatigue interventions into practice should be tested and outcomes evaluated.","Berger,A. M.,et al. (2009). \"Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens.\" Oncol Nurs Forum 36(5): 563-570.","USA",2009,"Cancer","Cancer treatments","PFS"]
[19,"Bernstein,D.,et al. (2002). \"Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients.\" Hepatology 35(3): 704-708.",null,"Bernstein,D.,et al.","Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients","Interferon therapy may exacerbate health-related quality of life (HRQL) deficits associated with hepatitis C virus (HCV) early in the course of therapy. Treatment with polyethylene glycol-modified interferon (peginterferon) alfa-2a (40 kd) provides improved sustained response over interferon alfa-2a,but its effect on HRQL is unknown. The objective of this study was to (1) evaluate the effect of sustained virologic response on HRQL in patients with HCV and (2) determine whether impairment of HRQL during treatment contributes to early treatment discontinuation. Data consisted of a pooled secondary analysis of patients (n = 1,441) across 3 international,multicenter,open-label,randomized studies that compared peginterferon alfa-2a (40 kd) with interferon alfa-2a. ANCOVA was used to examine the effect of sustained virologic response on HRQL. Repeated-measures mixed-models ANCOVA was used to compare Fatigue Severity Scale (FSS) and SF-36 scores during treatment by treatment group. Logistic regression analysis was used to examine the association between changes at baseline in on-treatment HRQL and early treatment discontinuation. Sustained virologic response was associated with marked improvements from baseline to end of follow-up in all subjects,including patients with cirrhosis. During treatment,patients receiving peginterferon alfa-2a (40 kd) had statistically significantly better scores on both the SF-36 and FSS. Baseline to 24-week changes in fatigue and SF-36 mental and physical summary scores significantly predicted treatment discontinuation. In conclusion,sustained virologic response is associated with improvements in quality of life in patients with or without advanced liver disease. This parameter may be an important consideration in maximizing treatment adherence.","Bernstein,D.,et al. (2002). \"Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients.\" Hepatology 35(3): 704-708.","USA",2002,"Infectious Disease","Other Drugs","FSS"]
[20,"Bertolasi,L.,et al. (2013). \"A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome.\" J Neurol Sci 330(1-2): 94-99.",null,"Bertolasi,L.,et al.","A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome","OBJECTIVE: To investigate in a single-center randomized control trial whether a single IVIg course improves short-term outcome in patients with postpolio syndrome (PPS). METHODS: Fifty-one patients with PPS were randomly allocated to receive 2g/kg IVIg body weight or placebo infused over 5 consecutive days. The primary endpoint was health-related quality of life (HRQoL) limited to the physical component score (PCS) in the Short-Form-36 (SF-36). Secondary endpoints included the SF-36 mental component score (MCS),6-minute walk test,visual analog scale,101-numeric rating,and fatigue severity scale. Muscle strength was graded according to the Medical Research Council scale and by dynamometer. Primary and secondary outcome variables were tested double-blind at baseline,2months,and 4months. RESULTS: At two months,although SF-36 PCS scores were similar in both arms,the role physical (RP) domain improved significantly in the treatment arm (p=0.05) and so did the composite MCS (p=0.015),and role emotional (RE) subscale (p=0.02). No differences were found in the remaining outcome measures. At 4months,none of the outcome variables differed significantly between groups. CONCLUSIONS: Although the study did not reach the primary endpoint,we showed that a single IVIg course improves HRQoL related to mental activity,as measured by the SF-36 composite MCS,and role limitations including RP and RE SF-36 subscales at 2months,in patients with PPS. A single IVIg course leaves,gait,muscle strength,fatigue and bodily pain unchanged in patients with PPS. CLASSIFICATION OF EVIDENCE: Class I evidence indicates that IVIg did not change SF-36 PCS,and Class II evidence indicates that IVIg improved scores on the SF-36 MCS,RP,and RE.","Bertolasi,L.,et al. (2013). \"A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome.\" J Neurol Sci 330(1-2): 94-99.","Italy",2013,"Neurological","Various","FSS"]
[21,"Bettoni,L.,et al. (2013). \"Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients.\" Clin Rheumatol 32(9): 1337-1345.",null,"Bettoni,L.,et al.","Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients","Fibromyalgia is a chronic widespread pain disorder in which,the neurogenic origin of the pain,featured by allodynia and hyperalgesia,results from an imbalance in the levels of neurotransmitters and consequently of the peripheral pro- and anti-inflammatory mediators. Whole body cryotherapy is a peculiar physical therapy known to relieve pain and inflammatory symptoms characteristics of rheumatic diseases,through the regulation of the cytokine expression. The aim of this study was to qualitatively evaluate the effects of cryotherapy on the clinical output of fibromyalgic patients. A total of 100 fibromyalgic patients (age range 17-70 years) were observed; 50 subjects were addressed to cryotherapy,while the second group (n = 50) did not underwent to the cryotherapic treatment. All subjects kept the prescribed pharmacological therapy during the study (analgesic and antioxidants). The referred health status pre- and post-observation was evaluated with the following scales: Visual Analogue Scale,Short Form-36,Global Health Status and Fatigue Severity Scale. Fibromyalgic patients treated with cryotherapy reported a more pronounced improvement of the quality of life,in comparison with the non-cryo treated fibromyalgic subjects,as indicated by the scores of the qualitative indexes and sub-indexes,that are widely recognized tools to assess the overall health status and the effect of the treatments. We speculate that this improvement is due to the known direct effect of cryotherapy on the balance between pro- and anti-inflammatory mediators having a recognized role in the modulation of pain.","Bettoni,L.,et al. (2013). \"Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients.\" Clin Rheumatol 32(9): 1337-1345.","Italy",2013,"Musculoskeletal","Various","VAS-F,FSS"]
[22,"Bianchi,W. A.,et al. (2014). \"Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis.\" Rev Bras Reumatol 54(3): 200-207.",null,"Bianchi,W. A.,et al.","Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis","OBJECTIVES: Fatigue is a highly subjective and extremely common symptom in patients with rheumatoid arthritis although it is difficult to characterize and define. The aim of this study was to assess fatigue in a cohort of Brazilian patients,and to analyze the relationship between fatigue and disease-specific variables. METHODS: 371 Brazilian patients diagnosed with rheumatoid arthritis according to the 1987 American College of Rheumatology classification criteria were prospectively investigated. Demographic,clinical and laboratorial data were obtained from hospitals records. The number of painful joints,bone mass index,disease duration,quality of life,functional capacity,anxiety and depression were recorded. Fatigue was evaluated using the subscale of Fatigue Assessment of Chronic Illness Therapy (FACIT-FATIGUE scale). RESULTS: The median fatigue score was 42.0 (10.0),negatively correlated with functional capacity (-0.507; P < 0.001),anxiety and depression (-0.542 and -0.545; P < 0.001 respectively),and predominantly with physical domain of Short Form 36-item quality of life questionnaire (SF-36P: 0.584; P < 0.001). The scores were not associated with the erythrocyte sedimentation rate (-0.118; P < 0.05),C-reactive protein (-0.089; P < 0.05),disease activity (-0.250; P < 0.001) or the number of painful joints (-0.135; P < 0.01). Confidence interval of 95% was applied for all measures. CONCLUSIONS: In this series of Brazilian patients with rheumatoid arthritis,we suggest a new significance for fatigue complains as an independent parameter not related with number of painful joints,disease or inflammatory activity scores. Psychological and functional impairments appear to be more related to fatigue. Additional studies and inclusion of standard measures for monitoring fatigue complains are required.","Bianchi,W. A.,et al. (2014). \"Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis.\" Rev Bras Reumatol 54(3): 200-207.","Brazil",2014,"Musculoskeletal","None","FACIT-F"]
[23,"Biermasz,N. R.,et al. (2004). \"Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess.\" J Clin Endocrinol Metab 89(11): 5369-5376.",null,"Biermasz,N. R.,et al.","Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess","The long-term impact of acromegaly on subjective well-being after treatment of GH excess is unclear. Therefore,we evaluated quality of life by validated questionnaires in a cross-sectional study of 118 successfully treated acromegalic patients. The initial treatment was transsphenoidal surgery in most patients (92%),if necessary followed by radiotherapy or octreotide. All patients were in remission at the time of assessment (GH,<1.9 mug/liter; normal IGF-I for age). General perceived well-being was reduced compared with controls for all subscales (P < 0.001) as measured by the Nottingham Health Profile and the Short Form-36. Acromegalic patients also had lower scores on fatigue (Multidimensional Fatigue Index) and anxiety and depression (Hospital Anxiety and Depression Scale). Radiotherapy was associated with decreased quality of life in all subscales except for the Hospital Anxiety and Depression Scale,and worsened quality of life significantly,according to the fatigue scores. Somatostatin analog treatment was not associated with improved quality of life. Independent predictors of quality of life were age (physical subscales and Nottingham Health Profile),disease duration (social isolation and personal relations),and radiotherapy (physical and fatigue subscales). In conclusion,patients cured after treatment for acromegaly have a persistently decreased quality of life despite long-term biochemical cure of GH excess. Radiotherapy especially is associated with a reduced quality of life.","Biermasz,N. R.,et al. (2004). \"Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess.\" J Clin Endocrinol Metab 89(11): 5369-5376.","Netherlands",2004,"Endocrine","Surgery,Cancer Treatments,Other Drugs","MFI"]
[24,"Bingham,C. O.,3rd,et al. (2014). \"The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial.\" J Rheumatol 41(6): 1067-1076.",null,"Bingham,C. O.,3rd,et al.","The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial","OBJECTIVE: To evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy. METHODS: In this randomized,multicenter,double-blind,placebo-controlled,phase III trial,adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0,Week 4,and every 8 weeks thereafter. All patients continued stable oral MTX (15-25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function),Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores,EQ-5D assessment of current health state,Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire,and disease effect on productivity [10-cm visual analog scale (VAS)]. RESULTS: Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12,Week 16,and Week 24,and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function,HRQOL,fatigue,and productivity significantly correlated with disease activity improvement. CONCLUSION: In active RA,IV golimumab + MTX significantly improved physical function,HRQOL,fatigue,and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479,EudraCT 2008-006064-11).","Bingham,C. O.,3rd,et al. (2014). \"The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial.\" J Rheumatol 41(6): 1067-1076.","USA",2014,"Musculoskeletal","Golimumab,Other Drugs","FACIT-F,VAS-F"]
[25,"Bivard,A.,et al. (2017). \"MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial.\" Stroke 48(5): 1293-1298.",null,"Bivard,A.,et al.","MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial","BACKGROUND AND PURPOSE: This study aimed to assess the efficacy of modafinil,a wakefulness-promoting agent in alleviating post-stroke fatigue >/=3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. METHODS: This single-center phase 2 trial used a randomized,double-blind,placebo-controlled,crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of >/=60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy,then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment,the Depression,Anxiety,and Stress Scale (DASS),and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person,baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). RESULTS: A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory,-7.38; 95% CI,-21.76 to -2.99; P<0.001) and improved quality of life (SSQoL,11.81; 95% CI,2.31 to 21.31; P=0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period (P>0.05). CONCLUSIONS: Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.","Bivard,A.,et al. (2017). \"MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial.\" Stroke 48(5): 1293-1298.","Australia",2017,"CVD","Other Drugs","MFI"]
[26,"Bjornsson,E.,et al. (2004). \"Fatigue in patients with primary sclerosing cholangitis.\" Scand J Gastroenterol 39(10): 961-968.",null,"Bjornsson,E.,et al.","Fatigue in patients with primary sclerosing cholangitis","BACKGROUND: The occurrence of fatigue in primary sclerosing cholangitis (PSC),its impact on quality of life and the role of concomitant inflammatory bowel disease (IBD) and coexisting irritable bowel syndrome (IBS) is unexplored. METHODS: Ninety-three patients with PSC,associated with IBD in 80% of cases and 77 patients with IBD alone,were enrolled in the study. The patients completed the following questionnaires: the Fatigue Impact Scale (FIS),the Psychological General Well-Being Index (PGWB),the Gastrointestinal Symptom Rating Scale (GSRS),the Beck Depression Inventory (BDI) and diagnostic criteria for IBS. Questionnaire data were related to liver tests and the latest liver biopsy in the PSC patients. Two sex- and age matched controls from the general population (GP) were assigned to each PSC patient and these controls completed the FIS and the BDI. RESULTS: Total fatigue score did not differ significantly between patients with PSC and IBD alone. Median total fatigue score among GP subjects was 39 (13-72),which was higher than in PSC (19 (6-52) (P = 0.02)) and in IBD patients (19 (5-35) (P < 0.0001)). PGWB and GSRS scores did not differ between patients with PSC and IBD alone. Depression and general health (PGWB) were independent predictors for total fatigue score in PSC. No correlation was observed between fatigue in PSC and the severity of the liver disease. CONCLUSIONS: Fatigue in patients with PSC is related to depression but not to the severity of the liver disease. Both the PSC and IBD patients had lower total fatigue scores than subjects from the general population. This argues against fatigue as a specific symptom of PSC and IBD patients.","Bjornsson,E.,et al. (2004). \"Fatigue in patients with primary sclerosing cholangitis.\" Scand J Gastroenterol 39(10): 961-968.","Sweden",2004,"Gastrointestinal","None","FIS"]
[27,"Boele,F. W.,et al. (2013). \"The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial.\" Neuro Oncol 15(10): 1420-1428.",null,"Boele,F. W.,et al.","The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial","BACKGROUND: Fatigue,cognitive deficits,and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue,depression,health-related quality of life (HRQOL),and cognitive functioning in PBT patients,we performed a multicenter,double-blind placebo-controlled crossover trial. METHODS: Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period,the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]),depression (Center for Epidemiologic Studies Depression Scale [CES-D]),HRQOL (Short-Form Health Survey [SF-36]),and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing. RESULTS: In total,37 patients participated. Relative to baseline,patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021,respectively) and the placebo condition (P < .001 and P = .027,respectively). The same held for physical health (SF-36 Physical Component Summary score; P = .001 and P = .008,respectively),working memory (P = .040 and P = .043),and information processing capacity (P = .036 and P = .040). No improvement in depressive symptoms was found in either condition. CONCLUSIONS: Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow,and relatively many patients dropped out during the trial,due mostly to side effects. Other,preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients.","Boele,F. W.,et al. (2013). \"The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial.\" Neuro Oncol 15(10): 1420-1428.","Netherlands",2013,"Cancer","Other Drugs","CIS-F"]
[28,"Bogdanovic,G.,et al. (2015). \"Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus.\" Tohoku J Exp Med 237(3): 193-199.",null,"Bogdanovic,G.,et al.","Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus","Given the crucial events in systemic lupus erythematosus (SLE) such as joint and muscle pain,fatigue,depression,obesity and osteoporosis,the very thought of exercising can be challenging. This prospective study included 60 patients diagnosed with SLE in stable condition. A randomly selected group of 30 women had aerobic training on a bicycle ergometer for a period of 15 minutes,3 times per week for 6 weeks,while the second group of 30 women performed isotonic exercises (to stretch and lengthen muscles and improve the range of motion) for 30 minutes,3 times per week during the same period. Fatigue Severity Scale (FSS),Short Form 36 (SF36) questionnaire on the quality of life and Beck depression inventory (BDI) were analyzed at baseline and after 6 weeks. At baseline FSS score was 53.8 +/- 5.7 and after the physical activity FSS score was 29.1 +/- 7.8 (FSS >/= 36; fatigue is present). The largest number of patients (66.7%) was in a moderate depressed state at the baseline,while after physical activities 61.7% of patients,had a mild mood disturbance. There were significant differences (p < 0.001) in values of all areas of quality of life questionnaire SF36 before and after the implementation of physical activity. The type of physical activity had no influence in FSS and BDI values. Continuous physical activity,regardless of its type,significantly improved quality of life of SLE patients. We recommend regular physical activity as an integral part of modern therapeutic approach in this patient population.","Bogdanovic,G.,et al. (2015). \"Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus.\" Tohoku J Exp Med 237(3): 193-199.","Unknown",2015,"Inflamatory Systemic Disease","Psychobehavioural","FSS"]
[29,"Bolk,N.,et al. (2010). \"Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.\" Arch Intern Med 170(22): 1996-2003.",null,"Bolk,N.,et al.","Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial","BACKGROUND: Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date,no large randomized trial investigating the best time of levothyroxine intake,including quality-of-life evaluation,has been performed. METHODS: To ascertain if levothyroxine intake at bedtime instead of in the morning improves thyroid hormone levels,a randomized double-blind crossover trial was performed between April 1,2007,and November 30,2008,among 105 consecutive patients with primary hypothyroidism at Maasstad Hospital Rotterdam in the Netherlands. Patients were instructed during 6 months to take 1 capsule in the morning and 1 capsule at bedtime (one containing levothyroxine and the other a placebo),with a switch after 3 months. Primary outcome measures were thyroid hormone levels; secondary outcome measures were creatinine and lipid levels,body mass index,heart rate,and quality of life. RESULTS: Ninety patients completed the trial and were available for analysis. Compared with morning intake,direct treatment effects when levothyroxine was taken at bedtime were a decrease in thyrotropin level of 1.25 mIU/L (95% confidence interval [CI],0.60-1.89 mIU/L; P < .001),an increase in free thyroxine level of 0.07 ng/dL (0.02-0.13 ng/dL; P = .01),and an increase in total triiodothyronine level of 6.5 ng/dL (0.9-12.1 ng/dL; P = .02) (to convert thyrotropin level to micrograms per liter,multiply by 1.0; free thyroxine level to picomoles per liter,multiply by 12.871; and total triiodothyronine level to nanomoles per liter,multiply by 0.0154). Secondary outcomes,including quality-of-life questionnaires (36-Item Short Form Health Survey,Hospital Anxiety and Depression Scale,20-Item Multidimensional Fatigue Inventory,and a symptoms questionnaire),showed no significant changes between morning vs bedtime intake of levothyroxine. CONCLUSIONS: Levothyroxine taken at bedtime significantly improved thyroid hormone levels. Quality-of-life variables and plasma lipid levels showed no significant changes with bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN17436693 (NTR959).","Bolk,N.,et al. (2010). \"Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.\" Arch Intern Med 170(22): 1996-2003.","Netherlands",2010,"Endocrine","Other Drugs","MFI"]
[30,"Bonner,A.,et al. (2013). \"Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study.\" Nurs Health Sci 15(3): 360-367.",null,"Bonner,A.,et al.","Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study","In this study we investigated the relationship between health-related quality of life,fatigue,and activity levels of people with anemia secondary to chronic kidney disease over a 12 month period following the introduction of an erythropoietin-stimulating agent. Using a longitudinal repeated-measure design,28 people with chronic kidney disease completed the Short Form-36 Health Survey,Human Activity Profile and Fatigue Severity Scale at the commencement of an erythropoietin-stimulating agent,and then at 3,6,and 12 months. Over a 12 month period,a significant change was found for health-related quality of life in relation to role-physical,vitality,mental health/emotional well-being,and overall mental health. However,activity levels did not significantly improve during that time. Renal nurses in dialysis units and chronic kidney disease outpatient clinics have repeated and frequent contact with people with chronic kidney disease over long periods of time,and are in an ideal position to routinely assess fatigue and activity levels and to institute timely interventions to optimize health-related quality of life and independent activity.","Bonner,A.,et al. (2013). \"Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study.\" Nurs Health Sci 15(3): 360-367.","Australia",2013,"Hematological","None","FSS"]
[31,"Boosman,H.,et al. (2011). \"Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study.\" Disabil Rehabil 33(8): 690-696.",null,"Boosman,H.,et al.","Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study","PURPOSE: An intervention for persons with neuromuscular diseases (NMD) or multiple sclerosis (MS) who experienced severe fatigue was developed which aimed at educating participants in maintaining a balance between capacity and load in their daily activities. This pilot study evaluated the results of this intervention. METHODS: Persons with NMD or MS who experienced severe fatigue were included. Outcome measures were: fatigue (Fatigue Severity Scale),health-related quality of life (HRQoL; SF-36) and self-efficacy (ALCOS-16). Changes in scores between the start of the intervention (T0) and 3 months post-intervention (T1) were tested with the Wilcoxon tests in the complete group and in subgroups (gender,education,high/low self-efficacy). RESULTS: Forty-three persons participated. Significant improvements of HRQoL were found for the domains role-physical,mental health and general health perceptions. Subgroup analyses showed more improvement in males (fatigue,role-physical,vitality,bodily pain,general health perceptions),participants with lower education (role-physical,vitality) and participants with low self-efficacy at T0 (self-efficacy,mental health,general health perceptions) than in females,participants with higher education and participants with higher initial self-efficacy. CONCLUSION: This pilot-study provides preliminary evidence for the effectiveness of a group educational intervention in improving HRQoL without increasing fatigue in persons with NMD and MS.","Boosman,H.,et al. (2011). \"Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study.\" Disabil Rehabil 33(8): 690-696.","Netherlands",2011,"Neurological","None","FSS"]
[32,"Bredemeier,M.,et al. (2014). \"Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis.\" Arthritis Care Res (Hoboken) 66(2): 228-235.",null,"Bredemeier,M.,et al.","Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis","OBJECTIVE: The approved dose of rituximab (RTX) for rheumatoid arthritis (RA) is 2 x 1,000 mg infusions given 2 weeks apart. There is contradictory evidence regarding the effectiveness of a lower-dose regimen (2 x 500 mg) of RTX. Our aim was to compare the efficacy and safety of low- and high-dose RTX and to test the noninferiority of the low-dose regimen. METHODS: A systematic literature review searching for randomized controlled trials (RCTs) and cohort studies comparing low- and high-dose RTX for RA was conducted using the Embase,PubMed,Cochrane Library,and Web of Science databases. The primary end points were the American College of Rheumatology criteria for 20% improvement (ACR20),ACR50,and ACR70 responses and the Disease Activity Score in 28 joints (DAS28) at 24 and 48 weeks. The secondary end points were patient-reported outcomes (PROs; Health Assessment Questionnaire,Short Form 36,and Functional Assessment of Chronic Illness Therapy-Fatigue scores) and adverse events. Noninferiority of low-dose RTX was tested using different approaches,one of which was based on the fixed margin method. RESULTS: In total,6 RCTs and 2 cohort studies were identified. Four RCTs were included in the meta-analysis of efficacy outcomes,which showed no significant differences in the primary outcomes between low- and high-dose RTX. Noninferiority criteria of low-dose RTX were met for the ACR20,ACR50,DAS28,and PROs (at 24 and 48 weeks). Serious adverse events did not differ significantly. The results of 2 additional RCTs and a meta-analysis of 2 cohort studies corroborated the results of the meta-analysis of RCTs. CONCLUSION: Low-dose RTX has similar effectiveness and met noninferiority criteria for most primary outcomes. Considering the lower cost,it should be the standard RTX regimen for RA.","Bredemeier,M.,et al. (2014). \"Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis.\" Arthritis Care Res (Hoboken) 66(2): 228-235.","Brazil",2014,"Musculoskeletal","Rituximab","FACIT-F"]
[33,"Breitbart,W.,et al. (2001). \"A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease.\" Arch Intern Med 161(3): 411-420.",null,"Breitbart,W.,et al.","A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease","BACKGROUND: Fatigue is a commonly encountered symptom of human immunodeficiency virus (HIV) disease,associated with significant psychological and functional morbidity and poor quality of life. Preliminary studies on the treatment of fatigue from the cancer and multiple sclerosis literature suggest that psychostimulants may be effective in reducing fatigue. OBJECTIVE: To compare the efficacy of 2 psychostimulant medications,methylphenidate hydrochloride (Ritalin) and pemoline (Cylert),with a placebo intervention for the treatment of fatigue in patients with HIV disease. METHODS: In this double-blind trial,144 ambulatory patients with HIV disease and persistent and severe fatigue were randomized to treatment with methylphenidate,pemoline,or placebo. Medications were titrated up to a maximum dose of 60 mg of methlyphenidate hydrochloride,150 mg of pemoline,or 8 capsules of placebo daily. Fatigue was measured using 2 self-reported rating scales,the Piper Fatigue Scale (PFS) and the Visual Analogue Scale for Fatigue (VAS-F). We also used the timed isometric unilateral straight leg-raising task,a measure of muscular endurance. Quality-of-life and psychological well-being measures included the Beck Depression Inventory,the Brief Symptom Inventory,and the 36-Item Short-Form Medical Outcomes Study Health Status Survey. Side effects were monitored using the Systematic Assessment for Treatment Emergent Events and the Extra-pyramidal Symptom Rating Scale. All measures were rated weekly. RESULTS: One hundred nine subjects completed the 6-week trial; 15 patients (41%) receiving methylphenidate and 12 patients (36%) receiving pemoline demonstrated clinically significant improvement compared with 6 patients (15%) receiving placebo. Patients receiving methylphenidate or pemoline demonstrated significantly more improvement in fatigue on several self-reported rating scales (PFS total score,P=.04; affective subscale,P=.008; sensory subscale,P=.04; and VAS-F energy subscale,P=.02). Analysis of the regression slopes by means of hierarchical linear modeling demonstrated a significantly greater rate of improvement in PFS total scores among patients receiving psychostimulants compared with the placebo group (P=.02). There were no significant differences in the efficacy between methlyphenidate and pemoline on any outcome measure studied. Improvement in fatigue was also significantly correlated with improvement in measures of depression,psychological distress,and overall quality of life. Severe side effects were relatively uncommon among this sample,and only hyperactivity or jitteriness occurred significantly more often among subjects receiving active medication. CONCLUSIONS: Many patients with HIV- and acquired immunodeficiency syndrome-unrelated fatigue respond favorably to treatment with methylphenidate or pemoline. Both psychostimulants appear to be equally effective and significantly superior to placebo in decreasing fatigue severity with minimal side effects. Moreover,improvement of fatigue was significantly associated with improved quality of life and decreased levels of depression and psychological distress.","Breitbart,W.,et al. (2001). \"A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease.\" Arch Intern Med 161(3): 411-420.","USA",2001,"Infectious Disease","Other Drugs","PFS,VAS-F"]
[34,"Breslin,E.,et al. (1998). \"Perception of fatigue and quality of life in patients with COPD.\" Chest 114(4): 958-964.",null,"Breslin,E.,et al.","Perception of fatigue and quality of life in patients with COPD","INTRODUCTION: Although dyspnea is considered the primary activity-limiting symptom in patients with COPD,other symptoms,such as fatigue,are frequently reported. The purpose of this study was to determine the relationship between fatigue and pulmonary function,exercise tolerance,depression,and quality of life in patients with COPD. METHODS: Forty-one patients (age = 62+/-8 years; FEV1 = 1.08+/-0.55 L; FEV1 percent predicted = 35.8+/-17%) from two sites participated in the study. Spirometric measures of pulmonary function were carried out in each patient. The Multidimensional Fatigue Inventory was used to measure five subscales of fatigue: general,physical and mental fatigue,reduction in activity,and reduction in motivation. The St. George Respiratory Questionnaire,used to measure quality of life,has three subscale dimensions (symptom,activity,and impact),as well as an overall or total quality of life score. Depression was measured with the Centers of Epidemiological Studies Depression Scale. In 19 patients,exercise tolerance was determined with the 6-min walking distance. RESULTS: General fatigue correlated with FEV1,percent predicted (r = -0.32,p < 0.05),exercise tolerance (r = -0.55,p < 0.05),depression (r = 0.44,p < 0.01),and overall quality of life (r = 0.75,p < 0.01). Among the dimensions of fatigue,depression correlated with general and mental fatigue only. Physical dimensions of fatigue correlated with an increase in the severity of pulmonary impairment and reduction in exercise tolerance. The cognitive components of fatigue,such as reduction in motivation and mental fatigue,were not found to be highly correlated with physical dimensions of quality of life. All five subscales of fatigue showed relationship to the functional impact dimension and total impairment score in quality of life. CONCLUSIONS: These data show a relationship between dimensions of fatigue and pulmonary function,exercise tolerance,and quality of life in COPD. Based on these results,fatigue is an important symptom requiring evaluation and management in patients with COPD. These data clarified also the relationship between depression and fatigue in this patient population.","Breslin,E.,et al. (1998). \"Perception of fatigue and quality of life in patients with COPD.\" Chest 114(4): 958-964.","USA",1998,"Respiratory Disease","Psychobehavioural","MFI"]
[35,"Brix, C., et al. (2008). \"The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer.\" J Psychosom Res 65(6): 541-548.",null,"Brix, C., et al.","The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer","OBJECTIVE: The primary goal of this study was to examine the need for psychosocial support in a consecutive sample of cancer patients undergoing radiotherapy (RT). Out of an initial sample of 250 patients, 239 patients could be assessed at the beginning of their RT. Two hundred eight patients were reassessed at the end of RT 4-8 weeks later. METHODS: Measures comprised the Hornheide Screening Instrument, the Multidimensional Fatigue Inventory, the Resilience Scale, and the Short Form 12 as a measure of health-related quality of life (QoL). Medical and radiological data were continuously registered. RESULTS: Within the sample, the need for psychosocial support as reflected in the screening instrument was high (>70%). Patients with the need for psychosocial support revealed significantly higher fatigue scores than patients who where not identified as needing psychosocial support. Furthermore, a negative correlation of the need for psychosocial support and QoL as well as resilience could be observed. QoL turned out to be the strongest predictor for the need of psychosocial support. CONCLUSION: The study confirmed that the need for psychosocial support is an important aspect in the treatment of cancer patients undergoing RT, which appeared to be powerfully predicted by the patients' health-related QoL. Fatigue turned out to be an important illness- and treatment-related factor that affects QoL. Psychological interventions for cancer patients should explicitly focus on decreasing patients' fatigue and increasing their resilience, thus improving their QoL.","Brix, C., et al. (2008). \"The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer.\" J Psychosom Res 65(6): 541-548.","Germany",2008,"Cancer","Cancer treatments","MFI"]
[36,"Brodsky, R. A., et al. (2008). \"Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria.\" Blood 111(4): 1840-1847.",null,"Brodsky, R. A., et al.","Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria","The terminal complement inhibitor eculizumab was recently shown to be effective and well tolerated in patients with paroxysmal nocturnal hemoglobinuria (PNH). Here, we extended these observations with results from an open-label, non-placebo-controlled, 52-week, phase 3 clinical safety and efficacy study evaluating eculizumab in a broader PNH patient population. Eculizumab was administered by intravenous infusion at 600 mg every 7 +/- 2 days for 4 weeks; 900 mg 7 +/- 2 days later; followed by 900 mg every 14 +/- 2 days for a total treatment period of 52 weeks. Ninety-seven patients at 33 international sites were enrolled. Patients treated with eculizumab responded with an 87% reduction in hemolysis, as measured by lactate dehydrogenase levels (P < .001). Baseline fatigue scores in the FACIT-Fatigue instrument improved by 12.2 +/- 1.1 points (P < .001). Eculizumab treatment led to an improvement in anemia. The increase in hemoglobin level occurred despite a reduction in transfusion requirements from a median of 8.0 units of packed red cells per patient before treatment to 0.0 units per patient during the study (P < .001). Overall, transfusions were reduced 52% from a mean of 12.3 to 5.9 units of packed red cells per patient. Forty-nine patients (51%) achieved transfusion independence for the entire 52-week period. Improvements in hemolysis, fatigue, and transfusion requirements with eculizumab were independent of baseline levels of hemolysis and degree of thrombocytopenia. Quality of life measures were also broadly improved with eculizumab treatment. This study demonstrates that the beneficial effects of eculizumab treatment in patients with PNH are applicable to a broader population of PNH patients than previously studied. This trial is registered at http://clinicaltrials.gov as NCT00130000.","Brodsky, R. A., et al. (2008). \"Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria.\" Blood 111(4): 1840-1847.","USA",2008,"Hematological","Eculizumab","FACIT-F"]
[37,"Bruce, I. N., et al. (1999). \"Factors associated with fatigue in patients with systemic lupus erythematosus.\" Ann Rheum Dis 58(6): 379-381.",null,"Bruce, I. N., et al.","Factors associated with fatigue in patients with systemic lupus erythematosus","OBJECTIVE: To examine the relation between fatigue, disease activity, damage, and quality of life measures in patients with systemic lupus erythematosus (SLE). METHODS: Consecutive patients attending the University of Toronto Lupus Clinic were studied. Disease activity was assessed using the SLEDAI and SLAM-R and damage using the SLICC/ACR Damage index. Fatigue was measured by the Fatigue Severity Score (FSS) and health status by the SF-36 questionnaire. In all cases a tender point count was also performed. RESULTS: 81 patients were studied. Their mean (SD) age and disease duration were 43 (12.5) years and 12.7 (8.0) years respectively. The FSS did not correlate with the SLEDAI nor with the SLAM-R. There was no correlation with the SLICC damage index. Fatigue severity correlated with the tender point count (SCC r=0.46, p<0.001), and negatively with all domains of the SF36 (r values -0.50 to -0.82). Disease activity and damage accounted for only 4.8% and 4% respectively of the variance in fatigue severity reported by patients. CONCLUSION: In an outpatient population of SLE patients, fatigue severity correlates with poor health status and a higher tender point count. In patients with SLE, factors associated with quality of life and fibromyalgia seem to have a greater influence on the severity of reported fatigue than does the level of current disease activity.","Bruce, I. N., et al. (1999). \"Factors associated with fatigue in patients with systemic lupus erythematosus.\" Ann Rheum Dis 58(6): 379-381.","Canada",1999,"Inflamatory Systemic Disease","None","FSS"]
[38,"Bruera, E., et al. (1998). \"Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study.\" Cancer Prev Control 2(2): 74-78.",null,"Bruera, E., et al.","Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study","PURPOSE: To evaluate the effect of megestrol acetate at a lower dose than previously investigated on the symptoms of cachexia in patients with advanced cancer. METHODS: A total of 84 patients with advanced, solid tumours not responsive to hormone therapy were enrolled in this double-blind, crossover study. During phase 1, patients were randomly assigned to receive megestrol acetate (160 mg 3 times daily) for 10 days or placebo. During phase 2, after a 2-day washout period, patients received the alternate treatment for 10 days. Patients underwent daily assessments of activity, nausea, appetite and well-being by means of a visual analogue scale (VAS). In addition, nutritional status (weight, tricep skinfold measure, arm muscle circumference), energy intake, fatigue (Piper Fatigue Scale) and quality of life (Functional Living Index-Cancer [FLIC]) were assessed. RESULTS: Among the 53 evaluable patients megestrol acetate resulted in a significant improvement in appetite (p = 0.005), activity (p = 0.007) and well-being (p = 0.03). There was no significant change in the intensity of nausea, nutritional parameters, energy intake or FLIC scores. There was a significant improvement in 2 of the 3 factors measured by the Piper Fatigue Scale and in the overall fatigue score. Upon completion of the study, while still blind to the treatment condition, 30 patients indicated that they felt better overall after megestrol, 15 said they felt better after placebo, and 10 indicated no preference (p = 0.001). CONCLUSION: Treatment with megestrol acetate results in rapid and significant improvement of symptoms in terminally ill patients at lower doses than previously reported. The effects are not secondary to nutritional changes. The FLIC quality-of-life questionnaire was unable to detect these changes.","Bruera, E., et al. (1998). \"Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study.\" Cancer Prev Control 2(2): 74-78.","USA",1998,"Cancer","Other Drugs","VAS-F,PFS"]
[39,"Brusse, I. A., et al. (2016). \"Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life.\" PLoS One 11(5): e0155299.",null,"Brusse, I. A., et al.","Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life","OBJECTIVES: To compare electroencephalography (EEG) findings during pregnancy and postpartum in women with normotensive pregnancies and pregnancies complicated by hypertensive disorders. Also the health related quality of life postpartum was related to these EEG findings. MATERIALS AND METHODS: An observational case-control study in a university hospital in the Netherlands. Twenty-nine normotensive and 58 hypertensive pregnant women were included. EEG's were recorded on several occasions during pregnancy and 6-8 weeks postpartum. Postpartum, the women filled out health related quality of life questionnaires. Main outcome measures were qualitative and quantitative assessments on EEG, multidimensional fatigue inventory, Short Form (36) Health Survey and EuroQoL visual analogue scale. RESULTS: In women with severe preeclampsia significantly lower alpha peak frequency, more delta and theta activity bilaterally and a higher EEG Sum Score were seen. Postpartum, these women showed impaired mental health, mental fatigue and social functioning, which could not be related to the EEG findings. CONCLUSIONS: Severe preeclamptic patients show more EEG abnormalities and have impaired mental wellbeing postpartum, but these findings are not correlated.","Brusse, I. A., et al. (2016). \"Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life.\" PLoS One 11(5): e0155299.","Netherlands",2016,"Various","None","MFI"]
[40,"Buss, T., et al. (2014). \"Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients.\" J Pain Symptom Manage 48(4): 730-737.",null,"Buss, T., et al.","Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients","CONTEXT: Multidimensional questionnaires estimating cancer-related fatigue (CRF) as a symptom cluster or a clinical syndrome primarily have been used and validated in English-speaking populations. However, cultural issues and language peculiarities can affect CRF assessment OBJECTIVES: The main aims of this study were to evaluate the psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 (MFI-20) and to deliver to clinicians a multidimensional tool for CRF assessment in Polish-speaking patients with cancer. METHODS: After forward-backward translation procedures, the Polish version of MFI-20 was administered to 340 cancer patients. The Polish MFI-20 was appraised in terms of acceptability, reliability, and validity. Internal consistency was assessed by calculating Cronbach's alpha coefficients. Structural validity was evaluated with confirmatory factor analysis. RESULTS: The translated MFI-20 was well accepted; 90% of subjects fully completed the questionnaire. The overall Cronbach's alpha coefficient was 0.9, ranging from 0.57 to 0.81. All correlation coefficients among Numeric Rating Scale-fatigue, fatigue-related items from the European Organization for Research and Treatment of Cancer Quality of Life Core-30 questionnaire, and the MFI--20 were statistically significant (P < 0.001). Confirmatory factor analysis demonstrated good structural validity and revealed only three dimensions in the Polish version of the MFI-20-physical and mental fatigue as well as reduced motivation. CONCLUSION: The Polish version of the MFI-20 is well accepted by patients, reliable, and a valid instrument to assess CRF in Polish cancer patients.","Buss, T., et al. (2014). \"Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients.\" J Pain Symptom Manage 48(4): 730-737.","Poland",2014,"Cancer","None","MFI"]
[41,"Butt, Z., et al. (2013). \"Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.\" J Psychosom Res 74(1): 64-68.",null,"Butt, Z., et al.","Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale","OBJECTIVE: Given the importance of fatigue in cancer, stroke and HIV, we sought to assess the measurement properties of a single, well-described fatigue scale in these populations. We hypothesized that the psychometric properties of the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale would be favorable and that the scale could serve as a useful indicator of fatigue in these populations. METHODS: Patients were eligible for the study if they were outpatients, aged 18 or older, with a diagnosis of cancer (n=297), stroke (n=51), or HIV/AIDS (n=51). All participants were able to understand and speak English. Patients answered study-related questions, including the FACIT-F using a touch-screen laptop, assisted by the research assistant as necessary. Clinical information was abstracted from patients' medical records. RESULTS: Item-level statistics on the FACIT-F were similar across the groups and internal consistency reliability was uniformly high (alpha>0.91). Correlations with performance status ratings were statistically significant across the groups (range r=-0.28 to -0.80). Fatigue scores were moderately to highly correlated with general quality of life (range r=0.66-0.80) in patients with cancer, stroke, and HIV. Divergent validity was supported in low correlations with variables not expected to correlate with fatigue. CONCLUSIONS: Originally developed to assess cancer-related fatigue, the FACIT-F has utility as a measure of fatigue in other populations, such as stroke and HIV. Ongoing research will soon allow for comparison of FACIT-F scores to those obtained using the fatigue measures from the Patient-Reported Outcomes Measurement Information System (PROMIS(R); www.nihpromis.org) initiative.","Butt, Z., et al. (2013). \"Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.\" J Psychosom Res 74(1): 64-68.","USA",2013,"Cancer","None","FACIT-F"]
[42,"Buttgereit, F., et al. (2013). \"Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).\" Ann Rheum Dis 72(2): 204-210.",null,"Buttgereit, F., et al.","Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)","OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","Buttgereit, F., et al. (2013). \"Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).\" Ann Rheum Dis 72(2): 204-210.","Germany",2013,"Musculoskeletal","Other Drugs","FACIT-F"]
[43,"Buyuktas, D., et al. (2015). \"Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey.\" Clin Exp Rheumatol 33(6 Suppl 94): S107-112.",null,"Buyuktas, D., et al.","Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey","OBJECTIVES: Fatigue is an important problem in inflammatory diseases and affects the quality of life (QoL). We aimed to evaluate the severity and impact of fatigue in Behcet's syndrome (BS) and to determine its association with type of organ involvement and gender. METHODS: One hundred and fifty-two BS, 51 rheumatoid arthritis (RA), 51 systemic lupus erythematosus (SLE), 51 ankylosing spondylitis (AS) patients and 65 healthy controls were evaluated by the fatigue severity scale, fatigue impact scale, fibromyalgia impact questionnaire (FIQ), RAPID3, SF-36 and Behcet's syndrome activity scale (the latter only in BS patients). We also analysed subgroups of BS patients with predominantly eye, vascular, joint and mucocutaneous involvement and did an additional gender analysis. RESULTS: Fatigue severity and fatigue impact scores were similar among BS, RA, SLE and AS patients and significantly higher than that in healthy controls (F4df=8.51; p<0.001 and F4df=8.67; p<0.001, respectively). The fatigue severity and fatigue impact scores were similarly high in BS subgroups with different types of organ involvement, and in both genders. CONCLUSIONS: Fatigue is an important problem in BS, as it is in other inflammatory conditions. It is similarly severe in subgroups of patients with eye, vascular, joint and mucocutaneous involvement and in either gender. Fatigue is a candidate outcome measure for clinical trials, to assess the life impact of Behcet's syndrome.","Buyuktas, D., et al. (2015). \"Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey.\" Clin Exp Rheumatol 33(6 Suppl 94): S107-112.","Turkey",2015,"Inflamatory Systemic Disease","None","FSS,FIS"]
[44,"Cakt, B. D., et al. (2010). \"Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study.\" Am J Phys Med Rehabil 89(6): 446-457.",null,"Cakt, B. D., et al.","Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study","OBJECTIVE: To evaluate the effects of cycling progressive resistance training combined with balance exercises on walking speed, balance, fatigue, fear of falling, depression, and quality of life in patients with multiple sclerosis. DESIGN: In this prospective randomized controlled trial, 45 patients were randomized into two exercise training (n = 30) groups and one control (n = 15) group. The patients in training group 1 (n = 15) underwent progressive resistance training on a bicycle ergometer and balance exercise, whereas group 2 (n = 15) patients received a home-based lower-limb strengthening and balance exercise. Outcome measures, including the duration of exercise, tolerated maximum workload, timed up and go test, Dynamic Gait Index, functional reach, Falls Efficacy scale, 10-m walk test, Fatigue Severity Scale, Beck Depression Inventory, and Short Form 36 scores, were assessed initially and at 8 wks. RESULTS: After dropouts, the whole study group consisted of 20 women and 13 men (mean age, 37.9 +/- 10.43 yrs). In training group 1, duration of exercise, tolerated maximum workload, timed up and go test, Dynamic Gait Index, functional reach, falls efficacy scale, 10-m walk test, Fatigue Severity scale, and Beck Depression Inventory scores, and in group 2, the mean duration of exercise, tolerated maximum workload, and Falls Efficacy scale scores were significantly improved after the training program (P < 0.05). There were no significant improvements in any of the outcome measurements in the control group (P > 0.05). In between-group comparisons, improvements in outcome measures of group 1 patients were significantly higher than those in other groups, except for 10-m walking test. Group 1 patients showed statistically significant improvement in physical functioning and role-physical functioning scales of the Short Form 36 (P < 0.01 and P < 0.05, respectively), and group 2 patients showed statistically significant improvement in only physical functioning scale of Short Form 36 (P < 0.05) after 8 wks. CONCLUSIONS: Specific exercise programs, including cycling progressive resistance training, may improve balance, fatigue, and depression and reduce fear of falling in patients with multiple sclerosis without worsening multiple sclerosis signs and symptoms.","Cakt, B. D., et al. (2010). \"Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study.\" Am J Phys Med Rehabil 89(6): 446-457.","Turkey",2010,"Neurological","Psychobehavioural","FSS"]
[45,"Calik-Kutukcu, E., et al. (2014). \"A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study.\" BMC Pulm Med 14: 6.",null,"Calik-Kutukcu, E., et al.","A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study","BACKGROUND: Chronic obstructive pulmonary disease (COPD) has significant systemic effects that substantially impact quality of life and survival. The purpose of this study was to assess and compare peripheral muscle strength and endurance, exercise capacity, fatigue perception and quality of life between patients with COPD and healthy subjects. METHODS: Twenty COPD patients (mean FEV1 49.3 +/- 19.2%) and 20 healthy subjects were included in the study. Pulmonary function testing and six-minute walk test (6MWT) were performed. Peripheral muscle strength was measured with a hand-held dynamometer, peripheral muscle endurance was evaluated with sit-ups, squats and modified push-ups tests. Fatigue perception was assessed using the Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS). General quality of life was determined with the Nottingham Health Profile (NHP), and cough-specific quality of life was evaluated with the Leicester Cough Questionnaire (LCQ). RESULTS: Pulmonary functions, strength of shoulder abductor and flexor muscles, numbers of sit-ups and squats, 6MWT distance and 6MWT% were significantly lower in COPD patients than in healthy subjects (p < 0.05). FIS psychosocial sub-dimension and total scores, NHP scores for all sub-dimensions except pain sub-dimension of the COPD group were significantly higher than those of healthy subjects (p < 0.05). The LCQ physical, psychological and social sub-dimensions and total scores were significantly lower in COPD patients than in healthy subjects (p < 0.05). CONCLUSIONS: Pulmonary functions, peripheral muscle strength and endurance, exercise capacity and quality of life were adversely affected in patients with COPD. There are greater effect of fatigue on psychosocial functioning and general daily life activities and effect of cough on the quality of life in patients with COPD. This study supports the idea that COPD patients must be evaluated in a comprehensive manner for planning pulmonary rehabilitation programs.","Calik-Kutukcu, E., et al. (2014). \"A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study.\" BMC Pulm Med 14: 6.","Turkey",2014,"Respiratory Disease","None","FIS,FSS"]
[46,"Calkwood, J., et al. (2014). \"Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.\" BMC Neurol 14: 220.",null,"Calkwood, J., et al.","Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial","BACKGROUND: The Evaluate Patient OutComes (EPOC) study assessed physician- and patient-reported outcomes in individuals with relapsing multiple sclerosis who switched directly from injectable disease-modifying therapy (iDMT; glatiramer acetate, intramuscular or subcutaneous interferon beta-1a, or interferon beta-1b) to once-daily, oral fingolimod. Post hoc analyses evaluated the impact of a switch to fingolimod versus staying on each of the four individual iDMTs. METHODS: Overall, 1053 patients were randomized 3:1 to switch to fingolimod or remain on iDMT. The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score. Secondary endpoints included changes in scores for TSQM Effectiveness, Side Effects and Convenience subscales, Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Activities, 36-item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) and mean investigator-reported Clinical Global Impressions of Improvement (CGI-I). All outcomes were evaluated after 6 months of treatment. RESULTS: Changes in TSQM Global Satisfaction scores were superior after a switch to fingolimod when compared with scores in patients remaining on any of the iDMTs (all p <0.001). Likewise, all TSQM subscale scores improved following a switch to fingolimod (all p <0.001), except when compared with glatiramer acetate for the TSQM Side Effects subscale (p = 0.111). FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; p = 0.030 and p = 0.022, respectively) and subcutaneous interferon beta-1a (PCS only; p = 0.024). Mean CGI-I scores were superior with fingolimod when compared with continuing treatment with any of the iDMTs (all p <0.001). CONCLUSIONS: After 6 months, a switch to fingolimod showed superiority compared with remaining on each iDMT for a range of patient- and physician-reported outcomes, including global satisfaction with treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01216072 .","Calkwood, J., et al. (2014). \"Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.\" BMC Neurol 14: 220.","USA",2014,"Neurological","Fingolimod,Other Drugs","FSS"]
[47,"Casellas, F., et al. (2012). \"Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease.\" Eur J Gastroenterol Hepatol 24(7): 762-769.",null,"Casellas, F., et al.","Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease","BACKGROUND: Inflammatory bowel disease (IBD) is a debilitating immune disorder that impairs function and health-related quality of life (HRQOL). A goal of IBD treatment is mucosal healing, but it is not known whether it achieves normalization of the patients' perception of health. This can be assessed by using a cut-off scoring threshold of the Inflammatory Bowel Disease Questonnaire-36 (IBDQ-36). AIMS: To determine whether patients with Crohn's disease (CD) and ulcerative colitis (UC) in clinical remission and with mucosal healing normalize their HRQOL. METHODS: This is a multicentric, prospective, observational, cross-sectional study of patients who are in stable clinical remission and having mucosal healing. Patients completed the IBDQ-36, the EuroQol-5D, and the Daily Fatigue Impact Scale fatigue questionnaires. Complete restoration of health was believed to have occurred when the global score in the IBDQ-36 was at least 209 points. RESULTS: A total of 115 patients (48 with CD, 67 with UC) were included. The median activity index (the Harvey-Bradshaw or the colitis activity index) was 1.0 and the median endoscopic index (Simple Endoscopic Score for Crohn's disease or Mayo) was 0. Eighty percent of the patients (79% in CD and 82% in UC patients, P=NS) normalized their HRQOL. Type of treatment was not related to normalization of HRQOL. The lack of restoration of health was significantly related to fatigue and anxiety/depression. CONCLUSION: Mucosal healing is associated with a normalization of the perception of health by most IBD patients independently of treatment. However, a significant group of patients do not achieve restoration of HRQOL, which reinforces the necessity of a global care addressed to all patient concerns to achieve patients' complete health restoration.","Casellas, F., et al. (2012). \"Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease.\" Eur J Gastroenterol Hepatol 24(7): 762-769.","Spain",2012,"Gastrointestinal","None","DFIS"]
[48,"Casellas, F., et al. (2013). \"Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease.\" Rev Esp Enferm Dig 105(10): 585-593.",null,"Casellas, F., et al.","Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease","INTRODUCTION: celiac disease is a chronic condition that requires continued treatment, with the resultant impact on health-related quality of life (HRQOL) of people who suffer it. Most studies in this field have used generic questionnaires to measure HRQOL in celiac patients. It was therefore decided to conduct a study to translate into Spanish and validate a specific questionnaire for celiac disease, the Celiac Disease Quality Of Life Survey (CD-QOL). OBJECTIVES: to translate and validate in Spanish the specific celiac disease questionnaire CD-QOL. METHODS: a multicenter, prospective, observational study was designed consisting of two phases: In the first phase, the questionnaire was translated and adapted into Spanish using the translation/back translation procedure and an understandability study. In the second phase, internal consistency of the translated questionnaire was analyzed. For this, results of the CD-QOL were compared to those of EuroQol and the Daily Fatigue Impact Scale (D-FIS). Understandability of the translated and adapted questionnaire was tested in six patients, and the validation study was done in 298 celiac patients (201 treated with a gluten-free diet and 97 at diagnosis). RESULTS: in both celiac groups, Cronbach s alpha coefficient was high (0.90), feasibility was excellent (99.2 % of patients completed all questions), and there were no ceiling and floor effects. Spearman correlation to EuroQol and D-FIS was statistically significant (p < 0.05). CD-QOL score was different depending on whether state of health was good, fair, or poor based on the EuroQol score. CONCLUSION: the Spanish version of the CD-QOL is a valid tool for measuring HRQOL in celiac patients.","Casellas, F., et al. (2013). \"Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease.\" Rev Esp Enferm Dig 105(10): 585-593.","Unknown",2013,"Gastrointestinal","None","DFIS"]
[49,"Catania, G., et al. (2013). \"Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI).\" Support Care Cancer 21(2): 413-419.",null,"Catania, G., et al.","Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI)","PURPOSE: Cancer-related fatigue (CRF) is one of the most common symptoms experienced by cancer patients (CPs). The Brief Fatigue Inventory (BFI) is a reliable instrument to assess CRF in CPs. The aim of this study was to evaluate the psychometric properties of the Italian version of the BFI (BFI-I). METHODS: The BFI-I was developed by using the forward-backward translation approach. The psychometric properties of the BFI-I were assessed in terms of acceptability, internal consistency, and validity. Outpatient CPs filled in BFI-I along with the Medical Outcome Study Quality of Life Short Form 36 (SF36). Demographic and health data were collected. RESULTS: The BFI-I had an overall Cronbach alpha for the nine items of 0.94. The inter-item mean correlation was 0.64, and coefficients ranged from 0.47 to 0.81 for the nine items. The results of the factor analysis suggested a 1-factor solution explaining 68 % of the variance, supporting the hypothesis of unidimensionality of the BFI-I. The BFI-I score was compared to SF36 subscales score to evaluate concurrent validity. An expected inverse correlation between the BFI-I and the vitality subscale of the SF36 was observed (r = -0.67, 95 % confidence interval -0.73 to -0.59). The correlation with the other subscales of the SF36 ranged between -0.56 and -0.13. Discriminant validity analysis showed the BFI-I mean score significantly increased with increasing Eastern Cooperative Oncology Group values (p < 0.001). CONCLUSIONS: BFI-I is a clinical instrument with satisfactory psychometric properties to assess CRF in Italian CPs.","Catania, G., et al. (2013). \"Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI).\" Support Care Cancer 21(2): 413-419.","Italy",2013,"Cancer","None","BFI"]
[50,"Cella, D. (1998). \"Factors influencing quality of life in cancer patients: anemia and fatigue.\" Semin Oncol 25(3 Suppl 7): 43-46.",null,"Cella, D.","Factors influencing quality of life in cancer patients: anemia and fatigue","Anemia is a multi-symptom syndrome involving both physical and emotional problems that can be evaluated for their impact on quality of life. Fatigue is the cardinal symptom of anemia, reported by three of four cancer patients using the general version of the Functional Assessment of Cancer Therapy (FACT-G) questionnaire. A subscale of the FACT-G, consisting of the FACT-Fatigue (FACT-F) and the FACT-Anemia (FACT-An), has been developed to specifically address this problem. The FACT-F is comprised of the FACT-G plus 13 questions related to fatigue, while the FACT-An is comprised of the FACT-F plus an additional set of seven miscellaneous (non-fatigue) questions relevant to anemia in cancer patients. The FACT-An subscale was initially validated in a cohort of 50 cancer patients. Tests of internal consistency and stability confirmed the reliability of the fatigue component, as well as that of the FACT-G (27 items), the FACT-F (FACT-G plus 13 fatigue items), and the FACT-An (FACT-G plus 20 anemia subscale items) measurement systems. Quality of life scores on these FACT scales significantly decline as patient performance status worsens, and the scales correlate well with other questionnaires (Profile of Mood States and Piper Fatigue Scale) purported to measure the same thing. The scores on the FACT-An subscale also clearly differentiate between patients with low and high hemoglobin levels. Low hemoglobin levels are associated with greater fatigue, poorer overall quality of life, and decreased ability to work (beyond that related directly to fatigue). Interventions that reverse fatigue and other anemia-related symptoms should have a positive effect on quality of life.","Cella, D. (1998). \"Factors influencing quality of life in cancer patients: anemia and fatigue.\" Semin Oncol 25(3 Suppl 7): 43-46.","USA",1998,"Hematological","None","FACT-F"]
[51,"Cerulli, C., et al. (2014). \"Therapeutic horseback riding in breast cancer survivors: a pilot study.\" J Altern Complement Med 20(8): 623-629.",null,"Cerulli, C., et al.","Therapeutic horseback riding in breast cancer survivors: a pilot study","PURPOSE: To evaluate the physiologic and psychological effects of an equine-assisted therapy protocol (EAT) in breast cancer survivors. METHODS: Twenty women (mean age, 45.61+/-2.71 years) whose breast cancer treatment had concluded at least 6 months previously underwent a screening protocol to certify their eligibility to participate in noncompetitive sports. The patients were randomly assigned to an intervention group (n=10) or a control group (n=10). Intervention patients participated in a 16-week EAT protocol consisting of 2 hours of activity per week. All patients were tested before and after the intervention for maximal oxygen consumption (VO2max), fat mass percentage, total body water percentage, strength of principal muscular groups (measured on five weight-lifting machines [leg press, leg extension, leg curl, shoulder press, vertical traction]), and quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F). RESULTS: After intervention, the intervention group showed an improvement in VO2max (28.29%; p<.001), a decrease in fat mass percentage (change, -7.73%; p<0.002), an increase in total body water percentage (6.90%; p=0.027), and an increase in strength (leg press, 17.75% [p=0.018]; leg extension, 21.55% [p=0.005]; leg curl, 26.04% [p<0.001]; shoulder press, 49.72% [p=0.003]; vertical traction, 19.27% [p=0.002]). Furthermore, the increase in the three FACIT-F scores (FACIT-F trial outcome: 9.29% [p=0.010]; Functional Assessment of Cancer Therapy-General total score, 14.80% [p=0.022]; FACIT-F total score, 11.48% [p=0.004]) showed an increase in quality of life. No significant changes for any variable were found for the control group. CONCLUSIONS: EAT had positive effects on both physiologic and psychological measures, enhancing quality of life of breast cancer survivors. RESULTS suggest a new method for rehabilitation intervention strategies after cancer in a nonmedical environment.","Cerulli, C., et al. (2014). \"Therapeutic horseback riding in breast cancer survivors: a pilot study.\" J Altern Complement Med 20(8): 623-629.","Italy",2014,"Cancer","Psychobehavioural","FACIT-F"]
[52,"Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.",null,"Cessna, J. M., et al.","Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients","OBJECTIVE: Fatigue is common among cancer patients and adversely impacts quality of life. As such, it is important to measure fatigue accurately in a way that is not burdensome to patients. The 7-item Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form scale was recently developed using item response theory (IRT). The current study evaluated the psychometric properties of this scale in two samples of cancer patients using classical test theory (CTT). METHODS: Two samples were used: 121 men with prostate cancer and 136 patients scheduled to undergo hematopoietic cell transplantation (HCT) for hematologic cancer. All participants completed the PROMIS Cancer Fatigue Short Form as well as validated measures of fatigue, vitality, and depression. HCT patients also completed measures of anxiety, perceived stress, and a clinical interview designed to identify cases of cancer-related fatigue. RESULTS: PROMIS Cancer Fatigue Short Form items loaded on a single factor (CFI=0.948) and the scale demonstrated good internal consistency reliability in both samples (Cronbach's alphas>0.86). Correlations with psychosocial measures were significant (p values<.0001) and in the expected direction, offering evidence for convergent and concurrent validity. PROMIS Fatigue scores were significantly higher in patients who met case definition criteria for cancer-related fatigue (p<.0001), demonstrating criterion validity. CONCLUSION: The current study provides evidence that the PROMIS Cancer Fatigue Short Form is a reliable and valid measure of fatigue in cancer patients.","Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.","USA",2016,"Cancer","None","PROMIS-F"]
[53,"Chaiamnuay, S., et al. (2007). \"The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected].\" J Clin Rheumatol 13(3): 128-133.",null,"Chaiamnuay, S., et al.","The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected]","OBJECTIVE: The aim of this study was to examine the impact of an increased body mass index (BMI) on disease activity, damage accrual, fatigue, self-reported health-related quality of life (HRQOL), and fibromyalgia in patients with lupus using longitudinal data from LUMINA, a large multiethnic cohort. METHODS: SLE patients (>/=4 ACR revised criteria), </=5 years disease duration at entry into the cohort (T0), of Hispanic (from Texas or from the Island of Puerto Rico), African American, or white ethnicity were included. BMI was ascertained at T0 or first recorded. The average scores from all visits for disease activity (SLAM-R), self-reported HRQOL (physical and mental component summary measures of the SF-36) and fatigue (Fatigue Severity Scale), the score at last visit for damage accrual (SLICC Damage Index), and fibromyalgia (ACR criteria), if present at any visit, were examined for their association with an increased BMI by univariable and multivariable analyses. RESULTS: Three-hundred sixty-four patients were included; 28% were obese (BMI >/=30 kg/m). An increased BMI was associated with older age, less social support, higher degree of helplessness, depression, more abnormal illness-related behaviors, poorer self-reported HRQOL, fatigue, and fibromyalgia, but not with disease activity or damage accrual by univariable analyses. In multivariable analyses, BMI was independently associated with fibromyalgia but not with disease activity, fatigue, or self-reported HRQOL. CONCLUSIONS: An increased BMI is independently associated with presence of fibromyalgia but not with disease activity, damage accrual, fatigue or self-reported quality of life in patients with SLE. Optimizing weight merits investigation to see if it can significantly impact this pervasive SLE-associated manifestation.","Chaiamnuay, S., et al. (2007). \"The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected].\" J Clin Rheumatol 13(3): 128-133.","USA",2007,"Musculoskeletal","None","FSS"]
[54,"Chasen, M. R. and R. Bhargava (2010). \"A rehabilitation program for patients with gastroesophageal cancer--a pilot study.\" Support Care Cancer 18 Suppl 2: S35-40.",null,"Chasen, M. R. and R. Bhargava","A rehabilitation program for patients with gastroesophageal cancer--a pilot study","PURPOSE: Gastroesophageal carcinoma has a 5-year survival rate of 20%. Esophagogastrectomy is a significant life-altering operation which interferes with a patient's ability to eat food as a normal social interaction. Dumping syndrome, delayed gastric emptying, and reflux are encountered after surgery. In addition, loss of appetite and body weight occurs. Fatigue is universally encountered. We conducted this study to evaluate whether a structured cancer nutrition and rehabilitation program has an effect on the symptoms and quality of life of patients with gastroesophageal cancer. MATERIALS AND METHODS: Fifty-three patients with histologically documented gastroesophageal carcinoma were evaluated before and after an 8-week multidisciplinary program consisting of physicians, oncology nurse, dietitian, physical and occupational therapists, social worker, and psychologist. Twenty-two patients completed all the following questionnaires pre- and post-program: The Edmonton Symptom Assessment Scale (ESAS), Patient-Generated Subjective Global Assessment (PG-SGA), Brief Fatigue Inventory (BFI), and the Distress Thermometer. RESULT: There were 42 male and 11 female patients. The median age was 63 years (22-80 years). Thirty patients had gastric cancer and 23 had esophageal cancer. On the ESAS, appetite, strength, shortness of breath, and constipation all improved (p = 0.01). The PG-SGA score decreased significantly (p = 0.05). Fatigue and general activity as measured on the BFI improved significantly. The 6-min walk increased from 384 to 435 m (p = 0.01). CONCLUSION: The Cancer Nutrition and Rehabilitation program offers a multidimensional, holistic treatment approach emphasizing the patient as an individual. Participation in a cancer rehabilitation program ameliorates symptoms, improves nutrition, decreases global distress, and increases physical activities.","Chasen, M. R. and R. Bhargava (2010). \"A rehabilitation program for patients with gastroesophageal cancer--a pilot study.\" Support Care Cancer 18 Suppl 2: S35-40.","Canada",2010,"Cancer","None","BFI"]
[55,"Chua, A. S., et al. (2015). \"Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure.\" Mult Scler Relat Disord 4(6): 598-606.",null,"Chua, A. S., et al.","Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure","Several patient-reported outcome (PRO) measures are commonly used in multiple sclerosis (MS) research, but the relationship among items across measures is uncertain. We proposed to evaluate the associations between items from a standard battery of PRO measures used in MS research and to develop a brief, reliable and valid instrument measure by combining these items into a single measure. Subjects (N = 537) enrolled in CLIMB complete a PRO battery that includes the Center for Epidemiologic Studies Depression Scale, Medical Outcomes Study Modified Social Support Survey, Modified Fatigue Impact Scale and Multiple Sclerosis Quality of Life-54. Subjects were randomly divided into two samples: calibration (n = 269) and validation (n = 268). In the calibration sample, an Exploratory Factor Analysis (EFA) was used to identify latent constructs within the battery. The model constructed based on the EFA was evaluated in the validation sample using Confirmatory Factor Analysis (CFA), and reliability and validity were assessed for the final measure. The EFA in the calibration sample revealed an eight factor solution, and a final model with one second-order factor along with the eight first-order factors provided the best fit. The model combined items from each of the four parent measures, showing important relationships among the parent measures. When the model was fit using the validation sample, the results confirmed the validity and reliability of the model. A brief PRO for MS (BPRO-MS) that combines MS-related psychosocial and quality of life domains can be used to assess overall functioning in mildly disabled MS patients.","Chua, A. S., et al. (2015). \"Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure.\" Mult Scler Relat Disord 4(6): 598-606.","USA",2015,"Neurological","None","MFI"]
[56,"Claesson, M., et al. (2003). \"Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease.\" Eur J Cardiovasc Prev Rehabil 10(4): 258-266.",null,"Claesson, M., et al.","Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease","BACKGROUND: Secondary prevention in patients with ischaemic heart disease (IHD) focusing on classical risk factors has been less successful in women than in men. Previous studies have suggested that psychosocial factors may be new targets for secondary prevention. In the present study, psychosocial factors have been compared in women with and without IHD. METHODS AND SUBJECTS: Using a cross-sectional comparison, classical cardiovascular risk factors and self-rated stress behaviour, vital exhaustion, stressful life events and quality of life were assessed in 198 women (age 35-77 years) who had IHD and a population-based sample of 206 women (age 45-74 years) without IHD. RESULTS: Control of classical risk factors was most often adequate in women with IHD. The prevalence of smoking was 9% in women with versus 18% in women without IHD (P<0.001), blood pressure levels were similar, and a very large share of women with IHD were on treatment with anti-thrombotic, anti-hypertensive and/or lipid-lowering drugs (P<0.001 compared with women free of IHD). In contrast, women with IHD scored significantly worse than women without IHD in self-rated stress behaviour (P=0.003 after adjustment for other possible determinants), and in vital exhaustion (P=0.003). In univariate analyses, quality of life was significantly worse in women with IHD. Stressful life events did not differ between the two groups. CONCLUSIONS: In this group of women with IHD, control of classical risk factors was good, whereas control of psychosocial risk factors was clearly inadequate. Secondary prevention by psychosocial intervention in women with IHD should be evaluated in randomized controlled trials.","Claesson, M., et al. (2003). \"Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease.\" Eur J Cardiovasc Prev Rehabil 10(4): 258-266.","Sweden",2003,"CVD","None","VE"]
[57,"Cohen, S. B., et al. (2006). \"Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks.\" Arthritis Rheum 54(9): 2793-2806.",null,"Cohen, S. B., et al.","Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks","OBJECTIVE: To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. METHODS: We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. RESULTS: Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. CONCLUSION: At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies.","Cohen, S. B., et al. (2006). \"Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks.\" Arthritis Rheum 54(9): 2793-2806.","USA",2006,"Musculoskeletal","Rituximab,Other Drugs","FACIT-F"]
[58,"Cook, K. F., et al. (2012). \"A PROMIS fatigue short form for use by individuals who have multiple sclerosis.\" Qual Life Res 21(6): 1021-1030.",null,"Cook, K. F., et al.","A PROMIS fatigue short form for use by individuals who have multiple sclerosis","PURPOSE: To derive from the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue item bank, a short form for individuals with multiple sclerosis (MS), the PROMIS-Fatigue(MS). METHODS: A panel of 37 clinicians and 46 individuals with MS ranked the relevance of PROMIS fatigue items to persons with MS. Eight items were selected for the PROMIS-Fatigue(MS) that maximized relevance rankings, content coverage, and item discrimination. The PROMIS-Fatigue(MS) and an existing, 7-item PROMIS fatigue short form (PROMIS-Fatigue(SFv1.0)) were administered to a new sample of 231 individuals with MS. Known groups and content validity were assessed. RESULTS: Scores from the short forms were highly correlated (r = 0.92). Discriminant validity of the PROMIS-Fatigue(MS) scores was supported in known groups comparisons. Scores of neither short form exhibited an advantage in quantitative analyses. The PROMIS-Fatigue(MS) targeted more of the content included in participants' responses to open-ended questions than did the PROMIS-Fatigue(SFv1.0). CONCLUSIONS: The PROMIS-Fatigue(MS) was derived to have content validity in MS samples. The validity of the measure was further supported by the ability of PROMIS-Fatigue(MS) items to discriminate among groups expected to differ in levels of fatigue. We recommend its use in measuring the fatigue of individuals with MS.","Cook, K. F., et al. (2012). \"A PROMIS fatigue short form for use by individuals who have multiple sclerosis.\" Qual Life Res 21(6): 1021-1030.","USA",2012,"Neurological","None","PROMIS-F"]
[59,"Dahm, J. and J. Ponsford (2015). \"Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?\" Injury 46(1): 142-149.",null,"Dahm, J. and J. Ponsford","Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?","OBJECTIVE: Whilst it has been well-demonstrated that traumatic brain injury (TBI) results in long-term cognitive, behavioural and emotional difficulties, less is understood about how these outcomes differ from those following traumatic orthopaedic injury (TOI). The aim of this study was to compare self-reported outcomes at 5-10 years post-injury for those with TBI, TOI, and uninjured controls. It was hypothesised that participants with TBI would have greater cognitive difficulties; participants with TOI and TBI would have similar functional and physical outcomes, both being poorer than controls; and participants with TBI would have poorer psychosocial outcomes than those with TOI. PARTICIPANTS AND METHODS: Eighty-eight individuals with complicated mild to severe TBI and 96 with TOI recruited during inpatient rehabilitation were followed up 5-10 years post-injury, together with 48 controls followed over a similar period. Self-report measures of global functioning (GOS-E), quality of life (SF-36), psychological wellbeing (SCL-90-R, HADS, PCL-S), psychosocial difficulties (SIP), cognitive difficulties (SF-36 COG), pain (BPI), and fatigue (FSS) were administered. RESULTS: Outcomes for individuals with TBI and TOI differed significantly from controls, with poorer global functioning, and greater psychological distress and interference from pain. Only participants with TBI reported greater cognitive difficulties and anxiety than controls, and were less likely to be employed or in a relationship. Participants with TBI reported greater anxiety, PTSD, psychological distress and psychosocial difficulties than those with TOI. CONCLUSIONS: Both TOI and TBI cause long-term disability, interference from pain, and psychological distress. However, cognitive impairments, unemployment, lack of long-term relationships, anxiety and PTSD are more substantial long-term problems following TBI. Findings from this study have implications for managing risks associated with these injury groups and tailoring rehabilitation to improve long-term outcomes.","Dahm, J. and J. Ponsford (2015). \"Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?\" Injury 46(1): 142-149.","Australia",2015,"Neurological","None","FSS"]
[60,"Dalgas, U., et al. (2010). \"Fatigue, mood and quality of life improve in MS patients after progressive resistance training.\" Mult Scler 16(4): 480-490.",null,"Dalgas, U., et al.","Fatigue, mood and quality of life improve in MS patients after progressive resistance training","Fatigue occurs in the majority of multiple sclerosis patients and therapeutic possibilities are few. Fatigue, mood and quality of life were studied in patients with multiple sclerosis following progressive resistance training leading to improvement of muscular strength and functional capacity. Fatigue (Fatigue Severity Scale, FSS), mood (Major Depression Inventory, MDI) and quality of life (physical and mental component scores, PCS and MCS, of SF36) were scored at start, end and follow-up of a randomized controlled clinical trial of 12 weeks of progressive resistance training in moderately disabled (Expanded Disability Status Scale, EDSS: 3-5.5) multiple sclerosis patients including a Control group (n = 15) and an Exercise group (n = 16). Fatigue (FSS > 4) was present in all patients. Scores of FSS, MDI, PCS-SF36 and MCS-SF36 were comparable at start of study in the two groups. Fatigue improved during exercise by -0.6 (95% confidence interval (CI) -1.4 to 0.4) a.u. vs. 0.1 (95% CI -0.4 to 0.6) a.u. in controls (p = 0.04), mood improved by -2.4 (95% CI -4.1 to 0.7) a.u. vs. 1.1 (-1.2 to 3.4) a.u. in controls (p = 0.01) and quality of life (PCS-SF36) improved by 3.5 (95% CI 1.4-5.7) a.u. vs. -1.0 (95% CI -3.4-1.4) a.u. in controls (p = 0.01). The beneficial effect of progressive resistance training on all scores was maintained at follow-up after further 12 weeks. Fatigue, mood and quality of life all improved following progressive resistance training, the beneficial effect being maintained for at least 12 weeks after end of intervention.","Dalgas, U., et al. (2010). \"Fatigue, mood and quality of life improve in MS patients after progressive resistance training.\" Mult Scler 16(4): 480-490.","Denmark",2010,"Neurological","Psychobehavioural","FSS"]
[61,"Dapueto, J. J., et al. (2014). \"Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay.\" J Pain Symptom Manage 47(5): 936-945.",null,"Dapueto, J. J., et al.","Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay","CONTEXT: Several instruments have been developed to assess the symptom burden and fatigue produced by cancer and its treatment. However, little research has been conducted in Latin American Spanish-speaking patients. OBJECTIVES: The aim of the study was to assess the psychometric properties of the Spanish versions of two commonly used patient-reported outcome measures, the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), and the fatigue subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), the FACIT-Fatigue. METHODS: A classic psychometric approach was followed to assess the reliability and validity of the instruments. Responsiveness to change and effect sizes were calculated. RESULTS: The translated version of the MSAS-SF proved to be comprehensible and easy to complete. Cronbach alpha reliability coefficients ranged from acceptable to excellent for the MSAS-SF subscale scores and the FACIT-Fatigue. There was evidence of convergent validity between the physical and the psychological subscales of the instruments. The MSAS-SF could discriminate among the known groups according to Eastern Cooperative Oncology performance status and level of anemia, and showed responsiveness to change of symptom burden at two times of treatment. CONCLUSION: The study showed that both the MSAS-SF and the FACIT-Fatigue have good reliability and validity for use with patients with cancer in Uruguay. When used simultaneously, these instruments may provide a complete picture of the impact of cancer and its treatment on the patient's quality of life.","Dapueto, J. J., et al. (2014). \"Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay.\" J Pain Symptom Manage 47(5): 936-945.","Uruguay",2014,"Cancer","None","FACIT-F"]
[62,"De Boer, S. and M. L. Wilsher (2012). \"Validation of the Sarcoidosis Health Questionnaire in a non-US population.\" Respirology 17(3): 519-524.",null,"De Boer, S. and M. L. Wilsher","Validation of the Sarcoidosis Health Questionnaire in a non-US population","BACKGROUND AND OBJECTIVE: Sarcoidosis is a multi-system disease with an unpredictable course and variable clinical manifestations that are often associated with impaired quality of life. The Sarcoidosis Health Questionnaire (SHQ), which was developed for an 80% African American population, assesses health-related quality of life in sarcoidosis patients. The aim of this study was to validate the SHQ in a predominantly European population of sarcoidosis patients. METHODS: Consecutive outpatients (n = 92) with sarcoidosis, who were attending a teaching hospital clinic, completed three questionnaires (SHQ, Short Form (SF) 36, Fatigue Assessment Scale (FAS)) and pulmonary function tests were performed. RESULTS: The mean age of the patients was 51 years, 52% were males and 74% were of European ethnicity. The mean number of organs involved was 1.3, with pulmonary involvement in 95% of patients (mean forced expiratory volume in 1 s 74.4%, forced vital capacity 84.6%). Seventy percent of patients had current symptoms and 26.5% were receiving immunosuppressant therapy. The SHQ total score (mean 5.13) was significantly correlated with the SF 36 physical component score (46.7, r = 0.78) and the FAS (20.8, r = -0.7) but only weakly correlated with pulmonary function. There were significant differences in SHQ scores when patients were stratified according to symptoms, oral therapy, health status (P < 0.0001 for all), forced expiratory volume in 1 s >/=70% (P = 0.008) and forced vital capacity >/=70% (P = 0.01). CONCLUSIONS: The SHQ correlated well with health-related quality of life and fatigue measures in a predominantly European population of sarcoidosis patients, despite differences in organ involvement and disease burden, when compared with the development study.","De Boer, S. and M. L. Wilsher (2012). \"Validation of the Sarcoidosis Health Questionnaire in a non-US population.\" Respirology 17(3): 519-524.","New Zealand",2012,"Inflamatory Systemic Disease","None","FAS"]
[63,"De Giglio, L., et al. (2015). \"A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study.\" Neurorehabil Neural Repair 29(5): 453-461.",null,"De Giglio, L., et al.","A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study","OBJECTIVE: To evaluate the effectiveness of a home-based cognitive rehabilitation (CR) program based on the video game Dr Kawashima's Brain Training (DKBT; Nintendo, Japan), in improving attention, processing speed, and working memory of patients with multiple sclerosis (MS). METHODS: This was a randomized, wait-list control study. Patients with MS and failure in at least one between Stroop Test (ST), Paced Auditory Serial Addition Test (PASAT), and Symbol Digit Modalities Test (SDMT) were submitted to an 8-week home-based CR program playing DKBT. Patients were evaluated at baseline and after DKBT by the aforementioned tests, by the Modified Fatigue Impact Scale (MFIS) and by the MS Quality of Life-54 questionnaire (MSQoL-54). RESULTS: Fifty-two 52 patients were screened for eligibility; 35 (mean [standard deviation] age of 43.9 [8.4] years, median Expanded Disability Status Scale score of 2.0 (range = 2.0-6.0) were randomly assigned to the intervention group (n = 18) or wait-list control group (n = 17). ANCOVA analysis showed a significant effect of DKBT on ST (F = 5.027; P = .034; F(2) = 0.210), SDMT (F = 4.240; P = .049; F(2) = 0.177), and on some subscales of MSQoL-54. The PASAT and cognitive subscale of MFIS also showed an improvement, but this was just not significant (F = 4.104, P = .054, F(2) = 0.171, and F = 4.226, P = .054, F(2) = 0.237, respectively). CONCLUSION: We suggest that a home-based DKBT program may improve cognitive functions, some aspects of QoL, and cognitive fatigue in patients with MS.","De Giglio, L., et al. (2015). \"A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study.\" Neurorehabil Neural Repair 29(5): 453-461.","Italy",2015,"Neurological","Psychobehavioural","MFI"]
[64,"de Oliveira Campos, M. P., et al. (2011). \"Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy.\" J Altern Complement Med 17(6): 505-512.",null,"de Oliveira Campos, M. P., et al.","Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy","BACKGROUND: In patients with breast cancer (BC) undergoing systemic chemotherapy, cancer-related fatigue (CRF) is a common problem that can negatively impact quality of life. Guarana (Paullinia cupana) is a plant native to the Amazon basin that has been used as a stimulant since pre-Columbian times. OBJECTIVE: The purpose of this study was to evaluate the effectiveness of guarana extract on fatigue, sleep quality, anxiety, depression symptoms, and menopause in a group of BC chemotherapy patients. PATIENTS AND METHODS: Patients with progressive fatigue after their first cycle of chemotherapy were randomized to receive either guarana 50 mg by mouth twice daily (32 patients) or placebo (43 patients) for 21 days. After a 7-day washout period, patients were crossed over to the opposite experimental arm. All patients were evaluated on days 1, 21, and 49. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire score, and secondary endpoints were the results of the Functional Assessment of Chronic Illness Therapy-Endocrine Symptoms (FACT-ES), Brief Fatigue Inventory (BFI), Pittsburg Sleep Quality Index, Chalder Fatigue Scale, and Hospital Anxiety and Depression Scale. RESULTS: Guarana significantly improved the FACIT-F, FACT-ES, and BFI global scores compared to placebo on days 21 and 49 (p < 0.01). The Chalder Scale improved significantly on day 21 (p < 0.01) but not on day 49 (p = 0.27). Guarana did not produce any Common Terminology Criteria for Adverse Events grades 2, 3, or 4 toxicities and did not worsen sleep quality or cause anxiety or depression. CONCLUSIONS: Guarana is an effective, inexpensive, and nontoxic alternative for the short-term treatment of fatigue in BC patients receiving systemic chemotherapy. Further studies are needed to confirm these results and to evaluate their generalizability to chronic CRF and to other types of cancer.","de Oliveira Campos, M. P., et al. (2011). \"Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy.\" J Altern Complement Med 17(6): 505-512.","Brazil",2011,"Cancer","Complementary","FACIT-F,CFS"]
[65,"Denkinger, M. D., et al. (2015). \"Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments.\" Z Gerontol Geriatr 48(2): 128-134.",null,"Denkinger, M. D., et al.","Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments","OBJECTIVES: Because of substantial toxicities in older adults, chemotherapy is often omitted while the frequency of radiotherapy changes only minimally. In this study, we addressed the value of different assessments for predicting fatigue after radiotherapy in older breast cancer patients. PATIENTS AND METHODS: We included 74 women with primary breast cancer over the age of 65 years treated with radiotherapy (26 % with additional chemotherapy). Assessments were conducted before adjuvant treatment and after radiotherapy. The assessments included the Vulnerable Elders Survey (VES-13), the Karnofsky Performance Status (KPS), the EORTC Quality of Life assessment (EORTC-QLQ-C30), a cancer-specific comprehensive geriatric assessment (cancer-specific CGA), and the Fried frailty score. Multiple linear regression analyses were used to assess correlations with the FACIT-fatigue scale. RESULTS: Patients were on average 71 years old (range, 65-86 years). Most tumors (n=62) were classified as intermediate risk according to the St. Gallen consensus. The cancer-specific CGA was best associated with fatigue (p < 0.001, beta estimate = 1.75), followed by the Fried frailty score (for the score of 1 versus reference of 2 and higher: p = 0.035, beta estimate = - 5.74). There were no significant ceiling effects but there were substantial floor effects for the VES-13, KPS, and frailty score. CONCLUSION: The cancer-specific CGA and the Fried frailty score (driven mainly by the item \"exhaustion\") outperformed the other indices in predicting fatigue in a group of rather well-functioning older women with primary breast cancer.","Denkinger, M. D., et al. (2015). \"Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments.\" Z Gerontol Geriatr 48(2): 128-134.","Germany",2015,"Cancer","Cancer treatments","FACIT-F"]
[66,"Deodhar, A. A., et al. (2016). \"Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).\" Arthritis Rheumatol 68(12): 2901-2910.",null,"Deodhar, A. A., et al.","Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1)","OBJECTIVE: To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). METHODS: In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV-->150 mg group), or SC secukinumab 75 mg every 4 weeks (IV-->75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). RESULTS: At week 16, secukinumab IV-->150 mg or IV-->75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. CONCLUSION: Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.","Deodhar, A. A., et al. (2016). \"Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).\" Arthritis Rheumatol 68(12): 2901-2910.","Netherlands",2016,"Musculoskeletal","Secukinumab","FACIT-F"]
[67,"Detert, J., et al. (2016). \"Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis.\" Clin Exp Rheumatol 34(5): 848-856.",null,"Detert, J., et al.","Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis","OBJECTIVES: To compare sleep quality, disease activity and patient-reported outcomes such as fatigue and immune parameters in patients with rheumatoid arthritis treated with etanercept (ETA) or methotrexate (MTX). METHODS: Of 36 patients (28-joint Disease Activity Score, DAS28CRP>/=3.2) in this 16-week (w), open, prospective study, 19 (11 women) received MTX 12.5-17 mg/w, and 17 (14 women) received ETA 25 mg x 2/w, alone or in combination with MTX. Clinical (DAS28CRP, visual analogue scale), laboratory (C-reactive protein [CRP]), sleep (polysomnography), functional (Multidimensional Fatigue Inventory; Health Assessment Questionnaire-Disability Index (HAQ-DI); 36-item Short-Form Health Survey (SF-36), immunological (humoral/cellular) and neuroendocrine (hormonal) parameters were recorded at baseline (BL), w8 and w16. RESULTS: BL characteristics did not differ significantly between the ETA and MTX groups except disease duration: mean age (years): 48.6+/-8.8 vs. 49.4+/-16.6; mean disease duration (months): 19.6+/-46.3 vs. 81.2+/-79.2; and DAS28CRP: 4.4+/-0.9 vs. 4.4+/-1.7, respectively. DAS28CRP, SF-36, and HAQ-DI improved significantly in both groups from BL to w16 (p</=0.05). The DAS28CRP improvements at w16 (mean changes -1.8 in the ETA group, and -1.4 in MTX group), were not statistically significant from each other. The absolute values of sleep efficiency, total sleep time, and stage 2 sleep duration increased significantly in the ETA group, but no significant changes were reported in the MTX group. CONCLUSIONS: Both therapies improved disease activity, CRP, SF-36 and HAQ-DI, with faster, more pronounced changes in DAS28CRP in the ETA group, which alone had significantly improved sleep parameters.","Detert, J., et al. (2016). \"Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis.\" Clin Exp Rheumatol 34(5): 848-856.","Germany",2016,"Musculoskeletal","Etanercept,Other Drugs","MFI"]
[68,"Dettmers, C., et al. (2009). \"Endurance exercise improves walking distance in MS patients with fatigue.\" Acta Neurol Scand 120(4): 251-257.",null,"Dettmers, C., et al.","Endurance exercise improves walking distance in MS patients with fatigue","OBJECTIVES: Effects of endurance training in multiple sclerosis (MS) patients complaining of motor fatigue. MATERIALS AND METHODS: Thirty MS patients complaining of fatigue with low to moderate disabilities randomly allocated to the intervention (thrice weekly 45-min intervals of endurance exercise) or control treatment (three 45-min episodes of stretching, balance training and coordination), both as 'add-on' therapy for 3 weeks during inpatient rehabilitation. RESULTS: Maximal walking distance before intervention averaged 1043 +/- 568 and 1163 +/- 750 m in the two groups. The intervention group increased its maximal walking distance by 650 +/- 474 m. The control group extended its walking distance by 96 +/- 70 m. CONCLUSIONS: The present data confirm a strong effect of endurance exercise on maximal walking distance. Remarkably, there were no parallel improvements on the Modified Fatigue Impact Scale, the Beck Depression Inventory and the Hamburg Quality of Life Questionnaire for MS.","Dettmers, C., et al. (2009). \"Endurance exercise improves walking distance in MS patients with fatigue.\" Acta Neurol Scand 120(4): 251-257.","Germany",2009,"Neurological","Psychobehavioural","MFI"]
[69,"Dols, L. F., et al. (2010). \"Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy.\" Am J Transplant 10(11): 2481-2487.",null,"Dols, L. F., et al.","Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy","Long-term physical and psychosocial effects of laparoscopic and open kidney donation are ill defined. We performed long-term follow-up of 100 live kidney donors, who had been randomly assigned to mini-incision open donor nephrectomy (MIDN) or laparoscopic donor nephrectomy (LDN). Data included blood pressure, glomerular filtration rate, quality of life (SF-36), fatigue (MFI-20) and graft survival. After median follow-up of 6 years clinical and laboratory data were available for 47 donors (94%) in both groups; quality of life data for 35 donors (70%) in the MIDN group, and 37 donors (74%) in the LDN group. After 6 years, mean estimated glomerular filtration rates did not significantly differ between MIDN (75 mL/min) and LDN (76 mL/min, p = 0.39). Most dimensions of the SF-36 and MFI-20 did not significantly differ between groups at long-term follow-up, and most scores had returned to baseline. Twelve percent of the donors reported persistent complaints, but no major complications requiring surgical intervention. Five-year death-censored graft survival was 90% for LDN, and 85% for MIDN (p = 0.50). Long-term outcome of live kidney donation is excellent from the perspective of both the donor and the recipient.","Dols, L. F., et al. (2010). \"Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy.\" Am J Transplant 10(11): 2481-2487.","Netherlands",2010,"Kidney Disease","Surgery","MFI"]
[70,"Donnellan, C. P. and J. Shanley (2008). \"Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial.\" Clin Rehabil 22(3): 195-205.",null,"Donnellan, C. P. and J. Shanley","Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial","OBJECTIVE: To compare the effect of two types of acupuncture on the quality of life of individuals with secondary progressive multiple sclerosis and provide preliminary evidence regarding the safety of this intervention for this population. DESIGN: Preliminary single-blind randomized controlled trial. SETTING: Outpatient attendance at rehabilitation unit. PARTICIPANTS: Fourteen participants with secondary progressive multiple sclerosis. INTERVENTIONS: Chinese medical acupuncture or minimal acupuncture. Participants received 10 treatments over five weeks. MEASURES: Multiple Sclerosis Impact Scale 29, Fatigue Severity Scale and General Health Questionnaire 12 were measured pre and post intervention. Adverse events and other responses during treatment were recorded prospectively. RESULTS: Participants receiving minimal acupuncture demonstrated statistically significant greater improvement in the Multiple Sclerosis Impact Scale 29 psychological subscale compared with those receiving Chinese medical acupuncture in an intention-to-treat analysis (P=0.04), with mean change in Chinese acupuncture group of 6.0 (SD 13.9) and in minimal acupuncture group of 23.0 (SD 21.0). No other statistically significant difference between the groups was found. No major adverse events were noted. Minor adverse events such as lower limb muscle spasms or pain were noted in some participants in both intervention groups. CONCLUSION: Minimal acupuncture resulted in greater improvement of Multiple Sclerosis Impact Scale 29 psychological subscale compared with Chinese medical acupuncture. No other differences between the groups were found. In view of the small sample these results are not conclusive. This study provides preliminary evidence to suggest that acupuncture is safe for people with secondary progressive multiple sclerosis. A large-scale trial is required to provide more definitive evidence.","Donnellan, C. P. and J. Shanley (2008). \"Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial.\" Clin Rehabil 22(3): 195-205.","UK",2008,"Neurological","Complementary","FSS"]
[71,"Donnelly, C. M., et al. (2011). \"A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors.\" Gynecol Oncol 122(3): 618-624.",null,"Donnelly, C. M., et al.","A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors","OBJECTIVE: To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments. METHODS: A two arm, single blind, randomised controlled trial was conducted within the Northern Ireland regional Cancer Centre. Thirty three sedentary gynaecological cancer survivors (stage I-III; </=3 years post diagnosis), experiencing cancer-related fatigue (mild-severe) took part. Participants were randomly assigned to a behavioural change, moderate intensity physical activity intervention (n=16) or a Contact Control group (n=17). The primary outcome was fatigue (Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale). Secondary outcomes included quality of life, physical functioning, positive and negative affect, depression, body composition, sleep dysfunction and self-reported physical activity. Feasibility was assessed based on the recruitment rate, programme and physical activity adherence and participants' programme evaluation, including optional focus groups (n=16). RESULTS: Twenty five percent of eligible women took part (33/134). Participants were 8.7 (SD=9.1) months post diagnosis, with a mean age of 53 (SD=10.3) years. The majority of the sample had a diagnosis of ovarian (n=12) or endometrial cancer (n=11). Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up (12 week: mean difference=-11.06; 95% confidence interval (CI)=-21.89 to -0.23; effect size (d)=0.13; p=0.046; 6 month: mean difference=-19.48; 95% CI=-19.67 to -19.15; effect size (d)=0.20; p=0.01). A mean of 10 calls (SD=1.2 calls) were delivered to the Physical Activity Group, and 10 (SD=1.6 calls) to the CC group. The intervention was positively perceived based on exit questionnaire and focus group findings. CONCLUSIONS: A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants' programme adherence and evaluation, and the intervention demonstrates improvements in fatigue. However, confirmation in the form of a larger fully powered RCT is warranted.","Donnelly, C. M., et al. (2011). \"A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors.\" Gynecol Oncol 122(3): 618-624.","UK",2011,"Cancer","Psychobehavioural","MFI,FACIT-F"]
[72,"Doorduijn, J., et al. (2005). \"Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy.\" Eur J Haematol 75(2): 116-123.",null,"Doorduijn, J., et al.","Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy","We studied the impact of CHOP chemotherapy on the quality of life (QoL) of elderly patients with aggressive non-Hodgkin's lymphoma (NHL). 132 patients aged 65 or older, who participated in a randomized, multicenter trial, completed QoL questionnaires (EuroQol-5D, EORTC QLQ-C30 and MFI-20) on 8 predefined time-points before, during and following treatment. At baseline, QoL was significantly better on almost all dimensions in patients with a lower compared to patients with a higher age-adjusted International Prognostic Index (aaPI). During treatment, physical and role functioning and global QoL deteriorated and fatigue increased in the lower aaPI group, whereas QoL of the higher aaPI group remained stable. During follow-up, the QoL was significantly better for patients in complete response (CR) or partial remission (PR) than for patients with progression/relapse. Soon after completion of therapy, the QoL of the lower aaPI group returned to pretreatment levels or better, while patients with higher aaPI showed a significant improvement in QoL compared to baseline levels. The effect of CHOP on the quality of life of elderly patients could be used in counseling this group of patients.","Doorduijn, J., et al. (2005). \"Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy.\" Eur J Haematol 75(2): 116-123.","Netherlands",2005,"Cancer","Cancer treatments","MFI"]
[73,"Dougados, M., et al. (2015). \"Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis.\" J Rheumatol 42(10): 1835-1841.",null,"Dougados, M., et al.","Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis","OBJECTIVE: Analyses were conducted to examine the baseline burden of illness and compare the effect of etanercept (ETN) versus placebo (PBO) on quality of life (QOL) in patients with nonradiographic axial spondyloarthritis (nr-axSpA) who failed nonsteroidal antiinflammatory drugs (NSAID). METHODS: Patients fulfilling the Assessment of Spondyloarthritis International Society axSpA criteria, not meeting the modified New York criteria for ankylosing spondylitis (AS), who were symptomatic 3 months to 5 years, with a Bath AS Disease Activity Index score >/= 4, and failed >/= 2 NSAID were randomized to ETN 50 mg weekly or PBO (double-blind) for 12 weeks, followed by open-label ETN 50 mg for 92 weeks. Stable NSAID were allowed throughout our study. QOL outcomes over 24 weeks were analyzed using ANCOVA models. RESULTS: At baseline, Multidimensional Fatigue Inventory (MFI; ETN mean 14.7, PBO mean 15.0), EQ-5D utility (0.52, 0.57), EQ-5D visual analog scale (56.5, 56.4), and Medical Outcomes Study (MOS) Sleep Index II (45.5, 48.1) were worse than population norms (6.6-8.0, 0.86, 82.5, and 25.8, respectively). At Week 12, Bath AS Patient Global Score, nocturnal and average back pain, MOS Short Form-36 (SF-36) physical component, and Work Productivity and Activity Index (WPAI) presenteeism and activity impairment favored ETN (p < 0.05). Nonsignificant improvements for ETN were seen in other WPAI domains, MFI, MOS-Sleep Index I and II, Hospital Anxiety and Depression Scale, EQ-5D utility score, and SF-36 mental component (p > 0.05). At Week 24, patients in the PBO group who had switched to ETN at Week 12 showed improvement in most QOL assessments, similar to that seen in patients receiving ETN for 24 weeks. CONCLUSION: Improvements favored ETN in QOL and productivity measures, with limited improvement on general QOL measures. Short disease duration, a short PBO-controlled period, and a wide range of QOL scores at baseline may have influenced improvements.","Dougados, M., et al. (2015). \"Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis.\" J Rheumatol 42(10): 1835-1841.","USA",2015,"Musculoskeletal","Etanercept","MFI,VAS-F"]
[74,"Drory, V. E., et al. (2001). \"The value of muscle exercise in patients with amyotrophic lateral sclerosis.\" J Neurol Sci 191(1-2): 133-137.",null,"Drory, V. E., et al.","The value of muscle exercise in patients with amyotrophic lateral sclerosis","The role of physical activity for patients with amyotrophic lateral sclerosis (ALS) is controversial. Twenty-five ALS patients were randomized to receive a moderate daily exercise program (n=14) or not to perform any physical activity beyond their usual daily requirements (n=11). At baseline and after 3, 6, 9 and 12 months, patients were assessed by manual muscle strength testing, the Ashworth spasticity scale, ALS functional rating scale (FRS), fatigue severity scale, a visual analogue scale for musculoskeletal pain and the quality-of-life scale (SF-36). At 3 months, patients who performed regular exercise showed less deterioration on FRS and Ashworth scales, but not on other parameters. At 6 months, there was no significant difference between groups, although a trend towards less deterioration in the treated group on most scales was observed. At 9 and 12 months, there were too few patients in each group for statistical evaluation. Our results show that a regular moderate physical exercise program has a short-lived positive effect on disability in ALS patients and should be recommended.","Drory, V. E., et al. (2001). \"The value of muscle exercise in patients with amyotrophic lateral sclerosis.\" J Neurol Sci 191(1-2): 133-137.","Israel",2001,"Neurological","Psychobehavioural","FSS,VAS-F"]
[75,"Duruturk, N., et al. (2016). \"A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial.\" Expert Rev Respir Med 10(1): 99-108.",null,"Duruturk, N., et al.","A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial","AIM: To compare the effects of calisthenic and cycle exercises with no exercise in chronic obstructive pulmonary disease patients. METHOD: Forty-seven participants were allocated to either a cycle or calisthenic exercise or control group. Outcome measures, including Saint George Respiratory Questionnaire, pulmonary functions, cardiopulmonary exercise testing, Fitness Testing, and Hospital Anxiety-Depression, Modified Medical Research Council Dyspnea, Fatigue Severity, Fatigue Impact Scales, were performed before and after the intervention. RESULTS: The change in VE/VCO2 significantly differed (p = 0.01) between two exercise groups. Physical fitness, quality of life, anxiety-depression, dyspnea and fatigue changed significantly in exercise groups, with no between-group differences. There were no significant improvements in control group. CONCLUSION: Calisthenics are as safe and effective as cycle exercise and could be included in comprehensive treatment programs.","Duruturk, N., et al. (2016). \"A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial.\" Expert Rev Respir Med 10(1): 99-108.","Turkey",2016,"Respiratory Disease","Psychobehavioural","FSS,FIS"]
[76,"Eikeland, R., et al. (2011). \"European neuroborreliosis: quality of life 30 months after treatment.\" Acta Neurol Scand 124(5): 349-354.",null,"Eikeland, R., et al.","European neuroborreliosis: quality of life 30 months after treatment","OBJECTIVES: The prognosis after Lyme neuroborreliosis (LNB) is debated. The aim of this study was to assess health-related Quality of Life (QoL) and neurological symptoms 30 months after treatment in European patients with LNB. MATERIALS AND METHODS: In a prospective case-control designed study, we investigated 50 well-characterized patients with LNB who had participated in a treatment trial for LNB 30 months earlier and 50 matched control persons with the health QoL questionnaire Short-Form 36 (SF-36), the Fatigue Severity Scale (FSS), the Montgomery and Asberg Depression Rating Scale (MADRS), the Starkstein Apathy Scale (SAS), and the Mini Mental State (MMS). Clinical and demographic data were collected by semi-structured interviews and clinical neurological examination. RESULTS: Lyme neuroborreliosis-treated patients scored lower than control persons in the SF-36 domains physical component summary (PCS) (44 vs 51 P < 0.001) and mental component summary (MCS) (49 vs 54 P = 0.010). They also scored lower than control persons in all the SF-36 subscales, except for bodily pain, and on FSS (3.5 vs 2.1 P < 0.001), but not on MMS (28 vs 29 P = 0.106). There was a difference in MADRS (3.1 vs 0. 8 P = 0.003) and SAS (13 vs 11 P = 0.016), but the scores were low in both groups. Fatigue was the most frequently reported symptom among LNB-treated patients (50%). Patients who reported complete recovery (56%) after LNB had similar QoL scores as the controls. CONCLUSION: European persons treated for LNB have poorer health-related QoL and have more fatigue than persons without LNB.","Eikeland, R., et al. (2011). \"European neuroborreliosis: quality of life 30 months after treatment.\" Acta Neurol Scand 124(5): 349-354.","Norway",2011,"Infectious Disease","None","FSS"]
[77,"Elfferich, M. D., et al. (2011). \"Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis.\" Sarcoidosis Vasc Diffuse Lung Dis 28(1): 65-71.",null,"Elfferich, M. D., et al.","Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis","BACKGROUND: Personality factors have shown to be related to mortality, morbidity, and psychological aspects in chronic disorders. Little is known about the effect of personality on disease severity in sarcoidosis and idiopathic pulmonary fibrosis (IPF). The aim of this study was to assess the prevalence of Type D personality and its relation with relevant clinical characteristics in sarcoidosis and IPF patients. METHODS: The study included 441 sarcoidosis and 49 IPF patients from the outpatient clinic of the ild care team of the MUMC, the Netherlands. They completed the DS14 (Type D questionnaire), the fatigue assessment scale (FAS), the WHO quality of life-BREF (WHOQOL-BREF) and the Centre for Epidemiological Studies-Depression Scale (CES-D). Moreover, relevant clinical data were collected. The control group consisted of 3678 subjects from a general population. RESULTS: Type D personality was found in 25.6% of the sarcoidosis patients compared to 21% in the controls, but only in 18.8% of the IPF patients. No relation with disease severity was found in either of these disorders. Fatigue was a substantial problem in both populations. Depressive symptoms but not Type D personality predicted fatigue and poorer QOL in sarcoidosis and IPF. CONCLUSION: Prevalence of Type D personality is not higher in sarcoidosis and IPF patients than in the general population and does not explain QOL impairment. Depressive symptoms explain QOL impairment and fatigue substantially. Therefore, in the multidisciplinary management of sarcoidosis and IPF psychological screening and psychological counselling concerning adequate coping strategies should be incorporated.","Elfferich, M. D., et al. (2011). \"Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis.\" Sarcoidosis Vasc Diffuse Lung Dis 28(1): 65-71.","Netherlands",2011,"Respiratory Disease","None","FAS"]
[78,"Elliott, C., et al. (2011). \"Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls.\" Transpl Int 24(6): 588-595.",null,"Elliott, C., et al.","Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls","We compared functional ability and symptom severity in liver transplant recipients and matched chronic liver disease (CLD) and community controls. A total of 103/140 consecutive liver transplant recipients from a single centre (73%) and matched controls completed the patient-reported functional outcome measure: Patient-Reported Outcomes Measurement Information System, Health Assessment Questionnaire (PROMIS HAQ). Symptoms frequently seen in CLD were quantified by (i) Fatigue Impact Scale (FIS), (ii) Orthostatic Grading Scale (OGS: autonomic dysfunction), (iii) Cognitive Failures Questionnaire (CFQ) and (iv) Epworth Sleepiness Scale (ESS: Daytime somnolence). Liver transplant recipients exhibited significant reduction in function (P<0.0001) across all domains of the PROMIS HAQ suggesting that functional impairment is broad-based. Seventy-seven per cent of all postliver transplants identified some difficulty with activities of daily living. There was no relationship between PROMIS HAQ and liver biochemistry (r(2)=0.04, P=NS) or time since transplant (r(2) =0.1, P=NS). Elevation in PROMIS HAQ (and therefore functional impairment) strongly associated with symptoms, particularly fatigue, cognitive impairment and daytime somnolence. Fatigue severity was independently associated with functional impairment (FIS) (Beta 0.727, P < 0.0001). Symptoms or functional ability was not different between liver transplant recipients and matched chronic liver disease controls. Although survival postliver transplantation is improving, our cross-sectional study suggests that functional ability may not improve postliver transplantation. Further study is warranted to address the mechanisms responsible for post-transplant functional impairment and to develop effective rehabilitation regimes to maximize function following liver transplantation.","Elliott, C., et al. (2011). \"Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls.\" Transpl Int 24(6): 588-595.","UK",2011,"Liver Disease","Surgery","FIS"]
[79,"Emery, P., et al. (2015). \"Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?\" Ann Rheum Dis 74(12): 2165-2174.",null,"Emery, P., et al.","Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?","BACKGROUND: This study assessed the impact of simultaneous achievement of clinical, functional and structural efficacy, herein referred to as comprehensive disease control (CDC), on short-term and long-term work-related outcomes, health-related quality of life (HRQoL), pain and fatigue. METHODS: Data were pooled from three randomised trials of adalimumab plus methotrexate for treatment of early-stage or late-stage rheumatoid arthritis (RA). CDC was defined as 28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in modified Total Sharp Score </=0.5. Changes in scores at weeks 26 and 52 for work-related outcomes, Short Form 36 (SF-36) physical (PCS) and mental component scores (MCS), a Visual Analogue Scale measuring pain (VAS-Pain) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were compared between patient groups defined by achievement of CDC at week 26 using linear regression with adjustment for baseline scores. RESULTS: Patients with RA who achieved CDC at week 26 (n=200) had significantly greater improvements in VAS-Pain (46.9 vs 26.9; p<0.0001), FACIT-F (13.3 vs 7.5; p<0.0001), SF-36 PCS (19.7 vs 8.9; p<0.0001) and SF-36 MCS (8.1 vs 5.0; p=0.0004) than those who did not (n=1267). Results were consistent at week 52 and among methotrexate-naive patients with early RA, methotrexate-experienced patients with late-stage RA and patients with inadequate response to methotrexate. CONCLUSIONS: Patients with RA who achieved CDC at week 26 had improved short-term and long-term HRQoL, pain, fatigue and work-related outcomes compared with patients who do not. These results demonstrate that the joint achievement of all CDC components provides meaningful benefits to patients. TRIAL REGISTRATION NUMBERS: DE019: NCT00195702, PREMIER: NCT00195702, OPTIMA: NCT00195702.","Emery, P., et al. (2015). \"Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?\" Ann Rheum Dis 74(12): 2165-2174.","USA",2015,"Musculoskeletal","Adalimumab,Other Drugs","VAS-F,FACIT-F"]
[80,"Epstein, E., et al. (2008). \"Health related quality of life measures in Friedreich Ataxia.\" J Neurol Sci 272(1-2): 123-128.",null,"Epstein, E., et al.","Health related quality of life measures in Friedreich Ataxia","Evaluation of therapeutic agents for Friedreich Ataxia (FA) has been limited by a lack of adequate markers of disease progression. We assessed the capacity of health related quality of life (HRQOL) questionnaires to reflect disease status in FA. The SF-36 and several symptom-specific scales were administered to an FA cohort. Scores were compared with norms for the United States population, and to a disease-free control group of similar age and gender. FA patients had significantly lower SF-36 Physical Component Summary scores (PCS) and Physical Functioning Subscale (PFS) scores, and both PCS and PFS scores correlated significantly with disease duration and disability status. Mental Component Summary scores (MCS) did not differ between FA patients and controls. Among symptom-specific scales, scores for the Pain Effects, Bladder Control, and Modified Fatigue Impact scales were significantly worse among FA patients than controls, and generally correlated with markers of disease progression. Findings of this study are consistent with the phenotypic characteristics of FA, and suggest that HRQOL measures are potentially useful as clinical markers of disease status in FA.","Epstein, E., et al. (2008). \"Health related quality of life measures in Friedreich Ataxia.\" J Neurol Sci 272(1-2): 123-128.","USA",2008,"Neurological","None","MFI"]
[81,"Etemadifar, M., et al. (2013). \"Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study.\" Int J Neurosci 123(7): 480-486.",null,"Etemadifar, M., et al.","Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study","BACKGROUND: Fatigue is one of the common complaints of multiple sclerosis (MS) patients, and its treatment is relatively unclear. Ginseng is one of the herbal medicines possessing antifatigue properties, and its administration in MS for such a purpose has been scarcely evaluated. The purpose of this study was to evaluate the efficacy and safety of ginseng in the treatment of fatigue and the quality of life of MS patients. METHODS: Eligible female MS patients were randomized in a double-blind manner, to receive 250-mg ginseng or placebo twice daily over 3 months. Outcome measures included the Modified Fatigue Impact Scale (MFIS) and the Iranian version of the Multiple Sclerosis Quality Of Life Questionnaire (MSQOL-54). The questionnaires were used after randomization, and again at the end of the study. RESULTS: Of 60 patients who were enrolled in the study, 52 (86%) subjects completed the trial with good drug tolerance. Statistical analysis showed better effects for ginseng than the placebo as regards MFIS (p = 0.046) and MSQOL (p </= 0.0001) after 3 months. No serious adverse events were observed during follow-up. CONCLUSIONS: This study indicates that 3-month ginseng treatment can reduce fatigue and has a significant positive effect on quality of life. Ginseng is probably a good candidate for the relief of MS-related fatigue. Further studies are needed to shed light on the efficacy of ginseng in this field.","Etemadifar, M., et al. (2013). \"Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study.\" Int J Neurosci 123(7): 480-486.","Iran",2013,"Neurological","Complementary","MFI"]
[82,"Feil, K., et al. (2017). \"Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.\" BMC Neurol 17(1): 7.",null,"Feil, K., et al.","Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial","BACKGROUND: Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA. METHODS/DESIGN: An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated. DISCUSSION: The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness. TRIAL REGISTRATION: The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).","Feil, K., et al. (2017). \"Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.\" BMC Neurol 17(1): 7.","Germany",2017,"Neurological","Various","FSS"]
[83,"Fichtner, S., et al. (2012). \"Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation.\" J Cardiovasc Electrophysiol 23(2): 121-127.",null,"Fichtner, S., et al.","Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation","BACKGROUND: This study prospectively assesses different aspects of short- and long-term quality of life (QoL) after catheter ablation for atrial fibrillation (AF). An analysis of 7 validated generic and tailored questionnaires was performed with regard to the relation of QoL to ablation success. METHODS: The study included 133 patients (74% men, age 57+/-10) who underwent pulmonary vein isolation +/- linear or electrogram-guided substrate modification for AF. QoL was quantitatively assessed at baseline, 3 months after ablation and at a median of 4.3 +/- 0.5 years after ablation by the AF severity scale (AFSS), AF symptom checklist (AFSC), WHO-5-Well-Being-Index (WHO), Major Depression Inventory (MDI), Sleep and Vegetative disorder (SV), Vital Exhaustion (VE), and Illness intrusiveness (Ii). RESULTS: QoL was improved significantly 3 months after ablation in all patients (regardless of ablation success or AF type) and stayed significantly improved after a median of 4.3+/-0.5 years (AFSS, AFSC, WHO, MDI, VE, PE (all P < 0.001), and SV (P = 0.007)). Patients who had a successful ablation improved significantly more than patients with an unsuccessful ablation in the AFSS, AFSC, and MDI questionnaire (delta change from baseline to long-term follow-up P = <0.001, P = <0.001, and P = 0.039, respectively). CONCLUSION: Overall, all patients significantly improved their QoL irrespective of the AF type in all questionnaires 3 months and 4 years after ablation. The increase in QoL was significantly greater in patients who underwent a successful ablation than patients with unsuccessful ablation in the AFSS, AFSC, and MDI questionnaire.","Fichtner, S., et al. (2012). \"Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation.\" J Cardiovasc Electrophysiol 23(2): 121-127.","Germany",2012,"CVD","Surgery","SV,VE"]
[84,"Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.",null,"Fillion, L., et al.","Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue","Cancer-related fatigue is the most reported symptom among patients with cancer. Researchers in the field of psychooncology have encouraged the development of short instruments, which allow for easier completion by clinical populations while still maintaining solid psychometric properties. The current study examined the validity and reliability of the French Canadian adaptation of the Multidimensional Fatigue Inventory (MFI) among women (n = 277) and men (n = 327) undergoing therapy for breast or prostate cancer, respectively. An exploratory factor analysis of the selected 15-item MFI yielded the following four factors: general/physical, mental, reduced motivation, and reduced activity. This was supported by a confirmatory factor analysis. The reliability, as evaluated by test-retest and Cronbach alpha internal consistency reliability coefficients of the French Canadian shortened MFI, was acceptable. In addition, the four factor-based scores correlated in a theoretically meaningful manner with existing measures of mood disturbance (Profile of Mood States and Hospital Anxiety and Depression Scale), cancer-related stressors (Inventory of Recent Life Experiences), coping with illness (Coping with Health Injuries and Problems Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and insomnia (Insomnia Severity Index), suggesting good construct, convergent, and concurrent criterion validity. Although further validation is recommended, the results for the French Canadian MFI in assessing cancer-related fatigue in both women and men undergoing cancer treatments showed good psychometric qualities.","Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.","Canada",2003,"Cancer","None","MFI"]
[85,"Frech, T., et al. (2011). \"Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study.\" Rheumatology (Oxford) 50(7): 1280-1287.",null,"Frech, T., et al.","Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study","OBJECTIVE: Rheumatologic disorders are associated with sleep disturbances. This study examines sleep disturbance correlates in patients with SSc. METHODS: Participants are 180 SSc patients in an observational study. At baseline, patients completed the Medical Outcomes Study Sleep measure (MOS-Sleep scale). In addition, patients were administered other patient-reported outcome (PRO) measures including the 36-item short form (SF-36), HAQ disability index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Center for Epidemiologic Studies Depression (CESD) scale and a University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Questionnaire (UCLA SCTC GIT 2.0). Descriptive statistics were assessed for six scales of MOS-Sleep and the 9-item sleep problem index (SLP-9; a composite index). We computed Spearman's rank-order correlations between the MOS-Sleep scales and the HAQ-DI, FACIT-Fatigue, CESD, SSc-SCTC GIT 2.0 and SF-36 scales. In addition, we developed a regression model to assess predictors of SLP-9 scores. Covariates included demographics, physician variables of disease severity and patient-reported variables of worsening symptoms and the PRO measures. RESULTS: SSc patients reported a mean (s.d.) of 7.1 (1.73) h of sleep a night. Patients reported worse scores on four of six scales (except for snoring and sleep quantity) compared with the US general population (P < 0.001). SLP-9 was correlated with worsening pain and dyspnoea over the past 1 month, reflux scale of the UCLA SCTC GIT 2.0, CESD and FACIT-Fatigue (rho 0.26-0.56). In the stepwise multivariate regression model, the CESD, worsening dyspnoea and reflux scale were significantly associated with SLP-9 index. CONCLUSION: Sleep disturbances are common in SSc and are associated with worsening dyspnoea, depressed mood and severity of reflux symptoms.","Frech, T., et al. (2011). \"Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study.\" Rheumatology (Oxford) 50(7): 1280-1287.","USA",2011,"Inflamatory Systemic Disease","None","FACIT-F"]
[86,"Gabbe, B. J., et al. (2016). \"Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project.\" Burns 42(8): 1652-1661.",null,"Gabbe, B. J., et al.","Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project","INTRODUCTION: Fatigue has been identified as an outcome of concern following burn but is rarely captured in outcomes studies. We aimed to: (i) describe the prevalence, and predictors, of moderate to severe fatigue in the first 12 months following burn, and (ii) establish the association between fatigue and health-related quality of life and work outcomes. METHODS: Adult burns patients, admitted >24h, were recruited from five BRANZ sites. Participants were followed-up at 1-, 6-, and 12-months after injury using the Brief Fatigue Inventory (BFI), 36-item Short Form Health Survey (SF-36) and the Sickness Impact Profile (SIP)-work scale. Moderate to severe fatigue was defined as a global BFI score of 4-10. Multivariable mixed effects regression modelling was used to identify demographic, socioeconomic, burn size and severity predictors of moderate/severe fatigue at follow-up. RESULTS: The mean+/-SD age of the 328 participants was 42.1+/-16.7years, 70% were male, 47% were flame burns, and the mean+/-SD %TBSA was 8.7+/-11.2. The prevalence of moderate/severe fatigue decreased from 37% at 1-month, to 32% at 6-months and 26% at 12-months. The adjusted odds of moderate/severe fatigue were 2.62 (95% CI: 1.27, 5.42) times higher for women compared to men, and 2.64 (95% CI: 1.03, 6.79) times higher in patients with a %TBSA>/=20. Compared to patients in major cities, the adjusted odds of reporting moderate/severe fatigue were 2.48 fold higher (95% CI: 1.17, 5.24) for patients residing in inner regional areas, and 3.60 fold (95% CI: 1.43, 9.05) higher for patients living in remote/very remote areas. At each time point, the physical and mental health summary scores, and each sub-scale score, of the SF-36 were significantly lower in patients reporting moderate/severe fatigue. Patients experiencing moderate to severe fatigue reported higher work-related disability on the SIP work scale at each time point after injury. DISCUSSION AND CONCLUSION: More than a quarter of participants reported moderate to severe fatigue on the BFI at 12-months and fatigue was strongly associated with poorer health-related quality of life and greater work-related disability.","Gabbe, B. J., et al. (2016). \"Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project.\" Burns 42(8): 1652-1661.","UK",2016,"Various","None","BFI"]
[87,"Galiano-Castillo, N., et al. (2013). \"Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.\" Trials 14: 187.",null,"Galiano-Castillo, N., et al.","Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial","BACKGROUND: Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women. METHODS / DESIGN: This study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters. DISCUSSION: This study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth systems could offer a choice of supportive care to cancer patients during the survivorship phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01801527.","Galiano-Castillo, N., et al. (2013). \"Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.\" Trials 14: 187.","Spain",2013,"Cancer","Psychobehavioural","PFS,Borg Fatigue Scale"]
[88,"Galiano-Castillo, N., et al. (2016). \"Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors.\" Cancer 122(20): 3166-3174.",null,"Galiano-Castillo, N., et al.","Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors","BACKGROUND: The chronicity status of breast cancer survivors suggests a growing need for cancer rehabilitation. Currently, the use of technology is a promising strategy for providing support, as reflected in the emergence of research interest in Web-based interventions in cancer survivorship. METHODS: A randomized controlled trial was conducted that included a total of 81 participants who had completed adjuvant therapy (except hormone treatment) for stage I to IIIA breast cancer. Participants were randomly assigned to an 8-week Internet-based, tailored exercise program (n = 40) or to a control group (n = 41).The instruments used at baseline, 8 weeks, and 6-month follow-up were the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and its breast cancer module, the Brief Pain Inventory, the handgrip dynamometer, the isometric abdominal test, the back dynamometer, the multiple sit-to-stand test, and the Piper Fatigue Scale. RESULTS: After the intervention, the telerehabilitation group had significantly improved scores for global health status, physical, role, cognitive functioning, and arm symptoms (all P < .01) as well as pain severity (P = .001) and pain interference (P = .045) compared with the control group. Significant improvements also were observed favoring the telerehabilitation group for affected and nonaffected side handgrip (both P = .006), abdominal, back and lower body strength (all P < .01), and total fatigue (P < .001). These findings were maintained after 6 months of follow-up, except for role functioning, pain severity, and nonaffected side handgrip. Analysis was based on an intention-to-treat principle. CONCLUSIONS: This program may improve adverse effects and maintain benefits in breast cancer survivors. The results of this study have encouraging implications for cancer care. Cancer 2016;122:3166-74. (c) 2016 American Cancer Society.","Galiano-Castillo, N., et al. (2016). \"Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors.\" Cancer 122(20): 3166-3174.","Spain",2016,"Cancer","Psychobehavioural","PFS"]
[89,"Garcia-Campayo, J., et al. (2007). \"Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42.\" Pain 132 Suppl 1: S68-76.",null,"Garcia-Campayo, J., et al.","Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42","There are few studies on coping with fibromyalgia (FM). The aim of the present study was to assess the usefulness of a Spanish version of the Chronic Pain Coping Inventory-42 (CPCI-42) in patients with FM. A random sample (N=402) of patients with FM was obtained from the Fibromyalgia Association of Aragon, Spain. Patients were assessed with the CPCI-42, the Fibrofatigue Scale (FFS), the EuroQol-5D (EQ-5D), and the Hospital Anxiety and Depression Scale (HADS). The psychometric properties of the CPCI-42 were valid and factor analyses supported the eight-factor structure described in patients with chronic pain. Illness-focused coping strategies (i.e., guarding, resting, and asking for assistance) were strongly correlated with each other, positively correlated with disability and depression, and negatively correlated with quality of life, indicating construct validity. Seeking social support was weakly correlated with any other scale or outcome, confirming it belongs to a different group of coping strategies. The wellness-focused group of coping strategies was the most incoherent group. Task persistence correlated with illness-focused strategies and negative outcomes, indicating that it should be included in the illness-focused group. However, other wellness-focused strategies, including relaxation, exercise, and coping self-statements, were correlated with each other, negatively correlated with depression, and positively correlated with quality of life. Future research directions and clinical implications are discussed.","Garcia-Campayo, J., et al. (2007). \"Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42.\" Pain 132 Suppl 1: S68-76.","Spain",2007,"Musculoskeletal","None","FFS"]
[90,"Garrett, A. L., et al. (2016). \"Uphill both ways: Fatigue and quality of life in valley fever.\" Med Mycol 54(3): 310-317.",null,"Garrett, A. L., et al.","Uphill both ways: Fatigue and quality of life in valley fever","Primary pulmonary coccidioidomycosis is characterized by prolonged respiratory and systemic symptoms and fatigue. We prospectively administered the fatigue severity scale (FSS) and Short Form-36 Health Status Questionnaire (SF-36) to patients with proven or probable primary pulmonary coccidioidomycosis to quantify disease effect on quality of life (QOL). The 24-week observational study did not specify whether antifungal treatment would be provided; the treating physician made treatment decisions. FSS and SF-36 were completed at 4-week intervals. Thirty-six patients participated, of whom 20 received antifungal treatment. At onset of coccidioidal illness, mean FSS score was higher (ie, more fatigue) in the treatment group. However, in early illness, both groups had higher fatigue levels than reference populations with other diseases (eg, multiple sclerosis). FSS scores gradually improved, and scores in each group were below the severe fatigue level at week 12 and week 16 in the nontreatment and treatment groups, respectively. By week 24, mean FSS score of the nontreatment group equaled the general population. SF-36 component and profile scores were lower (with more symptoms) in the treatment group at each time point than the nontreatment group; both groups showed similar improvement. Mental and emotional health SF-36 scores were not as severely affected as physical scores. Most patients reached a physical functioning level similar to the general population at week 12. Pulmonary coccidioidomycosis causes severe fatigue and substantially affects physical abilities. Fatigue was found to be prolonged, with gradual improvement in QOL, regardless of antifungal administration.","Garrett, A. L., et al. (2016). \"Uphill both ways: Fatigue and quality of life in valley fever.\" Med Mycol 54(3): 310-317.","USA",2016,"Respiratory Disease","None","FSS"]
[91,"Gauthier, L., et al. (2011). \"Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years.\" Sleep Med 12(9): 844-849.",null,"Gauthier, L., et al.","Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years","OBJECTIVE: The mandibular advancement appliance (MAA) is now recognized as a first-line therapy option for mild to moderate obstructive sleep apnea syndrome (OSAS). The aim of this follow-up study was to re-assess the long-term efficacy of MAAs provided to patients in a previous comparative study. METHODS: Sixteen subjects had participated in a previous comparative study in which the efficacy and compliance of two MAAs (Klearway - K and Silencer - S) were compared in a randomized cross-over design. At the end of the previous comparative study, subjects selected the MAA they preferred. Nine chose the K and seven the S. Fifteen subjects were available for a follow-up interview and 14 (4 women and 10 men; mean +/- SEM: 51.9 +/- 1.7 y.o.) agreed to participate in an overnight sleep recording at a hospital sleep laboratory from January to February 2009. The mean time lag between the end of the previous comparative study and the follow-up was 40.9 +/- 2.1 months (range of 2.5-4.5 years). Comparisons were made across the three polysomnographic evaluations (PSGE): baseline, the night with the appliance of their choice at the end of the previous comparative study, and the follow-up night. Subjects completed the Epworth sleepiness scale (ESS), the fatigue severity scale (FSS), and a quality of life questionnaire (FOSQ). RESULTS: At the follow-up, the respiratory disturbance index (RDI) remained significantly lower than baseline (p<0.001). Questionnaire responses revealed that ESS, FSS, and FOSQ remained improved at follow-up (p<0.02). Body mass index (BMI) increased slightly from baseline to follow-up (p<0.05). Diastolic and systolic blood pressure and cardiac rhythm decreased significantly from baseline to follow-up. CONCLUSIONS: The MAAs remained effective in improving RDI, sleepiness, blood pressure, cardiac rhythm, fatigue, sleep quality, and quality of life over a period of 2.5-4.5 years. The rise in BMI is a concern that merits further examination.","Gauthier, L., et al. (2011). \"Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years.\" Sleep Med 12(9): 844-849.","Canada",2011,"Respiratory Disease","Various","FSS"]
[92,"Genovese, M. C., et al. (2012). \"Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.\" J Rheumatol 39(6): 1185-1191.",null,"Genovese, M. C., et al.","Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study","OBJECTIVE: To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. RESULTS: Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52. CONCLUSION: Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).","Genovese, M. C., et al. (2012). \"Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.\" J Rheumatol 39(6): 1185-1191.","USA",2012,"Musculoskeletal","Golimumab","FACIT-F"]
[93,"Gielissen, M. F., et al. (2013). \"Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors.\" Psychol Assess 25(2): 658-663.",null,"Gielissen, M. F., et al.","Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors","OBJECTIVE: The Pictorial Representation of Self and Illness Measure (PRISM) measures in a simple, graphic way the burden of suffering due to illness. The question addressed in this study is whether the PRISM is a valid instrument to measure suffering in cancer survivors experiencing severe fatigue. METHOD: Quantitative and qualitative data of a previous randomized controlled trial demonstrating the efficacy of cognitive behavior therapy (CBT) especially designed for postcancer fatigue was used to assess convergent validity and sensitivity to change in a sample of 83 cancer survivors. MEASURES: The PRISM, yielding self-illness separation (SIS-fatigue = suffering due to fatigue; SIS-cancer = suffering due to cancer), fatigue severity (Checklist Individual Strength; CIS-fatigue), functional impairment, psychological well-being, quality of life, and coping with the experience of cancer (Impact of Event Scale; IES). RESULTS: Moderate significant correlations were found with the PRISM and the above-mentioned measures. On the basis of SIS scores, the sample was divided into two separate groups: cancer survivors who suffered more because of fatigue and cancer survivors who suffered more because they had cancer in the past. The two groups had different scores on CIS-fatigue and IES, in line with that aspect that caused them the most suffering. The qualitative data confirmed this finding. Participants in the CBT condition demonstrated a significant difference between SIS-fatigue at baseline versus 6 months later compared with those in the waiting list condition. No change of SIS-cancer was found. CONCLUSION: The PRISM seems to be a valuable tool in fatigue research and clinical practice.","Gielissen, M. F., et al. (2013). \"Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors.\" Psychol Assess 25(2): 658-663.","Netherlands",2013,"Cancer","Psychobehavioural","CIS-F"]
[94,"Gladman, D. D., et al. (2007). \"Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial.\" Ann Rheum Dis 66(2): 163-168.",null,"Gladman, D. D., et al.","Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial","OBJECTIVE: To evaluate the effects of adalimumab on patient-reported outcomes of joint-related and skin-related functional impairment, health-related quality of life, fatigue and pain in patients with psoriatic arthritis (PsA). METHODS: Patients with moderately- to severely- active PsA were treated with adalimumab, 40 mg, every other week, or placebo, in this 24-week, randomised, controlled trial. Patient-reported outcomes included the Health Assessment Questionnaire Disability Index (HAQ DI), Short-Form 36 Health Survey (SF-36), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale and the Dermatology Life Quality Index (DLQI). RESULTS: Adalimumab (n = 151) and placebo (n = 162) groups were comparable with respect to baseline demographics and disease severity. Significant changes from baseline in HAQ DI were reported for adalimumab v placebo (-0.4 v -0.1, p<0.001) at both 12 and 24 weeks. At week 24, significant improvements in the SF-36 domains of physical functioning, role-physical, bodily pain, general health, vitality and social functioning, as well as the physical component summary score, were observed for adalimumab versus placebo (p<0.01). These reported changes in HAQ DI and SF-36 were also clinically important. Significantly more patients treated with adalimumab had complete resolution of functional loss (HAQ DI = 0) and dermatological-related functional limitations (DLQI = 0) compared with placebo at weeks 12 and 24 (p< or =0.001). Adalimumab led to significantly greater improvements in FACIT-Fatigue scores, pain scores, and disease activity measures versus placebo at 12 and 24 weeks (p<0.001 for all). CONCLUSIONS: Adalimumab improved physical-related and dermatological-related functional limitations, HRQOL, fatigue and pain in patients with PsA treated for 24 weeks.","Gladman, D. D., et al. (2007). \"Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial.\" Ann Rheum Dis 66(2): 163-168.","Canada",2007,"musculoskeletal","Adalimumab","FACIT-F"]
[95,"Gladman, D. D., et al. (1996). \"A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE).\" Lupus 5(3): 190-195.",null,"Gladman, D. D., et al.","A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE)","The aim of the present investigation was to assess and compare health status instruments in SLE. One hundred and twenty-five patients completed five health status instruments: the Health Assessment Questionnaire (HAQ), Functional Ability Index, the Fatigue Severity Scale (FSS), the Disability Days Measure (DDM), the Centre for Epidemiological Studies-Depression Scale (CES-D), and the Medical Outcomes Study (MOS) Short Form Health Survey during their Clinic visit. Disease activity was measured using the SLE Disease Activity Index (SLEDAI). All instruments described a spectrum of quality of life outcomes in these patients. An inter-instrument correlation analysis revealed that components of the MOS correlated significantly with each of the other instruments used. There was no correlation between any of the instruments used and the SLEDAI. We conclude that health status assessment as measured by the MOS short form is a valid independent outcome measure in patients with SLE.","Gladman, D. D., et al. (1996). \"A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE).\" Lupus 5(3): 190-195.","Canada",1996,"Inflamatory Systemic Disease","None","FSS"]
[96,"Glossmann, J. P., et al. (2003). \"Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.\" Ann Hematol 82(8): 469-475.",null,"Glossmann, J. P., et al.","Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial","The aim of the study was to investigate the effects of erythropoietin (epoetin beta) on red blood cell (RBC) transfusions, hemoglobin (Hb) levels, and quality of life (QOL) in patients with relapsed lymphoma treated with an aggressive sequential salvage chemotherapy (SSCT) regimen. Sixty patients with early or late relapsed Hodgkin's disease ( n=39) or first relapse of aggressive non-Hodgkin's lymphoma ( n=21) were randomized to receive epoetin beta 10,000 IE subcutaneously three times a week or no epoetin during salvage chemotherapy. Patients in both study arms received two cycles of DHAP (dexamethasone, high-dose cytarabine, cisplatin); patients in partial remission (PR) or complete remission (CR) then received cyclophosphamide, followed by peripheral blood stem cell (PBSC) harvest, methotrexate plus vincristine, and etoposide. The final myeloablative course was BEAM (carmustine, etoposide, cytarabine, and melphalan) followed by autologous stem cell support. The primary endpoint of the study was the number of RBC units needed during SSCT. In addition, Hb levels and QOL were measured. The mean number of RBC units given in the epoetin beta arm was 4.5 compared to 8.3 in the control arm ( P=0.0134). The mean Hb levels during therapy were 10.4 g/dl in the epoetin beta arm and 9.7 g/dl in the control ( P=0.018). From baseline until BEAM therapy QOL (EORTC QLQ C30) and fatigue (MFI) assessment showed little QOL worsening or stable levels in both arms with a steeper increase of fatigue levels in the control group. Patients with relapsed lymphoma undergoing aggressive chemotherapy and stem cell support benefited from epoetin beta therapy, with a decrease of RBC transfusion requirements and lower rise of fatigue levels.","Glossmann, J. P., et al. (2003). \"Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.\" Ann Hematol 82(8): 469-475.","Germany",2003,"Cancer","Epoetin Beta","MFI"]
[97,"Goh, J., et al. (1999). \"Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection.\" Eur J Gastroenterol Hepatol 11(8): 833-838.",null,"Goh, J., et al.","Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection","BACKGROUND: Fatigue is probably the most commonly reported symptom in chronic hepatitis C virus (HCV) infection. It is unclear whether fatigue is related to the severity of underlying liver disease or other autoimmune disorders often described with chronic HCV infection. OBJECTIVE: To quantify fatigue in terms of its impact on quality of life in a homogeneous cohort and examine its relationship to the status of liver disease or associated autoimmunity. METHODS: The Fatigue Impact Scale (FIS) questionnaire (Fisk et al. Clin Infect Dis 1994; 18:S79-S83), a recently validated psychometric tool for assessing patients' perceptions of the functional limitations attributable to fatigue (40 statements; three subscales: physical, cognitive and psychological; maximum score = 160), was applied to a cohort of Irish women who were PCR-positive for HCV genotype 1b via inoculation with contaminated anti-D products in 1977. RIBA-positive, PCR-negative patients (n = 20) and healthy age-matched women (n = 50) served as controls. The degree of hepatitis was assessed using the Knodell histological activity index (HAI) score on previous liver biopsies. Clinical and laboratory evidence of cryoglobulinaemia, Sjogren's syndrome, connective tissue diseases, autoimmune thyroid disease and glomerulonephritis was sought. RESULTS: The mean FIS score of the 66 PCR-positive women (mean 78+/-36; range 7-153) was significantly higher than in age-matched controls (mean 31+/-24, range 0-78, P<0.001) but not statistically different from that of the RIBA-positive, PCR-negative group. The FIS score did not correlate with the HAI score (median HAI = 4; range 2-9; Pearson's correlation coefficient r=0.01, P=0.9). Significant levels of cryoglobulins were detected in 10 (15.2%). The sicca complex was diagnosed in six patients, three of whom had associated cryoglobulinaemia. Thyroid antibodies, anti-nuclear antibody, rheumatoid factor, antimitochondrial antibody and anti-smooth muscle antibody were detected in 15.2%, 6%, 4.5%, 4.5% and 1.5%, respectively. There was no significant difference in the FIS score between the groups with autoimmune diseases and those without. The FIS score of the nine patients previously treated with interferon was not statistically different from the untreated group (P=0.39). CONCLUSION: The perceived functional impact of fatigue on quality of life is significantly higher in patients with chronic HCV genotype 1b infection compared to healthy controls. However, it is unrelated to the degree of hepatitis and cannot be accounted for by the co-existence of autoimmune disorders alone.","Goh, J., et al. (1999). \"Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection.\" Eur J Gastroenterol Hepatol 11(8): 833-838.","Ireland",1999,"Infectious Disease","None","FIS"]
[98,"Gonzalez, H., et al. (2006). \"Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.\" Lancet Neurol 5(6): 493-500.",null,"Gonzalez, H., et al.","Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial","BACKGROUND: Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome. METHODS: 142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082. FINDINGS: Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the placebo group (p=0.037). Intravenous immunoglobulin was well tolerated. INTERPRETATION: Intravenous immunoglobulin could be a supportive treatment option for subgroups of patients with post-polio syndrome. Further studies on responding subgroups, long-term effects, and dosing schedules are needed.","Gonzalez, H., et al. (2006). \"Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.\" Lancet Neurol 5(6): 493-500.","Sweden",2006,"neurological","Various","MFI,VAS-F"]
[99,"Grimmett, C., et al. (2013). \"RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial.\" Trials 14: 184.",null,"Grimmett, C., et al.","RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial","BACKGROUND: There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment. METHODS/DESIGN: This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring >/=4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes. DISCUSSION: Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment. TRIAL REGISTRATION: ISRCTN67521059.","Grimmett, C., et al. (2013). \"RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial.\" Trials 14: 184.","UK",2013,"Cancer","None","BFI"]
[100,"Groenveld, H. F., et al. (2011). \"The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study.\" J Am Coll Cardiol 58(17): 1795-1803.",null,"Groenveld, H. F., et al.","The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study","OBJECTIVES: The aim of this study was to investigate the influence of rate control on quality of life (QOL). BACKGROUND: The RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) trial showed that lenient rate control is not inferior to strict rate control in terms of cardiovascular morbidity and mortality. The influence of stringency of rate control on QOL is unknown. METHODS: In RACE II, a total of 614 patients with permanent atrial fibrillation (AF) were randomized to lenient (resting heart rate [HR] <110 beats/min) or strict (resting HR <80 beats/min, HR during moderate exercise <110 beats/min) rate control. QOL was assessed in 437 patients using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) questionnaire, AF severity scale, and Multidimensional Fatigue Inventory-20 (MFI-20) at baseline, 1 year, and end of study. QOL changes were related to patient characteristics. RESULTS: Median follow-up was 3 years. Mean age was 68 +/- 8 years, and 66% were males. At the end of follow-up, all SF-36 subscales were comparable between both groups. The AF severity scale was similar at baseline and end of study. At baseline and at end of study there were no differences in the MFI-20 subscales between the 2 groups. Symptoms at baseline, younger age, and less severe underlying disease, rather than assigned therapy or heart rate, were associated with QOL improvements. Female sex and cardiovascular endpoints during the study were associated with worsening of QOL. CONCLUSIONS: Stringency of heart rate control does not influence QOL. Instead, symptoms, sex, age, and severity of the underlying disease influence QOL. (Rate Control Efficacy in Permanent Atrial Fibrillation; NCT00392613).","Groenveld, H. F., et al. (2011). \"The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study.\" J Am Coll Cardiol 58(17): 1795-1803.","Netherlands",2011,"CVD","None","MFI"]
[101,"Haldorsen, K., et al. (2011). \"A five-year prospective study of fatigue in primary Sjogren's syndrome.\" Arthritis Res Ther 13(5): R167.",null,"Haldorsen, K., et al.","A five-year prospective study of fatigue in primary Sjogren's syndrome","INTRODUCTION: Fatigue is prevalent in primary Sjogren's syndrome (pSS), and contributes to the considerably reduced health related quality of life in this disease. The symptom is included in proposed disease activity and outcome measures for pSS. Several studies indicate that there is an inflammatory component of fatigue in pSS and other chronic inflammatory rheumatic diseases. The purpose of this study was to investigate fatigue change in pSS in a longitudinal study, and explore whether any clinical or laboratory variables at baseline, including serum cytokines, were associated with a change in fatigue scores over time. METHODS: A clinical and laboratory investigation of 141 patients fulfilling the American-European consensus criteria of pSS was undertaken in the period May 2004 to April 2005. Median time since diagnosis was 5.5 years. Examinations included the fatigue questionnaires: fatigue severity scale (FSS), fatigue visual analogue scale (VAS), functional assessment of chronic illness therapy-fatigue (FACIT-F) and medical outcome study short form-36 (SF-36) vitality, which were repeated in a follow-up investigation in January and February 2010. RESULTS: A total of 122 patients (87%) responded at both time-points. Thirty-five percent of patients experienced a clinically significant FSS increase. On the group level, fatigue measures did not change except that there was a slight deterioration in SF-36 vitality score. High serum anti-Sjogren's syndrome A antigen (anti-SSA) showed weak associations with high baseline fatigue, and patients with increasing fatigue had lower baseline unstimulated whole salivary volume. Weak associations between increasing fatigue and serum immunoglobulin G (IgG), and the pro-inflammatory cytokine interleukin-17 (IL-17), were observed. Baseline sicca symptoms correlated with higher fatigue both at baseline and with increasing fatigue over time. Linear regression analysis did not identify any predictive ability of clinical or laboratory measures on fatigue change over time. CONCLUSIONS: Fatigue remained mainly unchanged over time. Using multivariate models did not reveal any clinical or laboratory predictors of fatigue change over time.","Haldorsen, K., et al. (2011). \"A five-year prospective study of fatigue in primary Sjogren's syndrome.\" Arthritis Res Ther 13(5): R167.","Norway",2011,"Inflamatory Systemic Disease","None","FACIT-F,VAS-F"]
[102,"Hamelin, S., et al. (2010). \"Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey.\" Epilepsy Res 91(2-3): 153-160.",null,"Hamelin, S., et al.","Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey","PURPOSE: Fatigue represents a frequent complaint in epileptic patients (EP). This study attempted to evaluate fatigue in both conditions (inter-ictally and post-ictally) and to investigate the relative contribution of depression, sleepiness and epilepsy characteristics. METHODS: Consecutive EP were enrolled prospectively during a 3-month period, providing they were aged over 15 and able to fill auto-questionnaires. Age, gender, co-morbidities, seizure frequency, treatment, epilepsy syndrome, seizure lateralization and localization and last seizure occurrence were collected. Fatigue, depression and sleepiness were evaluated in both groups using the Fatigue Impact Scale (FIS), the Beck Depression Inventory (BDI), and the Epworth Sleepiness Scale (ESS). Furthermore, FIS was prospectively scored by patients post-ictally (within 24h after an incident seizure). RESULTS: 122 EP filled inclusion criteria (65 women, mean age 39+/-15). Among them, 82% presented with non-idiopathic partial epilepsy and 18% idiopathic generalized epilepsy. EP exhibit high chronic fatigue scores (62/160) irrespective of the type of epilepsy, seizure frequency, and number of antiepileptic drugs. FIS score was higher in post-ictally (79/160) than inter-ictally. FIS positively correlated with BDI and ESS. DISCUSSION: Chronic inter-ictal and post-ictal fatigue could represent a further complication of epilepsy, associated with depression. The impact of fatigue should be considered with the aim of improving quality of life and care of patients with epilepsy.","Hamelin, S., et al. (2010). \"Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey.\" Epilepsy Res 91(2-3): 153-160.","France",2010,"Neurological","None","FIS"]
[103,"Harel, D., et al. (2012). \"Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale.\" Rheumatology (Oxford) 51(12): 2177-2185.",null,"Harel, D., et al.","Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale","OBJECTIVE: Fatigue is a common and important problem in SSc. No studies, however, have compared the properties of fatigue measures in SSc. The objective of this study was to compare the performances of the Short Form-36 (SF-36) Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT) in SSc. METHODS: Cross-sectional, multi-centre study of Canadian Scleroderma Research Group Registry patients. The associations of the two instruments with other patient-reported outcome measures, as well as physician- and patient-rated disease variables were compared. Item response theory models were used to compare the degree to which items and the total scores of each measure effectively covered the full spectrum of fatigue levels. RESULTS: There were 348 patients (297 women, 85%) in the study. The instruments correlated at r = 0.65 with each other. The FACIT tended to correlate slightly higher than the SF-36 Vitality subscale with physician- and patient-rated disease variables and patient-reported physical function and disability, whereas the SF-36 Vitality subscale correlated minimally higher with mental health measures. The FACIT had markedly better discrimination across the range of fatigue, particularly at average to high fatigue levels, whereas the SF-36 Vitality subscale discriminated well only among patients in the low to average range. CONCLUSION: The FACIT discriminates better than the SF-36 Vitality subscale at average to high ranges of fatigue, which is common in SSc, suggesting that it is preferred for measuring fatigue in SSc.","Harel, D., et al. (2012). \"Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale.\" Rheumatology (Oxford) 51(12): 2177-2185.","Canada",2012,"Inflamatory Systemic Disease","None","FACIT-F"]
[104,"Hassanein, T., et al. (2004). \"The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C.\" J Hepatol 40(4): 675-681.",null,"Hassanein, T., et al.","The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C","BACKGROUND/AIMS: Peginterferon alfa-2a plus ribavirin improves sustained virological responses compared with interferon alfa-2b and ribavirin, or peginterferon alfa-2a alone in chronic hepatitis C. We examined the impact of these treatments on health related quality of life (HRQOL). METHODS: Patients (n=1121) were randomized to peginterferon alfa-2a weekly plus ribavirin or placebo, or interferon alfa-2b thrice weekly plus ribavirin. HRQOL was assessed with the SF-36 Health Survey and Fatigue Severity Scale (FSS). RESULTS: Patients receiving peginterferon alfa-2a plus ribavirin reported better HRQOL than those receiving interferon alfa-2b plus ribavirin. These differences were statistically significant for three SF-36 domains and both FSS scores (p<=0.05). Patients receiving peginterferon alfa-2a plus placebo had the least impairment; adding ribavirin significantly decreased five domains of the SF-36 and both FSS scores. Sustained virological response was associated with improvement at follow-up on all SF-36 and FSS scores. CONCLUSIONS: The effects of combination therapy on HRQOL and fatigue are less with peginterferon alfa-2a plus ribavirin than interferon alfa-2b plus ribavirin. Each medication in combination therapy with interferon and ribavirin, affects patients' quality of life differently. Understanding the relationship of specific therapeutic options to HRQOL may help physicians minimize the impact of therapy on HRQOL.","Hassanein, T., et al. (2004). \"The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C.\" J Hepatol 40(4): 675-681.","USA",2004,"Infectious Disease","Other Drugs","FSS"]
[105,"Hassoun, Z., et al. (2002). \"Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale.\" Dig Dis Sci 47(12): 2674-2681.",null,"Hassoun, Z., et al.","Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale","The aim of this study was to assess the impact of fatigue on the quality of life of patients with chronic hepatitis C (CHC) and to examine its relationship with various parameters of the disease, including viral load. The Fatigue Impact Scale (FIS), a self-report questionnaire, was applied to 92 patients with CHC, and the results were compared to those of an age-matched cohort of 213 healthy blood donors. Fatigue was frequent and disabling, being present in 67% of CHC patients, and the FIS was significantly increased in CHC patients compared to the healthy controls. Fatigue severity was not correlated with the activity of the disease or with the level of viremia. The FIS proved to be a valuable tool to assess this symptom. It should be of help for better evaluation of the clinical spectrum of the disease and should be included in trials assessing the efficacy of therapeutic interventions.","Hassoun, Z., et al. (2002). \"Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale.\" Dig Dis Sci 47(12): 2674-2681.","Canada",2002,"Infectious Disease","None","FIS"]
[106,"Heij, L., et al. (2012). \"Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.\" Mol Med 18: 1430-1436.",null,"Heij, L., et al.","Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study","ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of >/=5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Delta -11.5 +/- 3.04 versus Delta -2.9 +/- 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Delta -23.4 +/- 5.5 and Delta -14.6 +/- 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.","Heij, L., et al. (2012). \"Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.\" Mol Med 18: 1430-1436.","Netherlands",2012,"Inflamatory Systemic Disease","Various","FAS"]
[107,"Herlofson, K. and J. P. Larsen (2003). \"The influence of fatigue on health-related quality of life in patients with Parkinson's disease.\" Acta Neurol Scand 107(1): 1-6.",null,"Herlofson, K. and J. P. Larsen","The influence of fatigue on health-related quality of life in patients with Parkinson's disease","OBJECTIVE: To examine the correlation between fatigue and health-related quality of life (HRQL) in patients with Parkinson's disease (PD). PATIENTS AND METHODS: Sixty-six patients with idiopathic PD. The patients did not have a depressive mood disorder or cognitive impairment. Fatigue was measured by the Fatigue Severity Scale (FSS). HRQL was measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Short-Form 36 (SF-36). RESULTS: Thirty-three (50%) of the patients had significant fatigue. Patients with fatigue had a more advanced disease than those without fatigue, measured by the UPDRS scale, including a higher Hoehn and Yahr stage and lower Schwab and England score. Patients with fatigue reported more distress in the dimensions of emotional well-being and mobility (PDQ-39) and also had a significantly higher PDQ summary index. On the SF-36 patients with fatigue reported more problems in the areas of physical functioning, role limitation (physical), social functioning and vitality. Correlations between the FSS and the HRQL scales were highest for the summary index of PDQ-39 and in the dimensions of ADL, mobility and emotional well-being (PDQ-39) and physical functioning, role limitation (physical), social functioning, general health and vitality (SF-36). CONCLUSIONS: PD has a substantial negative impact on HRQL. We found a strong correlation between fatigue and high distress scores on HRQL scales in a population of patients with PD who were not depressed or demented. The diversity of symptoms and high prevalence of non-motor features, including fatigue, is important to take into account in our efforts to optimize treatment and care for this patient group.","Herlofson, K. and J. P. Larsen (2003). \"The influence of fatigue on health-related quality of life in patients with Parkinson's disease.\" Acta Neurol Scand 107(1): 1-6.","Norway",2003,"Neurological","None","FSS"]
[108,"Holzner, B., et al. (2003). \"Fatigue in ovarian carcinoma patients: a neglected issue?\" Cancer 97(6): 1564-1572.",null,"Holzner, B., et al.","Fatigue in ovarian carcinoma patients: a neglected issue?","BACKGROUND: Although fatigue is a commonly reported symptom in cancer patients it is rarely investigated, especially in patients with ovarian carcinoma. The main focus of the current study was to assess fatigue in these patients and to investigate the impact of fatigue and other clinical and psychosocial variables on their quality of life (QOL). METHODS: Ninety-eight ovarian carcinoma survivors (average age of 57.4 +/- 12.5 years) were included in the study. All women had received cancer therapy but had not been treated for at least 6 months. The average time elapsed since first diagnosis was 5.7 +/- 5.5 years. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and QOL was measured with the Functional Assessment of Cancer Therapy (FACT)-ovarian carcinoma part and the European Organization for Research and Treatment of Cancer Care Questionnaire, including the ovarian carcinoma module. RESULTS: Thirty-two of 98 ovarian carcinoma patients (32.7%, 95% confidence interval, 23.5-42.9%) reported MFI-20 General Fatigue scores >/= 12.0 and therefore could be characterized as suffering from fatigue. This group of patients had a significantly lower QOL, had higher scores of anxiety and depression, and perceived that they had less social support. In a multiple regression model, mental adjustment, social support, anxiety, and depression as well as fatigue were significant predictors of QOL (FACT-generic part total score) whereas clinical and sociodemographic variables were not. CONCLUSION: A remarkably high proportion of ovarian carcinoma survivors suffered from fatigue. Because this symptom is a key predictor of QOL, it should be given more attention in aftercare programs.","Holzner, B., et al. (2003). \"Fatigue in ovarian carcinoma patients: a neglected issue?\" Cancer 97(6): 1564-1572.","Austria",2003,"Cancer","None","MFI"]
[109,"Hsieh, R. L. and W. C. Lee (2014). \"Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study.\" Lasers Med Sci 29(2): 671-679.",null,"Hsieh, R. L. and W. C. Lee","Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study","We conducted a double-blind randomized placebo-controlled study to investigate the effects of short-term 890-nm light therapy in patients with chronic low back pain in a rehabilitation clinic. Thirty-eight women and 22 men with chronic low back pain (mean age, 60.3 years; range, 32-80 years) received 40-min sessions of hot-pack therapy combined with active or placebo 890-nm light therapy (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 mW/cm(2) for 40 min, total energy = 83.2 J/cm(2)) over the lower back three times weekly for 2 weeks. Participants were assessed before and after treatment by using a range of motion measurements, a visual analog scale evaluation of pain, the Multidimensional Fatigue Inventory, the Biodex Stability System, the Fear-Avoidance Beliefs Questionnaire, repeated chair-rising times, the Frenchay Activity Index, the Oswestry Disability Questionnaire (ODQ), and the Osteoarthritis Quality of Life Questionnaire. The severity of disability based on the ODQ score was used as the primary clinical outcome measurement. Compared to the baseline measurements, participants in the treatment group reported significant reductions in fear-avoidance beliefs regarding physical activity (P = 0.040) and work (P = 0.007) and in the severity of disability (P = 0.021). Treatment with hot-pack therapy and 890-nm light therapy was associated with reductions in the severity of disability and fear avoidance beliefs in patients with chronic low back pain.","Hsieh, R. L. and W. C. Lee (2014). \"Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study.\" Lasers Med Sci 29(2): 671-679.","Taiwan",2014,"Musculoskeletal","Various","MFI"]
[110,"Hsieh, R. L., et al. (2012). \"Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.\" J Orthop Sports Phys Ther 42(11): 947-956.",null,"Hsieh, R. L., et al.","Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study","STUDY DESIGN: Randomized, double-blind, placebo-controlled study. OBJECTIVES: To examine the short-term therapeutic effects of monochromatic infrared energy (MIRE) on participants with knee osteoarthritis (OA). Patients were assessed according to the International Classification of Functioning, Disability and Health. BACKGROUND: MIRE is commonly used in therapy for patients with peripheral neuropathies. However, research has not focused intensively on the therapeutic effects of MIRE in patients with knee OA. METHODS: This study enrolled 73 participants with knee OA. Participants received six 40-minute sessions of active or placebo MIRE treatment (890-nm wavelength; power, 6.24 W; energy density, 2.08 J/cm2/min; total energy, 83.2 J/cm2) over the knee joints for 2 weeks. International Classification of Functioning, Disability and Health-related outcomes were collected weekly over 4 weeks using the Knee injury and Osteoarthritis Outcome Score, Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire. Data were analyzed by repeated-measures analysis of variance. RESULTS: No statistically significant differences were found for the interaction of group by time for Knee injury and Osteoarthritis Outcome Score scores, including pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores on the Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire also showed no significant differences between the 2 groups at any of the 4 follow-up assessments. CONCLUSION: Short-term MIRE therapy provided no beneficial effects to body functions, activities, participation, and quality of life in patients with knee OA.","Hsieh, R. L., et al. (2012). \"Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.\" J Orthop Sports Phys Ther 42(11): 947-956.","Taiwan",2012,"Musculoskeletal","Complementary","MFI"]
[111,"Huet, P. M., et al. (2000). \"Impact of fatigue on the quality of life of patients with primary biliary cirrhosis.\" Am J Gastroenterol 95(3): 760-767.",null,"Huet, P. M., et al.","Impact of fatigue on the quality of life of patients with primary biliary cirrhosis","OBJECTIVE: Fatigue is a frustrating symptom frequently reported by patients with primary biliary cirrhosis (PBC), but it is still poorly understood and not well evaluated. Our aim was to determine its importance and its impact on the quality of life and mental health status of patients with PBC. METHODS: Patients with PBC (103 women and 13 men with a mean age of 52.6 yr) completed self-report questionnaires to evaluate the impact of fatigue on their quality of life (Fatigue Impact Scale, FIS), the perception of their own mental health (Symptom Check list-90-R, SCL), and depression (Beck Depression Inventory, BDI). A cohort of age-matched healthy blood donors served as controls. RESULTS: Fatigue was present in 99 patients (85.3%) and was the worst or one of the worst symptoms in about half of them. In PBC patients, the mean FIS and SCL indexes were significantly increased, compared to healthy controls (1.49 +/- 1.11 vs 0.6 +/- 0.6 and 0.72 +/- 0.55 vs 0.36 +/- 0.35, respectively). Unexpectedly, 52 patients (44.8%) could be classified as having depression (BDI score > 10). Significant correlations were found between the FIS and SCL indexes, between the FIS index and the BDI score, as well as between the BDI score and the SCL index. Finally, fatigue was not related to the disease severity parameters, that is, clinical, biochemical, metabolic, and pathological. CONCLUSIONS: Fatigue is a frequent and disabling complaint that impairs the quality of life of PBC patients and their perception of their own mental health, which may be associated with an unexpected depressive condition. In addition, the FIS questionnaire can be considered as a useful tool to assess fatigue in PBC patients and may be used in the evaluation of specific treatments aimed at reducing this complaint in such patients.","Huet, P. M., et al. (2000). \"Impact of fatigue on the quality of life of patients with primary biliary cirrhosis.\" Am J Gastroenterol 95(3): 760-767.","Canada",2000,"Liver Disease","None","FIS"]
[112,"Husson, O., et al. (2013). \"Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry.\" Thyroid 23(10): 1247-1255.",null,"Husson, O., et al.","Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry","BACKGROUND: The aims of this study were (i) to obtain insight into the prevalence of fatigue among short- and long-term thyroid cancer (TC) survivors, by comparing a sample of TC survivors with an age- and sex-matched normative population, and (ii) to investigate which demographic, clinical, and TC-specific health-related quality of life (HRQoL) characteristics were associated with fatigue. METHODS: All patients found to have TC between 1990 and 2008, as registered in the Eindhoven Cancer Registry, received a cross-sectional survey on fatigue (Fatigue Assessment Scale), TC-specific HRQoL (THYCA-QoL), and psychological distress (Hospital Anxiety and Depression Scale). The fatigue scores were compared with those of an age- and sex-matched normative population (n=530). Multiple logistic regression analyses were conducted to investigate the independent associations between clinical and demographic characteristics, TC-specific HRQoL, and psychological distress with fatigue. RESULTS: Eighty-six percent (n=306) responded. TC survivors were more often classified as fatigued or very fatigued (short-term <5 years: 43%; long-term 5-10 years: 44%; long-term 10-15 years: 47%; long-term >15 years: 39%) compared to the normative population (25%; p<0.001). Anxiety (odds ratio (OR) 1.15, 95% confidence interval [CI] 1.03-1.28) and depression (OR 1.43 [CI 1.22-1.68]) were associated with fatigue, as was also the case for TC-specific neuromuscular (OR 1.03 [CI 1.01-1.06]), concentration (OR 1.03 [CI 1.01-1.06]), and psychological TC-specific HRQoL (OR 1.06 [CI 1.02-1.10]). CONCLUSION: Short- and long-term TC survivors report higher levels of fatigue than an age- and sex-matched normative population do. Both TC-specific HRQoL and psychological distress were associated with fatigue.","Husson, O., et al. (2013). \"Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry.\" Thyroid 23(10): 1247-1255.","Netherlands",2013,"Cancer","None","FAS"]
[113,"Hwang, S. S., et al. (2002). \"Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center.\" Cancer 94(9): 2481-2489.",null,"Hwang, S. S., et al.","Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center","BACKGROUND: The correlation of fatigue levels with functional interference, symptom distress, and quality of life may help determine clinically significant fatigue levels. METHODS: One hundred eighty consecutive patients with cancer completed the Functional Assessment of Cancer Therapy (FACT) General and Fatigue subscales (FACT-G and FACT-F, respectively), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), the Depression Scale (Zung), and the Brief Fatigue Inventory (BFI). The Karnofsky performance status (KPS) was determined for each patient. Multivariate analyses of variance were performed to compare fatigue models with different cut-off points to categorize fatigue levels. Cox proportional hazards analysis was performed to assess the association between fatigue severity and survival. RESULTS: Increased fatigue levels were associated with greater symptom distress and decreased quality of life. A model with usual fatigue cut-off points of 0 (no fatigue), 1-2 (mild fatigue), 3-6 (moderate fatigue), and 7-10 (severe fatigue) was optimal in relation to functional interference items (Wilks lambda, 0.36; F = 11.61; P < 0.0001), symptom distress scores (Wilks lambda, 0.52; F = 10.41; P < 0.0001), and quality-of-life scores (Wilks lambda, 0.50; F = 0.50; P < 0.0001). Fatigue severity predicted survival in univariate analysis (chi-square test, 25.42; P < 0.0001). The KPS, stage of disease, and number of symptoms independently predicted survival in patients with fatigue. CONCLUSIONS: Clinically relevant fatigue levels are correlated with symptom and quality-of-life measurements. Patients with a usual fatigue severity > 3 or a worst fatigue severity > 4 on a 1-10 scale may require further assessment.","Hwang, S. S., et al. (2002). \"Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center.\" Cancer 94(9): 2481-2489.","USA",2002,"Cancer","None","FACT-F"]
[114,"Hwang, S. S., et al. (2003). \"A comparison of three fatigue measures in veterans with cancer.\" Cancer Invest 21(3): 363-373.",null,"Hwang, S. S., et al.","A comparison of three fatigue measures in veterans with cancer","Fatigue is a highly prevalent and distressing symptom in cancer patients. The purpose of this study was to assess the validity of three fatigue measures [the Brief Fatigue Inventory (BFI), the Functional Assessment of Cancer Therapy Fatigue Subscale (FACT-F), and the lack of energy item from the Memorial Symptom Assessment Scale Short Form (MSAS-SF)] and compare these measures in relation to broader quality-of-life (QOL) constructs and clinical factors in veteran cancer patients. One-hundred-eighty cancer patients completed the BFI, FACT-F, FACT-G, MSAS-SF, and the Zung depression scale with concurrent Karnofsky performance status (KPS), laboratory tests, and demographic data. The Cronbach alpha coefficient was from 0.93 to 0.94 for BFI fatigue scales and 0.94 for FACT-F. There were significant correlations between BFI subscales, FACT-F, and lack of energy from MSAS-SF (p < 0.0001). All three fatigue measures showed significant correlation with MSAS-SF symptom subscales (p < 0.0001), FACT-G subscales (p < 0.0001), depression (p < 0.0001), KPS (p < 0.0001), inpatient status (P < 0.0001), insomnia (p < 0.05), hemoglobin (p < 0.05), and albumin levels (p < 0.01). Distress from lack of energy discriminated among levels from the BFI, FACT-F, and FACT-G subscales and MSAS-SF subsclea by one-way of variance analysis. Patient responses to BFI, FACT-F, and the lack of energy item yielded similar information about broader QOL constructs and clinical factors. Single questions about lack of energy, or fatigue severity, may provide a simple and acceptable way to assess fatigue.","Hwang, S. S., et al. (2003). \"A comparison of three fatigue measures in veterans with cancer.\" Cancer Invest 21(3): 363-373.","USA",2003,"Cancer","None","FACT-F,BFI"]
[115,"Iwase, S., et al. (2015). \"Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09).\" PLoS One 10(8): e0134022.",null,"Iwase, S., et al.","Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09)","INTRODUCTION: Cancer-related fatigue greatly influences quality of life in cancer patients; however, no specific treatments have been established for cancer-related fatigue, and at present, no medication has been approved in Japan. Systematic research using patient-reported outcome to examine symptoms, particularly fatigue, has not been conducted in palliative care settings in Japan. The objective was to evaluate fatigue, pain, and quality of life in cancer patients at the point of intervention by palliative care teams. MATERIALS AND METHODS: Patients who were referred to palliative care teams at three institutions and met the inclusion criteria were invited to complete the Brief Fatigue Inventory, Brief Pain Inventory, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative. RESULTS: Of 183 patients recruited, the majority (85.8%) were diagnosed with recurrence or metastasis. The largest group (42.6%) comprised lung cancer patients, of whom 67.2% had an Eastern Cooperative Oncology Group Performance Status of 0-1. The mean value for global health status/quality of life was 41.4, and the highest mean European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative symptom item score was for pain (51.0). The mean global fatigue score was 4.1, and 9.8%, 30.6%, 38.7%, and 20.8% of patients' fatigue severity was classified as none (score 0), mild (1-3), moderate (4-6), and severe (7-10), respectively. DISCUSSION: Cancer-related fatigue, considered to occur more frequently in cancer patients, was successfully assessed using patient-reported outcomes with the Brief Fatigue Inventory for the first time in Japan. Results suggested that fatigue is potentially as problematic as pain, which is the main reason for palliative care.","Iwase, S., et al. (2015). \"Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09).\" PLoS One 10(8): e0134022.","Japan",2015,"Cancer","None","BFI"]
[116,"Iwase, S., et al. (2016). \"Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).\" Support Care Cancer 24(2): 637-646.",null,"Iwase, S., et al.","Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01)","PURPOSE: Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients. This randomized trial investigated the efficacy of the amino acid jelly Inner Power((R)) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan. METHODS: Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events. RESULTS: Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Median patient age was 50 years. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed. CONCLUSION: IP may control moderate-severe CRF in breast cancer patients. TRIAL REGISTRATION: The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.","Iwase, S., et al. (2016). \"Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).\" Support Care Cancer 24(2): 637-646.","Japan",2016,"Cancer","Complementary","BFI"]
[117,"Janki, S., et al. (2015). \"More than a decade after live donor nephrectomy: a prospective cohort study.\" Transpl Int 28(11): 1268-1275.",null,"Janki, S., et al.","More than a decade after live donor nephrectomy: a prospective cohort study","Previously reported short-term results after live kidney donation show no negative consequences for the donor. The incidence of new-onset morbidity takes years to emerge, making it highly likely that this will be missed during short-term follow-up. Therefore, evidence on long-term outcome is essential. A 10-year follow-up on renal function, hypertension, quality of life (QOL), fatigue, and survival was performed of a prospective cohort of 100 donors. After a median follow-up time of 10 years, clinical data were available for 97 donors and QOL data for 74 donors. Nine donors died during follow-up of unrelated causes to donation, and one donor was lost to follow-up. There was a significant decrease in kidney function of 12.9 ml/min (P < 0.001) at follow-up. QOL showed significant clinically relevant decreases of 10-year follow-up scores in SF-36 dimensions of physical function (P < 0.001), bodily pain (P = 0.001), and general health (P < 0.001). MFI-20 scores were significantly higher for general fatigue (P < 0.001), physical fatigue (P < 0.001), reduced activity (P = 0.019), and reduced motivation (P = 0.030). New-onset hypertension was present in 25.6% of the donors. Donor outcomes are excellent 10 years post-donation. Kidney function appears stable, and hypertension does not seem to occur more frequently compared to the general population.","Janki, S., et al. (2015). \"More than a decade after live donor nephrectomy: a prospective cohort study.\" Transpl Int 28(11): 1268-1275.","Netherlands",2015,"Kidney Disease","Surgery","MFI"]
[118,"Jansen, A. J., et al. (2003). \"Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes.\" Br J Haematol 121(2): 270-274.",null,"Jansen, A. J., et al.","Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes","The myelodysplastic syndromes (MDS) are clonal disorders characterized by dysplasia in at least two myeloid cell lines. Fatigue is one of the most significant symptoms. MDS patients are treated with blood transfusions to improve their health-related quality of life (HRQoL). A cross-sectional pilot study was performed for psychometric evaluation of three internationally established HRQoL measures in MDS patients, and for investigation of the association between the severity of chronic anaemia and HRQoL. Fifty consecutive MDS patients completed the Short Form 36, the Multidimensional Fatigue Inventory and the EuroQoL-5D Visual Analogue Scale. Hb level was measured during the same visit. Psychometric analysis focused on feasibility, construct validity and reliability. The questionnaires showed a high feasibility, reliability and validity. MDS patients had worse HRQoL scores than the age- and sex-matched general population. We found a positive correlation between haemoglobin (Hb) level and HRQoL. This study provides insights into the suitability of established HRQoL measures for the evaluation of interventions in MDS patients. Hb value and HRQoL are complementary variables for evaluation of the severity of chronic anaemia in patients with MDS.","Jansen, A. J., et al. (2003). \"Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes.\" Br J Haematol 121(2): 270-274.","Netherlands",2003,"Hematological","None","MFI,VAS-F"]
[119,"Janssen, N., et al. (2003). \"Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work.\" Occup Environ Med 60 Suppl 1: i71-76.",null,"Janssen, N., et al.","Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work","OBJECTIVES: To investigate whether there is a relationship between fatigue and sickness absence. Two additional hypotheses were based on the theoretical distinction between involuntary, health related absence and voluntary, attitudinal absence. In the literature, the former term is usually used to describe long term sickness absence, the latter relates to short term sickness absence. In line with this, the first additional hypothesis was that higher fatigue would correspond with a higher risk of long term, primarily health related absence. The second additional hypothesis was that higher fatigue would correspond with a higher risk of short term, primarily motivational absence. METHODS: A multidimensional fatigue measure, as well as potential sociodemographic and work related confounders were assessed in the baseline questionnaire of the Maastricht cohort study on fatigue at work. Sickness absence was objectively assessed on the basis of organisational absence records and measured over the six months immediately following the baseline questionnaire. In the first, general hypothesis the effect of fatigue on time-to-onset of first sickness absence spell during follow up was investigated. For this purpose, a survival analysis was performed. The effect of fatigue on long term sickness absence was tested by a logistic regression analysis. The effect of fatigue on short term sickness absence was investigated by performing a survival analysis with time-to-onset of first short absence spell as an outcome. RESULTS: It was found that higher fatigue decreased the time-to-onset of the first sickness absence spell. Additional analyses showed that fatigue was related to long term as well as to short term sickness absence. The effect of fatigue on the first mentioned outcome was stronger than the effect on the latter outcome. Potential confounders only weakened the effect of fatigue on long term absence. CONCLUSIONS: Fatigue was associated with short term but particularly with long term sickness absence. The relation between fatigue and future sickness absence holds when controlling for work related and sociodemographic confounders. Fatigue as measured with the Checklist Individual Strength can be used as a screening instrument to assess the likelihood of sickness absence in the short term.","Janssen, N., et al. (2003). \"Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work.\" Occup Environ Med 60 Suppl 1: i71-76.","Netherlands",2003,"Various","None","MFI"]
[120,"Jayne, D., et al. (2017). \"Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.\" Jama 318(16): 1569-1580.",null,"Jayne, D., et al.","Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial","Importance: Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective: To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants: Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions: Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures: The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results: Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, -1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, -3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance: Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration: isrctn.org Identifier: ISRCTN80500123.","Jayne, D., et al. (2017). \"Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.\" Jama 318(16): 1569-1580.","UK",2017,"Cancer","Surgery","MFI"]
[121,"Johansson, B., et al. (2015). \"Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury.\" Brain Inj 29(6): 758-765.",null,"Johansson, B., et al.","Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury","OBJECTIVE: Post-traumatic brain injury symptoms, such as mental fatigue, have considerable negative impacts on quality-of-life. In the present study the effects of methylphenidate in two different dosages were assessed with regard to mental fatigue, pain and cognitive functions in persons who had suffered a traumatic brain injury. METHODS: Fifty-one subjects were included and 44 completed the study. The treatment continued for 12 weeks, including three treatment periods with no medication for 4 weeks, administration of low dose methylphenidate (up to 5 mg x 3) for 4 weeks and normal dose methylphenidate (up to 20 mg x 3) for a further 4 weeks. The patients were randomized into three groups where all groups were given all treatments. RESULTS: Significantly reduced mental fatigue, assessed with the Mental Fatigue Scale (MFS) and increased information processing speed (coding, WAIS-III), were detected. The SF-36 vitality and social functioning scales were also improved significantly. Pain was not reduced by methylphenidate. The positive effects of treatment were dose-dependent, with the most prominent effects being at 60 mg methylphenidate/day spread over three doses. Observed side-effects were increased blood pressure and increased heart rate. CONCLUSIONS: Methylphenidate was generally well-tolerated and it improved long-lasting mental fatigue and processing speed after traumatic brain injury.","Johansson, B., et al. (2015). \"Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury.\" Brain Inj 29(6): 758-765.","Sweden",2015,"Neurological","Other Drugs","MFS"]
[122,"Jongen, P. J., et al. (2010). \"Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study.\" Health Qual Life Outcomes 8: 133.",null,"Jongen, P. J., et al.","Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study","BACKGROUND: Glatiramer acetate (GA) and interferon-beta (INFb) are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS). Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL) in the first 12 months. It is not known whether HR-QoL increases during treatment with GA. METHODS: 197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32), fatigue (Fatigue Impact Scale [FIS]) and depressed mood (Beck Depression Inventory-Short Form [BDI-SF]) at baseline and 6 and 12 months after start of GA treatment. RESULTS: At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p < 0.001), not in the pre-treated group. At month 12 43% of treatment-naive patients had improved HR-QoL (increase LMS-QoL score 3 or more points) (p < 0.001). Likewise, mean FIS scores were decreased at months 6 and 12 in the treatment-naive group (p < 0.01), not in the pre-treated group. In both groups mean BDI-SF scores did not change. No demographic or clinical baseline factor was predictive of HR-QoL increase. HR-QoL changes were zero to negative for patients who had discontinued GA before month 12 (28.4% of patients). CONCLUSIONS: In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.","Jongen, P. J., et al. (2010). \"Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study.\" Health Qual Life Outcomes 8: 133.","Netherlands",2010,"Neurological","None","FIS"]
[123,"Jongen, P. J., et al. (2014). \"Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.\" Health Qual Life Outcomes 12: 40.",null,"Jongen, P. J., et al.","Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study","BACKGROUND: For persons with multiple sclerosis (MS) it is important to preserve their autonomy, in spite of increasing disability. A major factor mediating autonomy is self-efficacy. According to the social cognitive theory stressors are crucial determinants of self-efficacy, as well as the interaction with partners. METHODS: In an explorative observational study we assessed in 47 persons with MS (PwMS) the effect of an intense, multidisciplinary, 3-day, social cognitive wellness program with the participation of support partners, after 1, 3 and 6 months. PRIMARY OUTCOMES: self-efficacy-control and -function (Multiple Sclerosis Self-Efficacy Scale [MSSES]),limitations to and problems with participation and autonomy (Impact on Participation and Autonomy [IPA] scale). SECONDARY OUTCOMES: health-related quality of life (HRQoL) (MS Quality of Life-54 Items [MSQoL-54] questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and fatigue (Modified Fatigue Impact Scale-5 Items [MFIS-5]). Disability was measured with the Expanded Disability Status Scale (EDSS). Percentage changes from baseline were tested with T-tests, level of significance 0.05. RESULTS: In the whole group the MSQoL-54 Mental score was increased at 1, 3 and 6 months (+16.0%, +13.2%, +12.2%), and the MSQoL-54 Physical (+10.2%) at 6 months, with no changes in other outcomes. The relapsing remitting (RR) subgroup (n = 20) had at 6 months an increase in the MSSES-Control score (+24.8%) and in the MSQoL54 Mental and Physical scores (+22.3%, +17.6%). Progressive patients (n = 22) only showed an increase in the MSQoL-54 Mental score (+11.5%) at 1 month. In the low-disability (EDSS < 4.0) subgroup the MSSES-Control score was increased (+23.8%) at 6 months, and the IPA-Limitations and -Problems scores decreased at 3 months (-6.1%, -8.8%); the MSQoL-54 Mental score had increased at 1, 3 and 6 months (+19.3%, +21.5%, +19.3%). In the high-disability (EDSS > =4.0) subgroup no significant changes occurred. CONCLUSIONS: Results from this observational study suggest that 6 months after an intense, 3-day, multidisciplinary, social cognitive wellness program with support partners, PwMS with a RR course or low disability may experience an improved self-efficacy-control and HRQoL.","Jongen, P. J., et al. (2014). \"Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.\" Health Qual Life Outcomes 12: 40.","Netherlands",2014,"Neurological","Psychobehavioural","MFI"]
[124,"Kaasa, S., et al. (1998). \"Hodgkin's disease: quality of life in future trials.\" Ann Oncol 9 Suppl 5: 137-145.",null,"Kaasa, S., et al.","Hodgkin's disease: quality of life in future trials","It is of great importance to collect data of objective as well as subjective morbidity in patients cured for Hodgkin's disease. Such information may be used when new treatment strategies are discussed, in patients information and communication, to establish rehabilitation programs and to identify individuals who may benefit from rehabilitation. Measurement of health related quality of life (HRQOL) may give important information on how the cancer and/or the treatment has influenced the patients. There is no gold standard instrument for measurement of HRQOL in cancer. However, it is a consensus to use multidimensional patients rated measures with a standard format and scoring procedure. SF-36, EORTC QLQ-C30 and FACT are widely used in Europe and North America. Domain specific instruments includes a more comprehensive evaluation of a specific domain, for example anxiety or fatigue. Fatigue seems to be a prevalent symptom in Hodgkin's disease survivors and might affect patients' ability to perform normal activities and will often reduce their quality of life. Fatigue is defined as a subjective feeling of tiredness and might be measured by standardised and validated instruments such as the Fatigue Questionnaire (FQ) and the Multi-Dimensional Fatigue Inventory (MFI-20). Clinical significance might be defined as a meaningful difference based on consensus by the patient, the doctor and the society. In oncology there is no agreement of how long a meaningful difference in survival should be. For HRQOL a difference between 7 to 10 on a scale ranking from 0 to 100 has been regarded as clinical significant by some researchers. Another strategy to approach the issue of clinical significance is to use norms-estimates from the normal population- and/or reference estimates as guidelines. The long-term complication of the successful treatment of Hodgkin's disease reinforced the need for continued surveillance of treatment and related morbidities. Fatigue is a prevalent symptom and detailed diagnostic work-up is essential to identify patients with this problem. More knowledge about possible biological causes is required in order to understand fatigue and the impact on quality of life among Hodgkin's disease survivors.","Kaasa, S., et al. (1998). \"Hodgkin's disease: quality of life in future trials.\" Ann Oncol 9 Suppl 5: 137-145.","Norway",1998,"Cancer","None","FACT-F,MFI,FQ"]
[125,"Kaiser, K., et al. (2015). \"Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.\" Cancer Med 4(5): 690-698.",null,"Kaiser, K., et al.","Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale","The Functional Assessment of Cancer Therapy (FACT)-Antiangiogenesis (AntiA) Subscale was developed and validated to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies. Side effects related to anti-angiogenesis therapies were identified from the literature, clinician input, and patient input. Fifty-nine possible patient expressions of side effects were generated. Patient and clinician ratings of the importance of these expressions led us to develop a 24-item questionnaire with clinical and research potential. To assess the scale's reliability and validity, 167 patients completed the AntiA Subscale, the Functional Assessment of Cancer Therapy-general (FACT-G), the FACT-Kidney Symptom Index (FKSI), the FACIT-Fatigue Subscale, the Global Rating of Change Scale (GRC), and the PROMIS Global Health Scale. Patient responses to the AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. All tested scales were found to have good internal consistency reliability (Cronbach's alpha 0.70-0.92). Test-retest reliability was also good (0.72-0.88) for total and subscale scores and lower for individual items. The total score, subscale scores, and all single items (except nosebleeds) significantly differentiated between groups defined by level of side effect bother. Evaluation of responsiveness to change in this study was not conclusive, suggesting an area for further research. The AntiA is a reliable and valid measure of side effects from anti-angiogenesis therapy.","Kaiser, K., et al. (2015). \"Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.\" Cancer Med 4(5): 690-698.","USA",2015,"Cancer","Cancer treatments","FACIT-F"]
[126,"Kalaitzakis, E., et al. (2008). \"Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms.\" Scand J Gastroenterol 43(9): 1057-1065.",null,"Kalaitzakis, E., et al.","Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms","OBJECTIVE: Patients with short-bowel syndrome (SBS) have impaired health-related quality of life (QoL). However, comparisons of QoL data with the data on other chronic gastrointestinal diseases are not available. The aim of this study was to assess QoL in SBS patients compared with that in the general population and with patients with inflammatory bowel disease (IBD). The potential relation between fatigue and gastrointestinal symptoms and impaired QoL in these patients was also investigated. MATERIAL AND METHODS: Four validated questionnaires were used to measure aspects of QoL (SF-36), psychological distress (hospital anxiety and depression scale, HAD), fatigue (fatigue impact scale, FIS), and gastrointestinal symptoms (gastrointestinal symptom rating scale, GSRS) in 26/28 patients (93%) attending a SBS clinic (median age 62 years, 15 F/11 M) at a tertiary referral center. Persons from the general population (n=286) as well as patients with IBD (n=41) of similar age and gender distribution as the SBS group acted as controls. RESULTS: SBS patients had significantly lower SF-36 physical and mental component summaries than those in the general population as well as significantly lower SF-36 physical (p<0.05) but not mental (p>0.05) component summaries compared with those of IBD patients. Fatigue and gastrointestinal symptoms were more severe in SBS patients than in IBD patients (p>0.05). The SF-36 physical component summary was independently related to the physical FIS dimension (beta=-0.4, p=0.004), the GSRS eating dysfunction dimension (beta=-0.31, p=0.025), and opiate use (beta=-0.28, p=0.031), regardless of diagnosis (SBS or IBD). CONCLUSIONS: Patients with SBS show poor QoL compared with that in the general population and also impairment of mainly physical health compared with that in patients with IBD. Fatigue and gastrointestinal symptoms are more severe in patients with SBS, which has an impact on QoL.","Kalaitzakis, E., et al. (2008). \"Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms.\" Scand J Gastroenterol 43(9): 1057-1065.","Sweden",2008,"Gastrointestinal","None","FIS"]
[127,"Kalkanis, A., et al. (2013). \"The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS.\" Sarcoidosis Vasc Diffuse Lung Dis 30(1): 60-64.",null,"Kalkanis, A., et al.","The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS","INTRODUCTION: The Fatigue Assessment Scale (FAS) is a 10-item patient reported outcome (PRO) questionnaire that is used to measure fatigue in sarcoidosis. After several months of use, we began to question the reliability of the FAS in our clinic population. Therefore, we administered an additional fatigue PRO, the Patient Reported Outcomes Measurement Information Systems (PROMIS) Fatigue Instrument (PFI). Our hypothesis was that the internal consistency/reliability (Cronbach's alpha) of the PFI would be superior to the FAS in sarcoidosis patients because two of the ten FAS items (items #4 and #10) required reverse scoring (these items were scaled in the opposite direction to the other 8 items). METHODS: The FAS and PFI were administered during the same clinic visit to consecutive patients in our sarcoidosis clinic. We calculated a) the Cronbach's alpha for a) the FAS; b) the FAS without items #4 and #10; and c) the PFI. RESULTS: 107 consecutive sarcoidosis patients underwent FAS and PFI testing. The Cronbach's alpha was 0.740, 0.911, and 0.963 for the FAS, FAS with items #4 and #10 removed, and the PFI respectively. In female patients, the Cronbach's alpha of the FAS was 0.663, which is considered as \"questionable\" in terms of internal consistency. CONCLUSION: We found that the PFI had \"excellent\" consistency in our sarcoidosis clinic. The FAS did not demonstrate the same degree of internal consistency. The Cronbach's estimate of the FAS with items #4 and #10 removed was vastly superior to the FAS. These data support our contention that FAS items #4 and #10 detract from the internal consistency of this PRO. They also suggest that the PFI is superior to the FAS in terms of reliability.","Kalkanis, A., et al. (2013). \"The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS.\" Sarcoidosis Vasc Diffuse Lung Dis 30(1): 60-64.","USA",2013,"Inflamatory Systemic Disease","None","FAS,PROMIS-F"]
[128,"Kamath, J., et al. (2012). \"Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study.\" Support Care Cancer 20(8): 1745-1753.",null,"Kamath, J., et al.","Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study","BACKGROUND: Fatigue is a common and often disabling symptom for cancer patients. To date, no pharmacological interventions have shown reliable efficacy in treatment of cancer-related fatigue (CF). Thyrotropin-releasing hormone (TRH), a key regulator of homeostasis, exerts arousing and analeptic actions in instances of behavioral depression. In the present pilot, randomized, placebo-controlled, crossover study, we investigated the efficacy and safety of TRH as a treatment for CF. METHODS: Patients with cancer experiencing significant fatigue without medically reversible causes were enrolled in this study. The primary outcome measure was the visual analog scale for energy (VAS-E) assessed at 3, 7, and 24 h post-study medication administration. Secondary outcome measures included the profile of mood states (POMS) questionnaire, a 6-min walking test, the hospital anxiety and depression scale, the Leeds sleep questionnaire, and assessment of quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). RESULTS: Eight patients completed the study. TRH administration was associated with significant improvement in fatigue level as measured by the VAS-E, the fatigue and vigor subscales of the POMS, and the fatigue subscale of FACIT-F (p < 0.05). It was also associated with a positive impact on quality of life. TRH administration was associated with transient increases in blood pressure and heart rate. CONCLUSIONS: TRH administration was efficacious, safe, and tolerable in the treatment of CF with a positive impact on quality of life. These results provide a crucial impetus for pursuing TRH therapeutics to treat CF.","Kamath, J., et al. (2012). \"Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study.\" Support Care Cancer 20(8): 1745-1753.","USA",2012,"Cancer","Various","VAS-F,FACIT-F"]
[129,"Kargarfard, M., et al. (2012). \"Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis.\" Arch Phys Med Rehabil 93(10): 1701-1708.",null,"Kargarfard, M., et al.","Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis","OBJECTIVE: To examine the effectiveness of aquatic exercise training on fatigue and health-related quality of life (HRQOL) in women with multiple sclerosis (MS). DESIGN: Randomized controlled trial, 4-week and 8-week follow-up. SETTING: Referral center of a multiple sclerosis society. PARTICIPANTS: Women (N=32) diagnosed with relapsing-remitting MS (mean age +/- SD, 32.6+/-8.0y) were recruited into this study. After undergoing baseline testing by a neurologist, participants were randomly assigned to either an intervention (aquatic exercise) or a control group. INTERVENTIONS: The intervention consisted of 8 weeks supervised aquatic exercise in a swimming pool (3 times a week, each session lasting 60min). MAIN OUTCOME MEASURES: At baseline, 4 weeks, and 8 weeks, fatigue and HRQOL were assessed by a blind assessor using the Modified Fatigue Impact Scale and the Multiple Sclerosis Quality of Life-54 questionnaire, respectively. A mixed-model approach to repeated-measures analysis of variance was used to detect within- and between-subject effects. RESULTS: Findings are based on 21 patients (10 from the exercise group and 11 from the control group) who had data available on outcomes. There was no significant difference between the 2 groups at the baseline. Patients in the aquatic exercise group showed significant improvements in fatigue and subscores of HRQOL after 4 and 8 weeks compared with the control group. Results obtained from the intention-to-treat analysis were consistent with those of per-protocol analysis. CONCLUSIONS: The findings suggest that aquatic exercise training can effectively improve fatigue and HRQOL of patients with MS and should be considered in the management of this relatively common public health problem.","Kargarfard, M., et al. (2012). \"Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis.\" Arch Phys Med Rehabil 93(10): 1701-1708.","Iran",2012,"Neurological","Psychobehavioural","MFI"]
[130,"Kelderman-Bolk, N., et al. (2015). \"Quality of life in patients with primary hypothyroidism related to BMI.\" Eur J Endocrinol 173(4): 507-515.",null,"Kelderman-Bolk, N., et al.","Quality of life in patients with primary hypothyroidism related to BMI","OBJECTIVE: Many patients treated for primary hypothyroidism have an unexplained reduced quality of life (QOL). We studied the relation between QOL and various parameters in treated hypothyroid patients. DESIGN AND METHODS: QOL analysis was done in 90 consecutive patients (77.8% females) treated for primary hypothyroidism. QOL was measured by the questionnaires Short-Form 36, Hospital Anxiety and Depression Scale and MFI20. Post hoc analysis was performed on the relation of QOL at baseline and BMI, thyroid hormones and other serum values. QOL in patients was also compared to the general population. RESULTS: QOL was decreased compared to the general population. We found an inverse relationship between QOL and BMI. A relationship between QOL and serum thyroid parameters or auto-antibodies could not be found. Higher sex hormone binding globulin (SHBG) levels corresponded with a better QOL, which is explained by the negative association of SHBG with body weight and BMI. CONCLUSIONS: A decreased QOL in hypothyroid patients on thyroxine treatment is related to a higher body weight (BMI). Weight gain needs more attention in the treatment of hypothyroidism.","Kelderman-Bolk, N., et al. (2015). \"Quality of life in patients with primary hypothyroidism related to BMI.\" Eur J Endocrinol 173(4): 507-515.","Netherlands",2015,"Endocrine","None","MFI"]
[131,"Kennedy, R. H., et al. (2012). \"EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme.\" BMC Cancer 12: 181.",null,"Kennedy, R. H., et al.","EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme","BACKGROUND: During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. METHODS/DESIGN: EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients. DISCUSSION: Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation. TRIAL REGISTRATION: ISRCTN48516968.","Kennedy, R. H., et al. (2012). \"EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme.\" BMC Cancer 12: 181.","UK",2012,"Cancer","Surgery","MFI"]
[132,"Kerling, A., et al. (2015). \"Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS).\" Int J Mol Sci 16(7): 15761-15775.",null,"Kerling, A., et al.","Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS)","BACKGROUND: The aim of this prospective randomized controlled trial was to investigate if a short-term endurance or combined endurance/resistance exercise program was sufficient to improve aerobic capacity and maximum force in adult patients (18-65 years) with multiple sclerosis (MS). METHODS: All patients performed a three-month exercise program consisting of two training sessions per week, lasting 40 min each, with moderate intensity. All patients had a maximum value of 6 (low to moderate disability) on the Expanded Disability Status Scale (EDSS). One group (combined workout group (CWG); 15 females, 4 males) completed a combined endurance/resistance workout (20 min on a bicycle ergometer, followed by 20 min of resistance training), while the other group (endurance workout group (EWG); 13 females, 5 males) completed a 40 min endurance training program. Aerobic capacity was assessed as peak oxygen uptake, ventilatory anaerobic threshold, and workload expressed as Watts. Maximum force of knee and shoulder extensors and flexors was measured using isokinetic testing. Quality of life was assessed with the SF-36 questionnaire, and fatigue was measured using the Modified Fatigue Impact Scale. RESULTS: Both training groups increased in aerobic capacity and maximum force. EWG, as well as CWG, showed improvement in several subscales of the SF-36 questionnaire and decrease of their fatigue. CONCLUSION: A short exercise intervention increased both aerobic capacity and maximum force independent of whether endurance or combined endurance/resistance workouts were performed.","Kerling, A., et al. (2015). \"Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS).\" Int J Mol Sci 16(7): 15761-15775.","Germany",2015,"Neurological","Psychobehavioural","MFI"]
[133,"Keystone, E., et al. (2008). \"Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy.\" Arthritis Rheum 59(6): 785-793.",null,"Keystone, E., et al.","Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy","OBJECTIVE: To assess the effects of treatment with rituximab plus methotrexate on patient-reported outcomes in patients with active rheumatoid arthritis (RA) who experienced inadequate response to anti-tumor necrosis factor therapy. METHODS: Patients with active RA were randomly assigned to rituximab (1,000 mg on days 1 and 15) or placebo. The primary end point was the proportion of patients with an American College of Rheumatology 20% response at week 24. Additional goals were to assess treatment effects on pain, fatigue, functional disability, health-related quality of life, and disease activity by comparing mean changes between groups. The analysis was conducted in the intent-to-treat population. The proportion of patients who achieved the minimum clinically important difference on the Health Assessment Questionnaire (HAQ) disability index (DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Short Form 36 (SF-36) was determined. RESULTS: Rituximab patients had statistically significantly greater pain relief. The FACIT-F showed significantly greater improvement in rituximab patients than placebo patients from weeks 12 through 24. Mean improvement from baseline in functional disability (measured by the HAQ DI) was significantly greater in rituximab patients from weeks 8 to 24. The mean +/- SD change from baseline for the SF-36 Physical Component Score was 6.64 +/- 8.74 for rituximab patients and 1.48 +/- 7.32 for placebo patients (P < 0.0001). The mean change from baseline for the SF-36 Mental Component Score was 5.32 +/- 12.41 for rituximab patients and 2.25 +/- 12.23 for placebo patients (P = 0.0269). CONCLUSION: Rituximab produced rapid, clinically meaningful, and statistically significant improvements in patient-reported pain, fatigue, functional disability, health-related quality of life, and disease activity. These effects were sustained throughout the study.","Keystone, E., et al. (2008). \"Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy.\" Arthritis Rheum 59(6): 785-793.","Canada",2008,"Musculoskeletal","Rituximab","FACIT-F"]
[134,"Keystone, E. C., et al. (2017). \"Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study.\" Ann Rheum Dis 76(11): 1853-1861.",null,"Keystone, E. C., et al.","Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study","BACKGROUND: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX). METHODS: In this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables. RESULTS: Compared with placebo and adalimumab, baricitinib showed statistically significant improvements (p</=0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p</=0.05). CONCLUSIONS: Baricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52). TRIAL REGISTRATION: NCT01710358.","Keystone, E. C., et al. (2017). \"Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study.\" Ann Rheum Dis 76(11): 1853-1861.","UK,USA",2017,"Musculoskeletal","Baricitinib","FACIT-F,VAS-F"]
[135,"Khayatzadeh, M. M., et al. (2013). \"Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue.\" Disabil Rehabil 35(10): 803-808.",null,"Khayatzadeh, M. M., et al.","Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue","PURPOSE: This study aimed to compare the quality of life (QOL) of Mothers of Children with Cerebral Palsy (MCCPs) with mothers of Typically Developing (TD) children as a Control Group (CG). The association of the mediating variables including socio-economic status (SES), marital satisfaction and fatigue with maternal QOL was also evaluated. METHOD: The MCCPs group consisted of 120 mothers (mean age: 30.3 +/- 5.5 years) of children with CP. The CG included 100 mothers (mean age: 29.9 +/- 4.5 years) of TD children. Demographic characteristics of the participants were recorded and the data was collected by World Health Organization Quality of Life-BREF (WHOQOL-BREF), SES Questionnaire, Index of Marital Satisfaction (IMS) and Fatigue Severity Scale-Persian (FSS-P). Data analysis was done by SPSS version 16.0. RESULTS: The QOL and SES were lower, while FSS-P and IMS were higher in MCCPs group than CG (p < 0.001). The SES, IMS and FSS-P associated with all domains of QOL in MCCPs group, while they did just with some domains of QOL in CG (p < 0.05). CONCLUSIONS: The lower QOL in MCCPs group is supposed to be mediated by the SES, marital satisfaction and fatigue so, maternal empowerment in terms of these mediators and family-centered approach are recommended. IMPLICATIONS FOR REHABILITATION: * Improper activity of trapezius muscle motor units can be a reason of the cervicogenic headache. * Increased muscle tension at rest can lead to decrease of its contractile properties. * Rehabilitation of patients is effective when includes first postisometric relaxation procedures and myofascial mobilization of trigger points, then head protraction and retraction exercises according to McKenzie therapy and finally muscles strengthening exercises supplemented with self-control of the correct body posture.","Khayatzadeh, M. M., et al. (2013). \"Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue.\" Disabil Rehabil 35(10): 803-808.","Iran",2013,"Neurological","None","FSS"]
[136,"Kim, M., et al. (2017). \"Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.\" BMC Complement Altern Med 17(1): 353.",null,"Kim, M., et al.","Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial","BACKGROUND: Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue. METHODS/DESIGN: A multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 scores, and Montreal Cognitive Assessment scores between groups. Safety will be assessed by monitoring adverse events at each visit. DISCUSSION: The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue. TRIAL REGISTRATION: Clinical Research Information Service KCT0002170 . Registered 16 December 2016.","Kim, M., et al. (2017). \"Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.\" BMC Complement Altern Med 17(1): 353.","Korea",2017,"Cancer","Complementary","BFI,FACT-F"]
[137,"Klein, D., et al. (2011). \"Long-term quality of life after breast cancer: a French registry-based controlled study.\" Breast Cancer Res Treat 129(1): 125-134.",null,"Klein, D., et al.","Long-term quality of life after breast cancer: a French registry-based controlled study","Population-based studies on quality of life (QOL) of long-term breast cancer survivors are quite recent and insufficient attention has been paid to the effect of time since diagnosis. We compared long-term QOL of population-based breast cancer survivors 5, 10, and 15 years after diagnosis with that of healthy controls. Breast cancer survivors were randomly selected from three population-based cancer registries (Bas-Rhin, Calvados and Doubs, France) along with healthy controls, stratified for age and place of residence, randomly selected from electoral rolls. Participants completed five self-administered questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Short Form-36 (SF-36), Spielberger State-Trait Anxiety Inventory (STAI), Multidimensional Fatigue Inventory (MFI) and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of breast cancer survivors by period (5, 10, or 15 years) of diagnosis with those of controls, adjusted for sociodemographic data and comorbidities. Six hundred and fifty-two cases and 1,188 controls participated in the study. For many QOL scales, scores were significantly different between cancer survivors and controls. A clinically significant difference was evidenced for the fatigue scales, the SF36 physical functioning, role-physical, and role-emotional scales, with more favorable results for controls. Differences decreased with time and 15-year cancer survivors were generally not different from controls. Scores were particularly influenced by age and mean household income. More efforts should be made, specifically during the first 5 to 10 years after diagnosis, to help women with breast cancer to overcome their impairment in QOL.","Klein, D., et al. (2011). \"Long-term quality of life after breast cancer: a French registry-based controlled study.\" Breast Cancer Res Treat 129(1): 125-134.","France",2011,"Cancer","None","MFI"]
[138,"Kleinman, L., et al. (2000). \"Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.\" Qual Life Res 9(5): 499-508.",null,"Kleinman, L., et al.","Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C","Evidence exists demonstrating that infection with hepatitis C virus impairs health-related quality of life, but less is known about the effect of fatigue, a common symptom, on everyday life. The psychometric properties of the fatigue severity scale (FSS) were explored to determine suitability as an outcome measure in clinical trials. The FSS includes nine items developed to measure disabling fatigue and a visual analog scale (VAS) to measure overall fatigue. Using baseline data from three clinical trials (n = 1225) involving chronic hepatitis C patients, scaling and psychometric characteristics of the FSS were assessed. The SF-36 was also used in the trials. Item response theory analysis demonstrated that the FSS items can be placed along a single homogenous domain, fatigue. Internal consistency reliability was 0.94. Test-retest reliability was 0.82 for the total score and 0.80 for the VAS. The total score and the VAS were significantly correlated with the SF-36 vitality subscale (r = -0.76 and r = -0.76 respectively). Correlations with other SF-36 subscales were moderate (r = -0.46 to r = -0.67, all p < 0.0001). In summary, the FSS possesses good psychometric properties.","Kleinman, L., et al. (2000). \"Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.\" Qual Life Res 9(5): 499-508.","USA",2000,"Infectious Disease","None","FSS,VAS-F"]
[139,"Klingberg, E., et al. (2009). \"The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden.\" Scand J Rheumatol 38(6): 472-480.",null,"Klingberg, E., et al.","The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden","OBJECTIVES: To study the use of complementary and alternative medicine (CAM) drugs and methods in patients with inflammatory rheumatic diseases, at rheumatology clinics in western Sweden, and to investigate possible associations between CAM-using habits and other characteristics of the patients. METHODS: Randomly selected rheumatology outpatients were asked to complete questionnaires about CAM usage, diagnoses, medication, quality of life (using the 36-item Short Form Health Survey, SF-36), fatigue (using the 20-item Multiple Fatigue Inventory, MFI-20), the Health Assessment Questionnaire (HAQ), and visual analogue scales (VAS) for global health, pain, and fatigue. RESULT: A total of 200 patients were included, 137 women and 63 men, mean age 55+/-16 and 54+/-15 years, respectively. Ongoing CAM use was reported by 58 patients (29%): 45 (22.5%) were taking CAM drugs, 20 (10%) were using CAM methods. Altogether 130 patients (65%) had used CAM at some time of their lives; 103 patients (51%) had used CAM drugs ever and 90 patients (45%) had used CAM methods ever. Women used more CAM drugs compared with men. Younger patients used more CAM. CAM use was associated with parameters indicating poorer health, mental component score (MCS) and physical component score (PCS) of SF-36, and VAS for global health and fatigue. Ongoing CAM method was associated with less use of immunomodulatory drugs. CONCLUSION: CAM use is widespread among rheumatology patients in Sweden. A total of 65% of the patients had experience of CAM treatment. Female sex, younger age, and poor health were associated with CAM utilization.","Klingberg, E., et al. (2009). \"The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden.\" Scand J Rheumatol 38(6): 472-480.","Sweden",2009,"Musculoskeletal","None","MFI"]
[140,"Kluthcovsky, A. C. and A. A. Urbanetz (2015). \"Fatigue and quality of life in breast cancer survivors: a comparative study.\" Rev Bras Ginecol Obstet 37(3): 119-126.",null,"Kluthcovsky, A. C. and A. A. Urbanetz","Fatigue and quality of life in breast cancer survivors: a comparative study","PURPOSE: To assess fatigue and quality of life in disease-free breast cancer survivors in relation to a sample of age-matched women with no cancer history and to explore the relationship between fatigue and quality of life. METHODS: A cross-sectional study was conducted in a sample of 202 consecutive disease-free Brazilian breast cancer survivors, all of whom had completed treatment, treated at 2 large hospitals. The patients were compared to age-matched women with no cancer history attending a primary health care center. The Piper Fatigue Scale-Revised and the World Health Organization Quality of Life Instrument (WHOQOL-BREF) were used to measure the fatigue and quality of life, respectively. Socio-demographic and clinical variables were also obtained. The chi2 test, generalized linear model, and Spearman correlation coefficient were used for statistical purposes. The adopted level of significance was 5%. RESULTS: Breast cancer survivors experienced significantly greater total and subscale fatigue scores than comparison group (all p-values<0.05). In addition, survivors reported a poorer quality of life in physical (p=0.002), psychological (p=0.03), and social relationships (p=0.03) domains than comparison group. No difference was found for the environmental domain (p=0.08) for both groups. For survivors of breast cancer and for comparison group, the total and subscale fatigue scores were related to lower quality of life (all p-values<0.01). CONCLUSION: The findings of this study highlight the importance of assessing fatigue and quality of life in breast cancer survivors.","Kluthcovsky, A. C. and A. A. Urbanetz (2015). \"Fatigue and quality of life in breast cancer survivors: a comparative study.\" Rev Bras Ginecol Obstet 37(3): 119-126.","Brazil",2015,"Cancer","None","PFS"]
[141,"Ko, H. J., et al. (2016). \"Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial.\" Gerontology 62(2): 200-209.",null,"Ko, H. J., et al.","Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial","BACKGROUND: There is evidence that animal-assisted therapy has positive effects on mental health, especially in elderly people. Caring for insects is easy, relatively inexpensive, and does not require much space. OBJECTIVE: The aim of this 8-week randomized, controlled, single-blinded study was to investigate the effect of pet insects on the psychological health of community-dwelling elderly people. METHODS: Elderly subjects (>/=65 years old) attending a community center in Daegu, Korea, were enrolled in the study between April and May 2014 and randomized at a 1:1 ratio to receive insect therapy and health advice or only health advice. The insect group received 5 crickets in a cage with sufficient fodder and a detailed instruction manual. At baseline and at 8 weeks, all subjects underwent psychometric tests via a direct interview [Beck Anxiety Inventory, Geriatric Depression Scale (GDS-15), Mini-Mental State Examination (MMSE), 36-Item Short Form Health Survey, Insomnia Severity Index, Fatigue Severity Scale, and Brief Encounter Psychosocial Instrument] and laboratory analyses of inflammatory and oxidative stress markers (erythrocyte sedimentation rate, high-sensitivity C-reactive protein, biological antioxidant potential, and derivatives of reactive oxygen metabolites). RESULTS: The insect-caring (n = 46) and control (n = 48) groups did not differ in baseline characteristics. The insect-caring group had significantly lower GDS-15 scores at week 8 (3.20 vs. 4.90, p = 0.004) and, after adjustment for baseline values, a significantly greater change in GDS-15 scores relative to baseline (-1.12 vs. 0.20, p = 0.011). They also had a significantly greater change in MMSE scores relative to baseline (1.13 vs. 0.31, p = 0.045). The two groups did not differ in terms of other psychometric and laboratory tests. No serious risks or adverse events were reported. CONCLUSION: Caring for insects, which is cost-effective and safe, was associated with a small to medium positive effect on depression and cognitive function in community-dwelling elderly people.","Ko, H. J., et al. (2016). \"Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial.\" Gerontology 62(2): 200-209.","Korea",2016,"None","None","FSS"]
[142,"Kok, N. F., et al. (2006). \"Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.\" Bmj 333(7561): 221.",null,"Kok, N. F., et al.","Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial","OBJECTIVES: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. DESIGN: Single blind, randomised controlled trial. SETTING: Two university medical centres, the Netherlands. PARTICIPANTS: 100 living kidney donors. INTERVENTIONS: Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. MAIN OUTCOME MEASURES: The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. RESULTS: Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). CONCLUSIONS: Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.","Kok, N. F., et al. (2006). \"Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.\" Bmj 333(7561): 221.","Netherlands",2006,"Kidney Disease","Surgery","MFI"]
[143,"Korsen, M., et al. (2017). \"Dalfampridine effects on cognition, fatigue, and dexterity.\" Brain Behav 7(1): e00559.",null,"Korsen, M., et al.","Dalfampridine effects on cognition, fatigue, and dexterity","OBJECTIVES: Dalfampridine exerts beneficial effects on walking ability in a subgroup of patients with multiple sclerosis (MS). These patients are termed \"responders\". Here, we investigated whether the responder status with respect to mobility measures would determine whether dalfampridine treatment exerts a beneficial effect on other MS symptoms. We therefore assessed walking ability, upper limb function, cognition, fatigue, visual evoked potentials (VEPs), depression, and quality of life in patients before and after dalfampridine treatment. METHODS: Patients with MS and impaired mobility were recruited. Maximal walking distance, timed 25 Foot Walk, nine hole peg test, paced auditory serial addition test (PASAT), fatigue severity scale (FSS), VEPs, Beck Depression Inventory (BDI), EuroQol five dimensional questionnaire, and quality of life visual analogue scale were determined before and after 12-14 days of dalfampridine treatment. Repeated measures analysis of variance was applied to determine the effect of dalfampridine treatment. RESULTS: Of the 34 patients who completed the study, 22 patients were responders and 12 patients nonresponders, according to their performance in mobility measures. Treatment effects for the entire patient cohort were observed for PASAT (p = .029) and BDI (p = .032). Belonging to the responder cohort did not predict the response to treatment in these tests. For the FSS, response to dalfampridine treatment was dependent on the responder status (p = .001) while no effects in the total patient cohort were observed (p = .680). Other neurological functions remained unaltered. For VEP latencies, no significant improvements were detected. CONCLUSION: In this study, we observed beneficial effects of dalfampridine on cognition, depression, and fatigue. These effects were not limited to patients who responded to dalfampridine with improved mobility measures. These findings underscore the need to assess the beneficial effects of dalfampridine on neurological deficits in MS patients in additional randomized clinical trials.","Korsen, M., et al. (2017). \"Dalfampridine effects on cognition, fatigue, and dexterity.\" Brain Behav 7(1): e00559.","Germany",2017,"Neurological","None","FSS,VAS-F"]
[144,"Kramer, L., et al. (2002). \"Subclinical impairment of brain function in chronic hepatitis C infection.\" J Hepatol 37(3): 349-354.",null,"Kramer, L., et al.","Subclinical impairment of brain function in chronic hepatitis C infection","BACKGROUND/AIMS: Central nervous system abnormalities such as fatigue and depression occur more frequently in chronic hepatitis C virus (HCV) infection than in many other causes of chronic liver disease. The finding that fatigue is unrelated to activity of hepatitis or mode of infection could indicate an independent effect of HCV on brain function. This study tested the hypothesis of a subclinical cognitive dysfunction in HCV-infected patients. METHODS: One-hundred untreated HCV-RNA positive biopsy-proven patients were investigated by P300 event-related potentials, a sensitive electrophysiologic test of cognitive processing. Health-related quality of life and fatigue were assessed using the SF-36 questionnaire and the Fatigue Impact Scale, respectively. RESULTS: Cognitive brain function was subclinically impaired in the cohort of HCV-infected patients as indicated by significantly prolonged P300 latencies (P=0.01 for comparison to matched healthy subjects) and reduced P300 amplitudes (P<0.001, respectively). Seventeen of the 100 HCV-infected patients had P300 latencies outside the age-adjusted normal range. Abnormal P300 characteristics were not related to the degree of histologic or biochemical activity of hepatitis, severity of fatigue or mental health impairment. CONCLUSIONS: This study demonstrates that patients with HCV infection showed a slight but significant neurocognitive impairment, possibly indicating a further extrahepatic manifestation of chronic hepatitis C.","Kramer, L., et al. (2002). \"Subclinical impairment of brain function in chronic hepatitis C infection.\" J Hepatol 37(3): 349-354.","Austria",2002,"Infectious Disease","None","FIS"]
[145,"Kristenson, M., et al. (1998). \"Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study.\" Psychosom Med 60(3): 277-282.",null,"Kristenson, M., et al.","Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study","OBJECTIVE: Coronary heart disease (CHD) mortality is four times higher in 50-year-old Lithuanian men than in 50-year-old Swedish men. The difference cannot be explained by standard risk factors. The objective of this study was to examine differences in psychosocial risk factors for CHD in the two countries. METHODS: The LiVicordia study is a cross-sectional survey comparing 150 randomly selected 50-year-old men in each of the two cities: Vilnius, Lithuania, and Linkoping, Sweden. As part of the study, a broad range of psychosocial characteristics, known to predict CHD, were investigated. RESULTS: In the men from Vilnius compared with those from Linkoping, we found a cluster of psychosocial risk factors for CHD; higher job strain (p <.01), lower social support at work, lower emotional support, and lower social integration (p values <.001). Vilnius men also showed lower coping, self-esteem, and sense of coherence (p values < .001), higher vital exhaustion, and depression (p values < .001). Quality of life and perceived health were lower and expectations of ill health within 5 to 10 years were higher in Vilnius men (p values < .001). Correlations between measurements on traditional and psychosocial risk factors were few and weak. CONCLUSIONS: The Vilnius men, representing the population with a four-fold higher CHD mortality, had unfavorable characteristics on a cluster of psychosocial risk factors for CHD in comparison with the Linkoping men. We suggest that this finding may provide a basis for possible new explanations of the differences in CHD mortality between Lithuania and Sweden.","Kristenson, M., et al. (1998). \"Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study.\" Psychosom Med 60(3): 277-282.","Sweden",1998,"CVD","None","VE"]
[146,"Kuijper, T. M., et al. (2014). \"Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort.\" Arthritis Care Res (Hoboken) 66(3): 379-386.",null,"Kuijper, T. M., et al.","Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort","OBJECTIVE: To compare the burden of disease and its development over time in patients referred to an early arthritis cohort who were diagnosed either as having arthralgias without synovitis or as having rheumatoid arthritis (RA). METHODS: Patients diagnosed as having arthralgias without synovitis or RA were selected from the Rotterdam Early Arthritis Cohort. Data on clinical and psychological characteristics, demographics, pain scores (Rheumatoid Arthritis Disease Activity Index), functional ability (Health Assessment Questionnaire), health-related quality of life (HRQOL; Short Form 36), fatigue (visual analog scale and Fatigue Assessment Scale), and health care utilization (HCU) were collected at baseline and at 6 and 12 months of followup. The burden of disease measures (pain, functional ability, fatigue, and HRQOL) and HCU levels were plotted over time for both groups. A Poisson regression model for repeated data was used to identify determinants of HCU for both groups. RESULTS: At baseline, 330 patients with arthralgias without synovitis (nonsynovitis [NS] group) and 244 RA patients (RA group) were included. Overall, the burden of disease measures and HCU levels were very similar between groups. Both groups showed improvement over time with respect to pain scores, functional ability, HRQOL, and HCU levels. Independent predictors of high HCU were identified as more pain, worse physical health, and external locus of control in the NS group and as shorter duration of symptoms, low chance locus of control, and worse physical functioning in the RA group. CONCLUSION: Despite the absence of an inflammatory diagnosis, patients with arthralgias without synovitis experienced a similar burden of disease compared with RA patients.","Kuijper, T. M., et al. (2014). \"Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort.\" Arthritis Care Res (Hoboken) 66(3): 379-386.","Netherlands",2014,"Musculoskeletal","None","VAS-F,FAS"]
[147,"Labiano-Fontcuberta, A., et al. (2015). \"Psychiatric disturbances in radiologically isolated syndrome.\" J Psychiatr Res 68: 309-315.",null,"Labiano-Fontcuberta, A., et al.","Psychiatric disturbances in radiologically isolated syndrome","BACKGROUND: Radiologically isolated syndrome (RIS) is characterized by incidental lesions suggestive of multiple sclerosis (MS) on MRI without typical symptoms of MS. Clinically isolated syndrome (CIS) is characterized by a first episode of neurologic symptoms caused by demyelination in the central nervous system. To date, psychiatric disorders have not been systematically addressed in RIS subjects. We assessed emotional disturbances, personality features and health-related quality of life (HRQoL) in a cohort of RIS patients as compared with clinically isolated syndrome (CIS). METHODS: Twenty-eight RIS patients, 25 clinically isolated syndrome (CIS) patients, and 22 healthy subjects were enrolled in the study. Participants were administered a mood scale (Hamilton Depression Rating Scale), behavioural measures (Personality Assessment Inventory), and fatigue measures (Fatigue Impact Scale for Daily Use). HRQoL was quantified using the EuroQol-5. RESULTS: 14 (50%) of RIS patients had clinically significant depression, with over one-third of these having moderate depression, scores virtually identical to those observed in CIS patients. 11 of 28 (39.3%) subjects with RIS had anxious depression, a figure three times higher than that found in CIS patients. RIS patients' HAMD-17 total score showed a very strong correlation with severity of fatigue. In addition, RIS patients reported lower HRQoL (p = 0.036) and a significantly higher symptoms load for somatisation compared to both CIS and control groups (p < 0.002). CONCLUSION: RIS patients had high rates of depression, particularly anxious depression and somatization. Future studies are warranted to clarify whether these psychiatric disturbances are causally associated with a distinct white matter psychopathologic process.","Labiano-Fontcuberta, A., et al. (2015). \"Psychiatric disturbances in radiologically isolated syndrome.\" J Psychiatr Res 68: 309-315.","Spain",2015,"neurological","None","FIS"]
[148,"Lai, J. S., et al. (2016). \"Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma.\" Cancer 122(2): 287-295.",null,"Lai, J. S., et al.","Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma","BACKGROUND: Hand-foot syndrome and mucositis/stomatitis are frequent adverse events (AEs) of treatment with tyrosine kinase inhibitors in cancer therapy. Quality-of-life instruments that measure the functional consequences of these AEs are needed to assess the impact of therapeutic interventions and to guide patient care. The Hand-Foot and Mucositis Symptom and Impact Questionnaire (HAMSIQ [formerly the Supplementary Quality of Life Questionnaire]) was used in the COMPARZ trial (Pazopanib vs Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma [national clinical trial no. NCT00720941]) and the PISCES study (Patient Preference Study of Pazopanib vs Sunitinib in Advanced or Metastatic Kidney Cancer [clinicaltrials.gov NCT01064310]) to assess mouth/throat and hand/foot soreness symptoms and subsequent limitations in patients receiving pazopanib or sunitinib for metastatic renal cell carcinoma. The objective of the current analysis was to validate the HAMSIQ using data from the PISCES study. METHODS: The HAMSIQ was administered in the PISCES study at baseline and every 2 weeks over two 10-week periods to patients who were receiving pazopanib or sunitinib. Data from the first 10-week period were used to assess the feasibility, validity, and responsiveness of the HAMSIQ. RESULTS: In total, >/=85% of 169 patients completed the HAMSIQ (excluding the item concerning days off work). Correlations among items within the same limitation subscale generally were high (Cronbach alpha >/= .80). HAMSIQ limitation scores differentiated patients according to their baseline performance status and severity of soreness. Small-to-moderate correlations were observed for the symptoms/limitation scores and for changes from baseline scores between the HAMSIQ and the Functional Assessment of Chronic Illness Therapy fatigue survey. The HAMSIQ demonstrated responsiveness to changes in clinical status and the development of hand-foot syndrome AEs over time. CONCLUSIONS: The HAMSIQ is a feasible, valid, reliable, and responsive instrument for assessing the impact of hand-foot syndrome and mucositis in patients receiving tyrosine kinase inhibitors. Cancer 2016;122:287-295. (c) 2015 American Cancer Society.","Lai, J. S., et al. (2016). \"Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma.\" Cancer 122(2): 287-295.","Switzerland",2016,"Infectious Disease","Pazopanib,Sunitinib","FACIT-F"]
[149,"Lai, J. S., et al. (2011). \"How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example.\" Arch Phys Med Rehabil 92(10 Suppl): S20-27.",null,"Lai, J. S., et al.","How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example","OBJECTIVE: To illustrate how measurement practices can be advanced by using as an example the fatigue item bank (FIB) and its applications (short forms and computerized adaptive testing [CAT]) that were developed through the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. DESIGN: Psychometric analysis of data collected by an Internet survey company using item response theory-related techniques. SETTING: A U.S. general population representative sample collected through the Internet. PARTICIPANTS: Respondents used for dimensionality evaluation of the PROMIS FIB (N=603) and item calibrations (N=14,931). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Fatigue items (112) developed by the PROMIS fatigue domain working group, 13-item Functional Assessment of Chronic Illness Therapy-Fatigue, and 4-item Medical Outcomes Study 36-Item Short Form Health Survey Vitality scale. RESULTS: The PROMIS FIB version 1, which consists of 95 items, showed acceptable psychometric properties. CAT showed consistently better precision than short forms. However, all 3 short forms showed good precision for most participants in that more than 95% of the sample could be measured precisely with reliability greater than 0.9. CONCLUSIONS: Measurement practice can be advanced by using a psychometrically sound measurement tool and its applications. This example shows that CAT and short forms derived from the PROMIS FIB can reliably estimate fatigue reported by the U.S. general population. Evaluation in clinical populations is warranted before the item bank can be used for clinical trials.","Lai, J. S., et al. (2011). \"How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example.\" Arch Phys Med Rehabil 92(10 Suppl): S20-27.","USA",2011,"none","None","PROMIS-F,FACIT-F"]
[150,"Lai, J. S., et al. (2014). \"Linking fatigue measures on a common reporting metric.\" J Pain Symptom Manage 48(4): 639-648.",null,"Lai, J. S., et al.","Linking fatigue measures on a common reporting metric","CONTEXT: Fatigue is one of the most common and debilitating symptoms experienced by patients living with chronic conditions and is also commonly experienced in the general U.S. population. Linking fatigue scores from some of the most widely used measure of fatigue to the same metric will facilitate interpretation of fatigue outcomes. OBJECTIVES: The goal of this study is to report the methods used to develop linking (crosswalk) tables to enable the direct comparison of Patient-Reported Outcomes Measurement Information System-Fatigue with fatigue scores on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale, the Medical Outcomes Study Short Form-36 four-item Vitality Scale, and the Quality of Life in Neurological Disorders Fatigue Scale. METHODS: Participants were recruited from two data sets (n=1120 and n=803). Two item response theory-based linking methods, the Stocking-Lord calibration and fixed-parameter calibration, were used to establish linking between measures. The item response theory calibrations were derived using the graded response model. RESULTS: Both the Stocking-Lord calibration and fixed-parameter calibration linking methods produced comparable results. Final crosswalk tables are reported for the fixed-parameter calibration. CONCLUSION: Findings can facilitate comparison of scores across some of the most widely used fatigue measures and assist in comparing patient-reported fatigue outcomes in clinical trials, comparative effectiveness research, and clinical practice.","Lai, J. S., et al. (2014). \"Linking fatigue measures on a common reporting metric.\" J Pain Symptom Manage 48(4): 639-648.","USA",2014,"Various","None","FACIT-F,QoL-Neurological Disorders Fatigue Scale"]
[151,"Le Borgne, G., et al. (2013). \"Quality of life in long-term cervical cancer survivors: a population-based study.\" Gynecol Oncol 129(1): 222-228.",null,"Le Borgne, G., et al.","Quality of life in long-term cervical cancer survivors: a population-based study","OBJECTIVES: To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. METHODS: In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. RESULTS: A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p<0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p=0.0009) and 10-year CCSs (p=0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p=0.002), voiding and abdominal symptoms (p=0.01), and lymphedema (p=0.01). CONCLUSIONS: Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae.","Le Borgne, G., et al. (2013). \"Quality of life in long-term cervical cancer survivors: a population-based study.\" Gynecol Oncol 129(1): 222-228.","France",2013,"Cancer","None","MFI"]
[152,"Le Gal, M., et al. (2010). \"Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia.\" Joint Bone Spine 77(2): 165-170.",null,"Le Gal, M., et al.","Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia","CONTEXT: The multidimensional nature of the fibromyalgia syndrome means that different instruments need to be used to assess the patients' perception of this constellation of physical and psychological symptoms and their impact on their daily lives. Six questionnaires (Multidimensional Fatigue Inventory MFI, Fibromyalgia Impact Questionnaire FIQ, Multiple Ability Self-report Questionnaire MASQ, State-Trait Anxiety Inventory STAI, Beck Depression Inventory-II BDI-II and Patient Global Impression of Change PGIC) were linguistically validated into 12 languages. METHODS: The standardized cross-cultural adaptation process includes the following steps: forward translation, backward translation, and review of the version by a clinician and comprehension tests on subjects in the target country. RESULTS: Regardless of the instruments and dimensions studied, the same translation and cultural adaptation issues arose: (1) an issue that is strictly related to translation, for example, the word \"things\" was translated as \"something\"; (2) literal translation is possible but culturally irrelevant, for example the expression \"to walk several blocks\", which is a completely abstract concept in Europe, was translated as \"to walk for more than one kilometre\"; (3) the translation needed to be reformulated or the tense needed to be changed for idiomatic reasons. For example, the present perfect does not exist in German and so the present simple was used in the first version. The imperfect was eventually used with adverbs such as \"lately\". CONCLUSIONS: Linguistic adaptation was completed according to a recognized and rigorous method allowing for the wide-scale use of these patient-reported outcomes instruments in international studies.","Le Gal, M., et al. (2010). \"Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia.\" Joint Bone Spine 77(2): 165-170.","France",2010,"Musculoskeletal","None","MFI"]
[153,"Ledinek, A. H., et al. (2013). \"Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study.\" Clin Neurol Neurosurg 115 Suppl 1: S86-89.",null,"Ledinek, A. H., et al.","Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study","OBJECTIVE: Fatigue affects more than 60% of multiple sclerosis (MS) patients and is one of the most troublesome symptoms of the disease. Current treatment options for MS fatigue include amantadine, modafinil and acetyl-l-carnitine (ALCAR). The aim of our study was to compare efficacy of amantadine, modafinil and ALCAR with placebo in patients with MS. METHODS: Patients with MS and a disability level </= 5.5 on the Kurtzke Expanded Disability Status Scale (EDSS) and fatigue were included in the study. Patients were assigned to a one month treatment with either amantadine 200mg, ALCAR 2g, modafinil 200mg or placebo. Efficacy of the treatment was evaluated by using the modified fatigue impact scale (MFIS). RESULTS: Sixty patients were included in the study (39 females). The mean age of patients was 38 +/- 6.7 years and the mean disease duration was 6.6 +/- 1.2 years. Contrast analysis showed significantly lower mean MFIS score after one month in patients on amantadine compared to placebo (mean difference=17.3, p=0.001). There was also a trend of a lower MFIS score in ALCAR group in comparison to placebo (mean difference=12.4, p=0.05, with Keppel-corrected alpha of 0.046). The quality of life measured as SF 36 - PCS and SF 36 - MCS proved to be significantly influenced by treatment. CONCLUSION: One month treatment with amantadine improved fatigue in patients with relapsing-remitting MS as evaluated by MFIS. No or only a trend of improvement was seen in patients treated with modafinil or ALCAR, respectively.","Ledinek, A. H., et al. (2013). \"Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study.\" Clin Neurol Neurosurg 115 Suppl 1: S86-89.","Slovenia",2013,"Neurological","Other Drugs","MFI"]
[154,"Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.",null,"Lee, C. E., et al.","A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT. METHODS/DESIGN: A 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data. DISCUSSION: Musculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00834392.","Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.","Canada",2012,"Cancer","Psychobehavioural","FACIT-F"]
[155,"Lee, J. H., et al. (2015). \"The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue.\" J Altern Complement Med 21(7): 422-429.",null,"Lee, J. H., et al.","The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue","OBJECTIVE: Idiopathic chronic fatigue (ICF), defined as medically unexplained chronic fatigue, is common these days. To date, there is no definite cure for ICF, and alternative therapies are being investigated. Oriental medicine music therapy (OMMT), a novel music therapy that occurs through an active behavioral process, has been applied to various chronic diseases, including ICF. In the present study, we aimed to evaluate the effect of OMMT on ICF. DESIGN: Randomized controlled trial of OMMT compared with the waitlist control (6 sessions each) during a 2-week period. PARTICIPANTS: Thirty participants who had had ICF for at least 6 months before the experiments were recruited. OUTCOME MEASURES: We evaluated fatigue severity scale (FSS), visual analog scale (VAS) for overall fatigue, revised Chalder fatigue scale (RCFS), World Health Organization quality of life scale abbreviated version (WHOQOL-BREF), Buzhongyiqi-Tang questionnaire (BZTQ), and salivary cortisol level at baseline (week 0) and at the end of the study (week 2) in the two groups. RESULTS: FSS, VAS, and RCFS scores were significantly lower, and WHOQOL-BREF scores were significantly higher in the OMMT group than in the waitlist group (p=0.006, p=0.004, p=0.002, and p=0.002, respectively). In contrast, salivary cortisol level and BZTQ scores were not significantly different between the OMMT group and the waitlist group. CONCLUSIONS: The present study suggests that OMMT may be an alternative treatment for ICF. Based on this result, further studies including possible mechanisms are needed.","Lee, J. H., et al. (2015). \"The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue.\" J Altern Complement Med 21(7): 422-429.","Korea",2015,"Chronic Fatigue","Psychobehavioural","VAS-F,FSS,CFS"]
[156,"Lee, J. I., et al. (2010). \"Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea.\" Health Qual Life Outcomes 8: 101.",null,"Lee, J. I., et al.","Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea","BACKGROUND: Concern regarding the health-related quality of life (HRQOL) of long-term survivors of thyroid cancer has risen due to the rapid increase in the incidence of thyroid cancer, which generally has an excellent prognosis. The aim of this study was to evaluate the status of HRQOL in disease-free survivors of differentiated thyroid carcinoma (DTC) and to evaluate the important determinants of HRQOL. METHODS: This was a cross-sectional study in which we interviewed consecutive disease-free survivors of DTC. Three different validated questionnaires (\"EORTC QLQ-C30\" for various functional domains, the \"brief fatigue inventory (BFI)\" and the \"hospital anxiety and depression scale\" (HADS)) were used. Data from a large, population based survey of 1,000 people were used as a control. RESULTS: The response rate for the questionnaires was 78.9% (316/401). Disease-free survivors of DTC showed a decreased HRQOL in all five functional domains (physical, role, cognitive, emotional, and social) on the EORTC QLQ-C30 compared with controls (P < 0.01). BFI and HADS-anxiety scores also showed greater distress in disease-free survivors of DTC than in controls (P < 0.05). A multiple regression analysis for the determinants of HRQOL showed that the HADS-anxiety, HADS-depression, and BFI scores were the most significant components of decreased HRQOL. CONCLUSIONS: Although disease-free survivors of DTC are expected to have disease-specific survival comparable to the general population, they experience a significantly decreased HRQOL. Anxiety, depression, and fatigue were the major determinants of the decreased HRQOL. Supportive psychological care should be integrated into the management of long-term survivors of DTC.","Lee, J. I., et al. (2010). \"Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea.\" Health Qual Life Outcomes 8: 101.","Korea",2010,"Cancer","None","BFI"]
[157,"Lerdal, A. and C. L. Gay (2013). \"Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later.\" Neurology 81(18): 1581-1587.",null,"Lerdal, A. and C. L. Gay","Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later","OBJECTIVE: To determine whether fatigue in the acute phase following stroke predicts long-term patient-reported physical and mental health outcomes 18 months later. METHODS: Patients (n = 96, mean age 67.8 years, SD 12.9) were assessed within 2 weeks of hospital admission for first-ever stroke (acute phase) and 18 months later. Measures included the Fatigue Severity Scale and the Beck Depression Inventory II. The Short Form-36 was used to assess self-reported physical and mental health. Multivariate regression analysis was used to evaluate the relationship between acute phase fatigue and later health outcomes, controlling for relevant covariates. RESULTS: Acute phase fatigue was associated with physical health at 18-month follow-up, but not with mental health. After adjusting for other potential predictors of health outcomes, including age, sex, cohabitation status, acute phase physical or mental health, and depressive symptoms, acute phase fatigue remained a significant predictor of later physical health but not of later mental health. The reverse relationships were also examined, but neither physical nor mental health in the acute phase predicted fatigue at 18 months; the best predictor of fatigue at 18-month follow-up was acute phase fatigue. CONCLUSIONS: These findings suggest that acute phase fatigue is an independent risk factor for poor physical health 18 months after stroke. Diagnosis and treatment of acute phase fatigue may improve physical health-related quality of life among stroke survivors. Effective treatments for poststroke fatigue, both in the acute phase and later in the recovery period, are needed.","Lerdal, A. and C. L. Gay (2013). \"Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later.\" Neurology 81(18): 1581-1587.","Norway",2013,"CVD","None","FSS"]
[158,"Lesage, A. C., et al. (2011). \"Results of a national survey on quality of life in inflammatory bowel diseases.\" Clin Res Hepatol Gastroenterol 35(2): 117-124.",null,"Lesage, A. C., et al.","Results of a national survey on quality of life in inflammatory bowel diseases","AIMS: Inflammatory bowel diseases (IBD) have a negative impact on patients' quality of life. The aims of this survey were to learn more about patients' concerns, and to compare their feelings with the beliefs of their close relations and physicians. PATIENTS AND METHODS: A specific questionnaire, including the RFIPC and the MFI-20, was used. Patients' answers were compared with those given by their close relations and attending physicians. RESULTS: This national survey included 2424 French patients. At the time of diagnosis, 73% of patients expressed having fears, but were also relieved to understand their symptoms. IBD was responsible for fatigue and weariness, and had a negative impact on daily, occupational, leisure, family and personal life. The main fears concerned unpredictable flare-ups followed by need for an ostomy bag and risk of surgery. The answers provided by close relations and physicians matched those of the patients, but physicians overestimated the patient's knowledge and underestimated disease impact. CONCLUSION: IBD has a deleterious effect on quality of life. Close relations of the patient realize the impact the disease has on the patients' life, but attending physicians still tend to minimize patients' symptoms.","Lesage, A. C., et al. (2011). \"Results of a national survey on quality of life in inflammatory bowel diseases.\" Clin Res Hepatol Gastroenterol 35(2): 117-124.","France",2011,"Gastrointestinal","None","MFI"]
[159,"Lesser, G. J., et al. (2013). \"A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.\" J Support Oncol 11(1): 31-42.",null,"Lesser, G. J., et al.","A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer","BACKGROUND: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. OBJECTIVES: We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. RESULTS: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). CONCLUSIONS: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.","Lesser, G. J., et al. (2013). \"A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.\" J Support Oncol 11(1): 31-42.","USA",2013,"Cancer","Various","Profile of Mood States-Fatigue questionnaire,FACIT-F"]
[160,"Leuschen, M. P., et al. (2004). \"A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.\" Mult Scler 10(6): 636-642.",null,"Leuschen, M. P., et al.","A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis","Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in < or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.","Leuschen, M. P., et al. (2004). \"A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.\" Mult Scler 10(6): 636-642.","USA",2004,"Neurological","Other Drugs","MFI"]
[161,"Lewko, A., et al. (2014). \"Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme.\" Respir Med 108(1): 95-102.",null,"Lewko, A., et al.","Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme","INTRODUCTION: Subjective fatigue has been recognised as an important, multi-component symptom in COPD. Pulmonary Rehabilitation (PR) improves fatigue component of the Chronic Respiratory Questionnaire, a quality of life (QoL) measure. However, it is not clear if all fatigue dimensions are affected equally. This study aims to evaluate changes in subjective multidimensional fatigue among people with COPD who participated in PR. METHODS: Thirty seven stable COPD patients were recruited; 23 patients (15 male) mean age 68.5 (range 49-86) yrs, mean (SD) %predicted FEV1 45.3 (19.8); completed 7 weeks of PR. Assessments (pre and post PR) consisted of the Multidimensional Fatigue Inventory (MFI-20), QoL (SGRQ), Anxiety and Depression (HADS), the London Chest Activity of Daily Living Scale (LCADL), muscle strength, incremental (ISWT) and endurance (ESWT) shuttle walk tests. The differences between pre and post PR fatigue were tested using Wilcoxon's test and relationships with other outcomes were examined using Spearman's correlation. RESULTS: There were statistically significant improvements in Reduced Activity (RA) (p = 0.01), General (GF) (p < 0.01) and Physical Fatigue (PF) (p = 0.03) components of MFI-20 after PR, but there were no differences in Motivation or Mental Fatigue (p > 0.05). There were significant improvements in ISWT (p < 0.05), ESWT (p < 0.01) and muscle strength (p = 0.03). Statistically significant correlations (p < 0.05) were found between changes in GF and in both ISWT (r = -0.43) and SGRQ impact (r = 0.46); and between RA and ESWT changes (r = -0.45). CONCLUSIONS: Some dimensions of fatigue in COPD are modifiable by a 7-week PR programme. Change in fatigue dimensions in COPD may be associated with a change in maximal or endurance walking distances or QoL.","Lewko, A., et al. (2014). \"Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme.\" Respir Med 108(1): 95-102.","UK",2014,"Respiratory Disease","None","MFI"]
[162,"Li Voon Chong, J. S., et al. (2000). \"Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects.\" Clin Endocrinol (Oxf) 53(5): 551-559.",null,"Li Voon Chong, J. S., et al.","Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects","OBJECTIVE: In healthy adults the secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) declines with ageing and body composition alters, particularly with an increase in total body fat. In elderly people, hypothalamic-pituitary disease can cause GH deficiency (GHD), compared with age matched controls. This study aimed to clarify whether GHD in the elderly is associated with differences in body composition, circulating lipid levels and quality of life (QOL) compared with control subjects. SUBJECTS: Twenty-seven elderly patients (14 males, mean age 71 years, range 65-83) with hypothalamic-pituitary disorders (23 pituitary tumours) and GHD (mean (SD) peak stimulated GH response 1.6 mIU/l (1.03) range 0.6-5) were studied. Twenty-five patients had been treated surgically (six cranial surgery, 19 transsphenoidal) and eight patients had received external cranial irradiation. Twenty-seven control subjects (14 males, mean age 72 years, range 65-86) were also studied. METHODS: Weight, body mass index (BMI), total fat mass (FM, bioelectrical impedance), waist to hip ratio (WHR), serum IGF-1, fasting blood glucose and lipid profile were measured. QOL was assessed in both groups using five interviewer administered self-rating questionnaires: The Nottingham Health Profile, Short-Form 36, Hospital Anxiety and Depression Scale, Mental Fatigue Questionnaire and Life Fulfilment Scale. The GHD group also completed the Disease Impact Scale. RESULTS: The data (mean (SD)) from males and females were analyzed separately. The male patients had a higher BMI than controls, 28.9(4.5) vs. 25.2(2.3) kg/m2 (P = 0.01) but the BMI in the female patients and controls was similar. In the female patients compared with the controls, FM was higher 39. 4(6) vs. 33.1(8.3) % (P = 0.02), WHR was also higher 0.9(0.08) vs. 0. 83(0.09) (P = 0.03) and serum IGF-1 levels were lower 10.8(6.4) vs. 18.2(6.5) nmol/l (P = 0.01). However, in the male patients, FM, WHR and IGF-1 levels were similar to the controls. Fasting blood glucose was similar in both male and female patients and the controls. Two female patients and one male control subject were taking lipid-lowering agents and were therefore excluded from the analysis of lipid profiles. Total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol and total cholesterol/HDL cholesterol ratio were not significantly different for both male and female patients compared with the controls. The 27 patients with GHD reported significantly less energy (P < 0.05), mobility (P < 0.05) and personal life fulfillment (P < 0.01) than the 27 controls. There were significantly more problems with emotional reaction (P < 0.01), social isolation (P < 0.05) and mental fatigue (P < 0.05). Additionally the GHD group reported more impairment in areas of social functioning (P < 0.05), general health (P < 0.05) and mental health (P < 0.05). The GHD group reported a modest degree of disease impact (mean score of 14.1). There were no significant differences in the domains of material life fulfillment, pain, sleep, physical functioning, vitality, anxiety, depression, self-esteem or role physical functioning compared with the controls. CONCLUSION: Compared with control subjects, the elderly female patients with hypothalamic-pituitary disease and GHD had a significantly higher total fat mass, with the WHR indicating a more central fat distribution and lower female serum IGF-1 levels. In contrast, elderly male patients had similar total fat mass, WHR and IGF-1 levels compared to the controls. There were no significant differences in the lipid profiles between male or female patients compared to controls. However, many of the male patients were receiving androgen replacement which might have influenced these results. Low HDL cholesterol concentrations are probably a better predictor of future cardiovascular disease than raised LDL cholesterol levels in the elderly population and these were similar in patients and controls for both","Li Voon Chong, J. S., et al. (2000). \"Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects.\" Clin Endocrinol (Oxf) 53(5): 551-559.","UK",2000,"Endocrine","None","MFQ"]
[163,"Li Voon Chong, J. S., et al. (2002). \"Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls.\" Clin Endocrinol (Oxf) 56(2): 175-181.",null,"Li Voon Chong, J. S., et al.","Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls","OBJECTIVE: Elderly patients with GH deficiency (GHD) have significant impairments in multiple aspects of quality of life (QOL) but similar lipid profiles compared to age-matched control subjects. There are, however, no data on changes in these parameters with time. This study assessed the impact of untreated GHD over a period of 2 years in a group of elderly patients with hypothalamic-pituitary disease in relation to new illnesses and differences in body composition, circulating lipid profile levels and QOL. Control subjects were also followed for 2 years. SUBJECTS: Twenty-seven elderly patients (> 65 years) with hypothalamic-pituitary disorders and GHD (mean peak stimulated GH response 1.6 mIU/l, range 0.6--5.0) were studied initially. Two years later 21 (13 males) agreed to attend for reassessment. Mean age was then 72.7 +/- 5.04 years (range 67--85). Eighteen patients had pituitary tumours, three had craniopharyngiomas. Twenty-seven control subjects were studied at baseline and 17 (7 males) agreed to attend for reassessment. Mean age was then 75.9 +/- 6.97 years (range 67--88). METHODS: Weight, body mass index (BMI), total fat mass (FM) (bioelectrical impedance), serum IGF-1 and fasting lipid profile (total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol) were measured. QOL was assessed in both groups using five interviewer-administered self-rating questionnaires: the Nottingham Health Profile, Short Form-36, Hospital Anxiety and Depression Scale, Mental Fatigue Questionnaire and Life Fulfillment Scale. The GHD group also completed the Disease Impact Scale. RESULTS: Two of the 27 patients with GHD died during the 2-year follow-up (myocardial infarction and probable cerebrovascular accident). Four controls could not be traced but there were no deaths in the other 23. In the 21 GHD patients after 2 years, mean serum IGF-1 and BMI were unchanged (12.6 +/- 5.8 vs. 13.3 +/- 5.1 nmol/l, P = 0.5 and 28.3 +/- 4.3 vs. 29.1 +/- 4.2, P = 0.5, respectively) at the 2-year follow-up and there were no significant changes in the lipid profiles. However, there was a significant reduction in fat mass (31.7 +/- 11.2 vs. 28.5 +/- 10.9%, P = 0.04). In the 17 control subjects after 2 years, serum IGF-1 levels (17.2 +/- 4.0 vs. 15.7 +/- 5.6 nmol/l, P = 0.4), BMI and fat mass were unchanged. However, there was a significant fall in total cholesterol levels over the 2-year follow-up (6.3 +/- 0.9 vs. 5.7 +/- 0.9 mmol/l, P < 0.0001), although LDL cholesterol, triglycerides and HDL cholesterol were unchanged. Analysing the QOL data, the GHD patients had less energy (P < 0.05), more depression (P < 0.05), more pain (P < 0.05) and lower life fulfillment scores (P < 0.01) after 2 years. However, the control subjects also had less energy (P < 0.05), less vitality (P < 0.05) and lower self-esteem (P < 0.05), more depression (P < 0.05), worse mental health (P < 0.05), life fulfillment personal (P < 0.01), life fulfillment material (P < 0.02), physical functioning and role physical functioning (P < 0.05) after 2 years. Comparing the patients and controls at baseline, there were significant differences in IGF-1, BMI, FM, LDL cholesterol, personal life fulfillment, mental fatigue, general health and mental health. However, after 2 years, only BMI and depression scores were significantly different. CONCLUSION: These patients with untreated GHD did not have deterioration of body composition or lipid profiles when reassessed after a period of 2 years. In fact, fat mass fell. The control subjects did have a significant decrease in total cholesterol but no change in other lipids or body composition. Some quality of life domains did deteriorate in the patients with GHD. However, the control subjects also had worse quality of life scores after 2 years which were then little different from the GHD patients. These results raise doubts about the benefits of GH replacement in elderly people with GHD.","Li Voon Chong, J. S., et al. (2002). \"Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls.\" Clin Endocrinol (Oxf) 56(2): 175-181.","UK",2002,"Endocrine","None","MFQ"]
[164,"Liu, C. H., et al. (2016). \"Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study.\" J Ethnopharmacol 194: 954-962.",null,"Liu, C. H., et al.","Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study","BACKGROUND AND PURPOSE: Astragalus membranaceus (AM) is the first-choice herb for fatigue treatment in traditional Chinese medicine and the main herb used for stroke treatment in China and Taiwan. The purpose of this study was to evaluate the effect of AM on poststroke fatigue (PSF). MATERIALS AND METHODS: This study was designed as a double-blind, randomized, controlled preliminary study. Sixty-four patients with PSF were assigned to treatment group (TG; 31 patients), which received oral administration of AM (2.8g three times per day) for 28 days, and a control group (CG; 33 patients), which received a placebo. The primary outcome measures were the changes in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Brief Fatigue Index (BFI) scores RESULTS: A total of 61 patients (29 patients in the TG and 32 patients in the CG) completed the trial. The difference in BFI scores between Visit 2 and Visit 1 was -17.83+/-17.70 in the TG, which was greater than that in the CG (-8.03+/-9.95; p=0.01); additionally, the difference in BFI scores between Visit 3 and Visit 1 was -16.48+/-16.41 in the TG, which was also greater than that in the CG (-9.47+/-13.39; p=0.05). In the EORTC QLQ-C30, the difference in cognitive functioning scores between Visit 2 and Visit 1 was 14.37+/-13.89 in the TG, which was greater than that in the CG (3.65+/-19.74; p=0.02); additionally, the difference in these scores between Visit 3 and Visit 1 was 14.37+/-16.50 in the TG, which again was greater than that in the CG (6.25+/-19.74; p=0.04). The difference in social functioning scores between Visit 3 and Visit 1 was 9.77+/-15.12 in the TG, which was greater than that in the CG (-1.56+/-20.46; p=0.01). The difference in global quality of life (QOL) scores between Visit 2 and Visit 1 was 14.08+/-18.78 in the TG, which was also greater than that in the CG (1.56+/-18.14; p=0.003); moreover, the difference in these scores between Visit 3 and Visit 1 was 10.92+/-17.55 in the TG, and this was greater than that in the CG (1.82+/-15.8; p=0.05). CONCLUSION: AM can improve BFI scores; cognitive functioning, social functioning, and global QOL scores in the EORTC QLQ-C30. Our results suggest that physicians should pay close attention to the unmet medical needs of patients with PSF. AM is helpful for treating patients with PSF; however, additional studies with a larger sample and a longer period of investigation are required.","Liu, C. H., et al. (2016). \"Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study.\" J Ethnopharmacol 194: 954-962.","Taiwan",2016,"CVD","Complementary","BFI"]
[165,"Lobentanz, I. S., et al. (2004). \"Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality.\" Acta Neurol Scand 110(1): 6-13.",null,"Lobentanz, I. S., et al.","Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality","OBJECTIVES: In a series of 504 patients with multiple sclerosis (MS), quality of life (QOL) and its main clinical and demographic determinants were assessed in comparison with healthy individuals. MATERIALS AND METHODS: A postal questionnaire with self-completed measures of disability (Expanded Disability Status Scale, EDSS), QOL (Quality of Life Index, QLI), depressive mood (Self-rating Depression Scale, SDS), fatigue severity (Fatigue Severity Scale, FSS) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) was sent to this sample of MS patients. RESULTS: Most patients were severely disabled; almost half were mildly to severely depressed, suffering from reduced sleep quality and/or fatigue. The multiple sclerosis patients had significantly lower QLI scores than healthy controls. EDSS and SDS scores were found to be predictors of global QLI score. Regarding the different QLI domains, mean SDS scores remained predictive for all QLI items, while mean EDSS, PSQI and FSS scores were only predictive for physical domains. CONCLUSION: Our study clearly demonstrates that depressive mood is the main factor influencing QOL. The disability status, fatigue and reduced sleep quality have an impact mainly on physical domains of life quality.","Lobentanz, I. S., et al. (2004). \"Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality.\" Acta Neurol Scand 110(1): 6-13.","Austria",2004,"Neurological","None","FSS"]
[166,"Lorentzen, K., et al. (2014). \"Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus.\" Dan Med J 61(4): A4808.",null,"Lorentzen, K., et al.","Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus","INTRODUCTION: Fatigue is a symptom of systemic lupus erythematosus (SLE), which has a substantial effect on the patients' quality of life and is a parameter that is difficult to quantify. The Fatigue Severity Scale (FSS) is a validated and reliable tool for quantifying fatigue. However, no Danish translation has yet been developed or validated. The aim of this study was to translate the FSS from English into Danish and subsequently to test and describe its validity and reliability in Danish SLE patients. MATERIAL AND METHODS: The FSS was translated from English into Danish and then back-translated. The translation agreed upon by medical professionals was tested for construct validity in an unselected group of SLE patients. The final version was tested for content validity, internal consistency and test-retest reliability in a second unselected group of SLE patients using the Danish version of the Short-Form Health Survey (SF-36). All patients included were outpatients with SLE of low to moderate disease activity, and low to moderate organ damage. RESULTS: Correlations were found between the Danish FSS and the main component scores of the SF-36. We found a high Cronbach's alpha as well as acceptable results of the intraclass correlation coefficient and the Bland-Altman plot. CONCLUSION: The Danish FSS translation is a valid and reliable measure of fatigue in the Danish SLE patients included in this study. FUNDING: Anne Voss reported a grant from The Danish Rheumatism Association (R33-A1836) and grants from The A.P. Moller Foundation for the Advancement of Medical Science and finally grants from the Region of South Denmark during the conduct of the study. TRIAL REGISTRATION: not relevant.","Lorentzen, K., et al. (2014). \"Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus.\" Dan Med J 61(4): A4808.","Denmark",2014,"Inflamatory Systemic Disease","None","FSS"]
[167,"Lucas-Carrasco, R., et al. (2011). \"Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders.\" Neurodegener Dis 8(4): 178-186.",null,"Lucas-Carrasco, R., et al.","Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders","BACKGROUND/AIMS: Neurodegenerative disorders (ND) have a major impact on quality of life (QoL) and place a substantial burden on patients, their families and carers; they are the second leading cause of disability. The objective of this study was to examine QoL in persons with ND. METHODS: A battery of subjective assessments was used, including the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) and the World Health Organization Quality of Life - Disability (WHOQOL-DIS). Psychometric properties of the WHOQOL-BREF and WHOQOL-DIS were investigated using classical psychometric methods. RESULTS: Participants (n = 149) were recruited and interviewed at two specialized centers to obtain information on health and disability perceptions, depressive symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D), Fatigue Assessment Scale (FAS), Satisfaction with Life (SWL), generic QoL (WHOQOL-BREF, WHOQOL-DIS), specific QoL (Multiple Sclerosis Impact Scale, MSIS-29; Parkinson's Disease Questionnaire, PDQ-39) and sociodemographics. Internal consistency was acceptable, except for the WHOQOL-BREF social (0.67). Associations, using Pearson's and Spearman's rho correlations, were confirmed between WHOQOL-BREF and WHOQOL-DIS with MSIS-29, PDQ-39, HADS-D, FAS and SWL. Regarding 'known group' differences, Student's t tests showed that WHOQOL-BREF and WHOQOL-DIS scores significantly discriminated between depressed and nondepressed and those perceiving a more severe impact of the disability on their lives. CONCLUSION: This study is the first to report on use of the WHOQOL-BREF and WHOQOL-DIS in Spanish persons with ND; they are promising useful tools in assessing persons with ND through the continuum of care, as they include important dimensions commonly omitted from other QoL measures.","Lucas-Carrasco, R., et al. (2011). \"Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders.\" Neurodegener Dis 8(4): 178-186.","Spain",2011,"Neurological","None","FAS"]
[168,"Luckett, T., et al. (2010). \"Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change.\" Int J Gynecol Cancer 20(4): 664-684.",null,"Luckett, T., et al.","Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change","OBJECTIVES: Researchers wishing to assess the health-related quality of life (HRQoL) of women with gynecologic cancers have a range of questionnaires to choose from. In general, disease-, treatment-, or symptom-specific questionnaires are assumed to be better able to identify between-group differences (sensitivity) and changes over time (responsiveness) than are cancer-specific or generic questionnaires. However, little work has tested this assumption in oncology. We set out to (a) identify all multidimensional HRQoL questionnaires used in studies with women with gynecologic cancer and (b) evaluate their track records in identifying minimal clinically important differences (MCIDs), with a view to making recommendations. METHODS: We searched MEDLINE using the term quality of life and each gynecologic cancer type, as well as the names of identified questionnaires. We used 10% of the scale range as the threshold for an MCID. RESULTS: We identified 1 generic (SF-36/SF-12), 3 cancer-specific (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] C30, Functional Assessment of Cancer Therapy-General [FACT-G], and short-form Cancer Rehabilitation Evaluation System [CARES-SF]), and 1 disease-specific (QOL-Ovarian Cancer Patient Version) HRQoL questionnaires and 5 disease-specific (QLQ-OV28, FACT-O for ovarian, QLQ-CX24, FACT-Cx for cervical and FACT-V for vulvar), 1 treatment-specific (FACT and Gynecologic Oncology Group-Ntx for neurotoxicity), and 2 symptom-specific (FACT-Anemia and Functional Assessment of Chronic Illness and Therapy [FACIT]-Fatigue) modules. Twenty-seven articles reported results from 26 studies in which an MCID had been identified. The FACIT's anemia and fatigue subscales were more sensitive, and the neurotoxicity subscale more sensitive and responsive than the FACT-G on at least 1 comparison. However, we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT questionnaires or vice versa. CONCLUSIONS: The evidence we reviewed offered little support for the hypothesis that disease-, symptom-, or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic questionnaires. However, conclusions were limited by the small number of head-to-head comparisons available. We summarize the clinical contexts in which each instrument identified an MCID to inform choice of questionnaire(s), sample size calculations, and interpretation of results in future studies.","Luckett, T., et al. (2010). \"Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change.\" Int J Gynecol Cancer 20(4): 664-684.","Australia",2010,"none","None","FACIT-F"]
[169,"Lund Rasmussen, C., et al. (2015). \"Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.\" Cancer 121(20): 3727-3736.",null,"Lund Rasmussen, C., et al.","Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial","BACKGROUND: Patients with advanced cancer often experience fatigue and other symptoms that negatively impact their quality of life. The current trial investigated the effect of melatonin on fatigue and other symptoms in patients with advanced cancer. METHODS: Patients who were aged >/=18 years, had a histologically confirmed stage IV cancer (TNM Classification), and who reported feeling significantly tired were recruited from the palliative care unit at the study institution. The study was a double-blind, randomized, placebo-controlled crossover trial. Patients received 1 week of melatonin at a dose of 20 mg or a placebo orally each night, before crossing over and receiving the opposite treatment for 1 week. Between the 2 periods, a washout period of 2 days was implemented. Outcomes were measured using the Multidimensional Fatigue Inventory (MFI-20) and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Physical fatigue from the MFI-20 was the primary outcome. The primary analysis was a complete complier analysis (ie, it included only those patients who had consumed at least 5 capsules per week and who had answered the MFI-20 on days 1, 7, 10, and 17). Sensitivity analysis using multiple imputations including all randomized patients and all patients completing the intervention were conducted. RESULTS: A total of 72 patients were randomized. Fifty patients completed the intervention and 44 patients were complete compliers. No significant differences between the placebo and melatonin periods were found for physical fatigue, secondary outcomes, or explorative outcomes. CONCLUSIONS: In the current study, oral melatonin at a dose of 20 mg was not found to improve fatigue or other symptoms in patients with advanced cancer.","Lund Rasmussen, C., et al. (2015). \"Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.\" Cancer 121(20): 3727-3736.","Denmark",2015,"Cancer","Other Drugs","MFI"]
[170,"Ma, H., et al. (2011). \"Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report.\" BMC Complement Altern Med 11: 109.",null,"Ma, H., et al.","Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report","BACKGROUND: It remains unclear whether estrogenic botanical supplement (EBS) use influences breast cancer survivors' health-related outcomes. METHODS: We examined the associations of EBS use with health-related quality of life (HRQOL), with fatigue, and with 15 hormone-related symptoms such as hot flashes and night sweats among 767 breast cancer survivors participating in the Health, Eating, Activity, and Lifestyle (HEAL) Study. HRQOL was measured by the Medical Outcomes Study short form-36 physical and mental component scale summary score. Fatigue was measured by the Revised-Piper Fatigue Scale score. RESULTS: Neither overall EBS use nor the number of EBS types used was associated with HRQOL, fatigue, or hormone-related symptoms. However, comparisons of those using each specific type of EBS with non-EBS users revealed the following associations. Soy supplements users were more likely to have a better physical health summary score (odds ratio [OR] = 1.66, 95% confidence interval [CI] = 1.02-2.70). Flaxseed oil users were more likely to have a better mental health summary score (OR = 1.76, 95% CI = 1.05-2.94). Ginseng users were more likely to report severe fatigue and several hormone-related symptoms (all ORs >/= 1.7 and all 95% CIs exclude 1). Red clover users were less likely to report weight gain, night sweats, and difficulty concentrating (all OR approximately 0.4 and all 95% CIs exclude 1). Alfalfa users were less likely to experience sleep interruption (OR = 0.28, 95% CI = 0.12-0.68). Dehydroepiandrosterone users were less likely to have hot flashes (OR = 0.33, 95% CI = 0.14-0.82). CONCLUSIONS: Our findings indicate that several specific types of EBS might have important influences on a woman's various aspects of quality of life, but further verification is necessary.","Ma, H., et al. (2011). \"Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report.\" BMC Complement Altern Med 11: 109.","USA",2011,"Cancer","Complementary","PFS"]
[171,"Maddali Bongi, S., et al. (2016). \"Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome.\" Complement Ther Clin Pract 24: 109-115.",null,"Maddali Bongi, S., et al.","Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome","BACKGROUND: Fibromyalgia Syndrome (FMS) is characterized by musculoskeletal pain, muscle tenderness leading to disability, impaired quality of life (QoL), fatigue and it is accompanied by sleep disorders and psychological distress. Mind body therapies (MBT), such as Tai Ji Quan (TJQ), use different techniques to facilitate the ability of the mind to influence disease characteristics and symptoms. Some studies showed that TJQ, in patients with rheumatic diseases, particularly FMS, improved QoL, disability and psychological distress. OBJECTIVES: To evaluate the efficacy of TJQ on disability, QoL, fatigue, sleep and psychological distress in an Italian cohort of FMS patients. METHODS: We enrolled 44 FMS patients: 22 patients (Experimental Group) participated to a course of Tai Ji Quan style of (2/week for 16 weeks); 22 patients (Control Group) participated to an educational course about FMS (2/week for 16 weeks). At baseline (T0) and at the end of treatment (T1), patients were assessed for disability [Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ)], Quality of Life [Short-Form 36 (SF36)], fatigue [Functional Assessment of Chronic Illness-Fatigue (FACIT-F)], pain [Widespread Pain Index (WPI)], tenderness [Tender Points (TP)], Sleep Quality [Pittsburgh Sleep Quality Index (PSQI)] and mood disorders [Hospital Anxiety and Depression Scale (HADS)]. RESULTS: At T1 versus T0, patients of the Experimental Group showed a significant improvement in FIQ, FACIT, SF36 (Summary Physical Index, Physical activity, physical role, bodily pain, general health, vitality, emotional role limitations), in WPI, TP, PSQI (total, sleep duration, and sleep disturbance) and HADS (total score and anxiety subscale), while Patients in the Control Group did not improve in any parameter. CONCLUSIONS: In FMS patients TJQ, if performed by an expert physiotherapist, should be regarded as an effective rehabilitation method.","Maddali Bongi, S., et al. (2016). \"Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome.\" Complement Ther Clin Pract 24: 109-115.","Italy",2016,"Musculoskeletal","Psychobehavioural","FACIT-F"]
[172,"Malik, I. A., et al. (2003). \"Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects.\" Clin Endocrinol (Oxf) 59(1): 75-81.",null,"Malik, I. A., et al.","Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects","OBJECTIVE: There are few studies of quality of life (QOL) in adults with growth hormone deficiency (GHD) compared to matched control populations without GHD. These have shown impairments in a variety of QOL measures, which improve but do not normalize after short-term replacement with GH. There is little information on QOL in long-term treated GHD patients compared with controls without GHD. PATIENTS AND METHODS: A total of 120 adults with GHD who had received GH replacement for at least 1 year were identified from the neuroendocrine clinic. Patients were asked to complete eight QOL questionnaires and an Energy Visual Analogue Scale (VAS). Results were compared with 83 control subjects without GHD from the local population who agreed to complete seven of the QOL questionnaires (excluding Disease Impact scale) and the energy VAS. The eight questionnaires were a combination of generic and disease-specific questionnaires used to assess health related QOL, namely: Short Form-36 (SF-36), Nottingham Health Profile (NHP), Disease Impact, Life Fulfilment and Satisfaction scales, Mental Fatigue Questionnaire (MFQ) and Self Esteem scale, Hospital Anxiety Depression (HAD) scale and QOL-AGHDA (assessment of GHD in adults). RESULTS: Eighty-nine patients returned questionnaires and 85 (71%) had complete data for analysis. The mean (SD) duration of GH replacement was 36.0 +/- 26.4 (range 13-159) months. Mean age was 43.9 +/- 15.8 years (37 males) in treated GHD patients compared to a mean age 41.7 +/- 10.5 years (32 males) in the controls. Mean IGF-1 levels were 22.5 +/- 13.6 nmol/l in the GHD patients and the mean dose of GH replacement was 1.2 +/- 0.4 IU daily. Analysis of the QOL questionnaires from the GH treated patients revealed highly significant impairments in all measures (most P </= 0.0001, except life fulfilment-material, P = 0.33) compared to the control population. CONCLUSIONS: This large population with treated GH deficiency have significant impairments in multiple aspects of QOL despite replacement with GH and other pituitary hormones for at least 1 year (mean 3 years). It is likely therefore that other factors in addition to GH deficiency must influence QOL in these patients. Further strategies to improve QOL in these individuals should therefore be considered, e.g. psychological support and treatments and physical treatments (such as exercise programmes).","Malik, I. A., et al. (2003). \"Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects.\" Clin Endocrinol (Oxf) 59(1): 75-81.","UK",2003,"Endocrine","Various","MFQ"]
[173,"Maric, D., et al. (2014). \"Multivitamin mineral supplementation in patients with chronic fatigue syndrome.\" Med Sci Monit 20: 47-53.",null,"Maric, D., et al.","Multivitamin mineral supplementation in patients with chronic fatigue syndrome","BACKGROUND: Chronic fatigue syndrome (CFS) is characterized by medically unexplained persistent or reoccurring fatigue lasting at least 6 months. CFS has a multifactorial pathogenesis in which oxidative stress (OS) plays a prominent role. Treatment is with a vitamin and mineral supplement, but this therapeutic option so far has not been properly researched. MATERIAL AND METHODS: This prospective study included 38 women of reproductive age consecutively diagnosed by CDC definition of CFS and treated with a multivitamin mineral supplement. Before and after the 2-month supplementation, SOD activity was determined and patients self-assessed their improvement in 2 questionnaires: the Fibro Fatigue Scale (FFS) and the Quality of Life Scale (SF36). Results There was a significant improvement in SOD activity levels; and significant decreases in fatigue (p=0.0009), sleep disorders (p=0.008), autonomic nervous system symptoms (p=0.018), frequency and intensity of headaches (p=0.0001), and subjective feeling of infection (p=0.0002). No positive effect on quality of life was found. CONCLUSIONS: Treatment with a vitamin and mineral supplement could be a safe and easy way to improve symptoms and quality of life in patients with CFS.","Maric, D., et al. (2014). \"Multivitamin mineral supplementation in patients with chronic fatigue syndrome.\" Med Sci Monit 20: 47-53.","Serbia",2014,"Chronic Fatigue","Complementary","FFS"]
[174,"Martinez-Martin, P., et al. (2006). \"Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS).\" Qual Life Res 15(4): 597-606.",null,"Martinez-Martin, P., et al.","Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS)","The Fatigue Impact Scale for Daily Use (D-FIS) was used in a cross-sectional study including 142 consecutive Parkinson's disease (PD) patients. Usual clinical measures for PD, the Montgomery-Asberg Depression Rating Scale and the Parkinson's Disease Questionnaire-8 items were applied. In addition to the D-FIS, patients with fatigue (67.6%, PWF) completed the Multidimensional Fatigue Inventory (MFI), a visual analogue scale for fatigue (VAS-F) and a Global Perception of Fatigue scale (GPF). Relevant psychometric D-FIS results were: floor effect = 4.2%; ceiling effect = 1.1%; skewness = 0.44; item homogeneity = 0.63; Cronbach's alpha = 0.93; item-total correlation = 0.68 (item 1)-0.82 (item 8); standard error of measurement = 2.15; convergent validity with other fatigue measures = 0.54 [GPF]-0.62 [VAS-F] (p<0.001). In a multiple linear regression model, fatigue, depression, and disability independently influenced HRQoL, as measured by the PDQ-8. Patients on amantadine had lower prevalence of fatigue. In PD, D-FIS is a consistent and valid measure for fatigue, a frequent symptom previously found to impair patients' HRQoL. Fatigue was also linked to depression and disability in this study.","Martinez-Martin, P., et al. (2006). \"Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS).\" Qual Life Res 15(4): 597-606.","Spain",2006,"Neurological","None","DFIS,VAS-F,MFI,GFS"]
[175,"Mateen, F. J., et al. (2017). \"Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial.\" Medicine (Baltimore) 96(36): e8037.",null,"Mateen, F. J., et al.","Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial","BACKGROUND: Fatigue is the most commonly reported symptom among multiple sclerosis (MS) patients, more than a quarter of whom consider fatigue to be their most disabling symptom. However, there are few effective treatment options for fatigue. We aim to investigate whether supplemental exposure to bright white light will reduce MS-associated fatigue. METHODS: Eligible participants will have clinically confirmed multiple sclerosis based on the revised McDonald criteria (2010) and a score >/=36 on the Fatigue Severity Scale (FSS). Participants will be randomized 1:1 to bright white light (10,000 lux; active condition) or dim red light (<300 lux; control condition) self-administered for 1 hour twice daily. The study will include a 2-week baseline period, a 4-week treatment period, and a 4-week washout period. Participants will record their sleep duration, exercise, caffeine, and medication intake daily. Participants will record their fatigue using the Visual Analogue Fatigue Scale (VAFS) 4 times every third day, providing snapshots of their fatigue level at different times of day. Participants will self-report their fatigue severity using FSS on 3 separate visits: at baseline (week 0), following completion of the treatment phase (week 6), and at study completion (week 10). The primary outcome will be the change in the average FSS score after light therapy. We will perform an intention-to-treat analysis, comparing the active and control groups to assess the postintervention difference in fatigue levels reported on FSS. Secondary outcome measures include change in global VAFS scores during the light therapy and self-reported quality of life in the Multiple Sclerosis Quality of Life-54. DISCUSSION: We present a study design and rationale for randomizing a nonpharmacological intervention for MS-associated fatigue, using bright light therapy. The study limitations relate to the logistical issues of a self-administered intervention requiring frequent participant self-report in a relapsing condition. Ultimately, light therapy for the treatment of MS-associated fatigue may provide a low-cost, noninvasive, self-administered treatment for one of the most prevalent and burdensome symptoms experienced by people with MS.","Mateen, F. J., et al. (2017). \"Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial.\" Medicine (Baltimore) 96(36): e8037.","USA",2017,"Neurological","Various","FSS,VAS-F"]
[176,"Mathiowetz, V. G., et al. (2005). \"Randomized controlled trial of an energy conservation course for persons with multiple sclerosis.\" Mult Scler 11(5): 592-601.",null,"Mathiowetz, V. G., et al.","Randomized controlled trial of an energy conservation course for persons with multiple sclerosis","OBJECTIVE: To assess the short-term efficacy and effectiveness of a six-week energy conservation course on fatigue impact, quality of life and self-efficacy for persons with multiple sclerosis (MS). METHODS: In this randomized controlled trial, we randomly assigned 169 persons with MS to an immediate intervention group or a delayed control group using a crossover design. The outcome measures: Fatigue Impact Scale, SF-36 Health Survey and Self-Efficacy for Performing Energy Conservation Strategies were measured before and after courses and no intervention control periods. We performed intent-to-treat analysis and compliers-only analyses using mixed effects analysis of variance models. RESULTS: Taking the energy conservation course had significant effects on reducing the physical and social subscales of Fatigue Impact Scale and on increasing the Vitality subscale of the SF-36 scores compared with not taking the course. Additional subscales were significant depending on methods of analyses. Self-Efficacy for Performing Energy Conservation Strategies Assessment increased significantly (P <0.05) postcourse compared to precourse. CONCLUSIONS: Results support the efficacy and effectiveness of the energy conservation course to decrease fatigue impact, and to increase self-efficacy and some aspects of quality of life.","Mathiowetz, V. G., et al. (2005). \"Randomized controlled trial of an energy conservation course for persons with multiple sclerosis.\" Mult Scler 11(5): 592-601.","USA",2005,"Neurological","None","FIS"]
[177,"Matza, L. S., et al. (2011). \"Development and validation of a patient-report measure of fatigue associated with depression.\" J Affect Disord 134(1-3): 294-303.",null,"Matza, L. S., et al.","Development and validation of a patient-report measure of fatigue associated with depression","INTRODUCTION: Among researchers and clinicians who treat depression, there is growing interest in treatment of specific residual symptoms such as fatigue. However, there is no available measure that provides a detailed assessment of fatigue associated with depression. Thus, the purpose of the current study was to develop and validate a patient-reported outcome measure designed to assess depression-related fatigue and its impact. METHODS: The Fatigue Associated with Depression Questionnaire (FAsD) was developed based on literature review, clinician interviews, and focus groups and cognitive debriefing interviews with patients. Then, a draft questionnaire was administered to a sample of patients with depression. Statistical analysis first focused on item reduction and subscale identification, followed by psychometric evaluation of the FAsD. RESULTS: The per protocol sample (n = 317) was primarily female (68.1%), with a mean age of 47.0 years. Based on item performance and exploratory factor analysis, three items were dropped from the draft FAsD, yielding a final 13-item questionnaire with two subscales (experience and impact). The FAsD demonstrated good internal consistency reliability (Cronbach's alphas >/= 0.88) and test-retest reliability (intraclass correlation coefficients >/= 0.78). The FAsD demonstrated construct validity through strong correlations with measures assessing fatigue/energy and symptoms of depression. The FAsD also discriminated among groups of participants differentiated by clinician ratings of global severity of depression (CGI-S). LIMITATIONS: Limitations include heterogeneity of current treatments received by the sample, as well as lack of knowledge regarding the extent to which FAsD scores were influenced by patients' treatments rather than the depression itself. CONCLUSIONS: In this initial psychometric evaluation, the FAsD demonstrated good reliability, validity, and factor structure. This questionnaire may be a useful tool for evaluating treatment interventions that focus specifically on fatigue associated with depression.","Matza, L. S., et al. (2011). \"Development and validation of a patient-report measure of fatigue associated with depression.\" J Affect Disord 134(1-3): 294-303.","USA",2011,"Mental Health","None","FAsD"]
[178,"Maurer, M., et al. (2016). \"Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies.\" Mult Scler Relat Disord 7: 33-40.",null,"Maurer, M., et al.","Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies","BACKGROUND: Two pivotal phase 3 teriflunomide studies provided data on relapses, fatigue, and health-related quality of life (HRQoL) in patients with relapsing forms of multiple sclerosis (MS). OBJECTIVES: Using pooled data from the TEMSO (NCT00134563) and TOWER (NCT00751881) studies, we investigated the association between relapse severity, and changes from baseline to Week 108 in fatigue and HRQoL outcomes. METHODS: Four definitions of relapse severity were applied in this analysis: sequelae post-relapse; relapse leading to hospitalization; relapse requiring intravenous corticosteroids; and intense relapse. We assessed the association between relapse severity and changes in Fatigue Impact Scale score (n=959), physical and mental health component summary scores from the Short Form (SF)-36 questionnaire (n=904), and SF-6D utility index scores (n=820). RESULTS: Irrespective of the definition of relapse severity applied, in patients experiencing severe relapse(s), fatigue was increased and HRQoL was decreased; these changes were statistically significant (p<0.0001), and were also clinically significant in many cases. The greatest worsening in fatigue and HRQoL was observed in patients with relapses leading to hospitalization. CONCLUSIONS: Given that severe relapses adversely affect patient-reported fatigue and HRQoL, prevention of severe relapses should be an important therapeutic aim in the treatment of patients with MS.","Maurer, M., et al. (2016). \"Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies.\" Mult Scler Relat Disord 7: 33-40.","Germany",2016,"Neurological","None","FIS"]
[179,"McKenna, S. P., et al. (2010). \"International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS).\" Value Health 13(8): 946-951.",null,"McKenna, S. P., et al.","International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS)","BACKGROUND: The Patient-Reported Indices for Multiple Sclerosis (PRIMUS) comprises a suite of three scales for assessing symptoms, activity limitations, and quality of life in multiple sclerosis (MS). It was developed in the UK and has been shown to have excellent psychometric properties. This study describes the adaptation of eight language versions for Canadian English, Canadian French, French, German, Italian, Spanish, Swedish, and US English. METHODS: The PRIMUS was translated using the dual-panel process. Cognitive debriefing interviews conducted with MS patients assessed face and content validity. Psychometric and scaling properties were assessed via a two-administration postal survey conducted in each country involving the PRIMUS, the Nottingham Health Profile (NHP), the Unidimensional Fatigue Impact Scale (U-FIS), and demographic questions. RESULTS: Cognitive debriefing interviews demonstrated the acceptability of the new language versions. Analysis of survey data showed that the new language versions of the three PRIMUS scales were unidimensional (as indicated by fit to the Rasch model) and that they had good internal consistency and reproducibility. PRIMUS scale scores correlated as expected with those on the NHP and the U-FIS. The scales in all countries were able to discriminate between groups of patients on the basis of their self-reported MS severity, general health, and employment status. CONCLUSIONS: The PRIMUS was successfully adapted into eight new languages. Most of the tests showed the PRIMUS to have good unidimensionality and to have good internal consistency, reproducibility, and construct validity. The measure is now available for use in clinical studies and trials involving these countries and the UK. Further work is required to assess the measure's responsiveness.","McKenna, S. P., et al. (2010). \"International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS).\" Value Health 13(8): 946-951.","UK",2010,"Neurological","None","U-FIS"]
[180,"Mease, P. J., et al. (2008). \"Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial.\" J Rheumatol 35(1): 20-30.",null,"Mease, P. J., et al.","Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial","OBJECTIVE: To evaluate the effect of rituximab treatment on health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA), who have had an inadequate response to disease-modifying antirheumatic drugs, including biologic agents. METHODS: A randomized, multicenter, double-blind, placebo-controlled clinical trial involving 367 rheumatoid factor-positive patients was conducted. Patients received 2 infusions 2 weeks apart of placebo (n = 122), rituximab 500 mg (n = 123), or rituximab 1000 mg (n = 122), with or without glucocorticoids. All patients received stable doses of methotrexate (10 25 mg/wk). Measures included SF-36, assessed at baseline and at 24 weeks, as well as the HAQ and FACIT-Fatigue scale assessed at baseline and monthly for 24 weeks. Patients exceeding prespecified minimal clinically important differences (MCID) were examined. Clinical efficacy measurements (ACR20/50/70 and EULAR responses) were compared with HRQOL outcomes. RESULTS: At 24 weeks, the rituximab 500 mg and 1000 mg groups both reported statistically significantly greater improvements on the SF-36 physical component summary (4.37 and 4.89 points higher, respectively, vs placebo; p < 0.001). SF-36 physical function, bodily pain, vitality, social function, and role-physical subscale scores also statistically significantly improved vs placebo. At 24 weeks, 62.6% and 67.2% of the rituximab 500 mg and 1000 mg groups, respectively, exceeded the MCID of 0.22 in HAQ (p < 0.001). For FACIT-Fatigue, 55.3% and 65.6% of patients exceeded the MCID of 3.5 points compared with 35.2% of placebo over 24 weeks (p < 0.001). ACR20/50/70 and EULAR responders demonstrated greater improvements in mean baseline to 24 week changes in SF-36 and FACIT-Fatigue scores compared with nonresponders (p < 0.05). CONCLUSION: Both rituximab doses in combination with methotrexate were effective in improving all HRQOL outcomes in patients with active RA consistent with clinical efficacy.","Mease, P. J., et al. (2008). \"Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial.\" J Rheumatol 35(1): 20-30.","USA",2008,"Musculoskeletal","Rituximab","FACIT-F"]
[181,"Meeske, K., et al. (2007). \"Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report.\" Qual Life Res 16(6): 947-960.",null,"Meeske, K., et al.","Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report","PURPOSE: The purpose of this study was to estimate prevalence of fatigue, identify correlates of fatigue and evaluate the relationship between fatigue and health-related quality of life (HRQOL) in a large cohort of disease-free breast cancer survivors. METHODS: Participants are enrolled in the HEAL Study, a multi-center prospective study of women diagnosed with in-situ to Stage IIIA breast cancer. HEAL participants (n = 1183) completed a baseline and a 24-month follow-up interview. Women in this report (n = 800) also completed a quality of life questionnaire that included the Piper Fatigue Scale and the RAND SF-36 two to five years after diagnosis. Multivariate regression methods were used to identify significant factors associated with fatigue. SF-36 scores for fatigued survivors were compared to non-fatigued survivor scores and population norms. RESULTS: Forty-one percent of the breast cancer survivors were fatigued. Significant correlates of fatigue included pain, cognitive problems, physical inactivity, weight gain/personal appearance and antidepressant use. Fatigue was associated with poorer HRQOL, most notably in areas of role and social functioning. CONCLUSION: This study provides further support for the conclusion that a significant proportion of breast cancer survivors experience fatigue that compromises HRQOL two to five years post-diagnosis.","Meeske, K., et al. (2007). \"Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report.\" Qual Life Res 16(6): 947-960.","USA",2007,"Cancer","None","PFS"]
[182,"Mehnert, A., et al. (2007). \"The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy.\" Patient Educ Couns 66(1): 108-118.",null,"Mehnert, A., et al.","The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy","OBJECTIVE: The possible association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life has been studied in high-risk breast cancer survivors 5 years following standard adjuvant (n=23) versus high-dose chemotherapy (n=24) and in early-stage breast cancer patients (n=29) (comparison group) following radiation therapy. METHODS: A neuropsychological assessment covering attention, memory and executive functions was used together with the questionnaire for self-perceived deficits in attention (FEDA), the multidimensional fatigue inventory (MFI-20) and the EORTC-QLQ-C30. RESULTS: Findings have shown that neuropsychological impairment is not directly associated with self-perceived cognitive deficits, fatigue and HRQOL. However, 46% of patients reported self-perceived cognitive deficits and 82% of the patients complained about cancer related fatigue. Except for reduced activity we did not find significant group differences, even though patients who received standard-dose chemotherapy had consistently higher levels of self-perceived cognitive deficits and fatigue, and the lowest HRQOL. CONCLUSION: Results emphasize the need for psychosocial counseling and support during treatment phase and follow up care as well. Sensitive cancer-specific measures for the assessment of self-perceived cognitive deficits in different cognitive domains according to neuropsychological measurements are required. PRACTICE IMPLICATIONS: The role of self-perceived cognitive deficits and fatigue should be considered in educational interventions and counseling. Specific rehabilitation measures should be developed, implemented and evaluated in order to meet the needs of these patients and to decrease the frequency of cognitive deficits following cancer treatment.","Mehnert, A., et al. (2007). \"The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy.\" Patient Educ Couns 66(1): 108-118.","Germany",2007,"Cancer","None","MFI"]
[183,"Meneses-Echavez, J. F., et al. (2015). \"Supervised exercise reduces cancer-related fatigue: a systematic review.\" J Physiother 61(1): 3-9.",null,"Meneses-Echavez, J. F., et al.","Supervised exercise reduces cancer-related fatigue: a systematic review","QUESTION: Does supervised physical activity reduce cancer-related fatigue? DESIGN: Systematic review with meta-analysis of randomised trials. PARTICIPANTS: People diagnosed with any type of cancer, without restriction to a particular stage of diagnosis or treatment. INTERVENTION: Supervised physical activity interventions (eg, aerobic, resistance and stretching exercise), defined as any planned or structured body movement causing an increase in energy expenditure, designed to maintain or enhance health-related outcomes, and performed with systematic frequency, intensity and duration. OUTCOME MEASURES: The primary outcome measure was fatigue. Secondary outcomes were physical and functional wellbeing assessed using the Functional Assessment of Cancer Therapy Fatigue Scale, European Organisation for Research and Treatment of Cancer Quality of Life QUESTIONnaire, Piper Fatigue Scale, Schwartz Cancer Fatigue Scale and the Multidimensional Fatigue Inventory. Methodological quality, including risk of bias of the studies, was evaluated using the PEDro Scale. RESULTS: Eleven studies involving 1530 participants were included in the review. The assessment of quality showed a mean score of 6.5 (SD 1.1), indicating a low overall risk of bias. The pooled effect on fatigue, calculated as a standardised mean difference (SMD) using a random-effects model, was -1.69 (95% CI -2.99 to -0.39). Beneficial reductions in fatigue were also found with combined aerobic and resistance training with supervision (SMD=-0.41, 95% CI -0.70 to -0.13) and with combined aerobic, resistance and stretching training with supervision (SMD=-0.67, 95% CI -1.17 to -0.17). CONCLUSION: Supervised physical activity interventions reduce cancer-related fatigue. These findings suggest that combined aerobic and resistance exercise regimens with or without stretching should be included as part of rehabilitation programs for people who have been diagnosed with cancer. REGISTRATION: PROSPERO CRD42013005803.","Meneses-Echavez, J. F., et al. (2015). \"Supervised exercise reduces cancer-related fatigue: a systematic review.\" J Physiother 61(1): 3-9.","Spain",2015,"Cancer","Psychobehavioural","FACT-F,PFS,MFI,Schwartz Cancer-FS"]
[184,"Meng, H., et al. (2014). \"Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial.\" BMC Fam Pract 15: 184.",null,"Meng, H., et al.","Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial","BACKGROUND: Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care. METHODS: An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness. RESULTS: The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs. CONCLUSION: This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00997451, March 28, 2009).","Meng, H., et al. (2014). \"Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial.\" BMC Fam Pract 15: 184.","Unknown",2014,"Chronic Fatigue","None","FSS"]
[185,"Merritta, C., et al. (2010). \"Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury.\" Int J Rehabil Res 33(2): 109-114.",null,"Merritta, C., et al.","Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury","The aims of this study were to objectively measure the physical performance and physical endurance of patients with traumatic brain injury with minimization of cognitive and psychological fatigue, and to compare the physical performance of brain injured patients with that of healthy controls. This was a nonrandomized partially blinded controlled study. The study setting was the Outpatient Multidisciplinary Brain Injury Clinic in the Department of Physical Medicine and Rehabilitation of a tertiary care university teaching hospital. Participants included an experimental group that comprised independently ambulant men (age 18-55 years) with mild-to-moderate traumatic brain injury (n = 24) who complained of greater fatigue than before their injury and an age-matched and sex-matched control group (n = 24). The intervention included the Six-Minute Walk Test. The primary outcome measures were the Six-Minute Walk Distance, the Fatigue Severity Scale, Addenbrooke's Cognitive Examination, and the Fatigue Visual Numeric Scale; the secondary outcome measures were the Physiological Cost Index of Walking and the Borg Scale of Perceived Exertion. The Six-Minute Walk Distance of the experimental group (452.33+/-68.816) when compared with that of the control group (518.08+/-92.114) was reduced by 12.7 and 30.5%, respectively, when compared with the predicted Six-Minute Walking Distance (650.04+/-79.142) for the same age and sex. The mean Fatigue Severity Scale values were 2.51 and 1.62 for the experimental and control groups, respectively. The mean Addenbrooke's Cognitive Examination Score for the patients was 85.5+/-7.265. In conclusion, the Six-Minute Walk Test is useful in segregating physical fatigue from cognitive and psychological aspects of fatigue when cognitive and psychological dimensions are known. The Six-Minute Walk Test can be used as a tool for exercise intensity prescription in men with mild-to-moderate brain injury, to avoid the deleterious effects of fatigue.","Merritta, C., et al. (2010). \"Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury.\" Int J Rehabil Res 33(2): 109-114.","India",2010,"Neurological","None","FSS,VAS-F"]
[186,"Mesa, R. A., et al. (2013). \"Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial.\" J Clin Oncol 31(10): 1285-1292.",null,"Mesa, R. A., et al.","Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial","PURPOSE: To assess the effects of ruxolitinib on symptom burden and quality of life (QoL) and to evaluate the ability of the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 to measure meaningful changes in myelofibrosis-related symptoms in patients with myelofibrosis. PATIENTS AND METHODS: COMFORT-I (Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment-I) is a double-blind, placebo-controlled phase III study evaluating ruxolitinib in patients with intermediate-2 or high-risk myelofibrosis. Exploratory analyses were conducted on the following patient-reported outcomes (PROs) assessments: modified MFSAF v2.0 (individual symptoms and Total Symptom Score [TSS]), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, and Patient Global Impression of Change (PGIC). RESULTS: Patients receiving ruxolitinib experienced improvements in individual myelofibrosis-related symptoms, although patients receiving placebo experienced worsening (P < .001). The majority (91%) of ruxolitinib-treated patients designated as >/= 50% TSS responders (>/= 50% TSS improvement) self-reported their condition as either \"Much improved\" or \"Very much improved\" on the PGIC. These patients achieved significant improvements in the EORTC QLQ-C30 functional domains and Global Health Status/QoL versus patients receiving placebo, who experienced worsening on these measures (P </= .0135). Ruxolitinib-treated patients with a lesser degree of symptom improvement (< 50% TSS responders) also achieved improvements over placebo on these measures. The degree of spleen volume reduction with ruxolitinib correlated with improvements in TSS, PGIC, PROMIS Fatigue Scale, and EORTC Global Health Status/QoL. Ruxolitinib-treated patients who achieved a >/= 35% reduction in spleen volume experienced the greatest improvements in these PROs. CONCLUSION: Ruxolitinib-treated patients achieved clinically meaningful improvements in myelofibrosis-related symptoms and QoL, but patients receiving placebo reported worsening of symptoms and other PROs.","Mesa, R. A., et al. (2013). \"Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial.\" J Clin Oncol 31(10): 1285-1292.","USA",2013,"Hematological","Ruxolitinib","PROMIS-F"]
[187,"Milbury, K., et al. (2014). \"Randomized controlled trial of expressive writing for patients with renal cell carcinoma.\" J Clin Oncol 32(7): 663-670.",null,"Milbury, K., et al.","Randomized controlled trial of expressive writing for patients with renal cell carcinoma","PURPOSE: This randomized controlled trial examined the quality-of-life benefits of an expressive writing (EW) intervention for patients with renal cell carcinoma (RCC) and identified a potential underlying mechanism of intervention efficacy. PATIENTS AND METHODS: Patients (N = 277) with stage I to IV RCC were randomly assigned to write about their deepest thoughts and feelings regarding their cancer (EW) or about neutral topics (neutral writing [NW]) on four separate occasions. Patients completed the Center for Epidemiologic Studies Depression Scale (CES-D), MD Anderson Symptom Inventory (MDASI), Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form-36 (SF-36), and Impact of Event Scale (IES) at baseline and 1, 4, and 10 months after the intervention. RESULTS: The mean age of participants (28% stage IV; 41% female) was 58 years. Multilevel modeling analyses, using a Bonferroni-corrected alpha = .021 for six outcomes adjusted for the correlation among outcomes, revealed that, relative to the NW group, patients in the EW group reported significantly lower MDASI scores (P = .003) and higher physical component summary scores on the SF-36 (P = .019) at 10 months after the intervention. Mediation analyses revealed that significant group differences for MDASI scores at 10 months were mediated by lower IES scores at 1 month after the intervention in the EW group (P = .042). No significant group differences were observed in the BFI, CES-D, PSQI, and mental component summary of the SF-36. CONCLUSION: EW may reduce cancer-related symptoms and improve physical functioning in patients with RCC. Evidence suggests that this effect may occur through short-term improvements in cognitive processing.","Milbury, K., et al. (2014). \"Randomized controlled trial of expressive writing for patients with renal cell carcinoma.\" J Clin Oncol 32(7): 663-670.","USA",2014,"Cancer","Psychobehavioural","BFI"]
[188,"Miller, C. M., et al. (2016). \"The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study.\" Ann Hematol 95(12): 2049-2055.",null,"Miller, C. M., et al.","The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study","Postpartum anemia has been associated with postpartum morbidities, such as depression and poor cognition. However, it is unclear whether postpartum anemia is associated with reduced health-related quality of life. We performed a prospective study to examine the relations between postpartum Hb levels with postpartum health-related quality of life (HRQoL). We collected data from 60 women intending vaginal delivery and assessed HRQoL and maternal fatigue on admission and on the first postpartum day using the RAND 36-Item Short-Form Health Survey (SF-36) and the Multidimensional Fatigue Inventory (MFI), respectively. Maternal Hb levels were measured on admission and on the first postpartum day. We also assessed patients for postpartum depression using the Edinburgh Postpartum Depression Scale (EPDS). We performed unadjusted and multivariate linear regression (adjusting for maternal age, parity, mode of delivery, and race) to assess the associations between postdelivery Hb with each subscale of the SF-36 and MFI. The mean predelivery and postpartum Hb levels were 12.3 (1.2) and 10.8 (1.4) g/dl, respectively. In our unadjusted and adjusted regression analyses, we observed no statistically significant associations between postpartum Hb levels with any SF-36 or MFI subscale (P > 0.05). Based on the EPDS, only one patient was depressed; her postpartum Hb was 11.2 g/dl. Our findings suggest that postpartum Hb levels may not influence HRQoL or fatigue. However, our findings may only apply to women without predelivery anemia, severe blood loss or moderate-to-severe anemia after delivery. Future studies are needed to determine whether postpartum Hb influences HRQoL among women with moderate or severe postpartum anemia.","Miller, C. M., et al. (2016). \"The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study.\" Ann Hematol 95(12): 2049-2055.","USA",2016,"Various","None","MFI"]
[189,"Minderhoud, I. M., et al. (2003). \"High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency.\" Am J Gastroenterol 98(5): 1088-1093.",null,"Minderhoud, I. M., et al.","High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency","OBJECTIVES: Inflammatory bowel disease (IBD) patients, with active as well as quiescent disease, frequently complain of fatigue. This often has consequences for patients' work and daily lives. The primary aim of this study was to assess the prevalence and severity of fatigue in IBD patients in remission. Furthermore, we studied the correlation between fatigue and disease activity, quality of life, and biochemical and hematological test results, and the role of (secondary) hypocortisolism. METHODS: Eighty subjects with proven IBD were included. Disease activity was assessed using the Clinical Activity Index for Ulcerative Colitis and the Crohn's Disease Activity Index. Quality of life was measured by the Inflammatory Bowel Disease Questionnaire, and fatigue was assessed using the Multidimensional Fatigue Inventory (MFI). Routine biochemical and hematological tests were performed, and basal cortisol was determined. To evaluate adrenocortical reserve in subjects with a cortisol level of <0.4 micromol/L, a low dose adrenocorticotrophin hormone test was performed. Healthy age- and sex-matched subjects (n = 67) served as controls. RESULTS: More than 40% of the IBD patients in remission suffered from fatigue. Mean MFI scores of the IBD patients were comparable to mean MFI scores reported in cancer patients. The Inflammatory Bowel Disease Questionnaire showed a negative correlation with the MFI (r = -0.735; p < 0.001). No correlation was found between fatigue and basal cortisol levels or other laboratory parameters. CONCLUSION: Fatigue is an important feature in IBD in remission, adversely affecting the quality of life. It does not, however, affect all patients, nor does it seem to be the result of hypocortisolism.","Minderhoud, I. M., et al. (2003). \"High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency.\" Am J Gastroenterol 98(5): 1088-1093.","Netherlands",2003,"Gastrointestinal","None","MFI"]
[190,"Mittendorf, T., et al. (2007). \"Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis.\" J Rheumatol 34(12): 2343-2350.",null,"Mittendorf, T., et al.","Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis","OBJECTIVE: In patients with longstanding severe rheumatoid arthritis (RA) receiving chronic treatment with adalimumab, health related quality of life (HRQOL) was assessed using new instruments [Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) and Health Utilities Index Mark 3 (HUI3)] and a more conventional instrument [Medical Outcomes Study Short Form-36 Health Survey (SF-36)]. METHODS: Different measures for collecting patient-reported outcomes were applied simultaneously during the 3-year study period. Sociodemographic and medical history data were assessed at the baseline visit. Clinical examinations (e.g., joint examination and morning stiffness), disease assessments, and HRQOL data were recorded every 8 weeks. For dichotomous and categorical variables, absolute and relative frequencies were calculated. Metric measures were described using mean and standard deviation and/or standard error of the mean. HRQOL data were analyzed using observed cases. RESULTS: All assessed measures (FACIT-Fatigue, HUI3, SF-36) showed a rapid and statistically significant improvement from baseline following initiation of adalimumab therapy. This effect was maintained over the study period for a mean of 1.6 years in all applied measures. HRQOL data from all tested instruments were significantly correlated with each other. CONCLUSION: Chronic therapy with adalimumab improved measures of fatigue and HRQOL in patients with longstanding RA.","Mittendorf, T., et al. (2007). \"Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis.\" J Rheumatol 34(12): 2343-2350.","Germany",2007,"Musculoskeletal","None","FACIT-F"]
[191,"Mkacher, W., et al. (2015). \"Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES.\" J Cardiopulm Rehabil Prev 35(4): 278-285.",null,"Mkacher, W., et al.","Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES","PURPOSE: Balance impairment in chronic obstructive pulmonary disease (COPD) is associated with a worsening of quality of life (QOL) as related with fatigue perception, depression, and anxiety. The aim of this study was to examine the effect of balance training included in pulmonary rehabilitation (PR) on QOL, fatigue perception, depression, and anxiety in patients with COPD. METHODS: Patients were assigned randomly to an intervention or PR-only group. The intervention group underwent balance training 3 times a week for 6 months concurrently with PR. The PR-only group received 6 months of the standard PR program. Quality of life was assessed at the beginning and at the end of the program using the St. George's Respiratory Questionnaire, fatigue using the Multidimensional Fatigue Inventory, and anxiety and depression using the Hospital Anxiety and Depression Scale. Exercise tolerance was determined from the 6-minute walk test. RESULTS: After the 6 months of the intervention or PR-only, both the intervention (n = 32) and PR-only (n = 30) groups improved their QOL (activity, impact, and total) with a significant intergroup difference (P < .05) after PR. General fatigue, physical fatigue, and reduced activity decreased in both groups with an intergroup difference (P < .05). Anxiety decreased significantly in both groups with a greater change in the intervention group (P < .01). Only the intervention group had an improved depression score at the end of 6 months. CONCLUSIONS: Balance training added to PR improved health-related QOL, fatigue, and mental health in patients with COPD.","Mkacher, W., et al. (2015). \"Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES.\" J Cardiopulm Rehabil Prev 35(4): 278-285.","Tunisia",2015,"Respiratory Disease","Psychobehavioural","MFI"]
[192,"Montano-Pedroso, J. C., et al. (2016). \"Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial.\" Trials 17: 196.",null,"Montano-Pedroso, J. C., et al.","Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial","BACKGROUND: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients. METHODS/DESIGN: In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1:1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications. DISCUSSION: This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post-bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ .","Montano-Pedroso, J. C., et al. (2016). \"Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial.\" Trials 17: 196.","Brazil",2016,"Hematological","Other Drugs","FACIT-F"]
[193,"Moraska, A. R., et al. (2010). \"Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.\" J Clin Oncol 28(23): 3673-3679.",null,"Moraska, A. R., et al.","Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial","PURPOSE: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. PATIENTS AND METHODS: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. RESULTS: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. CONCLUSION: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.","Moraska, A. R., et al. (2010). \"Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.\" J Clin Oncol 28(23): 3673-3679.","USA",2010,"Cancer","Other Drugs","BFI"]
[194,"Mori, F., et al. (2011). \"Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis.\" J Neurol 258(7): 1281-1287.",null,"Mori, F., et al.","Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis","Exercise therapy (ET) can be beneficial in disabled multiple sclerosis (MS) patients. Intermittent transcranial magnetic theta burst stimulation (iTBS) induces long-term excitability changes of the cerebral cortex and may ameliorate spasticity in MS. We investigated whether the combination of iTBS and a program of ET can improve motor disability in MS patients. In a double-blind, sham-controlled trial, 30 participants were randomized to three different interventions: iTBS plus ET, sham stimulation plus ET, and iTBS alone. Before and after 2 weeks of treatment, measures of spasticity through the modified Ashworth scale (MAS) and the 88 items Multiple Sclerosis Spasticity Score questionnaire (MSSS-88), fatigue through the Fatigue Severity Scale (FSS), daily living activities (ADL) through the Barthel index and health-related quality of life (HRQoL) through the 54 items Multiple Sclerosis Quality of life inventory (MSQoL-54) were collected. iTBS plus ET reduced MAS, MSSS-88, FSS scores, while in the Barthel index and MSQoL-54, physical composite scores were increased. iTBS alone caused a reduction of the MAS score, while none of the measured scales showed significant changes after sham iTBS plus ET. iTBS associated with ET is a promising tool for motor rehabilitation of MS patients.","Mori, F., et al. (2011). \"Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis.\" J Neurol 258(7): 1281-1287.","Italy",2011,"neurological","Various","FSS"]
[195,"Morrison, E. H., et al. (2008). \"Ratings of perceived exertion during aerobic exercise in multiple sclerosis.\" Arch Phys Med Rehabil 89(8): 1570-1574.",null,"Morrison, E. H., et al.","Ratings of perceived exertion during aerobic exercise in multiple sclerosis","OBJECTIVE: To compare ratings of perceived exertion (RPEs) during aerobic exercise in people with multiple sclerosis (MS) and control participants. DESIGN: Prospective experimental study. SETTING: An exercise testing laboratory. PARTICIPANTS: Sedentary adults (n=12) with mild MS (Expanded Disability Status Scale score < or = 3) aged 30 to 45 years and sedentary age-matched and sex-matched controls (n=12). INTERVENTIONS: All participants underwent a graded aerobic exercise test on a cycle ergometer with breath-by-breath gas measurements and continuous heart rate monitoring. MAIN OUTCOME MEASURES: After completing the Modified Fatigue Impact Scale, participants rated their effort sense every 30 seconds during exercise using the modified Borg 10-point scale. RESULTS: The 2 study groups showed similar baseline characteristics except for higher fatigue scores in the MS group. There were no significant differences for any fitness measure, including oxygen cost slope (in VO(2) x min(-1) x W(-1)), VO(2), or work rate during exercise. Neither heart rate nor RPE--measured at 25%, 50%, 75%, and 100% of VO(2)peak--differed between groups. CONCLUSIONS: Despite greater reported fatigue levels, participants with MS showed similar RPE and physiologic responses to submaximal and maximal exercise compared with controls. In MS, the Borg 10-point scale may help improve evidence-based exercise prescriptions, which otherwise may be limited by fatigue, motor impairment, heat sensitivity, or autonomic dysfunction.","Morrison, E. H., et al. (2008). \"Ratings of perceived exertion during aerobic exercise in multiple sclerosis.\" Arch Phys Med Rehabil 89(8): 1570-1574.","USA",2008,"neurological","Psychobehavioural","MFI"]
[196,"Mostert, S. and J. Kesselring (2005). \"Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial.\" Mult Scler 11(3): 302-305.",null,"Mostert, S. and J. Kesselring","Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial","Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue severity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The 'Magnetic Cell Regeneration' system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3-4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and control group (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session which 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high 'placebo effect' of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.","Mostert, S. and J. Kesselring (2005). \"Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial.\" Mult Scler 11(3): 302-305.","Switzerland",2005,"neurological","Various","VAS-F,FSS"]
[197,"Mrowietz, U., et al. (2015). \"Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.\" J Eur Acad Dermatol Venereol 29(6): 1114-1120.",null,"Mrowietz, U., et al.","Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study","BACKGROUND: Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL). OBJECTIVE: The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial. METHODS: Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II. RESULTS: At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level >/=1) was reported by 96% of patients, 62% of whom had severe itching (level >/=4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients. CONCLUSION: Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.","Mrowietz, U., et al. (2015). \"Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.\" J Eur Acad Dermatol Venereol 29(6): 1114-1120.","USA",2015,"Inflamatory Systemic Disease","Etanercept","FACIT-F"]
[198,"Murdock, K. W., et al. (2017). \"The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome.\" Qual Life Res 26(4): 913-921.",null,"Murdock, K. W., et al.","The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome","PURPOSE: Debilitating fatigue is a core symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); however, the utility of patient-reported symptom outcome measures of fatigue for ME/CFS patients is problematic due to ceiling effects and issues with reliability and validity. We sought to evaluate the performance of three patient-reported symptom measures in a sample of ME/CFS patients and matched controls. METHODS: Two hundred and forty ME/CFS patients and 88 age, sex, race, and zip code matched controls participated in the study. Participants completed the Multidimensional Fatigue Inventory-20, DePaul Symptom Questionnaire, and RAND SF-36. RESULTS: The general and physical fatigue subscales on Multidimensional Fatigue Inventory-20, as well as the role of physical health on the RAND SF-36, demonstrated questionable or unacceptable internal consistency and problematic ceiling effects. The DePaul Symptom Questionnaire demonstrated excellent internal reliability, and less than 5 % of participants were at the ceiling on each subscale. The post-exertional malaise subscale on the DePaul Symptom Questionnaire demonstrated excellent clinical utility as it was able to differentiate between ME/CFS patients and controls (OR 1.23, p < .001) and predicted ceiling effects on other patient-reported outcome subscales. A score of 20 on the post-exertional malaise subscale of the DePaul Symptom Questionnaire optimally differentiated between patients and controls. CONCLUSIONS: Significant ceiling effects and concerns with reliability and validity were observed among Multidimensional Fatigue Inventory-20 and RAND SF-36 subscales for ME/CFS patients. The DePaul Symptom Questionnaire addresses a number of concerns typically identified when using patient-reported outcome measures with ME/CFS patients; however, an improved multidimensional patient-reported outcome tool for measuring ME/CFS-related symptoms is warranted.","Murdock, K. W., et al. (2017). \"The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome.\" Qual Life Res 26(4): 913-921.","USA",2017,"Chronic Fatigue","None","MFI"]
[199,"Murray, D., et al. (2014). \"Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates.\" Physiother Theory Pract 30(4): 229-235.",null,"Murray, D., et al.","Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates","PURPOSE: Polio survivors experience declining mobility, pain and fatigue. The extent of motor fatigue and its impact on mobility and quality of life, in addition to other commonly reported impairments requires evaluation. METHODS: An observational, case-control, cross-sectional design was used to assess 30 Polio survivors and 30 age- and sex-matched controls. Muscle strength and motor fatigue were assessed using fixed dynamometry. Fatigue, pain and quality of life were assessed using the Piper Fatigue Scale, the Fatigue Severity Scale, visual analogue scales and the RAND Short Form-36, respectively. An 8-min walking test, including physiological cost index (PCI), evaluated mobility. RESULTS: A significant difference in motor fatigue was identified only in hand grip (p = 0.03). Polio survivors were significantly weaker (p < 0.001) and more fatigued (p < 0.001) than controls. Motor fatigue was not related to subjective fatigue, mobility or quality of life. Muscle strength predicted mobility. Pain and fatigue were associated with lower mental quality of life, while PCI was associated with physical quality of life. CONCLUSION: Motor fatigue has been identified in Polio survivors but was only significantly different in hand grip, using this approach. Pain, fatigue and elevated energy cost of walking negatively influenced quality of life. Motor fatigue was unrelated to subjective fatigue, mobility or quality of life.","Murray, D., et al. (2014). \"Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates.\" Physiother Theory Pract 30(4): 229-235.","Ireland",2014,"Neurological","None","PFS,FSS,VAS-F"]
[200,"Murray, D., et al. (2012). \"The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial.\" BMC Neurol 12: 157.",null,"Murray, D., et al.","The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial","BACKGROUND: Many Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group. METHODS/DESIGN: This is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax) aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised. DISCUSSION: The efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study will provide information, which at present is lacking, on safety of aerobic exercise in Polio, as potential negative outcomes of activity including loss of muscle strength, increased pain and fatigue will be closely monitored.","Murray, D., et al. (2012). \"The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial.\" BMC Neurol 12: 157.","Ireland",2012,"Neurological","Psychobehavioural","FSS"]
[201,"Naegeli, A. N., et al. (2013). \"The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS).\" Health Qual Life Outcomes 11: 192.",null,"Naegeli, A. N., et al.","The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS)","BACKGROUND: Ankylosing spondylitis (AS) is an autoimmune disorder characterized by inflammation of the spine and large joints. Fatigue is a common symptom that many AS patients find significantly impacts their health-related quality of life. The Worst Fatigue - Numeric Rating Scale (WF-NRS) assesses the severity of this symptom during the previous 24-hour period. The objective of this study was to perform qualitative research to support the development and content validity of the WF-NRS. METHODS: Patients with AS were recruited from clinical sites in the U.S. for a qualitative study which first entailed concept elicitation interviews to gain understanding of the patients' experience with AS and fatigue. Subsequently, cognitive debriefing interviews were undertaken to assess the understandability, clarity, and appropriateness from the patient's perspective, of the content of a measure of fatigue severity. RESULTS: Thirteen patients with AS participated in concept elicitation interviews and cognitive debriefing of the Brief Fatigue Inventory (BFI) fatigue severity subscale. The WF-NRS was developed from the worst fatigue item of the BFI as patients generally reported it to be understandable and covered an important concept, the completion instructions were modified, but the response scale remained as it was familiar and readily completed, and the recall period was appropriate. CONCLUSIONS: Patient responses resulted in the development of and supported the content validity of the WF-NRS. Further quantitative evaluation of the WF-NRS is warranted in order to assess its psychometric properties and confirm its usefulness as a clinical trial tool.","Naegeli, A. N., et al. (2013). \"The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS).\" Health Qual Life Outcomes 11: 192.","USA",2013,"musculoskeletal","None","BFI"]
[202,"Neuzillet, C., et al. (2015). \"Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.\" Trials 16: 454.",null,"Neuzillet, C., et al.","Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial","BACKGROUND: Exercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). We aim to evaluate the effects of an exercise intervention in this setting. METHODS: This randomized, national, multicenter, interventional study will examine the effectiveness of an unsupervised, home-based, 16-week adapted physical activity (APA) program. Specificities of advanced PDAC for the implementation of the APA program will be taken into account (healthy volunteer as physical activity partner instead of patient groups, nutritional management). The main inclusion criteria are: patients with histologically confirmed, unresectable PDAC; scheduled for chemotherapy; performance status 0-2; age >/= 18; and physical activity partner. In total, 200 patients will be randomized into either the APA program (aerobic and resistance exercises) in addition to usual care (including chemotherapy at the investigator's choice), or usual care. The primary objective will be the effect on fatigue (Multidimensional Fatigue Inventory, MFI-20) and HRQoL (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC-QLQ-C30; co-primary endpoint) at week 16. As secondary objectives, the effects of the exercise intervention on pain, anxiety, depression, nutritional status, insulin resistance, tolerance of chemotherapy, survival, and adherence to the APA program will be evaluated. DISCUSSION: Patients with advanced PDAC are strongly affected by fatigue, and are thus likely to benefit from an exercise intervention. Moreover, exercise may have a potential beneficial effect on tumor outcome by reducing insulin resistance and insulin/insulin-like growth factor-1 (IGF-1) secretion. However, an exercise intervention may appear challenging due to multiple PDAC-related symptoms such as fatigue, depression, pain, and denutrition. We hypothesize that an APA program taking into account specific characteristics of PDAC may improve symptoms and HRQoL. If demonstrated to be feasible and effective, such APA programs will be systematically proposed to patients with advanced PDAC in addition to usual care. TRIAL REGISTRATION: ClinicalTrial.gov REGISTRATION NUMBER: NCT02184663 ; Registration date: 2 July 2014.","Neuzillet, C., et al. (2015). \"Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.\" Trials 16: 454.","France",2015,"Cancer","Psychobehavioural","MFI"]
[203,"Newman, M. A., et al. (2007). \"Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study.\" Mult Scler 13(1): 113-119.",null,"Newman, M. A., et al.","Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study","Impaired mobility in multiple sclerosis (MS) is associated with high-energy costs and effort when walking, gait abnormalities, poor endurance and fatigue. This repeated measures trial with blinded assessments investigated the effect of treadmill walking at an aerobic training intensity in 16 adults with MS. The intervention consisted of 12 sessions of up to 30 minutes treadmill training (TT), at 55-85% of age-predicted maximum heart rate. The primary outcome measure was walking effort, measured by oxygen consumption (mL/kg per metre), during treadmill walking at comfortable walking speed (CWS). Associated changes in gait parameters using the 'Gait-Rite' mat, 10-m time and 2-minute distance, and Fatigue Severity Scale were examined. Following training, oxygen consumption decreased at rest (P = 0.008), CWS increased (P = 0.002), and 10-m times (P = 0.032) and walking endurance (P = 0.020) increased. At increased CWS, oxygen consumption decreased (P = 0.020), with a decreased time spent in stance in the weaker leg (P = 0.034), and a greater stride distance with the stronger leg (P = 0.044). Reported fatigue levels remained the same. Aerobic TT presents the opportunity to alter a motor skill and reduce the effort of walking, whilst addressing cardiovascular de-conditioning, thereby, potentially reducing effort and fatigue for some people with MS.","Newman, M. A., et al. (2007). \"Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study.\" Mult Scler 13(1): 113-119.","UK",2007,"Neurological","Psychobehavioural","FSS"]
[204,"Newton, J. L., et al. (2006). \"Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence.\" Hepatology 44(1): 91-98.",null,"Newton, J. L., et al.","Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence","A significant proportion of patients with primary biliary cirrhosis (PBC) suffer from severe fatigue. The aim of this study was to characterize patterns of daytime sleep in patients with PBC (using both objective and subjective assessment approaches) and to study the association between sleep abnormality and fatigue severity. Fatigue severity was assessed in 48 female subjects with PBC (using a disease-specific quality of life instrument (the PBC-40) and a generic fatigue measure (Fatigue Impact Scale [FIS]) as well as 48 case-matched normal controls. All participants also completed the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS, which assesses daytime hypersomnolence). Objective sleep assessment was performed using accelerometry over 7 days. Global sleep quality assessed by the PSQI was significantly lower in the PBC group compared to controls (P < .0001). ESS scores were significantly higher in patients with PBC than controls (P = .0001), suggesting significantly greater daytime somnolence in the patients with PBC. Objective sleep assessment confirmed that subjects with PBC were sleeping on average almost twice as long as controls during the daytime. Both degree of daytime somnolence (ESS) and actual daytime sleep activity (accelerometry) correlated strongly with fatigue severity in the patient group (r2 = 0.5, P < .0001 and r2 = 0.2, P < .01, respectively). In conclusion, Sleep abnormality, in the form of excessive daytime somnolence, is present in a significant proportion of patients with PBC, with the degree of daytime somnolence correlating strongly with the degree of fatigue. Existing agents effective at reducing daytime somnolence (such as modafinil) hold potential for the treatment of fatigue in PBC.","Newton, J. L., et al. (2006). \"Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence.\" Hepatology 44(1): 91-98.","UK",2006,"Liver Disease","None","FIS"]
[205,"Nogueira, I. C., et al. (2017). \"Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer.\" J Bras Pneumol 43(3): 169-175.",null,"Nogueira, I. C., et al.","Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer","Objective:: To evaluate the properties of the Identity-Consequence Fatigue Scale (ICFS) in patients with lung cancer (LC), assessing the intensity of fatigue and associated factors. Methods:: This was a cross-sectional study involving LC patients, treated at a teaching hospital in Brazil, who completed the ICFS. Patients with chronic heart disease (CHD) and healthy controls, matched for age and gender, also completed the scale. Initially, a Brazilian Portuguese-language version of the ICFS was administered to 50 LC patients by two independent interviewers; to test for reproducibility, it was readministered to those same patients. At baseline, the LC patients were submitted to spirometry and the six-minute walk test, as well as completing the Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), and Fatigue Severity Scale (FSS). Inflammatory status was assessed by blood C-reactive protein (CRP) levels. To validate the ICFS, we assessed the correlations of its scores with those variables. Results:: The sample comprised 50 patients in each group (LC, CHD, and control). In the LC group, the intraclass correlation coefficients for intra-rater and inter-rater reliability regarding ICFS summary variables ranged from 0.94 to 0.76 and from 0.94 to 0.79, respectively. The ICFS presented excellent internal consistency, and Bland-Altman plots showed good test-retest reliability. The ICFS correlated significantly with FSS, HADS, and SF-36 scores, as well as with CRP levels. Mean ICFS scores in the LC group differed significantly from those in the CHD and control groups. Conclusions:: The ICFS is a valid, reliable instrument for evaluating LC patients, in whom depression, quality of life, and CRP levels seem to be significantly associated with fatigue. Objetivo:: Avaliar as propriedades da Escala de Identificacao e Consequencias da Fadiga (EICF) em pacientes com cancer de pulmao (CP), analisando a intensidade da fadiga e fatores associados. Metodos:: Estudo transversal com pacientes com CP, atendidos em um hospital-escola no Brasil, que preencheram a EICF. Pacientes com doencas cardiacas cronicas (DCC) e controles saudaveis, pareados por idade e sexo, tambem preencheram a escala. Inicialmente, uma versao brasileira da escala foi aplicada a 50 pacientes com CP por dois entrevistadores independentes; para testar a reprodutibilidade, ela foi reaplicada aos mesmos pacientes. No momento basal, os pacientes com CP realizaram espirometria e teste de caminhada de seis minutos, bem como preencheram a Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) e Fatigue Severity Scale (FSS). O estado inflamatorio foi avaliado pelos niveis de proteina C reativa (PCR) no sangue. Para validar a EICF, avaliamos as correlacoes entre as pontuacoes na mesma e essas variaveis. Resultados:: A amostra foi composta por 50 pacientes em cada grupo (CP, DCC e controle). No grupo CP, os coeficientes de correlacao intraclasse para confiabilidade intra e interobservador para as variaveis resumidas da EICF variaram de 0,94 a 0,76 e de 0,94 a 0,79, respectivamente. A EICF apresentou excelente consistencia interna, e as disposicoes graficas de Bland-Altman demonstraram boa confiabilidade teste-reteste. A EICF apresentou correlacoes significativas com as pontuacoes na FSS, HADS e SF-36, bem como com os niveis de PCR. As medias das pontuacoes na EICF do grupo CP diferiram significativamente das dos grupos DCC e controle. Conclusoes:: A EICF e um instrumento valido e confiavel para a avaliacao de pacientes com CP, nos quais depressao, qualidade de vida e niveis de PCR parecem estar significativamente associados a fadiga.","Nogueira, I. C., et al. (2017). \"Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer.\" J Bras Pneumol 43(3): 169-175.","Unknown",2017,"CVD","None","FSS"]
[206,"Noonan, V. K., et al. (2012). \"Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form.\" Qual Life Res 21(7): 1123-1133.",null,"Noonan, V. K., et al.","Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form","PURPOSE: To create cross-walk tables to associate scores for the Modified Fatigue Impact Scale (MFIS) with scores for the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) in persons with Multiple Sclerosis (MS). METHODS: Cross-walk tables were created using equipercentile linking and based on data collected at one time point in a longitudinal study of persons with MS (N = 458). Validation of the tables was conducted using data collected at a subsequent time point (N = 444). Deviations between estimates and actual scores were compared across levels of fatigue. The impact of sample size on the precision of sample mean estimates was evaluated using bootstrapping. RESULTS: Correlations between deviations and fatigue level for the PROMIS Fatigue SF and MFIS were (-0.31) and (-0.30), respectively, indicating moderately greater deviations with lower fatigue scores. Estimated sample means were impacted by sample size. CONCLUSIONS: Cross-walk tables allow data from studies using different measures of fatigue to be combined to achieve larger sample sizes and to compare results. These tables are valid for group-level analyses with sample sizes of 150 or greater.","Noonan, V. K., et al. (2012). \"Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form.\" Qual Life Res 21(7): 1123-1133.","USA",2012,"Neurological","None","PROMIS-F"]
[207,"Nostdahl, T., et al. (2016). \"Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS).\" J Psychosom Res 84: 1-7.",null,"Nostdahl, T., et al.","Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS)","OBJECTIVE: Postoperative fatigue is a common problem after otherwise uncomplicated surgery. It may defer patients from resuming their daily activities and is often reported to be among their most severe symptoms. There are few validated instruments for assessing postoperative fatigue. Our aim was to translate into Norwegian and explore a Short Form of the Identity-Consequences Fatigue Scale; a fatigue questionnaire specifically developed to assess postoperative fatigue. METHODS: The fatigue scale was translated to Norwegian through a forward-backward process, and subsequently validated in a large, mixed surgical population. We performed Principal Component Analyses on the complete 31-item scale and on the 10-item Short Form. The analyses were performed separately on pre- and postoperative data (n=422 and n=315, respectively). RESULTS: The factor analyses confirmed that the translation was valid and revealed three defined dimensions in the 10-item scale. There was no statistically significant difference between means of reported fatigue when measured with the 31- or 10-item scale. Ninety-eight% of change in fatigue from pre- to postoperative status was retained when using the 10-item scale as compared to the 31-item scale. CONCLUSION: The abridged, 10-item Short Form performed equal to the 31-item scale and may replace the complete 31-item ICSF scale in exploring the incidence of pre- and post-operative fatigue.","Nostdahl, T., et al. (2016). \"Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS).\" J Psychosom Res 84: 1-7.","Norway",2016,"none","None","Identity Consequences Fatigue Scale"]
[208,"Oechsle, K., et al. (2014). \"Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial.\" Support Care Cancer 22(1): 63-69.",null,"Oechsle, K., et al.","Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial","PURPOSE: Cancer and its treatment-related side effects induce loss of physical performance. This study evaluated the effects of multimodal aerobic and strength exercises on physical performance in hospitalized cancer patients while receiving myeloablative chemotherapy. METHODS: In this prospective pilot study, 48 evaluable patients were randomly assigned to a training (TG, n = 24) or control (CG, n = 24) group. The TG performed an individually supervised exercise program five times a week with ergometer training and strength exercises for 20 min each during the hospitalization period for chemotherapy. The CG received standard physiotherapy. Physical performance was evaluated using spiroergometry, lung function, and muscle strength testing. Treatment-related side effects were assessed by daily interviews, quality of life by EORTC-QLQ-C30, and fatigue using the Modified Fatigue Impact Scale (MFIS) questionnaire. RESULTS: Physical performance significantly increased in the TG (8.96 +/- 24 W) and decreased in the CG (-7.24 +/- 20 W, p = 0.02). At 2-mmol/ml blood lactate concentration, the TG achieved significantly increased oxygen consumption (p = 0.03) and expiratory minute ventilation (p = 0.04) compared to the CG. Furthermore, physical functioning increased significantly in the TG (p = 0.04). Patients in the TG required less antiemetics (p = 0.01) and experienced significantly less fatigue (p = 0.04), although MFIS analysis was not able to detect this beneficial effect. Patients of the CG displayed higher impairments of cognitive (p = 0.02) and psychosocial function (p = 0.03) after chemotherapy. No adverse events due to the study intervention were observed. CONCLUSIONS: Multimodal exercise has beneficial effects on physical performance, physical functioning, and treatment-related symptoms even during myeloablative chemotherapy. We suggest an enhanced physical activity intervention program during hospitalization of cancer patients.","Oechsle, K., et al. (2014). \"Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial.\" Support Care Cancer 22(1): 63-69.","Germany",2014,"Cancer","Psychobehavioural","MFI"]
[209,"Oken, B. S., et al. (2004). \"Randomized controlled trial of yoga and exercise in multiple sclerosis.\" Neurology 62(11): 2058-2064.",null,"Oken, B. S., et al.","Randomized controlled trial of yoga and exercise in multiple sclerosis","OBJECTIVE: To determine the effect of yoga and of aerobic exercise on cognitive function, fatigue, mood, and quality of life in multiple sclerosis (MS). METHODS: Subjects with clinically definite MS and Expanded Disability Status Score less than or equal to 6.0 were randomly assigned to one of three groups lasting 6 months: weekly Iyengar yoga class along with home practice, weekly exercise class using a stationary bicycle along with home exercise, or a waiting-list control group. Outcome assessments performed at baseline and at the end of the 6-month period included a battery of cognitive measures focused on attention, physiologic measures of alertness, Profile of Mood States, State-Trait Anxiety Inventory, Multi-Dimensional Fatigue Inventory (MFI), and Short Form (SF)-36 health-related quality of life. RESULTS: Sixty-nine subjects were recruited and randomized. Twelve subjects did not finish the 6-month intervention. There were no adverse events related to the intervention. There were no effects from either of the active interventions on either of the primary outcome measures of attention or alertness. Both active interventions produced improvement in secondary measures of fatigue compared to the control group: Energy and Fatigue (Vitality) on the SF-36 and general fatigue on the MFI. There were no clear changes in mood related to yoga or exercise. CONCLUSION: Subjects with MS participating in either a 6-month yoga class or exercise class showed significant improvement in measures of fatigue compared to a waiting-list control group. There was no relative improvement of cognitive function in either of the intervention groups.","Oken, B. S., et al. (2004). \"Randomized controlled trial of yoga and exercise in multiple sclerosis.\" Neurology 62(11): 2058-2064.","USA",2004,"Neurological","None","MFI"]
[210,"Oken, B. S., et al. (2006). \"Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life.\" Altern Ther Health Med 12(1): 40-47.",null,"Oken, B. S., et al.","Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life","CONTEXT: There are potential benefits of mind-body techniques on cognitive function because the techniques involve an active attentional or mindfulness component, but this has not been fully explored. OBJECTIVE: To determine the effect of yoga on cognitive function, fatigue, mood, and quality of life in seniors. DESIGN: Randomized, controlled trial comparing yoga, exercise, and wait-list control groups. PARTICIPANTS: One hundred thirty-five generally healthy men and women aged 65-85 years. INTERVENTION: Participants were randomized to 6 months of Hatha yoga class, walking exercise class, or wait-list control. Subjects assigned to classes also were asked to practice at home. MAIN OUTCOME MEASURES: Outcome assessments performed at baseline and after the 6-month period included a battery of cognitive measures focused on attention and alertness, the primary outcome measures being performance on the Stroop Test and a quantitative electroencephalogram (EEG) measure of alertness; SF-36 health-related quality of life; Profile of Mood States; Multi-Dimensional Fatigue Inventory; and physical measures related to the interventions. RESULTS: One hundred thirty-five subjects were recruited and randomized. Seventeen subjects did not finish the 6-month intervention. There were no effects from either of the active interventions on any of the cognitive and alertness outcome measures. The yoga intervention produced improvements in physical measures (eg, timed 1-legged standing, forward flexibility) as well as a number of quality-of-life measures related to sense of well-being and energy and fatigue compared to controls. CONCLUSIONS: There were no relative improvements of cognitive function among healthy seniors in the yoga or exercise group compared to the wait-list control group. Those in the yoga group showed significant improvement in quality-of-life and physical measures compared to exercise and wait-list control groups.","Oken, B. S., et al. (2006). \"Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life.\" Altern Ther Health Med 12(1): 40-47.","USA",2006,"none","Psychobehavioural","MFI"]
[211,"Olson, L. G., et al. (2003). \"A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome.\" Psychosomatics 44(1): 38-43.",null,"Olson, L. G., et al.","A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome","This study determined whether dexamphetamine improved symptoms and quality of life in patients with chronic fatigue syndrome. The setting was a specialized clinic within a tertiary referral hospital. This was a 6-week parallel-group, placebo-controlled trial with random allocation. There was a 2-week dose-adjustment phase and a 4-week stable treatment period. Outcome measures were the Fatigue Severity Scale, the Medical Outcomes Study 36-item Short-Form Health Survey, and two patient-determined outcomes. Ten patients were randomly assigned to dexamphetamine, and 10 were assigned to placebo. Fatigue Severity Scale scores improved in nine of 10 dexamphetamine and four of 10 placebo patients. The change in mean score was statistically significant. There were large but statistically nonsignificant changes in scores for the Short-Form Health Survey domains vitality and physical functioning. Dexamphetamine may be useful in the management of chronic fatigue syndrome; a larger and longer trial is justified by these results.","Olson, L. G., et al. (2003). \"A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome.\" Psychosomatics 44(1): 38-43.","Australia",2003,"Chronic Fatigue","Other Drugs","FSS"]
[212,"Oncu, J., et al. (2013). \"A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis.\" Rheumatol Int 33(12): 3031-3037.",null,"Oncu, J., et al.","A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis","This study was performed to compare the impact of fatigue on different aspects of quality of life in patients with rheumatoid arthritis (RA) and fibromyalgia syndrome (FM). This study involved subjects with FM (n = 45) and RA (n = 44). Impact of fatigue on physical, cognitive, and psychosocial status was measured with Fatigue Impact Scale (FIS) and health-related quality of life (HRQoL) with the Medical Outcome Study Short Form 36 (SF-36). Multiple regression analyses were used to evaluate impact of fatigue on quality of life by taking into account clinical symptoms and disease activity scores in these two patient groups. Although the severity of fatigue assessed by FSS was the same in FM and RA; according to Fatigue Impact Scale, fatigue has higher impact on cognitive function in FM (mean +/- SD; 28.8 +/- 19.9), and on the other hand, it has higher impact on mainly physical component (mean +/- SD; 26.3 +/- 4.9) in RA. Regarding all the clinical symptoms and disease activity scores, multiple regression models showed that fatigue together with pain affected the HRQoL (SF-36) in both patient groups. Fatigue has different impacts on QoL in FM and RA, respectively. Together with pain, fatigue lead FM patients to see disease as having worse health in terms of mental function, whereas it leads to poor health in terms of physical function in RA.","Oncu, J., et al. (2013). \"A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis.\" Rheumatol Int 33(12): 3031-3037.","Turkey",2013,"Musculoskeletal","None","FIS"]
[213,"Ong, S. Y., et al. (2015). \"Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).\" BMJ Open 5(8): e008938.",null,"Ong, S. Y., et al.","Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron)","INTRODUCTION: HFE p.C282Y homozygosity is the most common cause of hereditary haemochromatosis. There is currently insufficient evidence to assess whether non-specific symptoms or hepatic injury in homozygotes with moderately elevated iron defined as a serum ferritin (SF) of 300-1000 microg/L are related to iron overload. As such the evidence for intervention in this group is lacking. We present here methods for a study that aims to evaluate whether non-specific symptoms and hepatic fibrosis markers improve with short-term normalisation of SF in p.C282Y homozygotes with moderate elevation of SF. METHODS AND ANALYSIS: Mi-iron is a prospective, multicentre, randomised patient-blinded trial conducted in three centres in Victoria and Queensland, Australia. Participants who are HFE p.C282Y homozygotes with SF levels between 300 and 1000 mug/L are recruited and randomised to either the treatment group or to the sham treatment group. Those in the treatment group have normalisation of SF by 3-weekly erythrocytapheresis while those in the sham treatment group have 3-weekly plasmapheresis and thus do not have normalisation of SF. Patients are blinded to all procedures. All outcome measures are administered prior to and following the course of treatment/sham treatment. Patient reported outcome measures are the Modified Fatigue Impact Scale (MFIS-primary outcome), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item short form V.2 (SF36v2) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF). Liver injury and hepatic fibrosis are assessed with transient elastography (TE), Fibrometer and Hepascore, while oxidative stress is assessed by measurement of urine and serum F2-isoprostanes. ETHICS AND DISSEMINATION: This study has been approved by the Human Research Ethics Committees of Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: Trial identifier: NCT01631708; Registry: ClinicalTrials.gov.","Ong, S. Y., et al. (2015). \"Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).\" BMJ Open 5(8): e008938.","Australia",2015,"Hematological","None","MFI"]
[214,"Pallis, A. G. and I. A. Mouzas (2004). \"Instruments for quality of life assessment in patients with gastrointestinal cancer.\" Anticancer Res 24(3b): 2117-2121.",null,"Pallis, A. G. and I. A. Mouzas","Instruments for quality of life assessment in patients with gastrointestinal cancer","Health-related quality of life (HRQoL) is a multi-dimensional concept, encompassing all aspects of patient health and used widely as an outcome measure in clinical trials. In this review, the current status of HRQoL assessment in clinical studies of gastrointestinal cancer is examined and the various instruments proposed for this purpose are considered and compared. The cancer-specific questionnaires, among them the Spitzer Quality of Life Index, the Rotterdam Symptom Check List, the Functional Living Index-Cancer, the Functional Assessment of Cancer Therapy General (FACT-G) and the Quality of Life Questionnaire of the European Organization for Research and Treatment in Cancer (EORTC), provide essential information about particular concerns of cancer patients and are most sensitive in detecting changes over time. The domain-specific questionnaires, among them the Multidimensional Fatigue Inventory, the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale and the Anorectal Sphincter-Conservative Treatment Questionnaire, are designed to assess one specific domain of quality of life. The core-module cancer-specific questionnaires combine a core questionnaire for use in any type of cancer with a module questionnaire which assesses specific issues in cancer patient subgroups. Such core-module instruments have been evaluated for colorectal, pancreatic, hepatobiliary, oesophageal and gastric cancer. The most valid and standardized instruments for HRQoL assessment in cancer patients are the EORTC and the FACT questionnaires, which are widely used in Europe and around the world. Data provided by these specific instruments complement clinical outcomes and may help to evaluate the costs and benefits of different treatment options, thus being essential to further improvement of treatment and care of cancer patients.","Pallis, A. G. and I. A. Mouzas (2004). \"Instruments for quality of life assessment in patients with gastrointestinal cancer.\" Anticancer Res 24(3b): 2117-2121.","Greece",2004,"Cancer","None","MFI"]
[215,"Parameswaran, R., et al. (2013). \"Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.\" Ann Surg Oncol 20(6): 1970-1977.",null,"Parameswaran, R., et al.","Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers","BACKGROUND: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE). METHODS: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery. RESULTS: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group. CONCLUSIONS: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.","Parameswaran, R., et al. (2013). \"Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.\" Ann Surg Oncol 20(6): 1970-1977.","UK",2013,"Cancer","Surgery","MFI"]
[216,"Pashos, C. L., et al. (2013). \"Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.\" Support Care Cancer 21(10): 2853-2860.",null,"Pashos, C. L., et al.","Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia","PURPOSE: This analysis examined associations between gender and health-related quality of life (HRQOL) in patients with B-cell chronic lymphocytic leukemia (CLL) as they initiate therapy for CLL outside the clinical trial setting. METHODS: Baseline data were collected as part of Connect(R) CLL Registry, a prospective observational study initiated in community, academic, and government centers. Patient demographics and clinical characteristics were provided by clinicians. Patients reported HRQOL using the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Mean scores were analyzed, with statistical significance of differences determined by ANOVA. Multivariate analysis also considered age and line of therapy. RESULTS: Baseline HRQOL data were available for 1,140 patients: 710 (62 %) men and 430 (38 %) women from 161 centers. Patients were predominantly white (89 %) with mean age 69 +/- 11 years. Women reported significantly worse global fatigue (P <0.0001), fatigue severity (P <0.0001), and fatigue-related interference (P = 0.0005) versus men (BFI). Pain/discomfort (P = 0.0077), usual activities (P = 0.0015), and anxiety/depression (P = 0.0117) were significantly worse in women than in men (EQ-5D). With women reporting a better social/family score (P = 0.0238) and men reporting a better physical score (P = 0.0002), the mean FACT-G total score did not differ by gender. However, the mean FACT-Leu total score was better among men versus women (P = 0.0223), primarily because the mean leukemia subscale score was significantly better among men (P <0.0001). Multivariate analysis qualitatively confirmed these findings. CONCLUSIONS: Connect(R) CLL Registry results indicate that significant differences exist in certain HRQOL domains, as women reported greater levels of fatigue and worse functioning in physical domains.","Pashos, C. L., et al. (2013). \"Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.\" Support Care Cancer 21(10): 2853-2860.","USA",2013,"Cancer","None","BFI"]
[217,"Patti, F., et al. (2002). \"The impact of outpatient rehabilitation on quality of life in multiple sclerosis.\" J Neurol 249(8): 1027-1033.",null,"Patti, F., et al.","The impact of outpatient rehabilitation on quality of life in multiple sclerosis","It is well accepted that rehabilitative treatment can be effective in reducing disability and optimizing quality of life (QoL) of people with multiple sclerosis (MS). The aim of this study was to evaluate the effects of a comprehensive outpatient rehabilitative treatment on QoL in patients suffering from MS. We selected 111 patients from a sample of 407 patients who had consecutively entered the MS Center of Catania (which is located in southern Italy) in 1998. Fifty-eight were randomly assigned to the study treatment and 53 to a waiting list (control treatment). Kurtzke's EDSS and quality of Life (QoL)were the primary endpoints. QoL was measured with the generic multi-item SF-36 scales. We also used: the Beck Depression Inventory (BDI) for depression, the Tempelaar Social Experience Check-list (SET) for social activities and the Fatigue Impact Scale (FIS). The study treatment group was treated for 6 consecutive weeks, 6 days a week with a comprehensive rehabilitative outpatient model. The control treatment group was in a waiting list and was trained to self-exercises at home. EDSS remained unchanged in both groups. All health related QoL domains significantly improved in the study treatment (p < 0.001 in physical functioning, role physical, bodily pain, general health, and social functioning; p < 0.05 in vitality, role emotional and mental health). FIS, SET and BDI also improved significantly after the rehabilitative treatment in the study group (p < 0.001). The results of this study confirm the effectiveness of a short comprehensive outpatient model of rehabilitative treatment in people with MS and in particular in their QoL.","Patti, F., et al. (2002). \"The impact of outpatient rehabilitation on quality of life in multiple sclerosis.\" J Neurol 249(8): 1027-1033.","Italy",2002,"Neurological","None","FIS"]
[218,"Pavsic, K., et al. (2015). \"Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients.\" Clin Neurol Neurosurg 139: 35-40.",null,"Pavsic, K., et al.","Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients","OBJECTIVE: Previous studies have predominantly investigated the effect of fampridine on lower extremities motor functions while data on its impact on other symptoms of multiple sclerosis (MS) are scarce. The aim of our study was to assess the impact of fampridine on walking, arm/hand function, fatigue, cognitive function, mood and quality of life among responders. METHODS: Our prospective non-randomized study included 30 patients with different types of MS, aged 35-70, EDSS value 3.5-6.5. They were treated with 10mg of fampridine twice daily. The examinations were performed before the treatment, after 14 days, when responders were defined by T25FW (Timed 25-Foot Walk) and 2-min walk test (2MWT) was performed, and after 28 days of treatment, when only the responders were examined. Standardized protocols and questionnaires were used to evaluate the impact of fampridine on walking speed (T25FW, 2MWT), arm/hand function (9-HPT - Nine-Hole Peg Test), cognitive function (PASAT - Paced Auditory Serial Addition Test), total MSFC score (Multiple Sclerosis Functional Composite), fatigue (MFIS - Modified Fatigue Impact Scale), mood (BDI - Beck Depression Inventory) and quality of life (EQ-5D index, EQ-VAS - Euro Quality of Life - 5 Dimension questionnaire and visual analogue scale) in responders. RESULTS: Response rate was 56.7%. Average improvement of T25FW and 2MWT after 14 days of treatment in responders was 3.6s (34.5%) and 37.4m (42.3%), respectively. This improvement persisted after 28 days of treatment. In non-responders there was no significant improvement of T25FW after 14 days (p=0.689), but there was improvement of 2MWT for 13.4m (14.3%) (p=0.000). After 28 days of treatment significant improvement among responders occurred in total MSFC score (p=0.001), 9-HPT (p=0.002), BDI (p=0.005), MFIS total score (p=0.003), physical (p=0.001), cognitive (p=0.008) MFIS subscales, and EQ-5D index (p=0.012). There were implied trends towards improvement in EQ-VAS and psychosocial MFIS subscale, yet not significant (p=0.057 and p=0.127, respectively). There was no statistically significant improvement of PASAT (p=0.432). CONCLUSIONS: The results of our study highlight the potential of fampridine for improving not only walking speed but also arm/hand function, physical and cognitive fatigue, mood and quality of life. There was no objective improvement of cognitive function. Further placebo-controlled studies will be needed for precise definition of fampridine's action beyond its impact on walking.","Pavsic, K., et al. (2015). \"Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients.\" Clin Neurol Neurosurg 139: 35-40.","Slovenia",2015,"Neurological","Other Drugs","MFI"]
[219,"Penttinen, H. M., et al. (2011). \"Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments.\" Psychooncology 20(11): 1211-1220.",null,"Penttinen, H. M., et al.","Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments","OBJECTIVE: The study aimed at investigating the quality of life (QoL) and physical performance and activity, and their interrelations, in Finnish female breast cancer patients shortly after adjuvant treatments. METHODS: A total of 537 disease-free breast cancer survivors aged 35-68 years were surveyed at the beginning of a one year randomized exercise intervention. The patients were interviewed using EORTC QLQ-C30, FACIT-F, RBDI, and WHQ (for vasomotor symptoms) questionnaires. Physical performance was tested by a 2 km walking test. Physical activity was measured by a questionnaire and a prospective two-week diary. Multivariate analysis was used to study the factors associated with QoL. RESULTS: About 26% of the patients were rated as depressed, 20.4% as fatigued, and 82% suffered from menopausal symptoms. The global QoL was lower than in general population (69.4 vs 74.7, p<0.001). About 62% of the walking test results were below the population average. Fatigue (p<0.001), depression (p<0.001), body mass index (p = 0.016) and comorbidity (p = 0.032) impaired, and physical activity (p = 0.003) improved QoL. Physical activity level correlated positively to physical performance (r = -0.274, p<0.0001). CONCLUSIONS: The QoL of the patients shortly after adjuvant treatments was impaired and the physical performance poor as compared to general population. In particular, depression and fatigue were related to impaired QoL. Physical performance and activity level were the only factors that correlated positively to QoL. Thus, physical exercise could be useful in rehabilitation of cancer survivors, especially for depressed and fatigued patients.","Penttinen, H. M., et al. (2011). \"Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments.\" Psychooncology 20(11): 1211-1220.","Finland",2011,"Cancer","None","FACIT-F"]
[220,"Petri, M. A., et al. (2004). \"Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus.\" Arthritis Rheum 50(9): 2858-2868.",null,"Petri, M. A., et al.","Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus","OBJECTIVE: To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. METHODS: Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (</=10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for >/=6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). RESULTS: A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5%) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5%) (P = 0.017). Acne and hirsutism were reported in 33% and 16%, respectively, of the prasterone group and in 14% and 2%, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22% and 15%, respectively) than in the placebo group (36% and 23%, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. CONCLUSION: In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.","Petri, M. A., et al. (2004). \"Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus.\" Arthritis Rheum 50(9): 2858-2868.","USA",2004,"Inflamatory Systemic Disease","Other Drugs","KFSS"]
[221,"Petty, T. L., et al. (2006). \"Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease.\" J Cardiopulm Rehabil 26(2): 112-117.",null,"Petty, T. L., et al.","Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease","PURPOSE: To compare the impact of a library of pulmonary rehabilitation videotapes versus an older videotape and usual care on quality of life and ability to perform activities of daily living in persons with chronic obstructive pulmonary disease. METHODS: Two hundred fourteen patients diagnosed with chronic obstructive pulmonary disease, emphysema, or chronic bronchitis were recruited and randomized to receive customized videotapes, standard videotapes, or usual care. Outcome measures included the Fatigue Impact Scale, Seattle Obstructive Lung Disease Questionnaire, and the SF-36(R) Health Survey. RESULTS: Differences in coping skills and emotional functioning on the Seattle Obstructive Lung Disease Questionnaire were found among the 174 subjects who completed the study. The customized videotape group improved by 8.6 and 4.8 points, respectively, whereas the score of the other groups decreased by less than 1 point for the coping skills, and the scores of the standard video and the control groups decreased by 3.0 and 2.1 points, respectively, for emotional functioning (P < .05, all comparisons). The scores using the Fatigue Impact Scale also improved for the customized videotape group, whereas the scores of the others remained unchanged. Videotape users demonstrated better conversion to and retention of exercise habits, with over 80% of customized videotape subjects who reported exercise habits at baseline continuing the habits as compared with 40% in the usual care group. Sedentary subjects at baseline were more likely to begin and maintain exercise if randomized to videotapes. CONCLUSIONS: These findings demonstrate increased quality of life, lower fatigue, and better compliance with a prescribed exercise regimen among subjects using the customized videotapes. There was a significant improvement in emotional functioning and coping skills among customized videotape subjects.","Petty, T. L., et al. (2006). \"Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease.\" J Cardiopulm Rehabil 26(2): 112-117.","USA",2006,"Respiratory Disease","Psychobehavioural","FIS"]
[222,"Piche, T., et al. (2010). \"Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome.\" Neurogastroenterol Motil 22(6): 626-e174.",null,"Piche, T., et al.","Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome","BACKGROUND: Patients with irritable bowel syndrome (IBS) and Crohn disease (CD) have impaired quality of life (Qol) associated with fatigue. Whether IBS-like symptoms have a similar impact on Qol and fatigue in quiescent CD than in IBS is currently unknown. Our aims were (i) to evaluate the prevalence of IBS-like symptoms in quiescent CD and (ii) to compare the impact of IBS-like symptoms on Qol and fatigue in both diseases. METHODS: A total of 92 quiescent CD, 40 IBS and 20 healthy subjects similar in age were included prospectively in five French academic centers. IBS symptoms were evaluated through the Rome III criteria. The severity of IBS symptoms, Qol, fatigue, depression and anxiety was measured using questionnaires (Francis Score, Likert scales, Fatigue Impact Scale, short-form Beck and Hospital Anxiety and Depression Scale). KEY RESULTS: Irritable bowel syndrome-like symptoms were found in 42/92 (45.6%) patients with quiescent CD. The presence of IBS-like symptoms was associated with significant more profound alterations of Qol, high scores of fatigue, depression, but similar levels of anxiety. Compared to CD patients with IBS-like symptoms, IBS patients had more severe gastrointestinal symptoms and alterations of Qol, but similar scores of fatigue, depression and anxiety. In quiescent CD patients, fatigue was independently associated with the presence of IBS-like symptoms (OR = 1.018, 95% CI: 1.002-1.034, P = 0.02). CONCLUSIONS & INFERENCES: The prevalence of IBS-like symptoms is elevated in quiescent CD. The presence of IBS-like symptoms in quiescent CD is probably associated with the range of fatigue/depression disorders. The mechanism underlying the occurrence of IBS-like symptoms in quiescent CD needs to be further explored.","Piche, T., et al. (2010). \"Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome.\" Neurogastroenterol Motil 22(6): 626-e174.","France",2010,"Gastrointestinal","None","FIS"]
[223,"Plow, M., et al. (2012). \"Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol.\" BMC Neurol 12: 122.",null,"Plow, M., et al.","Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol","BACKGROUND: Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels. METHODS/DESIGN: A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy). DISCUSSION: The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS. TRIAL REGISTRATION: NCT01572714.","Plow, M., et al. (2012). \"Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol.\" BMC Neurol 12: 122.","USA",2012,"Neurological","Psychobehavioural","FIS"]
[224,"Poulsen, M. B., et al. (2015). \"Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.\" Stroke 46(12): 3470-3477.",null,"Poulsen, M. B., et al.","Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial","BACKGROUND AND PURPOSE: Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug modafinil. METHODS: The trial was randomized, double-blinded, and placebo-controlled. Patients were treated with 400-mg modafinil or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the Stroke-specific quality of Life questionnaire. Adult patients with a recent stroke achieving a score of >/=12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe cognitive disabilities and contraindications for modafinil treatment. RESULTS: One thousand one hundred twenty-one patients with stroke were screened and 41 patients included, 21 received modafinil. The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. Patients in the modafinil group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the stroke-specific quality of life questionnaire (0.001<P<0.05), which were secondary outcomes. No serious adverse reactions were observed and there was no difference in blood pressure between groups. CONCLUSIONS: There were no significant differences between the 2 groups with regard to the primary end point. There were secondary significant outcomes that should be explored in future trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800097.","Poulsen, M. B., et al. (2015). \"Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.\" Stroke 46(12): 3470-3477.","Denmark",2015,"CVD","Other Drugs","FSS,MFI"]
[225,"Prick, B. W., et al. (2015). \"Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage.\" Bjog 122(13): 1789-1797.",null,"Prick, B. W., et al.","Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage","OBJECTIVE: To determine clinical predictors of escape red blood cell (RBC) transfusion in postpartum anaemic women, initially managed expectantly, and the additional predictive value of health-related quality of life (HRQoL) measures. DESIGN: Secondary analysis of women after postpartum haemorrhage, either randomly allocated to, or opting for expectant management. SETTING: Thirty-seven hospitals in the Netherlands. POPULATION: A total of 261 randomised and 362 nonrandomised women. METHODS: We developed prediction models to assess the need for RBC transfusion: one using clinical variables (model 1), and one extended with scores on the HRQoL-measures Multidimensional Fatigue Inventory (MFI) and EuroQol-5D (model 2). Model performance was assessed by discrimination and calibration. Models were internally validated with bootstrapping techniques to correct for overfitting. MAIN OUTCOME MEASURES: Escape RBC transfusion. RESULTS: Seventy-five women (12%) received escape RBC transfusion. Independent predictors of escape RBC transfusion (model 1) were primiparity, multiple pregnancy, total blood loss during delivery and haemoglobin concentration postpartum. Maternal age, body mass index, ethnicity, education, medical indication of pregnancy, mode of delivery, preterm delivery, placental removal, perineal laceration, Apgar score and breastfeeding intention had no predictive value. Addition of HRQoL-scores (model 2), significantly improved the model's discriminative ability: c-statistics of model 1 and 2 were 0.65 (95% CI 0.58-0.72) and 0.72 (95% CI 0.65-0.79), respectively. The calibration of both models was good. CONCLUSIONS: In postpartum anaemic women, several clinical variables predict the need for escape RBC transfusion. Adding HRQoL-scores improves model performance. After external validation, the extended model may be an important tool for counselling and decision making in clinical practice.","Prick, B. W., et al. (2015). \"Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage.\" Bjog 122(13): 1789-1797.","Netherlands",2015,"Hematological","None","MFI"]
[226,"Prick, B. W., et al. (2010). \"Well being of obstetric patients on minimal blood transfusions (WOMB trial).\" BMC Pregnancy Childbirth 10: 83.",null,"Prick, B. W., et al.","Well being of obstetric patients on minimal blood transfusions (WOMB trial)","BACKGROUND: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. METHODS/DESIGN: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). DISCUSSION: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.","Prick, B. W., et al. (2010). \"Well being of obstetric patients on minimal blood transfusions (WOMB trial).\" BMC Pregnancy Childbirth 10: 83.","Netherlands",2010,"Hematological","Various","MFI"]
[227,"Purcell, A., et al. (2010). \"Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.\" Support Care Cancer 18(3): 307-315.",null,"Purcell, A., et al.","Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population","PURPOSE: The Multidimensional Fatigue Inventory (MFI) is a commonly used cancer-related fatigue assessment tool. Unlike other fatigue assessments, there are no published minimal clinically important difference (MCID) criteria for the MFI in cancer populations. MCID criteria determine the smallest change in scores that can be regarded as important, allowing clinicians and researchers to interpret the meaning of changes in patient's fatigue scores. This research aims to improve the clinical utility of the MFI by establishing MCID criteria for the MFI sub-scales in a radiotherapy population. MATERIALS AND METHODS: Two hundred ten patients undergoing radiotherapy were recruited to a single-centre prospective cohort study. Patients were assessed at three time points, at the start of radiotherapy, the end of radiotherapy and 6 weeks after radiotherapy completion. Assessment consisted of four clinically relevant constructs: (1) treatment impact on fatigue, (2) health-related quality of life, (3) performance status and (4) occupational productivity. These constructs were used as external or anchor-based measures to determine MCIDs for each sub-scale of the MFI. RESULTS: Multiple MCIDs were identified, each from a different perspective based on the constructs cited. Researchers seeking to use a generic MCID may wish to use a two-point reference for each MFI sub-scale as it was consistent across the pre- and post-radiotherapy comparison and occupational productivity anchors. CONCLUSIONS: MCIDs validated in this study allow better interpretation of changes in MFI sub-scale scores and allow effect size calculations for determining sample size in future studies.","Purcell, A., et al. (2010). \"Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.\" Support Care Cancer 18(3): 307-315.","Australia",2010,"Cancer","None","MFI"]
[228,"Qin, Z., et al. (2009). \"Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort.\" Parkinsonism Relat Disord 15(10): 767-771.",null,"Qin, Z., et al.","Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort","OBJECTIVE: To identify the motor and non-motor factors that are associated with health related quality of life (HR-QOL) in a subgroup of Parkinson's disease (PD) patients with Levodopa therapy in early clinical stages. METHODS: 391 Levodopa exposed patients were evaluated during the baseline assessment of a clinical trial in China. HR-QOL was measured by the Short Form 36 (SF-36). Motor and non-motor variables were determined during a structured interview and by clinical examination by movement disorder specialists. Multiple regression analyses were used to determine which variables were associated with low levels of HR-QOL. RESULTS: Even if excluding non-motor variables from the regression model, motor factors, particularly motor deficits (measured by motor score of UPDRS), rigidity (measured by item 22 of UPDRS), and disease severity (measured by Hoehn&Yahr scale), explained only 18.9% of the variance of total SF-36 score. Whereas, when non-motor variables were included in the model, especially depression (measured by CES-D), sleep disturbances (measured by PSQ-I), and fatigue (measured by FSS), 61.7% of the variance of SF-36 score could be explained. Two motor variables, UPDRS motor score and Hoehn&Yahr score, were also contributed to the model, however, the 95% confidence intervals (CIs) of these two motor factors were wide and included the null value (CIs -0.282, 0.019 for UPDRS motor score, and CIs -4.043, 0.856 for Hoehn&Yahr score). Neither, did higher daily levodopa dose contribute significantly to both models predicting SF-36 score. CONCLUSIONS: In our sample patients with levodopa therapy, motor disability and severity of parkinsonism contributed to a lesser extent to patients' self-report distress, within the first 5 years of disease onset. The clinical factors that showed the highest predictive value for worsen HR-QOL were non-motor symptoms, such as depression, sleep disorders, and fatigue. Great effort should be made to recognize and treat those conditions, thus improving all aspects of PD and giving these patients as a good HR-QOL as possible.","Qin, Z., et al. (2009). \"Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort.\" Parkinsonism Relat Disord 15(10): 767-771.","China",2009,"Neurological","None","FSS"]
[229,"Racciatti, D., et al. (2011). \"An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences.\" Int J Immunopathol Pharmacol 24(3): 673-681.",null,"Racciatti, D., et al.","An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences","Severe fatigue and a significantly reduced health-related quality of life (HRQoL) have been described in patients with chronic fatigue syndrome (CFS) in comparison with patients affected by chronic hepatitis C (CHC) and other chronic medical conditions. We examined 39 CFS and 49 CHC patients to explore whether fatigue and a poor HRQoL represent a greater medical and social problem in CFS than in CHC. The severity of fatigue and the HRQoL were assessed using the Fatigue Impact Scale (FIS) and the Health Status Questionnaire Short Form-36 (SF-36), respectively. The statistical analysis showed both a higher score of fatigue and a lower HRQoL in CFS than in CHC patients. Furthermore, in CHC patients the FIS evaluation showed a significantly reduced score of the psychosocial domain in comparison with the other domains. Multivariate linear regression analysis revealed female gender as the most important positive variable in chronic hepatitis C patients for total score of FIS. In conclusion, CFS was associated with a severe and disabling fatigue and an impaired HRQOL. In particular, both fatigue and all aspects of HRQOL perceived by CFS patients were significantly impaired compared to CHC patients. Consequently, management of fatigue should be considered a priority in order to improve HRQOL in CFS patients. In CHC patients the impact of fatigue on HRQoL was less significant than in CFS patients, even though the FIS evaluation showed a significant impairment of the psychosocial domain.","Racciatti, D., et al. (2011). \"An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences.\" Int J Immunopathol Pharmacol 24(3): 673-681.","Italy",2011,"Chronic Fatigue","None","FIS"]
[230,"Radbruch, L., et al. (2003). \"Validation of the German version of the brief fatigue inventory.\" J Pain Symptom Manage 25(5): 449-458.",null,"Radbruch, L., et al.","Validation of the German version of the brief fatigue inventory","Sedation and tiredness are among the most frequent symptoms among cancer patients. A detailed assessment of these symptoms is necessary to evaluate therapeutic effects, such as the use of methylphenidate or comparison of different opioids. The Brief Fatigue Inventory (BFI) has been validated as a short and comprehensive instrument to assess severity of fatigue and fatigue-related impairment in cancer patients. We validated the German version of the BFI in patients with chronic cancer-related and noncancer-related pain treated in a tertiary pain center. Patients treated in the Pain Clinic of the Department of Anesthesiology completed the BFI, the minimal documentation system (MIDOS) and the short form SF-36 quality-of-life questionnaire (SF-36). Test-retest reliability was assessed with a second BFI immediately after the consultation and in a subgroup of patients after 3 to 7 days. Nineteen percent of the 117 patients were treated for cancer-related pain (C); the other patients suffered from chronic severe pain of nonmalignant origin (NC). Patients reported mean values for average fatigue of 3.9 (C) and 4.9 (NC), and for worst fatigue of 5.5 (C) and 6.2 (NC). The mean score of the 6 impairment items was 4.3 in both groups. Factor analysis led to a solution with one common factor for all nine items. Fatigue on the BFI correlated highly with 'feeling tired' in the SF-36 and with 'sedation' in MIDOS, and less with 'being worn out' in SF-36 and 'weakness' in MIDOS. Internal consistency was high, as was test-retest reliability, with a correlation of the intensity, mean scores of 0.93 and the impairment mean scores of 0.87. In conclusion, we found the German version of the BFI to be reliable and valid for cancer and noncancer patients. Minor differences were seen in the validation compared to the original version.","Radbruch, L., et al. (2003). \"Validation of the German version of the brief fatigue inventory.\" J Pain Symptom Manage 25(5): 449-458.","Germany",2003,"Cancer","None","BFI"]
[231,"Rasenack, J., et al. (2003). \"Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.\" Pharmacoeconomics 21(5): 341-349.",null,"Rasenack, J., et al.","Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C","BACKGROUND: Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a. OBJECTIVES: To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon]. DESIGN: A randomised, international, multicentre, open-label, parallel group study. SETTING: 36 centres worldwide. PATIENTS: Interferon-naive patients (n = 531) with chronic hepatitis C. INTERVENTIONS: Peginterferon alpha-2a (40kD) 180 mirog once a week (n = 267) for 48 weeks or unmodified interferon alpha-2a 6 million IU three times a week for 12 weeks followed by 36 weeks of 3 million IU three times a week (n = 264). MEASUREMENTS: Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36). RESULTS: At weeks 2 and 12, differences favouring peginterferon alpha-2a (40kD) were seen on seven of eight domains and both summary scores of the SF-36 (p < 0.05 to p < 0.01). At weeks 2, 12 and 24, patients receiving peginterferon alpha-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon alpha-2a. CONCLUSION: Treatment with peginterferon alpha-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon alpha-2a. In addition to safety and efficacy, the impact on health-related quality of life may be an important consideration for physicians when selecting an optimal treatment regimen.","Rasenack, J., et al. (2003). \"Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.\" Pharmacoeconomics 21(5): 341-349.","Germany",2003,"Infectious disease","Other Drugs","FSS"]
[232,"Ray, A. D., et al. (2013). \"A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis.\" Arch Phys Med Rehabil 94(10): 1964-1970.",null,"Ray, A. D., et al.","A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis","OBJECTIVE: To determine the effects of a short-duration, combined (inspiratory and expiratory), progressive resistance respiratory muscle training (RMT) protocol on respiratory muscle strength, fatigue, health-related quality of life, and functional performance in individuals with mild-to-moderate multiple sclerosis (MS). DESIGN: Quasi-experimental before-after trial. SETTING: University rehabilitation research laboratory. PARTICIPANTS: Volunteers with MS (N=21) were divided into 2 groups: RMT (n=11; 9 women, 2 men; mean age +/- SD, 50.9 +/- 5.7y, mean Expanded Disability Status Scale score +/- SD, 3.2 +/- 1.9) and a control group that did not train (n=10; 7 women, 3 men; mean age +/- SD, 56.2 +/- 8.8y, mean Expanded Disability Status Scale score +/- SD, 4.4 +/- 2.1). Expanded Disability Status Scale scores ranged from 1 to </=6.5. No patients withdrew from the study. INTERVENTION: Training was a 5-week combined progressive resistance RMT program, 3d/wk, 30 minutes per session. MAIN OUTCOME MEASURES: The primary outcome measures were maximal inspiratory pressure and expiratory pressure and the Modified Fatigue Impact Scale. All subjects completed secondary measures of pulmonary function, the six-minute walk test, the timed stair climb, the Multiple Sclerosis Self-Efficacy Scale, the Medical Outcomes Study 36-Item Short-Form Health Survey, and the Physical Activity Disability Scale. RESULTS: Maximal inspiratory pressure and expiratory pressure (mean +/- SD) increased 35% +/- 22% (P<.001) and 26% +/- 17% (P<.001), respectively, whereas no changes were noted in the control group (12% +/- 23% and -4% +/- 17%, respectively). RMT improved fatigue (Modified Fatigue Impact Scale, P<.029), with no change or worsening in the control group. No changes were noted in the six-minute walk test, stair climb, Multiple Sclerosis Self-Efficacy Scale, or Physical Activity Disability Scale in the RMT group. The control group had decreases in emotional well-being and general health (Medical Outcomes Study 36-Item Short-Form Health Survey). CONCLUSIONS: A short-duration, combined RMT program improved inspiratory and expiratory muscle strength and reduced fatigue in patients with mild to moderate MS.","Ray, A. D., et al. (2013). \"A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis.\" Arch Phys Med Rehabil 94(10): 1964-1970.","USA",2013,"Neurological","Psychobehavioural","MFI"]
[233,"Reich, K., et al. (2009). \"Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis.\" Dermatology 219(3): 239-249.",null,"Reich, K., et al.","Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis","OBJECTIVE: To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administered etanercept 50 mg once weekly (QW). METHODS: Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits. RESULTS: At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms. CONCLUSIONS: Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated.","Reich, K., et al. (2009). \"Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis.\" Dermatology 219(3): 239-249.","Germany",2009,"Inflamatory Systemic Disease","Etanercept","FACIT-F"]
[234,"Revicki, D. A., et al. (2011). \"Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis.\" Health Qual Life Outcomes 9: 36.",null,"Revicki, D. A., et al.","Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis","BACKGROUND: We evaluated the psychometric characteristics of the Short Form 36 (SF-36) Health Survey and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale in patients with ankylosing spondylitis (AS). METHODS: We analyzed clinical and patient-reported outcome (PRO) data collected during 12-week, double-blind, placebo-controlled periods of two randomized controlled trials comparing adalimumab and placebo for the treatment of active AS. The Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and other clinical measures were collected during the clinical trial. We evaluated internal consistency/reliability, construct validity, and responsiveness to change for the SF-36 and FACIT-Fatigue. RESULTS: The SF-36 (Cronbach alpha, 0.74-0.92) and FACIT-Fatigue (Cronbach alpha, 0.82-0.86) both had good internal consistency/reliability. At baseline, SF-36 and FACIT-Fatigue scores correlated significantly with Ankylosing Spondylitis Quality of Life scores (r = -0.36 to -0.66 and r = -0.70, respectively; all p < 0.0001). SF-36 scores varied by indicators of clinical severity, with greater impairment observed for more severe degrees of clinical activity (all p < 0.0001). FACIT-Fatigue scores correlated significantly with SF-36 scores (r = 0.42 to 0.74; all p < 0.0001) and varied by clinical severity (p < 0.05 to p < 0.0001). CONCLUSIONS: The SF-36 is a reliable, valid, and responsive measure of health-related quality of life and the FACIT-Fatigue is a brief and psychometrically sound measure of the effects of fatigue on patients with AS. These PROs may be useful in evaluating effectiveness of new treatments for AS.","Revicki, D. A., et al. (2011). \"Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis.\" Health Qual Life Outcomes 9: 36.","USA",2011,"Musculoskeletal","None","FACIT-F"]
[235,"Ribas, C. G., et al. (2017). \"Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial.\" Parkinsonism Relat Disord 38: 13-18.",null,"Ribas, C. G., et al.","Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial","Although motor symptoms in Parkinson's disease (PD) are well established, few studies have described the effects of exergaming on the clinical and functional outcomes of PD. OBJECTIVES: To analyze the effectiveness of exergaming in improving functional balance, fatigue, functional exercise capacity and quality of life in PD. METHODS: The study population consisted of 20 patients (12 males and 8 females) aged 61 +/- 9.11 years allocated into two groups: an exergaming group (EGG) (n = 10) and a conventional exercise, or control, group (CG) (n = 10). The following variables were evaluated: functional balance (Berg Scale), fatigue (Fatigue Severity Scale), functional exercise capacity (Six-Minute Walk Test) and quality of life (PDQ-39 Quality of Life Questionnaire). RESULTS: RM-ANOVA showed that balance and fatigue differed significantly between time points: balance [F(1.29, 23.33) = 4.16, p = 0.043] and fatigue [F(2,36) = 5.96, p = 0.006]. In both cases post hoc Bonferroni testing revealed an improvement after 12 weeks of exergaming (p = 0.033 and p = 0.000, respectively). However, this benefit was not sustained after 60 days of follow-up for either outcome. There were no differences in functional exercise capacity or quality of life between the two groups after 12 weeks of treatment. CONCLUSION: Exergaming was effective in enhancing balance and reducing fatigue in PD patients after 12 weeks of treatment, but this benefit was not sustained in the long-term.","Ribas, C. G., et al. (2017). \"Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial.\" Parkinsonism Relat Disord 38: 13-18.","Brazil",2017,"Neurological","Psychobehavioural","FSS"]
[236,"Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.",null,"Richard, P. O., et al.","Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy","OBJECTIVES: To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale, in men with prostate cancer (PCa) treated with a luteinizing hormone-releasing hormone (LHRH) for a minimum of 6 months, and to assess changes in global fatigue and quality of life (QoL) as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively. PARTICIPANTS AND METHODS: We performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores. RESULTS: The study was closed prematurely because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [sd] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within-group analysis showed a significant improvement in fatigue scores in the methylphenidate arm (P = 0.008) but not in the placebo arm (P = 0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component summary scores than did the use of placebo (P = 0.04 for both component scores). CONCLUSIONS: Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.","Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.","Canada",2015,"Cancer","Other Drugs","GFS"]
[237,"Richardson, C. A., et al. (2015). \"Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot.\" J Gerontol A Biol Sci Med Sci 70(4): 487-494.",null,"Richardson, C. A., et al.","Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot","BACKGROUND: Slow gait speed increases morbidity and mortality in older adults. We examined how preferred gait speed is associated with energetic requirements of walking, fatigability, and fatigue. METHODS: Older adults (n = 36, 70-89 years) were categorized as slow or fast walkers based on median 400-m gait speed. We measured VO2peak by graded treadmill exercise test and VO2 during 5-minute treadmill walking tests at standard (0.72 m/s) and preferred gait speeds. Fatigability was assessed with the Situational Fatigue Scale and the Borg rating of perceived exertion at the end of walking tests. Fatigue was assessed by questionnaire. RESULTS: Preferred gait speed over 400 m (range: 0.75-1.58 m/s) averaged 1.34 m/s for fast walkers versus 1.05 m/s for slow walkers (p < .001). VO2peak was 26% lower (18.5 vs 25.1ml/kg/min, p = .001) in slow walkers than fast walkers. To walk at 0.72 m/s, slow walkers used a larger percentage of VO2peak (59% vs 42%, p < .001). To walk at preferred gait speed, slow walkers used more energy per unit distance (0.211 vs 0.186ml/kg/m, p = .047). Slow walkers reported higher rating of perceived exertion during walking and greater overall fatigability on the Situational Fatigue Scale, but no differences in fatigue. CONCLUSIONS: Slow walking was associated with reduced aerobic capacity, greater energetic cost of walking, and greater fatigability. Interventions to improve aerobic capacity or decrease energetic cost of walking may prevent slowing of gait speed and promote mobility in older adults.","Richardson, C. A., et al. (2015). \"Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot.\" J Gerontol A Biol Sci Med Sci 70(4): 487-494.","USA",2015,"none","Psychobehavioural","Situational Fatigue Scale,Borg Fatigue Scale"]
[238,"Riesenberg, H. and A. S. Lubbe (2010). \"In-patient rehabilitation of lung cancer patients--a prospective study.\" Support Care Cancer 18(7): 877-882.",null,"Riesenberg, H. and A. S. Lubbe","In-patient rehabilitation of lung cancer patients--a prospective study","PURPOSE: It has not previously been shown whether there is any benefit to multi-morbid patients with lung cancer who participate in complex interdisciplinary rehabilitation programmes after primary therapy. The purpose of this prospective study was to assess changes in exercise capacity and quality of life before and after an in-patient training programme. PATIENTS AND METHODS: Forty-five patients with lung cancer (WHO I-III after surgery and/or radiotherapy and/or chemotherapy) were enrolled in a 28-day in-patient rehabilitation programme that included standardised aerobic training. Functional status and health-related quality of life (QLQ-C30, QLQ-LC13, SF-36, and MFI-20) were examined at the beginning of the study and at day 28. RESULTS: A substantial increase in work performance (bicycle ergometry from 68 +/- 3 to 86 +/- 4 W, p < 0.001, and 6-minute walk test from 322 +/- 11 to 385 +/- 13 m, p < 0.001) was registered. In addition, heart rate at rest was reduced (from 84 +/- 2 to 80 +/- 1 beats per minute, p < 0.05) and heart rate variability (indicator of the efficacy of endurance training) was significantly increased (from 9.7 +/- 1 to 12.9 +/- 1 root mean square of successive differences, p < 0.001). Moreover, there was also a significant improvement in quality of life (48 +/- 3 to 62 +/- 2, p < 0.001) while fatigue was reduced from 66 +/- 3 to 41 +/- 4, p < 0.001. CONCLUSION: A standardised, aerobic endurance training programme as part of the in-patient oncological rehabilitation of patients with lung cancer results in improvements in both physiological and psychological parameters after therapy. A follow-on study in order to determine to what extent this benefit persists over the long-term, particularly, in comparison with patients who have not participated in a rehabilitation programme, is currently being conducted.","Riesenberg, H. and A. S. Lubbe (2010). \"In-patient rehabilitation of lung cancer patients--a prospective study.\" Support Care Cancer 18(7): 877-882.","Germany",2010,"Cancer","Psychobehavioural","MFI"]
[239,"Rigby, W., et al. (2011). \"Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate.\" Arthritis Care Res (Hoboken) 63(5): 711-720.",null,"Rigby, W., et al.","Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate","OBJECTIVE: To assess the effect of rituximab plus methotrexate (MTX) compared with MTX alone on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in patients with active early rheumatoid arthritis (RA) previously untreated with MTX. METHODS: Patients with active early RA were randomized to groups receiving placebo, rituximab 500 mg, or rituximab 1,000 mg. Rituximab was given by intravenous infusion on days 1 and 15. From week 24, patients with a Disease Activity Score in 28 joints-erythrocyte sedimentation rate of >/=2.6 were eligible for retreatment. Physical function was assessed by Health Assessment Questionnaire (HAQ) disability index (DI) and Short Form 36 (SF-36) scores. Patients achieving a minimal clinically important difference (MCID) for PROs were determined. Additional PROs, including fatigue and pain, were assessed. RESULTS: A total of 748 patients were randomized and received the study drug. Patient characteristics were well balanced. At week 52, treatment with rituximab in both dose groups showed significant improvements in the HAQ DI compared to the MTX alone group (-0.905 and -0.916 in the rituximab 500 mg plus MTX and 1,000 mg plus MTX groups, respectively, versus -0.628 in the MTX alone group; P < 0.0001). Higher proportions of patients achieved MCID in the HAQ DI in the rituximab plus MTX groups compared to MTX alone. Treatment with rituximab plus MTX led to a significant reduction in the SF-36 physical component summary for both rituximab dose groups, but did not show statistically significant differences in the SF-36 mental component summary. Compared to the MTX alone group, both doses of rituximab plus MTX were associated with significant reductions in the patient global assessment of disease activity and pain, and a significantly higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores from baseline to 52 weeks. CONCLUSIONS: Rituximab plus MTX was associated with significant improvement in physical function and HRQOL outcomes compared with MTX alone in patients previously untreated with MTX.","Rigby, W., et al. (2011). \"Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate.\" Arthritis Care Res (Hoboken) 63(5): 711-720.","USA",2011,"Musculoskeletal","Rituximab","FACIT-F"]
[240,"Rios Romenets, S., et al. (2013). \"Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study.\" Parkinsonism Relat Disord 19(7): 670-675.",null,"Rios Romenets, S., et al.","Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study","INTRODUCTION: Although a variety of pharmacologic and non-pharmacologic treatments are effective for insomnia in the general population, insomnia in Parkinson's disease differs in important ways and may need different treatments. No studies have conclusively demonstrated effective insomnia treatments in Parkinson's disease. METHODS: We conducted a three-arm six-week randomized pilot study assessing non-pharmacologic treatment (cognitive behavioural therapy with bright light therapy) or doxepin (10 mg daily), compared to an inactive placebo in Parkinson's patients with insomnia. Sleep outcomes included insomnia scales, clinical global impression, sleep diaries and actigraphy. Secondary outcomes included motor severity, fatigue, depression and quality of life. RESULTS: 18 patients were randomized, 6 to each group. Compared to placebo, doxepin improved the Insomnia Severity Index (-9 +/- 5.4 vs. -2 +/- 3.9, p = 0.03), the SCOPA-night score (-5.2 +/- 1.5 vs. -2.3 +/- 2.8, p = 0.049), the Pittsburgh Sleep Quality Index-sleep disturbances subscale (-0.5 +/- 0.5 vs 0.2 +/- 0.4, p = 0.02), and both patient and examiner-rated clinical global impression of change (1.7 +/- 0.8 vs. 0.5 +/- 0.8, p = 0.03 and 1.4 +/- 0.5 vs. 0.3 +/- 0.5, p = 0.003). On secondary outcomes doxepin reduced the fatigue severity scale (p = 0.02) and improved scores on the Montreal Cognitive Assessment (p = 0.007). Non-pharmacological treatment reduced the Insomnia Severity Index (-7.8 +/- 3.8 vs. -2.0 +/- 3.9, p = 0.03), and the examiner-reported clinical global impression of change (p = 0.006), but was associated with decline in Parkinson Disease Questionnaire-39. There were no changes in other primary and secondary outcomes, including actigraphy outcomes. Adverse events were comparable in all groups. CONCLUSION: Doxepin and non-pharmacologic treatment substantially improved insomnia in Parkinson's disease. These potential benefits must be replicated in a full confirmatory randomized controlled trial.","Rios Romenets, S., et al. (2013). \"Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study.\" Parkinsonism Relat Disord 19(7): 670-675.","Canada",2013,"Various","Psychobehavioural","FSS"]
[241,"Rizzo, M. A., et al. (2004). \"Prevalence and treatment of spasticity reported by multiple sclerosis patients.\" Mult Scler 10(5): 589-595.",null,"Rizzo, M. A., et al.","Prevalence and treatment of spasticity reported by multiple sclerosis patients","The objective of this study was to characterize the population of multiple sclerosis (MS) patients suffering from spasticity and to evaluate treatment patterns, including intrathecal baclofen (ITB) delivery, related to patient quality of life (QOL). We conducted a cross-sectional, two-level study using data from the Patient Registry of the North American Research Committee on MS (NARCOMS). In addition, we surveyed a subgroup of 198 preselected patients who are using ITB (ITBG) and a random sample of 315 oral drug users (ORALG). Among the registrants, 16% reported no spasticity, 31% minimal, 19% mild, 17% moderate (frequently affects activities), 13% severe (daily forced to modify activities) and 4% total (prevents daily activities). Patients experiencing greater severity included by proportion males, and those older and with longer duration of MS. QOL scores decreased inversely with severity. In the focused survey, ITBG reported lower levels of spasticity than ORALG, less stiffness in the legs, less pain and fewer spasms at any time. They scored significantly lower in the SF-36 physical component, yet reported less fatigue on the MFIS scale. Prevalence data reveal that one third of MS patients modify or eliminate daily activities as a result of spasticity. Treatment of spasticity can significantly impact QOL parameters by reducing spasms, pain and fatigue.","Rizzo, M. A., et al. (2004). \"Prevalence and treatment of spasticity reported by multiple sclerosis patients.\" Mult Scler 10(5): 589-595.","USA",2004,"Neurological","None","MFI"]
[242,"Robinson, D. W., Jr., et al. (2008). \"The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.\" J Support Oncol 6(6): 283-290.",null,"Robinson, D. W., Jr., et al.","The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia","Data from a clinical study of 86 pancreatic cancer patients with involuntary, significant weight loss (cachexia) were used to explore the relationship between patient-reported outcomes (PROs) and survival. In all, 28 pancreatic cancer patients with cachexia were given gemcitabine (Gemzar) plus 3 mg/kg of infliximab (Remicade), 28 were given gemcitabine plus 5 mg/kg of infliximab, and 30 were given gemcitabine plus placebo in a double-blinded, phase II, multicenter trial. PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Anorexia/ Cachexia Therapy (FAACT), Brief Pain Inventory (BPI), and the Short-Form 36 general health survey (SF-36). Population mean scores at baseline indicated fatigue problems (FACIT-F), nutritional health issues (FAACT), and mild-to-moderate pain (BPI \"worst pain\" score). Baseline normalized SF-36 values for physical functioning, vitality, and mental health indicated substantial impairment. Baseline fatigue and physical-functioning scores predicted survival as well as, or better than, baseline Karnofsky Performance Status or hemoglobin level. A cut-point in the FACIT-F score (median < or = 30) strongly predicted mortality; patients with greater fatigue had a lower median overall survival than did those with less fatigue. These findings supported several features of an a priori clinical-benefit model. Patient-reported fatigue provided powerful prognostic information; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia. These results must be confirmed by larger trials.","Robinson, D. W., Jr., et al. (2008). \"The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.\" J Support Oncol 6(6): 283-290.","USA",2008,"Cancer","Other Drugs,Infliximab","FACIT-F"]
[243,"Romito, F., et al. (2014). \"Patients attitudes towards sleep disturbances during chemotherapy.\" Eur J Cancer Care (Engl) 23(3): 385-393.",null,"Romito, F., et al.","Patients attitudes towards sleep disturbances during chemotherapy","Sleep disturbances are among the most distressing symptoms in cancer: they often co-occur with fatigue, pain and psychological distress. Despite the negative impact on quality of life, patients rarely seek help for managing their sleep disturbances. This paper presents the results of a multicentre observational study on patients' attitudes towards their sleep problems. The study also investigates symptom correlates. Patients responded to a semi-structured interview and completed the following questionnaires: Pittsburgh Sleep Quality Index; Brief Fatigue Inventory; Hospital Anxiety and Depression Scale; and European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life QLQ-C30 Questionnaire (QLQ-C30). Four hundred and three cancer patients were enrolled in the study. Bad sleepers constituted 66% of the sample. Thirty-eight per cent of them had not turned to any professional to solve their sleep disturbances because they had various beliefs about the importance of the problem and the possibility to be treated. The main correlates of sleep disturbances were psychological distress, reduced physical functioning and reduced overall quality of life. In conclusion, there is a need to sensitise patients to actively search for a solution to their sleep disturbances so they can be solved along with other co-occurring symptoms. Doctors could also be encouraged to dedicate more attention to routinely asking cancer patients about eventual sleep disturbances.","Romito, F., et al. (2014). \"Patients attitudes towards sleep disturbances during chemotherapy.\" Eur J Cancer Care (Engl) 23(3): 385-393.","Italy",2014,"Cancer","None","BFI"]
[244,"Roncella, A., et al. (2009). \"Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction).\" J Cardiovasc Med (Hagerstown) 10(12): 947-452.",null,"Roncella, A., et al.","Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction)","OBJECTIVE: A number of previous studies addressed the effect of psychological interventions in patients after acute myocardial infarction (AMI), but it is not known whether psychotherapy might be beneficial after medical and interventional therapy of AMI. We designed a randomized, controlled study to assess the effects of a short-term psychotherapy (STP) on the clinical outcomes of patients who underwent an emergency percutaneous coronary intervention after AMI. METHODS: One hundred consecutive patients undergoing an emergency percutaneous coronary intervention will be randomized 1 week after AMI to medical therapy (control group, C group) or to medical therapy and STP (STP group). Clinical follow-up visits are scheduled at 6 months, 1 and 5 years, whereas psychometric tests (Self-Evaluation test, Modified Maastricht Questionnaire, Social Support Questionnaire, Recent Life Change Questionnaire, Beck Depression Inventory, the MacNew Heart Disease Health-Related Quality of Life Questionnaire, Type D Personality test) are scheduled 1 week after AMI and at 1 year. The primary outcome measures of the study are the cumulative incidence of new cardiological events (myocardial reinfarction, death, stroke, life-threatening ventricular arrhythmias, and recurrence of angina) and the occurrence of new medical disorders. Secondary outcome measures are the incidence of rehospitalizations due to cardiological problems, the prevalence of patients with New York Heart Association class > or = II, left ventricular function, as assessed by echocardiography, and mean score of psychometric tests in the two groups at follow-up. CONCLUSION: Our study has been planned to obtain an insight into how a STP influences clinical outcomes after interventional and medical treatment of AMI.","Roncella, A., et al. (2009). \"Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction).\" J Cardiovasc Med (Hagerstown) 10(12): 947-452.","Italy",2009,"CVD","Psychobehavioural","Maastricht questionnaire"]
[245,"Rosen, C. F., et al. (2012). \"Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone.\" Rheumatology (Oxford) 51(3): 571-576.",null,"Rosen, C. F., et al.","Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone","OBJECTIVE: PsA is an inflammatory arthritis present in approximately 30% of people with psoriasis (PsC). Both conditions have a significant impact on quality of life (QoL). Our objective was to test the hypothesis that people with PsA have poorer QoL than patients with PsC because of the added burden of arthritis, age and comorbidities. METHODS: Consecutive patients with PsA (CASPAR criteria) and PsC were approached to participate in this study. Patients with PsC were examined by a rheumatologist using a standardized protocol to exclude PsA. Patients completed the HAQ, Medical Outcome Study 36-item Short Form Health Survey, Dermatology Life Quality Index (DLQI), EuroQoL 5 domains (EQ-5D) and Fatigue Severity Scale (FSS). Mean scores were compared and multivariate analyses were conducted to compare the QoL measures between the two patient groups. RESULTS: Two hundred and one patients with PsC and 201 patients with PsA were studied. A significant decrease in QoL for patients with PsA compared with those with PsC was identified by all questionnaires except for the DLQI. This skin-specific questionnaire revealed a lower QoL in patients with PsC. Multivariate analyses for each QoL measure confirmed the results of these analyses. After adjusting for age, sex, duration of PsC, comorbidities, DMARDs and biologic therapy, HAQ and DLQI were independently associated with PsA in a logistic regression. CONCLUSION: Patients with PsA have a poorer QoL compared with those with PsC as measured by all questionnaires except the DLQI.","Rosen, C. F., et al. (2012). \"Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone.\" Rheumatology (Oxford) 51(3): 571-576.","Canada",2012,"Musculoskeletal","None","FSS"]
[246,"Rotonda, C., et al. (2011). \"Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study.\" Contemp Clin Trials 32(2): 244-249.",null,"Rotonda, C., et al.","Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study","INTRODUCTION: Breast cancer is by far the most common form of cancer diagnosis in women. Cancer treatments are long, complex and often cumbersome with numerous side effects. Fatigue is now considered as the most distressing side effect of treatment. Fifty-eight percent to 94% of breast cancer patients experience fatigue during treatment with adjuvant chemotherapy. OBJECTIVE: The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effects of the different adjuvant treatments will be explored. RESEARCH DESIGN: A prospective longitudinal study in women diagnosed for the first time with stage I-IIIA breast cancer and who have undergone surgery, has been designed to meet the study aims. Recruitment began in September 2008 and target enrollment completion date is December 2010. (clinicaltrials.gov number, NCT01064427). The MFI-20 (Multidimensional Fatigue Inventory) and the EORTC QLQ-C30 (European Organization for Research and Treatment Quality of Life Questionnaire) will be completed, at several times. The follow-up is planned over a 24-month period. We studied adjuvant chemotherapy regimens with anthracyclines or with anthracycline/taxane combination. The LOR (Life Orientation Test) will be completed only at baseline to estimate the level of optimism of the patient and the STAI (State-Trait Anxiety Questionnaire) will be filled to measure a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening. OUTCOMES: The knowledge of determinants should facilitate screening of fatigue, and its evaluation on consequences on the patients' quality of life would allow physicians better help patients cope with the management of fatigue according to the adjuvant regimen.","Rotonda, C., et al. (2011). \"Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study.\" Contemp Clin Trials 32(2): 244-249.","France",2011,"Cancer","Cancer treatments","MFI"]
[247,"Ruffer, J. U., et al. (2003). \"Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG).\" Eur J Cancer 39(15): 2179-2186.",null,"Ruffer, J. U., et al.","Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG)","Although treatment regimens for Hodgkin's lymphoma have become more sophisticated, little is known about the prevalence of fatigue in long-term survivors. Therefore, we investigated the fatigue status of long-term survivors of Hodgkin's lymphoma and a control group using a pre-validated questionnaire. In 1995/1996, we contacted 1981 patients, who were enrolled in the German Hodgkin Studies HD 1-6. All patients were treated according to the treatment protocols HD1-3 (1981-1988) and HD 4-6 (1988-1993). The patients with a current status of complete remission were asked to complete a quality-of-life (QoL) questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ C-30)) and a fatigue questionnaire (Multidimensional Fatigue Inventory (MFI)). The results were compared with the data from 935 controls, matched for age, gender and living area. Eight-hundred and eighteen questionnaires from the patients were available for analysis. The median time between the end of treatment and completing the questionnaire is 5.2 years. Fatigue levels of patients with Hodgkin's lymphoma are high, even years after treatment. Fatigue dimensions are significantly influenced by several clinical and non-clinical factors. Fatigue levels of Hodgkin's lymphoma patients are significantly higher than those of the control group. Further investigations are warranted to explore the effectiveness of treatment strategies for fatigue.","Ruffer, J. U., et al. (2003). \"Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG).\" Eur J Cancer 39(15): 2179-2186.","Germany",2003,"Cancer","None","MFI"]
[248,"Rupp, I., et al. (2004). \"Impact of fatigue on health-related quality of life in rheumatoid arthritis.\" Arthritis Rheum 51(4): 578-585.",null,"Rupp, I., et al.","Impact of fatigue on health-related quality of life in rheumatoid arthritis","OBJECTIVE: To multidimensionally assess fatigue in rheumatoid arthritis (RA) and to evaluate the impact of fatigue on health-related quality of life (HRQOL). METHODS: The study was conducted in 1999 among 490 RA patients with varying disease duration. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and HRQOL with a validated Dutch version of the RAND 36-Item Health Survey. We evaluated the impact of fatigue on HRQOL by multiple linear regression analyses taking into account RA-related pain and depressive symptoms. RESULTS: Different aspects of fatigue selectively explained different dimensions of HRQOL. The MFI-20 was entered last to the linear regression models, resulting in an additional increase of explained variance of 1% (mental health) to 14% (vitality). CONCLUSION: The multidimensional portrayal of RA-related fatigue can be used to develop intervention strategies targeted to specific aspects of fatigue. Fatigue, supplementary to RA-related pain and depressive symptoms, appears to be a feasible and treatable target in the clinical management of RA to increase HRQOL.","Rupp, I., et al. (2004). \"Impact of fatigue on health-related quality of life in rheumatoid arthritis.\" Arthritis Rheum 51(4): 578-585.","Netherlands",2004,"Musculoskeletal","None","MFI"]
[249,"Sabapathy, N. M., et al. (2011). \"Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study.\" Clin Rehabil 25(1): 14-24.",null,"Sabapathy, N. M., et al.","Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study","OBJECTIVE: The purpose of this study was to compare adaptations in functional and quality of life measures following endurance- and resistance-exercise training in people with multiple sclerosis. DESIGN: Cross-over design with an eight-week washout period. SETTING: Community health centre. SUBJECTS: Sixteen individuals with multiple sclerosis. INTERVENTION: Subjects completed both an eight-week endurance- and an eight-week resistance-exercise training programme in a randomized order. The exercise training comprised individualized progressive programmes that were completed twice weekly in a supervised group setting. MAIN MEASURES: Grip strength, functional reach, four step square, timed up and go and six-minute walk tests, Multiple Sclerosis Impact and Modified Fatigue Impact Scales, Becks Depression Inventory and the Health Status Questionnaire Short Form-36. RESULTS: Sixteen of 21 (76%) subjects completed the study. Subjects attended 13.2 +/- 1.6 endurance- and 15.8 +/- 1.9 resistance-exercise training sessions. No adverse events were reported. No significant differences (P < 0.05) in any outcome measures were observed between the two exercise training programmes either at baseline or following the completion of both training programmes. CONCLUSION: Both endurance- and resistance-exercise training were well tolerated and appear to provide similar effects for people with multiple sclerosis, but larger studies are required to confirm these findings.","Sabapathy, N. M., et al. (2011). \"Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study.\" Clin Rehabil 25(1): 14-24.","Australia",2011,"Neurological","Psychobehavioural","MFI"]
[250,"Salsman, J. M., et al. (2015). \"Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.\" Support Care Cancer 23(5): 1355-1364.",null,"Salsman, J. M., et al.","Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia","PURPOSE: Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 (NCT01387282) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). METHODS: In the ROMANA 2 trial, 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 203 patients who reached the week 12 visit at the time of data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12. RESULTS: Two 4-item scales (fatigue/activity and appetite/eating) from the FACIT-F and FAACT questionnaires, respectively, demonstrated good internal consistency reliability, validity, and responsiveness (also referred to as the Simplified Evaluation of Fatigue (SEF) and Simplified Evaluation of Appetite (SEA), respectively). The estimated important difference for each scale was 1-2 points. CONCLUSIONS: These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine the clinical utility of these scales and their impact on treatment decision-making.","Salsman, J. M., et al. (2015). \"Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.\" Support Care Cancer 23(5): 1355-1364.","USA",2015,"Cancer,Various","None","FACIT-F"]
[251,"Samuels, N., et al. (2012). \"Acupuncture for symptoms of Gaucher disease.\" Complement Ther Med 20(3): 131-134.",null,"Samuels, N., et al.","Acupuncture for symptoms of Gaucher disease","OBJECTIVE: The purpose of this study was to examine the effect of acupuncture on bone/joint pain, headache and fatigue, as well as quality of life in patients with Gaucher disease (GD), within the framework of an integrated treatment programme. METHODS: Patients with GD suffering from any of the above symptoms were offered a series of 10-12 weekly acupuncture treatment sessions. Prior to initiation of treatment, participants were asked to score the severity of pain, as well as to complete the Functional Assessment of Chronic Illness Therapy-Fatigue measure (FACIT-F) and the Medical Outcomes Study (MOS) Short-Form (SF) questionnaire. These tools were evaluated again at the end of the treatment period. RESULTS: A total of 12 patients were evaluated. While the only pain outcome reduced by acupuncture was knee pain, a significant improvement was observed with respect to nearly all FACIT-Fatigue measures, including the Physical Well Being (PWB) subscales and the SF-12 Physical Composite Score (PCS), though not for the Mental Composite Score (MCS). Patients reported satisfaction with the treatment process, and no significant side effects were reported. CONCLUSION: Acupuncture may play a beneficial role for patients with GD when used in conjunction with conventional therapy, reducing fatigue and improving physical function. The preliminary finding of this observational study should encourage further research.","Samuels, N., et al. (2012). \"Acupuncture for symptoms of Gaucher disease.\" Complement Ther Med 20(3): 131-134.","Israel",2012,"Various","Complementary","FACIT-F"]
[252,"Sancho, A., et al. (2015). \"Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.\" BMC Cancer 15: 40.",null,"Sancho, A., et al.","Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial","BACKGROUND: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. DESIGN/METHODS: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. DISCUSSION: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.","Sancho, A., et al. (2015). \"Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.\" BMC Cancer 15: 40.","Spain",2015,"Cancer","Psychobehavioural","FACIT-F"]
[253,"Sandi, D., et al. (2015). \"The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life.\" Mult Scler Relat Disord 4(6): 499-504.",null,"Sandi, D., et al.","The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life","BACKGROUND: Multiple Sclerosis (MS) causes not only somatic, but also cognitive impairment regardless of the patients age or the course of the disease. The Brief International Cognitive Assessment for MS (BICAMS) test, published in 2011, is a short cognitive questionnaire: a fast, reliable, sensitive and specific tool for the evaluation of the patients cognitive state. OBJECTIVES: Our primary objective was to assess the validity of the Hungarian version of the BICAMS test. Our secondary objective was to evaluate the impact of the cognitive impairment on the patients quality of life and fatigues impact on the patients cognitive state. METHODS: 65 RR-MS patients and 65 age, sex and education matched healthy control (HC) subjects completed the test and were retested after 3 weeks. The patients also completed the MS Quality of Life 54 (MSQoL54) and the Fatigue Impact Scale (FIS) assessments. Group differences were calculated by paired sample T-tests. The test-retest reliability was measured by intraclass correlation coefficients. To analyze the difference between the test-retest performances of the two groups we used two-way repeated measures ANOVA where the BICAMS battery was the single composite outcome and one-way repeated measures ANOVA. To assess the impact of the cognitive decline on the patients quality of life and fatigues impact on the cognitive state, we examined the correlations between results in the BICAMS and the MSQoL54 and FIS. RESULTS: We found significant difference (p </= 0.001, p = 0.017 in the first CVLT-II assessment) between MS patients and members of the HC group in all four evaluated parameters of BICAMS test in both sessions. The correlation coefficients were very strong between the tests and retests (r > 0.8; p < 0.001; r = 0.678, p < 0.001 between the CVLT-II assessments). We found that the HC group performed significantly (p = 0.020) better in the retest sessions as compared to their original performance than the patients did and this difference is solely due to the difference between the CVLT-II performances. We have found significant negative correlation between the patients cognitive function and the fatigue score (r < -0.3, p < 0.05). Seven of the MSQoL-54 subscales correlated with the BICAMS performance (r > 0.3; < 0 .05). CONCLUSIONS: The Hungarian version of the BICAMS test is a valid and reliable method for the evaluation of MS patients cognitive function. It seems that because of the short retest period, the members of the HC group remembered the CVLT-II words thus performed better than the patients did. Also apparently fatigue can have a negative impact on the patients cognitive state, and cognitive impairment could worsen the patients quality of life.","Sandi, D., et al. (2015). \"The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life.\" Mult Scler Relat Disord 4(6): 499-504.","UK,Hungary",2015,"Neurological","None","FIS"]
[254,"Scherber, R., et al. (2011). \"The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.\" Blood 118(2): 401-408.",null,"Scherber, R., et al.","The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients","Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF], coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English [25%], Italian [46%], and Swedish [28%]) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P < .001) and highly reproducible (intraclass correlation coefficient > 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally.","Scherber, R., et al. (2011). \"The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.\" Blood 118(2): 401-408.","USA",2011,"Hematological","None","BFI"]
[255,"Schneider, R. A. (2004). \"Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers.\" J Clin Nurs 13(2): 219-225.",null,"Schneider, R. A.","Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers","BACKGROUND: Quality of life for caregivers of end-stage renal disease patients has not been well addressed yet the physical and psychological status of this overlooked group can be important in the recovery or adaptation of patients with chronic renal failure, not to mention the caregivers themselves. One particular feature of the overall quality of life of such caregivers is that of fatigue. AIMS AND OBJECTIVES: The purpose of the study was to test the Fatigue Severity Scale for potential usefulness in assessing fatigue among a non-medical population, caregivers of end-stage renal disease patients. METHODS: Subjects completed a short battery of measures at either a dialysis centre or at home. RESULTS: The Short Form-12 of the Short Form-36 and the Center for Epidemiologic Studies Depression Scale accounted for 56% of the variance on the Fatigue Severity Scale. The results suggest that physical fatigue may be more prominent than mental fatigue as a feature of caregiver quality of life. CONCLUSIONS: The Fatigue Severity Scale which has been used for multiple sclerosis patients may prove to be useful as a short assessment of fatigue among the non-medical population of end-stage renal disease caregivers. This may result in improved interventions for the population of caregivers. RELEVANCE TO CLINICAL PRACTICE: Physicians, nurses and allied health professionals will be called on more frequently to assess and intervene with fatigued and overburdened caregivers in addition to patients themselves. A more thorough understanding of the nature of caregiver fatigue may drive changes or innovations with caregivers who are too often overlooked in the current era of scarce resources. Accordingly results of the study suggest that the direction in intervention may focus more on rest and respite as opposed to a need for psychosocial support or counselling. While there are various modes for assessing end-stage renal disease caregivers' fatigue, a simple measure like the Fatigue Severity Scale is brief enough to be administered without undue demand on practitioners or caregivers.","Schneider, R. A. (2004). \"Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers.\" J Clin Nurs 13(2): 219-225.","USA",2004,"Kidney Disease","None","FSS"]
[256,"Schneider, S. M. and L. E. Hood (2007). \"Virtual reality: a distraction intervention for chemotherapy.\" Oncol Nurs Forum 34(1): 39-46.",null,"Schneider, S. M. and L. E. Hood","Virtual reality: a distraction intervention for chemotherapy","PURPOSE/OBJECTIVES: To explore virtual reality (VR) as a distraction intervention to relieve symptom distress in adults receiving chemotherapy treatments for breast, colon, and lung cancer. DESIGN: Crossover design in which participants served as their own control. SETTING: Outpatient clinic at a comprehensive cancer center in the southeastern United States. SAMPLE: 123 adults receiving initial chemotherapy treatments. METHODS: Participants were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and then received no intervention (control) during an alternate matched chemotherapy treatment. The Adapted Symptom Distress Scale-2, Revised Piper Fatigue Scale, and State Anxiety Inventory were used to measure symptom distress. The Presence Questionnaire and an open-ended questionnaire were used to evaluate the subjects' VR experience. The influence of type of cancer, age, and gender on symptom outcomes was explored. Mixed models were used to test for differences in levels of symptom distress. MAIN RESEARCH VARIABLES: Virtual reality and symptom distress. FINDINGS: Patients had an altered perception of time (p < 0.001) when using VR, which validates the distracting capacity of the intervention. Evaluation of the intervention indicated that patients believed the head-mounted device was easy to use, they experienced no cyber-sickness, and 82% would use VR again. However, analysis demonstrated no significant differences in symptom distress immediately or two days following chemotherapy treatments. CONCLUSIONS: Patients stated that using VR made the treatment seem shorter and that chemotherapy treatments with VR were better than treatments without the distraction intervention. However, positive experiences did not result in a decrease in symptom distress. The findings support the idea that using VR can help to make chemotherapy treatments more tolerable, but clinicians should not assume that use of VR will improve chemotherapy-related symptoms. IMPLICATIONS FOR NURSING: Patients found using VR during chemotherapy treatments to be enjoyable. VR is a feasible and cost-effective distraction intervention to implement in the clinical setting.","Schneider, S. M. and L. E. Hood (2007). \"Virtual reality: a distraction intervention for chemotherapy.\" Oncol Nurs Forum 34(1): 39-46.","USA",2007,"Cancer","Psychobehavioural","PFS"]
[257,"Schwartz, T. L., et al. (2004). \"An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy.\" J Clin Psychiatry 65(9): 1223-1227.",null,"Schwartz, T. L., et al.","An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy","OBJECTIVE: In patients with major depressive disorder (MDD), excessive sleepiness and fatigue not only are major components of the disorder, but also may occur as side effects of antidepressant therapy. In addition, sedation may be a consequence of antidepressant regimens. The novel wake-promoting agent modafinil improves wakefulness and reduces fatigue across a variety of clinical disorders. This study assessed the use of modafinil as an adjunctive treatment in patients with MDD who reported sedation related to serotonergic antidepressant therapy. METHOD: Data were collected between September 2001 and December 2003. Twenty men and women with DSM-IV-defined MDD were enrolled in this 3-week, open-label, single-center study. In addition to ongoing and stable treatment with selective serotonin reuptake inhibitors (SSRIs), clinic patients received modafinil once daily. Efficacy assessments were conducted at 1-week intervals. RESULTS: Sixteen patients (80%) completed the study. Modafinil plus SSRIs significantly improved overall depressive symptoms, as shown by reductions in mean Hamilton Rating Scale for Depression total scores (p <.001 vs. baseline). Adjunctive modafinil significantly improved subjective estimates of wakefulness on the Epworth Sleepiness Scale (p <.001, all weeks) and reduced fatigue on the Fatigue Severity Scale (p =.009). At the final visit, modafinil had improved overall health status and health-related quality of life, as shown by significant improvements in mean Medical Outcomes Study Short-Form 12-Item Health Survey total scores (p =.007) and in physical health (p =.04) and mental health (p =.006) subscores. CONCLUSION: In patients with MDD who experience sedation as a side effect of antidepressant therapy, adjunctive modafinil improved wakefulness and reduced fatigue. Modafinil plus SSRIs also improved mood and quality of life.","Schwartz, T. L., et al. (2004). \"An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy.\" J Clin Psychiatry 65(9): 1223-1227.","USA",2004,"Mental health","Other Drugs","FSS"]
[258,"Schwarz, R., et al. (2003). \"Fatigue in the general population.\" Onkologie 26(2): 140-144.",null,"Schwarz, R., et al.","Fatigue in the general population","BACKGROUND: Fatigue symptoms are often found in cancer patients. One test to assess fatigue is the Multidimensional Fatigue Inventory (MFI-20). It has been successfully applied to specific groups of cancer patients. However, until now population-based norm values are missing. METHODS: We conducted an investigation on a representative sample of the adult German population, which comprised 2,037 subjects aged 14-92 years. RESULTS: The reliability of the 5 MFI-20 subscales (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) is satisfying. The correlations between MFI-20 subscales and the fatigue scale of the quality-of-life questionnaire EORTC indicate convergent validity. As an important result we found that all subscales of the MFI-20 showed a clear and nearly linear dependency on age with higher fatigue values for older subjects (p < 0.0001). Females as compared with males are characterized by higher mean values in all MFI-20 subscales (p < 0.001). CONCLUSIONS: The results show that it is necessary to take into account age and sex when different groups of cancer patients have to be compared.","Schwarz, R., et al. (2003). \"Fatigue in the general population.\" Onkologie 26(2): 140-144.","Germany",2003,"Cancer","None","MFI"]
[259,"Scott, J., et al. (2014). \"Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection.\" BMC Infect Dis 14: 465.",null,"Scott, J., et al.","Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection","BACKGROUND: Fatigue is a common symptom of chronic hepatitis C virus (HCV) infection and a frequent side-effect of peginterferon/ribavirin (PR) therapy for HCV. This study evaluated the impact of adding the oral HCV NS3/4A protease inhibitor simeprevir to PR on patient-reported fatigue and health status among patients with chronic HCV genotype 1 infection enrolled in the Phase IIb PILLAR and ASPIRE trials [NCT00882908; NCT00980330]. METHODS: Treatment-naive patients (PILLAR, n = 386) and treatment-experienced patients (ASPIRE, n = 462) were randomized to simeprevir plus PR (simeprevir/PR) or placebo plus PR (placebo/PR). In PILLAR, duration of PR treatment in the simeprevir/PR groups was determined using response-guided therapy (RGT) criteria. PR could be terminated at Week 24, instead of Week 48, if HCV RNA was <25 IU/mL by Week 4 and then undetectable at Weeks 12, 16, and 20. In both studies, patients completed the Fatigue Severity Scale (FSS) and EQ-5D quality-of-life questionnaire in their native language at baseline and throughout the studies up until Week 72. RESULTS: During the first 24 weeks of treatment, mean FSS total score was increased to a similar degree compared with baseline among patients receiving simeprevir/PR or placebo/PR in both studies indicating increased fatigue severity. Mean FSS scores returned to values comparable with baseline among patients receiving simeprevir/PR after Week 24 in PILLAR (after treatment completion for the majority of patients) and in ASPIRE (after Week 48), consistent with RGT enabling early termination of all treatment at Week 24 in 82.2% of simeprevir/PR-treated patients in the PILLAR study. Similar results were observed for EQ-5D, with simeprevir/PR-treated patients experiencing less time with worse health problems according to EQ-5D scores compared with placebo/PR groups in both studies, and more rapid improvement in health status associated with shorter treatment duration in the PILLAR study. CONCLUSIONS: Combination of simeprevir with PR did not increase patient-reported fatigue severity or health status impairments beyond that reported by patients treated with PR alone. Many patients treated with simeprevir/PR returned to pretreatment fatigue and health status levels sooner due to increased treatment efficacy that enabled shorter duration of all therapy, compared with PR alone.","Scott, J., et al. (2014). \"Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection.\" BMC Infect Dis 14: 465.","UK",2014,"Infectious disease","Simeprevir","FSS"]
[260,"Seyidova-Khoshknabi, D., et al. (2011). \"Review article: a systematic review of cancer-related fatigue measurement questionnaires.\" Am J Hosp Palliat Care 28(2): 119-129.",null,"Seyidova-Khoshknabi, D., et al.","Review article: a systematic review of cancer-related fatigue measurement questionnaires","PURPOSE: Cancer-related fatigue (CRF) is a common symptom experienced by patients in all stages and in cancer survivors. The main objectives of this review were to identify validated CRF instruments, and populations in whom these tools have been validated. METHODS: We used a systematic review methodology. Three separate searches were performed using different MeSH terms in Pub Med and Ovid databases. Articles were analyzed for validation and reliability. RESULTS: A total of 1453 papers from 3 different searches identified 40 instruments (3 unidimensional and 37 multidimensional). Instruments varied by psychometric properties, items, scale, dimension, cancer site, and population. Five were optimally tested for validity and reliability. Completion rates, sensitivity to change, and test-retest reliability were reported for a few. DISCUSSION: Most tools had been validated in mixed populations and are relatively insensitive to differences in fatigue to cancer stage. Most instruments are burdensome for those with advanced cancer. The Brief Fatigue Inventory and 3 fatigue items of the European Organization for Research and Treatment Quality of Life Questionnaire Fatigue Scale (EORTC QLQ-C30) are optimal instruments in advanced cancer. CONCLUSIONS: In all, 40 CRF instruments were identified. Validity and reliability varied by questionnaire. The ideal item numbers, scale, and domains are not established and may be population dependent.","Seyidova-Khoshknabi, D., et al. (2011). \"Review article: a systematic review of cancer-related fatigue measurement questionnaires.\" Am J Hosp Palliat Care 28(2): 119-129.","USA",2011,"Cancer","None","BFI"]
[261,"Shinto, L., et al. (2008). \"A randomized pilot study of naturopathic medicine in multiple sclerosis.\" J Altern Complement Med 14(5): 489-496.",null,"Shinto, L., et al.","A randomized pilot study of naturopathic medicine in multiple sclerosis","BACKGROUND: Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. OBJECTIVE: To assess quality of life in MS subjects who received interventions designed to \"model\" the \"whole practice\" of naturopathy. DESIGN: A pilot, randomized, controlled study with a 6-month intervention period. PARTICIPANTS: Participants who met criteria for clinically definite MS. INTERVENTIONS: The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. OUTCOME MEASURES: The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. RESULTS: Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. CONCLUSIONS: Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.","Shinto, L., et al. (2008). \"A randomized pilot study of naturopathic medicine in multiple sclerosis.\" J Altern Complement Med 14(5): 489-496.","USA",2008,"Neurological","Complementary","MFI"]
[262,"Simmonds, M. J., et al. (2005). \"The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus.\" Clin J Pain 21(3): 200-206.",null,"Simmonds, M. J., et al.","The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus","OBJECTIVES: The purposes of this study were to: 1) characterize physical performance in individuals with human immunodeficiency virus; and 2) examine group differences by pain and fatigue on a multivariate profile of disease, physical, and psychologic symptoms. METHODS: One hundred outpatients, 78 men and 22 women (mean age 40.70 +/- 7.49 years) participated. Patients completed a battery of physical performance tests in which the time taken or the distance reached or walked was measured. Self-report questionnaires included measures of pain (0-10 numerical rating scale), fatigue (Brief Fatigue Inventory), and perceived health status (Medical Outcomes Survey-HIV scale). RESULTS: Physical performance was compromised in a task specific manner. Patients took twice as long as healthy individuals on a belt-tie and 4 times as long on a sit-to-stand task and in 6 minutes walked 75% of the distance covered by healthy individuals. Fifty percent of patients (n = 50) had pain at the time of testing (mean 6.3 +/- 2.4), and 98% had fatigue (mean 5.4 +/- 2.3). Multivariate analysis of variance showed pain had a greater influence on performance than fatigue. Pain, distance walked in 6 minutes, and unloaded forward reach accounted for 26% of the variability in quality of life (r = 0.51, P < or = 0.0001). DISCUSSION: Pain has a substantial impact on physical performance and quality of life among ambulatory human immunodeficiency virus patients. Fatigue also impacts physical performance. Compromised ability to perform certain physical tasks affects quality of life. Further investigation of the roles of these relevant variables should be investigated in path analyses.","Simmonds, M. J., et al. (2005). \"The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus.\" Clin J Pain 21(3): 200-206.","UK",2005,"Infectious disease","None","BFI"]
[263,"Small, S. P. and M. Lamb (2000). \"Measurement of fatigue in chronic obstructive pulmonary disease and in asthma.\" Int J Nurs Stud 37(2): 127-133.",null,"Small, S. P. and M. Lamb","Measurement of fatigue in chronic obstructive pulmonary disease and in asthma","Despite recognition of a high prevalence of fatigue in individuals with chronic airflow obstruction conditions, including chronic obstructive pulmonary disease and asthma, and its importance from a quality of life perspective, no research was found in which fatigue was measured directly in these populations. This may be due to a seeming lack of appropriate instruments for measuring fatigue in these populations. The purpose of this study, therefore, was to pretest an instrument, the Piper Fatigue Scale, which was developed to measure chronic fatigue in clinical populations. The outpatient sample consisted of 17 persons with chronic obstructive pulmonary disease and 19 with asthma. Findings revealed that the visual analogue scale version of the Piper Fatigue Scale may not be appropriate for measuring fatigue in these populations. Instruments with validity and reliability for fatigue in chronic obstructive pulmonary disease and asthma need to be developed.","Small, S. P. and M. Lamb (2000). \"Measurement of fatigue in chronic obstructive pulmonary disease and in asthma.\" Int J Nurs Stud 37(2): 127-133.","Canada",2000,"Respiratory Disease","None","PFS"]
[264,"Smith, S. K., et al. (2015). \"Evaluation of Pillars4life: a virtual coping skills program for cancer survivors.\" Psychooncology 24(11): 1407-1415.",null,"Smith, S. K., et al.","Evaluation of Pillars4life: a virtual coping skills program for cancer survivors","OBJECTIVE: Pillars4Life is an educational program that teaches coping skills to cancer patients in a virtual group setting; it was recently implemented at 17 hospitals across the USA. The cost-effective, scalable, and assessable Pillars4Life curriculum targets psychosocial resources (e.g., self-efficacy and coping skills) as a means to reduce symptoms (e.g., depression, anxiety, and posttraumatic stress) and enhance quality of life. METHODS: Cancer patients were recruited from hospitals that received the LIVESTRONG Community Impact Project Award to enroll in a pilot study of Pillars4Life. Consenting participants met with a certified instructor weekly for 10 weeks in a virtual environment; the manualized intervention trained participants in personal coping skills. Longitudinal assessments over 6 months were assessed using validated instruments to determine changes in Pillars4Life targeted resources and outcomes. Multiple linear regression models examined the relationship between changes in targeted resources and changes in outcome from baseline to 3 months post-intervention. RESULTS: Participants (n = 130) had the following characteristics: mean age of 56 +/- 11 years, 87% women, 11% non-Caucasian, and 77% with college degree. At 3- and 6-month follow-up, mean scores improved on all key outcome measures such as depression (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder), posttraumatic stress (Posttraumatic Stress Disorder Checklist), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and well-being (Functional Assessment of Cancer Therapy-General) from baseline (all p < 0.01); results were most pronounced among participants who reported >/=4/10 on the Distress Thermometer at baseline (all p < 0.001). Changes in each targeted resource were associated with 3-month improvements in at least one outcome. CONCLUSIONS: Participation in the Pillars4Life program was associated with statistically and clinically significant improvements in scores on pre-specified outcomes and targeted resources.","Smith, S. K., et al. (2015). \"Evaluation of Pillars4life: a virtual coping skills program for cancer survivors.\" Psychooncology 24(11): 1407-1415.","USA",2015,"Cancer","Psychobehavioural","FACIT-F"]
[265,"Snel, M., et al. (2012). \"Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise.\" Eur J Intern Med 23(2): 143-149.",null,"Snel, M., et al.","Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise","OBJECTIVE: To evaluate whether the addition of exercise to a very low calorie diet (VLCD) has beneficial short- and long-term effects on health-related quality of life (QoL) in obese patients with type 2 diabetes mellitus (T2DM). METHODS: We included 27 obese, insulin-dependent T2DM patients in a 16-week VLCD study, of whom 13 participated simultaneously in an exercise program (VLCD+E). Before, immediately after and 18 months after the intervention anthropometric measurements, glucoregulation and QoL (SF-36, HADS, NHP and MFI-20) were assessed. Patients were compared to healthy lean and obese (matched for body mass index) controls matched for gender and age. RESULTS: At baseline, T2DM patients had significantly worse QoL scores in 18 and 14 of the 22 subscales of the QoL questionnaires, compared to lean and obese controls, resp. The 16-week VLCD (n=27) decreased bodyweight (-25.4+/-1.3 kg, p<0.0001, p=0.179 between groups), and improved glucoregulation (HbA1c -1.3+/-0.3%, p<0.0001, p=0.488 between groups) and 9 (VLCD-only) and 11 (VLCD+E) of the 22 subscales of QoL. After 18 months, in the VLCD+E group the QoL subscales did not differ from those in obese controls and only 4 of the 22 subscales were significantly worse compared to lean controls. However, in the VLCD-only group 17 and 13 of the 22 QoL subscales were significantly worse compared to the lean and obese controls, resp. CONCLUSION: A 16-week VLCD induces considerable weight loss, metabolic amelioration, and major improvements in QoL in obese T2DM patients. The addition of exercise is of paramount importance for the maintenance of better QoL.","Snel, M., et al. (2012). \"Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise.\" Eur J Intern Med 23(2): 143-149.","Netherlands",2012,"Various","Psychobehavioural","MFI"]
[266,"So, W. K., et al. (2003). \"Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation.\" Cancer Nurs 26(3): 211-219; quiz 220-211.",null,"So, W. K., et al.","Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation","Fatigue is reported to be a major symptom for many patients with cancer. However, little is known about this symptom among Chinese people who have cancer. A cross-sectional design was used to examine the intensity of fatigue in patients who underwent bone marrow transplantation for a hematologic malignancy, and to determine whether fatigue affected the quality of life in a Chinese sample (N = 157). The Revised Piper Fatigue Scale-Chinese Version was used to measure fatigue, and the Chinese version of the SF-36 Health Survey was used to measure quality of life. Overall, the subjects perceived a moderate level of fatigue (mean total fatigue score, 4.7 +/- 1.7). More than 15% reported experiencing a high level of fatigue. Subjects more likely to perceive a high level of fatigue were older, married, not employed, and on lower incomes. On post hoc tests, the group with a high level of fatigue scored significantly lower on quality-of-life domains than the other two groups (P <.05). The results may help nurses working with Chinese populations in identifying patients at risk for increased fatigue and in planning fatigue-relieving strategies.","So, W. K., et al. (2003). \"Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation.\" Cancer Nurs 26(3): 211-219; quiz 220-211.","China",2003,"Cancer","Cancer treatments","PFS"]
[267,"So, W. K., et al. (2009). \"The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study.\" Oncol Nurs Forum 36(4): E205-214.",null,"So, W. K., et al.","The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study","PURPOSE/OBJECTIVES: To examine the symptom cluster of fatigue, pain, anxiety, and depression and its effect on the quality of life (QOL) of women receiving chemotherapy or radiotherapy for breast cancer. DESIGN: Descriptive. SETTING: Oncology outpatient sections of four public hospitals in Hong Kong. SAMPLE: 215 ethnic Chinese women who were midway through treatment for breast cancer. METHODS: Chinese versions of the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Brief Pain Inventory, Functional Assessment of Chronic Illness Therapy for Breast Cancer, and Medical Outcomes Study Social Support Survey were used. Spearman rho correlation and structural equation modeling were used to examine the relationships among the study variables. MAIN RESEARCH VARIABLES: Breast cancer, fatigue, pain, anxiety, depression, and QOL. FINDINGS: Most participants reported mild-to-moderate levels of fatigue and pain. Twenty-one percent and 36% of patients might have had an anxiety or depression disorder, respectively. Significant correlations among the four symptoms supported the existence of the symptom cluster. The participants receiving chemotherapy had inadequate social support, experienced higher levels of symptoms, and were more likely to have a poorer QOL. CONCLUSIONS: The findings supported the existence of the symptom cluster that had detrimental effects on QOL. IMPLICATIONS FOR NURSING: This study shed light on a contemporary approach of grouping several related symptoms together. The findings enhance nurses' clinical sensitivity when identifying patients in high-risk groups and provide useful information for designing and prioritizing symptom-management strategies to meet patients' needs.","So, W. K., et al. (2009). \"The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study.\" Oncol Nurs Forum 36(4): E205-214.","China",2009,"Cancer","None","BFI,FACIT-F"]
[268,"Srisurapanont, M., et al. (2013). \"Clinical features of depression in Asia: results of a large prospective, cross-sectional study.\" Asia Pac Psychiatry 5(4): 259-267.",null,"Srisurapanont, M., et al.","Clinical features of depression in Asia: results of a large prospective, cross-sectional study","INTRODUCTION: The objective of this study was to investigate the clinical features of depression in Asian patients. METHODS: It was a cross-sectional, observational study of depression in China, Korea, Malaysia, Singapore, Taiwan, and Thailand. Participants were drug-free outpatients with depressed mood and/or anhedonia. Symptoms and clinical features were assessed using the Montgomery-Asberg Depression Rating Scale, Symptoms Checklist 90-Revised (SCL-90-R), and the Fatigue Severity Scale. Other measures included the Medical Outcome Survey 36-Item Short-Form Health Survey (SF-36), the Sheehan Disability Scale, and the Multidimensional Scale of Perceived Social Support (MSPSS). RESULTS: A total of 547 outpatients with major depressive disorder were included in the analyses. Among the Montgomery-Asberg Depression Rating Scale symptoms, \"reported sadness\" and \"reduced sleep\" had the highest severity, with means (SDs) of 3.4 (1.2) and 3.4 (1.6), respectively. Apart from the SCL-90-R depression and anxiety domains, the SCL-90-R obsession-compulsion syndrome had the highest domain score, with a mean (SD) of 1.9 (0.9). Among eight domains, the mean (SD) SF-36 pain subscale score of 58.4 (27.7) was only second to that for the SF-36 physical function. In comparison to other disability domains, the Sheehan Disability Scale work/school had the highest subscale score, with a mean (SD) of 6.5 (2.9). The mean (SD) MSPSS \"family\" subscale score of 4.7 (1.7) was higher than the MSPSS \"friends\" and \"significant others\" subscale scores. DISCUSSION: This study suggests that pain has a minimal impact on the quality of life in Asian patients with depression. Noteworthy issues in this population may include insomnia, obsessive-compulsive symptoms, working/school disability, and family support.","Srisurapanont, M., et al. (2013). \"Clinical features of depression in Asia: results of a large prospective, cross-sectional study.\" Asia Pac Psychiatry 5(4): 259-267.","Thailand",2013,"Mental health","None","FSS"]
[269,"Stachler, R. J., et al. (2014). \"PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool.\" Laryngoscope 124(6): 1368-1376.",null,"Stachler, R. J., et al.","PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool","OBJECTIVES/HYPOTHESIS: The objective of this study was to evaluate the Patient-Reported Outcomes Measure Information System (PROMIS) in a head and neck cancer patient cohort by assessing the associations of the PROMIS instruments with the responses to the European Oncology Research and Treatment of Cancer (EORTC) general measures, EORTC head and neck (H&N) measures, and Voice Handicap Index (VHI-10). We hypothesized that PROMIS scores are related to the other measures and may be used as assessment tools to help determine quality-of-life outcomes in head and neck cancer patients. STUDY DESIGN: Prospective baseline assessment of quality-of-life outcomes. METHODS: Thirty-nine head and neck cancer patients were included in the study. PROMIS (domains of fatigue, physical functioning, sleep disturbance, sleep-related impairment, and negative perceived cognitive function, EORTC (general), EORTC H&N, and the VHI-10 were given to all patients at the onset of their cancer diagnosis. Spearman correlation coefficients were computed to assess relationships between the measures. Correlations with corresponding P values <.0083 (Bonferroni adjustment) were considered statistically significant. Descriptive statistics of means, standard deviations, medians, and ranges were computed for all the instruments and measures. RESULTS: Significant correlations between the PROMIS instruments and EORTC functional scales were observed. The PROMIS instruments were also associated with some of the EORTC symptom scales, as well as some of the EORTC H&N symptoms measures. PROMIS fatigue instrument was significantly correlated with the VHI-10 measure. CONCLUSIONS: PROMIS instruments are reasonable measures to determine quality-of-life outcomes in head and neck cancer patients. Computerized adaptive testing devices can be effectively utilized in this patient population. LEVEL OF EVIDENCE: 2c.","Stachler, R. J., et al. (2014). \"PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool.\" Laryngoscope 124(6): 1368-1376.","USA",2014,"Cancer","None","PROMIS-F"]
[270,"Sterkenburg, A. S., et al. (2015). \"Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes.\" Neuro Oncol 17(7): 1029-1038.",null,"Sterkenburg, A. S., et al.","Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes","BACKGROUND: Quality of life (QoL) and long-term prognosis are frequently, and often severely, impaired in craniopharyngioma (CP) patients. Knowledge of risk factors for long-term outcome is important for optimization of treatment. METHODS: Overall survival (OS) and progression-free survival (PFS), body mass index (BMI), neuropsychological status (EORTCQLQ-C30, MFI-20), and psychosocial status were analyzed in 261 patients with childhood-onset CP diagnosed before 2000 and longitudinally observed in HIT-Endo. RESULTS: Twenty-year OS was lower (P = .006) in CP with hypothalamic involvement (HI) (n = 132; 0.84 +/- 0.04) when compared with CP without HI (n = 82; 0.95 +/- 0.04). OS was not related to degree of resection, sex, age at diagnosis, or year of diagnosis (before/after 1990). PFS (n = 168; 0.58 +/- 0.05) was lower in younger patients (<5 y at diagnosis) (n = 30; 0.39 +/- 0.10) compared with patients aged 5-10 years (n = 66; 0.52 +/- 0.08) and older than 10 years (n = 72; 0.77 +/- 0.06) at diagnosis. PFS was not associated with HI, degree of resection, or sex. HI led to severe weight gain during the first 8-12 years of follow-up (median BMI increase: +4.59SD) compared with no HI (median increase: +1.20SD) (P = .00). During >12 years of follow-up, patients with HI presented no further increase in BMI. QoL in CP patients with HI was impaired by obesity, physical fatigue, reduced motivation, dyspnea, diarrhea, and nonoptimal psychosocial development. CONCLUSIONS: OS and QoL are impaired by HI in long-term survivors of CP. HI is associated with severe obesity, which plateaus after 12 years. OS/PFS are not related to degree of resection, but gross-total resection should be avoided in cases of HI to prevent further hypothalamic damage, which exacerbates sequelae.","Sterkenburg, A. S., et al. (2015). \"Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes.\" Neuro Oncol 17(7): 1029-1038.","Germany",2015,"Various","None","MFI"]
[271,"Sternberg, C. N., et al. (2013). \"Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.\" Ann Oncol 24(4): 1017-1025.",null,"Sternberg, C. N., et al.","Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy","BACKGROUND: Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo and prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients after docetaxel chemotherapy. This is the first phase III study in advanced prostate cancer to evaluate fatigue outcomes using a validated fatigue-specific instrument. PATIENTS AND METHODS: The Brief Fatigue Inventory (BFI) questionnaire was used to measure patient-reported fatigue intensity and fatigue interference with activities of daily life. All analyses were conducted using prespecified responder definitions of clinically meaningful changes. RESULTS: A total of 797 patients were randomized to abiraterone acetate and prednisone, and 398 were randomized to placebo and prednisone. Compared with prednisone alone, in patients with clinically significant fatigue at baseline, abiraterone acetate and prednisone significantly increased the proportion of patients reporting improvement in fatigue intensity (58.1% versus 40.3%, P = 0.0001), improved fatigue interference (55.0% versus 38.0%, P = 0.0075), and accelerated improvement in fatigue intensity (median 59 days versus 194 days, P = 0.0155). CONCLUSIONS: In patients with mCRPC progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient-reported fatigue compared with prednisone alone.","Sternberg, C. N., et al. (2013). \"Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.\" Ann Oncol 24(4): 1017-1025.","Italy",2013,"Cancer","Other Drugs","BFI"]
[272,"Stobaus, N., et al. (2015). \"Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy.\" Nutr Cancer 67(5): 818-824.",null,"Stobaus, N., et al.","Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy","Cancer patients, in general, suffer from anorexia hence diminished nutritional intake. In a prospective observational study, we investigated the impact of recent energy and protein intake on cancer-related fatigue and 6-month mortality in patients undergoing chemotherapy. Recent protein and energy intake was assessed by 24-h recall in 285 patients. Cancer-related fatigue was determined by Brief Fatigue Inventory, and fat free mass index (FFMI) was assessed with bioelectrical impedance analysis. Symptoms with the validated German version of European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (30 questions) and 6-month mortality was documented. Risk factors of cancer-related fatigue and predictors of mortality were investigated with logistic regression analysis and stepwise Cox regression analysis, respectively. Low protein intake (<1 g/kg body weight) was found in 66% of patients, who were characterized by higher age, weight, and body mass index. Recent protein intake emerged as the strongest contributor to cancer-related fatigue followed by nausea/vomiting, insomnia, and age. Reduced protein intake, male sex, number of comorbidities, and FFMI were identified as significant predictors for increased 6-month mortality. In conclusion, a low recent protein intake assessed by 24-h recall is associated with a more than twofold higher risk of cancer-related fatigue and 6-month mortality. Every effort should be taken to assess and guarantee proper nutritional intake in patients undergoing chemotherapy.","Stobaus, N., et al. (2015). \"Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy.\" Nutr Cancer 67(5): 818-824.","Germany",2015,"Cancer","None","BFI"]
[273,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.","UK",2001,"Cancer","Cancer treatments","Bidimensional Fatigue Scale,FSS"]
[274,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.","UK",2001,"Cancer","Cancer treatments","FSS,Bidimensional Fatigue Scale"]
[275,"Strand, V., et al. (2012). \"Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.\" Rheumatology (Oxford) 51(10): 1860-1869.",null,"Strand, V., et al.","Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study","OBJECTIVE: To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis). METHODS: In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed. RESULTS: At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P=0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P<0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P=0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P=0.0100), HAQ-DI (P=0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9-84.9% vs 35.0-51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2-51.2% vs 10-20.7% and 10.7-37.5% vs 0.0-3.4%, respectively). CONCLUSION: Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports. Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522.","Strand, V., et al. (2012). \"Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.\" Rheumatology (Oxford) 51(10): 1860-1869.","USA",2012,"Musculoskeletal","Tocilizumab","FACIT-F"]
[276,"Strand, V., et al. (2015). \"Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial.\" Arthritis Care Res (Hoboken) 67(4): 475-483.",null,"Strand, V., et al.","Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial","OBJECTIVE: To assess patient-reported outcomes (PROs) for tofacitinib, an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA), in a 6-month, phase III, randomized controlled trial. METHODS: Patients ages >/=18 years with active RA with an inadequate response to >/=1 tumor necrosis factor inhibitor (TNFi) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily, or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3. PROs measured at month 3 included patient global assessment of disease activity (PtGA), pain, Health Assessment Questionnaire (HAQ) disability index (DI), Medical Outcomes Study (MOS) Short Form 36 Health Survey version 2 (SF-36v2; acute), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and MOS Sleep Scale. RESULTS: Patients received tofacitinib 5 mg (n = 133) or 10 mg (n = 134) or placebo advanced to tofacitinib 5 mg (n = 66) or 10 mg (n = 66). HAQ DI (reported previously), PtGA (P < 0.0001), and SF-36v2 physical and mental component summary (P < 0.05) scores were improved for both tofacitinib doses versus placebo. Furthermore, improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib-treated patients versus placebo for PtGA (P < 0.05), pain (P < 0.0001), HAQ DI (P < 0.05), SF-36v2 physical and mental component summary scores (P < 0.05), and FACIT-F (P < 0.001 for 5 mg twice daily). No statistical differences were observed in the MOS Sleep Scale. CONCLUSION: Tofacitinib treatment resulted in significant, clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi.","Strand, V., et al. (2015). \"Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial.\" Arthritis Care Res (Hoboken) 67(4): 475-483.","USA",2015,"Musculoskeletal","Tofactinib","FACIT-F"]
[277,"Strand, V., et al. (2016). \"Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial.\" Arthritis Res Ther 18: 198.",null,"Strand, V., et al.","Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial","BACKGROUND: Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR). These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT. METHODS: Patients (n = 1197) were randomized to receive placebo, sarilumab 150 or 200 mg subcutaneously + MTX every 2 weeks for 52 weeks; after 16 weeks, patients without >/=20 % improvement from baseline in swollen or tender joint counts on two consecutive assessments were offered open-label treatment. PROs included patient global assessment of disease activity (PtGA), pain, health assessment questionnaire disability index (HAQ-DI), Short Form-36 Health Survey (SF-36), and functional assessment of chronic illness therapy-fatigue (FACIT-F). Changes from baseline at weeks 24 and 52 were analyzed using a mixed model for repeated measures. Post hoc analyses included percentages of patients reporting improvements equal to or greater than minimal clinically important differences (MCID) and normative values in the FACIT-F and SF-36. Pearson correlation between observed PRO scores and clinical measures of disease activity was tested at week 24. RESULTS: Both doses of sarilumab + MTX vs placebo + MTX resulted in improvement from baseline by week 24 in PtGA, pain, HAQ-DI, SF-36 and FACIT-F scores (p < 0.0001) that was clinically meaningful, and persisted until week 52. In post hoc analyses, the percentages of patients with improvement equal to or greater than the MCID across all PROs were greater with sarilumab than placebo (p < 0.05), with differences ranging from 11.6 to 26.2 %, as were those reporting equal to or greater than normative scores. CONCLUSIONS: In this RCT in patients with MTX-IR RA, sarilumab + MTX resulted in sustained improvement in PROs that were clinically meaningful, greater than placebo + MTX, and complement the previously reported clinical efficacy and safety of sarilumab. TRIAL REGISTRATION: ClinicalTrials.gov. NCT01061736 . February 2, 2010.","Strand, V., et al. (2016). \"Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial.\" Arthritis Res Ther 18: 198.","USA",2016,"Musculoskeletal","Sarilumab","FACIT-F"]
[278,"Strand, V., et al. (2014). \"Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.\" Health Qual Life Outcomes 12: 31.",null,"Strand, V., et al.","Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds","BACKGROUND: The primary aim of rheumatoid arthritis (RA) treatment is to induce remission, the absence of disease activity. The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life, fatigue, and physical function in RA patients treated with secukinumab in a phase 2 randomized controlled trial (RCT). METHOD: Adult RA patients (n = 237) with incomplete responses to methotrexate were randomized equally to receive monthly s.c. injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score. Patient-reported outcomes (PRO) included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study Short Form-36 [SF-36] Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint. Definitions of minimal important differences [MID] in each clinical endpoint were used to categorize patients, as well as thresholds beyond MID. Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint. Analyses were limited to patients randomized to secukinumab treatment. All dose groups were combined (n = 187). RESULTS: Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction. With few exceptions, there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinically meaningful. More importantly, results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL, fatigue, and physical function. CONCLUSION: Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures.","Strand, V., et al. (2014). \"Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.\" Health Qual Life Outcomes 12: 31.","USA",2014,"Musculoskeletal","Secukinumab","FACIT-F"]
[279,"Strand, V., et al. (2015). \"Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.\" Arthritis Res Ther 17: 307.",null,"Strand, V., et al.","Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs","INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. METHOD: In this 6-month, phase 3, randomized, placebo-controlled trial, 611 patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR) were randomized 4:4:1:1 to receive: tofacitinib 5 mg BID or tofacitinib 10 mg BID for the duration of the study, or placebo for 3 months followed by tofacitinib 5 mg BID or tofacitinib 10 mg BID. Patient-reported outcomes (PROs) included: Patient Global Assessment of Disease Activity (PtGA); Patient Assessment of Pain (Pain); Health Assessment Questionnaire-Disability Index (HAQ-DI); Medical Outcomes Survey (MOS) Short Form-36 (SF-36); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and MOS Sleep Scale. Time-to-event data (PtGA and Pain) were collected using an interactive voice response system daily diary (baseline through day 14). RESULTS: At month 3, tofacitinib 5 and 10 mg BID demonstrated statistically significant improvements versus placebo in PtGA (both p < 0.0001), Pain (both p < 0.0001), HAQ-DI (both p < 0.0001), SF-36 Physical (p < 0.0001) and Mental (p < 0.05 [5 mg BID] and p < 0.0001 [10 mg BID]), Component Summary scores and all domain scores (p < 0.05-p < 0.0001) and FACIT-F (both p < 0.0001). Statistically significant changes from baseline in MOS Sleep Scale were reported for 10 mg BID (p < 0.05). Benefits of tofacitinib treatment were rapid in onset and significant improvements were reported at week 2 for PtGA, Pain and HAQ-DI, and differentiation from baseline was seen as early as 3 days after treatment initiation for interactive voice response system (IVRS) PtGA and IVRS Pain. The numbers needed to treat for patients to report changes greater than or equal to the minimum clinically important difference in PtGA, Pain, HAQ-DI, SF-36 Physical Component Summary score and FACIT-F ranged between 4.0-6.1 (5 mg BID) and 3.2-5.0 (10 mg BID). CONCLUSION: Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months. TRIAL REGISTRATION: Clinicaltrials.gov registration NCT00814307 , registered 22 December 2008.","Strand, V., et al. (2015). \"Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.\" Arthritis Res Ther 17: 307.","USA",2015,"Musculoskeletal","Tofactinib","FACIT-F"]
[280,"Strand, V., et al. (2017). \"Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.\" Arthritis Care Res (Hoboken) 69(4): 592-598.",null,"Strand, V., et al.","Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial","OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). METHODS: In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with >/=1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). RESULTS: At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). CONCLUSION: Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo.","Strand, V., et al. (2017). \"Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.\" Arthritis Care Res (Hoboken) 69(4): 592-598.","USA",2017,"Musculoskeletal","Tofactinib","FACIT-F"]
[281,"Strand, V., et al. (2014). \"Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.\" Ann Rheum Dis 73(5): 838-844.",null,"Strand, V., et al.","Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials","OBJECTIVE: Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE. METHODS: Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks' duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D. RESULTS: Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses. CONCLUSIONS: The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials. CLINICALTRIALSGOV NUMBER: NCT00424476, NCT00410384.","Strand, V., et al. (2014). \"Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.\" Ann Rheum Dis 73(5): 838-844.","USA",2014,"Inflamatory Systemic Disease","Belimumab","FACIT-F"]
[282,"Strand, V., et al. (2012). \"Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study.\" J Rheumatol 39(1): 63-72.",null,"Strand, V., et al.","Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study","OBJECTIVE: Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA. METHODS: PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged >/= 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient's global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3). RESULTS: Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p <0.0001), vitality (p = 0.0139), role limitations-physical (p = 0.0005)], SF-6D (p = 0.0152), VAS-PtGA (p < 0.0001), VAS-pain (p < 0.0001), FACIT-F (p < 0.0001), and HUI-3 (p = 0.0034) scores versus patients treated with MTX monotherapy. Both SF-6D and HUI-3 were found to be sensitive preference-based measures for assessing the effects of treatment on multidimensional function. No clinically meaningful differences between adalimumab and MTX monotherapy groups were observed for most measures. For each measure, there was significant association between HRQOL improvement and ACR clinical response. CONCLUSION: Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).","Strand, V., et al. (2012). \"Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study.\" J Rheumatol 39(1): 63-72.","USA",2012,"Musculoskeletal","Adalimumab","FACIT-F"]
[283,"Strand, V., et al. (2013). \"Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study.\" J Rheumatol 40(7): 1158-1165.",null,"Strand, V., et al.","Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study","OBJECTIVE: Apremilast, a specific inhibitor of phosphodiesterase 4, modulates proinflammatory and antiinflammatory cytokine production. A phase IIb randomized, controlled trial (RCT) evaluated the effect of apremilast on patient-reported outcomes (PRO) in psoriatic arthritis (PsA). METHODS: In this 12-week RCT, patients with active disease (duration > 6 mo, >/= 3 swollen and >/= 3 tender joints) received apremilast (20 mg BID or 40 mg QD) or placebo. PRO included pain and global assessment of disease activity [visual analog scale (VAS)], Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Medical Outcomes Study Short-Form 36 Health Survey (SF-36) assessing health-related quality of life (HRQOL). Percentages of patients reporting improvements >/= minimum clinically important differences (MCID) and correlations between SF-36 domains and pain VAS, HAQ-DI, and FACIT-F were determined. RESULTS: Among the 204 randomized patients (52.5% men; mean age 50.6 yrs), baseline SF-36 scores reflected large impairments in HRQOL. Apremilast 20 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively, compared with no change/deterioration in placebo group. Patients receiving apremilast 20 mg BID and 40 mg QD reported significant improvements >/= MCID in global VAS scores and FACIT-F versus placebo, and significant improvements in pain VAS scores. Moderate-high, significant correlations were evident between SF-36 domains and other PRO. CONCLUSION: Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores.","Strand, V., et al. (2013). \"Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study.\" J Rheumatol 40(7): 1158-1165.","USA",2013,"Musculoskeletal","Other Drugs","FACIT-F,VAS-F"]
[284,"Strand, V., et al. (2016). \"Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.\" Rheumatology (Oxford) 55(6): 1031-1041.",null,"Strand, V., et al.","Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis","OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.","Strand, V., et al. (2016). \"Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.\" Rheumatology (Oxford) 55(6): 1031-1041.","Sweden,Korea,USA",2016,"Musculoskeletal","Tofactinib,Adalimumab","FACIT-F"]
[285,"Straudi, S., et al. (2016). \"The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial.\" Mult Scler 22(3): 373-384.",null,"Straudi, S., et al.","The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial","BACKGROUND: Gait and mobility impairments are common in progressive multiple sclerosis (MS), leading to reduced quality of life (QoL). OBJECTIVE: In this randomized controlled study, we tested the effects of robot-assisted gait training (RAGT) and compared it to conventional physiotherapy, measuring walking ability, depression, fatigue, and QoL in patients with progressive MS and severe gait disability. METHODS: Fifty-two participants (Expanded Disability Status Scale score 6-7) completed the study protocol. They received two sessions/week over 6 weeks of RAGT or conventional walking therapy. Outcome measures were Six-Minute Walk Test, Ten-Meter Walk Test, Timed Up and Go Test, Berg Balance Scale, Fatigue Severity Scale, Patient Health Questionnaire, and Short Form 36. They were performed pre-treatment, post-treatment, and at 3 months. RESULTS: Walking endurance (p < 0.01) and balance (p < 0.01) were improved among those in the RAGT group. Positive effects on depression in both treatment groups were highlighted. However, only among those in the RAGT group was perceived physical functioning QoL increased. No significant effects on fatigue were found. CONCLUSION: RAGT is a treatment option in progressive MS patients with severe gait impairments to induce short-lasting effects on mobility and QoL.","Straudi, S., et al. (2016). \"The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial.\" Mult Scler 22(3): 373-384.","Italy",2016,"Neurological","Psychobehavioural","FSS"]
[286,"Straudi, S., et al. (2014). \"A task-oriented circuit training in multiple sclerosis: a feasibility study.\" BMC Neurol 14: 124.",null,"Straudi, S., et al.","A task-oriented circuit training in multiple sclerosis: a feasibility study","BACKGROUND: The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training (TOCT) in a sample of multiple sclerosis (MS) subjects on walking competency, mobility, fatigue and health-related quality of life (HRQoL). METHODS: 24 MS subjects (EDSS 4.89 +/- 0.54, 17 female and 7 male, 52.58 +/- 11.21 years, MS duration 15.21 +/- 8.68 years) have been enrolled and randomly assigned to 2 treatment groups: (i) experimental group received 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group did not receive any specific rehabilitation intervention. A feasibility patient-reported questionnaire was administered after TOCT. Functional outcome measures were: walking endurance (Six Minute Walk Test), gait speed (10 Meter Walk Test), mobility (Timed Up and Go test) and balance (Dynamic Gait Index). Furthermore, self-reported questionnaire of motor fatigue (Fatigue Severity Scale), walking ability (Multiple Sclerosis Walking Scale - 12) and health-related quality of life (Multiple Sclerosis Impact Scale - 29) were included. Subjects' assessments were delivered at baseline (T0), after TOCT (T1) and 3 months of home-based exercise program (T2). RESULTS: After TOCT subjects reported a positive global rating on the received treatment. At 3 months, we found a 58.33% of adherence to the home-exercise program. After TOCT, walking ability and health-related quality of life were improved (p < 0.05) with minor retention after 3 months. The control group showed no significant changes in any variables. CONCLUSIONS: This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments; moreover it might improve walking abilities. TRIAL REGISTRATION: NCT01464749.","Straudi, S., et al. (2014). \"A task-oriented circuit training in multiple sclerosis: a feasibility study.\" BMC Neurol 14: 124.","Italy",2014,"Neurological","Psychobehavioural","FSS"]
[287,"Strickland, G., et al. (2012). \"Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools.\" Clin Rheumatol 31(8): 1215-1222.",null,"Strickland, G., et al.","Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools","This study evaluates predictors of health-related quality of life (HRQoL) and fatigue in systemic sclerosis (SSc) using two novel self-report indices. A cross-sectional study of patients with SSc was undertaken using a postal questionnaire including the EuroQol-5Domain health questionnaire (EQ-5D), Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F) and the Scleroderma Health Assessment Questionnaire (SHAQ). The EQ-5D assesses five domains of health quality and is quantified as a time trade-off (TTO) value and patient global assessment (0-100 visual analogue scale [VAS]). The FACIT-F is a 13-item questionnaire (0-52 scale). Higher scores for both the EQ-5D and FACIT-F indicate better health. Case notes were scrutinised for patient demographics, disease duration, serology and clinical phenotype. Sixty-eight patients (60 females, mean age 62.6 years) completed the questionnaires. Fatigue correlated closely with HRQoL (r (s) = 0.78 and 0.77 for FACIT-F vs. EQ-5D VAS and TTO respectively, p < 0.01) and disability (r (s) = -0.74 for FACIT-F vs. HAQ-DI, p < 0.01). Pain was the most frequently reported health problem (80 %) in the EQ-5D. HRQoL also correlated closely with disability (r (s) = 0.83 for EQ-5D vs. HAQ-DI, p < 0.01). SHAQ-VAS scores correlated well with the FACIT-F, EQ-5D and HAQ-DI scores (p < 0.05 for all comparisons). Of the patient demographics and clinical disease associations, only the absence of upper gastrointestinal complications was associated with better levels of fatigue, HRQoL and function. There is a strong correlation between disability, fatigue and HRQoL measured using self-reports, possibly reflecting similarly perceived health beliefs amongst patients across outcomes. There was little association between self-report indices and patient demographics and/or clinical phenotype.","Strickland, G., et al. (2012). \"Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools.\" Clin Rheumatol 31(8): 1215-1222.","UK",2012,"Inflamatory Systemic Disease","None","FACIT-F"]
[288,"Suzuki, Y., et al. (2008). \"Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy.\" Jpn J Clin Oncol 38(3): 214-221.",null,"Suzuki, Y., et al.","Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy","OBJECTIVE: This study was aimed at investigating the effectiveness and safety of once-weekly epoetin beta for anaemic cancer patients receiving chemotherapy. METHODS: A total of 104 patients with a haemoglobin level of </=11.0 g/dL were enrolled. Patients received a once-weekly subcutaneous dose of 36 000 IU epoetin beta for 12 weeks. If the increase in the haemoglobin level was <1.0 g/dL after 6 weeks, or a red blood cell transfusion was required between days 15 and 42, the dose of epoetin beta was increased to 54 000 IU from the subsequent week. The primary endpoint was the percentage of patients who achieved a haemoglobin increase of >/=2.0 g/dL; the haemoglobin response rate. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anaemia (FACT-An) questionnaire. RESULTS: The haemoglobin response rate was 66.3% among the 98 patients (breast cancer: n = 25; malignant lymphoma: n = 21; ovarian cancer: n = 20; lung cancer: n = 15; other cancers: n = 17) assessable for a haemoglobin response. Thirty-nine patients (39.8%) required a dose escalation to 54 000 IU. At the end of the study, QOL assessable patients (n = 96) showed a mean improvement in the FACT-An total fatigue subscale score (FSS) of 0.3 points from baseline. Patients with a haemoglobin response had a mean change in the total FSS of +3.2, compared with -3.4 for patients without a haemoglobin response. No serious adverse event of epoetin beta was observed. CONCLUSIONS: Epoetin beta administered at an initial dose of 36 000 IU once-weekly was well tolerated, with increased haemoglobin levels and improved QOL in anaemic cancer patients receiving myelosuppressive chemotherapy.","Suzuki, Y., et al. (2008). \"Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy.\" Jpn J Clin Oncol 38(3): 214-221.","Japan",2008,"Cancer","Cancer treatments","FSS"]
[289,"Svenningsson, A., et al. (2013). \"Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.\" PLoS One 8(3): e58643.",null,"Svenningsson, A., et al.","Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting","Fatigue is a significant symptom in multiple sclerosis (MS) patients. First-generation disease modifying therapies (DMTs) are at best moderately effective to improve fatigue. Observations from small cohorts have indicated that natalizumab, an antibody targeting VLA-4, may reduce MS-related fatigue. The TYNERGY study aimed to further evaluate the effects of natalizumab treatment on MS-related fatigue. In this one-armed clinical trial including 195 MS patients, natalizumab was prescribed in a real-life setting, and a validated questionnaire, the Fatigue Scale for Motor and Cognitive functions (FSMC), was used both before and after 12 months of treatment to evaluate a possible change in the fatigue experienced by the patients. In the treated cohort all measured variables, that is, fatigue score, quality of life, sleepiness, depression, cognition, and disability progression were improved from baseline (all p values<0.0001). Walking speed as measured by the six-minute walk-test also increased at month 12 (p = 0.0016). All patients were aware of the nature of the treatment agent, and of the study outcomes. CONCLUSION: Natalizumab, as used in a real-life setting, might improve MS-related fatigue based on the results from this one-armed un-controlled stud. Also other parameters related to patients' quality of life seemed to improve with natalizumab treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT00884481.","Svenningsson, A., et al. (2013). \"Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.\" PLoS One 8(3): e58643.","Sweden",2013,"Neurological","Natalizumab","Fatigue Scale for Motor and Cognitive functions"]
[290,"Takemoto, M. L., et al. (2015). \"Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study.\" Health Qual Life Outcomes 13: 119.",null,"Takemoto, M. L., et al.","Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study","BACKGROUND: Multiple sclerosis (MS) is a chronic disease associated with several impacts; especially regarding patients' health-related quality of life (HRQL). EuroQol 5 Dimensions questionnaire (EQ-5D) provides self-reported analysis of HRQL and utility scores. Although the British algorithm to convert EQ-5D responses into utility is the most used in the literature, national settings is more appropriate for health policy decision makers. A Brazilian algorithm is available, but not used in MS patients yet. Primarily, this study aimed to address potential differences in utility scores obtained through Brazilian and British value sets. Secondary objective was to determine the role of disability, fatigue and patients socio-demographic and clinical characteristics relevant to MS on the utility scores reported by Brazilian patients. METHODS: Cross-sectional study with MS patients treated in 8 Brazilian sites. Patients were interviewed about socio-demographic and clinical characteristics, self-reported disability level, HRQL and impact of fatigue on daily living. Disability level, HRQL and impact of fatigue were assessed using the Expanded Disability Status Scale (EDSS) and the Brazilian versions of EQ-5D-3 L and Modified Fatigue Impact Scale (MFIS-BR), respectively. Patients were classified in subgroups according to EDSS (mild: 0-3; moderate: 4-6.5; severe: >7) and the self-perceived impact of fatigue (absent: </= 38 points; low: 39-58; high: >/= 59). EQ-5D-3 L data was converted into a utility index using an algorithm developed by a Brazilian research group (QALY Brazil) and also the UK algorithm. Differences between utility scores were analysed through Wilcoxon test. RESULTS: Two hundred and ten patients were included in the study. Utility index mean scores of 0.59 (SD = 0.22) and 0.56 (SD = 0.32) for the Brazilian and UK algorithms were observed, respectively, without statistically significant difference for the distribution of data (p = 0.586). However, when utility scores were lower than 0.5, Brazilian algorithm provided higher estimates than UK with a better agreement between the scores found closer to 1. The same trend was observed when data was stratified for EDSS and impact of fatigue, with statistically significant difference between scores in categories of mild/severe disabilities and absent/high impact of fatigue. CONCLUSIONS: Results suggest that Brazilian value set provided higher utility scores than the UK, particularly for measures below 0.5.","Takemoto, M. L., et al. (2015). \"Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study.\" Health Qual Life Outcomes 13: 119.","Brazil",2015,"Neurological","None","MFI"]
[291,"Tang, S., et al. (2004). \"Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia.\" Rheumatology (Oxford) 43(5): 609-614.",null,"Tang, S., et al.","Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia","OBJECTIVE: Fibromyalgia (FM) is a major determinant of poor health status in systemic lupus erythematosus (SLE). FM has been shown to be associated with neurally mediated hypotension (NMH) in the general population, in which effective treatments exist. We explored whether NMH was more common in SLE patients with FM than those without. METHODS: Seventy-six SLE patients (4 male, 72 female; 1 ethnic Indian, 28 African American, 47 Caucasian; mean age 40.2 +/- 9.4 yr) were recruited and their FM status ascertained using American College of Rheumatology (ACR) classification criteria. Patients who were pregnant or deconditioned were excluded. A two-stage tilt-table test was used to detect NMH. All patients completed the SF-36 Heath Status Inventory (SF-36) and the Krupp Fatigue Severity Scale (KFSS) to evaluate their quality of life. Serological markers and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) were recorded. Medications that might interfere with testing were temporarily withheld before the tilt-table test. RESULTS: The prevalence of NMH (first stage) in SLE patients was 47.9%. Seven patients had both NMH and postural orthostatic tachycardia syndrome. Two patients had borderline results with symptoms reproduced but an inadequate drop in systolic blood pressure by definition (a drop of at least 25 mmHg defines an abnormal response). Eighteen (23.7%) SLE patients had FM and 51 (67.1%) had at least one tender point (TP). The frequency of NMH (first or second stage) in SLE with FM was 58.3% compared with 69.4% in SLE without FM (odds ratio 0.62, 95% CI 0.16-2.37). SF-36 and KFSS scores were not significantly different in SLE patients with and without NMH. However, both scores were found to be associated with FM status (P<0.001 and P = 0.014), reflecting poor health status in the FM group. No confounding variable was found to be significantly associated with both NMH and FM. CONCLUSION: NMH is common in SLE patients with a high prevalence rate. The large increase in NMH, a form of autonomic neuropathy, in SLE, has not been explained. However, NMH has no impact on quality of life above that determined by FM, and has no statistically significant association with FM status. Identification of NMH may be important in selected patients with SLE who have chronic fatigue, but NMH cannot explain the increased prevalence of FM in SLE.","Tang, S., et al. (2004). \"Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia.\" Rheumatology (Oxford) 43(5): 609-614.","China",2004,"Inflamatory Systemic Disease","None","KFSS"]
[292,"ter Borg, P. C., et al. (2004). \"Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634].\" BMC Gastroenterol 4: 13.",null,"ter Borg, P. C., et al.","Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634]","BACKGROUND: Fatigue is a major clinical problem in many patients with primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). An effective treatment has not been defined. Recently, a large proportion of patients with these diseases was found to have symptoms of depression. Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia, we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC. METHODS: Fatigued patients were randomised to receive fluvoxamine (75 mg BID) or placebo for a six-week period. Fatigue and quality of life were quantified using a visual analogue scale, the Fisk Fatigue Severity Scale, the Multidimensional Fatigue Inventory and the SF-36. RESULTS: Seventeen and 16 patients were allocated to fluvoxamine and placebo, respectively. There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life. The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0, 6.9 and 7.15 at day 14, 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation. CONCLUSION: We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.","ter Borg, P. C., et al. (2004). \"Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634].\" BMC Gastroenterol 4: 13.","Netherlands",2004,"Liver Disease","Other Drugs","Fisk Fatigue Severity Scale,VAS-F,MFI"]
[293,"Teuber, G., et al. (2008). \"Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis.\" J Hepatol 49(6): 923-929.",null,"Teuber, G., et al.","Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis","BACKGROUND/AIMS: Health-related quality of life (HRQoL) is impaired in patients with chronic hepatitis C. We investigated HRQoL and fatigue in patients with chronic hepatitis C virus (HCV) infection in relation to the degree of fibrosis and inflammation, and controlled for the influence of relevant demographic and medical variables. METHODS: We conducted a cross-sectional two-center study including 215 outpatients with chronic hepatitis C applying the Short-Form Health Survey (SF-36) and the Fatigue Impact Scale (FIS-D). The contribution to the variability of these psychometric scores was evaluated for the degree of fibrosis as well as viremia, gender, age, mode of transmission, genotype, and ALT. RESULTS: There was a strong negative association between the degree of liver fibrosis and the physical SF-36 summary score (p=0.016). This was independent of the covariate age, also significantly predicting physical HRQoL (p=0.001). The absolute FIS score was significantly increased in patients with advanced fibrosis (p=0.043). In females, mental SF-36 summary score (p=0.007) and fatigue (p=0.017) were significantly more impaired. CONCLUSIONS: Our study suggests a significant association of physical aspects of HRQoL and fatigue with the extent of fibrosis. Fibrosis stage should be considered for the identification and management of HCV patients at risk for reduced physical HRQoL.","Teuber, G., et al. (2008). \"Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis.\" J Hepatol 49(6): 923-929.","Germany",2008,"Inflamatory Systemic Disease","None","FIS"]
[294,"Thaci, D., et al. (2014). \"Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial.\" J Eur Acad Dermatol Venereol 28(7): 900-906.",null,"Thaci, D., et al.","Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial","BACKGROUND: Impaired sleep in patients with moderate-to-severe psoriasis and improvement on therapy has not been widely studied. OBJECTIVE: Quantify baseline aspects of sleep and improvement in patients with psoriasis receiving etanercept (ETN) when allowed concomitant topical medications (PRISTINE study). METHODS: Patients with moderate-to-severe psoriasis were randomized to 50 mg ETN once weekly (QW/QW) or 50 mg ETN twice weekly (BIW/QW) for weeks 1-12, followed by 50 mg QW for weeks 13-24; a broad range of topical therapies were permitted during weeks 13-24. Sleep impairment was measured by the Medical Outcomes Study (MOS) sleep questionnaire Index II (population norm = 25.8; minimum clinically important difference = 5.1); quality of life (QoL) measures included Dermatology Life Quality Index (DLQI), EuroQoL 5 Dimension (EQ-5D) Utility Index and Visual Analogue Scale (VAS) and Functional Activity in Chronic Therapy-Fatigue (FACIT-Fatigue). ancova and Fisher's exact test or chi-squared tests were used for between-group testing. RESULTS: Mean baseline MOS-Sleep scores were 34.0 for both groups indicating impairment (N = 270; QW/QW n = 137; BIW/QW n = 133, approximately 64% had impaired sleep). At week 12 of treatment, MOS-Sleep scores improved to 30.8 and 30.1, and at week 24, to 28.4 and 28.2 respectively. Poor sleep was significantly associated with clinically important problems in EQ-5D utility, VAS and FACIT-Fatigue; sleep improvement was associated with improved EQ-5D utility and FACIT-Fatigue (P < 0.001). CONCLUSION: This study confirms that most patients with moderate-to-severe psoriasis have impaired sleep which is associated with impaired QoL. Treatment with etanercept significantly improved sleep, with most improvement occurring before a broad range of topicals were allowed. Sleep improvement was associated with improved QoL.","Thaci, D., et al. (2014). \"Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial.\" J Eur Acad Dermatol Venereol 28(7): 900-906.","Germany",2014,"Inflamatory Systemic Disease","Etanercept","VAS-F,FACIT-F"]
[295,"Thomas, P. W., et al. (2014). \"One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.\" BMC Neurol 14: 109.",null,"Thomas, P. W., et al.","One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis","BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. METHODS: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). RESULTS: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. CONCLUSIONS: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. TRIAL REGISTRATION: ISRCTN76517470.","Thomas, P. W., et al. (2014). \"One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.\" BMC Neurol 14: 109.","UK",2014,"Neurological","None","FAI,GFS"]
[296,"Tillmann, H. L., et al. (2011). \"Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment.\" J Viral Hepat 18(4): 252-261.",null,"Tillmann, H. L., et al.","Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment","Little is known comparing and contrasting quality of life (QoL) in patients with hepatitis C, compared to patients with other liver diseases. We performed two independent prospective cross-sectional studies including 511 and 284 patients with different forms of liver diseases. SF-36 was used in both studies. Fatigue Impact Score, WHO-BREF and Hospital Anxiety and Depression Scale (HADS) were used in either study only. In both studies, HCV-positive patients scored worse in the mental aspects of health-related QoL compared to other liver diseases, except for HBV in one study. Surprisingly, in both studies, quality of life was also significantly impaired in patients with viral clearance after interferon therapy but not after spontaneous clearance. Furthermore, patients with primary biliary cirrhosis showed significantly better mental health but significantly worse physical well-being. Liver diseases differ in their form of impaired QoL. In HCV, this impairment might not always return to normal after treatment-induced viral clearance. This may suggest that HCV either may not be involved in QoL impairment or may induce a process which persists after viral clearance in some patients.","Tillmann, H. L., et al. (2011). \"Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment.\" J Viral Hepat 18(4): 252-261.","Germany",2011,"Infectious disease","None","FIS"]
[297,"Trojan, D. A., et al. (2001). \"Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome.\" J Neurol Sci 182(2): 107-115.",null,"Trojan, D. A., et al.","Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome","OBJECTIVES AND BACKGROUND: To determine if serum insulin-like growth factor-I (IGF-I) levels are associated with strength, body mass index (BMI), fatigue, or quality of life in post-poliomyelitis syndrome (PPS). PPS is likely due to a distal disintegration of enlarged post-polio motor units as a result of terminal axonal sprouting. Age-related decline in growth hormone and IGF-I (which support terminal axonal sprouts) is proposed as a contributing factor. METHODS: As part of the North American Post-Poliomyelitis Pyridostigmine Study (NAPPS), baseline data on maximum voluntary isometric contraction (MVIC), BMI, subjective fatigue (fatigue severity scale, Hare fatigue symptom scale), health-related quality of life (short form health survey-36; SF-36), and serum IGF-I levels were gathered on 112 PPS patients. Pearson correlation coefficients were calculated to evaluate the association between serum IGF-I and MVIC in 12 muscles, BMI, two fatigue scales, and SF-36 scale scores. RESULTS: There is a significant inverse correlation of IGF-I levels with MVIC in left ankle dorsiflexors (r=-0.30, P<0.01), and left and right knee extensors (r=-0.22, -0.25, P=<0.01, 0.01), but no significant correlations in other muscles. When men and women were evaluated separately, inverse correlations of IGF-I levels with MVIC were found only in men. IGF-I correlated inversely with BMI (r=-0.32, P=0006) and age (r=-0.32, P=0.0005). IGF-I did not correlate with the fatigue or SF-36 scales. CONCLUSIONS: In this exploratory study, we found that contrary to our expectations, IGF-I did not correlate positively with strength. IGF-I correlated negatively with strength in several lower extremity muscles, BMI, and age. IGF-I is likely not an important factor in the pathogenesis of fatigue and in determining quality of life in PPS, but its role on strength should be studied further.","Trojan, D. A., et al. (2001). \"Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome.\" J Neurol Sci 182(2): 107-115.","Canada",2001,"Neurological","Various","FSS,Hare Fatigue Symptom scale"]
[298,"Tsuboi, M., et al. (2009). \"Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study.\" Jpn J Clin Oncol 39(3): 163-168.",null,"Tsuboi, M., et al.","Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study","OBJECTIVE: The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. METHODS: One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. RESULTS: Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 +/- 1.9 g/dl versus -0.8 +/- 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level > or =2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94. CONCLUSION: Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.","Tsuboi, M., et al. (2009). \"Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study.\" Jpn J Clin Oncol 39(3): 163-168.","Japan",2009,"Hematological","Cancer treatments","FSS"]
[299,"Turner, J., et al. (2004). \"Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention.\" J Surg Oncol 86(3): 141-146.",null,"Turner, J., et al.","Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention","BACKGROUND AND OBJECTIVES: This pilot project assessed the acceptability of a mixed-type, moderate-intensity exercise programme following breast cancer treatment, and the impact on presence of lymphoedema, fitness, body composition, fatigue, mood and quality of life. METHODS: Ten women completed the programme and measures of fitness (sub-maximal ergometer test), body composition (bio-electrical impedance), lympoedema (bio-electrical impedance and arm circumferences), fatigue (revised Piper Fatigue Scale), mood (Hospital Anxiety and Depression Scale), quality of life (FACT-B) and general well-being, at baseline, completion of the programme, and 6-week and 3-month follow-up. RESULTS: Participation in the programme caused no adverse effect on the presence of lymphoedema. There was a trend towards reduction in fatigue and improved quality of life across the testing phases. Women rated the programme extremely favourably, citing benefits of the support of other women, trained guidance, and the opportunity to experience different types of exercise. CONCLUSIONS: A mixed-type, moderate-intensity exercise program in a group format is acceptable to women following breast cancer treatment, with the potential to reduce fatigue and improve quality of life, without exacerbating or precipitating lymphoedema. This pilot work needs to be confirmed in larger randomised studies.","Turner, J., et al. (2004). \"Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention.\" J Surg Oncol 86(3): 141-146.","Australia",2004,"Cancer","Psychobehavioural","PFS"]
[300,"Twiss, J., et al. (2010). \"Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS).\" Health Qual Life Outcomes 8: 117.",null,"Twiss, J., et al.","Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)","BACKGROUND: The PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of the present study was to validate the measures further in a specifically Relapse Remitting MS (RRMS) sample and to provide preliminary evidence of the responder definitions (RD; also known as minimal important difference) for these instruments. METHODS: Data were derived from a multi-country efficacy trial of MS patients with assessments at baseline and 12 months. Baseline data were used to assess the internal reliability and validity of the measures. Both anchor-based and distribution-based approaches were employed for estimating RD. Anchor-based estimates were based on published RD values for the EQ-5D and were assessed for those improving and deteriorating separately. Distribution-based estimates were based on standard error of measurement (SEM), change score equivalent to 0.30, and change score equivalent to 0.50, effect sizes (ES). RESULTS: The sample included 911 RRMS patients (67.3% female, age mean (SD) 36.2 (8.4) years, duration of MS mean (SD) 4.8 (5.2) years). Results showed that the PRIMUS and U-FIS had good internal consistency. Appropriate correlations were observed with comparator instruments and both measures were able to distinguish between participants based on Expanded Disability Status Scale scores and time since diagnosis. The anchor-based and distribution-based RD estimates were: PRIMUS Activities range = 1.2-2.3, PRIMUS QoL range = 1.0-2.2, and U-FIS range = 2.4-7.0. CONCLUSIONS: The results show that the PRIMUS and U-FIS are valid instruments for use with RRMS patients. The analyses provide preliminary information on how to interpret scores on the scales. These data will be useful for assessing treatment efficacy and for powering clinical studies. TRIAL REFERENCE NUMBER: ClinicalTrials.gov Identifier NCT00340834.","Twiss, J., et al. (2010). \"Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS).\" Health Qual Life Outcomes 8: 117.","UK",2010,"Neurological","None","U-FIS"]
[301,"Unal, G., et al. (2001). \"A psychometric comparison of health-related quality of life measures in chronic liver disease.\" J Clin Epidemiol 54(6): 587-596.",null,"Unal, G., et al.","A psychometric comparison of health-related quality of life measures in chronic liver disease","Four generic [the Sickness Impact Profile (SIP-68), Short-Form Health Survey (SF-36), EuroQol instrument (EQ-5D), COOP/WONCA charts], two domain-specific health-related quality of life measures [the sexuality scale of the HIV Overview Problems Evaluating System (HOPES), Multi-dimensional Fatigue Index (MFI-20)], and a self-developed 12-item symptom index were compared in terms of feasibility, test-retest reliability, internal consistency reliability, construct validity, and known groups validity in patients with chronic liver disease. All instruments could be completed within 10 min and exhibited a good psychometric performance in patients with chronic liver disease. The SF-36 and the MFI-20 performed relatively best in terms of reliability, construct validity, and discriminative ability. The sexuality scale of the HOPES demonstrated a relatively poor performance, as the missing value rate was higher than 5%. Further research is needed into the sensitivity to important clinical changes of the instruments.","Unal, G., et al. (2001). \"A psychometric comparison of health-related quality of life measures in chronic liver disease.\" J Clin Epidemiol 54(6): 587-596.","Netherlands",2001,"Various","None","MFI"]
[302,"Valko, P. O., et al. (2008). \"Validation of the fatigue severity scale in a Swiss cohort.\" Sleep 31(11): 1601-1607.",null,"Valko, P. O., et al.","Validation of the fatigue severity scale in a Swiss cohort","BACKGROUND: Fatigue is highly prevalent and has a negative impact on quality of life and performance in a variety of disorders. The 9-item Fatigue Severity Scale (FSS) is one of the most commonly used self-report questionnaires to measure fatigue, but has only been validated in small sample-sized studies and in single disorders. OBJECTIVE: To validate the FSS in healthy subjects and different disorders known to be commonly associated with fatigue. MATERIAL AND METHODS: The FSS was administered to 454 healthy subjects, 188 patients with multiple sclerosis (MS), 235 patients with recent ischemic stroke, and 429 patients with sleep-wake disorders including narcolepsy with cataplexy (n=22), restless legs syndrome (RLS) (n=79), sleep apnea (n=108), insomnia (n=62), parasomnia (n=25), excessive daytime sleepiness/hypersomnia of other origin (n=84, and other sleep-wake disorders (n=49. RESULTS: FSS scores were 4.66 +/- 1.64 (mean +/- SD) in patients with MS, 3.90 +/- 1.85 in patients after ischemic stroke, and 4.34 +/- 1.64 in patients with sleep-wake disorders. Compared to patients, values were significantly lower in healthy subjects (3.00 +/- 1.08, P < 0.01). Scores did not correlate with gender, age, or education. Item analysis showed an excellent internal consistency and reliability (Cronbach alpha = 0.93). Test-retest variability was assessed in 104 healthy subjects, showing stable values over time (2.94 +/- 0.90 vs. 2.90 +/- 0.74; P = 0.27). CONCLUSIONS: This first validation of a fatigue scale in a large sample size demonstrates that the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.","Valko, P. O., et al. (2008). \"Validation of the fatigue severity scale in a Swiss cohort.\" Sleep 31(11): 1601-1607.","Switzerland",2008,"Neurological,CVD","None","FSS"]
[303,"Vallejo, M. A., et al. (2010). \"Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF).\" Health Qual Life Outcomes 8: 2.",null,"Vallejo, M. A., et al.","Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF)","BACKGROUND: Fibromyalgia is a syndrome with heterogeneous symptoms. The evaluation in the clinical setting usually fails to cover the complexity of the syndrome. This study aims to determine how different aspects of fibromyalgia are inter-related when measured by means of a self-reporting tool. The objective is to develop a more complete evaluation model adjusted to the complexity and multi-dimensional nature of the syndrome. METHODS: Application was made of the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory, the Fatigue Assessment Scale, the Health Assessment Questionnaire, the General Health Questionnaire (GHQ-28), the Chronic Pain Coping Inventory, the Arthritis Self-efficacy Scale and the Sleep Quality Scale. An assessment was made, on the basis of clinical interviews, case histories and specific tests, of the patient sociodemographic data, comorbidity, physical exploration and other clinical indexes. An exploratory factor analysis was made, with comparisons of the clinical index scores in extreme groups of patients. RESULTS: The ICAF composed of 59 items was obtained, offering four factors that explain 64% of the variance, and referred to as Emotional Factor (33.7%), Physical-Activity (15%), Active Coping (9%) and Passive Coping (6.3%). A t-test between the extreme scores of these factors in the 301 patients revealed statistically significant differences in occupational status, medically unexplained syndromes, number of tender points, the six-minutes walk test, comorbidity and health care costs. CONCLUSIONS: This study offers a tool allowing more complete and rapid evaluation of patients with fibromyalgia. The test intrinsically evaluates the emotional aspects: anxiety and depression, and their impact upon social aspects. It also evaluates patient functional capacity, fatigue, sleep quality, pain, and the way in which the patient copes with the disease. This is achieved by means of a self-assessment questionnaire based on elements from well known tests.","Vallejo, M. A., et al. (2010). \"Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF).\" Health Qual Life Outcomes 8: 2.","Spain",2010,"Musculoskeletal","None","FAS"]
[304,"van Aken, M. O., et al. (2005). \"Quality of life in patients after long-term biochemical cure of Cushing's disease.\" J Clin Endocrinol Metab 90(6): 3279-3286.",null,"van Aken, M. O., et al.","Quality of life in patients after long-term biochemical cure of Cushing's disease","To evaluate the long-term impact of cured Cushing's disease on subjective well-being, we assessed quality of life by validated health-related questionnaires in 58 patients cured from Cushing's disease by transsphenoidal surgery (n = 58), some of whom received additional radiotherapy (n = 11) and/or bilateral adrenalectomy (n = 3). The mean duration of remission was 13.4 +/- 6.7 yr (range of 2-25 yr). Patient data were compared with a control group of 98 healthy subjects with the same age and sex distribution and with age-adjusted reference values available from the literature. General perceived well-being, measured by the Nottingham Health Profile and the Short Form, was reduced compared with controls for all subscales (P < 0.001). Patients with Cushing's disease had worse scores on subscales of fatigue Multidimensional Fatigue Index and anxiety and depression (Hospital Anxiety and Depression Scale). Compared with reference values from the literature, quality of life was also reduced in the patients according to all questionnaires and all items, except pain (Short Form), sleep (Nottingham Health Profile), and reduced activity (Multidimensional Fatigue Index). Despite conventional hormone replacement therapy, hypopituitarism was an important independent predictor of reduced quality of life. Patients without hypopituitarism (n = 28) showed reduced scores on physical items but normal scores on mental items compared with controls. In conclusion, despite long-term cure of Cushing's disease, patients experience a considerable decrease in quality of life, with physical and psychosocial impairments, especially in the presence of hypopituitarism.","van Aken, M. O., et al. (2005). \"Quality of life in patients after long-term biochemical cure of Cushing's disease.\" J Clin Endocrinol Metab 90(6): 3279-3286.","Netherlands",2005,"Endocrine","Surgery","MFI"]
[305,"Van Breugel, H. N., et al. (2010). \"A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery.\" J Cardiovasc Electrophysiol 21(5): 511-520.",null,"Van Breugel, H. N., et al.","A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery","INTRODUCTION: This is a multicenter, prospective, randomized controlled trial to determine the effect of add-on arrhythmia surgery on health-related quality of life during 1-year follow-up of cardiac surgery patients with atrial fibrillation. METHODS: 150 patients with documented atrial fibrillation were randomly assigned to undergo cardiac surgery with or without add-on surgery. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6, and 12 months following operation. RESULTS: 132 patients completed the questionnaires at a minimum of one time-point during follow-up. At baseline patient characteristics, operative data and health-related quality of life were comparable. At 12-month follow-up 62 patients were free of atrial fibrillation without significant differences between groups (P = 0.28). Conversion to SR occurred in 69.8% (37/53) of patients with paroxysmal AF, in 28.2% (11/39) of patients with permanent AF and in 44.4% (12/27) of patients in persistent AF. Cardiac surgery in general resulted in an overall improvement of the RAND SF-36 and the MFI-20. However, the EQ-5D showed a significant deterioration in the subscale Pain/Discomfort for both groups (P < 0.001), with a significant worse outcome for the control group (P = 0.006). CONCLUSIONS: Health-related quality of life in patients with paroxysmal, permanent and persistent atrial fibrillation improves after cardiac surgery regardless of giving add-on surgery or not, but this improvement is presumably more affected by treating the underlying heart disease than by restoring sinus rhythm.","Van Breugel, H. N., et al. (2010). \"A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery.\" J Cardiovasc Electrophysiol 21(5): 511-520.","Netherlands",2010,"CVD","Surgery","MFI"]
[306,"van Breugel, H. N., et al. (2016). \"Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?\" J Cardiothorac Surg 11(1): 75.",null,"van Breugel, H. N., et al.","Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?","BACKGROUND: We investigated the impact and the predictive value of sinus rhythm at 12 months (SR12) on subscales of three different HrQoL questionnaires: SF-36., EuroQoL and MFI 20. METHODS: Data of 125 cardiac surgery patients with pre-operative AF from our previous randomized trial were used. Based on their rhythm outcome patients were divided in two groups: SR12 or AF at 12 months follow up (non-SR12). All questionnaires were self-administered pre-operatively and at 3 months, 6 months and 12 months after surgery. RESULTS: Synus rhytm at 12 months was predictive of improvement of SF36- mental score (MS, p = 0.021), Euro-QoL-MS (p = 0.009), VAS (p = 0.006), and MFI 20-MS (p = 0.009). We failed to find any significant interactions between SR12 and any of the other significant risk factors: age <65 years, paroxysmal type of AF and preoperative AF duration <12 months. In contrast, SR12 was not significant in predicting physical score (PS) subscales of any of the questionnaires (all, p > 0.05) which were predicted by age <65 years (SF36-PS, p = 0.029) by paroxysmal type of AF and age <65 years (Euro-QoL-PS, p = 0.017 and p = 0.04, respectively) and by AF duration <12 months, paroxysmal type of AF and age < 65 years (MFI 20-PS, p = 0.019, p = 0.020 and p = 0.015, respectively). CONCLUSIONS: Specific mental-related HrQoL scales are much more sensitive to sinus rhythm conversion. Sinus rithm mantainance shows significant effects on mental scores independently of other cofactors. Successful conversion to sinus rhythm after surgical ablation during cardiac surgery does not significantly affect phisical health related quality of life during 1 year follow up.","van Breugel, H. N., et al. (2016). \"Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?\" J Cardiothorac Surg 11(1): 75.","Netherlands",2016,"CVD","Surgery","MFI"]
[307,"van der Klaauw, A. A., et al. (2008). \"Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly.\" Clin Endocrinol (Oxf) 69(1): 123-128.",null,"van der Klaauw, A. A., et al.","Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly","OBJECTIVE: Cross-sectional studies have shown impaired quality of life (QoL) in patients in biochemical control of acromegaly. The aim of this study was to assess longitudinal changes in QoL in a homogenous cohort of patients with sustained biochemical control of acromegaly. DESIGN: Prospective follow-up study. PATIENTS AND METHODS: QoL was assessed using four health-related QoL questionnaires (HADS, Hospital Anxiety and Depression Scale; MFI-20, Multidimensional Fatigue Index; NHP, Nottingham Health Profile; and SF-36, Short Form-36) and one disease-specific acromegaly quality of life (ACRO-QOL) questionnaire in 82 patients (43 men) with strict biochemical control of acromegaly, aged 56 years (range 29-84 years) at baseline and after 4 years of follow-up. The mean duration of controlled disease was 12 years (range 1-26 years). RESULTS: During follow-up, scores in 5 of 26 QoL subscales significantly worsened: physical and social functioning (SF-36), physical fatigue (MFI-20), and psychological well-being and personal relations (ACRO-QOL). Using linear regression analysis, baseline item scores predicted the follow-up scores, indicating individual stability over time. Previous radiotherapy (n = 27, 33%) negatively influenced several QoL subscales at follow-up: energy, pain and social isolation (NHP), physical fatigue and reduction in activity and motivation (MFI-20), depression and total anxiety and depression scores (HADS) and physical performance (ACRO-QOL). CONCLUSION: During 4 years of follow-up in patients with long-term biochemical control of ACRO-QOL is subtly, but progressively impaired. Radiotherapy was the predominant indicator of progressive impairment in QoL.","van der Klaauw, A. A., et al. (2008). \"Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly.\" Clin Endocrinol (Oxf) 69(1): 123-128.","Netherlands",2008,"Endocrine","Cancer treatments","MFI"]
[308,"van der Plas, S. M., et al. (2004). \"The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire.\" Qual Life Res 13(8): 1469-1481.",null,"van der Plas, S. M., et al.","The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire","The available liver disease-specific questionnaires do address severity of symptoms but hardly evaluate how patients experience these specific symptoms during daily activities. The Liver Disease Symptom Index 2.0 (LDSI) includes 18 items that measure symptom severity and symptom hindrance in the past week. In a large survey (n = 1175) conducted in collaboration with the Dutch liver patient association, convergent and divergent construct validity and the surplus value of including symptom severity and symptom hindrance items in the LDSI were examined. The LDSI items showed expected convergent and divergent correlations with Short Form-36 (SF-36) and Multidimensional Fatigue Index-20 (MFI-20) scales. Correlations revealed only a slight to moderate overlap between LDSI items and SF-36 and MFI-20 scales. The impact of symptom severity and symptom hindrance on generic health related quality of life (HRQoL) varied in a different way across liver patients, which indicated that symptom severity items and the symptom hindrance items measure different aspects of HRQoL. We conclude that the LDSI provides information complementary to the information given by the SF-36 and the MFI-20 and that it is psychometrically sound to include both symptom severity items and symptom hindrance items in the LDSI.","van der Plas, S. M., et al. (2004). \"The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire.\" Qual Life Res 13(8): 1469-1481.","Netherlands",2004,"Liver Disease","None","MFI"]
[309,"van der Plas, S. M., et al. (2007). \"Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey.\" Qual Life Res 16(3): 375-388.",null,"van der Plas, S. M., et al.","Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey","Most studies on health related quality of life (HRQoL) of chronic liver patients were done in small clinical populations or restricted to one aetiology or disease stage. There is still a need for a study in a large liver patient population with various aetiologies and disease stages, approaching a population-based study. We evaluated the impact of liver disease aetiology on generic HRQoL, disease-specific HRQoL and fatigue and we compared HRQoL and fatigue between aetiological groups and healthy Dutch controls. Members of the Dutch liver patient association completed the Liver Disease Symptom Index, Short Form-36, and Multidimensional Fatigue Index-20. We compared the HRQoL between patients with viral hepatitis, autoimmune hepatitis, cholestatic diseases, hemochromatosis and other liver diseases by linear, ordinal and logistic regression, corrected for disease stage and other significant factors. Viral hepatitis patients showed a worse mental health than other aetiological groups. Hemochromatosis patients demonstrated 17% more bodily pain than viral hepatitis patients and the strongest decrease in role emotional health with increasing age. Aetiological groups showed a worse generic HRQoL and more fatigue than controls. In conclusion, viral hepatitis and hemochromatosis patients have a more impaired HRQoL than patients of other liver disease aetiological groups.","van der Plas, S. M., et al. (2007). \"Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey.\" Qual Life Res 16(3): 375-388.","Netherlands",2007,"Liver Disease","None","MFI"]
[310,"van Rhee, F., et al. (2015). \"Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.\" Patient 8(2): 207-216.",null,"van Rhee, F., et al.","Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab","BACKGROUND: Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disorder driven by dysregulated interleukin-6 production. MCD has a poor prognosis, and treatment is generally noncurative and aimed at symptom relief. Siltuximab is a novel, monoclonal interleukin-6 antibody recently shown to be effective in a registration clinical trial. MCD symptoms, such as fatigue, pain, and weakness, are most appropriately quantified using patient-reported outcome (PRO) measures. We assessed the effect of siltuximab on patient perception of symptoms, functional status, and wellbeing using PRO instruments. METHODS: We analyzed results of a randomized, double-blind trial comparing siltuximab 11 mg/kg every 3 weeks with placebo to treat MCD. Subjects (N = 79) completed the recently developed MCD-Symptom Scale (MCD-SS), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, and the Short Form (SF)-36 at predetermined time points throughout the treatment period. Scores were compared at baseline and over time between the treatment arms and PRO instruments. RESULTS: At baseline, the mean number of symptoms reported was 9.2 (standard deviation 3.76) out of 16 total, as measured by the MCD-SS. Fatigue was a key symptom across all PRO instruments. Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale. Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health. CONCLUSIONS: Patients with MCD commonly report impairments in functioning, wellbeing, and fatigue at baseline. Siltuximab-treated patients reported significant improvements in these outcomes after treatment.","van Rhee, F., et al. (2015). \"Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.\" Patient 8(2): 207-216.","USA",2015,"Hematological","Siltuximab","FACIT-F"]
[311,"van Tubergen, A., et al. (2002). \"Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis.\" Arthritis Rheum 47(1): 8-16.",null,"van Tubergen, A., et al.","Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis","OBJECTIVES: To investigate whether the single-item fatigue question of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Multidimensional Fatigue Inventory (MFI) are appropriate instruments to measure fatigue in ankylosing spondylitis (AS); to identify factors that influence fatigue in AS; and to assess how fatigue in all its aspects is associated with quality of life in AS. METHODS: A total of 812 patients with AS were included. Patients completed questionnaires on disease activity (BASDAI), functional ability (Bath Ankylosing Spondylitis Functional Index [BASFI]), global well-being (Bath Ankylosing Spondylitis Global Score [BAS-G]), overall perceived health (EuroQoL visual analog scale), and quality of life (Ankylosing Spondylitis Quality of Life questionnaire, and Short Form 36 [SF-36]). Patients were dichotomized into a F+ group (fatigue = major symptom) if the BASDAI fatigue score was > 5.0 and a F- group (fatigue = minor symptom) if the fatigue score was < 5.0. Reproducibility was assessed with intraclass correlation coefficients, and responsiveness was calculated according to 3 different methods. Logistic regression analysis was used to determine which factors were associated with fatigue. Multiple regression analysis was used to investigate whether fatigue contributes in explaining quality of life. RESULTS: Fifty-three percent of the patients were assigned to the F+ group. They scored significantly worse compared with the F- group with respect to each dimension of the MFI and to all other questionnaires studied (all P < 0.001). The BASDAI fatigue question, as well as each separate dimension of the MFI, showed moderate to good reproducibility (0.57-0.75) and responsiveness (0.23-0.96). Fatigue was, in the opinion of the patients, highly associated with pain (70% of patients) and stiffness (54% of patients). Logistic regression analysis showed that scores on BASDAI, BASFI, BAS-G, and mental health status (SF-36) were independently associated with fatigue (R(2) = 0.52). Multiple regression analysis showed that scores on the BASDAI fatigue question were significantly associated with quality of life. With the 5 MFI dimensions as explanatory variables, different aspects of fatigue were associated with different domains of quality of life. CONCLUSIONS: Fatigue as a major symptom of AS can effectively be measured with either a single-item question on the intensity of fatigue or with the MFI. The MFI, however, provides more insight into specific dimensions of fatigue. Fatigue appears to be associated with the level of disease activity, functional ability, global well-being, and mental health status. In addition, fatigue negatively influences different aspects of quality of life.","van Tubergen, A., et al. (2002). \"Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis.\" Arthritis Rheum 47(1): 8-16.","Netherlands",2002,"Musculoskeletal","None","MFI"]
[312,"Vasconcelos, O. M., et al. (2007). \"Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.\" Neurology 68(20): 1680-1686.",null,"Vasconcelos, O. M., et al.","Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial","OBJECTIVE: To determine if modafinil can improve fatigue in patients with post-polio syndrome. METHODS: We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects. RESULTS: Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments. CONCLUSION: Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.","Vasconcelos, O. M., et al. (2007). \"Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.\" Neurology 68(20): 1680-1686.","USA",2007,"Neurological","Other Drugs","FSS,VAS-F,FIS"]
[313,"Velthuis, M. J., et al. (2010). \"Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial.\" BMC Cancer 10: 272.",null,"Velthuis, M. J., et al.","Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial","BACKGROUND: Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. METHODS/DESIGN: The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term) and after 9 months (long term). Validated questionnaires will be used. PRIMARY OUTCOME: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List) and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey), impact on functioning and autonomy (Impact on functioning and autonomy questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), physical fitness (aerobic peak capacity, muscle strength), body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level will be measured using the Short Questionnaire to Assess Health-Enhancing Physical Activity and will be monitored with an exercise log and a pedometer. DISCUSSION: This study investigates the (cost)-effectiveness of exercise during adjuvant treatment of patients with breast or colon cancer. If early physical exercise proves to be (cost) effective, establishing standardised physical exercise programmes during cancer treatment will be planned. TRIAL REGISTRATION: Current Controlled trials ISRCTN43801571, Dutch Trial Register NTR2138.","Velthuis, M. J., et al. (2010). \"Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial.\" BMC Cancer 10: 272.","Netherlands",2010,"Cancer","Psychobehavioural","MFI"]
[314,"Visser, M. R. and E. M. Smets (1998). \"Fatigue, depression and quality of life in cancer patients: how are they related?\" Support Care Cancer 6(2): 101-108.",null,"Visser, M. R. and E. M. Smets","Fatigue, depression and quality of life in cancer patients: how are they related?","In a study concerning a group of cancer patients undergoing radiotherapy three research questions were addressed. (1) Is fatigue a valid criterion for depression in these somatically ill patients? (2) What is the 'cause-and-effect' relation between fatigue and depression? (3) To what extent are fatigue and depression related to patients' quality of life. A heterogeneous sample of cancer patients (n = 250) were interviewed before treatment, 2 weeks after treatment and 9 months later. Fatigue was measured using the MFI, a self-report instrument covering five dimensions of fatigue. Depression was assessed with the non-somatic items of the CES-D. Quality of life had to be indicated on a Cantrill ladder. Fatigue and depression do not follow the same course over time. Just after radiotherapy, fatigue had either increased or remained stable, depending on the dimension under consideration. Depression, in contrast, decreased. Nine months later fatigue had decreased, whereas levels of depression remained stable. Concurrent relations between fatigue and depression were mostly moderate. There was no strong evidence for a cause-and-effect relationship between depression and fatigue. Depression showed highest concurrent relationships with quality of life, especially before treatment. Prospectively, depression and the dimension of physical fatigue were the main predictors for quality of life. Fatigue is not a valid criterion for depression in these patients. Nor is there a strong cause-and-effect relationship. Both depression and physical fatigue are relevant to patients' quality of life.","Visser, M. R. and E. M. Smets (1998). \"Fatigue, depression and quality of life in cancer patients: how are they related?\" Support Care Cancer 6(2): 101-108.","Netherlands",1998,"Cancer","None","MFI"]
[315,"Vogelaar, L., et al. (2014). \"Fatigue management in patients with IBD: a randomised controlled trial.\" Gut 63(6): 911-918.",null,"Vogelaar, L., et al.","Fatigue management in patients with IBD: a randomised controlled trial","OBJECTIVE: To assess the effectiveness of solution-focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD). DESIGN: Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength--Fatigue (CIS--fatigue) score of >/= 35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality. RESULTS: Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS-fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed. CONCLUSIONS: SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up.","Vogelaar, L., et al. (2014). \"Fatigue management in patients with IBD: a randomised controlled trial.\" Gut 63(6): 911-918.","Netherlands",2014,"Gastrointestinal","Psychobehavioural","CIS-F"]
[316,"Wallymahmed, M. E., et al. (1996). \"The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency.\" Clin Endocrinol (Oxf) 44(4): 403-411.",null,"Wallymahmed, M. E., et al.","The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency","OBJECTIVE: Adults with GH deficiency frequently complain of lack of energy, fatigue, social isolation and problems with sexual relationships resulting in a low perceived quality of life. Previous studies of quality of life (QOL) in GH deficient adults have involved small numbers of patients and used measures not specifically designed for this patient population. We have devised a health related QOL model specifically designed for use in adults with GH deficiency and to assess the impact of future GH replacement therapy. DESIGN: Six measurements were chosen for inclusion in the model. Two were adapted for use after clinical interviews with 12 adult GH deficient patients: the Impact and the Life Fulfilment scales. The others were the Nottingham Health Profile, the Hospital Anxiety and Depression Scale, the Self-Esteem Scale and the Mental Fatigue Questionnaire. The reliability of the 6 measures was assessed by 2 methods: test re-test correlation and internal consistency (Cronbach's alpha). The validity of the Impact and Life Fulfilment scales was assessed by correlation with the other 4 scales. PATIENTS: Questionnaires were completed by 32 adults with hypothalamic pituitary disorders and GH deficiency (11 male, mean age 35.1 years), with a stimulated maximum serum GH response less than 10 mU/l (mean 2.96). Two had previously received GH injections in childhood. The questionnaires were also completed by 32 age and sex matched control subjects. RESULTS: The 6 scales had test re-test correlations of 0.70-0.92 indicating reliability over time. The Impact and Life Fulfilment Scales and the Mental Fatigue Questionnaire had Cronbach's alpha scores of greater than 0.6 indicating their potential for use in clinical trials. The Impact and Life Fulfilment scales correlated significantly with many physical and psychological domains from the other 4 scales indicating these were valid in the assessment of health related QOL in GH deficient adults. Compared to the controls the patients with GH deficiency were significantly psychosocially disadvantaged in terms of depression, self-esteem, mental fatigue and life fulfilment. CONCLUSION: The results of the reliability and validity studies indicate that this health related quality of life model for use with adults with GH deficiency is a potentially valid and reliable tool that could be used to assess the effect of GH treatment.","Wallymahmed, M. E., et al. (1996). \"The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency.\" Clin Endocrinol (Oxf) 44(4): 403-411.","UK",1996,"Endocrine","None","MFQ"]
[317,"Wallymahmed, M. E., et al. (1999). \"The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects.\" Clin Endocrinol (Oxf) 51(3): 333-338.",null,"Wallymahmed, M. E., et al.","The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects","OBJECTIVE: Adults with GH deficiency (GHD) frequently report a poor quality of life (QOL). Whether this poor QOL is specifically due to hormone deficiency or a non specific effect of a chronic condition is not known. We therefore assessed QOL in adults with hypopituitarism and GHD and compared scores with a group of patients with diabetes mellitus, another life-long condition with potentially serious complications and a group of healthy controls. PATIENTS: We studied 57 patients with hypopituitarism and GHD (peak stimulated GH response < 9 mU/l) (23 male, mean age 36.4 years, mean stimulated GH response 2.3 mU/l), secondary to a variety of hypothalamic-pituitary disorders. Fifty had been treated surgically (39 cranial surgery, 11 transsphenoidal) and 37 had received external cranial irradiation involving the hypothalamic region. Fifty-seven age and sex matched patients with diabetes mellitus (31 insulin treated, 18 on oral hypoglycaemic agents, 8 on diet alone) and 57 matched healthy controls were also studied. DESIGN AND MEASUREMENTS: We assessed and compared health related QOL in the 3 groups using 4 self rating questionnaires: Hospital Anxiety and Depression Scale, Self Esteem Scale, Mental Fatigue Questionnaire and Life Fulfilment Scale. In addition the GHD and diabetic groups also completed the Disease Impact Scale. RESULTS: The GHD group reported significantly more depression (P < 0.05) and mental fatigue (P < 0.05) and significantly less self esteem (P < 0.05) and life fulfilment (P < 0. 05) than either the group with diabetes or the controls. Patients with GHD reported significantly higher anxiety scores (P < 0.05) than the controls. Within the GHD group there were no differences in QOL scores between patients with pituitary tumours (n = 24), craniopharyngiomas/hypothalamic tumours (n = 18) or other brain tumours. In addition there were no significant differences according to surgical treatment modality or radiotherapy. However subgroup analysis revealed that the patients who had undergone transsphenoidal surgery (n = 11) differed significantly from the control group in life fulfillment and depression (P < 0.01) only and did not differ from the DM group in any of the questionnaires used. There were no significant differences between the group with diabetes and the control group in any of the measures except depression (P < 0.05). CONCLUSIONS: This study revealed a significant impairment of QOL in adults with GHD, particularly those who had undergone cranial surgery, when compared to matched patients with diabetes and healthy controls.","Wallymahmed, M. E., et al. (1999). \"The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects.\" Clin Endocrinol (Oxf) 51(3): 333-338.","UK",1999,"Endocrine","None","MFQ"]
[318,"Wallymahmed, M. E., et al. (1997). \"Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years.\" Clin Endocrinol (Oxf) 47(4): 439-446.",null,"Wallymahmed, M. E., et al.","Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years","OBJECTIVE: Adults with GH deficiency complain frequently of low energy levels, emotional lability and mental fatigue resulting in a low perceived quality of life (QOL). Body composition is altered with increased fat mass and decreased lean body mass and muscle strength is reduced. The aims of this study were to determine the effects of replacement GH treatment on: (a) body composition and muscle strength and (b) QOL, using specifically selected and adapted measures. DESIGN: A 12-month study (double-blind placebo-controlled for the first 6 months and open for the second 6 months) of GH replacement injections (0.125 iu/kg/week for the first month and 0.25 iu/kg/week for the following 5 months of each study period) in GH deficient adults on QOL, body composition and muscle strength. This was followed by an open study of a further 12 months' GH treatment assessing QOL and muscle strength. Finally, QOL was assessed after up to 3 years of GH replacement treatment. PATIENTS: Thirty of the 32 adult patients with GH deficiency enrolled completed the initial 12-month study (10 male, mean age 33.5 years, mean (SD) stimulated serum GH response 3.0 mU/l (2.86)). Nineteen patients then opted to continue GH treatment. Of these, 13 patients were available for assessment after a further 12 months' and 24 months' treatment. MEASUREMENTS: Health-related QOL was assessed using 2 specifically adapted scales for adults with GH deficiency: the Life Fulfillment Scale and the Impact Scale. In addition 4 other self-rating questionnaires were used: Nottingham Health Profile, Hospital Anxiety and Depression Scale, Self Esteem Scale and Mental Fatigue Scale. Body composition was assessed by DEXA and quadriceps muscle strength by measuring maximum voluntary contractions. RESULTS: In the initial 12 months' placebo-controlled study perceived energy levels increased after 6 and 12 months of GH treatment (P < 0.01 compared with baseline) in the patients receiving GH for the full 12-month period. There were no changes in energy levels throughout the study in the group receiving placebo for the first 6 months. Also small improvements in impact scores were found after 6 months of GH treatment (P < 0.05) but this was not sustained at 12 months. In both GH and placebo groups life fulfillment worsened after 6 months, but then improved to baseline values after 12 months. In the patients who persisted with GH replacement, energy levels continued to improve (at 2 years, P < 0.01 compared with baseline) but then fell (at 3 years, P = NS compared with baseline). A similar pattern was observed in emotional reaction scores. However, improvements in self-esteem were maintained (at 3 years, P < 0.05 compared with baseline). Body composition altered favourably over the initial 12-month study period with a significant increase in lean mass and decrease in fat mass in both groups after 6-12 months of GH. There were no changes in muscle strength in either group during the initial 12-month study. However, in the patients who were available for assessment after a further 12 months of GH treatment, muscle strength increased significantly (P < 0.02 compared with baseline). CONCLUSION: GH replacement treatment for 6-12 months leads to significant improvements in body composition (DEXA) but longer-term treatment may be needed to increase muscle strength. Self-esteem scores improve and are maintained after 3 years of treatment. Energy levels and emotional reaction improve during treatment for up to 2 years but decline thereafter.","Wallymahmed, M. E., et al. (1997). \"Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years.\" Clin Endocrinol (Oxf) 47(4): 439-446.","UK",1997,"Endocrine","Various","MFS"]
[319,"Wang, S. Y., et al. (2016). \"Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study.\" Ren Fail 38(3): 442-450.",null,"Wang, S. Y., et al.","Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study","BACKGROUD: Fatigue is considered as a common symptom in patients with end-stage renal disease (ESRD) and can significantly decrease patients' quality of life. This study aimed to assess fatigue in hemodialysis patients and to investigate risk factors of fatigue in Chinese patients receiving maintenance hemodialysis (MHD) in China. METHODS: Eligible patients completed questionnaires including demographic information, a Chinese version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Family APGAR Index (APGAR), the medical outcomes study health status-Social Functioning subscale (SF-36,SocF), and the Pittsburgh sleep quality index (PSQI). Laboratory parameters were abstracted by medical records review. The multiple linear regression model was used to relate parameters with the FACIT-Fatigue score. RESULTS: A total of 345 MHD patients (216 men and 129 women, age 55.6 +/- 12.8) were recruited in this study. The score of FACIT-Fatigue was 39 (Interquartile Range, 31-44). Fatigue was correlated with PSQI scores (p < 0.001), SocF scores (p < 0.001), comorbidity (p = 0.006), exercise time <1 hour per day (p = 0.003), adequacy of dialysis (Kt/V) < 1.2 (p = 0.016), APGAR scores (p = 0.014), and high Scr (p = 0.043). CONCLUSIONS: Fatigue is related to sleep disturbance, social and family functioning, taking physical exercise time, comorbidity condition, Kt/V and serum creatinine level in Chinese MHD patients. Future studies and interventions should focus on developing strategies and improving the quality of life in patients by addressing these significant contributing factors.","Wang, S. Y., et al. (2016). \"Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study.\" Ren Fail 38(3): 442-450.","China",2016,"Kidney Disease","None","FACIT-F"]
[320,"Wang, Y. Y., et al. (2014). \"Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials.\" Complement Ther Med 22(4): 826-833.",null,"Wang, Y. Y., et al.","Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials","BACKGROUND: There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China. OBJECTIVE: To evaluate the effectiveness and safety of TCM for CFS. METHODS: The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results. RESULTS: 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder's fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell's fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events. CONCLUSIONS: TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.","Wang, Y. Y., et al. (2014). \"Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials.\" Complement Ther Med 22(4): 826-833.","China",2014,"Chronic Fatigue","Complementary","CFS,FSS,FAI,Bells Fatigue Scale"]
[321,"Weitz, I., et al. (2013). \"Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria.\" Intern Med J 43(3): 298-307.",null,"Weitz, I., et al.","Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria","BACKGROUND: Paroxysmal nocturnal haemoglobinuria (PNH) is a rare, acquired, clonal haemopoietic stem cell disorder that causes chronic intravascular haemolysis, increases the risk of thrombosis and results in significant patient morbidity and mortality. The symptoms of PNH may have a major impact on patient quality of life. AIMS: To assess patient fatigue and health-related quality of life in 29 patients with PNH using the Functional Assessment of Chronic Illness Therapy Fatigue subscale version 4 (FACIT-Fatigue) and the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30, version 3 (EORTC QLQ-C30). METHODS: Following completion of the questionnaires, patients were interviewed to assess the validity, clarity, relevance and comprehensiveness of the assessments. RESULTS: Overall, patients considered both the FACIT-Fatigue and EORTC QLQ-C30 instruments to be relevant and adequate in assessing the level of PNH-associated fatigue and other quality-of-life measures. The FACIT-Fatigue questionnaire was considered to be clear and to comprehensively cover PNH-related fatigue. The EORTC QLQ-C30 instrument was considered to be easy to understand, but of an overall lower relevance, although some differences between countries were observed. Patients suggested additional questions that could be incorporated into future EORTC QLQ-C30 versions to make it more relevant to PNH. CONCLUSIONS: This study confirms the validity of the FACIT-Fatigue and the EORTC QLQ-C30 questionnaires in this patient population and their routine use should be considered in the management of patients with PNH.","Weitz, I., et al. (2013). \"Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria.\" Intern Med J 43(3): 298-307.","USA",2013,"Hematological","None","FACIT-F"]
[322,"Werumeus Buning, J., et al. (2016). \"Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial.\" Neuroendocrinology 103(6): 771-778.",null,"Werumeus Buning, J., et al.","Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial","BACKGROUND: There is a major lack of randomized controlled trials (RCTs) evaluating the effects of hydrocortisone (HC) substitution therapy in patients with secondary adrenal insufficiency. Therefore, we evaluated the effects of two different replacement doses of HC on health-related quality of life (HRQoL) in a RCT. METHODS: This RCT with a double-blind cross-over design was performed at the University Medical Center Groningen. Forty-seven patients (29 men, age 51 +/- 14 years, range 19-73 years) with secondary adrenal insufficiency participated. Patients received both a lower and a higher dose of HC (0.2-0.3 and 0.4-0.6 mg/kg body weight/day) for 10 weeks in random order. HRQoL was assessed with a daily mood and symptom checklist (Patient Health Questionnaire-15 [PHQ-15], Generalized Anxiety Disorder-7 [GAD-7], Patient Health Questionnaire-9 [PHQ-9]) and with questionnaires assessing general well-being (RAND 36-Item Health Survey [RAND-36]), mood (Hospital Anxiety and Depression Scale [HADS]) and fatigue (Multidimensional Fatigue Inventory-20 [MFI-20]). ClinicalTrials.gov identifier: NCT01546922. RESULTS: Patients receiving the higher dose of HC reported significantly fewer symptoms of depression (p = 0.016 and p = 0.045 for HADS and PHQ-9, respectively), less general and mental fatigue (p = 0.004 and p = 0.003, respectively, both MFI-20), increased motivation (p = 0.021, MFI-20), better physical functioning (p = 0.041), better general health (p = 0.013) and more vitality (p = 0.025) (all RAND-36). In addition, while on the higher dose, fewer somatic symptoms (p = 0.022) and less pain (p < 0.001) (both PHQ-15) were experienced. CONCLUSIONS: On the higher dose of HC, patients reported a better HRQoL on various domains as compared to the lower dose of HC. The fact that a higher dose of HC may improve patient well-being should be taken into consideration when individualizing the HC substitution dose.","Werumeus Buning, J., et al. (2016). \"Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial.\" Neuroendocrinology 103(6): 771-778.","Netherlands",2016,"Endocrine","Other Drugs","MFI"]
[323,"Wesselius, T., et al. (2005). \"A randomized crossover study of bee sting therapy for multiple sclerosis.\" Neurology 65(11): 1764-1768.",null,"Wesselius, T., et al.","A randomized crossover study of bee sting therapy for multiple sclerosis","BACKGROUND: Bee sting therapy is increasingly used to treat patients with multiple sclerosis (MS) in the belief that it can stabilize or ameliorate the disease. However, there are no clinical studies to justify its use. METHODS: In a randomized, crossover study, we assigned 26 patients with relapsing-remitting or relapsing secondary progressive MS to 24 weeks of medically supervised bee sting therapy or 24 weeks of no treatment. Live bees (up to a maximum of 20) were used to administer bee venom three times per week. The primary outcome was the cumulative number of new gadolinium-enhancing lesions on T1-weighted MRI of the brain. Secondary outcomes were lesion load on T2*-weighted MRI, relapse rate, disability (Expanded Disability Status Scale, Multiple Sclerosis Functional Composite, Guy's Neurologic Disability Scale), fatigue (Abbreviated Fatigue Questionnaire, Fatigue Impact Scale), and health-related quality of life (Medical Outcomes Study 36-Item Short Form General Health Survey). RESULTS: During bee sting therapy, there was no significant reduction in the cumulative number of new gadolinium-enhancing lesions. The T2*-weighted lesion load further progressed, and there was no significant reduction in relapse rate. There was no improvement of disability, fatigue, and quality of life. Bee sting therapy was well tolerated, and there were no serious adverse events. CONCLUSIONS: In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity, disability, or fatigue and did not improve quality of life.","Wesselius, T., et al. (2005). \"A randomized crossover study of bee sting therapy for multiple sclerosis.\" Neurology 65(11): 1764-1768.","Netherlands",2005,"Neurological","Complementary","FQ,FIS"]
[324,"Wilburn, J., et al. (2015). \"Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).\" Qual Life Res 24(9): 2279-2288.",null,"Wilburn, J., et al.","Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ)","PURPOSE: Despite the significant impact of Crohn's disease (CD) on patients' physical and emotional well-being, no CD-specific patient-reported outcome (PRO) measure is available for determining the efficacy of interventions. The objective of the study was to develop and validate the Crohn's Life Impact Scale (CLIQ), the first such measure. METHODS: Questionnaire content was derived from qualitative interviews with CD patients and face and content validity assessed by cognitive debriefing interviews (CDIs) with patients. A postal survey was conducted to identify the final scale, confirm its unidimensionality and determine reproducibility and construct validity. A subset of the respondents was sent a second questionnaire package 2 weeks after the first. The survey included the CLIQ, Nottingham Health Profile (NHP) and Unidimensional Fatigue Impact Scale (U-FIS). RESULTS: Content analysis was conducted on the 30 interview transcripts and a draft scale produced. The CDIs indicated that the draft scale was relevant, clear and easy to use. The questionnaire package was completed by 273 CD patients (65.6 % male; aged 16-79 (mean 43.9; SD 15.1) years). Of these, 104 also completed the second package. Rasch analysis confirmed a 27-item unidimensional QoL scale (p < 0.05). Both internal consistency and test-retest reliability were high (0.91). Scores on the CLIQ were related to both physical and emotional impairments (NHP) and to fatigue (U-FIS). CONCLUSION: The CLIQ, the first CD-specific PRO, is unidimensional and has excellent psychometric properties. It should prove to be a valuable tool for evaluating the impact of CD and its treatment from the patients' perspective.","Wilburn, J., et al. (2015). \"Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).\" Qual Life Res 24(9): 2279-2288.","UK",2015,"Gastrointestinal","None","U-FIS"]
[325,"Williams, J. E., et al. (2010). \"Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study).\" Am J Cardiol 105(12): 1661-1665.",null,"Williams, J. E., et al.","Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study)","Vital exhaustion, defined as excessive fatigue, feelings of demoralization, and increased irritability, has been identified as a risk factor for incident and recurrent cardiac events, but there are no population-based prospective studies of this association in US samples. We examined the predictive value of vital exhaustion for incident myocardial infarction or fatal coronary heart disease in middle-aged men and women in 4 US communities. Participants were 12,895 black or white men and women enrolled in the Atherosclerosis Risk In Communities (ARIC) study cohort and followed for the occurrence of cardiac morbidity and mortality from 1990 through 2002 (maximum follow-up 13.0 years). Vital exhaustion was assessed using the 21-item Maastricht Questionnaire and scores were partitioned into approximate quartiles for statistical analyses. High vital exhaustion (fourth quartile) predicted adverse cardiac events in age-, gender-, and race-center-adjusted analyses (1.69, 95% confidence interval 1.40 to 2.05) and in analyses further adjusted for educational level, body mass index, plasma low-density lipoprotein and high-density lipoprotein cholesterol levels, systolic and diastolic blood pressure levels, diabetes mellitus, cigarette smoking status, and pack-years of cigarette smoking (1.46, 95% confidence interval 1.20 to 1.79). Risk for adverse cardiac events increased monotonically from the first through the fourth quartile of vital exhaustion. Probabilities of adverse cardiac events over time were significantly higher in people with high vital exhaustion compared to those with low exhaustion (p = 0.002). In conclusion, vital exhaustion predicts long-term risk for adverse cardiac events in men and women, independent of established biomedical risk factors.","Williams, J. E., et al. (2010). \"Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study).\" Am J Cardiol 105(12): 1661-1665.","USA",2010,"CVD","None","Maastricht questionnaire"]
[326,"Yadav, V., et al. (2016). \"Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.\" Mult Scler Relat Disord 9: 80-90.",null,"Yadav, V., et al.","Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial","BACKGROUND: The role that dietary interventions can play in multiple sclerosis (MS) management is of huge interest amongst patients and researchers but data evaluating this is limited. Possible effects of a very-low-fat, plant-based dietary intervention on MS related progression and disease activity as measured by brain imaging and MS related symptoms have not been evaluated in a randomized-controlled trial. Despite use of disease modifying therapies (DMT), poor quality of life (QOL) in MS patients can be a significant problem with fatigue being one of the common disabling symptoms. Effective treatment options for fatigue remain limited. Emerging evidence suggests diet and vascular risk factors including obesity and hyperlipidemia may influence MS disease progression and improve QOL. OBJECTIVES: To evaluate adherence, safety and effects of a very-low-fat, plant-based diet (Diet) on brain MRI, clinical [MS relapses and disability, body mass index (BMI)] and metabolic (blood lipids and insulin) outcomes, QOL [Short Form-36 (SF-36)], and fatigue [Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS)], in relapsing-remitting MS (RRMS). METHODS: This was a randomized-controlled, assessor-blinded, one-year long study with 61 participants assigned to either Diet (N=32) or wait-listed (Control, N=29) group. RESULTS: The mean age (years) [Control-40.9+/-8.48; Diet-40.8+/-8.86] and the mean disease duration (years) [Control -5.3+/-3.86; Diet-5.33+/-3.63] were comparable between the two groups. There was a slight difference between the two study groups in the baseline mean expanded disability status scale (EDSS) score [Control-2.22+/-0.90; Diet-2.72+/-1.05]. Eight subjects withdrew (Diet, N=6; Control, N=2). Adherence to the study diet based on monthly Food Frequency Questionnaire (FFQ) was excellent with the diet group showing significant difference in the total fat caloric intake compared to the control group [total fat intake/total calories averaged ~15% (Diet) versus ~40% (Control)]. The two groups showed no differences in brain MRI outcomes, number of MS relapses or disability at 12 months. The diet group showed improvements at six months in low-density lipoprotein cholesterol (Delta=-11.99mg/dL; p=0.031), total cholesterol (Delta=-13.18mg/dL; p=0.027) and insulin (Delta=-2.82mg/dL; p=0.0067), mean monthly reductions in BMI (Rate=-1.125kg/m2 per month; p<0.001) and fatigue [FSS (Rate=-0.0639 points/month; p=0.0010); MFIS (Rate=-0.233 points/month; p=0.0011)] during the 12-month period. CONCLUSIONS: While a very-low fat, plant-based diet was well adhered to and tolerated, it resulted in no significant improvement on brain MRI, relapse rate or disability as assessed by EDSS scores in subjects with RRMS over one year. The diet group however showed significant improvements in measures of fatigue, BMI and metabolic biomarkers. The study was powered to detect only very large effects on MRI activity so smaller but clinically meaningful effects cannot be excluded. The diet intervention resulted in a beneficial effect on the self-reported outcome of fatigue but these results should be interpreted cautiously as a wait-list control group may not completely control for a placebo effect and there was a baseline imbalance on fatigue scores between the groups. If maintained, the improved lipid profile and BMI could yield long-term vascular health benefits. Longer studies with larger sample sizes are needed to better understand the long-term health benefits of this diet.","Yadav, V., et al. (2016). \"Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.\" Mult Scler Relat Disord 9: 80-90.","USA",2016,"Neurological","Psychobehavioural","FSS,MFI"]
[327,"Yang, M., et al. (2009). \"Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference.\" Curr Med Res Opin 25(10): 2487-2494.",null,"Yang, M., et al.","Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference","OBJECTIVE: To estimate the minimally important difference (MID) for the Insomnia Severity Index (ISI) by examining the association of score differences of the ISI with health-related outcomes including health-related quality of life, productivity, and fatigue. METHODS: Data came from a randomized, placebo-controlled clinical trial evaluating the long-term efficacy of eszopiclone for primary insomnia (N = 828). Logistic regression models were used to characterize the relationship between ISI change scores (from baseline to 6 months post-treatment) and outcomes/anchors from the SF-36 Health Survey, Work Limitations Questionnaire (WLQ), and Fatigue Severity Scale (FSS). Odds ratios were derived from the regression coefficients to calculate the probability of a given outcome being associated with different ISI change scores. Convergence between anchor- and distribution-based estimates was assessed. RESULTS: Higher ISI scores (indicating more severe insomnia) were significantly associated with higher probabilities of negative outcome in all models. Individuals with a 6-point score reduction in ISI scores (which corresponded to 1(1/2) standard deviations) were 48% less likely to report 'feeling worn out' (SF-36) at 6 months, 46% less likely to be 'unable to think clearly' (WLQ), and 52% less likely to report 'feeling fatigued' (FSS). Similar results were found across a broad spectrum of all selected anchors. CONCLUSIONS: Based on results of the study, a 6-point reduction is recommended to represent a clinically meaningful improvement in individuals with primary insomnia. Research on generalizability of the recommended MID in this study to other patient populations and other type of treatment interventions is needed.","Yang, M., et al. (2009). \"Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference.\" Curr Med Res Opin 25(10): 2487-2494.","USA",2009,"Various","Eszopiclone","FSS"]
[328,"Yates, P., et al. (2005). \"Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer.\" J Clin Oncol 23(25): 6027-6036.",null,"Yates, P., et al.","Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer","PURPOSE: To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue. PATIENTS AND METHODS: This randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy-Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value. RESULTS: Compared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy-Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life. CONCLUSION: Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.","Yates, P., et al. (2005). \"Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer.\" J Clin Oncol 23(25): 6027-6036.","Australia",2005,"Cancer","Psychobehavioural","FACT-F,PFS"]
[329,"Yennurajalingam, S., et al. (2012). \"The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study.\" J Palliat Med 15(10): 1059-1064.",null,"Yennurajalingam, S., et al.","The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study","OBJECTIVES: To determine the effects of thalidomide and placebo on anorexia-cachexia and its related symptoms, body composition, resting metabolic rate, and serum cytokines and their receptors in patients with advanced cancer. METHODS: Included in the study were patients with advanced cancer with weight loss greater than 5% in 6 months and who reported anorexia, fatigue, and one of the following: anxiety, depression, or sleep disturbances. Patients on chemotherapy within 2 weeks prior or during the study were excluded from the study. Patients were randomly assigned to either 100 mg thalidomide or placebo once a day for 14 days. The Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Functional Assessment of Cancer Illness Therapy (FACIT-F), Hospital Anxiety Depression Scale (HADS) Pittsburgh Sleep Quality Index (PSQI) were utilized, and in addition body composition, Resting Energy Expenditure (REE), and serum cytokine levels were assessed. RESULTS: Of the 31 patients entered in the study, 15 were assigned to the thalidomide group and 16 to the placebo group. However only 21/31 patients were able to complete the study. Compared with their baseline values, both the thalidomide and the placebo groups showed significant reduction in cytokines. Tumor necrosis factor (TNF)-alpha (p=0.04) and its receptors TNFR1 (p=0.04), TNFR2 (p=0.04), and interleukin (IL)-8 (p=0.04) were statistically significant in the thalidomide group. In the placebo group, TNF-alpha (p=0.008), TNFR1 (p=0.005), TNFR2 (p=0.005), IL-RA (p=0.005), IL-6 (p=0.005), and IL-8 (p=0.005) were statistically significant. However, improvement in these symptoms and cytokine levels were not significantly different in the thalidomide group compared with the placebo group. None of the patients withdrew from the study because of toxicity of either thalidomide or placebo. CONCLUSIONS: Based on the poor accrual rate and attrition observed in this study, it is important that future research on thalidomide as a treatment for cancer-related anorexia-cachexia symptoms (ACS) in patients with advanced cancer use less stringent entry criteria and less exhaustive outcome measures.","Yennurajalingam, S., et al. (2012). \"The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study.\" J Palliat Med 15(10): 1059-1064.","USA",2012,"Cancer","Thalidomide","FACIT-F"]
[330,"Yeo, T. P., et al. (2012). \"A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients.\" J Am Coll Surg 214(4): 463-475; discussion 475-467.",null,"Yeo, T. P., et al.","A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients","BACKGROUND: As patients with pancreas and periampullary cancer (PPC) experience improved survival rates and longevity, the focus shifts toward living life while surviving cancer. Fatigue is the most commonly reported symptom in all cancer patients. Exercise has been found to effectively decrease fatigue levels and improve physical functioning in cancer patients. STUDY DESIGN: One hundred two patients with resected PPC consented to participate in this study and were randomized to either an intervention group (IG) or a usual care group (UCG). Subjects completed visual analog scales, the FACIT-Fatigue Scale and the Short Form-36v2 after surgery and again 3 to 6 months after hospital discharge. RESULTS: Patients in the IG and UCG were comparable with regard to demographics, comorbidities, cancer type and staging, type of resection, preoperative fatigue and pain levels, adjuvant therapy, and baseline walking distance. Patients in the IG had significantly improved scores on the FACIT-Fatigue Scale at study completion, improved fatigue and pain scores, as well as overall physical functioning and mental health composite scores. At study completion, participants in the IG were walking twice as far and were significantly more likely to have continued walking or another form of exercise as compared with the UCG. Using hierarchical cluster analysis, 3 mutually exclusive symptom groupings were identified in the cohort. Kaplan-Meier survival analysis did not indicate an overall survival benefit for the IG. CONCLUSIONS: This is the first prospective, randomized controlled trial to report that participation in a home walking program confers a significant benefit in resected PPC patients with regard to fatigue levels, physical functioning, and health-related quality of life.","Yeo, T. P., et al. (2012). \"A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients.\" J Am Coll Surg 214(4): 463-475; discussion 475-467.","USA",2012,"Cancer","None","FACIT-F"]
[331,"Yorke, J., et al. (2015). \"Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.\" Support Care Cancer 23(11): 3373-3384.",null,"Yorke, J., et al.","Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial","BACKGROUND: Breathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer. METHOD: This was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and 'bothered' by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12. RESULTS: One hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being 'bothered' by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue. CONCLUSIONS: The study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial.","Yorke, J., et al. (2015). \"Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.\" Support Care Cancer 23(11): 3373-3384.","UK",2015,"Cancer","Various","FACIT-F"]
[332,"Younossi, Z. M., et al. (2016). \"Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir.\" Medicine (Baltimore) 95(9): e2702.",null,"Younossi, Z. M., et al.","Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir","Prevalence of chronic hepatitis C (CH-C) infection in patients of Asian ancestry ranges between 1% and 20%. Interferon (IFN)- and ribavirin (RBV)-containing regimens for CH-C have a negative impact on patient-reported outcomes (PROs) during treatment. The aim of this study was to assess the impact of IFN-free RBV-free sofosbuvir (SOF)-based regimens on PROs in CH-C patients of Asian ancestry. In this observational retrospective study, the PRO data from 12 multicenter multinational phase 3 clinical trials (2012-2015, conducted in Europe, North America, Australia, and New Zealand) of SOF-based regimens with and without IFN, ledipasvir (LDV), and/or RBV were used. At baseline, during treatment, and post-treatment, patients completed 4 validated PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP). The resulting PROs in Asian patients were compared across the treatment regimens. Of 4485 of the trials' participants, 106 patients were of Asian ancestry (55.7% male, 69.8% treatment-naive, 17.0% cirrhotic). In comparison with other patients, the Asian CH-C cohort was younger, had lower BMI, and lower rates of pre-treatment psychiatric comorbidities (anxiety, depression, sleep disorders) (all P < .05). At baseline, Asian patients also had lower SF-36 physical functioning scores (on average, by -5.6% on a normalized 0-100% PRO scale, P = .001). During treatment, Asian CH-C patients experienced a decline in their PRO scores while receiving IFN and/or RBV-containing regimens (up to -19.6%, P < .001). In contrast, patients receiving LDV/SOF experienced no PRO decrement and improvement of some PRO scores during treatment (+9.0% in general health of SF-36, P = .03). After achieving SVR-12, some of the PRO scores in Asian patients improved regardless of the regimen (up to +9.3%, P < .001). In multivariate analysis of Asian patients, the use of LDV/SOF was independently associated with higher PRO scores during and soon after the end of treatment (betas +15.0% to +29.3%, all P < .05). Other predictors of PRO impairment included depression, type 2 diabetes mellitus, and cirrhosis. The use of IFN- and RBV-free LDV/SOF regimens leads to PRO improvement in Asian patients with CH-C during treatment. Achieving SVR-12 results in improvement of PRO scores.","Younossi, Z. M., et al. (2016). \"Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir.\" Medicine (Baltimore) 95(9): e2702.","China",2016,"Infectious disease","Other Drugs","FACIT-F"]
[333,"Younossi, Z. M., et al. (2017). \"Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity.\" Medicine (Baltimore) 96(7): e5914.",null,"Younossi, Z. M., et al.","Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity","Patient-reported outcomes (PROs) such as quality of life and work productivity are important for measuring patient's experience. We assessed PROs during and after treatment of hepatitis C virus (HCV) patients.Data were obtained from a phase 3 open label study of sofosbuvir and ribavirin (SOF + RBV) with and without interferon (IFN). Patients completed 4 PRO assessment instruments (SF-36, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire- HCV, Work Productivity and Activity-Specific Health Problem) before, during, and after treatment.A total of 533 patients with chronic HCV were enrolled; 28.9% treatment-naive, 23.1% cirrhotic, 219 received IFN + SOF + RBV and 314 received IFN-free SOF + RBV. At baseline, there were no differences in PROs between the IFN-free and IFN-containing treatment arms (all P > 0.05). During treatment, patients receiving IFN + SOF + RBV had a substantial impairment in their PROs (up to -24.4% by treatment week 12, up to -8.3% at week 4 post-treatment). The PRO decrements seen in the SOF + RBV arm were smaller in magnitude (up to -7.1% by treatment week 12), and all returned to baseline or improved by post-treatment week 4. By 12 weeks after treatment cessation, patients who achieved sustained viral response-12 showed some improvement of PRO scores regardless of the regimen (up to +7.1%, P < 0.0001) or previous treatment experience. In multivariate analysis, the use of IFN was independently associated with lower PROs.IFN-based regimens have a profoundly negative impact to PROs. By contrast, the impact of RBV on these PROs is relatively modest. Achieving HCV cure is associated with improvement of most of the PRO scores.","Younossi, Z. M., et al. (2017). \"Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity.\" Medicine (Baltimore) 96(7): e5914.","Spain",2017,"Infectious disease","Sofosbuvir,Other Drugs","FACIT-F"]
[334,"Younossi, Z. M., et al. (2016). \"Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus.\" J Viral Hepat 23(8): 623-630.",null,"Younossi, Z. M., et al.","Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus","Patients with HCV infection have reduced work productivity (WP), in terms of both presenteeism (impairment in work productivity while working) and absenteeism (productivity loss due to absence from work). The aim of this study was to identify clinical and patient-reported factors that are predictive of WP in HCV-infected patients. HCV-infected patients enrolled in clinical trials completed 3 PRO questionnaires (CLDQ-HCV, SF-36 and FACIT-F) and one work productivity (WPAI:SHP) questionnaire. In employed subjects, work productivity and its absenteeism and presenteeism components were calculated using WPAI:SHP instrument. Of 4121 HCV-infected patients with work productivity data, 2480 (60.2%) reported to be employed, and of those, 2190 had completed all PRO questionnaires before treatment initiation. Of the study cohort, 519/2190 (23.7%) had severe work impairment. In multiple linear regression analysis, work productivity was predicted by lower scores in activity/energy domain of CLDQ-HCV, physical well-being domain of FACIT-F, worry domain of CLDQ-HCV and role physical domain of SF-36 (all P < 0.0005). Furthermore, presenteeism was independently predicted by the activity/energy of CLDQ-HCV, physical well-being of FACIT-F, worry domain of CLDQ-HCV, role physical scale of SF-36 and fatigue scale of FACIT-F (P < 0.002). Finally, absenteeism was independently predicted by physical well-being scale of FACIT-F and role physical scale of SF-36 (all P < 0.002). Clinically, work productivity impairment was predicted by the presence of cirrhosis, anxiety, depression and clinically overt fatigue (P < 0.01). Thus, the most important drivers of WP in HCV are impairment of physical aspects of PROs and clinical history of depression, anxiety, fatigue and cirrhosis.","Younossi, Z. M., et al. (2016). \"Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus.\" J Viral Hepat 23(8): 623-630.","USA",2016,"Infectious disease","None","FACIT-F"]
[335,"Younossi, Z. M., et al. (2016). \"The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study.\" Liver Int 36(1): 42-48.",null,"Younossi, Z. M., et al.","The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study","BACKGROUND: Interferon- and ribavirin (RBV)-free regimens can improve patient-reported outcomes (PROs) during treatment. AIM: To compare PROs during treatment with ledipasvir and sofosbuvir (LDV/SOF) to placebo and to LDV/SOF + RBV. METHODS: Treatment-experienced CH-C genotype 1 patients with compensated cirrhosis (N = 154) were randomized to receive 24 weeks of LDV/SOF or 12 weeks of placebo followed by 12 weeks of LDV/SOF + RBV (the SIRIUS clinical trial). While blinded to their HCV RNA level and study treatment, patients completed PRO questionnaires (SF-36, FACIT-F, CLDQ-HCV, WPAI:SHP) at baseline, during and post-treatment. RESULTS: Baseline PRO scores were similar between the two study arms. Patients receiving LDV/SOF showed improvement in a number of PROs (predominantly related to mental health) starting as early as 4 weeks after treatment initiation; no PRO decrement from baseline were noted, and no PRO scores were inferior to placebo (all P > 0.05). In the second 12 weeks, patients who were receiving LDV/SOF continued to improve PROs (up to +9.2% from a 100% maximum possible score, P < 0.05), while patients receiving LDV/SOF + RBV had less gains or no improvement in their PRO scores. However, regardless of the regimen, patients who successfully cleared the virus (N = 149) had significant improvement in all aspects of PROs (up to +12.2% by post-treatment week 12, up to +16.9% by week 24). CONCLUSIONS: Treatment-experienced cirrhotic patients experience a notable improvement of their PROs during treatment with LDV/SOF. Furthermore, achieving SVR-12 is associated with significant PRO improvement, which further improves at post-treatment week 24 in this difficult to treat group of patients with chronic hepatitis C.","Younossi, Z. M., et al. (2016). \"The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study.\" Liver Int 36(1): 42-48.","USA",2016,"Infectious disease","Ledipasvir,Sofosbuvir","FACIT-F"]
[336,"Younossi, Z. M., et al. (2016). \"Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.\" J Viral Hepat 23(11): 857-865.",null,"Younossi, Z. M., et al.","Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus","A fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for treatment of HCV patients. We assessed the effect of LDV/SOF on patient-reported outcomes (PROs) in HIV-HCV-co-infected patients. Patient-reported outcomes data from HIV-HCV-co-infected patients who were treated with LDV/SOF for 12 weeks were collected as a part of a clinical trial (ION-4). Historical controls were HIV-HCV-co-infected patients treated with SOF and ribavirin (RBV) in PHOTON-1. We included 335 HIV-HCV-co-infected patients (SVR-12 in HCV genotype 1 was 96%) who received LDV/SOF, while 223 patients (SVR-12 in HCV genotype 1 was 76.3%) received SOF/RBV. During treatment, patients receiving LDV/SOF showed improvement in all of their PRO scores (+6.0% in activity/energy of CLDQ-HCV, +5.0% in fatigue score of FACIT-F, +6.8% in physical component of SF-36; all P < 0.0001) while those receiving SOF+RBV showed moderate decline in some of their PRO scores (-4.8% in physical functioning of SF-36, -4.4% in fatigue score of FACIT-F, both P < 0.001). Patients who achieved sustained virologic response with LDV/SOF also showed improvement of PROs (average +5.1%) while those treated with SOF/RBV showed less or no improvement (average +1.4%). In a multivariate analysis, in addition to depression and fatigue, receiving SOF+RBV (vs LDV/SOF) was independently associated with more PRO impairment during treatment (beta -6.1 to -12.1%, P < 0.001). Hence, HIV-HCV patients treated with LDV/SOF show significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation.","Younossi, Z. M., et al. (2016). \"Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.\" J Viral Hepat 23(11): 857-865.","USA",2016,"Infectious disease","Sofosbuvir,Ledipasvir","FACIT-F"]
[337,"Yun, Y. H., et al. (2012). \"Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial.\" J Clin Oncol 30(12): 1296-1303.",null,"Yun, Y. H., et al.","Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial","PURPOSE: To determine whether an Internet-based tailored education program is effective for disease-free cancer survivors with cancer-related fatigue (CRF). PATIENTS AND METHODS: We randomly assigned patients who had completed primary cancer treatment within the past 24 months in any of four Korean hospitals and had reported moderate to severe fatigue for at least 1 week to participate in a 12-week, Internet-based, individually tailored CRF education program or to receive routine care. We based the program on the CRF guidelines of the National Comprehensive Cancer Network (NCCN) and incorporated the transtheoretic model (TTM). At baseline and 12 weeks, we used the Brief Fatigue Inventory (BFI) and Fatigue Severity Scale (FSS) as primary outcomes and the Hospital Anxiety and Depression Scale (HADS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) for secondary outcomes. RESULTS: We recruited 273 participants and randomly assigned 136 to the intervention group. Compared with the control group, the intervention group had an improvement in fatigue as shown by a significantly greater decrease in BFI global score (-0.66 points; 95% CI -1.04 to -0.27) and FSS total score (-0.49; 95% CI, -0.78 to -0.21). In secondary outcomes, the intervention group experienced a significantly greater decrease in HADS anxiety score (-0.90; 95% CI, -1.51 to -0.29) as well as global quality of life (5.22; 95% CI, 0.93 to 9.50) and several functioning scores of the EORTC QLQ-C30. CONCLUSION: An Internet-based education program based on NCCN guidelines and TTM may help patients manage CRF.","Yun, Y. H., et al. (2012). \"Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial.\" J Clin Oncol 30(12): 1296-1303.","Korea",2012,"Cancer","Psychobehavioural","BFI,FSS"]
[338,"Yun, Y. H., et al. (2005). \"Validation study of the korean version of the brief fatigue inventory.\" J Pain Symptom Manage 29(2): 165-172.",null,"Yun, Y. H., et al.","Validation study of the korean version of the brief fatigue inventory","The goal of this study was to evaluate the reliability and validity of the Korean version of the Brief Fatigue Inventory (BFI-K). One hundred seventy-eight cancer patients and the same number of age- and sex-matched control subjects completed the BFI-K, the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30), the Beck Depression Inventory (BDI), and a Brief Pain Inventory (BPI). The Cronbach's alpha coefficient for the BFI-K was 0.956 in the cancer patient group and 0.955 in the control group. The global score and nine of the single item scores for the BFI-K were significantly correlated with the fatigue and global health status/QoL subscale of the EORTC QLQ-C30, BDI, and BPI (coefficient range 0.38-0.66). Discriminant validity showed that BFI-K could distinguish significant differences of performance status between subgroups of patients, and between the cancer patient group and the control group, as expected. Our study has shown that the BFI-K is a reliable, valid self-rating instrument in terms of its psychometric properties.","Yun, Y. H., et al. (2005). \"Validation study of the korean version of the brief fatigue inventory.\" J Pain Symptom Manage 29(2): 165-172.","Korea",2005,"Cancer","None","BFI"]
[339,"Zick, S. M., et al. (2016). \"Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.\" JAMA Oncol 2(11): 1470-1476.",null,"Zick, S. M., et al.","Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial","Importance: Fatigue is a common and debilitating late-term effect of breast cancer that is associated with poor sleep and decreased quality of life, yet therapies remain limited. Acupressure has reduced fatigue in previous small studies, but rigorous clinical trials are needed. Objectives: To investigate if 6 weeks of 2 types of self-administered acupressure improved fatigue, sleep, and quality of life vs usual care in breast cancer survivors and to determine if changes were sustained during a 4-week washout period. Design, Setting, and Participants: Phase 3 randomized, single-blind, clinical trial conducted from March 1, 2011, through October 31, 2014. Women were recruited from the Michigan Tumor Registry. Interventions: Randomization (1:1:1) to 6 weeks of daily self-administered relaxing acupressure, stimulating acupressure, or usual care. Main Outcomes and Measures: The primary outcome was change in the Brief Fatigue Inventory score from baseline to weeks 6 and 10. Secondary analyses were sleep (Pittsburgh Sleep Quality Index) and quality of life (Long-Term Quality of Life Instrument). Results: A total of 424 survivors of stages 0 to III breast cancer who had completed cancer treatments at least 12 months previously were screened, and 288 were randomized, with 270 receiving relaxing acupressure (n = 94), stimulating acupressure (n = 90), or usual care (n = 86). One woman withdrew owing to bruising at the acupoints. At week 6, the percentages of participants who achieved normal fatigue levels (Brief Fatigue Inventory score <4) were 66.2% (49 of 74) in relaxing acupressure, 60.9% (42 of 70) in stimulating acupressure, and 31.3% (26 of 84) in usual care. At week 10, a total of 56.3% (40 of 71) in relaxing acupressure, 60.9% (42 of 69) in stimulating acupressure, and 30.1% (25 of 83) in usual care continued to have normal fatigue. At neither time point were the 2 acupressure groups significantly different. Relaxing acupressure, but not stimulating acupressure, showed significant improvements in sleep quality compared with usual care at week 6, but not at week 10. Only relaxing acupressure significantly improved quality of life vs usual care at weeks 6 and 10. Conclusions and Relevance: Both acupressure arms significantly reduced persistent fatigue compared with usual care, but only relaxing acupressure had significant effects on sleep quality and quality of life. Relaxing acupressure offers a possible low-cost option for managing symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT01281904.","Zick, S. M., et al. (2016). \"Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.\" JAMA Oncol 2(11): 1470-1476.","USA",2016,"Cancer","Complementary","BFI"]
[340,"Zick, S. M., et al. (2012). \"Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial.\" BMC Complement Altern Med 12: 132.",null,"Zick, S. M., et al.","Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial","BACKGROUND: Despite high levels of clinically significant persistent cancer related fatigue in breast cancer survivors few treatments are currently available and most pose a significant burden on the part of the woman. Acupressure, a component of Traditional Chinese Medicine, has been shown to decrease fatigue levels by as much as 70% in cancer survivors while being inexpensive, non-toxic and an easy to use intervention. The primary aim of this study was to determine the efficacy of two types of self-administered acupressure (relaxation acupressure and stimulating acupressure), compared to standard of care on fatigue severity. Secondary aims were to evaluate the efficacy of two types of acupressure on sleep and kinetic parameters required for implementation of acupressure in a clinical setting; The purpose of this paper is to share the methodology used including challenges and insights. METHODS/DESIGN: This study is a three group, randomized clinical trial. 375 breast cancer survivors at least 12 months after completion of cancer treatments, with moderate to severe persistent fatigue, are being randomized to one of 3 groups: self-administered relaxation acupressure; self-administered stimulating acupressure; or standard of care. Participants are assessed at baseline, 3 weeks, and 6 weeks followed by a 4-week follow-up period. The primary aim is to examine the effect of 6-weeks of relaxation acupressure compared to stimulatory acupressure or standard of care on fatigue as assessed by: weekly self-report using the Brief Fatigue Inventory; objective daytime physical activity on actigraph; or fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include depression, anxiety, self-efficacy, and sleep quality. DISCUSSION: This study has the potential to develop a low-cost, self-care intervention for the most troubling of late-term effects in breast cancer populations, fatigue. The methods used may lend constructive ideas to other investigators working with this population and/or intervention. TRIAL REGISTRATION: ClinicalTrial.Gov Trials Register NCT01281904.","Zick, S. M., et al. (2012). \"Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial.\" BMC Complement Altern Med 12: 132.","USA",2012,"Cancer","Complementary","BFI,VAS-F"]
[341,"Zifko, U. A., et al. (2002). \"Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.\" J Neurol 249(8): 983-987.",null,"Zifko, U. A., et al.","Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study","BACKGROUND: Modafinil is a unique wake-promoting agent that is chemically distinct from traditional stimulants. Results of a placebo-controlled study showed it to improve fatigue in multiple sclerosis (MS) at a dose of 200 mg daily, but not at a dose of 400 mg daily. OBJECTIVE: To establish the efficacy, safety and appropriate dose of modafinil in the treatment of fatigue and sleepiness in patients with multiple sclerosis. METHOD: A total of 50 patients diagnosed with MS (mean age 40.4 +/- 10.3 years, 30 females/20 males; MS type: 36 relapsing remitting, 1 primary progressive, 13 secondary progressive; mean disability level 3.8 +/- 1.5 on the Kurtzke EDSS) and complaining of chronic fatigue were enrolled in a prospective 3-month, two-center, open-label study. Efficacy was evaluated with the Fatigue Severity Scale (FSS, score range 0-42), the Epworth Sleepiness Scale (ESS, score range 0-24) and by subjective patient appraisal of change of fatigue, quality of life and overall satisfaction with treatment. Adverse effects (AEs) were recorded throughout the study. Treatment was started with a single daily dose of 100 mg in all patients. In non-responders the dose was increased by 100 mg increments up to a maximum daily dose of 400 mg. RESULTS: Three patients discontinued modafinil because of AEs (nervousness, dizziness). Two patients (4 %) were treated with 50 mg, 25 (50 %) with 100 mg, 21 (42 %) with 200 mg and 2 (4 %) with 300 mg daily. No patient required 400 mg daily. Mean FSS scores were 30.3 +/- 8.5 at baseline and 25.4 +/- 3.7 at 3 months (p < 0.0001). Mean ESS scores were 9.7 +/- 3.9 at baseline and 4.9 +/- 2.9 at 3 months (p < 0.0001). Self-appraisal of change of fatigue showed clear improvement in 41 patients (87.2 %), some improvement in 4 (8.5 %) and no change in 2 (4.3 %). Overall clinical condition was clearly improved in 43 patients (91.5 %), somewhat improved in 1 patient (2.1 %), and unchanged in 3 patients (6.4 %). No patient reported worsening of overall clinical condition. CONCLUSIONS: Treatment with modafinil significantly improves fatigue and sleepiness and is well tolerated by patients with MS. Unlike the higher dose regimen required in narcolepsy, a low-dose regimen of modafinil is effective in MS.","Zifko, U. A., et al. (2002). \"Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.\" J Neurol 249(8): 983-987.","Austria",2002,"Neurological","Other Drugs","FSS"]

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[]
["Acronym","Full name","Type of PRO tool (if relevant)"]
["15D",null,"General"]
["ABC","Activities-specific Balance Confidence Scal","Symptom"]
["AUA-SI","American Urological Association Symptom Index","Complication"]
["BAI","Beck Anxiety Inventory","Comorbidity"]
["BDI","Beck Depression Inventory","Comorbidity"]
["BFS","Bruera Global Fatigue Severity Scale ","Symptom"]
["BHS","Beck Hopelessness Scale","Comorbidity"]
["BiFS","Bidimensional Fatigue Scale","Symptom"]
["BIS","Body Image Scale","Treatment"]
["BPI","Brief Pain Inventory","Symptom"]
["BSFI","Brief Sexual Function Inventory","Complication"]
["BSI","Brief Symptom Inventory","Symptom"]
["BSP-PC","Bononian Satisfaction Profile-Prostate Cancer","Treatment"]
["CARDI","Colon and Ano-Rectal Distress Inventory","Complication"]
["CARES-SF","Cancer Rehabilitation Evaluation System Short Form","Treatment"]
["CARIQ","Colon and Ano-Rectal Impact Questionnaire","Complication"]
["CAVIPRES-30","Prostate cancer-specific instrument","Disease"]
["CCCI","Coping with Cancer Instrument ","General"]
["CCFIS","Cleveland Clinic Fecal Incontinence Score","Complication"]
["CES-D","Center for Epidemiological Studies-Depression Scale","Comorbidity"]
["CHAMPS","Community Healthy Activities Model Program for Seniors","General"]
["CILFS","Cancer Interference with Life and Family Scale","Carer"]
["Cleary-30","Cleary 30-item questionnaire","General"]
["CLSS","Core Lower Urinary Tract Symptom Score","Symptom"]
["COIN","Collection of Indirect and Nonmedical Direct Costs","Costs"]
["CPQ","Cologne Patient Questionnaire","General"]
["CQOLC"," Caregiver Quality of Life Index-Cancer","Carer"]
["CSQ-8","Customer Satisfaction Questionnaire","Treatment"]
["CTCAE","Common Terminology Criteria for Adverse Events","Complication"]
["CTS","Cancer Treatment Scale","Treatment"]
["CUF","Changes in Urinary Function","Symptom"]
["DASS-21"," Depression, Anxiety and Stress Scale","Comorbidity"]
["DUKE","Duke Health Profile","General"]
["ED-EQoL","Erectile Dysfunction effect on QoL","Complication"]
["EMPK","Erfassung multipler psychischer Konstrukte","General"]
["EORTC QLQ-C30","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30","General"]
["EORTC QLQ-INFO25","European Organisation for Research and Treatment of Cancer Information Module","Knowledge"]
["EORTC QLQ-PR25","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate","Disease"]
["EORTC QLQ-PRT23","European Organization for Research and Treatment of Cancer Quality of Life -Proctitis","Complication"]
["EORTC-8D","European Organization for Research and Treatment of Cancer Utility index","Utility"]
["EPIC","Expanded Prostate Cancer Index Composite","Disease"]
["EPInv","Eysenck Personality Inventory","General"]
["EQ-5D","EuroQol Quality of Life","Utility"]
["EQ-VAS","EQ-5D Visual Analogue Scale","Utility"]
["ESAS","Edmonton Symptom Assessment Scale","Symptom"]
["FACIT-F","Functional Assessment of Chronic Illness Therapy - Fatigue Scale","Symptom"]
["FACT-F","Functional Assessment of Cancer Therapy: Fatigue ","Symptom"]
["FACT-G","Functional Assessment of Cancer Therapy-General","Treatment"]
["FACT-P","Functional Assessment of Cancer Therapy-Prostate","Disease"]
["FACT-TOI","Functional Assessment of Cancer Therapy-Treatment Outcome Index","Treatment"]
["FAIT-U","Functional Assessment of Incontinence Therapy-Urinary","Complication"]
["FAPSI-8","FACT Advanced Prostate Symptom Index-8","Disease"]
["FCRI","Fear of Cancer Recurrence Inventory","Disease"]
["FFQ","Food Frequency Questionnaire","General"]
["FLIC","Functional Living Index-Cancer","General"]
["GHI","General Health Index","General"]
["GISEQ","Gastrointestinal Side Effects Questionnaire","Complication"]
["HADS","Hospital Anxiety and Depression Scale","Comorbidity"]
["HCP","Healthcare professional"]
["HIFU","High intensity focused ultrasound"]
["HSC","Hopkins Symptom Checklist","Symptom"]
["HSQ","Health Status Questionnaire ","General"]
["HUI","Health Utility Index","Utility"]
["IBDQ","Inflammatory Bowel Disease Questionnaire","Complication"]
["ICIQ","International Consultation on Incontinence Modular Questionnaire","Complication"]
["ICI-SF","IPSS bother score and incontinence questionnaire","Complication"]
["ICSQ","International Continence Society Questionnaire","Complication"]
["IES","Impact of Event Scale","Complication"]
["IIEF","International Index of Erectile Function-5","Complication"]
["IIQ","Incontinence Impact Questionnaire","Complication"]
["IOC","Impact of Cancer","General"]
["IPAQ","International Physical Activity Questionnaire","General"]
["IPSS","International Prostate Symptom Score","Disease"]
["I-QoL","Incontinence Quality of Life Instrument","Complication"]
["ISvI","Insomnia Severity Index","Symptom"]
["ISyI","Incontinence Symptom Index ","Complication"]
["JOL","Joy-Of-Life Questionnaire","General"]
["KHQ","King's Health Questionnaire","General"]
["KUJ","Knowledge of cancer, Understanding treatment choices and Judgement of survival scale","Treatment"]
["LASA","Linear analog self-assessment scale","General"]
["LENT","Late Effects in Normal Tissues","Treatment"]
["LENT-SOMA","Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic scales","Treatment"]
["MASPC","Memorial Anxiety Scale for Prostate Cancer","Comorbidity"]
["MFI","Multidimensional Fatigue Inventory","Symptom"]
["MHI","Mental Health Index","Comorbidity"]
["MMAC","Mini-Mental Adjustment to Cancer","Disease"]
["MOS-MHI","MOS Mental Health Index","Comorbidity"]
["MOS-SP","MOS Sexual Problems ","Complication"]
["MOS-SSS","Medical Outcomes Study Social Support Survey","Social"]
["MPQ-PPI","McGill Pain Questionnaire Present Pain Intensity","Symptom"]
["MSAS","Memorial Symptom Assessment Scale","Symptom"]
["MUDI","Male Urogenital Distress Inventory","Complication"]
["MUSIQ"," Male Urinary Symptom Impact Questionnaire","Complication"]
["MYCWB","Measure Yourself Concerns and Well-Being","General"]
["NHP","Nottingham Health Profile ","General"]
["NPS","Numeric Pain Scale","Symptom"]
["OSGA","Ottery's Subjective Global Assessment","General"]
["PAIS","Psychological Adjustment to Illness Self-report Scale","General"]
["PBQ","Prostate Brachytherapy Questionnaire","Treatment"]
["PCIn","Prostate Cancer Index ","Disease"]
["PCKQ","Prostate Cancer Knowledge Questionnaire","Knowledge"]
["PC-QoL","Prostate cancer- Quality of Life","Disease"]
["PCRT-PCQoL","Prostate Cancer Radiotherapy Quality of Life Questionnaire","Treatment"]
["PCSI","Prostate Cancer Symptom Indices","Symptom"]
["PCSQLI","Prostate Cancer Specific Quality of Life Instrument","Disease"]
["PCTO-Q","Prostate Cancer Treatment Outcome Questionnaire","Treatment"]
["PDEi","Phosphodiesterase inhibitors"]
["PGI-I","Patient Global Impression of Improvement","Treatment"]
["PHQ-9","Patient Health Questionnaire","Comorbidity"]
["POMS","Profile of Mood States","Comorbidity"]
["PORPUS","Patient-Oriented Prostate Utility Scale","Disease"]
["PORT","Prostate Outcomes Research Team prostate cancer treatment complication profile","Treatment"]
["POSAS","Patient and Observer Scar Assessment Questionnair","Treatment"]
["PPB","Physical Performance Battery","Symptom"]
["PPP","Prostate Cancer Patient & Partner questionnaire","Disease"]
["PROMIS","Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form","Symptom"]
["PROSQoLI ","Prostate cancer Quality of Life ","Disease"]
["PSM-G","Prostate-specific instrument","Disease"]
["PSS"," Perceived Stress Scale","General"]
["PSSR","Prostate Symptom Self-Report","Disease"]
["PVP","PatientViewpoint","General"]
["QLACS","Quality of Life in Adult Cancer Survivors","General"]
["QLI","Quality of Life Index","General"]
["QOL-CS","Quality of Life - Cancer Survivor","General"]
["QOLM-P14","Quality of Life Module-Prostate 14","Disease"]
["QUFW94","Prostate cancer specific symptom questionnaire","Disease"]
["QWB","Quality of Well-Being Scale","General"]
["R-FAS","Rectal Function Assessment Score","Complication"]
["RMS","Royal Marsden Scale","Treatment"]
["RS","Rating Scale","Utility"]
["RSCL","Rotterdam Symptom Checklist","General"]
["RT-ARD","Condensed Anorectal Dysfunction Score","Complication"]
["RTOG-EORTC-SS","Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema","Complication"]
["SActQ"," Sexual Activity questionnaire","Complication"]
["SAQ","Sexual Adjustment Questionnaire","Complication"]
["SCL-90","Symptom Checklist-90","Symptom"]
["SCN-SF34","Supportive Care Needs Survey-SF34 Revised","Social"]
["SF-12","Medical Outcomes Study Short Form Health Survey-12","Utility"]
["SF-36","Medical Outcomes Study Short Form Health Survey SF-36","Utility"]
["SF-8","Medical Outcome Study 8-Item Short-Form Health Survey","Utility"]
["SFI","Sexual function Index","Complication"]
["SFQ","Sapporo Medical University Sexual Function Questionnaire","Complication"]
["SFQ","Sexuality Follow-up Questionnaire","Complication"]
["SG","Standard Gamble","Utility"]
["SHIM","Sexual Health Inventory for Men","Complication"]
["SIP","Sickness Impact Profile","General"]
["SOC","Sense of Coherence ","General"]
["SQLU","Selby's QL Uniscale","General"]
["SSQ","Subjective Significance Questionnaire","General"]
["STAI","State-Trait Anxiety Inventory","Comorbidity"]
["STAR","Symptom Tracking and Reporting","Symptom"]
["SUPPH","Strategies Used by Patients to Promote Health","General"]
["SWBS","Spiritual Well-Being Scale","General"]
["SWLS","Satisfaction With Life Scale","General"]
["SWOG-QLQ","Southwest Oncology Group Quality of Life Questionnaire","General"]
["TIBI-P","Total Illness Burden Index-Prostate","Comorbidity"]
["TOI","Trial Outcome Index","Treatment"]
["TTO","Time Trade-Off","Utility"]
["UCLA-PCI","UCLA Prostate Cancer Index","Disease"]
["UCLA-SFS","University of California-Los Angeles Sexual Functioning Scale","Complication"]
["UFQ-RP","Urinary Function Questionnaire for men after RP","Complication"]
["U-Titer","U-Titer","Utility"]
["UWIN","Urgency, weak stream, incomplete emptying and nocturia","Complication"]
["VAS","Visual analogue scale","General"]
["VRS","Verbal Rating Scale","General"]
["WHO-Pain","WHO Pain Score","Symptom"]
["WHO-PS","WHO Performance Status","General"]
["WHOQOL","World Health Organization Quality of Life scale","General"]
["WHOQOL-BREF","World Health Organization Quality of Life scale-BREF","General"]
["WHOQOL-OLD","World Health Organization Quality of Life scale for the elderly","General"]
["WOC","Ways of Coping Scale ","General"]
["WSFQ"," Watt's Sexual Function Questionnaire","Complication"]
["WTP","Willingness to Pay","Utility"]

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[1,"Aadahl,M.,et al. (2002). \"Fatigue and physical function after orthotopic liver transplantation.\" Liver Transpl 8(3): 251-259.",null,"Aadahl,M.,et al.","Fatigue and physical function after orthotopic liver transplantation","Over the last two decades,orthotopic liver transplantation (OLT) has become an established treatment for acute and chronic liver failure. OLT impacts not only on survival,but also on health-related quality of life. This study was undertaken to describe the self-rated health of Danish liver transplant recipients,compare their self-rated health against that of the general population,and to investigate associations between sex,age,diagnosis,time after OLT,and postoperative physical function and fatigue. All adult surviving liver transplant recipients who underwent OLT in Copenhagen,Denmark,from 1990 to 1998 (n = 154) were contacted by mail and asked to complete a self-administered questionnaire. The questionnaire contained the 36-Item Short Form Health Survey,the Multidimensional Fatigue Inventory,the Hospital Anxiety and Depression Scale,and questions on marital status,education,and work. The response rate was 84.4% (n = 130). Liver transplant recipients reported poorer self-rated health than the general population in physical,but not in mental,health areas. One health aspect,fatigue,was investigated in great detail. This study found that liver transplant recipients experienced physical,rather than mental,fatigue. Diagnosis was found to be a predictor of postoperative physical function and fatigue because patients with an alcoholic or cryptogenic cirrhosis background had significantly poorer physical function and experienced more physical fatigue than liver transplant recipients with other diagnoses. Work status and survival time after OLT had significant effects on postoperative physical function and fatigue. Working and having undergone transplantation 4 to 5 years previously were associated with significantly better physical function and less physical fatigue than not working and having undergone transplantation 1 to 3 years previously. This study suggests that liver transplant recipients experience physical,rather than mental,impairment and fatigue and that diagnosis,work status,and survival time after OLT are associated with physical function and fatigue.","Aadahl,M.,et al. (2002). \"Fatigue and physical function after orthotopic liver transplantation.\" Liver Transpl 8(3): 251-259.","Denmark",2002,"Liver Disease","Surgery","MFI",null,null,null,"Denmark",null,"Liver Disease","Surgery",null,null,"MFI","2000:2004"]
[2,"Abernethy,A. P.,et al. (2010). \"Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.\" J Pain Symptom Manage 40(4): 545-558.",null,"Abernethy,A. P.,et al.","Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients","CONTEXT: The Patient Care Monitor (PCM) is a review of systems survey delivered by means of an electronic patient-reported outcomes (ePRO) data capture system that uses wireless tablet computers. Although the PCM 1.0 is validated,the updated PCM 2.0 has not been validated nor tested in the academic setting. OBJECTIVES: To validate and test the PCM 2.0 in three cancer populations. METHODS: Two hundred seventy-five individuals participated in three clinical trials enrolling breast (n=65),gastrointestinal (n=113),and lung (n=97) cancer patients. Internal consistency was evaluated using Cronbach's alpha coefficients calculated for six PCM subscales (general physical symptoms,treatment side effects,distress,despair,impaired performance,and impaired ambulation) and a Quality-of-Life Index. Construct validity was evaluated through Pearson's correlation between PCM subscales and subscales of the Functional Assessment of Cancer Therapy--General (FACT-G),the M.D. Anderson Symptom Inventory (MDASI),and the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F). The participants had the following characteristics: mean age was 58 years (standard deviation: 11),52% were females,79% were whites,17% were blacks,62% had no college degree,and 78% had metastatic or recurrent disease. RESULTS: Raw and normalized scores for PCM 2.0 subscales were internally consistent across study cohorts. PCM 2.0 subscales correlated significantly (P<0.05) with the corresponding subscales on FACT-G,MDASI,and FACIT-F,with the exception of FACT-G social well-being,particularly for the lung cancer population. These correlations demonstrated construct validity. PCM 2.0 results followed expected patterns by cancer etiology. Prior reports demonstrate patient satisfaction with PCM 2.0. CONCLUSION: Within three unique academic oncology populations,PCM 2.0 is a valid ePRO instrument for assessing symptoms with seven patient-centered subscale or index domains.","Abernethy,A. P.,et al. (2010). \"Validation of the Patient Care Monitor (Version 2.0): a review of system assessment instrument for cancer patients.\" J Pain Symptom Manage 40(4): 545-558.","USA",2010,"Cancer","None","FACIT-F",null,null,null,"USA",null,"Cancer","None",null,null,"FACIT-F","2010:2014"]
[3,"Alsen,P.,et al. (2010). \"Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life.\" J Cardiovasc Nurs 25(2): E1-e10.",null,"Alsen,P.,et al.","Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life","BACKGROUND AND RESEARCH OBJECTIVE: : Health-related quality of life (HRQoL) is impaired in patients after a myocardial infarction (MI),and fatigue and depression are common health complaints among these patients. Patients' own beliefs about their illness (illness perceptions) influence health behavior and health outcomes. The aim of the present study was to examine illness perception and its association with self-reported HRQoL,fatigue,and emotional distress among patients with MI. SUBJECTS AND METHODS: : The sample consisted of 204 patients who had had MI and who completed the questionnaires during the first week in the hospital and 4 months after the MI. The questionnaires used were the Illness Perception Questionnaire,Multidimensional Fatigue Inventory,Hospital Anxiety and Depression Scale,and the Short Form Health Survey (SF-36). RESULTS: : Patient's illness perception changed over time from a more acute to a more chronic perception of illness,and beliefs in personal and treatment control of MI had decreased. Furthermore,these negative beliefs were associated with worse experiences of fatigue and lowered HRQoL. CONCLUSIONS: : Patients' illness perceptions influence health outcomes after an MI. Supporting MI patients in increasing their perception of personal control could be a primary nursing strategy in rehabilitation programs aimed at facilitating health behavior,decreasing experiences of fatigue,and increasing HRQoL.","Alsen,P.,et al. (2010). \"Illness perceptions after myocardial infarction: relations to fatigue,emotional distress,and health-related quality of life.\" J Cardiovasc Nurs 25(2): E1-e10.","Sweden",2010,"CVD","None","MFI",null,null,null,"Sweden",null,"CVD","None",null,null,"MFI","2010:2014"]
[4,"Amato,M. P.,et al. (2001). \"Quality of life in multiple sclerosis: the impact of depression,fatigue and disability.\" Mult Scler 7(5): 340-344.",null,"Amato,M. P.,et al.","Quality of life in multiple sclerosis: the impact of depression,fatigue and disability","This study deals with the assessment of quality of life and its main clinical and demographical determinants in a clinical series of 103 patients with multiple sclerosis (MS) (37 men; 66 women; mean age 44.89 years; mean disease duration 12.40 years; mean EDSS score 4.07). We used the MSQOL-54 inventory,a disease-specific instrument recently validated in an Italian population. Each patient underwent a complete clinical assessment,including that of disability status (Expanded Disability Status Scale),cognitive function (Mini Mental State Examination),depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Severity Scale). In terms of Pearson's correlations,there was a moderate inverse relationship between disability level and the MSQOL-54 physical composite score,and a moderate to strong inverse correlation between depression or fatigue severity and both the physical and mental composite scores. In a stepwise linear regression analysis,depression,fatigue and disability level were confirmed to be significant and independent predictors of quality of life. Quality of life instruments can help to provide a broader measure of the disease impact and to develop a care program tailored to the patient's needs.","Amato,M. P.,et al. (2001). \"Quality of life in multiple sclerosis: the impact of depression,fatigue and disability.\" Mult Scler 7(5): 340-344.","Italy",2001,"Neurological","None","FSS",null,null,null,"Italy",null,"Neurological","None",null,null,"FSS","2000:2004"]
[5,"Ameringer,S.,et al. (2016). \"Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.\" Nurs Res 65(4): 279-289.",null,"Ameringer,S.,et al.","Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations","BACKGROUND: The need for reliable,valid tools to measure patient-reported outcomes (PROs) is critical both for research and for evaluating treatment effects in practice. The Patient-Reported Outcomes Measurement Information System Fatigue-Short Form v1.0-Fatigue 7a (PROMIS F-SF) has had limited psychometric evaluation in various populations. OBJECTIVES: The aim of the study is to examine psychometric properties of PROMIS F-SF item responses across various populations. METHODS: Data from five studies with common data elements were used in this secondary analysis. Samples from patients with fibromyalgia,sickle cell disease,cardiometabolic risk,pregnancy,and healthy controls were used. Reliability was estimated using Cronbach's alpha. Dimensionality was evaluated with confirmatory factor analysis. Concurrent validity was evaluated by examining Pearson's correlations between scores from the PROMIS F-SF,the Multidimensional Fatigue Symptom Inventory-Short Form,and the Brief Fatigue Inventory. Discriminant validity was evaluated by examining Pearson's correlations between scores on the PROMIS F-SF and measures of stress and depressive symptoms. Known groups validity was assessed by comparing PROMIS F-SF scores in the clinical samples to healthy controls. RESULTS: Reliability of PROMIS F-SF scores was adequate across samples,ranging from .72 in the pregnancy sample to .88 in healthy controls. Unidimensionality was supported in each sample. Concurrent validity was strong; across the groups,correlations with scores on the Multidimensional Fatigue Symptom Inventory-Short Form and Brief Fatigue Inventory ranged from .60 to .85. Correlations of the PROMIS F-SF with measures of stress and depressive mood were moderate to strong,ranging from .37 to .64. PROMIS F-SF scores were significantly higher in clinical samples compared to healthy controls. DISCUSSION: Reliability and validity of the PROMIS F-SF were acceptable. The PROMIS F-SF is a suitable measure of fatigue across the four diverse clinical populations included in the analysis.","Ameringer,S.,et al. (2016). \"Psychometric Evaluation of the Patient-Reported Outcomes Measurement Information System Fatigue-Short Form Across Diverse Populations.\" Nurs Res 65(4): 279-289.","USA",2016,"Musculoskeletal,Hematological,Various","None","PROMIS-F,MFI,BFI",null,null,null,"USA",null,"Musculoskeletal,Hematological,Various","None",null,null,"PROMIS-F,MFI,BFI","2015:2018"]
[6,"Andela,C. D.,et al. (2016). \"The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary.\" Pituitary 19(3): 293-302.",null,"Andela,C. D.,et al.","The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary","BACKGROUND: Patients report persisting impairment in quality of life (QoL) after treatment for pituitary disease. At present,there is no questionnaire to assess (a) whether patients with pituitary disease are bothered by these consequences,and (b) their needs for support. OBJECTIVE: To develop and validate a disease-specific questionnaire for patients with pituitary disease which incorporates patient perceived bother related to the consequences of the disease,and their needs for support. METHODS: Items for the Leiden Bother and Needs Questionnaire for patients with pituitary disease (LBNQ-Pituitary) were formulated based on results of a recent focus group study (n = 49 items). 337 patients completed the LBNQ-Pituitary and six validated QoL questionnaires (EuroQoL-5D,SF-36,MFI-20,HADS,AcroQol,CushingQoL). Construct validity was examined by exploratory factor analysis. Reliabilities of the subscales were calculated with Cronbach's alphas,and concurrent validity was assessed by calculating Spearman's correlations between the LBNQ-Pituitary and the other measures. RESULTS: Factor analyses produced five subscales (i.e.,mood problems,negative illness perceptions,issues in sexual functioning,physical and cognitive complaints,issues in social functioning) containing a total of 26 items. All factors were found to be reliable (Cronbach's alphas all >/=.765),and the correlations between the dimensions of the LBNQ-Pituitary and other questionnaires (all P </= .0001) demonstrated convergent validity. CONCLUSIONS: The LBNQ-Pituitary can be used to assess the degree to which patients are bothered by the consequences of the pituitary disease,as well as their needs for support. It could also facilitate an efficient assessment of patients' needs for support in clinical practice. We postulate that paying attention to needs for support will lead to optimal patient care (e.g.,improvement in psychosocial care),and positively affect QoL.","Andela,C. D.,et al. (2016). \"The development and validation of the Leiden Bother and Needs Questionnaire for patients with pituitary disease: the LBNQ-Pituitary.\" Pituitary 19(3): 293-302.","Netherlands",2016,"Endocrine","None","MFI",null,null,null,"Netherlands",null,"Endocrine","None",null,null,"MFI","2015:2018"]
[7,"Appels,A.,et al. (2006). \"Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial.\" J Psychosom Res 61(1): 1-7; discussion 9-10.",null,"Appels,A.,et al.","Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial","OBJECTIVES: The EXhaustion Intervention Trial investigated the effect of a behavioural intervention programme on exhaustion,health-related quality of life (HRQL),depression,anxiety,hostility,and anginal complaints in angioplasty patients who felt exhausted after percutaneous coronary intervention (PCI). METHODS: Seven hundred ten patients were randomized into an intervention group and a usual care control group. The group intervention focused on stressors leading to exhaustion and on support of recovery. HRQL (measured by the MacNew questionnaire),exhaustion [measured by the Maastricht Questionnaire and the Maastricht Interview Vital Exhaustion (MIVE)],anxiety (measured by the State-Trait Inventory),and depression (measured by the structured clinical interview for DSM-IV) were assessed at intake and at 6 and 18 months. Presence of anginal complaints was assessed at 18 months. RESULTS: The intervention had a significant beneficial effect on all psychological factors except hostility and on the presence of anginal complaints. The effect of the intervention on exhaustion,as assessed by the MIVE,was modified by a previous history of coronary artery disease (CAD). Gender modified the effect of the intervention on exhaustion and on anxiety,the strongest effect being observed in women. CONCLUSIONS: The behavioural intervention improved HRQL and related psychological factors. Somatic comorbidity and a history of CAD limited the effect of the intervention.","Appels,A.,et al. (2006). \"Effects of a behavioural intervention on quality of life and related variables in angioplasty patients: results of the EXhaustion Intervention Trial.\" J Psychosom Res 61(1): 1-7; discussion 9-10.","Netherlands",2006,"CVD","Psychobehavioural","Maastricht questionnaire,MIVE",null,null,null,"Netherlands",null,"CVD","Psychobehavioural",null,null,"Maastricht questionnaire,MIVE","2005:2009"]
[8,"Arora,S.,et al. (2006). \"Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.\" J Gastroenterol Hepatol 21(2): 406-412.",null,"Arora,S.,et al.","Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life","BACKGROUND: Peginterferon alpha-2a (40 kDa) plus ribavirin is equally effective in chronic hepatitis C patients with normal or elevated alanine aminotransferase (ALT) values. This analysis,in patients with normal ALT levels,compared health-related quality of life (HRQoL) measurements between untreated control patients and treated patients grouped by virological response. HRQoL in the present population was also compared with HRQoL in patients with elevated ALT levels,observed in a previous study. METHODS: A total of 491 patients with persistently normal ALT levels were randomized to peginterferon alpha-2a (40 kDa)/ribavirin for 24 (group A) or 48 weeks (group B) or no treatment for 72 weeks (group C). Quality of life was assessed with valid instruments (self-administered Short Form (SF)-36 Health Survey and Fatigue Severity Scale). RESULTS: In groups A and B,patients with sustained virological responses after combination therapy had significantly better quality of life and less fatigue than patients without sustained responses. Differences were significant for five SF-36 domains,the SF-36 Physical Component score and both Fatigue Severity Scale scores. Viral clearance was not observed in any untreated patients (group C). Comparison with data from elevated ALT patients revealed little difference in baseline quality of life,although normal ALT patients had significantly higher scores related to mental health than elevated ALT patients. CONCLUSIONS: Eradication of HCV with peginterferon alpha-2a (40 kDa) plus ribavirin is associated with better quality of life and less fatigue in normal ALT patients. These patient benefits,coupled with the high probability of eradicating HCV,should be considered in making decisions about treating this population.","Arora,S.,et al. (2006). \"Treatment of chronic hepatitis C patients with persistently normal alanine aminotransferase levels with the combination of peginterferon alpha-2a (40 kDa) plus ribavirin: impact on health-related quality of life.\" J Gastroenterol Hepatol 21(2): 406-412.","USA",2006,"Infectious Disease","Other Drugs","FSS",null,null,null,"USA",null,"Infectious Disease","Other Drugs",null,null,"FSS","2005:2009"]
[9,"Arriens,C.,et al. (2015). \"Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus.\" Nutr J 14: 82.",null,"Arriens,C.,et al.","Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus","INTRODUCTION: A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus (SLE) found reduction of antioxidants and substrates for energy generation. These metabolic alterations may underlie one of the most common features of SLE--fatigue. The metabolomic studies also noted reduced omega-3 fatty acids,which are powerful anti- oxidants. This deficiency may be causally related to oxidative stress,inflammation,disease activity,and fatigue in SLE. Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies. The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue,quality of life,and disease activity as part of a randomized clinical trial. METHODS: Fifty SLE patients recruited in outpatient clinics were randomized 1:1 to fish oil supplementation or olive oil placebo,and blinded to their treatment group. At baseline and after 6 months of treatment,RAND Short Form-36 (RAND SF-36),Fatigue Severity Scale (FSS),SLE Disease Activity Index (SLEDAI),and Physician Global Assessment (PGA) were completed; serum was also collected for soluble mediator analysis. RESULTS: Thirty-two patients completed the study. PGA improved significantly in the fish oil group compared with the placebo group (p = 0.015). The RAND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends (p = 0.092 and 0.070). No clear difference was seen in FSS and SLEDAI (p = 0.350 and p = 0.417). Erythrocyte sedimentation rate and serum IL-12 were reduced (p = 0.008 and p = 0.058); while serum IL-13 was increased by fish oil supplementation (p = 0.033). CONCLUSIONS: In this randomized,placebo-controlled 6-month trial,SLE patients randomized to fish oil supplementation demonstrated improvement in their PGA,RAND SF-36,and some circulating inflammatory markers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).","Arriens,C.,et al. (2015). \"Placebo-controlled randomized clinical trial of fish oil's impact on fatigue,quality of life,and disease activity in Systemic Lupus Erythematosus.\" Nutr J 14: 82.","USA",2015,"Inflamatory Systemic Disease","Complementary","FSS",null,null,null,"USA",null,"Inflamatory Systemic Disease","Complementary",null,null,"FSS","2015:2018"]
[10,"Auret,K. A.,et al. (2009). \"A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer.\" J Pain Symptom Manage 37(4): 613-621.",null,"Auret,K. A.,et al.","A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer","Fatigue is very common in patients with cancer. Current guidelines suggest that psychostimulants are \"reasonable to consider for severe fatigue.\" This randomized,double-blind,placebo-controlled trial investigated the hypothesis that dexamphetamine in fatigued patients with advanced cancer would produce a clinically significant improvement with minimal side effects. Fifty patients with advanced cancer,who were receiving palliative care,were randomized to dexamphetamine 10mg twice daily or placebo for eight days. Effectiveness was assessed using the Brief Fatigue Inventory and the McGill Quality-of-Life Questionnaire. The side effects were recorded. The results were analyzed on an intention-to-treat basis. The baseline demographics,fatigue levels,and quality-of-life scores were similar between the two arms. Patients were elderly,had impaired performance status (Eastern Cooperative Oncology Group score=3),and were taking a range of neurologically active medications. Thirty-nine patients completed the trial. There was a transient improvement in the fatigue levels on day 2,but no significant difference in fatigue (P=0.267) or quality of life (P=0.579) by the end of the study. Statistical modeling did not reveal any significant predictors of response to dexamphetamine. These results suggest that dexamphetamine 20mg daily,although well tolerated,does not significantly improve fatigue or quality of life in patients with advanced cancer,as measured by the selected instruments.","Auret,K. A.,et al. (2009). \"A randomized,double-blind,placebo-controlled trial assessing the impact of dexamphetamine on fatigue in patients with advanced cancer.\" J Pain Symptom Manage 37(4): 613-621.","Australia",2009,"Cancer","Other Drugs","BFI",null,null,null,"Australia",null,"Cancer","Other Drugs",null,null,"BFI","2005:2009"]
[11,"Bae,S. C.,et al. (2013). \"Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis.\" BMC Musculoskelet Disord 14: 13.",null,"Bae,S. C.,et al.","Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis","BACKGROUND: Patient reported outcomes (PROs) are especially useful in assessing treatments for rheumatoid arthritis (RA) since they measure dimensions of health-related quality of life that cannot be captured using strictly objective physiological measures. The aim of this study was to compare the effects of combination etanercept and methotrexate (ETN + MTX) versus combination synthetic disease modifying antirheumatic drugs (DMARDs) and methotrexate (DMARD + MTX) on PRO measures among RA patients from the Asia-Pacific region,a population not widely studied to date. Patients with established moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate were studied. METHODS: Patients were randomized to either ETN + MTX (N = 197) or DMARD + MTX (N = 103) in an open-label,active-comparator,multicenter study,with PRO measures designed as prospective secondary endpoints. The Health Assessment Questionnaire (HAQ),Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue),Medical Outcomes Short Form-36 Health Survey (SF-36),Hospital Anxiety and Depression Scale (HADS) and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) were used. RESULTS: Significantly greater improvements were noted for the ETN + MTX group at week16 for HAQ mean scores and for proportion of patients achieving HAQ score </= 0.5,compared to patients in the DMARD + MTX group. SF-36 Summary Scores for physical and mental components and for 6 of 8 health domains showed significantly greater improvements at week16 for the ETN + MTX group; only scores for physical functioning and role-emotional domains did not differ significantly between the two treatment arms. Greater improvements at week16 were noted for the ETN + MTX group for FACIT-Fatigue,HADS,and WPAI:GH mean scores. CONCLUSION: Combination therapy using ETN + MTX demonstrated superior improvements using a comprehensive set of PRO measures,compared to combination therapy with usual standard of care DMARDs plus MTX in patients with established rheumatoid arthritis from the Asia-Pacific region. TRIAL REGISTRATION: clintrials.gov # NCT00422227.","Bae,S. C.,et al. (2013). \"Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis.\" BMC Musculoskelet Disord 14: 13.","Korea",2013,"Musculoskeletal","Etanercept,Other Drugs","FACIT-F",null,null,null,"Korea",null,"Musculoskeletal","Etanercept,Other Drugs",null,null,"FACIT-F","2010:2014"]
[12,"Bansi,J.,et al. (2013). \"Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue.\" J Neurol 260(12): 2993-3001.",null,"Bansi,J.,et al.","Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue","The influences of exercise on cytokine response,health-related quality of life (HR-QoL),and fatigue are important aspects of MS rehabilitation. Physical exercises performed within these programs are often practiced in water,but the effects of immersion have not been investigated. To investigate the influences of short-term immune responses and cardiorespiratory fitness on HR-QoL and fatigue during 3 weeks endurance training conducted on a cycle-ergometer or an aquatic-bike. Randomized controlled clinical trial in 60 MS patients. HR-QoL,fatigue,cardiorespiratory fitness,and short-term immune changes (serum concentrations in response to cardiopulmonary exercise test) of brain-derived neurotrophic factor (BDNF),nerve growth factor (NGF),interleukin-6,and the soluble receptor of IL-6 (sIL-6R) were determined at the beginning and end of 3 weeks of training intervention. Subjects performed daily 30 min training at 60 % of their VO2peak. SF-36 total (p = 0.031),physical (p = 0.004),and mental health (p = 0.057) scores show time effects within both groups. Between-group effects were shown for FSMC total (p = 0.040) and motor function score (p = 0.041). MFIS physical fatigue showed time effects (p = 0.008) for both groups. Linear regression models showed relationships between short-term immune responses and cardiorespiratory fitness with HR-QoL and fatigue after the intervention. This study indicates beneficial effects of endurance training independent of the training setting. Short-term immune adaptations and cardiorespiratory fitness have the potential to influence HR-QoL and fatigue in persons with MS. The specific immune responses of immersion to exercise need further clarification.","Bansi,J.,et al. (2013). \"Endurance training in MS: short-term immune responses and their relation to cardiorespiratory fitness,health-related quality of life,and fatigue.\" J Neurol 260(12): 2993-3001.","Switzerland",2013,"Neurological","Psychobehavioural","MFI",null,null,null,"Switzerland",null,"Neurological","Psychobehavioural",null,null,"MFI","2010:2014"]
[13,"Barak,Y. and A. Achiron (2006). \"Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project.\" J Neurol Sci 245(1-2): 73-76.",null,"Barak,Y. and A. Achiron","Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project","BACKGROUND: Multiple sclerosis (MS) patients commonly suffer from fatigue and define it as one of their most disabling symptom profoundly disrupting their lives. However,the relationship of fatigue to cognitive functions and its impact on quality of life have not been widely studied. AIM: To define (1) \"cognitive fatigue\",(2) survey its frequency and (3) characterize severity and impact on quality of life in MS patients in the first 10 years of the disease. METHODS: A two-wave design was utilized to enrich the studied population in subjects whose fatigue is significant. In the first wave,fatigue was measured by the self-reported fatigue severity scale (FSS) in randomly selected MS patients from our computerized database. Patients responding to the 9th item of the FSS i.e.,\"Fatigue interferes with my work,family,or social life\" by a grade of 3 or higher (of 7) were further assessed (wave two) by the fatigue impact scale (FIS) and the RAYS quality of life questionnaire. RESULTS: Of the 259 patients that completed the first-wave screening,158 patients (61%,118 females,mean age 41.1+/-9.2 years,mean disease duration 6.2+/-5.5 years) satisfied the additional criterion and were defined to suffer from significant fatigue. The great majority of these patients-91.7%-had a relapsing-remitting disease course,mean FIS score was 77+/-25.9 and their mean EDSS was 2.9+/-2.6. Fatigue was reported to occur most of the day in 30.9% of patients,persist in 69% for more than 1 year,and in 59.8%,it was reported not to be associated with effort. No correlations were found between age,gender,disease duration or neurological disability and FIS cognitive subscale score. Significant correlations were found between the FIS cognitive subscale score and the three domains (physical,psychological and social-familial) of the RAYS quality of life questionnaire (p<0.001). CONCLUSIONS: Cognitive fatigue was found in more than half of MS patients in the first decade from onset that were particularly selected for significant fatigue in their lives. This aspect of fatigue correlated with all quality of life domains and especially with psychological everyday tasks.","Barak,Y. and A. Achiron (2006). \"Cognitive fatigue in multiple sclerosis: findings from a two-wave screening project.\" J Neurol Sci 245(1-2): 73-76.","Israel",2006,"Neurological","None","FSS",null,null,null,"Israel",null,"Neurological","None",null,null,"FSS","2005:2009"]
[14,"Battaglini,C. L.,et al. (2009). \"The effects of an exercise program in leukemia patients.\" Integr Cancer Ther 8(2): 130-138.",null,"Battaglini,C. L.,et al.","The effects of an exercise program in leukemia patients","PURPOSE: To examine the feasibility of administering an in-hospital exercise program to acute leukemia patients undergoing chemotherapy. A secondary purpose explored the impact of exercise on selected physiological,psychological,and inflammatory markers. METHODS: Ten patients,aged 18 to 50 years,diagnosed with acute leukemia or newly relapsed were assessed for body weight,height,body composition (skinfolds),cardiorespiratory endurance (total minutes on bicycle ergometer at 60% heart rate reserve),dynamic muscular endurance (Rocky Mountain Cancer Rehabilitation Institute protocol),fatigue (Revised Piper Fatigue Scale),depression (Center for Epidemiologic Studies Depression scale,National Institute of Mental Health questionnaire),and quality of life (Functional Assessment of Cancer Therapy-General) at baseline (within 3 days of diagnosis) and at the end of induction phase of treatment. Blood draws were taken at baseline,midpoint,and at the end of induction for analyses of inflammatory markers (Linco Luminex assay). Combined aerobic and strength training exercises were administered 3 times per week,twice daily,for 30 minutes. Paired-samples t-tests were used for the analyses of physiological and psychological parameters. One-way repeated measures analysis of variance was used for the analyses of inflammatory markers. RESULTS: Significant improvements in cardiorespiratory endurance (P = .009,baseline 8.9 +/- 8.8 minutes,postexercise intervention 17 +/- 14.3 minutes) with significant reductions in total fatigue scores (P = .009,baseline 4.6 +/- 1.7,postexercise intervention 1.8 +/- 1.6) and depression scores (P = .023,baseline 19 +/- 11.5,postexercise intervention 12 +/- 8.2) were observed. Marginally significant decrease in interleukin-6 (IL-6; P = .059) with no significant changes in IL-10 (P = .223) or interferon-gamma (P = .882) were observed. CONCLUSION: Administration of exercise to acute leukemia patients undergoing treatment is feasible. The exercise protocol used increased cardiovascular endurance,reduced fatigue and depression scores,and maintained quality of life. Although no significant change in inflammation was observed,a trend demonstrating a reduction in IL-6 and an increase in IL-10 warrants further investigation.","Battaglini,C. L.,et al. (2009). \"The effects of an exercise program in leukemia patients.\" Integr Cancer Ther 8(2): 130-138.","USA",2009,"Cancer","Psychobehavioural","PFS",null,null,null,"USA",null,"Cancer","Psychobehavioural",null,null,"PFS","2005:2009"]
[15,"Beckerman,H.,et al. (2013). \"The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme.\" Trials 14: 250.",null,"Beckerman,H.,et al.","The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme","BACKGROUND: TREFAMS is an acronym for TReating FAtigue in Multiple Sclerosis,while ACE refers to the rehabilitation treatment methods under study,that is,Aerobic training,Cognitive behavioural therapy,and Energy conservation management. The TREFAMS-ACE research programme consists of four studies and has two main objectives: (1) to assess the effectiveness of three different rehabilitation treatment strategies in reducing fatigue and improving societal participation in patients with MS; and (2) to study the neurobiological mechanisms of action that underlie treatment effects and MS-related fatigue in general. METHODS/DESIGN: Ambulatory patients (n = 270) suffering from MS-related fatigue will be recruited to three single-blinded randomised clinical trials (RCTs). In each RCT,90 patients will be randomly allocated to the trial-specific intervention or to a low-intensity intervention that is the same for all RCTs. This low-intensity intervention consists of three individual consultations with a specialised MS-nurse. The trial-specific interventions are Aerobic Training,Cognitive Behavioural Therapy,and Energy Conservation Management. These interventions consist of 12 individual therapist-supervised sessions with additional intervention-specific home exercises. The therapy period lasts 16 weeks. All RCTs have the same design and the same primary outcome measures: fatigue - measured with the Checklist Individual Strength,and participation - measured with the Impact on Participation and Autonomy questionnaire. Outcomes will be assessed 1 week prior to,and at 0,8,16,26 and 52 weeks after randomisation. The assessors will be blinded to allocation. Pro- and anti-inflammatory cytokines in serum,salivary cortisol,physical fitness,physical activity,coping,self-efficacy,illness cognitions and other determinants will be longitudinally measured in order to study the neurobiological mechanisms of action. DISCUSSION: The TREFAMS-ACE programme is unique in its aim to assess the effectiveness of three rehabilitation treatments. The programme will provide important insights regarding the most effective treatment for MS-related fatigue and the mechanisms that underlie treatment response. A major strength of the programme is that the design involves three almost identical RCTs,enabling a close comparison of the treatment strategies and a strong overall meta-analysis. The results will also support clinical practice guidelines for the treatment of MS-related fatigue. TRIAL REGISTRATIONS: Current Controlled Trials ISRCTN69520623,ISRCTN58583714,and ISRCTN82353628.","Beckerman,H.,et al. (2013). \"The effectiveness of aerobic training,cognitive behavioural therapy,and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme.\" Trials 14: 250.","Netherlands",2013,"Neurological","Psychobehavioural","CIS-F",null,null,null,"Netherlands",null,"Neurological","Psychobehavioural",null,null,"CIS-F","2010:2014"]
[16,"Bedaiwi,M.,et al. (2015). \"Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort.\" J Rheumatol 42(12): 2354-2360.",null,"Bedaiwi,M.,et al.","Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort","OBJECTIVE: In this study,we aimed to address the prevalence of fatigue,its associated factors,and the effect of tumor necrosis factor inhibitors (TNFi) on this subgroup of patients in a large axial spondyloarthritis (axSpA) cohort. METHODS: The study included 681 patients [ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA)]. The Fatigue Severity Scale (FSS) and the Bath AS Disease Activity Index question 1 (BASDAI Q1) indices were used for fatigue assessment. Severe fatigue was defined as an FSS >/= 4 or a BASDAI Q1 >/= 5. Disease activity,function,and quality of life (QoL) measures were recorded. Patients who had been treated with TNFi were identified,and baseline and followup data were analyzed. RESULTS: Of the cohort,67.3% had severe fatigue,and the prevalence was similar between AS (67.2%) and nr-axSpA (68.2%). Severely fatigued patients tended to have higher disease activity scores,increased acute-phase proteins,and decreased QoL measures. TNFi therapy was associated with improvement in disease activity,and although this treatment led to significantly decreased fatigue scores,this reduction was not optimal in the majority of patients with 80% continuing to have severe fatigue according to their posttreatment scores. Health Assessment Questionnaire,mean scores of BASDAI Q5 and Q6,and BASDAI enthesitis were independent predictors of fatigue severity. CONCLUSION: Fatigue is a common symptom in axSpA,and the burden of fatigue among patients with nr-axSpA is similar to that seen in AS. While biologics are effective in improving disease activity,their effect on fatigue is more limited. In axSpA,fatigue remains unresponsive to TNFi in nearly 80% of patients.","Bedaiwi,M.,et al. (2015). \"Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort.\" J Rheumatol 42(12): 2354-2360.","Canada",2015,"Musculoskeletal","None","FSS",null,null,null,"Canada",null,"Musculoskeletal","None",null,null,"FSS","2015:2018"]
[17,"Bello-Haas,V. D.,et al. (2007). \"A randomized controlled trial of resistance exercise in individuals with ALS.\" Neurology 68(23): 2003-2007.",null,"Bello-Haas,V. D.,et al.","A randomized controlled trial of resistance exercise in individuals with ALS","OBJECTIVE: To determine the effects of resistance exercise on function,fatigue,and quality of life in individuals with ALS. METHODS: Subjects with a diagnosis of clinically definite,probable,or laboratory-supported ALS,forced vital capacity (FVC) of 90% predicted or greater,and an ALS Functional Rating Scale (ALSFRS) score of 30 or greater were randomly assigned to a resistance exercise group that received a home exercise program consisting of daily stretching and resistance exercises three times weekly or to a usual care group,who performed only the daily stretching exercises. ALSFRS,the Fatigue Severity Scale (FSS),and Short Form-36 (SF-36) were completed at baseline and monthly for 6 months. FVC and maximum voluntary isometric contraction (MVIC) were monitored monthly throughout the study. RESULTS: Of 33 subjects screened,27 were randomly assigned (resistance = 13; usual care = 14). Eight resistance exercise subjects and 10 usual care subjects completed the trial. At 6 months,the resistance exercise group had significantly higher ALSFRS and SF-36 physical function subscale scores. No adverse events related to the intervention occurred,MVIC and FVC indicated no negative effects,and less decline in leg strength measured by MVIC was found in the resistance exercise group. CONCLUSION: Our study,although small,showed that the resistance exercise group had significantly better function,as measured by total ALS Functional Rating Scale and upper and lower extremity subscale scores,and quality of life without adverse effects as compared with subjects receiving usual care.","Bello-Haas,V. D.,et al. (2007). \"A randomized controlled trial of resistance exercise in individuals with ALS.\" Neurology 68(23): 2003-2007.","Canada",2007,"Neurological","Psychobehavioural","FSS",null,null,null,"Canada",null,"Neurological","Psychobehavioural",null,null,"FSS","2005:2009"]
[18,"Berger,A. M.,et al. (2009). \"Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens.\" Oncol Nurs Forum 36(5): 563-570.",null,"Berger,A. M.,et al.","Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens","PURPOSE/OBJECTIVES: To examine the relationships among fatigue and physical and mental quality of life (QOL) and different adjuvant chemotherapy regimens in patients with stage I-IIIA breast cancer prior to,during,and after treatment. DESIGN: Longitudinal,descriptive design embedded in a randomized,clinical trial. SETTING: Outpatient oncology clinics in the midwestern United States. SAMPLE: 196 postoperative women,mean age of 52 years,receiving anthracycline-based chemotherapy regimens: dose-dense taxane,dose-standard taxane,or dose-standard without taxane. METHODS: The Piper Fatigue Scale and Medical Outcomes Study SF-36(R) (v.2) Survey were completed 48 hours prior to treatment 1,at treatments 4 and 8,and 30 days after the final treatment. MAIN RESEARCH VARIABLES: Fatigue,adjuvant chemotherapy regimen,and QOL. FINDINGS: Fatigue and mental QOL changed significantly over time for all regimens,but the patterns of change did not differ based on regimen. Physical QOL changed significantly over time for all regimens,and the pattern of change differed based on whether taxanes were received. Higher fatigue was correlated with lower physical and mental QOL prior to and 30 days after the final treatment,regardless of regimen. CONCLUSIONS: Women who receive taxanes are at higher risk for lower physical QOL over time. Higher fatigue was associated with lower QOL regardless of the chemotherapy regimens. IMPLICATIONS FOR NURSING: Clinicians should screen patients for fatigue and assess for contributing factors at clinic visits. Methods to integrate evidence-based fatigue interventions into practice should be tested and outcomes evaluated.","Berger,A. M.,et al. (2009). \"Variability of patterns of fatigue and quality of life over time based on different breast cancer adjuvant chemotherapy regimens.\" Oncol Nurs Forum 36(5): 563-570.","USA",2009,"Cancer","Cancer treatments","PFS",null,null,null,"USA",null,"Cancer","Cancer treatments",null,null,"PFS","2005:2009"]
[19,"Bernstein,D.,et al. (2002). \"Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients.\" Hepatology 35(3): 704-708.",null,"Bernstein,D.,et al.","Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients","Interferon therapy may exacerbate health-related quality of life (HRQL) deficits associated with hepatitis C virus (HCV) early in the course of therapy. Treatment with polyethylene glycol-modified interferon (peginterferon) alfa-2a (40 kd) provides improved sustained response over interferon alfa-2a,but its effect on HRQL is unknown. The objective of this study was to (1) evaluate the effect of sustained virologic response on HRQL in patients with HCV and (2) determine whether impairment of HRQL during treatment contributes to early treatment discontinuation. Data consisted of a pooled secondary analysis of patients (n = 1,441) across 3 international,multicenter,open-label,randomized studies that compared peginterferon alfa-2a (40 kd) with interferon alfa-2a. ANCOVA was used to examine the effect of sustained virologic response on HRQL. Repeated-measures mixed-models ANCOVA was used to compare Fatigue Severity Scale (FSS) and SF-36 scores during treatment by treatment group. Logistic regression analysis was used to examine the association between changes at baseline in on-treatment HRQL and early treatment discontinuation. Sustained virologic response was associated with marked improvements from baseline to end of follow-up in all subjects,including patients with cirrhosis. During treatment,patients receiving peginterferon alfa-2a (40 kd) had statistically significantly better scores on both the SF-36 and FSS. Baseline to 24-week changes in fatigue and SF-36 mental and physical summary scores significantly predicted treatment discontinuation. In conclusion,sustained virologic response is associated with improvements in quality of life in patients with or without advanced liver disease. This parameter may be an important consideration in maximizing treatment adherence.","Bernstein,D.,et al. (2002). \"Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients.\" Hepatology 35(3): 704-708.","USA",2002,"Infectious Disease","Other Drugs","FSS",null,null,null,"USA",null,"Infectious Disease","Other Drugs",null,null,"FSS","2000:2004"]
[20,"Bertolasi,L.,et al. (2013). \"A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome.\" J Neurol Sci 330(1-2): 94-99.",null,"Bertolasi,L.,et al.","A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome","OBJECTIVE: To investigate in a single-center randomized control trial whether a single IVIg course improves short-term outcome in patients with postpolio syndrome (PPS). METHODS: Fifty-one patients with PPS were randomly allocated to receive 2g/kg IVIg body weight or placebo infused over 5 consecutive days. The primary endpoint was health-related quality of life (HRQoL) limited to the physical component score (PCS) in the Short-Form-36 (SF-36). Secondary endpoints included the SF-36 mental component score (MCS),6-minute walk test,visual analog scale,101-numeric rating,and fatigue severity scale. Muscle strength was graded according to the Medical Research Council scale and by dynamometer. Primary and secondary outcome variables were tested double-blind at baseline,2months,and 4months. RESULTS: At two months,although SF-36 PCS scores were similar in both arms,the role physical (RP) domain improved significantly in the treatment arm (p=0.05) and so did the composite MCS (p=0.015),and role emotional (RE) subscale (p=0.02). No differences were found in the remaining outcome measures. At 4months,none of the outcome variables differed significantly between groups. CONCLUSIONS: Although the study did not reach the primary endpoint,we showed that a single IVIg course improves HRQoL related to mental activity,as measured by the SF-36 composite MCS,and role limitations including RP and RE SF-36 subscales at 2months,in patients with PPS. A single IVIg course leaves,gait,muscle strength,fatigue and bodily pain unchanged in patients with PPS. CLASSIFICATION OF EVIDENCE: Class I evidence indicates that IVIg did not change SF-36 PCS,and Class II evidence indicates that IVIg improved scores on the SF-36 MCS,RP,and RE.","Bertolasi,L.,et al. (2013). \"A randomized controlled trial of IV immunoglobulin in patients with postpolio syndrome.\" J Neurol Sci 330(1-2): 94-99.","Italy",2013,"Neurological","Various","FSS",null,null,null,"Italy",null,"Neurological","Various",null,null,"FSS","2010:2014"]
[21,"Bettoni,L.,et al. (2013). \"Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients.\" Clin Rheumatol 32(9): 1337-1345.",null,"Bettoni,L.,et al.","Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients","Fibromyalgia is a chronic widespread pain disorder in which,the neurogenic origin of the pain,featured by allodynia and hyperalgesia,results from an imbalance in the levels of neurotransmitters and consequently of the peripheral pro- and anti-inflammatory mediators. Whole body cryotherapy is a peculiar physical therapy known to relieve pain and inflammatory symptoms characteristics of rheumatic diseases,through the regulation of the cytokine expression. The aim of this study was to qualitatively evaluate the effects of cryotherapy on the clinical output of fibromyalgic patients. A total of 100 fibromyalgic patients (age range 17-70 years) were observed; 50 subjects were addressed to cryotherapy,while the second group (n = 50) did not underwent to the cryotherapic treatment. All subjects kept the prescribed pharmacological therapy during the study (analgesic and antioxidants). The referred health status pre- and post-observation was evaluated with the following scales: Visual Analogue Scale,Short Form-36,Global Health Status and Fatigue Severity Scale. Fibromyalgic patients treated with cryotherapy reported a more pronounced improvement of the quality of life,in comparison with the non-cryo treated fibromyalgic subjects,as indicated by the scores of the qualitative indexes and sub-indexes,that are widely recognized tools to assess the overall health status and the effect of the treatments. We speculate that this improvement is due to the known direct effect of cryotherapy on the balance between pro- and anti-inflammatory mediators having a recognized role in the modulation of pain.","Bettoni,L.,et al. (2013). \"Effects of 15 consecutive cryotherapy sessions on the clinical output of fibromyalgic patients.\" Clin Rheumatol 32(9): 1337-1345.","Italy",2013,"Musculoskeletal","Various","VAS-F,FSS",null,null,null,"Italy",null,"Musculoskeletal","Various",null,null,"VAS-F,FSS","2010:2014"]
[22,"Bianchi,W. A.,et al. (2014). \"Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis.\" Rev Bras Reumatol 54(3): 200-207.",null,"Bianchi,W. A.,et al.","Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis","OBJECTIVES: Fatigue is a highly subjective and extremely common symptom in patients with rheumatoid arthritis although it is difficult to characterize and define. The aim of this study was to assess fatigue in a cohort of Brazilian patients,and to analyze the relationship between fatigue and disease-specific variables. METHODS: 371 Brazilian patients diagnosed with rheumatoid arthritis according to the 1987 American College of Rheumatology classification criteria were prospectively investigated. Demographic,clinical and laboratorial data were obtained from hospitals records. The number of painful joints,bone mass index,disease duration,quality of life,functional capacity,anxiety and depression were recorded. Fatigue was evaluated using the subscale of Fatigue Assessment of Chronic Illness Therapy (FACIT-FATIGUE scale). RESULTS: The median fatigue score was 42.0 (10.0),negatively correlated with functional capacity (-0.507; P < 0.001),anxiety and depression (-0.542 and -0.545; P < 0.001 respectively),and predominantly with physical domain of Short Form 36-item quality of life questionnaire (SF-36P: 0.584; P < 0.001). The scores were not associated with the erythrocyte sedimentation rate (-0.118; P < 0.05),C-reactive protein (-0.089; P < 0.05),disease activity (-0.250; P < 0.001) or the number of painful joints (-0.135; P < 0.01). Confidence interval of 95% was applied for all measures. CONCLUSIONS: In this series of Brazilian patients with rheumatoid arthritis,we suggest a new significance for fatigue complains as an independent parameter not related with number of painful joints,disease or inflammatory activity scores. Psychological and functional impairments appear to be more related to fatigue. Additional studies and inclusion of standard measures for monitoring fatigue complains are required.","Bianchi,W. A.,et al. (2014). \"Analysis of the association of fatigue with clinical and psychological variables in a series of 371 Brazilian patients with rheumatoid arthritis.\" Rev Bras Reumatol 54(3): 200-207.","Brazil",2014,"Musculoskeletal","None","FACIT-F",null,null,null,"Brazil",null,"Musculoskeletal","None",null,null,"FACIT-F","2010:2014"]
[23,"Biermasz,N. R.,et al. (2004). \"Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess.\" J Clin Endocrinol Metab 89(11): 5369-5376.",null,"Biermasz,N. R.,et al.","Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess","The long-term impact of acromegaly on subjective well-being after treatment of GH excess is unclear. Therefore,we evaluated quality of life by validated questionnaires in a cross-sectional study of 118 successfully treated acromegalic patients. The initial treatment was transsphenoidal surgery in most patients (92%),if necessary followed by radiotherapy or octreotide. All patients were in remission at the time of assessment (GH,<1.9 mug/liter; normal IGF-I for age). General perceived well-being was reduced compared with controls for all subscales (P < 0.001) as measured by the Nottingham Health Profile and the Short Form-36. Acromegalic patients also had lower scores on fatigue (Multidimensional Fatigue Index) and anxiety and depression (Hospital Anxiety and Depression Scale). Radiotherapy was associated with decreased quality of life in all subscales except for the Hospital Anxiety and Depression Scale,and worsened quality of life significantly,according to the fatigue scores. Somatostatin analog treatment was not associated with improved quality of life. Independent predictors of quality of life were age (physical subscales and Nottingham Health Profile),disease duration (social isolation and personal relations),and radiotherapy (physical and fatigue subscales). In conclusion,patients cured after treatment for acromegaly have a persistently decreased quality of life despite long-term biochemical cure of GH excess. Radiotherapy especially is associated with a reduced quality of life.","Biermasz,N. R.,et al. (2004). \"Decreased quality of life in patients with acromegaly despite long-term cure of growth hormone excess.\" J Clin Endocrinol Metab 89(11): 5369-5376.","Netherlands",2004,"Endocrine","Surgery,Cancer Treatments,Other Drugs","MFI",null,null,null,"Netherlands",null,"Endocrine","Surgery,Cancer treatments,Other Drugs",null,null,"MFI","2000:2004"]
[24,"Bingham,C. O.,3rd,et al. (2014). \"The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial.\" J Rheumatol 41(6): 1067-1076.",null,"Bingham,C. O.,3rd,et al.","The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial","OBJECTIVE: To evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy. METHODS: In this randomized,multicenter,double-blind,placebo-controlled,phase III trial,adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0,Week 4,and every 8 weeks thereafter. All patients continued stable oral MTX (15-25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function),Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores,EQ-5D assessment of current health state,Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire,and disease effect on productivity [10-cm visual analog scale (VAS)]. RESULTS: Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12,Week 16,and Week 24,and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function,HRQOL,fatigue,and productivity significantly correlated with disease activity improvement. CONCLUSION: In active RA,IV golimumab + MTX significantly improved physical function,HRQOL,fatigue,and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479,EudraCT 2008-006064-11).","Bingham,C. O.,3rd,et al. (2014). \"The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial.\" J Rheumatol 41(6): 1067-1076.","USA",2014,"Musculoskeletal","Golimumab,Other Drugs","FACIT-F,VAS-F",null,null,null,"USA",null,"Musculoskeletal","Golimumab,Other Drugs",null,null,"FACIT-F,VAS-F","2010:2014"]
[25,"Bivard,A.,et al. (2017). \"MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial.\" Stroke 48(5): 1293-1298.",null,"Bivard,A.,et al.","MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial","BACKGROUND AND PURPOSE: This study aimed to assess the efficacy of modafinil,a wakefulness-promoting agent in alleviating post-stroke fatigue >/=3 months after stroke. We hypothesized that 200 mg of modafinil daily for 6 weeks would result in reduced symptoms of fatigue compared with placebo. METHODS: This single-center phase 2 trial used a randomized,double-blind,placebo-controlled,crossover design. The key inclusion criterion was a multidimensional fatigue inventory score of >/=60. Patients were randomized to either modafinil or placebo for 6 weeks of therapy,then after a 1 week washout period swapped treatment arms for a second 6 weeks of therapy. The primary outcome was the multidimensional fatigue inventory; secondary outcomes included the Montreal cognitive assessment,the Depression,Anxiety,and Stress Scale (DASS),and the Stroke-Specific Quality of Life (SSQoL) scale. The multidimensional fatigue inventory is a self-administered questionnaire with a range of 0 to 100. Treatment efficacy was assessed using linear regression by estimating within-person,baseline-adjusted differences in mean outcomes after therapy. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000350527). RESULTS: A total of 232 stroke survivors were screened and 36 were randomized. Participants receiving modafinil reported a significant decrease in fatigue (multidimensional fatigue inventory,-7.38; 95% CI,-21.76 to -2.99; P<0.001) and improved quality of life (SSQoL,11.81; 95% CI,2.31 to 21.31; P=0.0148) compared with placebo. Montreal cognitive assessment and DASS were not significantly improved with modafinil therapy during the study period (P>0.05). CONCLUSIONS: Stroke survivors with nonresolving fatigue reported reduced fatigue and improved quality of life after taking 200 mg daily treatment with modafinil. CLINICAL TRIAL REGISTRATION: URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368268. Unique identifier: ACTRN12615000350527.","Bivard,A.,et al. (2017). \"MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized,Double-Blind,Placebo-Controlled,Cross-Over Trial.\" Stroke 48(5): 1293-1298.","Australia",2017,"CVD","Other Drugs","MFI",null,null,null,"Australia",null,"CVD","Other Drugs",null,null,"MFI","2015:2018"]
[26,"Bjornsson,E.,et al. (2004). \"Fatigue in patients with primary sclerosing cholangitis.\" Scand J Gastroenterol 39(10): 961-968.",null,"Bjornsson,E.,et al.","Fatigue in patients with primary sclerosing cholangitis","BACKGROUND: The occurrence of fatigue in primary sclerosing cholangitis (PSC),its impact on quality of life and the role of concomitant inflammatory bowel disease (IBD) and coexisting irritable bowel syndrome (IBS) is unexplored. METHODS: Ninety-three patients with PSC,associated with IBD in 80% of cases and 77 patients with IBD alone,were enrolled in the study. The patients completed the following questionnaires: the Fatigue Impact Scale (FIS),the Psychological General Well-Being Index (PGWB),the Gastrointestinal Symptom Rating Scale (GSRS),the Beck Depression Inventory (BDI) and diagnostic criteria for IBS. Questionnaire data were related to liver tests and the latest liver biopsy in the PSC patients. Two sex- and age matched controls from the general population (GP) were assigned to each PSC patient and these controls completed the FIS and the BDI. RESULTS: Total fatigue score did not differ significantly between patients with PSC and IBD alone. Median total fatigue score among GP subjects was 39 (13-72),which was higher than in PSC (19 (6-52) (P = 0.02)) and in IBD patients (19 (5-35) (P < 0.0001)). PGWB and GSRS scores did not differ between patients with PSC and IBD alone. Depression and general health (PGWB) were independent predictors for total fatigue score in PSC. No correlation was observed between fatigue in PSC and the severity of the liver disease. CONCLUSIONS: Fatigue in patients with PSC is related to depression but not to the severity of the liver disease. Both the PSC and IBD patients had lower total fatigue scores than subjects from the general population. This argues against fatigue as a specific symptom of PSC and IBD patients.","Bjornsson,E.,et al. (2004). \"Fatigue in patients with primary sclerosing cholangitis.\" Scand J Gastroenterol 39(10): 961-968.","Sweden",2004,"Gastrointestinal","None","FIS",null,null,null,"Sweden",null,"Gastrointestinal","None",null,null,"FIS","2000:2004"]
[27,"Boele,F. W.,et al. (2013). \"The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial.\" Neuro Oncol 15(10): 1420-1428.",null,"Boele,F. W.,et al.","The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial","BACKGROUND: Fatigue,cognitive deficits,and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue,depression,health-related quality of life (HRQOL),and cognitive functioning in PBT patients,we performed a multicenter,double-blind placebo-controlled crossover trial. METHODS: Patients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period,the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]),depression (Center for Epidemiologic Studies Depression Scale [CES-D]),HRQOL (Short-Form Health Survey [SF-36]),and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing. RESULTS: In total,37 patients participated. Relative to baseline,patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021,respectively) and the placebo condition (P < .001 and P = .027,respectively). The same held for physical health (SF-36 Physical Component Summary score; P = .001 and P = .008,respectively),working memory (P = .040 and P = .043),and information processing capacity (P = .036 and P = .040). No improvement in depressive symptoms was found in either condition. CONCLUSIONS: Modafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow,and relatively many patients dropped out during the trial,due mostly to side effects. Other,preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients.","Boele,F. W.,et al. (2013). \"The effect of modafinil on fatigue,cognitive functioning,and mood in primary brain tumor patients: a multicenter randomized controlled trial.\" Neuro Oncol 15(10): 1420-1428.","Netherlands",2013,"Cancer","Other Drugs","CIS-F",null,null,null,"Netherlands",null,"Cancer","Other Drugs",null,null,"CIS-F","2010:2014"]
[28,"Bogdanovic,G.,et al. (2015). \"Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus.\" Tohoku J Exp Med 237(3): 193-199.",null,"Bogdanovic,G.,et al.","Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus","Given the crucial events in systemic lupus erythematosus (SLE) such as joint and muscle pain,fatigue,depression,obesity and osteoporosis,the very thought of exercising can be challenging. This prospective study included 60 patients diagnosed with SLE in stable condition. A randomly selected group of 30 women had aerobic training on a bicycle ergometer for a period of 15 minutes,3 times per week for 6 weeks,while the second group of 30 women performed isotonic exercises (to stretch and lengthen muscles and improve the range of motion) for 30 minutes,3 times per week during the same period. Fatigue Severity Scale (FSS),Short Form 36 (SF36) questionnaire on the quality of life and Beck depression inventory (BDI) were analyzed at baseline and after 6 weeks. At baseline FSS score was 53.8 +/- 5.7 and after the physical activity FSS score was 29.1 +/- 7.8 (FSS >/= 36; fatigue is present). The largest number of patients (66.7%) was in a moderate depressed state at the baseline,while after physical activities 61.7% of patients,had a mild mood disturbance. There were significant differences (p < 0.001) in values of all areas of quality of life questionnaire SF36 before and after the implementation of physical activity. The type of physical activity had no influence in FSS and BDI values. Continuous physical activity,regardless of its type,significantly improved quality of life of SLE patients. We recommend regular physical activity as an integral part of modern therapeutic approach in this patient population.","Bogdanovic,G.,et al. (2015). \"Physical Activity Program Is Helpful for Improving Quality of Life in Patients with Systemic Lupus Erythematosus.\" Tohoku J Exp Med 237(3): 193-199.","Unknown",2015,"Inflamatory Systemic Disease","Psychobehavioural","FSS",null,null,null,"Unknown",null,"Inflamatory Systemic Disease","Psychobehavioural",null,null,"FSS","2015:2018"]
[29,"Bolk,N.,et al. (2010). \"Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.\" Arch Intern Med 170(22): 1996-2003.",null,"Bolk,N.,et al.","Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial","BACKGROUND: Levothyroxine sodium is widely prescribed to treat primary hypothyroidism. There is consensus that levothyroxine should be taken in the morning on an empty stomach. A pilot study showed that levothyroxine intake at bedtime significantly decreased thyrotropin levels and increased free thyroxine and total triiodothyronine levels. To date,no large randomized trial investigating the best time of levothyroxine intake,including quality-of-life evaluation,has been performed. METHODS: To ascertain if levothyroxine intake at bedtime instead of in the morning improves thyroid hormone levels,a randomized double-blind crossover trial was performed between April 1,2007,and November 30,2008,among 105 consecutive patients with primary hypothyroidism at Maasstad Hospital Rotterdam in the Netherlands. Patients were instructed during 6 months to take 1 capsule in the morning and 1 capsule at bedtime (one containing levothyroxine and the other a placebo),with a switch after 3 months. Primary outcome measures were thyroid hormone levels; secondary outcome measures were creatinine and lipid levels,body mass index,heart rate,and quality of life. RESULTS: Ninety patients completed the trial and were available for analysis. Compared with morning intake,direct treatment effects when levothyroxine was taken at bedtime were a decrease in thyrotropin level of 1.25 mIU/L (95% confidence interval [CI],0.60-1.89 mIU/L; P < .001),an increase in free thyroxine level of 0.07 ng/dL (0.02-0.13 ng/dL; P = .01),and an increase in total triiodothyronine level of 6.5 ng/dL (0.9-12.1 ng/dL; P = .02) (to convert thyrotropin level to micrograms per liter,multiply by 1.0; free thyroxine level to picomoles per liter,multiply by 12.871; and total triiodothyronine level to nanomoles per liter,multiply by 0.0154). Secondary outcomes,including quality-of-life questionnaires (36-Item Short Form Health Survey,Hospital Anxiety and Depression Scale,20-Item Multidimensional Fatigue Inventory,and a symptoms questionnaire),showed no significant changes between morning vs bedtime intake of levothyroxine. CONCLUSIONS: Levothyroxine taken at bedtime significantly improved thyroid hormone levels. Quality-of-life variables and plasma lipid levels showed no significant changes with bedtime vs morning intake. Clinicians should consider prescribing levothyroxine intake at bedtime. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN17436693 (NTR959).","Bolk,N.,et al. (2010). \"Effects of evening vs morning levothyroxine intake: a randomized double-blind crossover trial.\" Arch Intern Med 170(22): 1996-2003.","Netherlands",2010,"Endocrine","Other Drugs","MFI",null,null,null,"Netherlands",null,"Endocrine","Other Drugs",null,null,"MFI","2010:2014"]
[30,"Bonner,A.,et al. (2013). \"Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study.\" Nurs Health Sci 15(3): 360-367.",null,"Bonner,A.,et al.","Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study","In this study we investigated the relationship between health-related quality of life,fatigue,and activity levels of people with anemia secondary to chronic kidney disease over a 12 month period following the introduction of an erythropoietin-stimulating agent. Using a longitudinal repeated-measure design,28 people with chronic kidney disease completed the Short Form-36 Health Survey,Human Activity Profile and Fatigue Severity Scale at the commencement of an erythropoietin-stimulating agent,and then at 3,6,and 12 months. Over a 12 month period,a significant change was found for health-related quality of life in relation to role-physical,vitality,mental health/emotional well-being,and overall mental health. However,activity levels did not significantly improve during that time. Renal nurses in dialysis units and chronic kidney disease outpatient clinics have repeated and frequent contact with people with chronic kidney disease over long periods of time,and are in an ideal position to routinely assess fatigue and activity levels and to institute timely interventions to optimize health-related quality of life and independent activity.","Bonner,A.,et al. (2013). \"Quality of life,fatigue,and activity in Australians with chronic kidney disease: a longitudinal study.\" Nurs Health Sci 15(3): 360-367.","Australia",2013,"Hematological","None","FSS",null,null,null,"Australia",null,"Hematological","None",null,null,"FSS","2010:2014"]
[31,"Boosman,H.,et al. (2011). \"Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study.\" Disabil Rehabil 33(8): 690-696.",null,"Boosman,H.,et al.","Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study","PURPOSE: An intervention for persons with neuromuscular diseases (NMD) or multiple sclerosis (MS) who experienced severe fatigue was developed which aimed at educating participants in maintaining a balance between capacity and load in their daily activities. This pilot study evaluated the results of this intervention. METHODS: Persons with NMD or MS who experienced severe fatigue were included. Outcome measures were: fatigue (Fatigue Severity Scale),health-related quality of life (HRQoL; SF-36) and self-efficacy (ALCOS-16). Changes in scores between the start of the intervention (T0) and 3 months post-intervention (T1) were tested with the Wilcoxon tests in the complete group and in subgroups (gender,education,high/low self-efficacy). RESULTS: Forty-three persons participated. Significant improvements of HRQoL were found for the domains role-physical,mental health and general health perceptions. Subgroup analyses showed more improvement in males (fatigue,role-physical,vitality,bodily pain,general health perceptions),participants with lower education (role-physical,vitality) and participants with low self-efficacy at T0 (self-efficacy,mental health,general health perceptions) than in females,participants with higher education and participants with higher initial self-efficacy. CONCLUSION: This pilot-study provides preliminary evidence for the effectiveness of a group educational intervention in improving HRQoL without increasing fatigue in persons with NMD and MS.","Boosman,H.,et al. (2011). \"Evaluation of change in fatigue,self-efficacy and health-related quality of life,after a group educational intervention programme for persons with neuromuscular diseases or multiple sclerosis: a pilot study.\" Disabil Rehabil 33(8): 690-696.","Netherlands",2011,"Neurological","None","FSS",null,null,null,"Netherlands",null,"Neurological","None",null,null,"FSS","2010:2014"]
[32,"Bredemeier,M.,et al. (2014). \"Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis.\" Arthritis Care Res (Hoboken) 66(2): 228-235.",null,"Bredemeier,M.,et al.","Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis","OBJECTIVE: The approved dose of rituximab (RTX) for rheumatoid arthritis (RA) is 2 x 1,000 mg infusions given 2 weeks apart. There is contradictory evidence regarding the effectiveness of a lower-dose regimen (2 x 500 mg) of RTX. Our aim was to compare the efficacy and safety of low- and high-dose RTX and to test the noninferiority of the low-dose regimen. METHODS: A systematic literature review searching for randomized controlled trials (RCTs) and cohort studies comparing low- and high-dose RTX for RA was conducted using the Embase,PubMed,Cochrane Library,and Web of Science databases. The primary end points were the American College of Rheumatology criteria for 20% improvement (ACR20),ACR50,and ACR70 responses and the Disease Activity Score in 28 joints (DAS28) at 24 and 48 weeks. The secondary end points were patient-reported outcomes (PROs; Health Assessment Questionnaire,Short Form 36,and Functional Assessment of Chronic Illness Therapy-Fatigue scores) and adverse events. Noninferiority of low-dose RTX was tested using different approaches,one of which was based on the fixed margin method. RESULTS: In total,6 RCTs and 2 cohort studies were identified. Four RCTs were included in the meta-analysis of efficacy outcomes,which showed no significant differences in the primary outcomes between low- and high-dose RTX. Noninferiority criteria of low-dose RTX were met for the ACR20,ACR50,DAS28,and PROs (at 24 and 48 weeks). Serious adverse events did not differ significantly. The results of 2 additional RCTs and a meta-analysis of 2 cohort studies corroborated the results of the meta-analysis of RCTs. CONCLUSION: Low-dose RTX has similar effectiveness and met noninferiority criteria for most primary outcomes. Considering the lower cost,it should be the standard RTX regimen for RA.","Bredemeier,M.,et al. (2014). \"Low- versus high-dose rituximab for rheumatoid arthritis: a systematic review and meta-analysis.\" Arthritis Care Res (Hoboken) 66(2): 228-235.","Brazil",2014,"Musculoskeletal","Rituximab","FACIT-F",null,null,null,"Brazil",null,"Musculoskeletal","Rituximab",null,null,"FACIT-F","2010:2014"]
[33,"Breitbart,W.,et al. (2001). \"A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease.\" Arch Intern Med 161(3): 411-420.",null,"Breitbart,W.,et al.","A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease","BACKGROUND: Fatigue is a commonly encountered symptom of human immunodeficiency virus (HIV) disease,associated with significant psychological and functional morbidity and poor quality of life. Preliminary studies on the treatment of fatigue from the cancer and multiple sclerosis literature suggest that psychostimulants may be effective in reducing fatigue. OBJECTIVE: To compare the efficacy of 2 psychostimulant medications,methylphenidate hydrochloride (Ritalin) and pemoline (Cylert),with a placebo intervention for the treatment of fatigue in patients with HIV disease. METHODS: In this double-blind trial,144 ambulatory patients with HIV disease and persistent and severe fatigue were randomized to treatment with methylphenidate,pemoline,or placebo. Medications were titrated up to a maximum dose of 60 mg of methlyphenidate hydrochloride,150 mg of pemoline,or 8 capsules of placebo daily. Fatigue was measured using 2 self-reported rating scales,the Piper Fatigue Scale (PFS) and the Visual Analogue Scale for Fatigue (VAS-F). We also used the timed isometric unilateral straight leg-raising task,a measure of muscular endurance. Quality-of-life and psychological well-being measures included the Beck Depression Inventory,the Brief Symptom Inventory,and the 36-Item Short-Form Medical Outcomes Study Health Status Survey. Side effects were monitored using the Systematic Assessment for Treatment Emergent Events and the Extra-pyramidal Symptom Rating Scale. All measures were rated weekly. RESULTS: One hundred nine subjects completed the 6-week trial; 15 patients (41%) receiving methylphenidate and 12 patients (36%) receiving pemoline demonstrated clinically significant improvement compared with 6 patients (15%) receiving placebo. Patients receiving methylphenidate or pemoline demonstrated significantly more improvement in fatigue on several self-reported rating scales (PFS total score,P=.04; affective subscale,P=.008; sensory subscale,P=.04; and VAS-F energy subscale,P=.02). Analysis of the regression slopes by means of hierarchical linear modeling demonstrated a significantly greater rate of improvement in PFS total scores among patients receiving psychostimulants compared with the placebo group (P=.02). There were no significant differences in the efficacy between methlyphenidate and pemoline on any outcome measure studied. Improvement in fatigue was also significantly correlated with improvement in measures of depression,psychological distress,and overall quality of life. Severe side effects were relatively uncommon among this sample,and only hyperactivity or jitteriness occurred significantly more often among subjects receiving active medication. CONCLUSIONS: Many patients with HIV- and acquired immunodeficiency syndrome-unrelated fatigue respond favorably to treatment with methylphenidate or pemoline. Both psychostimulants appear to be equally effective and significantly superior to placebo in decreasing fatigue severity with minimal side effects. Moreover,improvement of fatigue was significantly associated with improved quality of life and decreased levels of depression and psychological distress.","Breitbart,W.,et al. (2001). \"A randomized,double-blind,placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease.\" Arch Intern Med 161(3): 411-420.","USA",2001,"Infectious Disease","Other Drugs","PFS,VAS-F",null,null,null,"USA",null,"Infectious Disease","Other Drugs",null,null,"PFS,VAS-F","2000:2004"]
[34,"Breslin,E.,et al. (1998). \"Perception of fatigue and quality of life in patients with COPD.\" Chest 114(4): 958-964.",null,"Breslin,E.,et al.","Perception of fatigue and quality of life in patients with COPD","INTRODUCTION: Although dyspnea is considered the primary activity-limiting symptom in patients with COPD,other symptoms,such as fatigue,are frequently reported. The purpose of this study was to determine the relationship between fatigue and pulmonary function,exercise tolerance,depression,and quality of life in patients with COPD. METHODS: Forty-one patients (age = 62+/-8 years; FEV1 = 1.08+/-0.55 L; FEV1 percent predicted = 35.8+/-17%) from two sites participated in the study. Spirometric measures of pulmonary function were carried out in each patient. The Multidimensional Fatigue Inventory was used to measure five subscales of fatigue: general,physical and mental fatigue,reduction in activity,and reduction in motivation. The St. George Respiratory Questionnaire,used to measure quality of life,has three subscale dimensions (symptom,activity,and impact),as well as an overall or total quality of life score. Depression was measured with the Centers of Epidemiological Studies Depression Scale. In 19 patients,exercise tolerance was determined with the 6-min walking distance. RESULTS: General fatigue correlated with FEV1,percent predicted (r = -0.32,p < 0.05),exercise tolerance (r = -0.55,p < 0.05),depression (r = 0.44,p < 0.01),and overall quality of life (r = 0.75,p < 0.01). Among the dimensions of fatigue,depression correlated with general and mental fatigue only. Physical dimensions of fatigue correlated with an increase in the severity of pulmonary impairment and reduction in exercise tolerance. The cognitive components of fatigue,such as reduction in motivation and mental fatigue,were not found to be highly correlated with physical dimensions of quality of life. All five subscales of fatigue showed relationship to the functional impact dimension and total impairment score in quality of life. CONCLUSIONS: These data show a relationship between dimensions of fatigue and pulmonary function,exercise tolerance,and quality of life in COPD. Based on these results,fatigue is an important symptom requiring evaluation and management in patients with COPD. These data clarified also the relationship between depression and fatigue in this patient population.","Breslin,E.,et al. (1998). \"Perception of fatigue and quality of life in patients with COPD.\" Chest 114(4): 958-964.","USA",1998,"Respiratory Disease","Psychobehavioural","MFI",null,null,null,"USA",null,"Respiratory Disease","Psychobehavioural",null,null,"MFI","1960:1999"]
[35,"Brix, C., et al. (2008). \"The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer.\" J Psychosom Res 65(6): 541-548.",null,"Brix, C., et al.","The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer","OBJECTIVE: The primary goal of this study was to examine the need for psychosocial support in a consecutive sample of cancer patients undergoing radiotherapy (RT). Out of an initial sample of 250 patients, 239 patients could be assessed at the beginning of their RT. Two hundred eight patients were reassessed at the end of RT 4-8 weeks later. METHODS: Measures comprised the Hornheide Screening Instrument, the Multidimensional Fatigue Inventory, the Resilience Scale, and the Short Form 12 as a measure of health-related quality of life (QoL). Medical and radiological data were continuously registered. RESULTS: Within the sample, the need for psychosocial support as reflected in the screening instrument was high (>70%). Patients with the need for psychosocial support revealed significantly higher fatigue scores than patients who where not identified as needing psychosocial support. Furthermore, a negative correlation of the need for psychosocial support and QoL as well as resilience could be observed. QoL turned out to be the strongest predictor for the need of psychosocial support. CONCLUSION: The study confirmed that the need for psychosocial support is an important aspect in the treatment of cancer patients undergoing RT, which appeared to be powerfully predicted by the patients' health-related QoL. Fatigue turned out to be an important illness- and treatment-related factor that affects QoL. Psychological interventions for cancer patients should explicitly focus on decreasing patients' fatigue and increasing their resilience, thus improving their QoL.","Brix, C., et al. (2008). \"The need for psychosocial support and its determinants in a sample of patients undergoing radiooncological treatment of cancer.\" J Psychosom Res 65(6): 541-548.","Germany",2008,"Cancer","Cancer treatments","MFI",null,null,null,"Germany",null,"Cancer","Cancer treatments",null,null,"MFI","2005:2009"]
[36,"Brodsky, R. A., et al. (2008). \"Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria.\" Blood 111(4): 1840-1847.",null,"Brodsky, R. A., et al.","Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria","The terminal complement inhibitor eculizumab was recently shown to be effective and well tolerated in patients with paroxysmal nocturnal hemoglobinuria (PNH). Here, we extended these observations with results from an open-label, non-placebo-controlled, 52-week, phase 3 clinical safety and efficacy study evaluating eculizumab in a broader PNH patient population. Eculizumab was administered by intravenous infusion at 600 mg every 7 +/- 2 days for 4 weeks; 900 mg 7 +/- 2 days later; followed by 900 mg every 14 +/- 2 days for a total treatment period of 52 weeks. Ninety-seven patients at 33 international sites were enrolled. Patients treated with eculizumab responded with an 87% reduction in hemolysis, as measured by lactate dehydrogenase levels (P < .001). Baseline fatigue scores in the FACIT-Fatigue instrument improved by 12.2 +/- 1.1 points (P < .001). Eculizumab treatment led to an improvement in anemia. The increase in hemoglobin level occurred despite a reduction in transfusion requirements from a median of 8.0 units of packed red cells per patient before treatment to 0.0 units per patient during the study (P < .001). Overall, transfusions were reduced 52% from a mean of 12.3 to 5.9 units of packed red cells per patient. Forty-nine patients (51%) achieved transfusion independence for the entire 52-week period. Improvements in hemolysis, fatigue, and transfusion requirements with eculizumab were independent of baseline levels of hemolysis and degree of thrombocytopenia. Quality of life measures were also broadly improved with eculizumab treatment. This study demonstrates that the beneficial effects of eculizumab treatment in patients with PNH are applicable to a broader population of PNH patients than previously studied. This trial is registered at http://clinicaltrials.gov as NCT00130000.","Brodsky, R. A., et al. (2008). \"Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria.\" Blood 111(4): 1840-1847.","USA",2008,"Hematological","Eculizumab","FACIT-F",null,null,null,"USA",null,"Hematological","Eculizumab",null,null,"FACIT-F","2005:2009"]
[37,"Bruce, I. N., et al. (1999). \"Factors associated with fatigue in patients with systemic lupus erythematosus.\" Ann Rheum Dis 58(6): 379-381.",null,"Bruce, I. N., et al.","Factors associated with fatigue in patients with systemic lupus erythematosus","OBJECTIVE: To examine the relation between fatigue, disease activity, damage, and quality of life measures in patients with systemic lupus erythematosus (SLE). METHODS: Consecutive patients attending the University of Toronto Lupus Clinic were studied. Disease activity was assessed using the SLEDAI and SLAM-R and damage using the SLICC/ACR Damage index. Fatigue was measured by the Fatigue Severity Score (FSS) and health status by the SF-36 questionnaire. In all cases a tender point count was also performed. RESULTS: 81 patients were studied. Their mean (SD) age and disease duration were 43 (12.5) years and 12.7 (8.0) years respectively. The FSS did not correlate with the SLEDAI nor with the SLAM-R. There was no correlation with the SLICC damage index. Fatigue severity correlated with the tender point count (SCC r=0.46, p<0.001), and negatively with all domains of the SF36 (r values -0.50 to -0.82). Disease activity and damage accounted for only 4.8% and 4% respectively of the variance in fatigue severity reported by patients. CONCLUSION: In an outpatient population of SLE patients, fatigue severity correlates with poor health status and a higher tender point count. In patients with SLE, factors associated with quality of life and fibromyalgia seem to have a greater influence on the severity of reported fatigue than does the level of current disease activity.","Bruce, I. N., et al. (1999). \"Factors associated with fatigue in patients with systemic lupus erythematosus.\" Ann Rheum Dis 58(6): 379-381.","Canada",1999,"Inflamatory Systemic Disease","None","FSS",null,null,null,"Canada",null,"Inflamatory Systemic Disease","None",null,null,"FSS","1960:1999"]
[38,"Bruera, E., et al. (1998). \"Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study.\" Cancer Prev Control 2(2): 74-78.",null,"Bruera, E., et al.","Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study","PURPOSE: To evaluate the effect of megestrol acetate at a lower dose than previously investigated on the symptoms of cachexia in patients with advanced cancer. METHODS: A total of 84 patients with advanced, solid tumours not responsive to hormone therapy were enrolled in this double-blind, crossover study. During phase 1, patients were randomly assigned to receive megestrol acetate (160 mg 3 times daily) for 10 days or placebo. During phase 2, after a 2-day washout period, patients received the alternate treatment for 10 days. Patients underwent daily assessments of activity, nausea, appetite and well-being by means of a visual analogue scale (VAS). In addition, nutritional status (weight, tricep skinfold measure, arm muscle circumference), energy intake, fatigue (Piper Fatigue Scale) and quality of life (Functional Living Index-Cancer [FLIC]) were assessed. RESULTS: Among the 53 evaluable patients megestrol acetate resulted in a significant improvement in appetite (p = 0.005), activity (p = 0.007) and well-being (p = 0.03). There was no significant change in the intensity of nausea, nutritional parameters, energy intake or FLIC scores. There was a significant improvement in 2 of the 3 factors measured by the Piper Fatigue Scale and in the overall fatigue score. Upon completion of the study, while still blind to the treatment condition, 30 patients indicated that they felt better overall after megestrol, 15 said they felt better after placebo, and 10 indicated no preference (p = 0.001). CONCLUSION: Treatment with megestrol acetate results in rapid and significant improvement of symptoms in terminally ill patients at lower doses than previously reported. The effects are not secondary to nutritional changes. The FLIC quality-of-life questionnaire was unable to detect these changes.","Bruera, E., et al. (1998). \"Effectiveness of megestrol acetate in patients with advanced cancer: a randomized, double-blind, crossover study.\" Cancer Prev Control 2(2): 74-78.","USA",1998,"Cancer","Other Drugs","VAS-F,PFS",null,null,null,"USA",null,"Cancer","Other Drugs",null,null,"VAS-F,PFS","1960:1999"]
[39,"Brusse, I. A., et al. (2016). \"Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life.\" PLoS One 11(5): e0155299.",null,"Brusse, I. A., et al.","Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life","OBJECTIVES: To compare electroencephalography (EEG) findings during pregnancy and postpartum in women with normotensive pregnancies and pregnancies complicated by hypertensive disorders. Also the health related quality of life postpartum was related to these EEG findings. MATERIALS AND METHODS: An observational case-control study in a university hospital in the Netherlands. Twenty-nine normotensive and 58 hypertensive pregnant women were included. EEG's were recorded on several occasions during pregnancy and 6-8 weeks postpartum. Postpartum, the women filled out health related quality of life questionnaires. Main outcome measures were qualitative and quantitative assessments on EEG, multidimensional fatigue inventory, Short Form (36) Health Survey and EuroQoL visual analogue scale. RESULTS: In women with severe preeclampsia significantly lower alpha peak frequency, more delta and theta activity bilaterally and a higher EEG Sum Score were seen. Postpartum, these women showed impaired mental health, mental fatigue and social functioning, which could not be related to the EEG findings. CONCLUSIONS: Severe preeclamptic patients show more EEG abnormalities and have impaired mental wellbeing postpartum, but these findings are not correlated.","Brusse, I. A., et al. (2016). \"Electroencephalography in Normotensive and Hypertensive Pregnancies and Subsequent Quality of Life.\" PLoS One 11(5): e0155299.","Netherlands",2016,"Various","None","MFI",null,null,null,"Netherlands",null,"Various","None",null,null,"MFI","2015:2018"]
[40,"Buss, T., et al. (2014). \"Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients.\" J Pain Symptom Manage 48(4): 730-737.",null,"Buss, T., et al.","Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients","CONTEXT: Multidimensional questionnaires estimating cancer-related fatigue (CRF) as a symptom cluster or a clinical syndrome primarily have been used and validated in English-speaking populations. However, cultural issues and language peculiarities can affect CRF assessment OBJECTIVES: The main aims of this study were to evaluate the psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 (MFI-20) and to deliver to clinicians a multidimensional tool for CRF assessment in Polish-speaking patients with cancer. METHODS: After forward-backward translation procedures, the Polish version of MFI-20 was administered to 340 cancer patients. The Polish MFI-20 was appraised in terms of acceptability, reliability, and validity. Internal consistency was assessed by calculating Cronbach's alpha coefficients. Structural validity was evaluated with confirmatory factor analysis. RESULTS: The translated MFI-20 was well accepted; 90% of subjects fully completed the questionnaire. The overall Cronbach's alpha coefficient was 0.9, ranging from 0.57 to 0.81. All correlation coefficients among Numeric Rating Scale-fatigue, fatigue-related items from the European Organization for Research and Treatment of Cancer Quality of Life Core-30 questionnaire, and the MFI--20 were statistically significant (P < 0.001). Confirmatory factor analysis demonstrated good structural validity and revealed only three dimensions in the Polish version of the MFI-20-physical and mental fatigue as well as reduced motivation. CONCLUSION: The Polish version of the MFI-20 is well accepted by patients, reliable, and a valid instrument to assess CRF in Polish cancer patients.","Buss, T., et al. (2014). \"Psychometric properties of the Polish version of the Multidimensional Fatigue Inventory-20 in cancer patients.\" J Pain Symptom Manage 48(4): 730-737.","Poland",2014,"Cancer","None","MFI",null,null,null,"Poland",null,"Cancer","None",null,null,"MFI","2010:2014"]
[41,"Butt, Z., et al. (2013). \"Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.\" J Psychosom Res 74(1): 64-68.",null,"Butt, Z., et al.","Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale","OBJECTIVE: Given the importance of fatigue in cancer, stroke and HIV, we sought to assess the measurement properties of a single, well-described fatigue scale in these populations. We hypothesized that the psychometric properties of the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale would be favorable and that the scale could serve as a useful indicator of fatigue in these populations. METHODS: Patients were eligible for the study if they were outpatients, aged 18 or older, with a diagnosis of cancer (n=297), stroke (n=51), or HIV/AIDS (n=51). All participants were able to understand and speak English. Patients answered study-related questions, including the FACIT-F using a touch-screen laptop, assisted by the research assistant as necessary. Clinical information was abstracted from patients' medical records. RESULTS: Item-level statistics on the FACIT-F were similar across the groups and internal consistency reliability was uniformly high (alpha>0.91). Correlations with performance status ratings were statistically significant across the groups (range r=-0.28 to -0.80). Fatigue scores were moderately to highly correlated with general quality of life (range r=0.66-0.80) in patients with cancer, stroke, and HIV. Divergent validity was supported in low correlations with variables not expected to correlate with fatigue. CONCLUSIONS: Originally developed to assess cancer-related fatigue, the FACIT-F has utility as a measure of fatigue in other populations, such as stroke and HIV. Ongoing research will soon allow for comparison of FACIT-F scores to those obtained using the fatigue measures from the Patient-Reported Outcomes Measurement Information System (PROMIS(R); www.nihpromis.org) initiative.","Butt, Z., et al. (2013). \"Measurement of fatigue in cancer, stroke, and HIV using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.\" J Psychosom Res 74(1): 64-68.","USA",2013,"Cancer","None","FACIT-F",null,null,null,"USA",null,"Cancer","None",null,null,"FACIT-F","2010:2014"]
[42,"Buttgereit, F., et al. (2013). \"Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).\" Ann Rheum Dis 72(2): 204-210.",null,"Buttgereit, F., et al.","Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2)","OBJECTIVE: To assess the efficacy and safety of low-dose prednisone chronotherapy using a new modified-release (MR) formulation for the treatment of rheumatoid arthritis (RA). METHODS: In this 12-week, double-blind, placebo-controlled study, patients with active RA (n=350) were randomised 2:1 to receive MR prednisone 5 mg or placebo once daily in the evening in addition to their existing RA disease-modifying antirheumatic drug (DMARD) treatment. The primary end point was the percentage of patients achieving a 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria (ie, an ACR20 response) at week 12. Changes in morning pain, duration of morning stiffness, 28-joint Disease Activity Score and health-related quality of life were also assessed. RESULTS: MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) and ACR50 (22% vs 10%, p<0.006) and a greater median relative reduction from baseline in morning stiffness (55% vs 35%, p<0.002) at week 12 than placebo plus DMARD treatment. Significantly greater reductions in severity of RA (Disease Activity Score 28) (p<0.001) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score) (p=0.003) as well as a greater improvement in physical function (36-item Short-Form Health Survey score) (p<0.001) were seen at week 12 for MR prednisone versus placebo. The incidence of adverse events was similar for MR prednisone (43%) and placebo (49%). CONCLUSION: Low-dose MR prednisone added to existing DMARD treatment produced rapid and relevant improvements in RA signs and symptoms. CLINICALTRIALS.GOV, NUMBER: NCT00650078.","Buttgereit, F., et al. (2013). \"Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2).\" Ann Rheum Dis 72(2): 204-210.","Germany",2013,"Musculoskeletal","Other Drugs","FACIT-F",null,null,null,"Germany",null,"Musculoskeletal","Other Drugs",null,null,"FACIT-F","2010:2014"]
[43,"Buyuktas, D., et al. (2015). \"Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey.\" Clin Exp Rheumatol 33(6 Suppl 94): S107-112.",null,"Buyuktas, D., et al.","Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey","OBJECTIVES: Fatigue is an important problem in inflammatory diseases and affects the quality of life (QoL). We aimed to evaluate the severity and impact of fatigue in Behcet's syndrome (BS) and to determine its association with type of organ involvement and gender. METHODS: One hundred and fifty-two BS, 51 rheumatoid arthritis (RA), 51 systemic lupus erythematosus (SLE), 51 ankylosing spondylitis (AS) patients and 65 healthy controls were evaluated by the fatigue severity scale, fatigue impact scale, fibromyalgia impact questionnaire (FIQ), RAPID3, SF-36 and Behcet's syndrome activity scale (the latter only in BS patients). We also analysed subgroups of BS patients with predominantly eye, vascular, joint and mucocutaneous involvement and did an additional gender analysis. RESULTS: Fatigue severity and fatigue impact scores were similar among BS, RA, SLE and AS patients and significantly higher than that in healthy controls (F4df=8.51; p<0.001 and F4df=8.67; p<0.001, respectively). The fatigue severity and fatigue impact scores were similarly high in BS subgroups with different types of organ involvement, and in both genders. CONCLUSIONS: Fatigue is an important problem in BS, as it is in other inflammatory conditions. It is similarly severe in subgroups of patients with eye, vascular, joint and mucocutaneous involvement and in either gender. Fatigue is a candidate outcome measure for clinical trials, to assess the life impact of Behcet's syndrome.","Buyuktas, D., et al. (2015). \"Fatigue is correlated with disease activity but not with the type of organ involvement in Behcet's syndrome: a comparative clinical survey.\" Clin Exp Rheumatol 33(6 Suppl 94): S107-112.","Turkey",2015,"Inflamatory Systemic Disease","None","FSS,FIS",null,null,null,"Turkey",null,"Inflamatory Systemic Disease","None",null,null,"FSS,FIS","2015:2018"]
[44,"Cakt, B. D., et al. (2010). \"Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study.\" Am J Phys Med Rehabil 89(6): 446-457.",null,"Cakt, B. D., et al.","Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study","OBJECTIVE: To evaluate the effects of cycling progressive resistance training combined with balance exercises on walking speed, balance, fatigue, fear of falling, depression, and quality of life in patients with multiple sclerosis. DESIGN: In this prospective randomized controlled trial, 45 patients were randomized into two exercise training (n = 30) groups and one control (n = 15) group. The patients in training group 1 (n = 15) underwent progressive resistance training on a bicycle ergometer and balance exercise, whereas group 2 (n = 15) patients received a home-based lower-limb strengthening and balance exercise. Outcome measures, including the duration of exercise, tolerated maximum workload, timed up and go test, Dynamic Gait Index, functional reach, Falls Efficacy scale, 10-m walk test, Fatigue Severity Scale, Beck Depression Inventory, and Short Form 36 scores, were assessed initially and at 8 wks. RESULTS: After dropouts, the whole study group consisted of 20 women and 13 men (mean age, 37.9 +/- 10.43 yrs). In training group 1, duration of exercise, tolerated maximum workload, timed up and go test, Dynamic Gait Index, functional reach, falls efficacy scale, 10-m walk test, Fatigue Severity scale, and Beck Depression Inventory scores, and in group 2, the mean duration of exercise, tolerated maximum workload, and Falls Efficacy scale scores were significantly improved after the training program (P < 0.05). There were no significant improvements in any of the outcome measurements in the control group (P > 0.05). In between-group comparisons, improvements in outcome measures of group 1 patients were significantly higher than those in other groups, except for 10-m walking test. Group 1 patients showed statistically significant improvement in physical functioning and role-physical functioning scales of the Short Form 36 (P < 0.01 and P < 0.05, respectively), and group 2 patients showed statistically significant improvement in only physical functioning scale of Short Form 36 (P < 0.05) after 8 wks. CONCLUSIONS: Specific exercise programs, including cycling progressive resistance training, may improve balance, fatigue, and depression and reduce fear of falling in patients with multiple sclerosis without worsening multiple sclerosis signs and symptoms.","Cakt, B. D., et al. (2010). \"Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study.\" Am J Phys Med Rehabil 89(6): 446-457.","Turkey",2010,"Neurological","Psychobehavioural","FSS",null,null,null,"Turkey",null,"Neurological","Psychobehavioural",null,null,"FSS","2010:2014"]
[45,"Calik-Kutukcu, E., et al. (2014). \"A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study.\" BMC Pulm Med 14: 6.",null,"Calik-Kutukcu, E., et al.","A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study","BACKGROUND: Chronic obstructive pulmonary disease (COPD) has significant systemic effects that substantially impact quality of life and survival. The purpose of this study was to assess and compare peripheral muscle strength and endurance, exercise capacity, fatigue perception and quality of life between patients with COPD and healthy subjects. METHODS: Twenty COPD patients (mean FEV1 49.3 +/- 19.2%) and 20 healthy subjects were included in the study. Pulmonary function testing and six-minute walk test (6MWT) were performed. Peripheral muscle strength was measured with a hand-held dynamometer, peripheral muscle endurance was evaluated with sit-ups, squats and modified push-ups tests. Fatigue perception was assessed using the Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS). General quality of life was determined with the Nottingham Health Profile (NHP), and cough-specific quality of life was evaluated with the Leicester Cough Questionnaire (LCQ). RESULTS: Pulmonary functions, strength of shoulder abductor and flexor muscles, numbers of sit-ups and squats, 6MWT distance and 6MWT% were significantly lower in COPD patients than in healthy subjects (p < 0.05). FIS psychosocial sub-dimension and total scores, NHP scores for all sub-dimensions except pain sub-dimension of the COPD group were significantly higher than those of healthy subjects (p < 0.05). The LCQ physical, psychological and social sub-dimensions and total scores were significantly lower in COPD patients than in healthy subjects (p < 0.05). CONCLUSIONS: Pulmonary functions, peripheral muscle strength and endurance, exercise capacity and quality of life were adversely affected in patients with COPD. There are greater effect of fatigue on psychosocial functioning and general daily life activities and effect of cough on the quality of life in patients with COPD. This study supports the idea that COPD patients must be evaluated in a comprehensive manner for planning pulmonary rehabilitation programs.","Calik-Kutukcu, E., et al. (2014). \"A comparison of muscle strength and endurance, exercise capacity, fatigue perception and quality of life in patients with chronic obstructive pulmonary disease and healthy subjects: a cross-sectional study.\" BMC Pulm Med 14: 6.","Turkey",2014,"Respiratory Disease","None","FIS,FSS",null,null,null,"Turkey",null,"Respiratory Disease","None",null,null,"FIS,FSS","2010:2014"]
[46,"Calkwood, J., et al. (2014). \"Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.\" BMC Neurol 14: 220.",null,"Calkwood, J., et al.","Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial","BACKGROUND: The Evaluate Patient OutComes (EPOC) study assessed physician- and patient-reported outcomes in individuals with relapsing multiple sclerosis who switched directly from injectable disease-modifying therapy (iDMT; glatiramer acetate, intramuscular or subcutaneous interferon beta-1a, or interferon beta-1b) to once-daily, oral fingolimod. Post hoc analyses evaluated the impact of a switch to fingolimod versus staying on each of the four individual iDMTs. METHODS: Overall, 1053 patients were randomized 3:1 to switch to fingolimod or remain on iDMT. The primary endpoint was the change in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction score. Secondary endpoints included changes in scores for TSQM Effectiveness, Side Effects and Convenience subscales, Beck Depression Inventory-II (BDI-II), Fatigue Severity Scale (FSS), Patient-Reported Outcome Indices for Multiple Sclerosis (PRIMUS) Activities, 36-item Short-Form Health Survey (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) and mean investigator-reported Clinical Global Impressions of Improvement (CGI-I). All outcomes were evaluated after 6 months of treatment. RESULTS: Changes in TSQM Global Satisfaction scores were superior after a switch to fingolimod when compared with scores in patients remaining on any of the iDMTs (all p <0.001). Likewise, all TSQM subscale scores improved following a switch to fingolimod (all p <0.001), except when compared with glatiramer acetate for the TSQM Side Effects subscale (p = 0.111). FSS scores were found to be superior for fingolimod versus remaining on subcutaneous interferon beta-1a and interferon beta-1b, BDI-II scores were significantly improved for fingolimod except for the comparison with intramuscular interferon beta-1a, and SF-36 scores were superior with fingolimod compared with remaining on interferon beta-1b (MCS and PCS; p = 0.030 and p = 0.022, respectively) and subcutaneous interferon beta-1a (PCS only; p = 0.024). Mean CGI-I scores were superior with fingolimod when compared with continuing treatment with any of the iDMTs (all p <0.001). CONCLUSIONS: After 6 months, a switch to fingolimod showed superiority compared with remaining on each iDMT for a range of patient- and physician-reported outcomes, including global satisfaction with treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01216072 .","Calkwood, J., et al. (2014). \"Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial.\" BMC Neurol 14: 220.","USA",2014,"Neurological","Fingolimod,Other Drugs","FSS",null,null,null,"USA",null,"Neurological","Fingolimod,Other Drugs",null,null,"FSS","2010:2014"]
[47,"Casellas, F., et al. (2012). \"Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease.\" Eur J Gastroenterol Hepatol 24(7): 762-769.",null,"Casellas, F., et al.","Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease","BACKGROUND: Inflammatory bowel disease (IBD) is a debilitating immune disorder that impairs function and health-related quality of life (HRQOL). A goal of IBD treatment is mucosal healing, but it is not known whether it achieves normalization of the patients' perception of health. This can be assessed by using a cut-off scoring threshold of the Inflammatory Bowel Disease Questonnaire-36 (IBDQ-36). AIMS: To determine whether patients with Crohn's disease (CD) and ulcerative colitis (UC) in clinical remission and with mucosal healing normalize their HRQOL. METHODS: This is a multicentric, prospective, observational, cross-sectional study of patients who are in stable clinical remission and having mucosal healing. Patients completed the IBDQ-36, the EuroQol-5D, and the Daily Fatigue Impact Scale fatigue questionnaires. Complete restoration of health was believed to have occurred when the global score in the IBDQ-36 was at least 209 points. RESULTS: A total of 115 patients (48 with CD, 67 with UC) were included. The median activity index (the Harvey-Bradshaw or the colitis activity index) was 1.0 and the median endoscopic index (Simple Endoscopic Score for Crohn's disease or Mayo) was 0. Eighty percent of the patients (79% in CD and 82% in UC patients, P=NS) normalized their HRQOL. Type of treatment was not related to normalization of HRQOL. The lack of restoration of health was significantly related to fatigue and anxiety/depression. CONCLUSION: Mucosal healing is associated with a normalization of the perception of health by most IBD patients independently of treatment. However, a significant group of patients do not achieve restoration of HRQOL, which reinforces the necessity of a global care addressed to all patient concerns to achieve patients' complete health restoration.","Casellas, F., et al. (2012). \"Mucosal healing restores normal health and quality of life in patients with inflammatory bowel disease.\" Eur J Gastroenterol Hepatol 24(7): 762-769.","Spain",2012,"Gastrointestinal","None","DFIS",null,null,null,"Spain",null,"Gastrointestinal","None",null,null,"DFIS","2010:2014"]
[48,"Casellas, F., et al. (2013). \"Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease.\" Rev Esp Enferm Dig 105(10): 585-593.",null,"Casellas, F., et al.","Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease","INTRODUCTION: celiac disease is a chronic condition that requires continued treatment, with the resultant impact on health-related quality of life (HRQOL) of people who suffer it. Most studies in this field have used generic questionnaires to measure HRQOL in celiac patients. It was therefore decided to conduct a study to translate into Spanish and validate a specific questionnaire for celiac disease, the Celiac Disease Quality Of Life Survey (CD-QOL). OBJECTIVES: to translate and validate in Spanish the specific celiac disease questionnaire CD-QOL. METHODS: a multicenter, prospective, observational study was designed consisting of two phases: In the first phase, the questionnaire was translated and adapted into Spanish using the translation/back translation procedure and an understandability study. In the second phase, internal consistency of the translated questionnaire was analyzed. For this, results of the CD-QOL were compared to those of EuroQol and the Daily Fatigue Impact Scale (D-FIS). Understandability of the translated and adapted questionnaire was tested in six patients, and the validation study was done in 298 celiac patients (201 treated with a gluten-free diet and 97 at diagnosis). RESULTS: in both celiac groups, Cronbach s alpha coefficient was high (0.90), feasibility was excellent (99.2 % of patients completed all questions), and there were no ceiling and floor effects. Spearman correlation to EuroQol and D-FIS was statistically significant (p < 0.05). CD-QOL score was different depending on whether state of health was good, fair, or poor based on the EuroQol score. CONCLUSION: the Spanish version of the CD-QOL is a valid tool for measuring HRQOL in celiac patients.","Casellas, F., et al. (2013). \"Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL) Survey, a specific questionnaire to measure quality of life in patients with celiac disease.\" Rev Esp Enferm Dig 105(10): 585-593.","Unknown",2013,"Gastrointestinal","None","DFIS",null,null,null,"Unknown",null,"Gastrointestinal","None",null,null,"DFIS","2010:2014"]
[49,"Catania, G., et al. (2013). \"Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI).\" Support Care Cancer 21(2): 413-419.",null,"Catania, G., et al.","Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI)","PURPOSE: Cancer-related fatigue (CRF) is one of the most common symptoms experienced by cancer patients (CPs). The Brief Fatigue Inventory (BFI) is a reliable instrument to assess CRF in CPs. The aim of this study was to evaluate the psychometric properties of the Italian version of the BFI (BFI-I). METHODS: The BFI-I was developed by using the forward-backward translation approach. The psychometric properties of the BFI-I were assessed in terms of acceptability, internal consistency, and validity. Outpatient CPs filled in BFI-I along with the Medical Outcome Study Quality of Life Short Form 36 (SF36). Demographic and health data were collected. RESULTS: The BFI-I had an overall Cronbach alpha for the nine items of 0.94. The inter-item mean correlation was 0.64, and coefficients ranged from 0.47 to 0.81 for the nine items. The results of the factor analysis suggested a 1-factor solution explaining 68 % of the variance, supporting the hypothesis of unidimensionality of the BFI-I. The BFI-I score was compared to SF36 subscales score to evaluate concurrent validity. An expected inverse correlation between the BFI-I and the vitality subscale of the SF36 was observed (r = -0.67, 95 % confidence interval -0.73 to -0.59). The correlation with the other subscales of the SF36 ranged between -0.56 and -0.13. Discriminant validity analysis showed the BFI-I mean score significantly increased with increasing Eastern Cooperative Oncology Group values (p < 0.001). CONCLUSIONS: BFI-I is a clinical instrument with satisfactory psychometric properties to assess CRF in Italian CPs.","Catania, G., et al. (2013). \"Cancer-related fatigue in Italian cancer patients: validation of the Italian version of the Brief Fatigue Inventory (BFI).\" Support Care Cancer 21(2): 413-419.","Italy",2013,"Cancer","None","BFI",null,null,null,"Italy",null,"Cancer","None",null,null,"BFI","2010:2014"]
[50,"Cella, D. (1998). \"Factors influencing quality of life in cancer patients: anemia and fatigue.\" Semin Oncol 25(3 Suppl 7): 43-46.",null,"Cella, D.","Factors influencing quality of life in cancer patients: anemia and fatigue","Anemia is a multi-symptom syndrome involving both physical and emotional problems that can be evaluated for their impact on quality of life. Fatigue is the cardinal symptom of anemia, reported by three of four cancer patients using the general version of the Functional Assessment of Cancer Therapy (FACT-G) questionnaire. A subscale of the FACT-G, consisting of the FACT-Fatigue (FACT-F) and the FACT-Anemia (FACT-An), has been developed to specifically address this problem. The FACT-F is comprised of the FACT-G plus 13 questions related to fatigue, while the FACT-An is comprised of the FACT-F plus an additional set of seven miscellaneous (non-fatigue) questions relevant to anemia in cancer patients. The FACT-An subscale was initially validated in a cohort of 50 cancer patients. Tests of internal consistency and stability confirmed the reliability of the fatigue component, as well as that of the FACT-G (27 items), the FACT-F (FACT-G plus 13 fatigue items), and the FACT-An (FACT-G plus 20 anemia subscale items) measurement systems. Quality of life scores on these FACT scales significantly decline as patient performance status worsens, and the scales correlate well with other questionnaires (Profile of Mood States and Piper Fatigue Scale) purported to measure the same thing. The scores on the FACT-An subscale also clearly differentiate between patients with low and high hemoglobin levels. Low hemoglobin levels are associated with greater fatigue, poorer overall quality of life, and decreased ability to work (beyond that related directly to fatigue). Interventions that reverse fatigue and other anemia-related symptoms should have a positive effect on quality of life.","Cella, D. (1998). \"Factors influencing quality of life in cancer patients: anemia and fatigue.\" Semin Oncol 25(3 Suppl 7): 43-46.","USA",1998,"Hematological","None","FACT-F",null,null,null,"USA",null,"Hematological","None",null,null,"FACT-F","1960:1999"]
[51,"Cerulli, C., et al. (2014). \"Therapeutic horseback riding in breast cancer survivors: a pilot study.\" J Altern Complement Med 20(8): 623-629.",null,"Cerulli, C., et al.","Therapeutic horseback riding in breast cancer survivors: a pilot study","PURPOSE: To evaluate the physiologic and psychological effects of an equine-assisted therapy protocol (EAT) in breast cancer survivors. METHODS: Twenty women (mean age, 45.61+/-2.71 years) whose breast cancer treatment had concluded at least 6 months previously underwent a screening protocol to certify their eligibility to participate in noncompetitive sports. The patients were randomly assigned to an intervention group (n=10) or a control group (n=10). Intervention patients participated in a 16-week EAT protocol consisting of 2 hours of activity per week. All patients were tested before and after the intervention for maximal oxygen consumption (VO2max), fat mass percentage, total body water percentage, strength of principal muscular groups (measured on five weight-lifting machines [leg press, leg extension, leg curl, shoulder press, vertical traction]), and quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire (FACIT-F). RESULTS: After intervention, the intervention group showed an improvement in VO2max (28.29%; p<.001), a decrease in fat mass percentage (change, -7.73%; p<0.002), an increase in total body water percentage (6.90%; p=0.027), and an increase in strength (leg press, 17.75% [p=0.018]; leg extension, 21.55% [p=0.005]; leg curl, 26.04% [p<0.001]; shoulder press, 49.72% [p=0.003]; vertical traction, 19.27% [p=0.002]). Furthermore, the increase in the three FACIT-F scores (FACIT-F trial outcome: 9.29% [p=0.010]; Functional Assessment of Cancer Therapy-General total score, 14.80% [p=0.022]; FACIT-F total score, 11.48% [p=0.004]) showed an increase in quality of life. No significant changes for any variable were found for the control group. CONCLUSIONS: EAT had positive effects on both physiologic and psychological measures, enhancing quality of life of breast cancer survivors. RESULTS suggest a new method for rehabilitation intervention strategies after cancer in a nonmedical environment.","Cerulli, C., et al. (2014). \"Therapeutic horseback riding in breast cancer survivors: a pilot study.\" J Altern Complement Med 20(8): 623-629.","Italy",2014,"Cancer","Psychobehavioural","FACIT-F",null,null,null,"Italy",null,"Cancer","Psychobehavioural",null,null,"FACIT-F","2010:2014"]
[52,"Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.",null,"Cessna, J. M., et al.","Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients","OBJECTIVE: Fatigue is common among cancer patients and adversely impacts quality of life. As such, it is important to measure fatigue accurately in a way that is not burdensome to patients. The 7-item Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form scale was recently developed using item response theory (IRT). The current study evaluated the psychometric properties of this scale in two samples of cancer patients using classical test theory (CTT). METHODS: Two samples were used: 121 men with prostate cancer and 136 patients scheduled to undergo hematopoietic cell transplantation (HCT) for hematologic cancer. All participants completed the PROMIS Cancer Fatigue Short Form as well as validated measures of fatigue, vitality, and depression. HCT patients also completed measures of anxiety, perceived stress, and a clinical interview designed to identify cases of cancer-related fatigue. RESULTS: PROMIS Cancer Fatigue Short Form items loaded on a single factor (CFI=0.948) and the scale demonstrated good internal consistency reliability in both samples (Cronbach's alphas>0.86). Correlations with psychosocial measures were significant (p values<.0001) and in the expected direction, offering evidence for convergent and concurrent validity. PROMIS Fatigue scores were significantly higher in patients who met case definition criteria for cancer-related fatigue (p<.0001), demonstrating criterion validity. CONCLUSION: The current study provides evidence that the PROMIS Cancer Fatigue Short Form is a reliable and valid measure of fatigue in cancer patients.","Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.","USA",2016,"Cancer","None","PROMIS-F",null,null,null,"USA",null,"Cancer","None",null,null,"PROMIS-F","2015:2018"]
[53,"Chaiamnuay, S., et al. (2007). \"The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected].\" J Clin Rheumatol 13(3): 128-133.",null,"Chaiamnuay, S., et al.","The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected]","OBJECTIVE: The aim of this study was to examine the impact of an increased body mass index (BMI) on disease activity, damage accrual, fatigue, self-reported health-related quality of life (HRQOL), and fibromyalgia in patients with lupus using longitudinal data from LUMINA, a large multiethnic cohort. METHODS: SLE patients (>/=4 ACR revised criteria), </=5 years disease duration at entry into the cohort (T0), of Hispanic (from Texas or from the Island of Puerto Rico), African American, or white ethnicity were included. BMI was ascertained at T0 or first recorded. The average scores from all visits for disease activity (SLAM-R), self-reported HRQOL (physical and mental component summary measures of the SF-36) and fatigue (Fatigue Severity Scale), the score at last visit for damage accrual (SLICC Damage Index), and fibromyalgia (ACR criteria), if present at any visit, were examined for their association with an increased BMI by univariable and multivariable analyses. RESULTS: Three-hundred sixty-four patients were included; 28% were obese (BMI >/=30 kg/m). An increased BMI was associated with older age, less social support, higher degree of helplessness, depression, more abnormal illness-related behaviors, poorer self-reported HRQOL, fatigue, and fibromyalgia, but not with disease activity or damage accrual by univariable analyses. In multivariable analyses, BMI was independently associated with fibromyalgia but not with disease activity, fatigue, or self-reported HRQOL. CONCLUSIONS: An increased BMI is independently associated with presence of fibromyalgia but not with disease activity, damage accrual, fatigue or self-reported quality of life in patients with SLE. Optimizing weight merits investigation to see if it can significantly impact this pervasive SLE-associated manifestation.","Chaiamnuay, S., et al. (2007). \"The impact of increased body mass index on systemic lupus erythematosus: data from LUMINA, a multiethnic cohort (LUMINA XLVI) [corrected].\" J Clin Rheumatol 13(3): 128-133.","USA",2007,"Musculoskeletal","None","FSS",null,null,null,"USA",null,"Musculoskeletal","None",null,null,"FSS","2005:2009"]
[54,"Chasen, M. R. and R. Bhargava (2010). \"A rehabilitation program for patients with gastroesophageal cancer--a pilot study.\" Support Care Cancer 18 Suppl 2: S35-40.",null,"Chasen, M. R. and R. Bhargava","A rehabilitation program for patients with gastroesophageal cancer--a pilot study","PURPOSE: Gastroesophageal carcinoma has a 5-year survival rate of 20%. Esophagogastrectomy is a significant life-altering operation which interferes with a patient's ability to eat food as a normal social interaction. Dumping syndrome, delayed gastric emptying, and reflux are encountered after surgery. In addition, loss of appetite and body weight occurs. Fatigue is universally encountered. We conducted this study to evaluate whether a structured cancer nutrition and rehabilitation program has an effect on the symptoms and quality of life of patients with gastroesophageal cancer. MATERIALS AND METHODS: Fifty-three patients with histologically documented gastroesophageal carcinoma were evaluated before and after an 8-week multidisciplinary program consisting of physicians, oncology nurse, dietitian, physical and occupational therapists, social worker, and psychologist. Twenty-two patients completed all the following questionnaires pre- and post-program: The Edmonton Symptom Assessment Scale (ESAS), Patient-Generated Subjective Global Assessment (PG-SGA), Brief Fatigue Inventory (BFI), and the Distress Thermometer. RESULT: There were 42 male and 11 female patients. The median age was 63 years (22-80 years). Thirty patients had gastric cancer and 23 had esophageal cancer. On the ESAS, appetite, strength, shortness of breath, and constipation all improved (p = 0.01). The PG-SGA score decreased significantly (p = 0.05). Fatigue and general activity as measured on the BFI improved significantly. The 6-min walk increased from 384 to 435 m (p = 0.01). CONCLUSION: The Cancer Nutrition and Rehabilitation program offers a multidimensional, holistic treatment approach emphasizing the patient as an individual. Participation in a cancer rehabilitation program ameliorates symptoms, improves nutrition, decreases global distress, and increases physical activities.","Chasen, M. R. and R. Bhargava (2010). \"A rehabilitation program for patients with gastroesophageal cancer--a pilot study.\" Support Care Cancer 18 Suppl 2: S35-40.","Canada",2010,"Cancer","None","BFI",null,null,null,"Canada",null,"Cancer","None",null,null,"BFI","2010:2014"]
[55,"Chua, A. S., et al. (2015). \"Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure.\" Mult Scler Relat Disord 4(6): 598-606.",null,"Chua, A. S., et al.","Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure","Several patient-reported outcome (PRO) measures are commonly used in multiple sclerosis (MS) research, but the relationship among items across measures is uncertain. We proposed to evaluate the associations between items from a standard battery of PRO measures used in MS research and to develop a brief, reliable and valid instrument measure by combining these items into a single measure. Subjects (N = 537) enrolled in CLIMB complete a PRO battery that includes the Center for Epidemiologic Studies Depression Scale, Medical Outcomes Study Modified Social Support Survey, Modified Fatigue Impact Scale and Multiple Sclerosis Quality of Life-54. Subjects were randomly divided into two samples: calibration (n = 269) and validation (n = 268). In the calibration sample, an Exploratory Factor Analysis (EFA) was used to identify latent constructs within the battery. The model constructed based on the EFA was evaluated in the validation sample using Confirmatory Factor Analysis (CFA), and reliability and validity were assessed for the final measure. The EFA in the calibration sample revealed an eight factor solution, and a final model with one second-order factor along with the eight first-order factors provided the best fit. The model combined items from each of the four parent measures, showing important relationships among the parent measures. When the model was fit using the validation sample, the results confirmed the validity and reliability of the model. A brief PRO for MS (BPRO-MS) that combines MS-related psychosocial and quality of life domains can be used to assess overall functioning in mildly disabled MS patients.","Chua, A. S., et al. (2015). \"Patient-reported outcomes in multiple sclerosis: Relationships among existing scales and the development of a brief measure.\" Mult Scler Relat Disord 4(6): 598-606.","USA",2015,"Neurological","None","MFI",null,null,null,"USA",null,"Neurological","None",null,null,"MFI","2015:2018"]
[56,"Claesson, M., et al. (2003). \"Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease.\" Eur J Cardiovasc Prev Rehabil 10(4): 258-266.",null,"Claesson, M., et al.","Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease","BACKGROUND: Secondary prevention in patients with ischaemic heart disease (IHD) focusing on classical risk factors has been less successful in women than in men. Previous studies have suggested that psychosocial factors may be new targets for secondary prevention. In the present study, psychosocial factors have been compared in women with and without IHD. METHODS AND SUBJECTS: Using a cross-sectional comparison, classical cardiovascular risk factors and self-rated stress behaviour, vital exhaustion, stressful life events and quality of life were assessed in 198 women (age 35-77 years) who had IHD and a population-based sample of 206 women (age 45-74 years) without IHD. RESULTS: Control of classical risk factors was most often adequate in women with IHD. The prevalence of smoking was 9% in women with versus 18% in women without IHD (P<0.001), blood pressure levels were similar, and a very large share of women with IHD were on treatment with anti-thrombotic, anti-hypertensive and/or lipid-lowering drugs (P<0.001 compared with women free of IHD). In contrast, women with IHD scored significantly worse than women without IHD in self-rated stress behaviour (P=0.003 after adjustment for other possible determinants), and in vital exhaustion (P=0.003). In univariate analyses, quality of life was significantly worse in women with IHD. Stressful life events did not differ between the two groups. CONCLUSIONS: In this group of women with IHD, control of classical risk factors was good, whereas control of psychosocial risk factors was clearly inadequate. Secondary prevention by psychosocial intervention in women with IHD should be evaluated in randomized controlled trials.","Claesson, M., et al. (2003). \"Psychosocial distress and impaired quality of life--targets neglected in the secondary prevention in women with ischaemic heart disease.\" Eur J Cardiovasc Prev Rehabil 10(4): 258-266.","Sweden",2003,"CVD","None","VE",null,null,null,"Sweden",null,"CVD","None",null,null,"VE","2000:2004"]
[57,"Cohen, S. B., et al. (2006). \"Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks.\" Arthritis Rheum 54(9): 2793-2806.",null,"Cohen, S. B., et al.","Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks","OBJECTIVE: To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. METHODS: We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. RESULTS: Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. CONCLUSION: At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies.","Cohen, S. B., et al. (2006). \"Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks.\" Arthritis Rheum 54(9): 2793-2806.","USA",2006,"Musculoskeletal","Rituximab,Other Drugs","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Rituximab,Other Drugs",null,null,"FACIT-F","2005:2009"]
[58,"Cook, K. F., et al. (2012). \"A PROMIS fatigue short form for use by individuals who have multiple sclerosis.\" Qual Life Res 21(6): 1021-1030.",null,"Cook, K. F., et al.","A PROMIS fatigue short form for use by individuals who have multiple sclerosis","PURPOSE: To derive from the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue item bank, a short form for individuals with multiple sclerosis (MS), the PROMIS-Fatigue(MS). METHODS: A panel of 37 clinicians and 46 individuals with MS ranked the relevance of PROMIS fatigue items to persons with MS. Eight items were selected for the PROMIS-Fatigue(MS) that maximized relevance rankings, content coverage, and item discrimination. The PROMIS-Fatigue(MS) and an existing, 7-item PROMIS fatigue short form (PROMIS-Fatigue(SFv1.0)) were administered to a new sample of 231 individuals with MS. Known groups and content validity were assessed. RESULTS: Scores from the short forms were highly correlated (r = 0.92). Discriminant validity of the PROMIS-Fatigue(MS) scores was supported in known groups comparisons. Scores of neither short form exhibited an advantage in quantitative analyses. The PROMIS-Fatigue(MS) targeted more of the content included in participants' responses to open-ended questions than did the PROMIS-Fatigue(SFv1.0). CONCLUSIONS: The PROMIS-Fatigue(MS) was derived to have content validity in MS samples. The validity of the measure was further supported by the ability of PROMIS-Fatigue(MS) items to discriminate among groups expected to differ in levels of fatigue. We recommend its use in measuring the fatigue of individuals with MS.","Cook, K. F., et al. (2012). \"A PROMIS fatigue short form for use by individuals who have multiple sclerosis.\" Qual Life Res 21(6): 1021-1030.","USA",2012,"Neurological","None","PROMIS-F",null,null,null,"USA",null,"Neurological","None",null,null,"PROMIS-F","2010:2014"]
[59,"Dahm, J. and J. Ponsford (2015). \"Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?\" Injury 46(1): 142-149.",null,"Dahm, J. and J. Ponsford","Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?","OBJECTIVE: Whilst it has been well-demonstrated that traumatic brain injury (TBI) results in long-term cognitive, behavioural and emotional difficulties, less is understood about how these outcomes differ from those following traumatic orthopaedic injury (TOI). The aim of this study was to compare self-reported outcomes at 5-10 years post-injury for those with TBI, TOI, and uninjured controls. It was hypothesised that participants with TBI would have greater cognitive difficulties; participants with TOI and TBI would have similar functional and physical outcomes, both being poorer than controls; and participants with TBI would have poorer psychosocial outcomes than those with TOI. PARTICIPANTS AND METHODS: Eighty-eight individuals with complicated mild to severe TBI and 96 with TOI recruited during inpatient rehabilitation were followed up 5-10 years post-injury, together with 48 controls followed over a similar period. Self-report measures of global functioning (GOS-E), quality of life (SF-36), psychological wellbeing (SCL-90-R, HADS, PCL-S), psychosocial difficulties (SIP), cognitive difficulties (SF-36 COG), pain (BPI), and fatigue (FSS) were administered. RESULTS: Outcomes for individuals with TBI and TOI differed significantly from controls, with poorer global functioning, and greater psychological distress and interference from pain. Only participants with TBI reported greater cognitive difficulties and anxiety than controls, and were less likely to be employed or in a relationship. Participants with TBI reported greater anxiety, PTSD, psychological distress and psychosocial difficulties than those with TOI. CONCLUSIONS: Both TOI and TBI cause long-term disability, interference from pain, and psychological distress. However, cognitive impairments, unemployment, lack of long-term relationships, anxiety and PTSD are more substantial long-term problems following TBI. Findings from this study have implications for managing risks associated with these injury groups and tailoring rehabilitation to improve long-term outcomes.","Dahm, J. and J. Ponsford (2015). \"Comparison of long-term outcomes following traumatic injury: what is the unique experience for those with brain injury compared with orthopaedic injury?\" Injury 46(1): 142-149.","Australia",2015,"Neurological","None","FSS",null,null,null,"Australia",null,"Neurological","None",null,null,"FSS","2015:2018"]
[60,"Dalgas, U., et al. (2010). \"Fatigue, mood and quality of life improve in MS patients after progressive resistance training.\" Mult Scler 16(4): 480-490.",null,"Dalgas, U., et al.","Fatigue, mood and quality of life improve in MS patients after progressive resistance training","Fatigue occurs in the majority of multiple sclerosis patients and therapeutic possibilities are few. Fatigue, mood and quality of life were studied in patients with multiple sclerosis following progressive resistance training leading to improvement of muscular strength and functional capacity. Fatigue (Fatigue Severity Scale, FSS), mood (Major Depression Inventory, MDI) and quality of life (physical and mental component scores, PCS and MCS, of SF36) were scored at start, end and follow-up of a randomized controlled clinical trial of 12 weeks of progressive resistance training in moderately disabled (Expanded Disability Status Scale, EDSS: 3-5.5) multiple sclerosis patients including a Control group (n = 15) and an Exercise group (n = 16). Fatigue (FSS > 4) was present in all patients. Scores of FSS, MDI, PCS-SF36 and MCS-SF36 were comparable at start of study in the two groups. Fatigue improved during exercise by -0.6 (95% confidence interval (CI) -1.4 to 0.4) a.u. vs. 0.1 (95% CI -0.4 to 0.6) a.u. in controls (p = 0.04), mood improved by -2.4 (95% CI -4.1 to 0.7) a.u. vs. 1.1 (-1.2 to 3.4) a.u. in controls (p = 0.01) and quality of life (PCS-SF36) improved by 3.5 (95% CI 1.4-5.7) a.u. vs. -1.0 (95% CI -3.4-1.4) a.u. in controls (p = 0.01). The beneficial effect of progressive resistance training on all scores was maintained at follow-up after further 12 weeks. Fatigue, mood and quality of life all improved following progressive resistance training, the beneficial effect being maintained for at least 12 weeks after end of intervention.","Dalgas, U., et al. (2010). \"Fatigue, mood and quality of life improve in MS patients after progressive resistance training.\" Mult Scler 16(4): 480-490.","Denmark",2010,"Neurological","Psychobehavioural","FSS",null,null,null,"Denmark",null,"Neurological","Psychobehavioural",null,null,"FSS","2010:2014"]
[61,"Dapueto, J. J., et al. (2014). \"Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay.\" J Pain Symptom Manage 47(5): 936-945.",null,"Dapueto, J. J., et al.","Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay","CONTEXT: Several instruments have been developed to assess the symptom burden and fatigue produced by cancer and its treatment. However, little research has been conducted in Latin American Spanish-speaking patients. OBJECTIVES: The aim of the study was to assess the psychometric properties of the Spanish versions of two commonly used patient-reported outcome measures, the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), and the fatigue subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), the FACIT-Fatigue. METHODS: A classic psychometric approach was followed to assess the reliability and validity of the instruments. Responsiveness to change and effect sizes were calculated. RESULTS: The translated version of the MSAS-SF proved to be comprehensible and easy to complete. Cronbach alpha reliability coefficients ranged from acceptable to excellent for the MSAS-SF subscale scores and the FACIT-Fatigue. There was evidence of convergent validity between the physical and the psychological subscales of the instruments. The MSAS-SF could discriminate among the known groups according to Eastern Cooperative Oncology performance status and level of anemia, and showed responsiveness to change of symptom burden at two times of treatment. CONCLUSION: The study showed that both the MSAS-SF and the FACIT-Fatigue have good reliability and validity for use with patients with cancer in Uruguay. When used simultaneously, these instruments may provide a complete picture of the impact of cancer and its treatment on the patient's quality of life.","Dapueto, J. J., et al. (2014). \"Psychometric assessment of the MSAS-SF and the FACIT-Fatigue Scale in Spanish-speaking patients with cancer in Uruguay.\" J Pain Symptom Manage 47(5): 936-945.","Uruguay",2014,"Cancer","None","FACIT-F",null,null,null,"Uruguay",null,"Cancer","None",null,null,"FACIT-F","2010:2014"]
[62,"De Boer, S. and M. L. Wilsher (2012). \"Validation of the Sarcoidosis Health Questionnaire in a non-US population.\" Respirology 17(3): 519-524.",null,"De Boer, S. and M. L. Wilsher","Validation of the Sarcoidosis Health Questionnaire in a non-US population","BACKGROUND AND OBJECTIVE: Sarcoidosis is a multi-system disease with an unpredictable course and variable clinical manifestations that are often associated with impaired quality of life. The Sarcoidosis Health Questionnaire (SHQ), which was developed for an 80% African American population, assesses health-related quality of life in sarcoidosis patients. The aim of this study was to validate the SHQ in a predominantly European population of sarcoidosis patients. METHODS: Consecutive outpatients (n = 92) with sarcoidosis, who were attending a teaching hospital clinic, completed three questionnaires (SHQ, Short Form (SF) 36, Fatigue Assessment Scale (FAS)) and pulmonary function tests were performed. RESULTS: The mean age of the patients was 51 years, 52% were males and 74% were of European ethnicity. The mean number of organs involved was 1.3, with pulmonary involvement in 95% of patients (mean forced expiratory volume in 1 s 74.4%, forced vital capacity 84.6%). Seventy percent of patients had current symptoms and 26.5% were receiving immunosuppressant therapy. The SHQ total score (mean 5.13) was significantly correlated with the SF 36 physical component score (46.7, r = 0.78) and the FAS (20.8, r = -0.7) but only weakly correlated with pulmonary function. There were significant differences in SHQ scores when patients were stratified according to symptoms, oral therapy, health status (P < 0.0001 for all), forced expiratory volume in 1 s >/=70% (P = 0.008) and forced vital capacity >/=70% (P = 0.01). CONCLUSIONS: The SHQ correlated well with health-related quality of life and fatigue measures in a predominantly European population of sarcoidosis patients, despite differences in organ involvement and disease burden, when compared with the development study.","De Boer, S. and M. L. Wilsher (2012). \"Validation of the Sarcoidosis Health Questionnaire in a non-US population.\" Respirology 17(3): 519-524.","New Zealand",2012,"Inflamatory Systemic Disease","None","FAS",null,null,null,"New Zealand",null,"Inflamatory Systemic Disease","None",null,null,"FAS","2010:2014"]
[63,"De Giglio, L., et al. (2015). \"A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study.\" Neurorehabil Neural Repair 29(5): 453-461.",null,"De Giglio, L., et al.","A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study","OBJECTIVE: To evaluate the effectiveness of a home-based cognitive rehabilitation (CR) program based on the video game Dr Kawashima's Brain Training (DKBT; Nintendo, Japan), in improving attention, processing speed, and working memory of patients with multiple sclerosis (MS). METHODS: This was a randomized, wait-list control study. Patients with MS and failure in at least one between Stroop Test (ST), Paced Auditory Serial Addition Test (PASAT), and Symbol Digit Modalities Test (SDMT) were submitted to an 8-week home-based CR program playing DKBT. Patients were evaluated at baseline and after DKBT by the aforementioned tests, by the Modified Fatigue Impact Scale (MFIS) and by the MS Quality of Life-54 questionnaire (MSQoL-54). RESULTS: Fifty-two 52 patients were screened for eligibility; 35 (mean [standard deviation] age of 43.9 [8.4] years, median Expanded Disability Status Scale score of 2.0 (range = 2.0-6.0) were randomly assigned to the intervention group (n = 18) or wait-list control group (n = 17). ANCOVA analysis showed a significant effect of DKBT on ST (F = 5.027; P = .034; F(2) = 0.210), SDMT (F = 4.240; P = .049; F(2) = 0.177), and on some subscales of MSQoL-54. The PASAT and cognitive subscale of MFIS also showed an improvement, but this was just not significant (F = 4.104, P = .054, F(2) = 0.171, and F = 4.226, P = .054, F(2) = 0.237, respectively). CONCLUSION: We suggest that a home-based DKBT program may improve cognitive functions, some aspects of QoL, and cognitive fatigue in patients with MS.","De Giglio, L., et al. (2015). \"A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study.\" Neurorehabil Neural Repair 29(5): 453-461.","Italy",2015,"Neurological","Psychobehavioural","MFI",null,null,null,"Italy",null,"Neurological","Psychobehavioural",null,null,"MFI","2015:2018"]
[64,"de Oliveira Campos, M. P., et al. (2011). \"Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy.\" J Altern Complement Med 17(6): 505-512.",null,"de Oliveira Campos, M. P., et al.","Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy","BACKGROUND: In patients with breast cancer (BC) undergoing systemic chemotherapy, cancer-related fatigue (CRF) is a common problem that can negatively impact quality of life. Guarana (Paullinia cupana) is a plant native to the Amazon basin that has been used as a stimulant since pre-Columbian times. OBJECTIVE: The purpose of this study was to evaluate the effectiveness of guarana extract on fatigue, sleep quality, anxiety, depression symptoms, and menopause in a group of BC chemotherapy patients. PATIENTS AND METHODS: Patients with progressive fatigue after their first cycle of chemotherapy were randomized to receive either guarana 50 mg by mouth twice daily (32 patients) or placebo (43 patients) for 21 days. After a 7-day washout period, patients were crossed over to the opposite experimental arm. All patients were evaluated on days 1, 21, and 49. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire score, and secondary endpoints were the results of the Functional Assessment of Chronic Illness Therapy-Endocrine Symptoms (FACT-ES), Brief Fatigue Inventory (BFI), Pittsburg Sleep Quality Index, Chalder Fatigue Scale, and Hospital Anxiety and Depression Scale. RESULTS: Guarana significantly improved the FACIT-F, FACT-ES, and BFI global scores compared to placebo on days 21 and 49 (p < 0.01). The Chalder Scale improved significantly on day 21 (p < 0.01) but not on day 49 (p = 0.27). Guarana did not produce any Common Terminology Criteria for Adverse Events grades 2, 3, or 4 toxicities and did not worsen sleep quality or cause anxiety or depression. CONCLUSIONS: Guarana is an effective, inexpensive, and nontoxic alternative for the short-term treatment of fatigue in BC patients receiving systemic chemotherapy. Further studies are needed to confirm these results and to evaluate their generalizability to chronic CRF and to other types of cancer.","de Oliveira Campos, M. P., et al. (2011). \"Guarana (Paullinia cupana) improves fatigue in breast cancer patients undergoing systemic chemotherapy.\" J Altern Complement Med 17(6): 505-512.","Brazil",2011,"Cancer","Complementary","FACIT-F,CFS",null,null,null,"Brazil",null,"Cancer","Complementary",null,null,"FACIT-F,CFS","2010:2014"]
[65,"Denkinger, M. D., et al. (2015). \"Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments.\" Z Gerontol Geriatr 48(2): 128-134.",null,"Denkinger, M. D., et al.","Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments","OBJECTIVES: Because of substantial toxicities in older adults, chemotherapy is often omitted while the frequency of radiotherapy changes only minimally. In this study, we addressed the value of different assessments for predicting fatigue after radiotherapy in older breast cancer patients. PATIENTS AND METHODS: We included 74 women with primary breast cancer over the age of 65 years treated with radiotherapy (26 % with additional chemotherapy). Assessments were conducted before adjuvant treatment and after radiotherapy. The assessments included the Vulnerable Elders Survey (VES-13), the Karnofsky Performance Status (KPS), the EORTC Quality of Life assessment (EORTC-QLQ-C30), a cancer-specific comprehensive geriatric assessment (cancer-specific CGA), and the Fried frailty score. Multiple linear regression analyses were used to assess correlations with the FACIT-fatigue scale. RESULTS: Patients were on average 71 years old (range, 65-86 years). Most tumors (n=62) were classified as intermediate risk according to the St. Gallen consensus. The cancer-specific CGA was best associated with fatigue (p < 0.001, beta estimate = 1.75), followed by the Fried frailty score (for the score of 1 versus reference of 2 and higher: p = 0.035, beta estimate = - 5.74). There were no significant ceiling effects but there were substantial floor effects for the VES-13, KPS, and frailty score. CONCLUSION: The cancer-specific CGA and the Fried frailty score (driven mainly by the item \"exhaustion\") outperformed the other indices in predicting fatigue in a group of rather well-functioning older women with primary breast cancer.","Denkinger, M. D., et al. (2015). \"Predicting fatigue in older breast cancer patients receiving radiotherapy. A head-to-head comparison of established assessments.\" Z Gerontol Geriatr 48(2): 128-134.","Germany",2015,"Cancer","Cancer treatments","FACIT-F",null,null,null,"Germany",null,"Cancer","Cancer treatments",null,null,"FACIT-F","2015:2018"]
[66,"Deodhar, A. A., et al. (2016). \"Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).\" Arthritis Rheumatol 68(12): 2901-2910.",null,"Deodhar, A. A., et al.","Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1)","OBJECTIVE: To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). METHODS: In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV-->150 mg group), or SC secukinumab 75 mg every 4 weeks (IV-->75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). RESULTS: At week 16, secukinumab IV-->150 mg or IV-->75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. CONCLUSION: Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.","Deodhar, A. A., et al. (2016). \"Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1).\" Arthritis Rheumatol 68(12): 2901-2910.","Netherlands",2016,"Musculoskeletal","Secukinumab","FACIT-F",null,null,null,"Netherlands",null,"Musculoskeletal","Secukinumab",null,null,"FACIT-F","2015:2018"]
[67,"Detert, J., et al. (2016). \"Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis.\" Clin Exp Rheumatol 34(5): 848-856.",null,"Detert, J., et al.","Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis","OBJECTIVES: To compare sleep quality, disease activity and patient-reported outcomes such as fatigue and immune parameters in patients with rheumatoid arthritis treated with etanercept (ETA) or methotrexate (MTX). METHODS: Of 36 patients (28-joint Disease Activity Score, DAS28CRP>/=3.2) in this 16-week (w), open, prospective study, 19 (11 women) received MTX 12.5-17 mg/w, and 17 (14 women) received ETA 25 mg x 2/w, alone or in combination with MTX. Clinical (DAS28CRP, visual analogue scale), laboratory (C-reactive protein [CRP]), sleep (polysomnography), functional (Multidimensional Fatigue Inventory; Health Assessment Questionnaire-Disability Index (HAQ-DI); 36-item Short-Form Health Survey (SF-36), immunological (humoral/cellular) and neuroendocrine (hormonal) parameters were recorded at baseline (BL), w8 and w16. RESULTS: BL characteristics did not differ significantly between the ETA and MTX groups except disease duration: mean age (years): 48.6+/-8.8 vs. 49.4+/-16.6; mean disease duration (months): 19.6+/-46.3 vs. 81.2+/-79.2; and DAS28CRP: 4.4+/-0.9 vs. 4.4+/-1.7, respectively. DAS28CRP, SF-36, and HAQ-DI improved significantly in both groups from BL to w16 (p</=0.05). The DAS28CRP improvements at w16 (mean changes -1.8 in the ETA group, and -1.4 in MTX group), were not statistically significant from each other. The absolute values of sleep efficiency, total sleep time, and stage 2 sleep duration increased significantly in the ETA group, but no significant changes were reported in the MTX group. CONCLUSIONS: Both therapies improved disease activity, CRP, SF-36 and HAQ-DI, with faster, more pronounced changes in DAS28CRP in the ETA group, which alone had significantly improved sleep parameters.","Detert, J., et al. (2016). \"Effects of treatment with etanercept versus methotrexate on sleep quality, fatigue and selected immune parameters in patients with active rheumatoid arthritis.\" Clin Exp Rheumatol 34(5): 848-856.","Germany",2016,"Musculoskeletal","Etanercept,Other Drugs","MFI",null,null,null,"Germany",null,"Musculoskeletal","Etanercept,Other Drugs",null,null,"MFI","2015:2018"]
[68,"Dettmers, C., et al. (2009). \"Endurance exercise improves walking distance in MS patients with fatigue.\" Acta Neurol Scand 120(4): 251-257.",null,"Dettmers, C., et al.","Endurance exercise improves walking distance in MS patients with fatigue","OBJECTIVES: Effects of endurance training in multiple sclerosis (MS) patients complaining of motor fatigue. MATERIALS AND METHODS: Thirty MS patients complaining of fatigue with low to moderate disabilities randomly allocated to the intervention (thrice weekly 45-min intervals of endurance exercise) or control treatment (three 45-min episodes of stretching, balance training and coordination), both as 'add-on' therapy for 3 weeks during inpatient rehabilitation. RESULTS: Maximal walking distance before intervention averaged 1043 +/- 568 and 1163 +/- 750 m in the two groups. The intervention group increased its maximal walking distance by 650 +/- 474 m. The control group extended its walking distance by 96 +/- 70 m. CONCLUSIONS: The present data confirm a strong effect of endurance exercise on maximal walking distance. Remarkably, there were no parallel improvements on the Modified Fatigue Impact Scale, the Beck Depression Inventory and the Hamburg Quality of Life Questionnaire for MS.","Dettmers, C., et al. (2009). \"Endurance exercise improves walking distance in MS patients with fatigue.\" Acta Neurol Scand 120(4): 251-257.","Germany",2009,"Neurological","Psychobehavioural","MFI",null,null,null,"Germany",null,"Neurological","Psychobehavioural",null,null,"MFI","2005:2009"]
[69,"Dols, L. F., et al. (2010). \"Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy.\" Am J Transplant 10(11): 2481-2487.",null,"Dols, L. F., et al.","Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy","Long-term physical and psychosocial effects of laparoscopic and open kidney donation are ill defined. We performed long-term follow-up of 100 live kidney donors, who had been randomly assigned to mini-incision open donor nephrectomy (MIDN) or laparoscopic donor nephrectomy (LDN). Data included blood pressure, glomerular filtration rate, quality of life (SF-36), fatigue (MFI-20) and graft survival. After median follow-up of 6 years clinical and laboratory data were available for 47 donors (94%) in both groups; quality of life data for 35 donors (70%) in the MIDN group, and 37 donors (74%) in the LDN group. After 6 years, mean estimated glomerular filtration rates did not significantly differ between MIDN (75 mL/min) and LDN (76 mL/min, p = 0.39). Most dimensions of the SF-36 and MFI-20 did not significantly differ between groups at long-term follow-up, and most scores had returned to baseline. Twelve percent of the donors reported persistent complaints, but no major complications requiring surgical intervention. Five-year death-censored graft survival was 90% for LDN, and 85% for MIDN (p = 0.50). Long-term outcome of live kidney donation is excellent from the perspective of both the donor and the recipient.","Dols, L. F., et al. (2010). \"Long-term follow-up of a randomized trial comparing laparoscopic and mini-incision open live donor nephrectomy.\" Am J Transplant 10(11): 2481-2487.","Netherlands",2010,"Kidney Disease","Surgery","MFI",null,null,null,"Netherlands",null,"Kidney Disease","Surgery",null,null,"MFI","2010:2014"]
[70,"Donnellan, C. P. and J. Shanley (2008). \"Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial.\" Clin Rehabil 22(3): 195-205.",null,"Donnellan, C. P. and J. Shanley","Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial","OBJECTIVE: To compare the effect of two types of acupuncture on the quality of life of individuals with secondary progressive multiple sclerosis and provide preliminary evidence regarding the safety of this intervention for this population. DESIGN: Preliminary single-blind randomized controlled trial. SETTING: Outpatient attendance at rehabilitation unit. PARTICIPANTS: Fourteen participants with secondary progressive multiple sclerosis. INTERVENTIONS: Chinese medical acupuncture or minimal acupuncture. Participants received 10 treatments over five weeks. MEASURES: Multiple Sclerosis Impact Scale 29, Fatigue Severity Scale and General Health Questionnaire 12 were measured pre and post intervention. Adverse events and other responses during treatment were recorded prospectively. RESULTS: Participants receiving minimal acupuncture demonstrated statistically significant greater improvement in the Multiple Sclerosis Impact Scale 29 psychological subscale compared with those receiving Chinese medical acupuncture in an intention-to-treat analysis (P=0.04), with mean change in Chinese acupuncture group of 6.0 (SD 13.9) and in minimal acupuncture group of 23.0 (SD 21.0). No other statistically significant difference between the groups was found. No major adverse events were noted. Minor adverse events such as lower limb muscle spasms or pain were noted in some participants in both intervention groups. CONCLUSION: Minimal acupuncture resulted in greater improvement of Multiple Sclerosis Impact Scale 29 psychological subscale compared with Chinese medical acupuncture. No other differences between the groups were found. In view of the small sample these results are not conclusive. This study provides preliminary evidence to suggest that acupuncture is safe for people with secondary progressive multiple sclerosis. A large-scale trial is required to provide more definitive evidence.","Donnellan, C. P. and J. Shanley (2008). \"Comparison of the effect of two types of acupuncture on quality of life in secondary progressive multiple sclerosis: a preliminary single-blind randomized controlled trial.\" Clin Rehabil 22(3): 195-205.","UK",2008,"Neurological","Complementary","FSS",null,null,null,"UK",null,"Neurological","Complementary",null,null,"FSS","2005:2009"]
[71,"Donnelly, C. M., et al. (2011). \"A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors.\" Gynecol Oncol 122(3): 618-624.",null,"Donnelly, C. M., et al.","A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors","OBJECTIVE: To determine the feasibility and efficacy of a physical activity behavioural change intervention in managing cancer-related fatigue among gynaecological cancer survivors during and post anti-cancer treatments. METHODS: A two arm, single blind, randomised controlled trial was conducted within the Northern Ireland regional Cancer Centre. Thirty three sedentary gynaecological cancer survivors (stage I-III; </=3 years post diagnosis), experiencing cancer-related fatigue (mild-severe) took part. Participants were randomly assigned to a behavioural change, moderate intensity physical activity intervention (n=16) or a Contact Control group (n=17). The primary outcome was fatigue (Multidimensional Fatigue Symptom Inventory-Short Form and Functional Assessment in Chronic Illness Therapy-Fatigue subscale). Secondary outcomes included quality of life, physical functioning, positive and negative affect, depression, body composition, sleep dysfunction and self-reported physical activity. Feasibility was assessed based on the recruitment rate, programme and physical activity adherence and participants' programme evaluation, including optional focus groups (n=16). RESULTS: Twenty five percent of eligible women took part (33/134). Participants were 8.7 (SD=9.1) months post diagnosis, with a mean age of 53 (SD=10.3) years. The majority of the sample had a diagnosis of ovarian (n=12) or endometrial cancer (n=11). Significant differences favouring the intervention group were observed for fatigue at 12 weeks and 6 months follow-up (12 week: mean difference=-11.06; 95% confidence interval (CI)=-21.89 to -0.23; effect size (d)=0.13; p=0.046; 6 month: mean difference=-19.48; 95% CI=-19.67 to -19.15; effect size (d)=0.20; p=0.01). A mean of 10 calls (SD=1.2 calls) were delivered to the Physical Activity Group, and 10 (SD=1.6 calls) to the CC group. The intervention was positively perceived based on exit questionnaire and focus group findings. CONCLUSIONS: A physical activity behavioural change intervention for gynaecological cancer survivors is feasible in terms of participants' programme adherence and evaluation, and the intervention demonstrates improvements in fatigue. However, confirmation in the form of a larger fully powered RCT is warranted.","Donnelly, C. M., et al. (2011). \"A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors.\" Gynecol Oncol 122(3): 618-624.","UK",2011,"Cancer","Psychobehavioural","MFI,FACIT-F",null,null,null,"UK",null,"Cancer","Psychobehavioural",null,null,"MFI,FACIT-F","2010:2014"]
[72,"Doorduijn, J., et al. (2005). \"Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy.\" Eur J Haematol 75(2): 116-123.",null,"Doorduijn, J., et al.","Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy","We studied the impact of CHOP chemotherapy on the quality of life (QoL) of elderly patients with aggressive non-Hodgkin's lymphoma (NHL). 132 patients aged 65 or older, who participated in a randomized, multicenter trial, completed QoL questionnaires (EuroQol-5D, EORTC QLQ-C30 and MFI-20) on 8 predefined time-points before, during and following treatment. At baseline, QoL was significantly better on almost all dimensions in patients with a lower compared to patients with a higher age-adjusted International Prognostic Index (aaPI). During treatment, physical and role functioning and global QoL deteriorated and fatigue increased in the lower aaPI group, whereas QoL of the higher aaPI group remained stable. During follow-up, the QoL was significantly better for patients in complete response (CR) or partial remission (PR) than for patients with progression/relapse. Soon after completion of therapy, the QoL of the lower aaPI group returned to pretreatment levels or better, while patients with higher aaPI showed a significant improvement in QoL compared to baseline levels. The effect of CHOP on the quality of life of elderly patients could be used in counseling this group of patients.","Doorduijn, J., et al. (2005). \"Self-reported quality of life in elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy.\" Eur J Haematol 75(2): 116-123.","Netherlands",2005,"Cancer","Cancer treatments","MFI",null,null,null,"Netherlands",null,"Cancer","Cancer treatments",null,null,"MFI","2005:2009"]
[73,"Dougados, M., et al. (2015). \"Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis.\" J Rheumatol 42(10): 1835-1841.",null,"Dougados, M., et al.","Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis","OBJECTIVE: Analyses were conducted to examine the baseline burden of illness and compare the effect of etanercept (ETN) versus placebo (PBO) on quality of life (QOL) in patients with nonradiographic axial spondyloarthritis (nr-axSpA) who failed nonsteroidal antiinflammatory drugs (NSAID). METHODS: Patients fulfilling the Assessment of Spondyloarthritis International Society axSpA criteria, not meeting the modified New York criteria for ankylosing spondylitis (AS), who were symptomatic 3 months to 5 years, with a Bath AS Disease Activity Index score >/= 4, and failed >/= 2 NSAID were randomized to ETN 50 mg weekly or PBO (double-blind) for 12 weeks, followed by open-label ETN 50 mg for 92 weeks. Stable NSAID were allowed throughout our study. QOL outcomes over 24 weeks were analyzed using ANCOVA models. RESULTS: At baseline, Multidimensional Fatigue Inventory (MFI; ETN mean 14.7, PBO mean 15.0), EQ-5D utility (0.52, 0.57), EQ-5D visual analog scale (56.5, 56.4), and Medical Outcomes Study (MOS) Sleep Index II (45.5, 48.1) were worse than population norms (6.6-8.0, 0.86, 82.5, and 25.8, respectively). At Week 12, Bath AS Patient Global Score, nocturnal and average back pain, MOS Short Form-36 (SF-36) physical component, and Work Productivity and Activity Index (WPAI) presenteeism and activity impairment favored ETN (p < 0.05). Nonsignificant improvements for ETN were seen in other WPAI domains, MFI, MOS-Sleep Index I and II, Hospital Anxiety and Depression Scale, EQ-5D utility score, and SF-36 mental component (p > 0.05). At Week 24, patients in the PBO group who had switched to ETN at Week 12 showed improvement in most QOL assessments, similar to that seen in patients receiving ETN for 24 weeks. CONCLUSION: Improvements favored ETN in QOL and productivity measures, with limited improvement on general QOL measures. Short disease duration, a short PBO-controlled period, and a wide range of QOL scores at baseline may have influenced improvements.","Dougados, M., et al. (2015). \"Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis.\" J Rheumatol 42(10): 1835-1841.","USA",2015,"Musculoskeletal","Etanercept","MFI,VAS-F",null,null,null,"USA",null,"Musculoskeletal","Etanercept",null,null,"MFI,VAS-F","2015:2018"]
[74,"Drory, V. E., et al. (2001). \"The value of muscle exercise in patients with amyotrophic lateral sclerosis.\" J Neurol Sci 191(1-2): 133-137.",null,"Drory, V. E., et al.","The value of muscle exercise in patients with amyotrophic lateral sclerosis","The role of physical activity for patients with amyotrophic lateral sclerosis (ALS) is controversial. Twenty-five ALS patients were randomized to receive a moderate daily exercise program (n=14) or not to perform any physical activity beyond their usual daily requirements (n=11). At baseline and after 3, 6, 9 and 12 months, patients were assessed by manual muscle strength testing, the Ashworth spasticity scale, ALS functional rating scale (FRS), fatigue severity scale, a visual analogue scale for musculoskeletal pain and the quality-of-life scale (SF-36). At 3 months, patients who performed regular exercise showed less deterioration on FRS and Ashworth scales, but not on other parameters. At 6 months, there was no significant difference between groups, although a trend towards less deterioration in the treated group on most scales was observed. At 9 and 12 months, there were too few patients in each group for statistical evaluation. Our results show that a regular moderate physical exercise program has a short-lived positive effect on disability in ALS patients and should be recommended.","Drory, V. E., et al. (2001). \"The value of muscle exercise in patients with amyotrophic lateral sclerosis.\" J Neurol Sci 191(1-2): 133-137.","Israel",2001,"Neurological","Psychobehavioural","FSS,VAS-F",null,null,null,"Israel",null,"Neurological","Psychobehavioural",null,null,"FSS,VAS-F","2000:2004"]
[75,"Duruturk, N., et al. (2016). \"A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial.\" Expert Rev Respir Med 10(1): 99-108.",null,"Duruturk, N., et al.","A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial","AIM: To compare the effects of calisthenic and cycle exercises with no exercise in chronic obstructive pulmonary disease patients. METHOD: Forty-seven participants were allocated to either a cycle or calisthenic exercise or control group. Outcome measures, including Saint George Respiratory Questionnaire, pulmonary functions, cardiopulmonary exercise testing, Fitness Testing, and Hospital Anxiety-Depression, Modified Medical Research Council Dyspnea, Fatigue Severity, Fatigue Impact Scales, were performed before and after the intervention. RESULTS: The change in VE/VCO2 significantly differed (p = 0.01) between two exercise groups. Physical fitness, quality of life, anxiety-depression, dyspnea and fatigue changed significantly in exercise groups, with no between-group differences. There were no significant improvements in control group. CONCLUSION: Calisthenics are as safe and effective as cycle exercise and could be included in comprehensive treatment programs.","Duruturk, N., et al. (2016). \"A comparison of calisthenic and cycle exercise training in chronic obstructive pulmonary disease patients: a randomized controlled trial.\" Expert Rev Respir Med 10(1): 99-108.","Turkey",2016,"Respiratory Disease","Psychobehavioural","FSS,FIS",null,null,null,"Turkey",null,"Respiratory Disease","Psychobehavioural",null,null,"FSS,FIS","2015:2018"]
[76,"Eikeland, R., et al. (2011). \"European neuroborreliosis: quality of life 30 months after treatment.\" Acta Neurol Scand 124(5): 349-354.",null,"Eikeland, R., et al.","European neuroborreliosis: quality of life 30 months after treatment","OBJECTIVES: The prognosis after Lyme neuroborreliosis (LNB) is debated. The aim of this study was to assess health-related Quality of Life (QoL) and neurological symptoms 30 months after treatment in European patients with LNB. MATERIALS AND METHODS: In a prospective case-control designed study, we investigated 50 well-characterized patients with LNB who had participated in a treatment trial for LNB 30 months earlier and 50 matched control persons with the health QoL questionnaire Short-Form 36 (SF-36), the Fatigue Severity Scale (FSS), the Montgomery and Asberg Depression Rating Scale (MADRS), the Starkstein Apathy Scale (SAS), and the Mini Mental State (MMS). Clinical and demographic data were collected by semi-structured interviews and clinical neurological examination. RESULTS: Lyme neuroborreliosis-treated patients scored lower than control persons in the SF-36 domains physical component summary (PCS) (44 vs 51 P < 0.001) and mental component summary (MCS) (49 vs 54 P = 0.010). They also scored lower than control persons in all the SF-36 subscales, except for bodily pain, and on FSS (3.5 vs 2.1 P < 0.001), but not on MMS (28 vs 29 P = 0.106). There was a difference in MADRS (3.1 vs 0. 8 P = 0.003) and SAS (13 vs 11 P = 0.016), but the scores were low in both groups. Fatigue was the most frequently reported symptom among LNB-treated patients (50%). Patients who reported complete recovery (56%) after LNB had similar QoL scores as the controls. CONCLUSION: European persons treated for LNB have poorer health-related QoL and have more fatigue than persons without LNB.","Eikeland, R., et al. (2011). \"European neuroborreliosis: quality of life 30 months after treatment.\" Acta Neurol Scand 124(5): 349-354.","Norway",2011,"Infectious Disease","None","FSS",null,null,null,"Norway",null,"Infectious Disease","None",null,null,"FSS","2010:2014"]
[77,"Elfferich, M. D., et al. (2011). \"Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis.\" Sarcoidosis Vasc Diffuse Lung Dis 28(1): 65-71.",null,"Elfferich, M. D., et al.","Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis","BACKGROUND: Personality factors have shown to be related to mortality, morbidity, and psychological aspects in chronic disorders. Little is known about the effect of personality on disease severity in sarcoidosis and idiopathic pulmonary fibrosis (IPF). The aim of this study was to assess the prevalence of Type D personality and its relation with relevant clinical characteristics in sarcoidosis and IPF patients. METHODS: The study included 441 sarcoidosis and 49 IPF patients from the outpatient clinic of the ild care team of the MUMC, the Netherlands. They completed the DS14 (Type D questionnaire), the fatigue assessment scale (FAS), the WHO quality of life-BREF (WHOQOL-BREF) and the Centre for Epidemiological Studies-Depression Scale (CES-D). Moreover, relevant clinical data were collected. The control group consisted of 3678 subjects from a general population. RESULTS: Type D personality was found in 25.6% of the sarcoidosis patients compared to 21% in the controls, but only in 18.8% of the IPF patients. No relation with disease severity was found in either of these disorders. Fatigue was a substantial problem in both populations. Depressive symptoms but not Type D personality predicted fatigue and poorer QOL in sarcoidosis and IPF. CONCLUSION: Prevalence of Type D personality is not higher in sarcoidosis and IPF patients than in the general population and does not explain QOL impairment. Depressive symptoms explain QOL impairment and fatigue substantially. Therefore, in the multidisciplinary management of sarcoidosis and IPF psychological screening and psychological counselling concerning adequate coping strategies should be incorporated.","Elfferich, M. D., et al. (2011). \"Type D or 'distressed' personality in sarcoidosis and idiopathic pulmonary fibrosis.\" Sarcoidosis Vasc Diffuse Lung Dis 28(1): 65-71.","Netherlands",2011,"Respiratory Disease","None","FAS",null,null,null,"Netherlands",null,"Respiratory Disease","None",null,null,"FAS","2010:2014"]
[78,"Elliott, C., et al. (2011). \"Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls.\" Transpl Int 24(6): 588-595.",null,"Elliott, C., et al.","Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls","We compared functional ability and symptom severity in liver transplant recipients and matched chronic liver disease (CLD) and community controls. A total of 103/140 consecutive liver transplant recipients from a single centre (73%) and matched controls completed the patient-reported functional outcome measure: Patient-Reported Outcomes Measurement Information System, Health Assessment Questionnaire (PROMIS HAQ). Symptoms frequently seen in CLD were quantified by (i) Fatigue Impact Scale (FIS), (ii) Orthostatic Grading Scale (OGS: autonomic dysfunction), (iii) Cognitive Failures Questionnaire (CFQ) and (iv) Epworth Sleepiness Scale (ESS: Daytime somnolence). Liver transplant recipients exhibited significant reduction in function (P<0.0001) across all domains of the PROMIS HAQ suggesting that functional impairment is broad-based. Seventy-seven per cent of all postliver transplants identified some difficulty with activities of daily living. There was no relationship between PROMIS HAQ and liver biochemistry (r(2)=0.04, P=NS) or time since transplant (r(2) =0.1, P=NS). Elevation in PROMIS HAQ (and therefore functional impairment) strongly associated with symptoms, particularly fatigue, cognitive impairment and daytime somnolence. Fatigue severity was independently associated with functional impairment (FIS) (Beta 0.727, P < 0.0001). Symptoms or functional ability was not different between liver transplant recipients and matched chronic liver disease controls. Although survival postliver transplantation is improving, our cross-sectional study suggests that functional ability may not improve postliver transplantation. Further study is warranted to address the mechanisms responsible for post-transplant functional impairment and to develop effective rehabilitation regimes to maximize function following liver transplantation.","Elliott, C., et al. (2011). \"Reduction in functional ability is significant postliver transplantation compared with matched liver disease and community dwelling controls.\" Transpl Int 24(6): 588-595.","UK",2011,"Liver Disease","Surgery","FIS",null,null,null,"UK",null,"Liver Disease","Surgery",null,null,"FIS","2010:2014"]
[79,"Emery, P., et al. (2015). \"Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?\" Ann Rheum Dis 74(12): 2165-2174.",null,"Emery, P., et al.","Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?","BACKGROUND: This study assessed the impact of simultaneous achievement of clinical, functional and structural efficacy, herein referred to as comprehensive disease control (CDC), on short-term and long-term work-related outcomes, health-related quality of life (HRQoL), pain and fatigue. METHODS: Data were pooled from three randomised trials of adalimumab plus methotrexate for treatment of early-stage or late-stage rheumatoid arthritis (RA). CDC was defined as 28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in modified Total Sharp Score </=0.5. Changes in scores at weeks 26 and 52 for work-related outcomes, Short Form 36 (SF-36) physical (PCS) and mental component scores (MCS), a Visual Analogue Scale measuring pain (VAS-Pain) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were compared between patient groups defined by achievement of CDC at week 26 using linear regression with adjustment for baseline scores. RESULTS: Patients with RA who achieved CDC at week 26 (n=200) had significantly greater improvements in VAS-Pain (46.9 vs 26.9; p<0.0001), FACIT-F (13.3 vs 7.5; p<0.0001), SF-36 PCS (19.7 vs 8.9; p<0.0001) and SF-36 MCS (8.1 vs 5.0; p=0.0004) than those who did not (n=1267). Results were consistent at week 52 and among methotrexate-naive patients with early RA, methotrexate-experienced patients with late-stage RA and patients with inadequate response to methotrexate. CONCLUSIONS: Patients with RA who achieved CDC at week 26 had improved short-term and long-term HRQoL, pain, fatigue and work-related outcomes compared with patients who do not. These results demonstrate that the joint achievement of all CDC components provides meaningful benefits to patients. TRIAL REGISTRATION NUMBERS: DE019: NCT00195702, PREMIER: NCT00195702, OPTIMA: NCT00195702.","Emery, P., et al. (2015). \"Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis?\" Ann Rheum Dis 74(12): 2165-2174.","USA",2015,"Musculoskeletal","Adalimumab,Other Drugs","VAS-F,FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Adalimumab,Other Drugs",null,null,"VAS-F,FACIT-F","2015:2018"]
[80,"Epstein, E., et al. (2008). \"Health related quality of life measures in Friedreich Ataxia.\" J Neurol Sci 272(1-2): 123-128.",null,"Epstein, E., et al.","Health related quality of life measures in Friedreich Ataxia","Evaluation of therapeutic agents for Friedreich Ataxia (FA) has been limited by a lack of adequate markers of disease progression. We assessed the capacity of health related quality of life (HRQOL) questionnaires to reflect disease status in FA. The SF-36 and several symptom-specific scales were administered to an FA cohort. Scores were compared with norms for the United States population, and to a disease-free control group of similar age and gender. FA patients had significantly lower SF-36 Physical Component Summary scores (PCS) and Physical Functioning Subscale (PFS) scores, and both PCS and PFS scores correlated significantly with disease duration and disability status. Mental Component Summary scores (MCS) did not differ between FA patients and controls. Among symptom-specific scales, scores for the Pain Effects, Bladder Control, and Modified Fatigue Impact scales were significantly worse among FA patients than controls, and generally correlated with markers of disease progression. Findings of this study are consistent with the phenotypic characteristics of FA, and suggest that HRQOL measures are potentially useful as clinical markers of disease status in FA.","Epstein, E., et al. (2008). \"Health related quality of life measures in Friedreich Ataxia.\" J Neurol Sci 272(1-2): 123-128.","USA",2008,"Neurological","None","MFI",null,null,null,"USA",null,"Neurological","None",null,null,"MFI","2005:2009"]
[81,"Etemadifar, M., et al. (2013). \"Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study.\" Int J Neurosci 123(7): 480-486.",null,"Etemadifar, M., et al.","Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study","BACKGROUND: Fatigue is one of the common complaints of multiple sclerosis (MS) patients, and its treatment is relatively unclear. Ginseng is one of the herbal medicines possessing antifatigue properties, and its administration in MS for such a purpose has been scarcely evaluated. The purpose of this study was to evaluate the efficacy and safety of ginseng in the treatment of fatigue and the quality of life of MS patients. METHODS: Eligible female MS patients were randomized in a double-blind manner, to receive 250-mg ginseng or placebo twice daily over 3 months. Outcome measures included the Modified Fatigue Impact Scale (MFIS) and the Iranian version of the Multiple Sclerosis Quality Of Life Questionnaire (MSQOL-54). The questionnaires were used after randomization, and again at the end of the study. RESULTS: Of 60 patients who were enrolled in the study, 52 (86%) subjects completed the trial with good drug tolerance. Statistical analysis showed better effects for ginseng than the placebo as regards MFIS (p = 0.046) and MSQOL (p </= 0.0001) after 3 months. No serious adverse events were observed during follow-up. CONCLUSIONS: This study indicates that 3-month ginseng treatment can reduce fatigue and has a significant positive effect on quality of life. Ginseng is probably a good candidate for the relief of MS-related fatigue. Further studies are needed to shed light on the efficacy of ginseng in this field.","Etemadifar, M., et al. (2013). \"Ginseng in the treatment of fatigue in multiple sclerosis: a randomized, placebo-controlled, double-blind pilot study.\" Int J Neurosci 123(7): 480-486.","Iran",2013,"Neurological","Complementary","MFI",null,null,null,"Iran",null,"Neurological","Complementary",null,null,"MFI","2010:2014"]
[82,"Feil, K., et al. (2017). \"Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.\" BMC Neurol 17(1): 7.",null,"Feil, K., et al.","Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial","BACKGROUND: Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA. METHODS/DESIGN: An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated. DISCUSSION: The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness. TRIAL REGISTRATION: The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).","Feil, K., et al. (2017). \"Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.\" BMC Neurol 17(1): 7.","Germany",2017,"Neurological","Various","FSS",null,null,null,"Germany",null,"Neurological","Various",null,null,"FSS","2015:2018"]
[83,"Fichtner, S., et al. (2012). \"Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation.\" J Cardiovasc Electrophysiol 23(2): 121-127.",null,"Fichtner, S., et al.","Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation","BACKGROUND: This study prospectively assesses different aspects of short- and long-term quality of life (QoL) after catheter ablation for atrial fibrillation (AF). An analysis of 7 validated generic and tailored questionnaires was performed with regard to the relation of QoL to ablation success. METHODS: The study included 133 patients (74% men, age 57+/-10) who underwent pulmonary vein isolation +/- linear or electrogram-guided substrate modification for AF. QoL was quantitatively assessed at baseline, 3 months after ablation and at a median of 4.3 +/- 0.5 years after ablation by the AF severity scale (AFSS), AF symptom checklist (AFSC), WHO-5-Well-Being-Index (WHO), Major Depression Inventory (MDI), Sleep and Vegetative disorder (SV), Vital Exhaustion (VE), and Illness intrusiveness (Ii). RESULTS: QoL was improved significantly 3 months after ablation in all patients (regardless of ablation success or AF type) and stayed significantly improved after a median of 4.3+/-0.5 years (AFSS, AFSC, WHO, MDI, VE, PE (all P < 0.001), and SV (P = 0.007)). Patients who had a successful ablation improved significantly more than patients with an unsuccessful ablation in the AFSS, AFSC, and MDI questionnaire (delta change from baseline to long-term follow-up P = <0.001, P = <0.001, and P = 0.039, respectively). CONCLUSION: Overall, all patients significantly improved their QoL irrespective of the AF type in all questionnaires 3 months and 4 years after ablation. The increase in QoL was significantly greater in patients who underwent a successful ablation than patients with unsuccessful ablation in the AFSS, AFSC, and MDI questionnaire.","Fichtner, S., et al. (2012). \"Prospective assessment of short- and long-term quality of life after ablation for atrial fibrillation.\" J Cardiovasc Electrophysiol 23(2): 121-127.","Germany",2012,"CVD","Surgery","SV,VE",null,null,null,"Germany",null,"CVD","Surgery",null,null,"SV,VE","2010:2014"]
[84,"Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.",null,"Fillion, L., et al.","Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue","Cancer-related fatigue is the most reported symptom among patients with cancer. Researchers in the field of psychooncology have encouraged the development of short instruments, which allow for easier completion by clinical populations while still maintaining solid psychometric properties. The current study examined the validity and reliability of the French Canadian adaptation of the Multidimensional Fatigue Inventory (MFI) among women (n = 277) and men (n = 327) undergoing therapy for breast or prostate cancer, respectively. An exploratory factor analysis of the selected 15-item MFI yielded the following four factors: general/physical, mental, reduced motivation, and reduced activity. This was supported by a confirmatory factor analysis. The reliability, as evaluated by test-retest and Cronbach alpha internal consistency reliability coefficients of the French Canadian shortened MFI, was acceptable. In addition, the four factor-based scores correlated in a theoretically meaningful manner with existing measures of mood disturbance (Profile of Mood States and Hospital Anxiety and Depression Scale), cancer-related stressors (Inventory of Recent Life Experiences), coping with illness (Coping with Health Injuries and Problems Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and insomnia (Insomnia Severity Index), suggesting good construct, convergent, and concurrent criterion validity. Although further validation is recommended, the results for the French Canadian MFI in assessing cancer-related fatigue in both women and men undergoing cancer treatments showed good psychometric qualities.","Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.","Canada",2003,"Cancer","None","MFI",null,null,null,"Canada",null,"Cancer","None",null,null,"MFI","2000:2004"]
[85,"Frech, T., et al. (2011). \"Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study.\" Rheumatology (Oxford) 50(7): 1280-1287.",null,"Frech, T., et al.","Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study","OBJECTIVE: Rheumatologic disorders are associated with sleep disturbances. This study examines sleep disturbance correlates in patients with SSc. METHODS: Participants are 180 SSc patients in an observational study. At baseline, patients completed the Medical Outcomes Study Sleep measure (MOS-Sleep scale). In addition, patients were administered other patient-reported outcome (PRO) measures including the 36-item short form (SF-36), HAQ disability index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Center for Epidemiologic Studies Depression (CESD) scale and a University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Questionnaire (UCLA SCTC GIT 2.0). Descriptive statistics were assessed for six scales of MOS-Sleep and the 9-item sleep problem index (SLP-9; a composite index). We computed Spearman's rank-order correlations between the MOS-Sleep scales and the HAQ-DI, FACIT-Fatigue, CESD, SSc-SCTC GIT 2.0 and SF-36 scales. In addition, we developed a regression model to assess predictors of SLP-9 scores. Covariates included demographics, physician variables of disease severity and patient-reported variables of worsening symptoms and the PRO measures. RESULTS: SSc patients reported a mean (s.d.) of 7.1 (1.73) h of sleep a night. Patients reported worse scores on four of six scales (except for snoring and sleep quantity) compared with the US general population (P < 0.001). SLP-9 was correlated with worsening pain and dyspnoea over the past 1 month, reflux scale of the UCLA SCTC GIT 2.0, CESD and FACIT-Fatigue (rho 0.26-0.56). In the stepwise multivariate regression model, the CESD, worsening dyspnoea and reflux scale were significantly associated with SLP-9 index. CONCLUSION: Sleep disturbances are common in SSc and are associated with worsening dyspnoea, depressed mood and severity of reflux symptoms.","Frech, T., et al. (2011). \"Prevalence and correlates of sleep disturbance in systemic sclerosis--results from the UCLA scleroderma quality of life study.\" Rheumatology (Oxford) 50(7): 1280-1287.","USA",2011,"Inflamatory Systemic Disease","None","FACIT-F",null,null,null,"USA",null,"Inflamatory Systemic Disease","None",null,null,"FACIT-F","2010:2014"]
[86,"Gabbe, B. J., et al. (2016). \"Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project.\" Burns 42(8): 1652-1661.",null,"Gabbe, B. J., et al.","Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project","INTRODUCTION: Fatigue has been identified as an outcome of concern following burn but is rarely captured in outcomes studies. We aimed to: (i) describe the prevalence, and predictors, of moderate to severe fatigue in the first 12 months following burn, and (ii) establish the association between fatigue and health-related quality of life and work outcomes. METHODS: Adult burns patients, admitted >24h, were recruited from five BRANZ sites. Participants were followed-up at 1-, 6-, and 12-months after injury using the Brief Fatigue Inventory (BFI), 36-item Short Form Health Survey (SF-36) and the Sickness Impact Profile (SIP)-work scale. Moderate to severe fatigue was defined as a global BFI score of 4-10. Multivariable mixed effects regression modelling was used to identify demographic, socioeconomic, burn size and severity predictors of moderate/severe fatigue at follow-up. RESULTS: The mean+/-SD age of the 328 participants was 42.1+/-16.7years, 70% were male, 47% were flame burns, and the mean+/-SD %TBSA was 8.7+/-11.2. The prevalence of moderate/severe fatigue decreased from 37% at 1-month, to 32% at 6-months and 26% at 12-months. The adjusted odds of moderate/severe fatigue were 2.62 (95% CI: 1.27, 5.42) times higher for women compared to men, and 2.64 (95% CI: 1.03, 6.79) times higher in patients with a %TBSA>/=20. Compared to patients in major cities, the adjusted odds of reporting moderate/severe fatigue were 2.48 fold higher (95% CI: 1.17, 5.24) for patients residing in inner regional areas, and 3.60 fold (95% CI: 1.43, 9.05) higher for patients living in remote/very remote areas. At each time point, the physical and mental health summary scores, and each sub-scale score, of the SF-36 were significantly lower in patients reporting moderate/severe fatigue. Patients experiencing moderate to severe fatigue reported higher work-related disability on the SIP work scale at each time point after injury. DISCUSSION AND CONCLUSION: More than a quarter of participants reported moderate to severe fatigue on the BFI at 12-months and fatigue was strongly associated with poorer health-related quality of life and greater work-related disability.","Gabbe, B. J., et al. (2016). \"Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project.\" Burns 42(8): 1652-1661.","UK",2016,"Various","None","BFI",null,null,null,"UK",null,"Various","None",null,null,"BFI","2015:2018"]
[87,"Galiano-Castillo, N., et al. (2013). \"Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.\" Trials 14: 187.",null,"Galiano-Castillo, N., et al.","Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial","BACKGROUND: Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women. METHODS / DESIGN: This study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters. DISCUSSION: This study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth systems could offer a choice of supportive care to cancer patients during the survivorship phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01801527.","Galiano-Castillo, N., et al. (2013). \"Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial.\" Trials 14: 187.","Spain",2013,"Cancer","Psychobehavioural","PFS,Borg Fatigue Scale",null,null,null,"Spain",null,"Cancer","Psychobehavioural",null,null,"PFS,Borg Fatigue Scale","2010:2014"]
[88,"Galiano-Castillo, N., et al. (2016). \"Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors.\" Cancer 122(20): 3166-3174.",null,"Galiano-Castillo, N., et al.","Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors","BACKGROUND: The chronicity status of breast cancer survivors suggests a growing need for cancer rehabilitation. Currently, the use of technology is a promising strategy for providing support, as reflected in the emergence of research interest in Web-based interventions in cancer survivorship. METHODS: A randomized controlled trial was conducted that included a total of 81 participants who had completed adjuvant therapy (except hormone treatment) for stage I to IIIA breast cancer. Participants were randomly assigned to an 8-week Internet-based, tailored exercise program (n = 40) or to a control group (n = 41).The instruments used at baseline, 8 weeks, and 6-month follow-up were the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and its breast cancer module, the Brief Pain Inventory, the handgrip dynamometer, the isometric abdominal test, the back dynamometer, the multiple sit-to-stand test, and the Piper Fatigue Scale. RESULTS: After the intervention, the telerehabilitation group had significantly improved scores for global health status, physical, role, cognitive functioning, and arm symptoms (all P < .01) as well as pain severity (P = .001) and pain interference (P = .045) compared with the control group. Significant improvements also were observed favoring the telerehabilitation group for affected and nonaffected side handgrip (both P = .006), abdominal, back and lower body strength (all P < .01), and total fatigue (P < .001). These findings were maintained after 6 months of follow-up, except for role functioning, pain severity, and nonaffected side handgrip. Analysis was based on an intention-to-treat principle. CONCLUSIONS: This program may improve adverse effects and maintain benefits in breast cancer survivors. The results of this study have encouraging implications for cancer care. Cancer 2016;122:3166-74. (c) 2016 American Cancer Society.","Galiano-Castillo, N., et al. (2016). \"Telehealth system: A randomized controlled trial evaluating the impact of an internet-based exercise intervention on quality of life, pain, muscle strength, and fatigue in breast cancer survivors.\" Cancer 122(20): 3166-3174.","Spain",2016,"Cancer","Psychobehavioural","PFS",null,null,null,"Spain",null,"Cancer","Psychobehavioural",null,null,"PFS","2015:2018"]
[89,"Garcia-Campayo, J., et al. (2007). \"Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42.\" Pain 132 Suppl 1: S68-76.",null,"Garcia-Campayo, J., et al.","Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42","There are few studies on coping with fibromyalgia (FM). The aim of the present study was to assess the usefulness of a Spanish version of the Chronic Pain Coping Inventory-42 (CPCI-42) in patients with FM. A random sample (N=402) of patients with FM was obtained from the Fibromyalgia Association of Aragon, Spain. Patients were assessed with the CPCI-42, the Fibrofatigue Scale (FFS), the EuroQol-5D (EQ-5D), and the Hospital Anxiety and Depression Scale (HADS). The psychometric properties of the CPCI-42 were valid and factor analyses supported the eight-factor structure described in patients with chronic pain. Illness-focused coping strategies (i.e., guarding, resting, and asking for assistance) were strongly correlated with each other, positively correlated with disability and depression, and negatively correlated with quality of life, indicating construct validity. Seeking social support was weakly correlated with any other scale or outcome, confirming it belongs to a different group of coping strategies. The wellness-focused group of coping strategies was the most incoherent group. Task persistence correlated with illness-focused strategies and negative outcomes, indicating that it should be included in the illness-focused group. However, other wellness-focused strategies, including relaxation, exercise, and coping self-statements, were correlated with each other, negatively correlated with depression, and positively correlated with quality of life. Future research directions and clinical implications are discussed.","Garcia-Campayo, J., et al. (2007). \"Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42.\" Pain 132 Suppl 1: S68-76.","Spain",2007,"Musculoskeletal","None","FFS",null,null,null,"Spain",null,"Musculoskeletal","None",null,null,"FFS","2005:2009"]
[90,"Garrett, A. L., et al. (2016). \"Uphill both ways: Fatigue and quality of life in valley fever.\" Med Mycol 54(3): 310-317.",null,"Garrett, A. L., et al.","Uphill both ways: Fatigue and quality of life in valley fever","Primary pulmonary coccidioidomycosis is characterized by prolonged respiratory and systemic symptoms and fatigue. We prospectively administered the fatigue severity scale (FSS) and Short Form-36 Health Status Questionnaire (SF-36) to patients with proven or probable primary pulmonary coccidioidomycosis to quantify disease effect on quality of life (QOL). The 24-week observational study did not specify whether antifungal treatment would be provided; the treating physician made treatment decisions. FSS and SF-36 were completed at 4-week intervals. Thirty-six patients participated, of whom 20 received antifungal treatment. At onset of coccidioidal illness, mean FSS score was higher (ie, more fatigue) in the treatment group. However, in early illness, both groups had higher fatigue levels than reference populations with other diseases (eg, multiple sclerosis). FSS scores gradually improved, and scores in each group were below the severe fatigue level at week 12 and week 16 in the nontreatment and treatment groups, respectively. By week 24, mean FSS score of the nontreatment group equaled the general population. SF-36 component and profile scores were lower (with more symptoms) in the treatment group at each time point than the nontreatment group; both groups showed similar improvement. Mental and emotional health SF-36 scores were not as severely affected as physical scores. Most patients reached a physical functioning level similar to the general population at week 12. Pulmonary coccidioidomycosis causes severe fatigue and substantially affects physical abilities. Fatigue was found to be prolonged, with gradual improvement in QOL, regardless of antifungal administration.","Garrett, A. L., et al. (2016). \"Uphill both ways: Fatigue and quality of life in valley fever.\" Med Mycol 54(3): 310-317.","USA",2016,"Respiratory Disease","None","FSS",null,null,null,"USA",null,"Respiratory Disease","None",null,null,"FSS","2015:2018"]
[91,"Gauthier, L., et al. (2011). \"Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years.\" Sleep Med 12(9): 844-849.",null,"Gauthier, L., et al.","Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years","OBJECTIVE: The mandibular advancement appliance (MAA) is now recognized as a first-line therapy option for mild to moderate obstructive sleep apnea syndrome (OSAS). The aim of this follow-up study was to re-assess the long-term efficacy of MAAs provided to patients in a previous comparative study. METHODS: Sixteen subjects had participated in a previous comparative study in which the efficacy and compliance of two MAAs (Klearway - K and Silencer - S) were compared in a randomized cross-over design. At the end of the previous comparative study, subjects selected the MAA they preferred. Nine chose the K and seven the S. Fifteen subjects were available for a follow-up interview and 14 (4 women and 10 men; mean +/- SEM: 51.9 +/- 1.7 y.o.) agreed to participate in an overnight sleep recording at a hospital sleep laboratory from January to February 2009. The mean time lag between the end of the previous comparative study and the follow-up was 40.9 +/- 2.1 months (range of 2.5-4.5 years). Comparisons were made across the three polysomnographic evaluations (PSGE): baseline, the night with the appliance of their choice at the end of the previous comparative study, and the follow-up night. Subjects completed the Epworth sleepiness scale (ESS), the fatigue severity scale (FSS), and a quality of life questionnaire (FOSQ). RESULTS: At the follow-up, the respiratory disturbance index (RDI) remained significantly lower than baseline (p<0.001). Questionnaire responses revealed that ESS, FSS, and FOSQ remained improved at follow-up (p<0.02). Body mass index (BMI) increased slightly from baseline to follow-up (p<0.05). Diastolic and systolic blood pressure and cardiac rhythm decreased significantly from baseline to follow-up. CONCLUSIONS: The MAAs remained effective in improving RDI, sleepiness, blood pressure, cardiac rhythm, fatigue, sleep quality, and quality of life over a period of 2.5-4.5 years. The rise in BMI is a concern that merits further examination.","Gauthier, L., et al. (2011). \"Mandibular advancement appliances remain effective in lowering respiratory disturbance index for 2.5-4.5 years.\" Sleep Med 12(9): 844-849.","Canada",2011,"Respiratory Disease","Various","FSS",null,null,null,"Canada",null,"Respiratory Disease","Various",null,null,"FSS","2010:2014"]
[92,"Genovese, M. C., et al. (2012). \"Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.\" J Rheumatol 39(6): 1185-1191.",null,"Genovese, M. C., et al.","Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study","OBJECTIVE: To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. RESULTS: Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52. CONCLUSION: Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).","Genovese, M. C., et al. (2012). \"Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study.\" J Rheumatol 39(6): 1185-1191.","USA",2012,"Musculoskeletal","Golimumab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Golimumab",null,null,"FACIT-F","2010:2014"]
[93,"Gielissen, M. F., et al. (2013). \"Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors.\" Psychol Assess 25(2): 658-663.",null,"Gielissen, M. F., et al.","Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors","OBJECTIVE: The Pictorial Representation of Self and Illness Measure (PRISM) measures in a simple, graphic way the burden of suffering due to illness. The question addressed in this study is whether the PRISM is a valid instrument to measure suffering in cancer survivors experiencing severe fatigue. METHOD: Quantitative and qualitative data of a previous randomized controlled trial demonstrating the efficacy of cognitive behavior therapy (CBT) especially designed for postcancer fatigue was used to assess convergent validity and sensitivity to change in a sample of 83 cancer survivors. MEASURES: The PRISM, yielding self-illness separation (SIS-fatigue = suffering due to fatigue; SIS-cancer = suffering due to cancer), fatigue severity (Checklist Individual Strength; CIS-fatigue), functional impairment, psychological well-being, quality of life, and coping with the experience of cancer (Impact of Event Scale; IES). RESULTS: Moderate significant correlations were found with the PRISM and the above-mentioned measures. On the basis of SIS scores, the sample was divided into two separate groups: cancer survivors who suffered more because of fatigue and cancer survivors who suffered more because they had cancer in the past. The two groups had different scores on CIS-fatigue and IES, in line with that aspect that caused them the most suffering. The qualitative data confirmed this finding. Participants in the CBT condition demonstrated a significant difference between SIS-fatigue at baseline versus 6 months later compared with those in the waiting list condition. No change of SIS-cancer was found. CONCLUSION: The PRISM seems to be a valuable tool in fatigue research and clinical practice.","Gielissen, M. F., et al. (2013). \"Pictorial Representation of Self and Illness Measure (PRISM): a graphic instrument to assess suffering in fatigued cancer survivors.\" Psychol Assess 25(2): 658-663.","Netherlands",2013,"Cancer","Psychobehavioural","CIS-F",null,null,null,"Netherlands",null,"Cancer","Psychobehavioural",null,null,"CIS-F","2010:2014"]
[94,"Gladman, D. D., et al. (2007). \"Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial.\" Ann Rheum Dis 66(2): 163-168.",null,"Gladman, D. D., et al.","Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial","OBJECTIVE: To evaluate the effects of adalimumab on patient-reported outcomes of joint-related and skin-related functional impairment, health-related quality of life, fatigue and pain in patients with psoriatic arthritis (PsA). METHODS: Patients with moderately- to severely- active PsA were treated with adalimumab, 40 mg, every other week, or placebo, in this 24-week, randomised, controlled trial. Patient-reported outcomes included the Health Assessment Questionnaire Disability Index (HAQ DI), Short-Form 36 Health Survey (SF-36), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale and the Dermatology Life Quality Index (DLQI). RESULTS: Adalimumab (n = 151) and placebo (n = 162) groups were comparable with respect to baseline demographics and disease severity. Significant changes from baseline in HAQ DI were reported for adalimumab v placebo (-0.4 v -0.1, p<0.001) at both 12 and 24 weeks. At week 24, significant improvements in the SF-36 domains of physical functioning, role-physical, bodily pain, general health, vitality and social functioning, as well as the physical component summary score, were observed for adalimumab versus placebo (p<0.01). These reported changes in HAQ DI and SF-36 were also clinically important. Significantly more patients treated with adalimumab had complete resolution of functional loss (HAQ DI = 0) and dermatological-related functional limitations (DLQI = 0) compared with placebo at weeks 12 and 24 (p< or =0.001). Adalimumab led to significantly greater improvements in FACIT-Fatigue scores, pain scores, and disease activity measures versus placebo at 12 and 24 weeks (p<0.001 for all). CONCLUSIONS: Adalimumab improved physical-related and dermatological-related functional limitations, HRQOL, fatigue and pain in patients with PsA treated for 24 weeks.","Gladman, D. D., et al. (2007). \"Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial.\" Ann Rheum Dis 66(2): 163-168.","Canada",2007,"musculoskeletal","Adalimumab","FACIT-F",null,null,null,"Canada",null,"Musculoskeletal","Adalimumab",null,null,"FACIT-F","2005:2009"]
[95,"Gladman, D. D., et al. (1996). \"A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE).\" Lupus 5(3): 190-195.",null,"Gladman, D. D., et al.","A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE)","The aim of the present investigation was to assess and compare health status instruments in SLE. One hundred and twenty-five patients completed five health status instruments: the Health Assessment Questionnaire (HAQ), Functional Ability Index, the Fatigue Severity Scale (FSS), the Disability Days Measure (DDM), the Centre for Epidemiological Studies-Depression Scale (CES-D), and the Medical Outcomes Study (MOS) Short Form Health Survey during their Clinic visit. Disease activity was measured using the SLE Disease Activity Index (SLEDAI). All instruments described a spectrum of quality of life outcomes in these patients. An inter-instrument correlation analysis revealed that components of the MOS correlated significantly with each of the other instruments used. There was no correlation between any of the instruments used and the SLEDAI. We conclude that health status assessment as measured by the MOS short form is a valid independent outcome measure in patients with SLE.","Gladman, D. D., et al. (1996). \"A comparison of five health status instruments in patients with systemic lupus erythematosus (SLE).\" Lupus 5(3): 190-195.","Canada",1996,"Inflamatory Systemic Disease","None","FSS",null,null,null,"Canada",null,"Inflamatory Systemic Disease","None",null,null,"FSS","1960:1999"]
[96,"Glossmann, J. P., et al. (2003). \"Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.\" Ann Hematol 82(8): 469-475.",null,"Glossmann, J. P., et al.","Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial","The aim of the study was to investigate the effects of erythropoietin (epoetin beta) on red blood cell (RBC) transfusions, hemoglobin (Hb) levels, and quality of life (QOL) in patients with relapsed lymphoma treated with an aggressive sequential salvage chemotherapy (SSCT) regimen. Sixty patients with early or late relapsed Hodgkin's disease ( n=39) or first relapse of aggressive non-Hodgkin's lymphoma ( n=21) were randomized to receive epoetin beta 10,000 IE subcutaneously three times a week or no epoetin during salvage chemotherapy. Patients in both study arms received two cycles of DHAP (dexamethasone, high-dose cytarabine, cisplatin); patients in partial remission (PR) or complete remission (CR) then received cyclophosphamide, followed by peripheral blood stem cell (PBSC) harvest, methotrexate plus vincristine, and etoposide. The final myeloablative course was BEAM (carmustine, etoposide, cytarabine, and melphalan) followed by autologous stem cell support. The primary endpoint of the study was the number of RBC units needed during SSCT. In addition, Hb levels and QOL were measured. The mean number of RBC units given in the epoetin beta arm was 4.5 compared to 8.3 in the control arm ( P=0.0134). The mean Hb levels during therapy were 10.4 g/dl in the epoetin beta arm and 9.7 g/dl in the control ( P=0.018). From baseline until BEAM therapy QOL (EORTC QLQ C30) and fatigue (MFI) assessment showed little QOL worsening or stable levels in both arms with a steeper increase of fatigue levels in the control group. Patients with relapsed lymphoma undergoing aggressive chemotherapy and stem cell support benefited from epoetin beta therapy, with a decrease of RBC transfusion requirements and lower rise of fatigue levels.","Glossmann, J. P., et al. (2003). \"Recombinant human erythropoietin, epoetin beta, in patients with relapsed lymphoma treated with aggressive sequential salvage chemotherapy--results of a randomized trial.\" Ann Hematol 82(8): 469-475.","Germany",2003,"Cancer","Epoetin Beta","MFI",null,null,null,"Germany",null,"Cancer","Epoetin Beta",null,null,"MFI","2000:2004"]
[97,"Goh, J., et al. (1999). \"Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection.\" Eur J Gastroenterol Hepatol 11(8): 833-838.",null,"Goh, J., et al.","Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection","BACKGROUND: Fatigue is probably the most commonly reported symptom in chronic hepatitis C virus (HCV) infection. It is unclear whether fatigue is related to the severity of underlying liver disease or other autoimmune disorders often described with chronic HCV infection. OBJECTIVE: To quantify fatigue in terms of its impact on quality of life in a homogeneous cohort and examine its relationship to the status of liver disease or associated autoimmunity. METHODS: The Fatigue Impact Scale (FIS) questionnaire (Fisk et al. Clin Infect Dis 1994; 18:S79-S83), a recently validated psychometric tool for assessing patients' perceptions of the functional limitations attributable to fatigue (40 statements; three subscales: physical, cognitive and psychological; maximum score = 160), was applied to a cohort of Irish women who were PCR-positive for HCV genotype 1b via inoculation with contaminated anti-D products in 1977. RIBA-positive, PCR-negative patients (n = 20) and healthy age-matched women (n = 50) served as controls. The degree of hepatitis was assessed using the Knodell histological activity index (HAI) score on previous liver biopsies. Clinical and laboratory evidence of cryoglobulinaemia, Sjogren's syndrome, connective tissue diseases, autoimmune thyroid disease and glomerulonephritis was sought. RESULTS: The mean FIS score of the 66 PCR-positive women (mean 78+/-36; range 7-153) was significantly higher than in age-matched controls (mean 31+/-24, range 0-78, P<0.001) but not statistically different from that of the RIBA-positive, PCR-negative group. The FIS score did not correlate with the HAI score (median HAI = 4; range 2-9; Pearson's correlation coefficient r=0.01, P=0.9). Significant levels of cryoglobulins were detected in 10 (15.2%). The sicca complex was diagnosed in six patients, three of whom had associated cryoglobulinaemia. Thyroid antibodies, anti-nuclear antibody, rheumatoid factor, antimitochondrial antibody and anti-smooth muscle antibody were detected in 15.2%, 6%, 4.5%, 4.5% and 1.5%, respectively. There was no significant difference in the FIS score between the groups with autoimmune diseases and those without. The FIS score of the nine patients previously treated with interferon was not statistically different from the untreated group (P=0.39). CONCLUSION: The perceived functional impact of fatigue on quality of life is significantly higher in patients with chronic HCV genotype 1b infection compared to healthy controls. However, it is unrelated to the degree of hepatitis and cannot be accounted for by the co-existence of autoimmune disorders alone.","Goh, J., et al. (1999). \"Fatigue does not correlate with the degree of hepatitis or the presence of autoimmune disorders in chronic hepatitis C infection.\" Eur J Gastroenterol Hepatol 11(8): 833-838.","Ireland",1999,"Infectious Disease","None","FIS",null,null,null,"Ireland",null,"Infectious Disease","None",null,null,"FIS","1960:1999"]
[98,"Gonzalez, H., et al. (2006). \"Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.\" Lancet Neurol 5(6): 493-500.",null,"Gonzalez, H., et al.","Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial","BACKGROUND: Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome. METHODS: 142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082. FINDINGS: Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the placebo group (p=0.037). Intravenous immunoglobulin was well tolerated. INTERPRETATION: Intravenous immunoglobulin could be a supportive treatment option for subgroups of patients with post-polio syndrome. Further studies on responding subgroups, long-term effects, and dosing schedules are needed.","Gonzalez, H., et al. (2006). \"Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.\" Lancet Neurol 5(6): 493-500.","Sweden",2006,"neurological","Various","MFI,VAS-F",null,null,null,"Sweden",null,"Neurological","Various",null,null,"MFI,VAS-F","2005:2009"]
[99,"Grimmett, C., et al. (2013). \"RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial.\" Trials 14: 184.",null,"Grimmett, C., et al.","RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial","BACKGROUND: There are over 25 million people worldwide living with or beyond cancer and this number is increasing. Cancer survivors face a range of problems following primary treatment. One of the most frequently reported and distressing symptoms experienced by cancer survivors is fatigue. There is growing support for survivors who are experiencing problems after cancer treatment to engage in supported self-management. To date there is some evidence of effective interventions to manage fatigue in this population; however, to our knowledge there are no online resources that draw on this information to support self-management of fatigue. This paper describes the protocol for an exploratory randomized controlled trial of an online intervention to support self-management of cancer-related fatigue after primary cancer treatment. METHODS/DESIGN: This is a parallel-group two-armed (1:1) exploratory randomized controlled trial including 125 cancer survivors experiencing fatigue (scoring >/=4 on a unidimensional 11-point numeric rating scale for fatigue intensity) within five years of primary treatment completion with curative intent. Participants will be recruited from 13 NHS Trusts across the UK and randomized to either the online intervention (RESTORE), or a leaflet comparator (Macmillan Cancer Backup, Coping with Fatigue). The primary outcome is a change in Perceived Self-Efficacy for Fatigue Self-Management (as measured by the Perceived Self-Efficacy for Fatigue Self-Management Instrument). Secondary outcomes include impact on perception and experience of fatigue (measured by the Brief Fatigue Inventory), and quality of life (measured by the Functional Assessment of Cancer Therapy - General and the Personal Wellbeing Index). Outcome measures will be collected at baseline, 6 weeks (completion of intervention), and 3 months. Process evaluation (including telephone interviews with recruiting staff and participants) will determine acceptability of the intervention and trial processes. DISCUSSION: Data from this trial will be used to refine the intervention and contribute to the design of an effectiveness trial. This intervention will be expanded to address other cancer-related problems important to cancer survivors following primary cancer treatment. TRIAL REGISTRATION: ISRCTN67521059.","Grimmett, C., et al. (2013). \"RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial.\" Trials 14: 184.","UK",2013,"Cancer","None","BFI",null,null,null,"UK",null,"Cancer","None",null,null,"BFI","2010:2014"]
[100,"Groenveld, H. F., et al. (2011). \"The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study.\" J Am Coll Cardiol 58(17): 1795-1803.",null,"Groenveld, H. F., et al.","The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study","OBJECTIVES: The aim of this study was to investigate the influence of rate control on quality of life (QOL). BACKGROUND: The RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) trial showed that lenient rate control is not inferior to strict rate control in terms of cardiovascular morbidity and mortality. The influence of stringency of rate control on QOL is unknown. METHODS: In RACE II, a total of 614 patients with permanent atrial fibrillation (AF) were randomized to lenient (resting heart rate [HR] <110 beats/min) or strict (resting HR <80 beats/min, HR during moderate exercise <110 beats/min) rate control. QOL was assessed in 437 patients using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) questionnaire, AF severity scale, and Multidimensional Fatigue Inventory-20 (MFI-20) at baseline, 1 year, and end of study. QOL changes were related to patient characteristics. RESULTS: Median follow-up was 3 years. Mean age was 68 +/- 8 years, and 66% were males. At the end of follow-up, all SF-36 subscales were comparable between both groups. The AF severity scale was similar at baseline and end of study. At baseline and at end of study there were no differences in the MFI-20 subscales between the 2 groups. Symptoms at baseline, younger age, and less severe underlying disease, rather than assigned therapy or heart rate, were associated with QOL improvements. Female sex and cardiovascular endpoints during the study were associated with worsening of QOL. CONCLUSIONS: Stringency of heart rate control does not influence QOL. Instead, symptoms, sex, age, and severity of the underlying disease influence QOL. (Rate Control Efficacy in Permanent Atrial Fibrillation; NCT00392613).","Groenveld, H. F., et al. (2011). \"The effect of rate control on quality of life in patients with permanent atrial fibrillation: data from the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) study.\" J Am Coll Cardiol 58(17): 1795-1803.","Netherlands",2011,"CVD","None","MFI",null,null,null,"Netherlands",null,"CVD","None",null,null,"MFI","2010:2014"]
[101,"Haldorsen, K., et al. (2011). \"A five-year prospective study of fatigue in primary Sjogren's syndrome.\" Arthritis Res Ther 13(5): R167.",null,"Haldorsen, K., et al.","A five-year prospective study of fatigue in primary Sjogren's syndrome","INTRODUCTION: Fatigue is prevalent in primary Sjogren's syndrome (pSS), and contributes to the considerably reduced health related quality of life in this disease. The symptom is included in proposed disease activity and outcome measures for pSS. Several studies indicate that there is an inflammatory component of fatigue in pSS and other chronic inflammatory rheumatic diseases. The purpose of this study was to investigate fatigue change in pSS in a longitudinal study, and explore whether any clinical or laboratory variables at baseline, including serum cytokines, were associated with a change in fatigue scores over time. METHODS: A clinical and laboratory investigation of 141 patients fulfilling the American-European consensus criteria of pSS was undertaken in the period May 2004 to April 2005. Median time since diagnosis was 5.5 years. Examinations included the fatigue questionnaires: fatigue severity scale (FSS), fatigue visual analogue scale (VAS), functional assessment of chronic illness therapy-fatigue (FACIT-F) and medical outcome study short form-36 (SF-36) vitality, which were repeated in a follow-up investigation in January and February 2010. RESULTS: A total of 122 patients (87%) responded at both time-points. Thirty-five percent of patients experienced a clinically significant FSS increase. On the group level, fatigue measures did not change except that there was a slight deterioration in SF-36 vitality score. High serum anti-Sjogren's syndrome A antigen (anti-SSA) showed weak associations with high baseline fatigue, and patients with increasing fatigue had lower baseline unstimulated whole salivary volume. Weak associations between increasing fatigue and serum immunoglobulin G (IgG), and the pro-inflammatory cytokine interleukin-17 (IL-17), were observed. Baseline sicca symptoms correlated with higher fatigue both at baseline and with increasing fatigue over time. Linear regression analysis did not identify any predictive ability of clinical or laboratory measures on fatigue change over time. CONCLUSIONS: Fatigue remained mainly unchanged over time. Using multivariate models did not reveal any clinical or laboratory predictors of fatigue change over time.","Haldorsen, K., et al. (2011). \"A five-year prospective study of fatigue in primary Sjogren's syndrome.\" Arthritis Res Ther 13(5): R167.","Norway",2011,"Inflamatory Systemic Disease","None","FACIT-F,VAS-F",null,null,null,"Norway",null,"Inflamatory Systemic Disease","None",null,null,"FACIT-F,VAS-F","2010:2014"]
[102,"Hamelin, S., et al. (2010). \"Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey.\" Epilepsy Res 91(2-3): 153-160.",null,"Hamelin, S., et al.","Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey","PURPOSE: Fatigue represents a frequent complaint in epileptic patients (EP). This study attempted to evaluate fatigue in both conditions (inter-ictally and post-ictally) and to investigate the relative contribution of depression, sleepiness and epilepsy characteristics. METHODS: Consecutive EP were enrolled prospectively during a 3-month period, providing they were aged over 15 and able to fill auto-questionnaires. Age, gender, co-morbidities, seizure frequency, treatment, epilepsy syndrome, seizure lateralization and localization and last seizure occurrence were collected. Fatigue, depression and sleepiness were evaluated in both groups using the Fatigue Impact Scale (FIS), the Beck Depression Inventory (BDI), and the Epworth Sleepiness Scale (ESS). Furthermore, FIS was prospectively scored by patients post-ictally (within 24h after an incident seizure). RESULTS: 122 EP filled inclusion criteria (65 women, mean age 39+/-15). Among them, 82% presented with non-idiopathic partial epilepsy and 18% idiopathic generalized epilepsy. EP exhibit high chronic fatigue scores (62/160) irrespective of the type of epilepsy, seizure frequency, and number of antiepileptic drugs. FIS score was higher in post-ictally (79/160) than inter-ictally. FIS positively correlated with BDI and ESS. DISCUSSION: Chronic inter-ictal and post-ictal fatigue could represent a further complication of epilepsy, associated with depression. The impact of fatigue should be considered with the aim of improving quality of life and care of patients with epilepsy.","Hamelin, S., et al. (2010). \"Fatigue in epilepsy: a prospective inter-ictal and post-ictal survey.\" Epilepsy Res 91(2-3): 153-160.","France",2010,"Neurological","None","FIS",null,null,null,"France",null,"Neurological","None",null,null,"FIS","2010:2014"]
[103,"Harel, D., et al. (2012). \"Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale.\" Rheumatology (Oxford) 51(12): 2177-2185.",null,"Harel, D., et al.","Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale","OBJECTIVE: Fatigue is a common and important problem in SSc. No studies, however, have compared the properties of fatigue measures in SSc. The objective of this study was to compare the performances of the Short Form-36 (SF-36) Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT) in SSc. METHODS: Cross-sectional, multi-centre study of Canadian Scleroderma Research Group Registry patients. The associations of the two instruments with other patient-reported outcome measures, as well as physician- and patient-rated disease variables were compared. Item response theory models were used to compare the degree to which items and the total scores of each measure effectively covered the full spectrum of fatigue levels. RESULTS: There were 348 patients (297 women, 85%) in the study. The instruments correlated at r = 0.65 with each other. The FACIT tended to correlate slightly higher than the SF-36 Vitality subscale with physician- and patient-rated disease variables and patient-reported physical function and disability, whereas the SF-36 Vitality subscale correlated minimally higher with mental health measures. The FACIT had markedly better discrimination across the range of fatigue, particularly at average to high fatigue levels, whereas the SF-36 Vitality subscale discriminated well only among patients in the low to average range. CONCLUSION: The FACIT discriminates better than the SF-36 Vitality subscale at average to high ranges of fatigue, which is common in SSc, suggesting that it is preferred for measuring fatigue in SSc.","Harel, D., et al. (2012). \"Measuring fatigue in SSc: a comparison of the Short Form-36 Vitality subscale and Functional Assessment of Chronic Illness Therapy-Fatigue scale.\" Rheumatology (Oxford) 51(12): 2177-2185.","Canada",2012,"Inflamatory Systemic Disease","None","FACIT-F",null,null,null,"Canada",null,"Inflamatory Systemic Disease","None",null,null,"FACIT-F","2010:2014"]
[104,"Hassanein, T., et al. (2004). \"The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C.\" J Hepatol 40(4): 675-681.",null,"Hassanein, T., et al.","The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C","BACKGROUND/AIMS: Peginterferon alfa-2a plus ribavirin improves sustained virological responses compared with interferon alfa-2b and ribavirin, or peginterferon alfa-2a alone in chronic hepatitis C. We examined the impact of these treatments on health related quality of life (HRQOL). METHODS: Patients (n=1121) were randomized to peginterferon alfa-2a weekly plus ribavirin or placebo, or interferon alfa-2b thrice weekly plus ribavirin. HRQOL was assessed with the SF-36 Health Survey and Fatigue Severity Scale (FSS). RESULTS: Patients receiving peginterferon alfa-2a plus ribavirin reported better HRQOL than those receiving interferon alfa-2b plus ribavirin. These differences were statistically significant for three SF-36 domains and both FSS scores (p<=0.05). Patients receiving peginterferon alfa-2a plus placebo had the least impairment; adding ribavirin significantly decreased five domains of the SF-36 and both FSS scores. Sustained virological response was associated with improvement at follow-up on all SF-36 and FSS scores. CONCLUSIONS: The effects of combination therapy on HRQOL and fatigue are less with peginterferon alfa-2a plus ribavirin than interferon alfa-2b plus ribavirin. Each medication in combination therapy with interferon and ribavirin, affects patients' quality of life differently. Understanding the relationship of specific therapeutic options to HRQOL may help physicians minimize the impact of therapy on HRQOL.","Hassanein, T., et al. (2004). \"The impact of peginterferon alfa-2a plus ribavirin combination therapy on health-related quality of life in chronic hepatitis C.\" J Hepatol 40(4): 675-681.","USA",2004,"Infectious Disease","Other Drugs","FSS",null,null,null,"USA",null,"Infectious Disease","Other Drugs",null,null,"FSS","2000:2004"]
[105,"Hassoun, Z., et al. (2002). \"Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale.\" Dig Dis Sci 47(12): 2674-2681.",null,"Hassoun, Z., et al.","Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale","The aim of this study was to assess the impact of fatigue on the quality of life of patients with chronic hepatitis C (CHC) and to examine its relationship with various parameters of the disease, including viral load. The Fatigue Impact Scale (FIS), a self-report questionnaire, was applied to 92 patients with CHC, and the results were compared to those of an age-matched cohort of 213 healthy blood donors. Fatigue was frequent and disabling, being present in 67% of CHC patients, and the FIS was significantly increased in CHC patients compared to the healthy controls. Fatigue severity was not correlated with the activity of the disease or with the level of viremia. The FIS proved to be a valuable tool to assess this symptom. It should be of help for better evaluation of the clinical spectrum of the disease and should be included in trials assessing the efficacy of therapeutic interventions.","Hassoun, Z., et al. (2002). \"Assessment of fatigue in patients with chronic hepatitis C using the Fatigue Impact Scale.\" Dig Dis Sci 47(12): 2674-2681.","Canada",2002,"Infectious Disease","None","FIS",null,null,null,"Canada",null,"Infectious Disease","None",null,null,"FIS","2000:2004"]
[106,"Heij, L., et al. (2012). \"Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.\" Mol Med 18: 1430-1436.",null,"Heij, L., et al.","Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study","ARA 290 (a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, antiinflammation and healing) reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. A total of 22 patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double-blind, placebo-controlled exploratory trial consisting of three times weekly intravenous dosing of ARA 290 (2 mg; n = 12) or placebo (n = 10) for 4 wks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain score of >/=5 (Brief Pain Inventory [BPI]). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF-36), depressive symptoms (Inventory of Depressive Symptomatology [IDS]) and fatigue (Fatigue Assessment Scale [FAS]). No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at wk 4 in SFNSL score compared with placebo (Delta -11.5 +/- 3.04 versus Delta -2.9 +/- 3.34 [standard error of the mean]). Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF-36 (Delta -23.4 +/- 5.5 and Delta -14.6 +/- 3.9, respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.","Heij, L., et al. (2012). \"Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.\" Mol Med 18: 1430-1436.","Netherlands",2012,"Inflamatory Systemic Disease","Various","FAS",null,null,null,"Netherlands",null,"Inflamatory Systemic Disease","Various",null,null,"FAS","2010:2014"]
[107,"Herlofson, K. and J. P. Larsen (2003). \"The influence of fatigue on health-related quality of life in patients with Parkinson's disease.\" Acta Neurol Scand 107(1): 1-6.",null,"Herlofson, K. and J. P. Larsen","The influence of fatigue on health-related quality of life in patients with Parkinson's disease","OBJECTIVE: To examine the correlation between fatigue and health-related quality of life (HRQL) in patients with Parkinson's disease (PD). PATIENTS AND METHODS: Sixty-six patients with idiopathic PD. The patients did not have a depressive mood disorder or cognitive impairment. Fatigue was measured by the Fatigue Severity Scale (FSS). HRQL was measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Short-Form 36 (SF-36). RESULTS: Thirty-three (50%) of the patients had significant fatigue. Patients with fatigue had a more advanced disease than those without fatigue, measured by the UPDRS scale, including a higher Hoehn and Yahr stage and lower Schwab and England score. Patients with fatigue reported more distress in the dimensions of emotional well-being and mobility (PDQ-39) and also had a significantly higher PDQ summary index. On the SF-36 patients with fatigue reported more problems in the areas of physical functioning, role limitation (physical), social functioning and vitality. Correlations between the FSS and the HRQL scales were highest for the summary index of PDQ-39 and in the dimensions of ADL, mobility and emotional well-being (PDQ-39) and physical functioning, role limitation (physical), social functioning, general health and vitality (SF-36). CONCLUSIONS: PD has a substantial negative impact on HRQL. We found a strong correlation between fatigue and high distress scores on HRQL scales in a population of patients with PD who were not depressed or demented. The diversity of symptoms and high prevalence of non-motor features, including fatigue, is important to take into account in our efforts to optimize treatment and care for this patient group.","Herlofson, K. and J. P. Larsen (2003). \"The influence of fatigue on health-related quality of life in patients with Parkinson's disease.\" Acta Neurol Scand 107(1): 1-6.","Norway",2003,"Neurological","None","FSS",null,null,null,"Norway",null,"Neurological","None",null,null,"FSS","2000:2004"]
[108,"Holzner, B., et al. (2003). \"Fatigue in ovarian carcinoma patients: a neglected issue?\" Cancer 97(6): 1564-1572.",null,"Holzner, B., et al.","Fatigue in ovarian carcinoma patients: a neglected issue?","BACKGROUND: Although fatigue is a commonly reported symptom in cancer patients it is rarely investigated, especially in patients with ovarian carcinoma. The main focus of the current study was to assess fatigue in these patients and to investigate the impact of fatigue and other clinical and psychosocial variables on their quality of life (QOL). METHODS: Ninety-eight ovarian carcinoma survivors (average age of 57.4 +/- 12.5 years) were included in the study. All women had received cancer therapy but had not been treated for at least 6 months. The average time elapsed since first diagnosis was 5.7 +/- 5.5 years. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and QOL was measured with the Functional Assessment of Cancer Therapy (FACT)-ovarian carcinoma part and the European Organization for Research and Treatment of Cancer Care Questionnaire, including the ovarian carcinoma module. RESULTS: Thirty-two of 98 ovarian carcinoma patients (32.7%, 95% confidence interval, 23.5-42.9%) reported MFI-20 General Fatigue scores >/= 12.0 and therefore could be characterized as suffering from fatigue. This group of patients had a significantly lower QOL, had higher scores of anxiety and depression, and perceived that they had less social support. In a multiple regression model, mental adjustment, social support, anxiety, and depression as well as fatigue were significant predictors of QOL (FACT-generic part total score) whereas clinical and sociodemographic variables were not. CONCLUSION: A remarkably high proportion of ovarian carcinoma survivors suffered from fatigue. Because this symptom is a key predictor of QOL, it should be given more attention in aftercare programs.","Holzner, B., et al. (2003). \"Fatigue in ovarian carcinoma patients: a neglected issue?\" Cancer 97(6): 1564-1572.","Austria",2003,"Cancer","None","MFI",null,null,null,"Austria",null,"Cancer","None",null,null,"MFI","2000:2004"]
[109,"Hsieh, R. L. and W. C. Lee (2014). \"Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study.\" Lasers Med Sci 29(2): 671-679.",null,"Hsieh, R. L. and W. C. Lee","Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study","We conducted a double-blind randomized placebo-controlled study to investigate the effects of short-term 890-nm light therapy in patients with chronic low back pain in a rehabilitation clinic. Thirty-eight women and 22 men with chronic low back pain (mean age, 60.3 years; range, 32-80 years) received 40-min sessions of hot-pack therapy combined with active or placebo 890-nm light therapy (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 mW/cm(2) for 40 min, total energy = 83.2 J/cm(2)) over the lower back three times weekly for 2 weeks. Participants were assessed before and after treatment by using a range of motion measurements, a visual analog scale evaluation of pain, the Multidimensional Fatigue Inventory, the Biodex Stability System, the Fear-Avoidance Beliefs Questionnaire, repeated chair-rising times, the Frenchay Activity Index, the Oswestry Disability Questionnaire (ODQ), and the Osteoarthritis Quality of Life Questionnaire. The severity of disability based on the ODQ score was used as the primary clinical outcome measurement. Compared to the baseline measurements, participants in the treatment group reported significant reductions in fear-avoidance beliefs regarding physical activity (P = 0.040) and work (P = 0.007) and in the severity of disability (P = 0.021). Treatment with hot-pack therapy and 890-nm light therapy was associated with reductions in the severity of disability and fear avoidance beliefs in patients with chronic low back pain.","Hsieh, R. L. and W. C. Lee (2014). \"Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: a double-blind randomized placebo-controlled study.\" Lasers Med Sci 29(2): 671-679.","Taiwan",2014,"Musculoskeletal","Various","MFI",null,null,null,"Taiwan",null,"Musculoskeletal","Various",null,null,"MFI","2010:2014"]
[110,"Hsieh, R. L., et al. (2012). \"Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.\" J Orthop Sports Phys Ther 42(11): 947-956.",null,"Hsieh, R. L., et al.","Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study","STUDY DESIGN: Randomized, double-blind, placebo-controlled study. OBJECTIVES: To examine the short-term therapeutic effects of monochromatic infrared energy (MIRE) on participants with knee osteoarthritis (OA). Patients were assessed according to the International Classification of Functioning, Disability and Health. BACKGROUND: MIRE is commonly used in therapy for patients with peripheral neuropathies. However, research has not focused intensively on the therapeutic effects of MIRE in patients with knee OA. METHODS: This study enrolled 73 participants with knee OA. Participants received six 40-minute sessions of active or placebo MIRE treatment (890-nm wavelength; power, 6.24 W; energy density, 2.08 J/cm2/min; total energy, 83.2 J/cm2) over the knee joints for 2 weeks. International Classification of Functioning, Disability and Health-related outcomes were collected weekly over 4 weeks using the Knee injury and Osteoarthritis Outcome Score, Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire. Data were analyzed by repeated-measures analysis of variance. RESULTS: No statistically significant differences were found for the interaction of group by time for Knee injury and Osteoarthritis Outcome Score scores, including pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores on the Lysholm Knee Scale, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, Chronic Pain Grade questionnaire, World Health Organization Quality of Life-brief version, and OA Quality of Life Questionnaire also showed no significant differences between the 2 groups at any of the 4 follow-up assessments. CONCLUSION: Short-term MIRE therapy provided no beneficial effects to body functions, activities, participation, and quality of life in patients with knee OA.","Hsieh, R. L., et al. (2012). \"Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study.\" J Orthop Sports Phys Ther 42(11): 947-956.","Taiwan",2012,"Musculoskeletal","Complementary","MFI",null,null,null,"Taiwan",null,"Musculoskeletal","Complementary",null,null,"MFI","2010:2014"]
[111,"Huet, P. M., et al. (2000). \"Impact of fatigue on the quality of life of patients with primary biliary cirrhosis.\" Am J Gastroenterol 95(3): 760-767.",null,"Huet, P. M., et al.","Impact of fatigue on the quality of life of patients with primary biliary cirrhosis","OBJECTIVE: Fatigue is a frustrating symptom frequently reported by patients with primary biliary cirrhosis (PBC), but it is still poorly understood and not well evaluated. Our aim was to determine its importance and its impact on the quality of life and mental health status of patients with PBC. METHODS: Patients with PBC (103 women and 13 men with a mean age of 52.6 yr) completed self-report questionnaires to evaluate the impact of fatigue on their quality of life (Fatigue Impact Scale, FIS), the perception of their own mental health (Symptom Check list-90-R, SCL), and depression (Beck Depression Inventory, BDI). A cohort of age-matched healthy blood donors served as controls. RESULTS: Fatigue was present in 99 patients (85.3%) and was the worst or one of the worst symptoms in about half of them. In PBC patients, the mean FIS and SCL indexes were significantly increased, compared to healthy controls (1.49 +/- 1.11 vs 0.6 +/- 0.6 and 0.72 +/- 0.55 vs 0.36 +/- 0.35, respectively). Unexpectedly, 52 patients (44.8%) could be classified as having depression (BDI score > 10). Significant correlations were found between the FIS and SCL indexes, between the FIS index and the BDI score, as well as between the BDI score and the SCL index. Finally, fatigue was not related to the disease severity parameters, that is, clinical, biochemical, metabolic, and pathological. CONCLUSIONS: Fatigue is a frequent and disabling complaint that impairs the quality of life of PBC patients and their perception of their own mental health, which may be associated with an unexpected depressive condition. In addition, the FIS questionnaire can be considered as a useful tool to assess fatigue in PBC patients and may be used in the evaluation of specific treatments aimed at reducing this complaint in such patients.","Huet, P. M., et al. (2000). \"Impact of fatigue on the quality of life of patients with primary biliary cirrhosis.\" Am J Gastroenterol 95(3): 760-767.","Canada",2000,"Liver Disease","None","FIS",null,null,null,"Canada",null,"Liver Disease","None",null,null,"FIS","2000:2004"]
[112,"Husson, O., et al. (2013). \"Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry.\" Thyroid 23(10): 1247-1255.",null,"Husson, O., et al.","Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry","BACKGROUND: The aims of this study were (i) to obtain insight into the prevalence of fatigue among short- and long-term thyroid cancer (TC) survivors, by comparing a sample of TC survivors with an age- and sex-matched normative population, and (ii) to investigate which demographic, clinical, and TC-specific health-related quality of life (HRQoL) characteristics were associated with fatigue. METHODS: All patients found to have TC between 1990 and 2008, as registered in the Eindhoven Cancer Registry, received a cross-sectional survey on fatigue (Fatigue Assessment Scale), TC-specific HRQoL (THYCA-QoL), and psychological distress (Hospital Anxiety and Depression Scale). The fatigue scores were compared with those of an age- and sex-matched normative population (n=530). Multiple logistic regression analyses were conducted to investigate the independent associations between clinical and demographic characteristics, TC-specific HRQoL, and psychological distress with fatigue. RESULTS: Eighty-six percent (n=306) responded. TC survivors were more often classified as fatigued or very fatigued (short-term <5 years: 43%; long-term 5-10 years: 44%; long-term 10-15 years: 47%; long-term >15 years: 39%) compared to the normative population (25%; p<0.001). Anxiety (odds ratio (OR) 1.15, 95% confidence interval [CI] 1.03-1.28) and depression (OR 1.43 [CI 1.22-1.68]) were associated with fatigue, as was also the case for TC-specific neuromuscular (OR 1.03 [CI 1.01-1.06]), concentration (OR 1.03 [CI 1.01-1.06]), and psychological TC-specific HRQoL (OR 1.06 [CI 1.02-1.10]). CONCLUSION: Short- and long-term TC survivors report higher levels of fatigue than an age- and sex-matched normative population do. Both TC-specific HRQoL and psychological distress were associated with fatigue.","Husson, O., et al. (2013). \"Fatigue among short- and long-term thyroid cancer survivors: results from the population-based PROFILES registry.\" Thyroid 23(10): 1247-1255.","Netherlands",2013,"Cancer","None","FAS",null,null,null,"Netherlands",null,"Cancer","None",null,null,"FAS","2010:2014"]
[113,"Hwang, S. S., et al. (2002). \"Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center.\" Cancer 94(9): 2481-2489.",null,"Hwang, S. S., et al.","Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center","BACKGROUND: The correlation of fatigue levels with functional interference, symptom distress, and quality of life may help determine clinically significant fatigue levels. METHODS: One hundred eighty consecutive patients with cancer completed the Functional Assessment of Cancer Therapy (FACT) General and Fatigue subscales (FACT-G and FACT-F, respectively), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), the Depression Scale (Zung), and the Brief Fatigue Inventory (BFI). The Karnofsky performance status (KPS) was determined for each patient. Multivariate analyses of variance were performed to compare fatigue models with different cut-off points to categorize fatigue levels. Cox proportional hazards analysis was performed to assess the association between fatigue severity and survival. RESULTS: Increased fatigue levels were associated with greater symptom distress and decreased quality of life. A model with usual fatigue cut-off points of 0 (no fatigue), 1-2 (mild fatigue), 3-6 (moderate fatigue), and 7-10 (severe fatigue) was optimal in relation to functional interference items (Wilks lambda, 0.36; F = 11.61; P < 0.0001), symptom distress scores (Wilks lambda, 0.52; F = 10.41; P < 0.0001), and quality-of-life scores (Wilks lambda, 0.50; F = 0.50; P < 0.0001). Fatigue severity predicted survival in univariate analysis (chi-square test, 25.42; P < 0.0001). The KPS, stage of disease, and number of symptoms independently predicted survival in patients with fatigue. CONCLUSIONS: Clinically relevant fatigue levels are correlated with symptom and quality-of-life measurements. Patients with a usual fatigue severity > 3 or a worst fatigue severity > 4 on a 1-10 scale may require further assessment.","Hwang, S. S., et al. (2002). \"Clinical relevance of fatigue levels in cancer patients at a Veterans Administration Medical Center.\" Cancer 94(9): 2481-2489.","USA",2002,"Cancer","None","FACT-F",null,null,null,"USA",null,"Cancer","None",null,null,"FACT-F","2000:2004"]
[114,"Hwang, S. S., et al. (2003). \"A comparison of three fatigue measures in veterans with cancer.\" Cancer Invest 21(3): 363-373.",null,"Hwang, S. S., et al.","A comparison of three fatigue measures in veterans with cancer","Fatigue is a highly prevalent and distressing symptom in cancer patients. The purpose of this study was to assess the validity of three fatigue measures [the Brief Fatigue Inventory (BFI), the Functional Assessment of Cancer Therapy Fatigue Subscale (FACT-F), and the lack of energy item from the Memorial Symptom Assessment Scale Short Form (MSAS-SF)] and compare these measures in relation to broader quality-of-life (QOL) constructs and clinical factors in veteran cancer patients. One-hundred-eighty cancer patients completed the BFI, FACT-F, FACT-G, MSAS-SF, and the Zung depression scale with concurrent Karnofsky performance status (KPS), laboratory tests, and demographic data. The Cronbach alpha coefficient was from 0.93 to 0.94 for BFI fatigue scales and 0.94 for FACT-F. There were significant correlations between BFI subscales, FACT-F, and lack of energy from MSAS-SF (p < 0.0001). All three fatigue measures showed significant correlation with MSAS-SF symptom subscales (p < 0.0001), FACT-G subscales (p < 0.0001), depression (p < 0.0001), KPS (p < 0.0001), inpatient status (P < 0.0001), insomnia (p < 0.05), hemoglobin (p < 0.05), and albumin levels (p < 0.01). Distress from lack of energy discriminated among levels from the BFI, FACT-F, and FACT-G subscales and MSAS-SF subsclea by one-way of variance analysis. Patient responses to BFI, FACT-F, and the lack of energy item yielded similar information about broader QOL constructs and clinical factors. Single questions about lack of energy, or fatigue severity, may provide a simple and acceptable way to assess fatigue.","Hwang, S. S., et al. (2003). \"A comparison of three fatigue measures in veterans with cancer.\" Cancer Invest 21(3): 363-373.","USA",2003,"Cancer","None","FACT-F,BFI",null,null,null,"USA",null,"Cancer","None",null,null,"FACT-F,BFI","2000:2004"]
[115,"Iwase, S., et al. (2015). \"Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09).\" PLoS One 10(8): e0134022.",null,"Iwase, S., et al.","Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09)","INTRODUCTION: Cancer-related fatigue greatly influences quality of life in cancer patients; however, no specific treatments have been established for cancer-related fatigue, and at present, no medication has been approved in Japan. Systematic research using patient-reported outcome to examine symptoms, particularly fatigue, has not been conducted in palliative care settings in Japan. The objective was to evaluate fatigue, pain, and quality of life in cancer patients at the point of intervention by palliative care teams. MATERIALS AND METHODS: Patients who were referred to palliative care teams at three institutions and met the inclusion criteria were invited to complete the Brief Fatigue Inventory, Brief Pain Inventory, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative. RESULTS: Of 183 patients recruited, the majority (85.8%) were diagnosed with recurrence or metastasis. The largest group (42.6%) comprised lung cancer patients, of whom 67.2% had an Eastern Cooperative Oncology Group Performance Status of 0-1. The mean value for global health status/quality of life was 41.4, and the highest mean European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative symptom item score was for pain (51.0). The mean global fatigue score was 4.1, and 9.8%, 30.6%, 38.7%, and 20.8% of patients' fatigue severity was classified as none (score 0), mild (1-3), moderate (4-6), and severe (7-10), respectively. DISCUSSION: Cancer-related fatigue, considered to occur more frequently in cancer patients, was successfully assessed using patient-reported outcomes with the Brief Fatigue Inventory for the first time in Japan. Results suggested that fatigue is potentially as problematic as pain, which is the main reason for palliative care.","Iwase, S., et al. (2015). \"Assessment of Cancer-Related Fatigue, Pain, and Quality of Life in Cancer Patients at Palliative Care Team Referral: A Multicenter Observational Study (JORTC PAL-09).\" PLoS One 10(8): e0134022.","Japan",2015,"Cancer","None","BFI",null,null,null,"Japan",null,"Cancer","None",null,null,"BFI","2015:2018"]
[116,"Iwase, S., et al. (2016). \"Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).\" Support Care Cancer 24(2): 637-646.",null,"Iwase, S., et al.","Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01)","PURPOSE: Cancer-related fatigue (CRF) is one of the most common symptoms reported by cancer patients. This randomized trial investigated the efficacy of the amino acid jelly Inner Power((R)) (IP), a semi-solid, orally administrable dietary supplement containing coenzyme Q10 and L-carnitine, in controlling CRF in breast cancer patients in Japan. METHODS: Breast cancer patients with CRF undergoing chemotherapy were randomly assigned to receive IP once daily or regular care for 21 days. The primary endpoint was the change in the worst level of fatigue during the past 24 h (Brief Fatigue Inventory [BFI] item 3 score) from day 1 (baseline) to day 22. Secondary endpoints were change in global fatigue score (GFS; the average of all BFI items), anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific QLQ (EORTC QLQ-BR23), and adverse events. RESULTS: Fifty-nine patients were enrolled in the study, of whom 57 were included in the efficacy analysis. Median patient age was 50 years. Changes in the worst level of fatigue, GFS, and current feeling of fatigue were significantly different between the intervention and control groups, whereas the change in the average feeling of fatigue was not significantly different between groups. HADS, EORTC QLQ-C30, and EORTC QLQ-BR23 scores were not significantly different between the two groups. No severe adverse events were observed. CONCLUSION: IP may control moderate-severe CRF in breast cancer patients. TRIAL REGISTRATION: The registration number of this study in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) is UMIN000008646.","Iwase, S., et al. (2016). \"Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01).\" Support Care Cancer 24(2): 637-646.","Japan",2016,"Cancer","Complementary","BFI",null,null,null,"Japan",null,"Cancer","Complementary",null,null,"BFI","2015:2018"]
[117,"Janki, S., et al. (2015). \"More than a decade after live donor nephrectomy: a prospective cohort study.\" Transpl Int 28(11): 1268-1275.",null,"Janki, S., et al.","More than a decade after live donor nephrectomy: a prospective cohort study","Previously reported short-term results after live kidney donation show no negative consequences for the donor. The incidence of new-onset morbidity takes years to emerge, making it highly likely that this will be missed during short-term follow-up. Therefore, evidence on long-term outcome is essential. A 10-year follow-up on renal function, hypertension, quality of life (QOL), fatigue, and survival was performed of a prospective cohort of 100 donors. After a median follow-up time of 10 years, clinical data were available for 97 donors and QOL data for 74 donors. Nine donors died during follow-up of unrelated causes to donation, and one donor was lost to follow-up. There was a significant decrease in kidney function of 12.9 ml/min (P < 0.001) at follow-up. QOL showed significant clinically relevant decreases of 10-year follow-up scores in SF-36 dimensions of physical function (P < 0.001), bodily pain (P = 0.001), and general health (P < 0.001). MFI-20 scores were significantly higher for general fatigue (P < 0.001), physical fatigue (P < 0.001), reduced activity (P = 0.019), and reduced motivation (P = 0.030). New-onset hypertension was present in 25.6% of the donors. Donor outcomes are excellent 10 years post-donation. Kidney function appears stable, and hypertension does not seem to occur more frequently compared to the general population.","Janki, S., et al. (2015). \"More than a decade after live donor nephrectomy: a prospective cohort study.\" Transpl Int 28(11): 1268-1275.","Netherlands",2015,"Kidney Disease","Surgery","MFI",null,null,null,"Netherlands",null,"Kidney Disease","Surgery",null,null,"MFI","2015:2018"]
[118,"Jansen, A. J., et al. (2003). \"Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes.\" Br J Haematol 121(2): 270-274.",null,"Jansen, A. J., et al.","Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes","The myelodysplastic syndromes (MDS) are clonal disorders characterized by dysplasia in at least two myeloid cell lines. Fatigue is one of the most significant symptoms. MDS patients are treated with blood transfusions to improve their health-related quality of life (HRQoL). A cross-sectional pilot study was performed for psychometric evaluation of three internationally established HRQoL measures in MDS patients, and for investigation of the association between the severity of chronic anaemia and HRQoL. Fifty consecutive MDS patients completed the Short Form 36, the Multidimensional Fatigue Inventory and the EuroQoL-5D Visual Analogue Scale. Hb level was measured during the same visit. Psychometric analysis focused on feasibility, construct validity and reliability. The questionnaires showed a high feasibility, reliability and validity. MDS patients had worse HRQoL scores than the age- and sex-matched general population. We found a positive correlation between haemoglobin (Hb) level and HRQoL. This study provides insights into the suitability of established HRQoL measures for the evaluation of interventions in MDS patients. Hb value and HRQoL are complementary variables for evaluation of the severity of chronic anaemia in patients with MDS.","Jansen, A. J., et al. (2003). \"Quality of life measurement in patients with transfusion-dependent myelodysplastic syndromes.\" Br J Haematol 121(2): 270-274.","Netherlands",2003,"Hematological","None","MFI,VAS-F",null,null,null,"Netherlands",null,"Hematological","None",null,null,"MFI,VAS-F","2000:2004"]
[119,"Janssen, N., et al. (2003). \"Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work.\" Occup Environ Med 60 Suppl 1: i71-76.",null,"Janssen, N., et al.","Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work","OBJECTIVES: To investigate whether there is a relationship between fatigue and sickness absence. Two additional hypotheses were based on the theoretical distinction between involuntary, health related absence and voluntary, attitudinal absence. In the literature, the former term is usually used to describe long term sickness absence, the latter relates to short term sickness absence. In line with this, the first additional hypothesis was that higher fatigue would correspond with a higher risk of long term, primarily health related absence. The second additional hypothesis was that higher fatigue would correspond with a higher risk of short term, primarily motivational absence. METHODS: A multidimensional fatigue measure, as well as potential sociodemographic and work related confounders were assessed in the baseline questionnaire of the Maastricht cohort study on fatigue at work. Sickness absence was objectively assessed on the basis of organisational absence records and measured over the six months immediately following the baseline questionnaire. In the first, general hypothesis the effect of fatigue on time-to-onset of first sickness absence spell during follow up was investigated. For this purpose, a survival analysis was performed. The effect of fatigue on long term sickness absence was tested by a logistic regression analysis. The effect of fatigue on short term sickness absence was investigated by performing a survival analysis with time-to-onset of first short absence spell as an outcome. RESULTS: It was found that higher fatigue decreased the time-to-onset of the first sickness absence spell. Additional analyses showed that fatigue was related to long term as well as to short term sickness absence. The effect of fatigue on the first mentioned outcome was stronger than the effect on the latter outcome. Potential confounders only weakened the effect of fatigue on long term absence. CONCLUSIONS: Fatigue was associated with short term but particularly with long term sickness absence. The relation between fatigue and future sickness absence holds when controlling for work related and sociodemographic confounders. Fatigue as measured with the Checklist Individual Strength can be used as a screening instrument to assess the likelihood of sickness absence in the short term.","Janssen, N., et al. (2003). \"Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work.\" Occup Environ Med 60 Suppl 1: i71-76.","Netherlands",2003,"Various","None","MFI",null,null,null,"Netherlands",null,"Various","None",null,null,"MFI","2000:2004"]
[120,"Jayne, D., et al. (2017). \"Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.\" Jama 318(16): 1569-1580.",null,"Jayne, D., et al.","Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial","Importance: Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective: To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants: Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions: Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures: The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results: Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, -1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, -3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance: Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration: isrctn.org Identifier: ISRCTN80500123.","Jayne, D., et al. (2017). \"Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial.\" Jama 318(16): 1569-1580.","UK",2017,"Cancer","Surgery","MFI",null,null,null,"UK",null,"Cancer","Surgery",null,null,"MFI","2015:2018"]
[121,"Johansson, B., et al. (2015). \"Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury.\" Brain Inj 29(6): 758-765.",null,"Johansson, B., et al.","Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury","OBJECTIVE: Post-traumatic brain injury symptoms, such as mental fatigue, have considerable negative impacts on quality-of-life. In the present study the effects of methylphenidate in two different dosages were assessed with regard to mental fatigue, pain and cognitive functions in persons who had suffered a traumatic brain injury. METHODS: Fifty-one subjects were included and 44 completed the study. The treatment continued for 12 weeks, including three treatment periods with no medication for 4 weeks, administration of low dose methylphenidate (up to 5 mg x 3) for 4 weeks and normal dose methylphenidate (up to 20 mg x 3) for a further 4 weeks. The patients were randomized into three groups where all groups were given all treatments. RESULTS: Significantly reduced mental fatigue, assessed with the Mental Fatigue Scale (MFS) and increased information processing speed (coding, WAIS-III), were detected. The SF-36 vitality and social functioning scales were also improved significantly. Pain was not reduced by methylphenidate. The positive effects of treatment were dose-dependent, with the most prominent effects being at 60 mg methylphenidate/day spread over three doses. Observed side-effects were increased blood pressure and increased heart rate. CONCLUSIONS: Methylphenidate was generally well-tolerated and it improved long-lasting mental fatigue and processing speed after traumatic brain injury.","Johansson, B., et al. (2015). \"Methylphenidate reduces mental fatigue and improves processing speed in persons suffered a traumatic brain injury.\" Brain Inj 29(6): 758-765.","Sweden",2015,"Neurological","Other Drugs","MFS",null,null,null,"Sweden",null,"Neurological","Other Drugs",null,null,"MFS","2015:2018"]
[122,"Jongen, P. J., et al. (2010). \"Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study.\" Health Qual Life Outcomes 8: 133.",null,"Jongen, P. J., et al.","Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study","BACKGROUND: Glatiramer acetate (GA) and interferon-beta (INFb) are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS). Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL) in the first 12 months. It is not known whether HR-QoL increases during treatment with GA. METHODS: 197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32), fatigue (Fatigue Impact Scale [FIS]) and depressed mood (Beck Depression Inventory-Short Form [BDI-SF]) at baseline and 6 and 12 months after start of GA treatment. RESULTS: At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p < 0.001), not in the pre-treated group. At month 12 43% of treatment-naive patients had improved HR-QoL (increase LMS-QoL score 3 or more points) (p < 0.001). Likewise, mean FIS scores were decreased at months 6 and 12 in the treatment-naive group (p < 0.01), not in the pre-treated group. In both groups mean BDI-SF scores did not change. No demographic or clinical baseline factor was predictive of HR-QoL increase. HR-QoL changes were zero to negative for patients who had discontinued GA before month 12 (28.4% of patients). CONCLUSIONS: In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.","Jongen, P. J., et al. (2010). \"Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study.\" Health Qual Life Outcomes 8: 133.","Netherlands",2010,"Neurological","None","FIS",null,null,null,"Netherlands",null,"Neurological","None",null,null,"FIS","2010:2014"]
[123,"Jongen, P. J., et al. (2014). \"Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.\" Health Qual Life Outcomes 12: 40.",null,"Jongen, P. J., et al.","Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study","BACKGROUND: For persons with multiple sclerosis (MS) it is important to preserve their autonomy, in spite of increasing disability. A major factor mediating autonomy is self-efficacy. According to the social cognitive theory stressors are crucial determinants of self-efficacy, as well as the interaction with partners. METHODS: In an explorative observational study we assessed in 47 persons with MS (PwMS) the effect of an intense, multidisciplinary, 3-day, social cognitive wellness program with the participation of support partners, after 1, 3 and 6 months. PRIMARY OUTCOMES: self-efficacy-control and -function (Multiple Sclerosis Self-Efficacy Scale [MSSES]),limitations to and problems with participation and autonomy (Impact on Participation and Autonomy [IPA] scale). SECONDARY OUTCOMES: health-related quality of life (HRQoL) (MS Quality of Life-54 Items [MSQoL-54] questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale [HADS]), and fatigue (Modified Fatigue Impact Scale-5 Items [MFIS-5]). Disability was measured with the Expanded Disability Status Scale (EDSS). Percentage changes from baseline were tested with T-tests, level of significance 0.05. RESULTS: In the whole group the MSQoL-54 Mental score was increased at 1, 3 and 6 months (+16.0%, +13.2%, +12.2%), and the MSQoL-54 Physical (+10.2%) at 6 months, with no changes in other outcomes. The relapsing remitting (RR) subgroup (n = 20) had at 6 months an increase in the MSSES-Control score (+24.8%) and in the MSQoL54 Mental and Physical scores (+22.3%, +17.6%). Progressive patients (n = 22) only showed an increase in the MSQoL-54 Mental score (+11.5%) at 1 month. In the low-disability (EDSS < 4.0) subgroup the MSSES-Control score was increased (+23.8%) at 6 months, and the IPA-Limitations and -Problems scores decreased at 3 months (-6.1%, -8.8%); the MSQoL-54 Mental score had increased at 1, 3 and 6 months (+19.3%, +21.5%, +19.3%). In the high-disability (EDSS > =4.0) subgroup no significant changes occurred. CONCLUSIONS: Results from this observational study suggest that 6 months after an intense, 3-day, multidisciplinary, social cognitive wellness program with support partners, PwMS with a RR course or low disability may experience an improved self-efficacy-control and HRQoL.","Jongen, P. J., et al. (2014). \"Improved self-efficacy in persons with relapsing remitting multiple sclerosis after an intensive social cognitive wellness program with participation of support partners: a 6-months observational study.\" Health Qual Life Outcomes 12: 40.","Netherlands",2014,"Neurological","Psychobehavioural","MFI",null,null,null,"Netherlands",null,"Neurological","Psychobehavioural",null,null,"MFI","2010:2014"]
[124,"Kaasa, S., et al. (1998). \"Hodgkin's disease: quality of life in future trials.\" Ann Oncol 9 Suppl 5: 137-145.",null,"Kaasa, S., et al.","Hodgkin's disease: quality of life in future trials","It is of great importance to collect data of objective as well as subjective morbidity in patients cured for Hodgkin's disease. Such information may be used when new treatment strategies are discussed, in patients information and communication, to establish rehabilitation programs and to identify individuals who may benefit from rehabilitation. Measurement of health related quality of life (HRQOL) may give important information on how the cancer and/or the treatment has influenced the patients. There is no gold standard instrument for measurement of HRQOL in cancer. However, it is a consensus to use multidimensional patients rated measures with a standard format and scoring procedure. SF-36, EORTC QLQ-C30 and FACT are widely used in Europe and North America. Domain specific instruments includes a more comprehensive evaluation of a specific domain, for example anxiety or fatigue. Fatigue seems to be a prevalent symptom in Hodgkin's disease survivors and might affect patients' ability to perform normal activities and will often reduce their quality of life. Fatigue is defined as a subjective feeling of tiredness and might be measured by standardised and validated instruments such as the Fatigue Questionnaire (FQ) and the Multi-Dimensional Fatigue Inventory (MFI-20). Clinical significance might be defined as a meaningful difference based on consensus by the patient, the doctor and the society. In oncology there is no agreement of how long a meaningful difference in survival should be. For HRQOL a difference between 7 to 10 on a scale ranking from 0 to 100 has been regarded as clinical significant by some researchers. Another strategy to approach the issue of clinical significance is to use norms-estimates from the normal population- and/or reference estimates as guidelines. The long-term complication of the successful treatment of Hodgkin's disease reinforced the need for continued surveillance of treatment and related morbidities. Fatigue is a prevalent symptom and detailed diagnostic work-up is essential to identify patients with this problem. More knowledge about possible biological causes is required in order to understand fatigue and the impact on quality of life among Hodgkin's disease survivors.","Kaasa, S., et al. (1998). \"Hodgkin's disease: quality of life in future trials.\" Ann Oncol 9 Suppl 5: 137-145.","Norway",1998,"Cancer","None","FACT-F,MFI,FQ",null,null,null,"Norway",null,"Cancer","None",null,null,"FACT-F,MFI,FQ","1960:1999"]
[125,"Kaiser, K., et al. (2015). \"Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.\" Cancer Med 4(5): 690-698.",null,"Kaiser, K., et al.","Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale","The Functional Assessment of Cancer Therapy (FACT)-Antiangiogenesis (AntiA) Subscale was developed and validated to enhance treatment decision-making and side effect management for patients receiving anti-angiogenesis therapies. Side effects related to anti-angiogenesis therapies were identified from the literature, clinician input, and patient input. Fifty-nine possible patient expressions of side effects were generated. Patient and clinician ratings of the importance of these expressions led us to develop a 24-item questionnaire with clinical and research potential. To assess the scale's reliability and validity, 167 patients completed the AntiA Subscale, the Functional Assessment of Cancer Therapy-general (FACT-G), the FACT-Kidney Symptom Index (FKSI), the FACIT-Fatigue Subscale, the Global Rating of Change Scale (GRC), and the PROMIS Global Health Scale. Patient responses to the AntiA were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. All tested scales were found to have good internal consistency reliability (Cronbach's alpha 0.70-0.92). Test-retest reliability was also good (0.72-0.88) for total and subscale scores and lower for individual items. The total score, subscale scores, and all single items (except nosebleeds) significantly differentiated between groups defined by level of side effect bother. Evaluation of responsiveness to change in this study was not conclusive, suggesting an area for further research. The AntiA is a reliable and valid measure of side effects from anti-angiogenesis therapy.","Kaiser, K., et al. (2015). \"Development and validation of the functional assessment of cancer therapy-antiangiogenesis subscale.\" Cancer Med 4(5): 690-698.","USA",2015,"Cancer","Cancer treatments","FACIT-F",null,null,null,"USA",null,"Cancer","Cancer treatments",null,null,"FACIT-F","2015:2018"]
[126,"Kalaitzakis, E., et al. (2008). \"Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms.\" Scand J Gastroenterol 43(9): 1057-1065.",null,"Kalaitzakis, E., et al.","Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms","OBJECTIVE: Patients with short-bowel syndrome (SBS) have impaired health-related quality of life (QoL). However, comparisons of QoL data with the data on other chronic gastrointestinal diseases are not available. The aim of this study was to assess QoL in SBS patients compared with that in the general population and with patients with inflammatory bowel disease (IBD). The potential relation between fatigue and gastrointestinal symptoms and impaired QoL in these patients was also investigated. MATERIAL AND METHODS: Four validated questionnaires were used to measure aspects of QoL (SF-36), psychological distress (hospital anxiety and depression scale, HAD), fatigue (fatigue impact scale, FIS), and gastrointestinal symptoms (gastrointestinal symptom rating scale, GSRS) in 26/28 patients (93%) attending a SBS clinic (median age 62 years, 15 F/11 M) at a tertiary referral center. Persons from the general population (n=286) as well as patients with IBD (n=41) of similar age and gender distribution as the SBS group acted as controls. RESULTS: SBS patients had significantly lower SF-36 physical and mental component summaries than those in the general population as well as significantly lower SF-36 physical (p<0.05) but not mental (p>0.05) component summaries compared with those of IBD patients. Fatigue and gastrointestinal symptoms were more severe in SBS patients than in IBD patients (p>0.05). The SF-36 physical component summary was independently related to the physical FIS dimension (beta=-0.4, p=0.004), the GSRS eating dysfunction dimension (beta=-0.31, p=0.025), and opiate use (beta=-0.28, p=0.031), regardless of diagnosis (SBS or IBD). CONCLUSIONS: Patients with SBS show poor QoL compared with that in the general population and also impairment of mainly physical health compared with that in patients with IBD. Fatigue and gastrointestinal symptoms are more severe in patients with SBS, which has an impact on QoL.","Kalaitzakis, E., et al. (2008). \"Quality of life in short-bowel syndrome: impact of fatigue and gastrointestinal symptoms.\" Scand J Gastroenterol 43(9): 1057-1065.","Sweden",2008,"Gastrointestinal","None","FIS",null,null,null,"Sweden",null,"Gastrointestinal","None",null,null,"FIS","2005:2009"]
[127,"Kalkanis, A., et al. (2013). \"The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS.\" Sarcoidosis Vasc Diffuse Lung Dis 30(1): 60-64.",null,"Kalkanis, A., et al.","The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS","INTRODUCTION: The Fatigue Assessment Scale (FAS) is a 10-item patient reported outcome (PRO) questionnaire that is used to measure fatigue in sarcoidosis. After several months of use, we began to question the reliability of the FAS in our clinic population. Therefore, we administered an additional fatigue PRO, the Patient Reported Outcomes Measurement Information Systems (PROMIS) Fatigue Instrument (PFI). Our hypothesis was that the internal consistency/reliability (Cronbach's alpha) of the PFI would be superior to the FAS in sarcoidosis patients because two of the ten FAS items (items #4 and #10) required reverse scoring (these items were scaled in the opposite direction to the other 8 items). METHODS: The FAS and PFI were administered during the same clinic visit to consecutive patients in our sarcoidosis clinic. We calculated a) the Cronbach's alpha for a) the FAS; b) the FAS without items #4 and #10; and c) the PFI. RESULTS: 107 consecutive sarcoidosis patients underwent FAS and PFI testing. The Cronbach's alpha was 0.740, 0.911, and 0.963 for the FAS, FAS with items #4 and #10 removed, and the PFI respectively. In female patients, the Cronbach's alpha of the FAS was 0.663, which is considered as \"questionable\" in terms of internal consistency. CONCLUSION: We found that the PFI had \"excellent\" consistency in our sarcoidosis clinic. The FAS did not demonstrate the same degree of internal consistency. The Cronbach's estimate of the FAS with items #4 and #10 removed was vastly superior to the FAS. These data support our contention that FAS items #4 and #10 detract from the internal consistency of this PRO. They also suggest that the PFI is superior to the FAS in terms of reliability.","Kalkanis, A., et al. (2013). \"The internal consistency of PRO fatigue instruments in sarcoidosis: superiority of the PFI over the FAS.\" Sarcoidosis Vasc Diffuse Lung Dis 30(1): 60-64.","USA",2013,"Inflamatory Systemic Disease","None","FAS,PROMIS-F",null,null,null,"USA",null,"Inflamatory Systemic Disease","None",null,null,"FAS,PROMIS-F","2010:2014"]
[128,"Kamath, J., et al. (2012). \"Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study.\" Support Care Cancer 20(8): 1745-1753.",null,"Kamath, J., et al.","Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study","BACKGROUND: Fatigue is a common and often disabling symptom for cancer patients. To date, no pharmacological interventions have shown reliable efficacy in treatment of cancer-related fatigue (CF). Thyrotropin-releasing hormone (TRH), a key regulator of homeostasis, exerts arousing and analeptic actions in instances of behavioral depression. In the present pilot, randomized, placebo-controlled, crossover study, we investigated the efficacy and safety of TRH as a treatment for CF. METHODS: Patients with cancer experiencing significant fatigue without medically reversible causes were enrolled in this study. The primary outcome measure was the visual analog scale for energy (VAS-E) assessed at 3, 7, and 24 h post-study medication administration. Secondary outcome measures included the profile of mood states (POMS) questionnaire, a 6-min walking test, the hospital anxiety and depression scale, the Leeds sleep questionnaire, and assessment of quality of life using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). RESULTS: Eight patients completed the study. TRH administration was associated with significant improvement in fatigue level as measured by the VAS-E, the fatigue and vigor subscales of the POMS, and the fatigue subscale of FACIT-F (p < 0.05). It was also associated with a positive impact on quality of life. TRH administration was associated with transient increases in blood pressure and heart rate. CONCLUSIONS: TRH administration was efficacious, safe, and tolerable in the treatment of CF with a positive impact on quality of life. These results provide a crucial impetus for pursuing TRH therapeutics to treat CF.","Kamath, J., et al. (2012). \"Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study.\" Support Care Cancer 20(8): 1745-1753.","USA",2012,"Cancer","Various","VAS-F,FACIT-F",null,null,null,"USA",null,"Cancer","Various",null,null,"VAS-F,FACIT-F","2010:2014"]
[129,"Kargarfard, M., et al. (2012). \"Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis.\" Arch Phys Med Rehabil 93(10): 1701-1708.",null,"Kargarfard, M., et al.","Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis","OBJECTIVE: To examine the effectiveness of aquatic exercise training on fatigue and health-related quality of life (HRQOL) in women with multiple sclerosis (MS). DESIGN: Randomized controlled trial, 4-week and 8-week follow-up. SETTING: Referral center of a multiple sclerosis society. PARTICIPANTS: Women (N=32) diagnosed with relapsing-remitting MS (mean age +/- SD, 32.6+/-8.0y) were recruited into this study. After undergoing baseline testing by a neurologist, participants were randomly assigned to either an intervention (aquatic exercise) or a control group. INTERVENTIONS: The intervention consisted of 8 weeks supervised aquatic exercise in a swimming pool (3 times a week, each session lasting 60min). MAIN OUTCOME MEASURES: At baseline, 4 weeks, and 8 weeks, fatigue and HRQOL were assessed by a blind assessor using the Modified Fatigue Impact Scale and the Multiple Sclerosis Quality of Life-54 questionnaire, respectively. A mixed-model approach to repeated-measures analysis of variance was used to detect within- and between-subject effects. RESULTS: Findings are based on 21 patients (10 from the exercise group and 11 from the control group) who had data available on outcomes. There was no significant difference between the 2 groups at the baseline. Patients in the aquatic exercise group showed significant improvements in fatigue and subscores of HRQOL after 4 and 8 weeks compared with the control group. Results obtained from the intention-to-treat analysis were consistent with those of per-protocol analysis. CONCLUSIONS: The findings suggest that aquatic exercise training can effectively improve fatigue and HRQOL of patients with MS and should be considered in the management of this relatively common public health problem.","Kargarfard, M., et al. (2012). \"Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis.\" Arch Phys Med Rehabil 93(10): 1701-1708.","Iran",2012,"Neurological","Psychobehavioural","MFI",null,null,null,"Iran",null,"Neurological","Psychobehavioural",null,null,"MFI","2010:2014"]
[130,"Kelderman-Bolk, N., et al. (2015). \"Quality of life in patients with primary hypothyroidism related to BMI.\" Eur J Endocrinol 173(4): 507-515.",null,"Kelderman-Bolk, N., et al.","Quality of life in patients with primary hypothyroidism related to BMI","OBJECTIVE: Many patients treated for primary hypothyroidism have an unexplained reduced quality of life (QOL). We studied the relation between QOL and various parameters in treated hypothyroid patients. DESIGN AND METHODS: QOL analysis was done in 90 consecutive patients (77.8% females) treated for primary hypothyroidism. QOL was measured by the questionnaires Short-Form 36, Hospital Anxiety and Depression Scale and MFI20. Post hoc analysis was performed on the relation of QOL at baseline and BMI, thyroid hormones and other serum values. QOL in patients was also compared to the general population. RESULTS: QOL was decreased compared to the general population. We found an inverse relationship between QOL and BMI. A relationship between QOL and serum thyroid parameters or auto-antibodies could not be found. Higher sex hormone binding globulin (SHBG) levels corresponded with a better QOL, which is explained by the negative association of SHBG with body weight and BMI. CONCLUSIONS: A decreased QOL in hypothyroid patients on thyroxine treatment is related to a higher body weight (BMI). Weight gain needs more attention in the treatment of hypothyroidism.","Kelderman-Bolk, N., et al. (2015). \"Quality of life in patients with primary hypothyroidism related to BMI.\" Eur J Endocrinol 173(4): 507-515.","Netherlands",2015,"Endocrine","None","MFI",null,null,null,"Netherlands",null,"Endocrine","None",null,null,"MFI","2015:2018"]
[131,"Kennedy, R. H., et al. (2012). \"EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme.\" BMC Cancer 12: 181.",null,"Kennedy, R. H., et al.","EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme","BACKGROUND: During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic) examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. METHODS/DESIGN: EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20) with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20. Pathological assessment of surgical quality will also be undertaken and compliance with the enhanced recovery programme will be recorded for all patients. DISCUSSION: Should this trial demonstrate that laparoscopic surgery confers a significant clinical and/or health economic benefit this will further support the transition to this type of surgery, with implications for the training of surgeons and resource allocation. TRIAL REGISTRATION: ISRCTN48516968.","Kennedy, R. H., et al. (2012). \"EnROL: a multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme.\" BMC Cancer 12: 181.","UK",2012,"Cancer","Surgery","MFI",null,null,null,"UK",null,"Cancer","Surgery",null,null,"MFI","2010:2014"]
[132,"Kerling, A., et al. (2015). \"Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS).\" Int J Mol Sci 16(7): 15761-15775.",null,"Kerling, A., et al.","Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS)","BACKGROUND: The aim of this prospective randomized controlled trial was to investigate if a short-term endurance or combined endurance/resistance exercise program was sufficient to improve aerobic capacity and maximum force in adult patients (18-65 years) with multiple sclerosis (MS). METHODS: All patients performed a three-month exercise program consisting of two training sessions per week, lasting 40 min each, with moderate intensity. All patients had a maximum value of 6 (low to moderate disability) on the Expanded Disability Status Scale (EDSS). One group (combined workout group (CWG); 15 females, 4 males) completed a combined endurance/resistance workout (20 min on a bicycle ergometer, followed by 20 min of resistance training), while the other group (endurance workout group (EWG); 13 females, 5 males) completed a 40 min endurance training program. Aerobic capacity was assessed as peak oxygen uptake, ventilatory anaerobic threshold, and workload expressed as Watts. Maximum force of knee and shoulder extensors and flexors was measured using isokinetic testing. Quality of life was assessed with the SF-36 questionnaire, and fatigue was measured using the Modified Fatigue Impact Scale. RESULTS: Both training groups increased in aerobic capacity and maximum force. EWG, as well as CWG, showed improvement in several subscales of the SF-36 questionnaire and decrease of their fatigue. CONCLUSION: A short exercise intervention increased both aerobic capacity and maximum force independent of whether endurance or combined endurance/resistance workouts were performed.","Kerling, A., et al. (2015). \"Effects of a Short Physical Exercise Intervention on Patients with Multiple Sclerosis (MS).\" Int J Mol Sci 16(7): 15761-15775.","Germany",2015,"Neurological","Psychobehavioural","MFI",null,null,null,"Germany",null,"Neurological","Psychobehavioural",null,null,"MFI","2015:2018"]
[133,"Keystone, E., et al. (2008). \"Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy.\" Arthritis Rheum 59(6): 785-793.",null,"Keystone, E., et al.","Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy","OBJECTIVE: To assess the effects of treatment with rituximab plus methotrexate on patient-reported outcomes in patients with active rheumatoid arthritis (RA) who experienced inadequate response to anti-tumor necrosis factor therapy. METHODS: Patients with active RA were randomly assigned to rituximab (1,000 mg on days 1 and 15) or placebo. The primary end point was the proportion of patients with an American College of Rheumatology 20% response at week 24. Additional goals were to assess treatment effects on pain, fatigue, functional disability, health-related quality of life, and disease activity by comparing mean changes between groups. The analysis was conducted in the intent-to-treat population. The proportion of patients who achieved the minimum clinically important difference on the Health Assessment Questionnaire (HAQ) disability index (DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Short Form 36 (SF-36) was determined. RESULTS: Rituximab patients had statistically significantly greater pain relief. The FACIT-F showed significantly greater improvement in rituximab patients than placebo patients from weeks 12 through 24. Mean improvement from baseline in functional disability (measured by the HAQ DI) was significantly greater in rituximab patients from weeks 8 to 24. The mean +/- SD change from baseline for the SF-36 Physical Component Score was 6.64 +/- 8.74 for rituximab patients and 1.48 +/- 7.32 for placebo patients (P < 0.0001). The mean change from baseline for the SF-36 Mental Component Score was 5.32 +/- 12.41 for rituximab patients and 2.25 +/- 12.23 for placebo patients (P = 0.0269). CONCLUSION: Rituximab produced rapid, clinically meaningful, and statistically significant improvements in patient-reported pain, fatigue, functional disability, health-related quality of life, and disease activity. These effects were sustained throughout the study.","Keystone, E., et al. (2008). \"Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy.\" Arthritis Rheum 59(6): 785-793.","Canada",2008,"Musculoskeletal","Rituximab","FACIT-F",null,null,null,"Canada",null,"Musculoskeletal","Rituximab",null,null,"FACIT-F","2005:2009"]
[134,"Keystone, E. C., et al. (2017). \"Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study.\" Ann Rheum Dis 76(11): 1853-1861.",null,"Keystone, E. C., et al.","Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study","BACKGROUND: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX). METHODS: In this double-blind phase 3 study, patients were randomised 3:3:2 to placebo (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analogue scale, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Ttiredness and Worst Joint Pain. The primary study endpoint was at week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables. RESULTS: Compared with placebo and adalimumab, baricitinib showed statistically significant improvements (p</=0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores and WPAI-RA daily activity at week 12. Improvements were maintained for measures assessed to week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), worst tiredness and worst joint pain were observed for baricitinib versus placebo and adalimumab at week 12 (p</=0.05). CONCLUSIONS: Baricitinib provided significantly greater improvement in most PROs compared with placebo and adalimumab, including physical function MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (week 52). TRIAL REGISTRATION: NCT01710358.","Keystone, E. C., et al. (2017). \"Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study.\" Ann Rheum Dis 76(11): 1853-1861.","UK,USA",2017,"Musculoskeletal","Baricitinib","FACIT-F,VAS-F",null,null,null,"UK,USA",null,"Musculoskeletal","Baricitinib",null,null,"FACIT-F,VAS-F","2015:2018"]
[135,"Khayatzadeh, M. M., et al. (2013). \"Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue.\" Disabil Rehabil 35(10): 803-808.",null,"Khayatzadeh, M. M., et al.","Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue","PURPOSE: This study aimed to compare the quality of life (QOL) of Mothers of Children with Cerebral Palsy (MCCPs) with mothers of Typically Developing (TD) children as a Control Group (CG). The association of the mediating variables including socio-economic status (SES), marital satisfaction and fatigue with maternal QOL was also evaluated. METHOD: The MCCPs group consisted of 120 mothers (mean age: 30.3 +/- 5.5 years) of children with CP. The CG included 100 mothers (mean age: 29.9 +/- 4.5 years) of TD children. Demographic characteristics of the participants were recorded and the data was collected by World Health Organization Quality of Life-BREF (WHOQOL-BREF), SES Questionnaire, Index of Marital Satisfaction (IMS) and Fatigue Severity Scale-Persian (FSS-P). Data analysis was done by SPSS version 16.0. RESULTS: The QOL and SES were lower, while FSS-P and IMS were higher in MCCPs group than CG (p < 0.001). The SES, IMS and FSS-P associated with all domains of QOL in MCCPs group, while they did just with some domains of QOL in CG (p < 0.05). CONCLUSIONS: The lower QOL in MCCPs group is supposed to be mediated by the SES, marital satisfaction and fatigue so, maternal empowerment in terms of these mediators and family-centered approach are recommended. IMPLICATIONS FOR REHABILITATION: * Improper activity of trapezius muscle motor units can be a reason of the cervicogenic headache. * Increased muscle tension at rest can lead to decrease of its contractile properties. * Rehabilitation of patients is effective when includes first postisometric relaxation procedures and myofascial mobilization of trigger points, then head protraction and retraction exercises according to McKenzie therapy and finally muscles strengthening exercises supplemented with self-control of the correct body posture.","Khayatzadeh, M. M., et al. (2013). \"Investigation of quality of life in mothers of children withcerebral palsy in Iran: association with socio-economic status,marital satisfaction and fatigue.\" Disabil Rehabil 35(10): 803-808.","Iran",2013,"Neurological","None","FSS",null,null,null,"Iran",null,"Neurological","None",null,null,"FSS","2010:2014"]
[136,"Kim, M., et al. (2017). \"Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.\" BMC Complement Altern Med 17(1): 353.",null,"Kim, M., et al.","Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial","BACKGROUND: Cancer-related fatigue is one of the most common symptoms experienced by cancer patients, and it diminishes their quality of life. However, there is currently no confirmed standard treatment for cancer-related fatigue, and thus, many patients who suffer cancer-related fatigue seek complementary and alternative medicines such as moxibustion. Moxibustion is one of the most popular therapies in traditional Korean medicine used to manage fatigue. Recent studies have also demonstrated that moxibustion is effective for treating chronic fatigue. However, there is insufficient evidence supporting the effect of moxibustion against cancer-related fatigue. The aim of this study is to assess the efficacy and safety of moxibustion treatment for cancer-related fatigue. METHODS/DESIGN: A multi-center, three-armed parallel, randomized controlled trial will be conducted. Ninety-six patients with cancer-related fatigue will be recruited from three clinical research centers. They will be randomly allocated to one of three groups in a 1:1:1 ratio. The moxibustion group will receive moxibustion treatment at CV8, CV12, LI4 and ST36. The sham moxibustion group will receive sham moxibustion at non-acupoints. Both the moxibustion and sham moxibustion groups will receive 30-min treatments twice a week for 8 weeks. The usual care group will not receive moxibustion treatment. All participants will be educated via a brochure on how to manage cancer-related fatigue in daily life. The outcome measurements will be evaluated at baseline, week 5, week 9, and week 13 by assessors who are blinded to the group allocation. The primary outcome measure will be the mean change in the average scores of the Brief Fatigue Inventory before and after treatments between groups. The secondary outcome measures will be the mean difference in changes from baseline of the Brief Fatigue Inventory, functional assessments of cancer therapy-fatigue, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 scores, and Montreal Cognitive Assessment scores between groups. Safety will be assessed by monitoring adverse events at each visit. DISCUSSION: The results of this study will provide evidence to confirm whether moxibustion can be used as a therapeutic option for treating cancer-related fatigue. TRIAL REGISTRATION: Clinical Research Information Service KCT0002170 . Registered 16 December 2016.","Kim, M., et al. (2017). \"Moxibustion for cancer-related fatigue: study protocol for a randomized controlled trial.\" BMC Complement Altern Med 17(1): 353.","Korea",2017,"Cancer","Complementary","BFI,FACT-F",null,null,null,"Korea",null,"Cancer","Complementary",null,null,"BFI,FACT-F","2015:2018"]
[137,"Klein, D., et al. (2011). \"Long-term quality of life after breast cancer: a French registry-based controlled study.\" Breast Cancer Res Treat 129(1): 125-134.",null,"Klein, D., et al.","Long-term quality of life after breast cancer: a French registry-based controlled study","Population-based studies on quality of life (QOL) of long-term breast cancer survivors are quite recent and insufficient attention has been paid to the effect of time since diagnosis. We compared long-term QOL of population-based breast cancer survivors 5, 10, and 15 years after diagnosis with that of healthy controls. Breast cancer survivors were randomly selected from three population-based cancer registries (Bas-Rhin, Calvados and Doubs, France) along with healthy controls, stratified for age and place of residence, randomly selected from electoral rolls. Participants completed five self-administered questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Short Form-36 (SF-36), Spielberger State-Trait Anxiety Inventory (STAI), Multidimensional Fatigue Inventory (MFI) and a life conditions questionnaire. An analysis of variance was used to compare QOL scores of breast cancer survivors by period (5, 10, or 15 years) of diagnosis with those of controls, adjusted for sociodemographic data and comorbidities. Six hundred and fifty-two cases and 1,188 controls participated in the study. For many QOL scales, scores were significantly different between cancer survivors and controls. A clinically significant difference was evidenced for the fatigue scales, the SF36 physical functioning, role-physical, and role-emotional scales, with more favorable results for controls. Differences decreased with time and 15-year cancer survivors were generally not different from controls. Scores were particularly influenced by age and mean household income. More efforts should be made, specifically during the first 5 to 10 years after diagnosis, to help women with breast cancer to overcome their impairment in QOL.","Klein, D., et al. (2011). \"Long-term quality of life after breast cancer: a French registry-based controlled study.\" Breast Cancer Res Treat 129(1): 125-134.","France",2011,"Cancer","None","MFI",null,null,null,"France",null,"Cancer","None",null,null,"MFI","2010:2014"]
[138,"Kleinman, L., et al. (2000). \"Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.\" Qual Life Res 9(5): 499-508.",null,"Kleinman, L., et al.","Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C","Evidence exists demonstrating that infection with hepatitis C virus impairs health-related quality of life, but less is known about the effect of fatigue, a common symptom, on everyday life. The psychometric properties of the fatigue severity scale (FSS) were explored to determine suitability as an outcome measure in clinical trials. The FSS includes nine items developed to measure disabling fatigue and a visual analog scale (VAS) to measure overall fatigue. Using baseline data from three clinical trials (n = 1225) involving chronic hepatitis C patients, scaling and psychometric characteristics of the FSS were assessed. The SF-36 was also used in the trials. Item response theory analysis demonstrated that the FSS items can be placed along a single homogenous domain, fatigue. Internal consistency reliability was 0.94. Test-retest reliability was 0.82 for the total score and 0.80 for the VAS. The total score and the VAS were significantly correlated with the SF-36 vitality subscale (r = -0.76 and r = -0.76 respectively). Correlations with other SF-36 subscales were moderate (r = -0.46 to r = -0.67, all p < 0.0001). In summary, the FSS possesses good psychometric properties.","Kleinman, L., et al. (2000). \"Psychometric evaluation of the fatigue severity scale for use in chronic hepatitis C.\" Qual Life Res 9(5): 499-508.","USA",2000,"Infectious Disease","None","FSS,VAS-F",null,null,null,"USA",null,"Infectious Disease","None",null,null,"FSS,VAS-F","2000:2004"]
[139,"Klingberg, E., et al. (2009). \"The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden.\" Scand J Rheumatol 38(6): 472-480.",null,"Klingberg, E., et al.","The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden","OBJECTIVES: To study the use of complementary and alternative medicine (CAM) drugs and methods in patients with inflammatory rheumatic diseases, at rheumatology clinics in western Sweden, and to investigate possible associations between CAM-using habits and other characteristics of the patients. METHODS: Randomly selected rheumatology outpatients were asked to complete questionnaires about CAM usage, diagnoses, medication, quality of life (using the 36-item Short Form Health Survey, SF-36), fatigue (using the 20-item Multiple Fatigue Inventory, MFI-20), the Health Assessment Questionnaire (HAQ), and visual analogue scales (VAS) for global health, pain, and fatigue. RESULT: A total of 200 patients were included, 137 women and 63 men, mean age 55+/-16 and 54+/-15 years, respectively. Ongoing CAM use was reported by 58 patients (29%): 45 (22.5%) were taking CAM drugs, 20 (10%) were using CAM methods. Altogether 130 patients (65%) had used CAM at some time of their lives; 103 patients (51%) had used CAM drugs ever and 90 patients (45%) had used CAM methods ever. Women used more CAM drugs compared with men. Younger patients used more CAM. CAM use was associated with parameters indicating poorer health, mental component score (MCS) and physical component score (PCS) of SF-36, and VAS for global health and fatigue. Ongoing CAM method was associated with less use of immunomodulatory drugs. CONCLUSION: CAM use is widespread among rheumatology patients in Sweden. A total of 65% of the patients had experience of CAM treatment. Female sex, younger age, and poor health were associated with CAM utilization.","Klingberg, E., et al. (2009). \"The use of complementary and alternative medicine in outpatients with inflammatory rheumatic diseases in Sweden.\" Scand J Rheumatol 38(6): 472-480.","Sweden",2009,"Musculoskeletal","None","MFI",null,null,null,"Sweden",null,"Musculoskeletal","None",null,null,"MFI","2005:2009"]
[140,"Kluthcovsky, A. C. and A. A. Urbanetz (2015). \"Fatigue and quality of life in breast cancer survivors: a comparative study.\" Rev Bras Ginecol Obstet 37(3): 119-126.",null,"Kluthcovsky, A. C. and A. A. Urbanetz","Fatigue and quality of life in breast cancer survivors: a comparative study","PURPOSE: To assess fatigue and quality of life in disease-free breast cancer survivors in relation to a sample of age-matched women with no cancer history and to explore the relationship between fatigue and quality of life. METHODS: A cross-sectional study was conducted in a sample of 202 consecutive disease-free Brazilian breast cancer survivors, all of whom had completed treatment, treated at 2 large hospitals. The patients were compared to age-matched women with no cancer history attending a primary health care center. The Piper Fatigue Scale-Revised and the World Health Organization Quality of Life Instrument (WHOQOL-BREF) were used to measure the fatigue and quality of life, respectively. Socio-demographic and clinical variables were also obtained. The chi2 test, generalized linear model, and Spearman correlation coefficient were used for statistical purposes. The adopted level of significance was 5%. RESULTS: Breast cancer survivors experienced significantly greater total and subscale fatigue scores than comparison group (all p-values<0.05). In addition, survivors reported a poorer quality of life in physical (p=0.002), psychological (p=0.03), and social relationships (p=0.03) domains than comparison group. No difference was found for the environmental domain (p=0.08) for both groups. For survivors of breast cancer and for comparison group, the total and subscale fatigue scores were related to lower quality of life (all p-values<0.01). CONCLUSION: The findings of this study highlight the importance of assessing fatigue and quality of life in breast cancer survivors.","Kluthcovsky, A. C. and A. A. Urbanetz (2015). \"Fatigue and quality of life in breast cancer survivors: a comparative study.\" Rev Bras Ginecol Obstet 37(3): 119-126.","Brazil",2015,"Cancer","None","PFS",null,null,null,"Brazil",null,"Cancer","None",null,null,"PFS","2015:2018"]
[141,"Ko, H. J., et al. (2016). \"Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial.\" Gerontology 62(2): 200-209.",null,"Ko, H. J., et al.","Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial","BACKGROUND: There is evidence that animal-assisted therapy has positive effects on mental health, especially in elderly people. Caring for insects is easy, relatively inexpensive, and does not require much space. OBJECTIVE: The aim of this 8-week randomized, controlled, single-blinded study was to investigate the effect of pet insects on the psychological health of community-dwelling elderly people. METHODS: Elderly subjects (>/=65 years old) attending a community center in Daegu, Korea, were enrolled in the study between April and May 2014 and randomized at a 1:1 ratio to receive insect therapy and health advice or only health advice. The insect group received 5 crickets in a cage with sufficient fodder and a detailed instruction manual. At baseline and at 8 weeks, all subjects underwent psychometric tests via a direct interview [Beck Anxiety Inventory, Geriatric Depression Scale (GDS-15), Mini-Mental State Examination (MMSE), 36-Item Short Form Health Survey, Insomnia Severity Index, Fatigue Severity Scale, and Brief Encounter Psychosocial Instrument] and laboratory analyses of inflammatory and oxidative stress markers (erythrocyte sedimentation rate, high-sensitivity C-reactive protein, biological antioxidant potential, and derivatives of reactive oxygen metabolites). RESULTS: The insect-caring (n = 46) and control (n = 48) groups did not differ in baseline characteristics. The insect-caring group had significantly lower GDS-15 scores at week 8 (3.20 vs. 4.90, p = 0.004) and, after adjustment for baseline values, a significantly greater change in GDS-15 scores relative to baseline (-1.12 vs. 0.20, p = 0.011). They also had a significantly greater change in MMSE scores relative to baseline (1.13 vs. 0.31, p = 0.045). The two groups did not differ in terms of other psychometric and laboratory tests. No serious risks or adverse events were reported. CONCLUSION: Caring for insects, which is cost-effective and safe, was associated with a small to medium positive effect on depression and cognitive function in community-dwelling elderly people.","Ko, H. J., et al. (2016). \"Effect of Pet Insects on the Psychological Health of Community-Dwelling Elderly People: A Single-Blinded, Randomized, Controlled Trial.\" Gerontology 62(2): 200-209.","Korea",2016,"None","None","FSS",null,null,null,"Korea",null,"None","None",null,null,"FSS","2015:2018"]
[142,"Kok, N. F., et al. (2006). \"Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.\" Bmj 333(7561): 221.",null,"Kok, N. F., et al.","Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial","OBJECTIVES: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. DESIGN: Single blind, randomised controlled trial. SETTING: Two university medical centres, the Netherlands. PARTICIPANTS: 100 living kidney donors. INTERVENTIONS: Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. MAIN OUTCOME MEASURES: The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. RESULTS: Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). CONCLUSIONS: Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.","Kok, N. F., et al. (2006). \"Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.\" Bmj 333(7561): 221.","Netherlands",2006,"Kidney Disease","Surgery","MFI",null,null,null,"Netherlands",null,"Kidney Disease","Surgery",null,null,"MFI","2005:2009"]
[143,"Korsen, M., et al. (2017). \"Dalfampridine effects on cognition, fatigue, and dexterity.\" Brain Behav 7(1): e00559.",null,"Korsen, M., et al.","Dalfampridine effects on cognition, fatigue, and dexterity","OBJECTIVES: Dalfampridine exerts beneficial effects on walking ability in a subgroup of patients with multiple sclerosis (MS). These patients are termed \"responders\". Here, we investigated whether the responder status with respect to mobility measures would determine whether dalfampridine treatment exerts a beneficial effect on other MS symptoms. We therefore assessed walking ability, upper limb function, cognition, fatigue, visual evoked potentials (VEPs), depression, and quality of life in patients before and after dalfampridine treatment. METHODS: Patients with MS and impaired mobility were recruited. Maximal walking distance, timed 25 Foot Walk, nine hole peg test, paced auditory serial addition test (PASAT), fatigue severity scale (FSS), VEPs, Beck Depression Inventory (BDI), EuroQol five dimensional questionnaire, and quality of life visual analogue scale were determined before and after 12-14 days of dalfampridine treatment. Repeated measures analysis of variance was applied to determine the effect of dalfampridine treatment. RESULTS: Of the 34 patients who completed the study, 22 patients were responders and 12 patients nonresponders, according to their performance in mobility measures. Treatment effects for the entire patient cohort were observed for PASAT (p = .029) and BDI (p = .032). Belonging to the responder cohort did not predict the response to treatment in these tests. For the FSS, response to dalfampridine treatment was dependent on the responder status (p = .001) while no effects in the total patient cohort were observed (p = .680). Other neurological functions remained unaltered. For VEP latencies, no significant improvements were detected. CONCLUSION: In this study, we observed beneficial effects of dalfampridine on cognition, depression, and fatigue. These effects were not limited to patients who responded to dalfampridine with improved mobility measures. These findings underscore the need to assess the beneficial effects of dalfampridine on neurological deficits in MS patients in additional randomized clinical trials.","Korsen, M., et al. (2017). \"Dalfampridine effects on cognition, fatigue, and dexterity.\" Brain Behav 7(1): e00559.","Germany",2017,"Neurological","None","FSS,VAS-F",null,null,null,"Germany",null,"Neurological","None",null,null,"FSS,VAS-F","2015:2018"]
[144,"Kramer, L., et al. (2002). \"Subclinical impairment of brain function in chronic hepatitis C infection.\" J Hepatol 37(3): 349-354.",null,"Kramer, L., et al.","Subclinical impairment of brain function in chronic hepatitis C infection","BACKGROUND/AIMS: Central nervous system abnormalities such as fatigue and depression occur more frequently in chronic hepatitis C virus (HCV) infection than in many other causes of chronic liver disease. The finding that fatigue is unrelated to activity of hepatitis or mode of infection could indicate an independent effect of HCV on brain function. This study tested the hypothesis of a subclinical cognitive dysfunction in HCV-infected patients. METHODS: One-hundred untreated HCV-RNA positive biopsy-proven patients were investigated by P300 event-related potentials, a sensitive electrophysiologic test of cognitive processing. Health-related quality of life and fatigue were assessed using the SF-36 questionnaire and the Fatigue Impact Scale, respectively. RESULTS: Cognitive brain function was subclinically impaired in the cohort of HCV-infected patients as indicated by significantly prolonged P300 latencies (P=0.01 for comparison to matched healthy subjects) and reduced P300 amplitudes (P<0.001, respectively). Seventeen of the 100 HCV-infected patients had P300 latencies outside the age-adjusted normal range. Abnormal P300 characteristics were not related to the degree of histologic or biochemical activity of hepatitis, severity of fatigue or mental health impairment. CONCLUSIONS: This study demonstrates that patients with HCV infection showed a slight but significant neurocognitive impairment, possibly indicating a further extrahepatic manifestation of chronic hepatitis C.","Kramer, L., et al. (2002). \"Subclinical impairment of brain function in chronic hepatitis C infection.\" J Hepatol 37(3): 349-354.","Austria",2002,"Infectious Disease","None","FIS",null,null,null,"Austria",null,"Infectious Disease","None",null,null,"FIS","2000:2004"]
[145,"Kristenson, M., et al. (1998). \"Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study.\" Psychosom Med 60(3): 277-282.",null,"Kristenson, M., et al.","Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study","OBJECTIVE: Coronary heart disease (CHD) mortality is four times higher in 50-year-old Lithuanian men than in 50-year-old Swedish men. The difference cannot be explained by standard risk factors. The objective of this study was to examine differences in psychosocial risk factors for CHD in the two countries. METHODS: The LiVicordia study is a cross-sectional survey comparing 150 randomly selected 50-year-old men in each of the two cities: Vilnius, Lithuania, and Linkoping, Sweden. As part of the study, a broad range of psychosocial characteristics, known to predict CHD, were investigated. RESULTS: In the men from Vilnius compared with those from Linkoping, we found a cluster of psychosocial risk factors for CHD; higher job strain (p <.01), lower social support at work, lower emotional support, and lower social integration (p values <.001). Vilnius men also showed lower coping, self-esteem, and sense of coherence (p values < .001), higher vital exhaustion, and depression (p values < .001). Quality of life and perceived health were lower and expectations of ill health within 5 to 10 years were higher in Vilnius men (p values < .001). Correlations between measurements on traditional and psychosocial risk factors were few and weak. CONCLUSIONS: The Vilnius men, representing the population with a four-fold higher CHD mortality, had unfavorable characteristics on a cluster of psychosocial risk factors for CHD in comparison with the Linkoping men. We suggest that this finding may provide a basis for possible new explanations of the differences in CHD mortality between Lithuania and Sweden.","Kristenson, M., et al. (1998). \"Increased psychosocial strain in Lithuanian versus Swedish men: the LiVicordia study.\" Psychosom Med 60(3): 277-282.","Sweden",1998,"CVD","None","VE",null,null,null,"Sweden",null,"CVD","None",null,null,"VE","1960:1999"]
[146,"Kuijper, T. M., et al. (2014). \"Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort.\" Arthritis Care Res (Hoboken) 66(3): 379-386.",null,"Kuijper, T. M., et al.","Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort","OBJECTIVE: To compare the burden of disease and its development over time in patients referred to an early arthritis cohort who were diagnosed either as having arthralgias without synovitis or as having rheumatoid arthritis (RA). METHODS: Patients diagnosed as having arthralgias without synovitis or RA were selected from the Rotterdam Early Arthritis Cohort. Data on clinical and psychological characteristics, demographics, pain scores (Rheumatoid Arthritis Disease Activity Index), functional ability (Health Assessment Questionnaire), health-related quality of life (HRQOL; Short Form 36), fatigue (visual analog scale and Fatigue Assessment Scale), and health care utilization (HCU) were collected at baseline and at 6 and 12 months of followup. The burden of disease measures (pain, functional ability, fatigue, and HRQOL) and HCU levels were plotted over time for both groups. A Poisson regression model for repeated data was used to identify determinants of HCU for both groups. RESULTS: At baseline, 330 patients with arthralgias without synovitis (nonsynovitis [NS] group) and 244 RA patients (RA group) were included. Overall, the burden of disease measures and HCU levels were very similar between groups. Both groups showed improvement over time with respect to pain scores, functional ability, HRQOL, and HCU levels. Independent predictors of high HCU were identified as more pain, worse physical health, and external locus of control in the NS group and as shorter duration of symptoms, low chance locus of control, and worse physical functioning in the RA group. CONCLUSION: Despite the absence of an inflammatory diagnosis, patients with arthralgias without synovitis experienced a similar burden of disease compared with RA patients.","Kuijper, T. M., et al. (2014). \"Quality of life and health care use in patients with arthralgias without synovitis compared with patients diagnosed with early rheumatoid arthritis: data from an early arthritis cohort.\" Arthritis Care Res (Hoboken) 66(3): 379-386.","Netherlands",2014,"Musculoskeletal","None","VAS-F,FAS",null,null,null,"Netherlands",null,"Musculoskeletal","None",null,null,"VAS-F,FAS","2010:2014"]
[147,"Labiano-Fontcuberta, A., et al. (2015). \"Psychiatric disturbances in radiologically isolated syndrome.\" J Psychiatr Res 68: 309-315.",null,"Labiano-Fontcuberta, A., et al.","Psychiatric disturbances in radiologically isolated syndrome","BACKGROUND: Radiologically isolated syndrome (RIS) is characterized by incidental lesions suggestive of multiple sclerosis (MS) on MRI without typical symptoms of MS. Clinically isolated syndrome (CIS) is characterized by a first episode of neurologic symptoms caused by demyelination in the central nervous system. To date, psychiatric disorders have not been systematically addressed in RIS subjects. We assessed emotional disturbances, personality features and health-related quality of life (HRQoL) in a cohort of RIS patients as compared with clinically isolated syndrome (CIS). METHODS: Twenty-eight RIS patients, 25 clinically isolated syndrome (CIS) patients, and 22 healthy subjects were enrolled in the study. Participants were administered a mood scale (Hamilton Depression Rating Scale), behavioural measures (Personality Assessment Inventory), and fatigue measures (Fatigue Impact Scale for Daily Use). HRQoL was quantified using the EuroQol-5. RESULTS: 14 (50%) of RIS patients had clinically significant depression, with over one-third of these having moderate depression, scores virtually identical to those observed in CIS patients. 11 of 28 (39.3%) subjects with RIS had anxious depression, a figure three times higher than that found in CIS patients. RIS patients' HAMD-17 total score showed a very strong correlation with severity of fatigue. In addition, RIS patients reported lower HRQoL (p = 0.036) and a significantly higher symptoms load for somatisation compared to both CIS and control groups (p < 0.002). CONCLUSION: RIS patients had high rates of depression, particularly anxious depression and somatization. Future studies are warranted to clarify whether these psychiatric disturbances are causally associated with a distinct white matter psychopathologic process.","Labiano-Fontcuberta, A., et al. (2015). \"Psychiatric disturbances in radiologically isolated syndrome.\" J Psychiatr Res 68: 309-315.","Spain",2015,"neurological","None","FIS",null,null,null,"Spain",null,"Neurological","None",null,null,"FIS","2015:2018"]
[148,"Lai, J. S., et al. (2016). \"Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma.\" Cancer 122(2): 287-295.",null,"Lai, J. S., et al.","Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma","BACKGROUND: Hand-foot syndrome and mucositis/stomatitis are frequent adverse events (AEs) of treatment with tyrosine kinase inhibitors in cancer therapy. Quality-of-life instruments that measure the functional consequences of these AEs are needed to assess the impact of therapeutic interventions and to guide patient care. The Hand-Foot and Mucositis Symptom and Impact Questionnaire (HAMSIQ [formerly the Supplementary Quality of Life Questionnaire]) was used in the COMPARZ trial (Pazopanib vs Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma [national clinical trial no. NCT00720941]) and the PISCES study (Patient Preference Study of Pazopanib vs Sunitinib in Advanced or Metastatic Kidney Cancer [clinicaltrials.gov NCT01064310]) to assess mouth/throat and hand/foot soreness symptoms and subsequent limitations in patients receiving pazopanib or sunitinib for metastatic renal cell carcinoma. The objective of the current analysis was to validate the HAMSIQ using data from the PISCES study. METHODS: The HAMSIQ was administered in the PISCES study at baseline and every 2 weeks over two 10-week periods to patients who were receiving pazopanib or sunitinib. Data from the first 10-week period were used to assess the feasibility, validity, and responsiveness of the HAMSIQ. RESULTS: In total, >/=85% of 169 patients completed the HAMSIQ (excluding the item concerning days off work). Correlations among items within the same limitation subscale generally were high (Cronbach alpha >/= .80). HAMSIQ limitation scores differentiated patients according to their baseline performance status and severity of soreness. Small-to-moderate correlations were observed for the symptoms/limitation scores and for changes from baseline scores between the HAMSIQ and the Functional Assessment of Chronic Illness Therapy fatigue survey. The HAMSIQ demonstrated responsiveness to changes in clinical status and the development of hand-foot syndrome AEs over time. CONCLUSIONS: The HAMSIQ is a feasible, valid, reliable, and responsive instrument for assessing the impact of hand-foot syndrome and mucositis in patients receiving tyrosine kinase inhibitors. Cancer 2016;122:287-295. (c) 2015 American Cancer Society.","Lai, J. S., et al. (2016). \"Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma.\" Cancer 122(2): 287-295.","Switzerland",2016,"Infectious Disease","Pazopanib,Sunitinib","FACIT-F",null,null,null,"Switzerland",null,"Infectious Disease","Pazopanib,Sunitinib",null,null,"FACIT-F","2015:2018"]
[149,"Lai, J. S., et al. (2011). \"How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example.\" Arch Phys Med Rehabil 92(10 Suppl): S20-27.",null,"Lai, J. S., et al.","How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example","OBJECTIVE: To illustrate how measurement practices can be advanced by using as an example the fatigue item bank (FIB) and its applications (short forms and computerized adaptive testing [CAT]) that were developed through the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Cooperative Group. DESIGN: Psychometric analysis of data collected by an Internet survey company using item response theory-related techniques. SETTING: A U.S. general population representative sample collected through the Internet. PARTICIPANTS: Respondents used for dimensionality evaluation of the PROMIS FIB (N=603) and item calibrations (N=14,931). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Fatigue items (112) developed by the PROMIS fatigue domain working group, 13-item Functional Assessment of Chronic Illness Therapy-Fatigue, and 4-item Medical Outcomes Study 36-Item Short Form Health Survey Vitality scale. RESULTS: The PROMIS FIB version 1, which consists of 95 items, showed acceptable psychometric properties. CAT showed consistently better precision than short forms. However, all 3 short forms showed good precision for most participants in that more than 95% of the sample could be measured precisely with reliability greater than 0.9. CONCLUSIONS: Measurement practice can be advanced by using a psychometrically sound measurement tool and its applications. This example shows that CAT and short forms derived from the PROMIS FIB can reliably estimate fatigue reported by the U.S. general population. Evaluation in clinical populations is warranted before the item bank can be used for clinical trials.","Lai, J. S., et al. (2011). \"How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example.\" Arch Phys Med Rehabil 92(10 Suppl): S20-27.","USA",2011,"none","None","PROMIS-F,FACIT-F",null,null,null,"USA",null,"None","None",null,null,"PROMIS-F,FACIT-F","2010:2014"]
[150,"Lai, J. S., et al. (2014). \"Linking fatigue measures on a common reporting metric.\" J Pain Symptom Manage 48(4): 639-648.",null,"Lai, J. S., et al.","Linking fatigue measures on a common reporting metric","CONTEXT: Fatigue is one of the most common and debilitating symptoms experienced by patients living with chronic conditions and is also commonly experienced in the general U.S. population. Linking fatigue scores from some of the most widely used measure of fatigue to the same metric will facilitate interpretation of fatigue outcomes. OBJECTIVES: The goal of this study is to report the methods used to develop linking (crosswalk) tables to enable the direct comparison of Patient-Reported Outcomes Measurement Information System-Fatigue with fatigue scores on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale, the Medical Outcomes Study Short Form-36 four-item Vitality Scale, and the Quality of Life in Neurological Disorders Fatigue Scale. METHODS: Participants were recruited from two data sets (n=1120 and n=803). Two item response theory-based linking methods, the Stocking-Lord calibration and fixed-parameter calibration, were used to establish linking between measures. The item response theory calibrations were derived using the graded response model. RESULTS: Both the Stocking-Lord calibration and fixed-parameter calibration linking methods produced comparable results. Final crosswalk tables are reported for the fixed-parameter calibration. CONCLUSION: Findings can facilitate comparison of scores across some of the most widely used fatigue measures and assist in comparing patient-reported fatigue outcomes in clinical trials, comparative effectiveness research, and clinical practice.","Lai, J. S., et al. (2014). \"Linking fatigue measures on a common reporting metric.\" J Pain Symptom Manage 48(4): 639-648.","USA",2014,"Various","None","FACIT-F,QoL-Neurological Disorders Fatigue Scale",null,null,null,"USA",null,"Various","None",null,null,"FACIT-F,QoL-Neurological Disorders Fatigue Scale","2010:2014"]
[151,"Le Borgne, G., et al. (2013). \"Quality of life in long-term cervical cancer survivors: a population-based study.\" Gynecol Oncol 129(1): 222-228.",null,"Le Borgne, G., et al.","Quality of life in long-term cervical cancer survivors: a population-based study","OBJECTIVES: To assess long-term quality of life (QOL) in cervical cancer survivors (CCSs), 5, 10, and 15 years after diagnosis. METHODS: In a cross-sectional population-based study, CCSs diagnosed in 1990, 1995, or 2000 were randomly selected from 3 tumor registries in France. Healthy controls were randomly selected from electoral rolls, stratifying on age group and residence area. Five QOL questionnaires (SF-36, EORTC QLQ-C30, the cervical cancer-specific module (EORTC QLQ-CX24), the MFI fatigue questionnaire, the STAI for anxiety) and a life condition questionnaire were used. Analysis of variance was used to compare QOL scores of survivors by period of diagnosis (5, 10, and 15 years) with those of controls and according to treatment modality, adjusted for socio-demographic data. RESULTS: A total of 173 localized CCSs (42% treated with surgery alone and 58% with a combination of treatments) and 594 controls participated in the study. Compared with controls, CCSs expressed globally similar good QOL, except for impaired psychoemotional domains in 15-year survivors (p<0.01). Worsening of some symptoms was observed over time, 15-year survivors in particular reported significantly more lymphedema than 5-year (p=0.0009) and 10-year CCSs (p=0.002). Compared with CCSs treated by surgery alone, QOL of CCSs who received radiotherapy was significantly more affected in terms of cervical cancer specific problems, such as sexual dysfunction (p=0.002), voiding and abdominal symptoms (p=0.01), and lymphedema (p=0.01). CONCLUSIONS: Even after 15 years, QOL of CCSs is impacted in psychological domains, compared with healthy controls. Among CCSs, women treated by adjuvant radiotherapy expressed more physical sequelae.","Le Borgne, G., et al. (2013). \"Quality of life in long-term cervical cancer survivors: a population-based study.\" Gynecol Oncol 129(1): 222-228.","France",2013,"Cancer","None","MFI",null,null,null,"France",null,"Cancer","None",null,null,"MFI","2010:2014"]
[152,"Le Gal, M., et al. (2010). \"Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia.\" Joint Bone Spine 77(2): 165-170.",null,"Le Gal, M., et al.","Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia","CONTEXT: The multidimensional nature of the fibromyalgia syndrome means that different instruments need to be used to assess the patients' perception of this constellation of physical and psychological symptoms and their impact on their daily lives. Six questionnaires (Multidimensional Fatigue Inventory MFI, Fibromyalgia Impact Questionnaire FIQ, Multiple Ability Self-report Questionnaire MASQ, State-Trait Anxiety Inventory STAI, Beck Depression Inventory-II BDI-II and Patient Global Impression of Change PGIC) were linguistically validated into 12 languages. METHODS: The standardized cross-cultural adaptation process includes the following steps: forward translation, backward translation, and review of the version by a clinician and comprehension tests on subjects in the target country. RESULTS: Regardless of the instruments and dimensions studied, the same translation and cultural adaptation issues arose: (1) an issue that is strictly related to translation, for example, the word \"things\" was translated as \"something\"; (2) literal translation is possible but culturally irrelevant, for example the expression \"to walk several blocks\", which is a completely abstract concept in Europe, was translated as \"to walk for more than one kilometre\"; (3) the translation needed to be reformulated or the tense needed to be changed for idiomatic reasons. For example, the present perfect does not exist in German and so the present simple was used in the first version. The imperfect was eventually used with adverbs such as \"lately\". CONCLUSIONS: Linguistic adaptation was completed according to a recognized and rigorous method allowing for the wide-scale use of these patient-reported outcomes instruments in international studies.","Le Gal, M., et al. (2010). \"Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia.\" Joint Bone Spine 77(2): 165-170.","France",2010,"Musculoskeletal","None","MFI",null,null,null,"France",null,"Musculoskeletal","None",null,null,"MFI","2010:2014"]
[153,"Ledinek, A. H., et al. (2013). \"Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study.\" Clin Neurol Neurosurg 115 Suppl 1: S86-89.",null,"Ledinek, A. H., et al.","Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study","OBJECTIVE: Fatigue affects more than 60% of multiple sclerosis (MS) patients and is one of the most troublesome symptoms of the disease. Current treatment options for MS fatigue include amantadine, modafinil and acetyl-l-carnitine (ALCAR). The aim of our study was to compare efficacy of amantadine, modafinil and ALCAR with placebo in patients with MS. METHODS: Patients with MS and a disability level </= 5.5 on the Kurtzke Expanded Disability Status Scale (EDSS) and fatigue were included in the study. Patients were assigned to a one month treatment with either amantadine 200mg, ALCAR 2g, modafinil 200mg or placebo. Efficacy of the treatment was evaluated by using the modified fatigue impact scale (MFIS). RESULTS: Sixty patients were included in the study (39 females). The mean age of patients was 38 +/- 6.7 years and the mean disease duration was 6.6 +/- 1.2 years. Contrast analysis showed significantly lower mean MFIS score after one month in patients on amantadine compared to placebo (mean difference=17.3, p=0.001). There was also a trend of a lower MFIS score in ALCAR group in comparison to placebo (mean difference=12.4, p=0.05, with Keppel-corrected alpha of 0.046). The quality of life measured as SF 36 - PCS and SF 36 - MCS proved to be significantly influenced by treatment. CONCLUSION: One month treatment with amantadine improved fatigue in patients with relapsing-remitting MS as evaluated by MFIS. No or only a trend of improvement was seen in patients treated with modafinil or ALCAR, respectively.","Ledinek, A. H., et al. (2013). \"Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis--result of a pilot randomized, blind study.\" Clin Neurol Neurosurg 115 Suppl 1: S86-89.","Slovenia",2013,"Neurological","Other Drugs","MFI",null,null,null,"Slovenia",null,"Neurological","Other Drugs",null,null,"MFI","2010:2014"]
[154,"Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.",null,"Lee, C. E., et al.","A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT. METHODS/DESIGN: A 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data. DISCUSSION: Musculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00834392.","Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.","Canada",2012,"Cancer","Psychobehavioural","FACIT-F",null,null,null,"Canada",null,"Cancer","Psychobehavioural",null,null,"FACIT-F","2010:2014"]
[155,"Lee, J. H., et al. (2015). \"The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue.\" J Altern Complement Med 21(7): 422-429.",null,"Lee, J. H., et al.","The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue","OBJECTIVE: Idiopathic chronic fatigue (ICF), defined as medically unexplained chronic fatigue, is common these days. To date, there is no definite cure for ICF, and alternative therapies are being investigated. Oriental medicine music therapy (OMMT), a novel music therapy that occurs through an active behavioral process, has been applied to various chronic diseases, including ICF. In the present study, we aimed to evaluate the effect of OMMT on ICF. DESIGN: Randomized controlled trial of OMMT compared with the waitlist control (6 sessions each) during a 2-week period. PARTICIPANTS: Thirty participants who had had ICF for at least 6 months before the experiments were recruited. OUTCOME MEASURES: We evaluated fatigue severity scale (FSS), visual analog scale (VAS) for overall fatigue, revised Chalder fatigue scale (RCFS), World Health Organization quality of life scale abbreviated version (WHOQOL-BREF), Buzhongyiqi-Tang questionnaire (BZTQ), and salivary cortisol level at baseline (week 0) and at the end of the study (week 2) in the two groups. RESULTS: FSS, VAS, and RCFS scores were significantly lower, and WHOQOL-BREF scores were significantly higher in the OMMT group than in the waitlist group (p=0.006, p=0.004, p=0.002, and p=0.002, respectively). In contrast, salivary cortisol level and BZTQ scores were not significantly different between the OMMT group and the waitlist group. CONCLUSIONS: The present study suggests that OMMT may be an alternative treatment for ICF. Based on this result, further studies including possible mechanisms are needed.","Lee, J. H., et al. (2015). \"The Effect of Oriental Medicine Music Therapy on Idiopathic Chronic Fatigue.\" J Altern Complement Med 21(7): 422-429.","Korea",2015,"Chronic Fatigue","Psychobehavioural","VAS-F,FSS,CFS",null,null,null,"Korea",null,"Chronic Fatigue","Psychobehavioural",null,null,"VAS-F,FSS,CFS","2015:2018"]
[156,"Lee, J. I., et al. (2010). \"Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea.\" Health Qual Life Outcomes 8: 101.",null,"Lee, J. I., et al.","Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea","BACKGROUND: Concern regarding the health-related quality of life (HRQOL) of long-term survivors of thyroid cancer has risen due to the rapid increase in the incidence of thyroid cancer, which generally has an excellent prognosis. The aim of this study was to evaluate the status of HRQOL in disease-free survivors of differentiated thyroid carcinoma (DTC) and to evaluate the important determinants of HRQOL. METHODS: This was a cross-sectional study in which we interviewed consecutive disease-free survivors of DTC. Three different validated questionnaires (\"EORTC QLQ-C30\" for various functional domains, the \"brief fatigue inventory (BFI)\" and the \"hospital anxiety and depression scale\" (HADS)) were used. Data from a large, population based survey of 1,000 people were used as a control. RESULTS: The response rate for the questionnaires was 78.9% (316/401). Disease-free survivors of DTC showed a decreased HRQOL in all five functional domains (physical, role, cognitive, emotional, and social) on the EORTC QLQ-C30 compared with controls (P < 0.01). BFI and HADS-anxiety scores also showed greater distress in disease-free survivors of DTC than in controls (P < 0.05). A multiple regression analysis for the determinants of HRQOL showed that the HADS-anxiety, HADS-depression, and BFI scores were the most significant components of decreased HRQOL. CONCLUSIONS: Although disease-free survivors of DTC are expected to have disease-specific survival comparable to the general population, they experience a significantly decreased HRQOL. Anxiety, depression, and fatigue were the major determinants of the decreased HRQOL. Supportive psychological care should be integrated into the management of long-term survivors of DTC.","Lee, J. I., et al. (2010). \"Decreased health-related quality of life in disease-free survivors of differentiated thyroid cancer in Korea.\" Health Qual Life Outcomes 8: 101.","Korea",2010,"Cancer","None","BFI",null,null,null,"Korea",null,"Cancer","None",null,null,"BFI","2010:2014"]
[157,"Lerdal, A. and C. L. Gay (2013). \"Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later.\" Neurology 81(18): 1581-1587.",null,"Lerdal, A. and C. L. Gay","Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later","OBJECTIVE: To determine whether fatigue in the acute phase following stroke predicts long-term patient-reported physical and mental health outcomes 18 months later. METHODS: Patients (n = 96, mean age 67.8 years, SD 12.9) were assessed within 2 weeks of hospital admission for first-ever stroke (acute phase) and 18 months later. Measures included the Fatigue Severity Scale and the Beck Depression Inventory II. The Short Form-36 was used to assess self-reported physical and mental health. Multivariate regression analysis was used to evaluate the relationship between acute phase fatigue and later health outcomes, controlling for relevant covariates. RESULTS: Acute phase fatigue was associated with physical health at 18-month follow-up, but not with mental health. After adjusting for other potential predictors of health outcomes, including age, sex, cohabitation status, acute phase physical or mental health, and depressive symptoms, acute phase fatigue remained a significant predictor of later physical health but not of later mental health. The reverse relationships were also examined, but neither physical nor mental health in the acute phase predicted fatigue at 18 months; the best predictor of fatigue at 18-month follow-up was acute phase fatigue. CONCLUSIONS: These findings suggest that acute phase fatigue is an independent risk factor for poor physical health 18 months after stroke. Diagnosis and treatment of acute phase fatigue may improve physical health-related quality of life among stroke survivors. Effective treatments for poststroke fatigue, both in the acute phase and later in the recovery period, are needed.","Lerdal, A. and C. L. Gay (2013). \"Fatigue in the acute phase after first stroke predicts poorer physical health 18 months later.\" Neurology 81(18): 1581-1587.","Norway",2013,"CVD","None","FSS",null,null,null,"Norway",null,"CVD","None",null,null,"FSS","2010:2014"]
[158,"Lesage, A. C., et al. (2011). \"Results of a national survey on quality of life in inflammatory bowel diseases.\" Clin Res Hepatol Gastroenterol 35(2): 117-124.",null,"Lesage, A. C., et al.","Results of a national survey on quality of life in inflammatory bowel diseases","AIMS: Inflammatory bowel diseases (IBD) have a negative impact on patients' quality of life. The aims of this survey were to learn more about patients' concerns, and to compare their feelings with the beliefs of their close relations and physicians. PATIENTS AND METHODS: A specific questionnaire, including the RFIPC and the MFI-20, was used. Patients' answers were compared with those given by their close relations and attending physicians. RESULTS: This national survey included 2424 French patients. At the time of diagnosis, 73% of patients expressed having fears, but were also relieved to understand their symptoms. IBD was responsible for fatigue and weariness, and had a negative impact on daily, occupational, leisure, family and personal life. The main fears concerned unpredictable flare-ups followed by need for an ostomy bag and risk of surgery. The answers provided by close relations and physicians matched those of the patients, but physicians overestimated the patient's knowledge and underestimated disease impact. CONCLUSION: IBD has a deleterious effect on quality of life. Close relations of the patient realize the impact the disease has on the patients' life, but attending physicians still tend to minimize patients' symptoms.","Lesage, A. C., et al. (2011). \"Results of a national survey on quality of life in inflammatory bowel diseases.\" Clin Res Hepatol Gastroenterol 35(2): 117-124.","France",2011,"Gastrointestinal","None","MFI",null,null,null,"France",null,"Gastrointestinal","None",null,null,"MFI","2010:2014"]
[159,"Lesser, G. J., et al. (2013). \"A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.\" J Support Oncol 11(1): 31-42.",null,"Lesser, G. J., et al.","A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer","BACKGROUND: Coenzyme Q10 (CoQ10) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits. OBJECTIVES: We performed a randomized, double-blind, placebo-controlled study of oral CoQ10 in female breast cancer patients with the primary objective of determining CoQ10's effects on self-reported fatigue, depression, and quality of life (QOL). Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oral supplements of 300 mg CoQ10 or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment was continued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ10 and vitamin E were obtained at baseline and at 8, 16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time. RESULTS: Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age (range, 28-85 years), pathologic stage (stage 0, 91%; stage 1, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ10 levels in the CoQ10 and placebo arms were 0.70 and 0.73 microg/mL, respectively; the 24-week CoQ10 levels were 1.83 and 0.79 microg/mL, respectively. There were no significant differences between the CoQ10 and placebo arms at 24 weeks for scores on the Profile of Mood States-Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy-Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy-Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies-Depression scale (11.6 vs 12.3, P = .632). CONCLUSIONS: Supplementation with conventional doses of CoQ10 led to sustained increases in plasma CoQ10 levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.","Lesser, G. J., et al. (2013). \"A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer.\" J Support Oncol 11(1): 31-42.","USA",2013,"Cancer","Various","Profile of Mood States-Fatigue questionnaire,FACIT-F",null,null,null,"USA",null,"Cancer","Various",null,null,"Profile of Mood States-Fatigue questionnaire,FACIT-F","2010:2014"]
[160,"Leuschen, M. P., et al. (2004). \"A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.\" Mult Scler 10(6): 636-642.",null,"Leuschen, M. P., et al.","A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis","Multiple sclerosis (MS) patients initiating IFN beta-1a, Avonex, therapy (Group 1, n = 30) or experiencing side effects after 6 months on therapy (Group 2, n = 30) were randomized for 5 weeks open label adjunct therapy to naproxen (Aleve), acetaminophen (Tylenol) or ibuprofen (Advil). Our hypothesis was that non-prescription pain medications are effective in decreasing or alleviating the side effects associated with IFN beta-1a therapy. Contrary to the hypothesis, most patients in both groups continued to report side effects on all pain medications. After 5 weeks, headache, fever, chills and injection site pain were low in < or = 50% of patients. Moderate to significant fatigue, muscle or joint pain continued in most patients. As a quality of life measure, the Modified Fatigue Impact Scale (mFIS) improved for Group 1 on naproxen or ibuprofen with greatest improvement in physical subset (P = 0.002 for naproxen and P<0.01 for ibuprofen). Total mFIS for Group 1 on acetaminophen improved (P = 0.04) due to improved cognitive subset rather than physical subset. Group 2, with side effects initially, reported less significant fatigue (severity 5-10) but more moderate fatigue (severity 2-4) at study end for all three medications. All medications improved cognitive subset (P = 0.05). Physical mFIS subset did not improve for Group 2 on acetaminophen, but did with naproxen (P = 0.05) or ibuprofen (P = 0.03). Naproxen and ibuprofen were more effective than acetaminophen in minimizing physical side effects of IFN beta-1a. None of the three pain medications tested were as effective as hypothesized for minimizing fatigue or muscle and joint pain.","Leuschen, M. P., et al. (2004). \"A randomized open label study of pain medications (naproxen, acetaminophen and ibuprofen) for controlling side effects during initiation of IFN beta-1a therapy and during its ongoing use for relapsing-remitting multiple sclerosis.\" Mult Scler 10(6): 636-642.","USA",2004,"Neurological","Other Drugs","MFI",null,null,null,"USA",null,"Neurological","Other Drugs",null,null,"MFI","2000:2004"]
[161,"Lewko, A., et al. (2014). \"Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme.\" Respir Med 108(1): 95-102.",null,"Lewko, A., et al.","Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme","INTRODUCTION: Subjective fatigue has been recognised as an important, multi-component symptom in COPD. Pulmonary Rehabilitation (PR) improves fatigue component of the Chronic Respiratory Questionnaire, a quality of life (QoL) measure. However, it is not clear if all fatigue dimensions are affected equally. This study aims to evaluate changes in subjective multidimensional fatigue among people with COPD who participated in PR. METHODS: Thirty seven stable COPD patients were recruited; 23 patients (15 male) mean age 68.5 (range 49-86) yrs, mean (SD) %predicted FEV1 45.3 (19.8); completed 7 weeks of PR. Assessments (pre and post PR) consisted of the Multidimensional Fatigue Inventory (MFI-20), QoL (SGRQ), Anxiety and Depression (HADS), the London Chest Activity of Daily Living Scale (LCADL), muscle strength, incremental (ISWT) and endurance (ESWT) shuttle walk tests. The differences between pre and post PR fatigue were tested using Wilcoxon's test and relationships with other outcomes were examined using Spearman's correlation. RESULTS: There were statistically significant improvements in Reduced Activity (RA) (p = 0.01), General (GF) (p < 0.01) and Physical Fatigue (PF) (p = 0.03) components of MFI-20 after PR, but there were no differences in Motivation or Mental Fatigue (p > 0.05). There were significant improvements in ISWT (p < 0.05), ESWT (p < 0.01) and muscle strength (p = 0.03). Statistically significant correlations (p < 0.05) were found between changes in GF and in both ISWT (r = -0.43) and SGRQ impact (r = 0.46); and between RA and ESWT changes (r = -0.45). CONCLUSIONS: Some dimensions of fatigue in COPD are modifiable by a 7-week PR programme. Change in fatigue dimensions in COPD may be associated with a change in maximal or endurance walking distances or QoL.","Lewko, A., et al. (2014). \"Evaluation of multidimensional COPD-related subjective fatigue following a pulmonary rehabilitation programme.\" Respir Med 108(1): 95-102.","UK",2014,"Respiratory Disease","None","MFI",null,null,null,"UK",null,"Respiratory Disease","None",null,null,"MFI","2010:2014"]
[162,"Li Voon Chong, J. S., et al. (2000). \"Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects.\" Clin Endocrinol (Oxf) 53(5): 551-559.",null,"Li Voon Chong, J. S., et al.","Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects","OBJECTIVE: In healthy adults the secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) declines with ageing and body composition alters, particularly with an increase in total body fat. In elderly people, hypothalamic-pituitary disease can cause GH deficiency (GHD), compared with age matched controls. This study aimed to clarify whether GHD in the elderly is associated with differences in body composition, circulating lipid levels and quality of life (QOL) compared with control subjects. SUBJECTS: Twenty-seven elderly patients (14 males, mean age 71 years, range 65-83) with hypothalamic-pituitary disorders (23 pituitary tumours) and GHD (mean (SD) peak stimulated GH response 1.6 mIU/l (1.03) range 0.6-5) were studied. Twenty-five patients had been treated surgically (six cranial surgery, 19 transsphenoidal) and eight patients had received external cranial irradiation. Twenty-seven control subjects (14 males, mean age 72 years, range 65-86) were also studied. METHODS: Weight, body mass index (BMI), total fat mass (FM, bioelectrical impedance), waist to hip ratio (WHR), serum IGF-1, fasting blood glucose and lipid profile were measured. QOL was assessed in both groups using five interviewer administered self-rating questionnaires: The Nottingham Health Profile, Short-Form 36, Hospital Anxiety and Depression Scale, Mental Fatigue Questionnaire and Life Fulfilment Scale. The GHD group also completed the Disease Impact Scale. RESULTS: The data (mean (SD)) from males and females were analyzed separately. The male patients had a higher BMI than controls, 28.9(4.5) vs. 25.2(2.3) kg/m2 (P = 0.01) but the BMI in the female patients and controls was similar. In the female patients compared with the controls, FM was higher 39. 4(6) vs. 33.1(8.3) % (P = 0.02), WHR was also higher 0.9(0.08) vs. 0. 83(0.09) (P = 0.03) and serum IGF-1 levels were lower 10.8(6.4) vs. 18.2(6.5) nmol/l (P = 0.01). However, in the male patients, FM, WHR and IGF-1 levels were similar to the controls. Fasting blood glucose was similar in both male and female patients and the controls. Two female patients and one male control subject were taking lipid-lowering agents and were therefore excluded from the analysis of lipid profiles. Total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol and total cholesterol/HDL cholesterol ratio were not significantly different for both male and female patients compared with the controls. The 27 patients with GHD reported significantly less energy (P < 0.05), mobility (P < 0.05) and personal life fulfillment (P < 0.01) than the 27 controls. There were significantly more problems with emotional reaction (P < 0.01), social isolation (P < 0.05) and mental fatigue (P < 0.05). Additionally the GHD group reported more impairment in areas of social functioning (P < 0.05), general health (P < 0.05) and mental health (P < 0.05). The GHD group reported a modest degree of disease impact (mean score of 14.1). There were no significant differences in the domains of material life fulfillment, pain, sleep, physical functioning, vitality, anxiety, depression, self-esteem or role physical functioning compared with the controls. CONCLUSION: Compared with control subjects, the elderly female patients with hypothalamic-pituitary disease and GHD had a significantly higher total fat mass, with the WHR indicating a more central fat distribution and lower female serum IGF-1 levels. In contrast, elderly male patients had similar total fat mass, WHR and IGF-1 levels compared to the controls. There were no significant differences in the lipid profiles between male or female patients compared to controls. However, many of the male patients were receiving androgen replacement which might have influenced these results. Low HDL cholesterol concentrations are probably a better predictor of future cardiovascular disease than raised LDL cholesterol levels in the elderly population and these were similar in patients and controls for both","Li Voon Chong, J. S., et al. (2000). \"Elderly people with hypothalamic-pituitary disease and growth hormone deficiency: lipid profiles, body composition and quality of life compared with control subjects.\" Clin Endocrinol (Oxf) 53(5): 551-559.","UK",2000,"Endocrine","None","MFQ",null,null,null,"UK",null,"Endocrine","None",null,null,"MFQ","2000:2004"]
[163,"Li Voon Chong, J. S., et al. (2002). \"Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls.\" Clin Endocrinol (Oxf) 56(2): 175-181.",null,"Li Voon Chong, J. S., et al.","Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls","OBJECTIVE: Elderly patients with GH deficiency (GHD) have significant impairments in multiple aspects of quality of life (QOL) but similar lipid profiles compared to age-matched control subjects. There are, however, no data on changes in these parameters with time. This study assessed the impact of untreated GHD over a period of 2 years in a group of elderly patients with hypothalamic-pituitary disease in relation to new illnesses and differences in body composition, circulating lipid profile levels and QOL. Control subjects were also followed for 2 years. SUBJECTS: Twenty-seven elderly patients (> 65 years) with hypothalamic-pituitary disorders and GHD (mean peak stimulated GH response 1.6 mIU/l, range 0.6--5.0) were studied initially. Two years later 21 (13 males) agreed to attend for reassessment. Mean age was then 72.7 +/- 5.04 years (range 67--85). Eighteen patients had pituitary tumours, three had craniopharyngiomas. Twenty-seven control subjects were studied at baseline and 17 (7 males) agreed to attend for reassessment. Mean age was then 75.9 +/- 6.97 years (range 67--88). METHODS: Weight, body mass index (BMI), total fat mass (FM) (bioelectrical impedance), serum IGF-1 and fasting lipid profile (total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol) were measured. QOL was assessed in both groups using five interviewer-administered self-rating questionnaires: the Nottingham Health Profile, Short Form-36, Hospital Anxiety and Depression Scale, Mental Fatigue Questionnaire and Life Fulfillment Scale. The GHD group also completed the Disease Impact Scale. RESULTS: Two of the 27 patients with GHD died during the 2-year follow-up (myocardial infarction and probable cerebrovascular accident). Four controls could not be traced but there were no deaths in the other 23. In the 21 GHD patients after 2 years, mean serum IGF-1 and BMI were unchanged (12.6 +/- 5.8 vs. 13.3 +/- 5.1 nmol/l, P = 0.5 and 28.3 +/- 4.3 vs. 29.1 +/- 4.2, P = 0.5, respectively) at the 2-year follow-up and there were no significant changes in the lipid profiles. However, there was a significant reduction in fat mass (31.7 +/- 11.2 vs. 28.5 +/- 10.9%, P = 0.04). In the 17 control subjects after 2 years, serum IGF-1 levels (17.2 +/- 4.0 vs. 15.7 +/- 5.6 nmol/l, P = 0.4), BMI and fat mass were unchanged. However, there was a significant fall in total cholesterol levels over the 2-year follow-up (6.3 +/- 0.9 vs. 5.7 +/- 0.9 mmol/l, P < 0.0001), although LDL cholesterol, triglycerides and HDL cholesterol were unchanged. Analysing the QOL data, the GHD patients had less energy (P < 0.05), more depression (P < 0.05), more pain (P < 0.05) and lower life fulfillment scores (P < 0.01) after 2 years. However, the control subjects also had less energy (P < 0.05), less vitality (P < 0.05) and lower self-esteem (P < 0.05), more depression (P < 0.05), worse mental health (P < 0.05), life fulfillment personal (P < 0.01), life fulfillment material (P < 0.02), physical functioning and role physical functioning (P < 0.05) after 2 years. Comparing the patients and controls at baseline, there were significant differences in IGF-1, BMI, FM, LDL cholesterol, personal life fulfillment, mental fatigue, general health and mental health. However, after 2 years, only BMI and depression scores were significantly different. CONCLUSION: These patients with untreated GHD did not have deterioration of body composition or lipid profiles when reassessed after a period of 2 years. In fact, fat mass fell. The control subjects did have a significant decrease in total cholesterol but no change in other lipids or body composition. Some quality of life domains did deteriorate in the patients with GHD. However, the control subjects also had worse quality of life scores after 2 years which were then little different from the GHD patients. These results raise doubts about the benefits of GH replacement in elderly people with GHD.","Li Voon Chong, J. S., et al. (2002). \"Elderly people with hypothalamic-pituitary disease and untreated GH deficiency: clinical outcome, body composition, lipid profiles and quality of life after 2 years compared to controls.\" Clin Endocrinol (Oxf) 56(2): 175-181.","UK",2002,"Endocrine","None","MFQ",null,null,null,"UK",null,"Endocrine","None",null,null,"MFQ","2000:2004"]
[164,"Liu, C. H., et al. (2016). \"Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study.\" J Ethnopharmacol 194: 954-962.",null,"Liu, C. H., et al.","Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study","BACKGROUND AND PURPOSE: Astragalus membranaceus (AM) is the first-choice herb for fatigue treatment in traditional Chinese medicine and the main herb used for stroke treatment in China and Taiwan. The purpose of this study was to evaluate the effect of AM on poststroke fatigue (PSF). MATERIALS AND METHODS: This study was designed as a double-blind, randomized, controlled preliminary study. Sixty-four patients with PSF were assigned to treatment group (TG; 31 patients), which received oral administration of AM (2.8g three times per day) for 28 days, and a control group (CG; 33 patients), which received a placebo. The primary outcome measures were the changes in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Brief Fatigue Index (BFI) scores RESULTS: A total of 61 patients (29 patients in the TG and 32 patients in the CG) completed the trial. The difference in BFI scores between Visit 2 and Visit 1 was -17.83+/-17.70 in the TG, which was greater than that in the CG (-8.03+/-9.95; p=0.01); additionally, the difference in BFI scores between Visit 3 and Visit 1 was -16.48+/-16.41 in the TG, which was also greater than that in the CG (-9.47+/-13.39; p=0.05). In the EORTC QLQ-C30, the difference in cognitive functioning scores between Visit 2 and Visit 1 was 14.37+/-13.89 in the TG, which was greater than that in the CG (3.65+/-19.74; p=0.02); additionally, the difference in these scores between Visit 3 and Visit 1 was 14.37+/-16.50 in the TG, which again was greater than that in the CG (6.25+/-19.74; p=0.04). The difference in social functioning scores between Visit 3 and Visit 1 was 9.77+/-15.12 in the TG, which was greater than that in the CG (-1.56+/-20.46; p=0.01). The difference in global quality of life (QOL) scores between Visit 2 and Visit 1 was 14.08+/-18.78 in the TG, which was also greater than that in the CG (1.56+/-18.14; p=0.003); moreover, the difference in these scores between Visit 3 and Visit 1 was 10.92+/-17.55 in the TG, and this was greater than that in the CG (1.82+/-15.8; p=0.05). CONCLUSION: AM can improve BFI scores; cognitive functioning, social functioning, and global QOL scores in the EORTC QLQ-C30. Our results suggest that physicians should pay close attention to the unmet medical needs of patients with PSF. AM is helpful for treating patients with PSF; however, additional studies with a larger sample and a longer period of investigation are required.","Liu, C. H., et al. (2016). \"Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study.\" J Ethnopharmacol 194: 954-962.","Taiwan",2016,"CVD","Complementary","BFI",null,null,null,"Taiwan",null,"CVD","Complementary",null,null,"BFI","2015:2018"]
[165,"Lobentanz, I. S., et al. (2004). \"Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality.\" Acta Neurol Scand 110(1): 6-13.",null,"Lobentanz, I. S., et al.","Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality","OBJECTIVES: In a series of 504 patients with multiple sclerosis (MS), quality of life (QOL) and its main clinical and demographic determinants were assessed in comparison with healthy individuals. MATERIALS AND METHODS: A postal questionnaire with self-completed measures of disability (Expanded Disability Status Scale, EDSS), QOL (Quality of Life Index, QLI), depressive mood (Self-rating Depression Scale, SDS), fatigue severity (Fatigue Severity Scale, FSS) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) was sent to this sample of MS patients. RESULTS: Most patients were severely disabled; almost half were mildly to severely depressed, suffering from reduced sleep quality and/or fatigue. The multiple sclerosis patients had significantly lower QLI scores than healthy controls. EDSS and SDS scores were found to be predictors of global QLI score. Regarding the different QLI domains, mean SDS scores remained predictive for all QLI items, while mean EDSS, PSQI and FSS scores were only predictive for physical domains. CONCLUSION: Our study clearly demonstrates that depressive mood is the main factor influencing QOL. The disability status, fatigue and reduced sleep quality have an impact mainly on physical domains of life quality.","Lobentanz, I. S., et al. (2004). \"Factors influencing quality of life in multiple sclerosis patients: disability, depressive mood, fatigue and sleep quality.\" Acta Neurol Scand 110(1): 6-13.","Austria",2004,"Neurological","None","FSS",null,null,null,"Austria",null,"Neurological","None",null,null,"FSS","2000:2004"]
[166,"Lorentzen, K., et al. (2014). \"Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus.\" Dan Med J 61(4): A4808.",null,"Lorentzen, K., et al.","Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus","INTRODUCTION: Fatigue is a symptom of systemic lupus erythematosus (SLE), which has a substantial effect on the patients' quality of life and is a parameter that is difficult to quantify. The Fatigue Severity Scale (FSS) is a validated and reliable tool for quantifying fatigue. However, no Danish translation has yet been developed or validated. The aim of this study was to translate the FSS from English into Danish and subsequently to test and describe its validity and reliability in Danish SLE patients. MATERIAL AND METHODS: The FSS was translated from English into Danish and then back-translated. The translation agreed upon by medical professionals was tested for construct validity in an unselected group of SLE patients. The final version was tested for content validity, internal consistency and test-retest reliability in a second unselected group of SLE patients using the Danish version of the Short-Form Health Survey (SF-36). All patients included were outpatients with SLE of low to moderate disease activity, and low to moderate organ damage. RESULTS: Correlations were found between the Danish FSS and the main component scores of the SF-36. We found a high Cronbach's alpha as well as acceptable results of the intraclass correlation coefficient and the Bland-Altman plot. CONCLUSION: The Danish FSS translation is a valid and reliable measure of fatigue in the Danish SLE patients included in this study. FUNDING: Anne Voss reported a grant from The Danish Rheumatism Association (R33-A1836) and grants from The A.P. Moller Foundation for the Advancement of Medical Science and finally grants from the Region of South Denmark during the conduct of the study. TRIAL REGISTRATION: not relevant.","Lorentzen, K., et al. (2014). \"Validation of the Fatigue Severity Scale in Danish patients with systemic lupus erythematosus.\" Dan Med J 61(4): A4808.","Denmark",2014,"Inflamatory Systemic Disease","None","FSS",null,null,null,"Denmark",null,"Inflamatory Systemic Disease","None",null,null,"FSS","2010:2014"]
[167,"Lucas-Carrasco, R., et al. (2011). \"Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders.\" Neurodegener Dis 8(4): 178-186.",null,"Lucas-Carrasco, R., et al.","Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders","BACKGROUND/AIMS: Neurodegenerative disorders (ND) have a major impact on quality of life (QoL) and place a substantial burden on patients, their families and carers; they are the second leading cause of disability. The objective of this study was to examine QoL in persons with ND. METHODS: A battery of subjective assessments was used, including the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF) and the World Health Organization Quality of Life - Disability (WHOQOL-DIS). Psychometric properties of the WHOQOL-BREF and WHOQOL-DIS were investigated using classical psychometric methods. RESULTS: Participants (n = 149) were recruited and interviewed at two specialized centers to obtain information on health and disability perceptions, depressive symptoms (Hospital Anxiety and Depression Scale - Depression, HADS-D), Fatigue Assessment Scale (FAS), Satisfaction with Life (SWL), generic QoL (WHOQOL-BREF, WHOQOL-DIS), specific QoL (Multiple Sclerosis Impact Scale, MSIS-29; Parkinson's Disease Questionnaire, PDQ-39) and sociodemographics. Internal consistency was acceptable, except for the WHOQOL-BREF social (0.67). Associations, using Pearson's and Spearman's rho correlations, were confirmed between WHOQOL-BREF and WHOQOL-DIS with MSIS-29, PDQ-39, HADS-D, FAS and SWL. Regarding 'known group' differences, Student's t tests showed that WHOQOL-BREF and WHOQOL-DIS scores significantly discriminated between depressed and nondepressed and those perceiving a more severe impact of the disability on their lives. CONCLUSION: This study is the first to report on use of the WHOQOL-BREF and WHOQOL-DIS in Spanish persons with ND; they are promising useful tools in assessing persons with ND through the continuum of care, as they include important dimensions commonly omitted from other QoL measures.","Lucas-Carrasco, R., et al. (2011). \"Using the WHOQOL-DIS to measure quality of life in persons with physical disabilities caused by neurodegenerative disorders.\" Neurodegener Dis 8(4): 178-186.","Spain",2011,"Neurological","None","FAS",null,null,null,"Spain",null,"Neurological","None",null,null,"FAS","2010:2014"]
[168,"Luckett, T., et al. (2010). \"Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change.\" Int J Gynecol Cancer 20(4): 664-684.",null,"Luckett, T., et al.","Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change","OBJECTIVES: Researchers wishing to assess the health-related quality of life (HRQoL) of women with gynecologic cancers have a range of questionnaires to choose from. In general, disease-, treatment-, or symptom-specific questionnaires are assumed to be better able to identify between-group differences (sensitivity) and changes over time (responsiveness) than are cancer-specific or generic questionnaires. However, little work has tested this assumption in oncology. We set out to (a) identify all multidimensional HRQoL questionnaires used in studies with women with gynecologic cancer and (b) evaluate their track records in identifying minimal clinically important differences (MCIDs), with a view to making recommendations. METHODS: We searched MEDLINE using the term quality of life and each gynecologic cancer type, as well as the names of identified questionnaires. We used 10% of the scale range as the threshold for an MCID. RESULTS: We identified 1 generic (SF-36/SF-12), 3 cancer-specific (European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ] C30, Functional Assessment of Cancer Therapy-General [FACT-G], and short-form Cancer Rehabilitation Evaluation System [CARES-SF]), and 1 disease-specific (QOL-Ovarian Cancer Patient Version) HRQoL questionnaires and 5 disease-specific (QLQ-OV28, FACT-O for ovarian, QLQ-CX24, FACT-Cx for cervical and FACT-V for vulvar), 1 treatment-specific (FACT and Gynecologic Oncology Group-Ntx for neurotoxicity), and 2 symptom-specific (FACT-Anemia and Functional Assessment of Chronic Illness and Therapy [FACIT]-Fatigue) modules. Twenty-seven articles reported results from 26 studies in which an MCID had been identified. The FACIT's anemia and fatigue subscales were more sensitive, and the neurotoxicity subscale more sensitive and responsive than the FACT-G on at least 1 comparison. However, we found no evidence for superior performance by the FACT-G compared with the SF-36 or EORTC and FACIT disease-specific modules versus the QLQ-C30 and FACT-G. There was also little evidence to favor EORTC versus FACIT questionnaires or vice versa. CONCLUSIONS: The evidence we reviewed offered little support for the hypothesis that disease-, symptom-, or treatment-specific instruments are more sensitive and responsive than cancer-specific or generic questionnaires. However, conclusions were limited by the small number of head-to-head comparisons available. We summarize the clinical contexts in which each instrument identified an MCID to inform choice of questionnaire(s), sample size calculations, and interpretation of results in future studies.","Luckett, T., et al. (2010). \"Assessing health-related quality of life in gynecologic oncology: a systematic review of questionnaires and their ability to detect clinically important differences and change.\" Int J Gynecol Cancer 20(4): 664-684.","Australia",2010,"none","None","FACIT-F",null,null,null,"Australia",null,"None","None",null,null,"FACIT-F","2010:2014"]
[169,"Lund Rasmussen, C., et al. (2015). \"Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.\" Cancer 121(20): 3727-3736.",null,"Lund Rasmussen, C., et al.","Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial","BACKGROUND: Patients with advanced cancer often experience fatigue and other symptoms that negatively impact their quality of life. The current trial investigated the effect of melatonin on fatigue and other symptoms in patients with advanced cancer. METHODS: Patients who were aged >/=18 years, had a histologically confirmed stage IV cancer (TNM Classification), and who reported feeling significantly tired were recruited from the palliative care unit at the study institution. The study was a double-blind, randomized, placebo-controlled crossover trial. Patients received 1 week of melatonin at a dose of 20 mg or a placebo orally each night, before crossing over and receiving the opposite treatment for 1 week. Between the 2 periods, a washout period of 2 days was implemented. Outcomes were measured using the Multidimensional Fatigue Inventory (MFI-20) and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Physical fatigue from the MFI-20 was the primary outcome. The primary analysis was a complete complier analysis (ie, it included only those patients who had consumed at least 5 capsules per week and who had answered the MFI-20 on days 1, 7, 10, and 17). Sensitivity analysis using multiple imputations including all randomized patients and all patients completing the intervention were conducted. RESULTS: A total of 72 patients were randomized. Fifty patients completed the intervention and 44 patients were complete compliers. No significant differences between the placebo and melatonin periods were found for physical fatigue, secondary outcomes, or explorative outcomes. CONCLUSIONS: In the current study, oral melatonin at a dose of 20 mg was not found to improve fatigue or other symptoms in patients with advanced cancer.","Lund Rasmussen, C., et al. (2015). \"Effects of melatonin on physical fatigue and other symptoms in patients with advanced cancer receiving palliative care: A double-blind placebo-controlled crossover trial.\" Cancer 121(20): 3727-3736.","Denmark",2015,"Cancer","Other Drugs","MFI",null,null,null,"Denmark",null,"Cancer","Other Drugs",null,null,"MFI","2015:2018"]
[170,"Ma, H., et al. (2011). \"Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report.\" BMC Complement Altern Med 11: 109.",null,"Ma, H., et al.","Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report","BACKGROUND: It remains unclear whether estrogenic botanical supplement (EBS) use influences breast cancer survivors' health-related outcomes. METHODS: We examined the associations of EBS use with health-related quality of life (HRQOL), with fatigue, and with 15 hormone-related symptoms such as hot flashes and night sweats among 767 breast cancer survivors participating in the Health, Eating, Activity, and Lifestyle (HEAL) Study. HRQOL was measured by the Medical Outcomes Study short form-36 physical and mental component scale summary score. Fatigue was measured by the Revised-Piper Fatigue Scale score. RESULTS: Neither overall EBS use nor the number of EBS types used was associated with HRQOL, fatigue, or hormone-related symptoms. However, comparisons of those using each specific type of EBS with non-EBS users revealed the following associations. Soy supplements users were more likely to have a better physical health summary score (odds ratio [OR] = 1.66, 95% confidence interval [CI] = 1.02-2.70). Flaxseed oil users were more likely to have a better mental health summary score (OR = 1.76, 95% CI = 1.05-2.94). Ginseng users were more likely to report severe fatigue and several hormone-related symptoms (all ORs >/= 1.7 and all 95% CIs exclude 1). Red clover users were less likely to report weight gain, night sweats, and difficulty concentrating (all OR approximately 0.4 and all 95% CIs exclude 1). Alfalfa users were less likely to experience sleep interruption (OR = 0.28, 95% CI = 0.12-0.68). Dehydroepiandrosterone users were less likely to have hot flashes (OR = 0.33, 95% CI = 0.14-0.82). CONCLUSIONS: Our findings indicate that several specific types of EBS might have important influences on a woman's various aspects of quality of life, but further verification is necessary.","Ma, H., et al. (2011). \"Estrogenic botanical supplements, health-related quality of life, fatigue, and hormone-related symptoms in breast cancer survivors: a HEAL study report.\" BMC Complement Altern Med 11: 109.","USA",2011,"Cancer","Complementary","PFS",null,null,null,"USA",null,"Cancer","Complementary",null,null,"PFS","2010:2014"]
[171,"Maddali Bongi, S., et al. (2016). \"Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome.\" Complement Ther Clin Pract 24: 109-115.",null,"Maddali Bongi, S., et al.","Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome","BACKGROUND: Fibromyalgia Syndrome (FMS) is characterized by musculoskeletal pain, muscle tenderness leading to disability, impaired quality of life (QoL), fatigue and it is accompanied by sleep disorders and psychological distress. Mind body therapies (MBT), such as Tai Ji Quan (TJQ), use different techniques to facilitate the ability of the mind to influence disease characteristics and symptoms. Some studies showed that TJQ, in patients with rheumatic diseases, particularly FMS, improved QoL, disability and psychological distress. OBJECTIVES: To evaluate the efficacy of TJQ on disability, QoL, fatigue, sleep and psychological distress in an Italian cohort of FMS patients. METHODS: We enrolled 44 FMS patients: 22 patients (Experimental Group) participated to a course of Tai Ji Quan style of (2/week for 16 weeks); 22 patients (Control Group) participated to an educational course about FMS (2/week for 16 weeks). At baseline (T0) and at the end of treatment (T1), patients were assessed for disability [Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ)], Quality of Life [Short-Form 36 (SF36)], fatigue [Functional Assessment of Chronic Illness-Fatigue (FACIT-F)], pain [Widespread Pain Index (WPI)], tenderness [Tender Points (TP)], Sleep Quality [Pittsburgh Sleep Quality Index (PSQI)] and mood disorders [Hospital Anxiety and Depression Scale (HADS)]. RESULTS: At T1 versus T0, patients of the Experimental Group showed a significant improvement in FIQ, FACIT, SF36 (Summary Physical Index, Physical activity, physical role, bodily pain, general health, vitality, emotional role limitations), in WPI, TP, PSQI (total, sleep duration, and sleep disturbance) and HADS (total score and anxiety subscale), while Patients in the Control Group did not improve in any parameter. CONCLUSIONS: In FMS patients TJQ, if performed by an expert physiotherapist, should be regarded as an effective rehabilitation method.","Maddali Bongi, S., et al. (2016). \"Efficacy of rehabilitation with Tai Ji Quan in an Italian cohort of patients with Fibromyalgia Syndrome.\" Complement Ther Clin Pract 24: 109-115.","Italy",2016,"Musculoskeletal","Psychobehavioural","FACIT-F",null,null,null,"Italy",null,"Musculoskeletal","Psychobehavioural",null,null,"FACIT-F","2015:2018"]
[172,"Malik, I. A., et al. (2003). \"Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects.\" Clin Endocrinol (Oxf) 59(1): 75-81.",null,"Malik, I. A., et al.","Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects","OBJECTIVE: There are few studies of quality of life (QOL) in adults with growth hormone deficiency (GHD) compared to matched control populations without GHD. These have shown impairments in a variety of QOL measures, which improve but do not normalize after short-term replacement with GH. There is little information on QOL in long-term treated GHD patients compared with controls without GHD. PATIENTS AND METHODS: A total of 120 adults with GHD who had received GH replacement for at least 1 year were identified from the neuroendocrine clinic. Patients were asked to complete eight QOL questionnaires and an Energy Visual Analogue Scale (VAS). Results were compared with 83 control subjects without GHD from the local population who agreed to complete seven of the QOL questionnaires (excluding Disease Impact scale) and the energy VAS. The eight questionnaires were a combination of generic and disease-specific questionnaires used to assess health related QOL, namely: Short Form-36 (SF-36), Nottingham Health Profile (NHP), Disease Impact, Life Fulfilment and Satisfaction scales, Mental Fatigue Questionnaire (MFQ) and Self Esteem scale, Hospital Anxiety Depression (HAD) scale and QOL-AGHDA (assessment of GHD in adults). RESULTS: Eighty-nine patients returned questionnaires and 85 (71%) had complete data for analysis. The mean (SD) duration of GH replacement was 36.0 +/- 26.4 (range 13-159) months. Mean age was 43.9 +/- 15.8 years (37 males) in treated GHD patients compared to a mean age 41.7 +/- 10.5 years (32 males) in the controls. Mean IGF-1 levels were 22.5 +/- 13.6 nmol/l in the GHD patients and the mean dose of GH replacement was 1.2 +/- 0.4 IU daily. Analysis of the QOL questionnaires from the GH treated patients revealed highly significant impairments in all measures (most P </= 0.0001, except life fulfilment-material, P = 0.33) compared to the control population. CONCLUSIONS: This large population with treated GH deficiency have significant impairments in multiple aspects of QOL despite replacement with GH and other pituitary hormones for at least 1 year (mean 3 years). It is likely therefore that other factors in addition to GH deficiency must influence QOL in these patients. Further strategies to improve QOL in these individuals should therefore be considered, e.g. psychological support and treatments and physical treatments (such as exercise programmes).","Malik, I. A., et al. (2003). \"Assessment of quality of life in adults receiving long-term growth hormone replacement compared to control subjects.\" Clin Endocrinol (Oxf) 59(1): 75-81.","UK",2003,"Endocrine","Various","MFQ",null,null,null,"UK",null,"Endocrine","Various",null,null,"MFQ","2000:2004"]
[173,"Maric, D., et al. (2014). \"Multivitamin mineral supplementation in patients with chronic fatigue syndrome.\" Med Sci Monit 20: 47-53.",null,"Maric, D., et al.","Multivitamin mineral supplementation in patients with chronic fatigue syndrome","BACKGROUND: Chronic fatigue syndrome (CFS) is characterized by medically unexplained persistent or reoccurring fatigue lasting at least 6 months. CFS has a multifactorial pathogenesis in which oxidative stress (OS) plays a prominent role. Treatment is with a vitamin and mineral supplement, but this therapeutic option so far has not been properly researched. MATERIAL AND METHODS: This prospective study included 38 women of reproductive age consecutively diagnosed by CDC definition of CFS and treated with a multivitamin mineral supplement. Before and after the 2-month supplementation, SOD activity was determined and patients self-assessed their improvement in 2 questionnaires: the Fibro Fatigue Scale (FFS) and the Quality of Life Scale (SF36). Results There was a significant improvement in SOD activity levels; and significant decreases in fatigue (p=0.0009), sleep disorders (p=0.008), autonomic nervous system symptoms (p=0.018), frequency and intensity of headaches (p=0.0001), and subjective feeling of infection (p=0.0002). No positive effect on quality of life was found. CONCLUSIONS: Treatment with a vitamin and mineral supplement could be a safe and easy way to improve symptoms and quality of life in patients with CFS.","Maric, D., et al. (2014). \"Multivitamin mineral supplementation in patients with chronic fatigue syndrome.\" Med Sci Monit 20: 47-53.","Serbia",2014,"Chronic Fatigue","Complementary","FFS",null,null,null,"Serbia",null,"Chronic Fatigue","Complementary",null,null,"FFS","2010:2014"]
[174,"Martinez-Martin, P., et al. (2006). \"Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS).\" Qual Life Res 15(4): 597-606.",null,"Martinez-Martin, P., et al.","Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS)","The Fatigue Impact Scale for Daily Use (D-FIS) was used in a cross-sectional study including 142 consecutive Parkinson's disease (PD) patients. Usual clinical measures for PD, the Montgomery-Asberg Depression Rating Scale and the Parkinson's Disease Questionnaire-8 items were applied. In addition to the D-FIS, patients with fatigue (67.6%, PWF) completed the Multidimensional Fatigue Inventory (MFI), a visual analogue scale for fatigue (VAS-F) and a Global Perception of Fatigue scale (GPF). Relevant psychometric D-FIS results were: floor effect = 4.2%; ceiling effect = 1.1%; skewness = 0.44; item homogeneity = 0.63; Cronbach's alpha = 0.93; item-total correlation = 0.68 (item 1)-0.82 (item 8); standard error of measurement = 2.15; convergent validity with other fatigue measures = 0.54 [GPF]-0.62 [VAS-F] (p<0.001). In a multiple linear regression model, fatigue, depression, and disability independently influenced HRQoL, as measured by the PDQ-8. Patients on amantadine had lower prevalence of fatigue. In PD, D-FIS is a consistent and valid measure for fatigue, a frequent symptom previously found to impair patients' HRQoL. Fatigue was also linked to depression and disability in this study.","Martinez-Martin, P., et al. (2006). \"Impact of fatigue in Parkinson's disease: the Fatigue Impact Scale for Daily Use (D-FIS).\" Qual Life Res 15(4): 597-606.","Spain",2006,"Neurological","None","DFIS,VAS-F,MFI,GFS",null,null,null,"Spain",null,"Neurological","None",null,null,"DFIS,VAS-F,MFI,GFS","2005:2009"]
[175,"Mateen, F. J., et al. (2017). \"Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial.\" Medicine (Baltimore) 96(36): e8037.",null,"Mateen, F. J., et al.","Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial","BACKGROUND: Fatigue is the most commonly reported symptom among multiple sclerosis (MS) patients, more than a quarter of whom consider fatigue to be their most disabling symptom. However, there are few effective treatment options for fatigue. We aim to investigate whether supplemental exposure to bright white light will reduce MS-associated fatigue. METHODS: Eligible participants will have clinically confirmed multiple sclerosis based on the revised McDonald criteria (2010) and a score >/=36 on the Fatigue Severity Scale (FSS). Participants will be randomized 1:1 to bright white light (10,000 lux; active condition) or dim red light (<300 lux; control condition) self-administered for 1 hour twice daily. The study will include a 2-week baseline period, a 4-week treatment period, and a 4-week washout period. Participants will record their sleep duration, exercise, caffeine, and medication intake daily. Participants will record their fatigue using the Visual Analogue Fatigue Scale (VAFS) 4 times every third day, providing snapshots of their fatigue level at different times of day. Participants will self-report their fatigue severity using FSS on 3 separate visits: at baseline (week 0), following completion of the treatment phase (week 6), and at study completion (week 10). The primary outcome will be the change in the average FSS score after light therapy. We will perform an intention-to-treat analysis, comparing the active and control groups to assess the postintervention difference in fatigue levels reported on FSS. Secondary outcome measures include change in global VAFS scores during the light therapy and self-reported quality of life in the Multiple Sclerosis Quality of Life-54. DISCUSSION: We present a study design and rationale for randomizing a nonpharmacological intervention for MS-associated fatigue, using bright light therapy. The study limitations relate to the logistical issues of a self-administered intervention requiring frequent participant self-report in a relapsing condition. Ultimately, light therapy for the treatment of MS-associated fatigue may provide a low-cost, noninvasive, self-administered treatment for one of the most prevalent and burdensome symptoms experienced by people with MS.","Mateen, F. J., et al. (2017). \"Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial.\" Medicine (Baltimore) 96(36): e8037.","USA",2017,"Neurological","Various","FSS,VAS-F",null,null,null,"USA",null,"Neurological","Various",null,null,"FSS,VAS-F","2015:2018"]
[176,"Mathiowetz, V. G., et al. (2005). \"Randomized controlled trial of an energy conservation course for persons with multiple sclerosis.\" Mult Scler 11(5): 592-601.",null,"Mathiowetz, V. G., et al.","Randomized controlled trial of an energy conservation course for persons with multiple sclerosis","OBJECTIVE: To assess the short-term efficacy and effectiveness of a six-week energy conservation course on fatigue impact, quality of life and self-efficacy for persons with multiple sclerosis (MS). METHODS: In this randomized controlled trial, we randomly assigned 169 persons with MS to an immediate intervention group or a delayed control group using a crossover design. The outcome measures: Fatigue Impact Scale, SF-36 Health Survey and Self-Efficacy for Performing Energy Conservation Strategies were measured before and after courses and no intervention control periods. We performed intent-to-treat analysis and compliers-only analyses using mixed effects analysis of variance models. RESULTS: Taking the energy conservation course had significant effects on reducing the physical and social subscales of Fatigue Impact Scale and on increasing the Vitality subscale of the SF-36 scores compared with not taking the course. Additional subscales were significant depending on methods of analyses. Self-Efficacy for Performing Energy Conservation Strategies Assessment increased significantly (P <0.05) postcourse compared to precourse. CONCLUSIONS: Results support the efficacy and effectiveness of the energy conservation course to decrease fatigue impact, and to increase self-efficacy and some aspects of quality of life.","Mathiowetz, V. G., et al. (2005). \"Randomized controlled trial of an energy conservation course for persons with multiple sclerosis.\" Mult Scler 11(5): 592-601.","USA",2005,"Neurological","None","FIS",null,null,null,"USA",null,"Neurological","None",null,null,"FIS","2005:2009"]
[177,"Matza, L. S., et al. (2011). \"Development and validation of a patient-report measure of fatigue associated with depression.\" J Affect Disord 134(1-3): 294-303.",null,"Matza, L. S., et al.","Development and validation of a patient-report measure of fatigue associated with depression","INTRODUCTION: Among researchers and clinicians who treat depression, there is growing interest in treatment of specific residual symptoms such as fatigue. However, there is no available measure that provides a detailed assessment of fatigue associated with depression. Thus, the purpose of the current study was to develop and validate a patient-reported outcome measure designed to assess depression-related fatigue and its impact. METHODS: The Fatigue Associated with Depression Questionnaire (FAsD) was developed based on literature review, clinician interviews, and focus groups and cognitive debriefing interviews with patients. Then, a draft questionnaire was administered to a sample of patients with depression. Statistical analysis first focused on item reduction and subscale identification, followed by psychometric evaluation of the FAsD. RESULTS: The per protocol sample (n = 317) was primarily female (68.1%), with a mean age of 47.0 years. Based on item performance and exploratory factor analysis, three items were dropped from the draft FAsD, yielding a final 13-item questionnaire with two subscales (experience and impact). The FAsD demonstrated good internal consistency reliability (Cronbach's alphas >/= 0.88) and test-retest reliability (intraclass correlation coefficients >/= 0.78). The FAsD demonstrated construct validity through strong correlations with measures assessing fatigue/energy and symptoms of depression. The FAsD also discriminated among groups of participants differentiated by clinician ratings of global severity of depression (CGI-S). LIMITATIONS: Limitations include heterogeneity of current treatments received by the sample, as well as lack of knowledge regarding the extent to which FAsD scores were influenced by patients' treatments rather than the depression itself. CONCLUSIONS: In this initial psychometric evaluation, the FAsD demonstrated good reliability, validity, and factor structure. This questionnaire may be a useful tool for evaluating treatment interventions that focus specifically on fatigue associated with depression.","Matza, L. S., et al. (2011). \"Development and validation of a patient-report measure of fatigue associated with depression.\" J Affect Disord 134(1-3): 294-303.","USA",2011,"Mental Health","None","FAsD",null,null,null,"USA",null,"Mental Health","None",null,null,"FAsD","2010:2014"]
[178,"Maurer, M., et al. (2016). \"Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies.\" Mult Scler Relat Disord 7: 33-40.",null,"Maurer, M., et al.","Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies","BACKGROUND: Two pivotal phase 3 teriflunomide studies provided data on relapses, fatigue, and health-related quality of life (HRQoL) in patients with relapsing forms of multiple sclerosis (MS). OBJECTIVES: Using pooled data from the TEMSO (NCT00134563) and TOWER (NCT00751881) studies, we investigated the association between relapse severity, and changes from baseline to Week 108 in fatigue and HRQoL outcomes. METHODS: Four definitions of relapse severity were applied in this analysis: sequelae post-relapse; relapse leading to hospitalization; relapse requiring intravenous corticosteroids; and intense relapse. We assessed the association between relapse severity and changes in Fatigue Impact Scale score (n=959), physical and mental health component summary scores from the Short Form (SF)-36 questionnaire (n=904), and SF-6D utility index scores (n=820). RESULTS: Irrespective of the definition of relapse severity applied, in patients experiencing severe relapse(s), fatigue was increased and HRQoL was decreased; these changes were statistically significant (p<0.0001), and were also clinically significant in many cases. The greatest worsening in fatigue and HRQoL was observed in patients with relapses leading to hospitalization. CONCLUSIONS: Given that severe relapses adversely affect patient-reported fatigue and HRQoL, prevention of severe relapses should be an important therapeutic aim in the treatment of patients with MS.","Maurer, M., et al. (2016). \"Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies.\" Mult Scler Relat Disord 7: 33-40.","Germany",2016,"Neurological","None","FIS",null,null,null,"Germany",null,"Neurological","None",null,null,"FIS","2015:2018"]
[179,"McKenna, S. P., et al. (2010). \"International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS).\" Value Health 13(8): 946-951.",null,"McKenna, S. P., et al.","International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS)","BACKGROUND: The Patient-Reported Indices for Multiple Sclerosis (PRIMUS) comprises a suite of three scales for assessing symptoms, activity limitations, and quality of life in multiple sclerosis (MS). It was developed in the UK and has been shown to have excellent psychometric properties. This study describes the adaptation of eight language versions for Canadian English, Canadian French, French, German, Italian, Spanish, Swedish, and US English. METHODS: The PRIMUS was translated using the dual-panel process. Cognitive debriefing interviews conducted with MS patients assessed face and content validity. Psychometric and scaling properties were assessed via a two-administration postal survey conducted in each country involving the PRIMUS, the Nottingham Health Profile (NHP), the Unidimensional Fatigue Impact Scale (U-FIS), and demographic questions. RESULTS: Cognitive debriefing interviews demonstrated the acceptability of the new language versions. Analysis of survey data showed that the new language versions of the three PRIMUS scales were unidimensional (as indicated by fit to the Rasch model) and that they had good internal consistency and reproducibility. PRIMUS scale scores correlated as expected with those on the NHP and the U-FIS. The scales in all countries were able to discriminate between groups of patients on the basis of their self-reported MS severity, general health, and employment status. CONCLUSIONS: The PRIMUS was successfully adapted into eight new languages. Most of the tests showed the PRIMUS to have good unidimensionality and to have good internal consistency, reproducibility, and construct validity. The measure is now available for use in clinical studies and trials involving these countries and the UK. Further work is required to assess the measure's responsiveness.","McKenna, S. P., et al. (2010). \"International development of the patient-reported outcome indices for multiple sclerosis (PRIMUS).\" Value Health 13(8): 946-951.","UK",2010,"Neurological","None","U-FIS",null,null,null,"UK",null,"Neurological","None",null,null,"U-FIS","2010:2014"]
[180,"Mease, P. J., et al. (2008). \"Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial.\" J Rheumatol 35(1): 20-30.",null,"Mease, P. J., et al.","Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial","OBJECTIVE: To evaluate the effect of rituximab treatment on health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA), who have had an inadequate response to disease-modifying antirheumatic drugs, including biologic agents. METHODS: A randomized, multicenter, double-blind, placebo-controlled clinical trial involving 367 rheumatoid factor-positive patients was conducted. Patients received 2 infusions 2 weeks apart of placebo (n = 122), rituximab 500 mg (n = 123), or rituximab 1000 mg (n = 122), with or without glucocorticoids. All patients received stable doses of methotrexate (10 25 mg/wk). Measures included SF-36, assessed at baseline and at 24 weeks, as well as the HAQ and FACIT-Fatigue scale assessed at baseline and monthly for 24 weeks. Patients exceeding prespecified minimal clinically important differences (MCID) were examined. Clinical efficacy measurements (ACR20/50/70 and EULAR responses) were compared with HRQOL outcomes. RESULTS: At 24 weeks, the rituximab 500 mg and 1000 mg groups both reported statistically significantly greater improvements on the SF-36 physical component summary (4.37 and 4.89 points higher, respectively, vs placebo; p < 0.001). SF-36 physical function, bodily pain, vitality, social function, and role-physical subscale scores also statistically significantly improved vs placebo. At 24 weeks, 62.6% and 67.2% of the rituximab 500 mg and 1000 mg groups, respectively, exceeded the MCID of 0.22 in HAQ (p < 0.001). For FACIT-Fatigue, 55.3% and 65.6% of patients exceeded the MCID of 3.5 points compared with 35.2% of placebo over 24 weeks (p < 0.001). ACR20/50/70 and EULAR responders demonstrated greater improvements in mean baseline to 24 week changes in SF-36 and FACIT-Fatigue scores compared with nonresponders (p < 0.05). CONCLUSION: Both rituximab doses in combination with methotrexate were effective in improving all HRQOL outcomes in patients with active RA consistent with clinical efficacy.","Mease, P. J., et al. (2008). \"Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial.\" J Rheumatol 35(1): 20-30.","USA",2008,"Musculoskeletal","Rituximab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Rituximab",null,null,"FACIT-F","2005:2009"]
[181,"Meeske, K., et al. (2007). \"Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report.\" Qual Life Res 16(6): 947-960.",null,"Meeske, K., et al.","Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report","PURPOSE: The purpose of this study was to estimate prevalence of fatigue, identify correlates of fatigue and evaluate the relationship between fatigue and health-related quality of life (HRQOL) in a large cohort of disease-free breast cancer survivors. METHODS: Participants are enrolled in the HEAL Study, a multi-center prospective study of women diagnosed with in-situ to Stage IIIA breast cancer. HEAL participants (n = 1183) completed a baseline and a 24-month follow-up interview. Women in this report (n = 800) also completed a quality of life questionnaire that included the Piper Fatigue Scale and the RAND SF-36 two to five years after diagnosis. Multivariate regression methods were used to identify significant factors associated with fatigue. SF-36 scores for fatigued survivors were compared to non-fatigued survivor scores and population norms. RESULTS: Forty-one percent of the breast cancer survivors were fatigued. Significant correlates of fatigue included pain, cognitive problems, physical inactivity, weight gain/personal appearance and antidepressant use. Fatigue was associated with poorer HRQOL, most notably in areas of role and social functioning. CONCLUSION: This study provides further support for the conclusion that a significant proportion of breast cancer survivors experience fatigue that compromises HRQOL two to five years post-diagnosis.","Meeske, K., et al. (2007). \"Fatigue in breast cancer survivors two to five years post diagnosis: a HEAL Study report.\" Qual Life Res 16(6): 947-960.","USA",2007,"Cancer","None","PFS",null,null,null,"USA",null,"Cancer","None",null,null,"PFS","2005:2009"]
[182,"Mehnert, A., et al. (2007). \"The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy.\" Patient Educ Couns 66(1): 108-118.",null,"Mehnert, A., et al.","The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy","OBJECTIVE: The possible association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life has been studied in high-risk breast cancer survivors 5 years following standard adjuvant (n=23) versus high-dose chemotherapy (n=24) and in early-stage breast cancer patients (n=29) (comparison group) following radiation therapy. METHODS: A neuropsychological assessment covering attention, memory and executive functions was used together with the questionnaire for self-perceived deficits in attention (FEDA), the multidimensional fatigue inventory (MFI-20) and the EORTC-QLQ-C30. RESULTS: Findings have shown that neuropsychological impairment is not directly associated with self-perceived cognitive deficits, fatigue and HRQOL. However, 46% of patients reported self-perceived cognitive deficits and 82% of the patients complained about cancer related fatigue. Except for reduced activity we did not find significant group differences, even though patients who received standard-dose chemotherapy had consistently higher levels of self-perceived cognitive deficits and fatigue, and the lowest HRQOL. CONCLUSION: Results emphasize the need for psychosocial counseling and support during treatment phase and follow up care as well. Sensitive cancer-specific measures for the assessment of self-perceived cognitive deficits in different cognitive domains according to neuropsychological measurements are required. PRACTICE IMPLICATIONS: The role of self-perceived cognitive deficits and fatigue should be considered in educational interventions and counseling. Specific rehabilitation measures should be developed, implemented and evaluated in order to meet the needs of these patients and to decrease the frequency of cognitive deficits following cancer treatment.","Mehnert, A., et al. (2007). \"The association between neuropsychological impairment, self-perceived cognitive deficits, fatigue and health related quality of life in breast cancer survivors following standard adjuvant versus high-dose chemotherapy.\" Patient Educ Couns 66(1): 108-118.","Germany",2007,"Cancer","None","MFI",null,null,null,"Germany",null,"Cancer","None",null,null,"MFI","2005:2009"]
[183,"Meneses-Echavez, J. F., et al. (2015). \"Supervised exercise reduces cancer-related fatigue: a systematic review.\" J Physiother 61(1): 3-9.",null,"Meneses-Echavez, J. F., et al.","Supervised exercise reduces cancer-related fatigue: a systematic review","QUESTION: Does supervised physical activity reduce cancer-related fatigue? DESIGN: Systematic review with meta-analysis of randomised trials. PARTICIPANTS: People diagnosed with any type of cancer, without restriction to a particular stage of diagnosis or treatment. INTERVENTION: Supervised physical activity interventions (eg, aerobic, resistance and stretching exercise), defined as any planned or structured body movement causing an increase in energy expenditure, designed to maintain or enhance health-related outcomes, and performed with systematic frequency, intensity and duration. OUTCOME MEASURES: The primary outcome measure was fatigue. Secondary outcomes were physical and functional wellbeing assessed using the Functional Assessment of Cancer Therapy Fatigue Scale, European Organisation for Research and Treatment of Cancer Quality of Life QUESTIONnaire, Piper Fatigue Scale, Schwartz Cancer Fatigue Scale and the Multidimensional Fatigue Inventory. Methodological quality, including risk of bias of the studies, was evaluated using the PEDro Scale. RESULTS: Eleven studies involving 1530 participants were included in the review. The assessment of quality showed a mean score of 6.5 (SD 1.1), indicating a low overall risk of bias. The pooled effect on fatigue, calculated as a standardised mean difference (SMD) using a random-effects model, was -1.69 (95% CI -2.99 to -0.39). Beneficial reductions in fatigue were also found with combined aerobic and resistance training with supervision (SMD=-0.41, 95% CI -0.70 to -0.13) and with combined aerobic, resistance and stretching training with supervision (SMD=-0.67, 95% CI -1.17 to -0.17). CONCLUSION: Supervised physical activity interventions reduce cancer-related fatigue. These findings suggest that combined aerobic and resistance exercise regimens with or without stretching should be included as part of rehabilitation programs for people who have been diagnosed with cancer. REGISTRATION: PROSPERO CRD42013005803.","Meneses-Echavez, J. F., et al. (2015). \"Supervised exercise reduces cancer-related fatigue: a systematic review.\" J Physiother 61(1): 3-9.","Spain",2015,"Cancer","Psychobehavioural","FACT-F,PFS,MFI,Schwartz Cancer-FS",null,null,null,"Spain",null,"Cancer","Psychobehavioural",null,null,"FACT-F,PFS,MFI,Schwartz Cancer-FS","2015:2018"]
[184,"Meng, H., et al. (2014). \"Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial.\" BMC Fam Pract 15: 184.",null,"Meng, H., et al.","Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial","BACKGROUND: Fatigue is a common yet difficult to treat condition in primary care. The objective of this study is to evaluate the cost-effectiveness of a brief cognitive behavioral therapy (CBT) based fatigue self-management (FSM) intervention as compared to usual care among patients with chronic fatigue in primary care. METHODS: An economic evaluation alongside of a parallel randomized controlled study design was used. Computer-generated variable-sized block randomization plan was used to assign patients into treatment groups and data collection staff were blinded to group assignments. Patients aged between 18 and 65 years with at least six months of persistent fatigue and no medical or psychiatric exclusions were enrolled from a large primary care practice in Stony Brook, New York. The FSM group (n = 37) received two sessions of a nurse-delivered, fatigue self-management protocol and a self-help book and the usual care group (n = 36) received regular medical care. The effectiveness measure was the Fatigue Severity Scale and the cost measure was total health care expenditures derived from monthly health services use diaries during follow-up. A societal perspective was adopted and bootstrapped incremental cost-effectiveness ratios (ICERs) and net monetary benefit (NMB) were calculated as measures of cost-effectiveness. RESULTS: The ICER for FSM was -$$2358, indicating that FSM dominates UC and it may generate societal cost savings as compared to usual care. Complete case analysis yielded smaller ICER (-$1199) with greater uncertainties. Net monetary benefit analysis showed that FSM has a probability of 0.833 (95% CI: 0.819, 0.847) to achieve positive NMB and the favorable results were not sensitive to assumptions about informal care or treatment costs. CONCLUSION: This economic evaluation found initial evidence that a two-session brief CBT-based FSM may be cost-effective as compared to usual care over 12 months. The FSM intervention is potentially a promising intervention for chronic fatigue patients in primary care. Additional research is needed to examine the reproducibility and generalizability of these findings. TRIAL REGISTRATION: ClinicalTrials.gov (NCT00997451, March 28, 2009).","Meng, H., et al. (2014). \"Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial.\" BMC Fam Pract 15: 184.","Unknown",2014,"Chronic Fatigue","None","FSS",null,null,null,"Unknown",null,"Chronic Fatigue","None",null,null,"FSS","2010:2014"]
[185,"Merritta, C., et al. (2010). \"Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury.\" Int J Rehabil Res 33(2): 109-114.",null,"Merritta, C., et al.","Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury","The aims of this study were to objectively measure the physical performance and physical endurance of patients with traumatic brain injury with minimization of cognitive and psychological fatigue, and to compare the physical performance of brain injured patients with that of healthy controls. This was a nonrandomized partially blinded controlled study. The study setting was the Outpatient Multidisciplinary Brain Injury Clinic in the Department of Physical Medicine and Rehabilitation of a tertiary care university teaching hospital. Participants included an experimental group that comprised independently ambulant men (age 18-55 years) with mild-to-moderate traumatic brain injury (n = 24) who complained of greater fatigue than before their injury and an age-matched and sex-matched control group (n = 24). The intervention included the Six-Minute Walk Test. The primary outcome measures were the Six-Minute Walk Distance, the Fatigue Severity Scale, Addenbrooke's Cognitive Examination, and the Fatigue Visual Numeric Scale; the secondary outcome measures were the Physiological Cost Index of Walking and the Borg Scale of Perceived Exertion. The Six-Minute Walk Distance of the experimental group (452.33+/-68.816) when compared with that of the control group (518.08+/-92.114) was reduced by 12.7 and 30.5%, respectively, when compared with the predicted Six-Minute Walking Distance (650.04+/-79.142) for the same age and sex. The mean Fatigue Severity Scale values were 2.51 and 1.62 for the experimental and control groups, respectively. The mean Addenbrooke's Cognitive Examination Score for the patients was 85.5+/-7.265. In conclusion, the Six-Minute Walk Test is useful in segregating physical fatigue from cognitive and psychological aspects of fatigue when cognitive and psychological dimensions are known. The Six-Minute Walk Test can be used as a tool for exercise intensity prescription in men with mild-to-moderate brain injury, to avoid the deleterious effects of fatigue.","Merritta, C., et al. (2010). \"Measurement of physical performance and objective fatigability in people with mild-to-moderate traumatic brain injury.\" Int J Rehabil Res 33(2): 109-114.","India",2010,"Neurological","None","FSS,VAS-F",null,null,null,"India",null,"Neurological","None",null,null,"FSS,VAS-F","2010:2014"]
[186,"Mesa, R. A., et al. (2013). \"Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial.\" J Clin Oncol 31(10): 1285-1292.",null,"Mesa, R. A., et al.","Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial","PURPOSE: To assess the effects of ruxolitinib on symptom burden and quality of life (QoL) and to evaluate the ability of the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 to measure meaningful changes in myelofibrosis-related symptoms in patients with myelofibrosis. PATIENTS AND METHODS: COMFORT-I (Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment-I) is a double-blind, placebo-controlled phase III study evaluating ruxolitinib in patients with intermediate-2 or high-risk myelofibrosis. Exploratory analyses were conducted on the following patient-reported outcomes (PROs) assessments: modified MFSAF v2.0 (individual symptoms and Total Symptom Score [TSS]), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, and Patient Global Impression of Change (PGIC). RESULTS: Patients receiving ruxolitinib experienced improvements in individual myelofibrosis-related symptoms, although patients receiving placebo experienced worsening (P < .001). The majority (91%) of ruxolitinib-treated patients designated as >/= 50% TSS responders (>/= 50% TSS improvement) self-reported their condition as either \"Much improved\" or \"Very much improved\" on the PGIC. These patients achieved significant improvements in the EORTC QLQ-C30 functional domains and Global Health Status/QoL versus patients receiving placebo, who experienced worsening on these measures (P </= .0135). Ruxolitinib-treated patients with a lesser degree of symptom improvement (< 50% TSS responders) also achieved improvements over placebo on these measures. The degree of spleen volume reduction with ruxolitinib correlated with improvements in TSS, PGIC, PROMIS Fatigue Scale, and EORTC Global Health Status/QoL. Ruxolitinib-treated patients who achieved a >/= 35% reduction in spleen volume experienced the greatest improvements in these PROs. CONCLUSION: Ruxolitinib-treated patients achieved clinically meaningful improvements in myelofibrosis-related symptoms and QoL, but patients receiving placebo reported worsening of symptoms and other PROs.","Mesa, R. A., et al. (2013). \"Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial.\" J Clin Oncol 31(10): 1285-1292.","USA",2013,"Hematological","Ruxolitinib","PROMIS-F",null,null,null,"USA",null,"Hematological","Ruxolitinib",null,null,"PROMIS-F","2010:2014"]
[187,"Milbury, K., et al. (2014). \"Randomized controlled trial of expressive writing for patients with renal cell carcinoma.\" J Clin Oncol 32(7): 663-670.",null,"Milbury, K., et al.","Randomized controlled trial of expressive writing for patients with renal cell carcinoma","PURPOSE: This randomized controlled trial examined the quality-of-life benefits of an expressive writing (EW) intervention for patients with renal cell carcinoma (RCC) and identified a potential underlying mechanism of intervention efficacy. PATIENTS AND METHODS: Patients (N = 277) with stage I to IV RCC were randomly assigned to write about their deepest thoughts and feelings regarding their cancer (EW) or about neutral topics (neutral writing [NW]) on four separate occasions. Patients completed the Center for Epidemiologic Studies Depression Scale (CES-D), MD Anderson Symptom Inventory (MDASI), Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), Medical Outcomes Study Short Form-36 (SF-36), and Impact of Event Scale (IES) at baseline and 1, 4, and 10 months after the intervention. RESULTS: The mean age of participants (28% stage IV; 41% female) was 58 years. Multilevel modeling analyses, using a Bonferroni-corrected alpha = .021 for six outcomes adjusted for the correlation among outcomes, revealed that, relative to the NW group, patients in the EW group reported significantly lower MDASI scores (P = .003) and higher physical component summary scores on the SF-36 (P = .019) at 10 months after the intervention. Mediation analyses revealed that significant group differences for MDASI scores at 10 months were mediated by lower IES scores at 1 month after the intervention in the EW group (P = .042). No significant group differences were observed in the BFI, CES-D, PSQI, and mental component summary of the SF-36. CONCLUSION: EW may reduce cancer-related symptoms and improve physical functioning in patients with RCC. Evidence suggests that this effect may occur through short-term improvements in cognitive processing.","Milbury, K., et al. (2014). \"Randomized controlled trial of expressive writing for patients with renal cell carcinoma.\" J Clin Oncol 32(7): 663-670.","USA",2014,"Cancer","Psychobehavioural","BFI",null,null,null,"USA",null,"Cancer","Psychobehavioural",null,null,"BFI","2010:2014"]
[188,"Miller, C. M., et al. (2016). \"The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study.\" Ann Hematol 95(12): 2049-2055.",null,"Miller, C. M., et al.","The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study","Postpartum anemia has been associated with postpartum morbidities, such as depression and poor cognition. However, it is unclear whether postpartum anemia is associated with reduced health-related quality of life. We performed a prospective study to examine the relations between postpartum Hb levels with postpartum health-related quality of life (HRQoL). We collected data from 60 women intending vaginal delivery and assessed HRQoL and maternal fatigue on admission and on the first postpartum day using the RAND 36-Item Short-Form Health Survey (SF-36) and the Multidimensional Fatigue Inventory (MFI), respectively. Maternal Hb levels were measured on admission and on the first postpartum day. We also assessed patients for postpartum depression using the Edinburgh Postpartum Depression Scale (EPDS). We performed unadjusted and multivariate linear regression (adjusting for maternal age, parity, mode of delivery, and race) to assess the associations between postdelivery Hb with each subscale of the SF-36 and MFI. The mean predelivery and postpartum Hb levels were 12.3 (1.2) and 10.8 (1.4) g/dl, respectively. In our unadjusted and adjusted regression analyses, we observed no statistically significant associations between postpartum Hb levels with any SF-36 or MFI subscale (P > 0.05). Based on the EPDS, only one patient was depressed; her postpartum Hb was 11.2 g/dl. Our findings suggest that postpartum Hb levels may not influence HRQoL or fatigue. However, our findings may only apply to women without predelivery anemia, severe blood loss or moderate-to-severe anemia after delivery. Future studies are needed to determine whether postpartum Hb influences HRQoL among women with moderate or severe postpartum anemia.","Miller, C. M., et al. (2016). \"The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study.\" Ann Hematol 95(12): 2049-2055.","USA",2016,"Various","None","MFI",null,null,null,"USA",null,"Various","None",null,null,"MFI","2015:2018"]
[189,"Minderhoud, I. M., et al. (2003). \"High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency.\" Am J Gastroenterol 98(5): 1088-1093.",null,"Minderhoud, I. M., et al.","High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency","OBJECTIVES: Inflammatory bowel disease (IBD) patients, with active as well as quiescent disease, frequently complain of fatigue. This often has consequences for patients' work and daily lives. The primary aim of this study was to assess the prevalence and severity of fatigue in IBD patients in remission. Furthermore, we studied the correlation between fatigue and disease activity, quality of life, and biochemical and hematological test results, and the role of (secondary) hypocortisolism. METHODS: Eighty subjects with proven IBD were included. Disease activity was assessed using the Clinical Activity Index for Ulcerative Colitis and the Crohn's Disease Activity Index. Quality of life was measured by the Inflammatory Bowel Disease Questionnaire, and fatigue was assessed using the Multidimensional Fatigue Inventory (MFI). Routine biochemical and hematological tests were performed, and basal cortisol was determined. To evaluate adrenocortical reserve in subjects with a cortisol level of <0.4 micromol/L, a low dose adrenocorticotrophin hormone test was performed. Healthy age- and sex-matched subjects (n = 67) served as controls. RESULTS: More than 40% of the IBD patients in remission suffered from fatigue. Mean MFI scores of the IBD patients were comparable to mean MFI scores reported in cancer patients. The Inflammatory Bowel Disease Questionnaire showed a negative correlation with the MFI (r = -0.735; p < 0.001). No correlation was found between fatigue and basal cortisol levels or other laboratory parameters. CONCLUSION: Fatigue is an important feature in IBD in remission, adversely affecting the quality of life. It does not, however, affect all patients, nor does it seem to be the result of hypocortisolism.","Minderhoud, I. M., et al. (2003). \"High prevalence of fatigue in quiescent inflammatory bowel disease is not related to adrenocortical insufficiency.\" Am J Gastroenterol 98(5): 1088-1093.","Netherlands",2003,"Gastrointestinal","None","MFI",null,null,null,"Netherlands",null,"Gastrointestinal","None",null,null,"MFI","2000:2004"]
[190,"Mittendorf, T., et al. (2007). \"Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis.\" J Rheumatol 34(12): 2343-2350.",null,"Mittendorf, T., et al.","Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis","OBJECTIVE: In patients with longstanding severe rheumatoid arthritis (RA) receiving chronic treatment with adalimumab, health related quality of life (HRQOL) was assessed using new instruments [Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) and Health Utilities Index Mark 3 (HUI3)] and a more conventional instrument [Medical Outcomes Study Short Form-36 Health Survey (SF-36)]. METHODS: Different measures for collecting patient-reported outcomes were applied simultaneously during the 3-year study period. Sociodemographic and medical history data were assessed at the baseline visit. Clinical examinations (e.g., joint examination and morning stiffness), disease assessments, and HRQOL data were recorded every 8 weeks. For dichotomous and categorical variables, absolute and relative frequencies were calculated. Metric measures were described using mean and standard deviation and/or standard error of the mean. HRQOL data were analyzed using observed cases. RESULTS: All assessed measures (FACIT-Fatigue, HUI3, SF-36) showed a rapid and statistically significant improvement from baseline following initiation of adalimumab therapy. This effect was maintained over the study period for a mean of 1.6 years in all applied measures. HRQOL data from all tested instruments were significantly correlated with each other. CONCLUSION: Chronic therapy with adalimumab improved measures of fatigue and HRQOL in patients with longstanding RA.","Mittendorf, T., et al. (2007). \"Improvement and longterm maintenance of quality of life during treatment with adalimumab in severe rheumatoid arthritis.\" J Rheumatol 34(12): 2343-2350.","Germany",2007,"Musculoskeletal","None","FACIT-F",null,null,null,"Germany",null,"Musculoskeletal","None",null,null,"FACIT-F","2005:2009"]
[191,"Mkacher, W., et al. (2015). \"Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES.\" J Cardiopulm Rehabil Prev 35(4): 278-285.",null,"Mkacher, W., et al.","Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES","PURPOSE: Balance impairment in chronic obstructive pulmonary disease (COPD) is associated with a worsening of quality of life (QOL) as related with fatigue perception, depression, and anxiety. The aim of this study was to examine the effect of balance training included in pulmonary rehabilitation (PR) on QOL, fatigue perception, depression, and anxiety in patients with COPD. METHODS: Patients were assigned randomly to an intervention or PR-only group. The intervention group underwent balance training 3 times a week for 6 months concurrently with PR. The PR-only group received 6 months of the standard PR program. Quality of life was assessed at the beginning and at the end of the program using the St. George's Respiratory Questionnaire, fatigue using the Multidimensional Fatigue Inventory, and anxiety and depression using the Hospital Anxiety and Depression Scale. Exercise tolerance was determined from the 6-minute walk test. RESULTS: After the 6 months of the intervention or PR-only, both the intervention (n = 32) and PR-only (n = 30) groups improved their QOL (activity, impact, and total) with a significant intergroup difference (P < .05) after PR. General fatigue, physical fatigue, and reduced activity decreased in both groups with an intergroup difference (P < .05). Anxiety decreased significantly in both groups with a greater change in the intervention group (P < .01). Only the intervention group had an improved depression score at the end of 6 months. CONCLUSIONS: Balance training added to PR improved health-related QOL, fatigue, and mental health in patients with COPD.","Mkacher, W., et al. (2015). \"Balance Training in Pulmonary Rehabilitation: EFFECTS ON PSYCHOSOCIAL OUTCOMES.\" J Cardiopulm Rehabil Prev 35(4): 278-285.","Tunisia",2015,"Respiratory Disease","Psychobehavioural","MFI",null,null,null,"Tunisia",null,"Respiratory Disease","Psychobehavioural",null,null,"MFI","2015:2018"]
[192,"Montano-Pedroso, J. C., et al. (2016). \"Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial.\" Trials 17: 196.",null,"Montano-Pedroso, J. C., et al.","Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial","BACKGROUND: Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients. METHODS/DESIGN: In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1:1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications. DISCUSSION: This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post-bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ .","Montano-Pedroso, J. C., et al. (2016). \"Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial.\" Trials 17: 196.","Brazil",2016,"Hematological","Other Drugs","FACIT-F",null,null,null,"Brazil",null,"Hematological","Other Drugs",null,null,"FACIT-F","2015:2018"]
[193,"Moraska, A. R., et al. (2010). \"Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.\" J Clin Oncol 28(23): 3673-3679.",null,"Moraska, A. R., et al.","Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial","PURPOSE: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. PATIENTS AND METHODS: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. RESULTS: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. CONCLUSION: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.","Moraska, A. R., et al. (2010). \"Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.\" J Clin Oncol 28(23): 3673-3679.","USA",2010,"Cancer","Other Drugs","BFI",null,null,null,"USA",null,"Cancer","Other Drugs",null,null,"BFI","2010:2014"]
[194,"Mori, F., et al. (2011). \"Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis.\" J Neurol 258(7): 1281-1287.",null,"Mori, F., et al.","Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis","Exercise therapy (ET) can be beneficial in disabled multiple sclerosis (MS) patients. Intermittent transcranial magnetic theta burst stimulation (iTBS) induces long-term excitability changes of the cerebral cortex and may ameliorate spasticity in MS. We investigated whether the combination of iTBS and a program of ET can improve motor disability in MS patients. In a double-blind, sham-controlled trial, 30 participants were randomized to three different interventions: iTBS plus ET, sham stimulation plus ET, and iTBS alone. Before and after 2 weeks of treatment, measures of spasticity through the modified Ashworth scale (MAS) and the 88 items Multiple Sclerosis Spasticity Score questionnaire (MSSS-88), fatigue through the Fatigue Severity Scale (FSS), daily living activities (ADL) through the Barthel index and health-related quality of life (HRQoL) through the 54 items Multiple Sclerosis Quality of life inventory (MSQoL-54) were collected. iTBS plus ET reduced MAS, MSSS-88, FSS scores, while in the Barthel index and MSQoL-54, physical composite scores were increased. iTBS alone caused a reduction of the MAS score, while none of the measured scales showed significant changes after sham iTBS plus ET. iTBS associated with ET is a promising tool for motor rehabilitation of MS patients.","Mori, F., et al. (2011). \"Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis.\" J Neurol 258(7): 1281-1287.","Italy",2011,"neurological","Various","FSS",null,null,null,"Italy",null,"Neurological","Various",null,null,"FSS","2010:2014"]
[195,"Morrison, E. H., et al. (2008). \"Ratings of perceived exertion during aerobic exercise in multiple sclerosis.\" Arch Phys Med Rehabil 89(8): 1570-1574.",null,"Morrison, E. H., et al.","Ratings of perceived exertion during aerobic exercise in multiple sclerosis","OBJECTIVE: To compare ratings of perceived exertion (RPEs) during aerobic exercise in people with multiple sclerosis (MS) and control participants. DESIGN: Prospective experimental study. SETTING: An exercise testing laboratory. PARTICIPANTS: Sedentary adults (n=12) with mild MS (Expanded Disability Status Scale score < or = 3) aged 30 to 45 years and sedentary age-matched and sex-matched controls (n=12). INTERVENTIONS: All participants underwent a graded aerobic exercise test on a cycle ergometer with breath-by-breath gas measurements and continuous heart rate monitoring. MAIN OUTCOME MEASURES: After completing the Modified Fatigue Impact Scale, participants rated their effort sense every 30 seconds during exercise using the modified Borg 10-point scale. RESULTS: The 2 study groups showed similar baseline characteristics except for higher fatigue scores in the MS group. There were no significant differences for any fitness measure, including oxygen cost slope (in VO(2) x min(-1) x W(-1)), VO(2), or work rate during exercise. Neither heart rate nor RPE--measured at 25%, 50%, 75%, and 100% of VO(2)peak--differed between groups. CONCLUSIONS: Despite greater reported fatigue levels, participants with MS showed similar RPE and physiologic responses to submaximal and maximal exercise compared with controls. In MS, the Borg 10-point scale may help improve evidence-based exercise prescriptions, which otherwise may be limited by fatigue, motor impairment, heat sensitivity, or autonomic dysfunction.","Morrison, E. H., et al. (2008). \"Ratings of perceived exertion during aerobic exercise in multiple sclerosis.\" Arch Phys Med Rehabil 89(8): 1570-1574.","USA",2008,"neurological","Psychobehavioural","MFI",null,null,null,"USA",null,"Neurological","Psychobehavioural",null,null,"MFI","2005:2009"]
[196,"Mostert, S. and J. Kesselring (2005). \"Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial.\" Mult Scler 11(3): 302-305.",null,"Mostert, S. and J. Kesselring","Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial","Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue severity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The 'Magnetic Cell Regeneration' system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3-4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and control group (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session which 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high 'placebo effect' of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.","Mostert, S. and J. Kesselring (2005). \"Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis--a randomized controlled trial.\" Mult Scler 11(3): 302-305.","Switzerland",2005,"neurological","Various","VAS-F,FSS",null,null,null,"Switzerland",null,"Neurological","Various",null,null,"VAS-F,FSS","2005:2009"]
[197,"Mrowietz, U., et al. (2015). \"Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.\" J Eur Acad Dermatol Venereol 29(6): 1114-1120.",null,"Mrowietz, U., et al.","Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study","BACKGROUND: Pruritus is a clinically important symptom of psoriasis that has a major impact on quality of life (QoL). OBJECTIVE: The objective of this study was to examine pruritus and QoL in patients with moderate-to-severe psoriasis treated with etanercept (ETN) in the PRISTINE clinical trial. METHODS: Patients were randomized (1 : 1, double-blind) to ETN 50 mg QW or 50 mg BIW for 12 weeks, followed by 50 mg QW for 12 weeks. Pruritus was reported as 0 (no itching) to 5 (severe itching). Associations were examined between pruritus and Psoriasis Area and Severity Index, Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Screening (HADS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Euro-Qol 5D (EQ-5D) and Medical Outcomes Study (MOS) Sleep Index II. RESULTS: At baseline, patients (n = 270) had a mean pruritus level of 3.6. Itching (level >/=1) was reported by 96% of patients, 62% of whom had severe itching (level >/=4) and 26% had the highest level of itching. DLQI, HADS-Anxiety, HADS-Depression, FACIT-Fatigue, EQ-5D visual analog scale, and MOS Sleep Index II were significantly associated with itch. At week 12, mean pruritus improvement in the ETN BIW/QW group was greater than in the QW/QW group (2.4 vs. 1.6, P < 0.001), but not at week 24 (2.2 vs. 2.0, P = 0.180). Patients with the most severe itching at baseline (score of 5) had a mean score of 1.7 at week 24. Overall, patients with clinically meaningful pruritus improvement at week 24 reported greater improvement in QoL measures than other patients. CONCLUSION: Most patients with moderate-to-severe psoriasis in this study (96%) reported pruritus. Pruritus improved significantly with ETN therapy and was strongly associated with improvements in QoL. These data support the clinical relevance of pruritus as an important symptom of patients with moderate/severe psoriasis.","Mrowietz, U., et al. (2015). \"Pruritus and quality of life in moderate-to-severe plaque psoriasis: post hoc explorative analysis from the PRISTINE study.\" J Eur Acad Dermatol Venereol 29(6): 1114-1120.","USA",2015,"Inflamatory Systemic Disease","Etanercept","FACIT-F",null,null,null,"USA",null,"Inflamatory Systemic Disease","Etanercept",null,null,"FACIT-F","2015:2018"]
[198,"Murdock, K. W., et al. (2017). \"The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome.\" Qual Life Res 26(4): 913-921.",null,"Murdock, K. W., et al.","The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome","PURPOSE: Debilitating fatigue is a core symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); however, the utility of patient-reported symptom outcome measures of fatigue for ME/CFS patients is problematic due to ceiling effects and issues with reliability and validity. We sought to evaluate the performance of three patient-reported symptom measures in a sample of ME/CFS patients and matched controls. METHODS: Two hundred and forty ME/CFS patients and 88 age, sex, race, and zip code matched controls participated in the study. Participants completed the Multidimensional Fatigue Inventory-20, DePaul Symptom Questionnaire, and RAND SF-36. RESULTS: The general and physical fatigue subscales on Multidimensional Fatigue Inventory-20, as well as the role of physical health on the RAND SF-36, demonstrated questionable or unacceptable internal consistency and problematic ceiling effects. The DePaul Symptom Questionnaire demonstrated excellent internal reliability, and less than 5 % of participants were at the ceiling on each subscale. The post-exertional malaise subscale on the DePaul Symptom Questionnaire demonstrated excellent clinical utility as it was able to differentiate between ME/CFS patients and controls (OR 1.23, p < .001) and predicted ceiling effects on other patient-reported outcome subscales. A score of 20 on the post-exertional malaise subscale of the DePaul Symptom Questionnaire optimally differentiated between patients and controls. CONCLUSIONS: Significant ceiling effects and concerns with reliability and validity were observed among Multidimensional Fatigue Inventory-20 and RAND SF-36 subscales for ME/CFS patients. The DePaul Symptom Questionnaire addresses a number of concerns typically identified when using patient-reported outcome measures with ME/CFS patients; however, an improved multidimensional patient-reported outcome tool for measuring ME/CFS-related symptoms is warranted.","Murdock, K. W., et al. (2017). \"The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome.\" Qual Life Res 26(4): 913-921.","USA",2017,"Chronic Fatigue","None","MFI",null,null,null,"USA",null,"Chronic Fatigue","None",null,null,"MFI","2015:2018"]
[199,"Murray, D., et al. (2014). \"Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates.\" Physiother Theory Pract 30(4): 229-235.",null,"Murray, D., et al.","Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates","PURPOSE: Polio survivors experience declining mobility, pain and fatigue. The extent of motor fatigue and its impact on mobility and quality of life, in addition to other commonly reported impairments requires evaluation. METHODS: An observational, case-control, cross-sectional design was used to assess 30 Polio survivors and 30 age- and sex-matched controls. Muscle strength and motor fatigue were assessed using fixed dynamometry. Fatigue, pain and quality of life were assessed using the Piper Fatigue Scale, the Fatigue Severity Scale, visual analogue scales and the RAND Short Form-36, respectively. An 8-min walking test, including physiological cost index (PCI), evaluated mobility. RESULTS: A significant difference in motor fatigue was identified only in hand grip (p = 0.03). Polio survivors were significantly weaker (p < 0.001) and more fatigued (p < 0.001) than controls. Motor fatigue was not related to subjective fatigue, mobility or quality of life. Muscle strength predicted mobility. Pain and fatigue were associated with lower mental quality of life, while PCI was associated with physical quality of life. CONCLUSION: Motor fatigue has been identified in Polio survivors but was only significantly different in hand grip, using this approach. Pain, fatigue and elevated energy cost of walking negatively influenced quality of life. Motor fatigue was unrelated to subjective fatigue, mobility or quality of life.","Murray, D., et al. (2014). \"Assessment of subjective and motor fatigue in Polio survivors, attending a Postpolio clinic, comparison with healthy controls and an exploration of clinical correlates.\" Physiother Theory Pract 30(4): 229-235.","Ireland",2014,"Neurological","None","PFS,FSS,VAS-F",null,null,null,"Ireland",null,"Neurological","None",null,null,"PFS,FSS,VAS-F","2010:2014"]
[200,"Murray, D., et al. (2012). \"The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial.\" BMC Neurol 12: 157.",null,"Murray, D., et al.","The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial","BACKGROUND: Many Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group. METHODS/DESIGN: This is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax) aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised. DISCUSSION: The efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study will provide information, which at present is lacking, on safety of aerobic exercise in Polio, as potential negative outcomes of activity including loss of muscle strength, increased pain and fatigue will be closely monitored.","Murray, D., et al. (2012). \"The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial.\" BMC Neurol 12: 157.","Ireland",2012,"Neurological","Psychobehavioural","FSS",null,null,null,"Ireland",null,"Neurological","Psychobehavioural",null,null,"FSS","2010:2014"]
[201,"Naegeli, A. N., et al. (2013). \"The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS).\" Health Qual Life Outcomes 11: 192.",null,"Naegeli, A. N., et al.","The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS)","BACKGROUND: Ankylosing spondylitis (AS) is an autoimmune disorder characterized by inflammation of the spine and large joints. Fatigue is a common symptom that many AS patients find significantly impacts their health-related quality of life. The Worst Fatigue - Numeric Rating Scale (WF-NRS) assesses the severity of this symptom during the previous 24-hour period. The objective of this study was to perform qualitative research to support the development and content validity of the WF-NRS. METHODS: Patients with AS were recruited from clinical sites in the U.S. for a qualitative study which first entailed concept elicitation interviews to gain understanding of the patients' experience with AS and fatigue. Subsequently, cognitive debriefing interviews were undertaken to assess the understandability, clarity, and appropriateness from the patient's perspective, of the content of a measure of fatigue severity. RESULTS: Thirteen patients with AS participated in concept elicitation interviews and cognitive debriefing of the Brief Fatigue Inventory (BFI) fatigue severity subscale. The WF-NRS was developed from the worst fatigue item of the BFI as patients generally reported it to be understandable and covered an important concept, the completion instructions were modified, but the response scale remained as it was familiar and readily completed, and the recall period was appropriate. CONCLUSIONS: Patient responses resulted in the development of and supported the content validity of the WF-NRS. Further quantitative evaluation of the WF-NRS is warranted in order to assess its psychometric properties and confirm its usefulness as a clinical trial tool.","Naegeli, A. N., et al. (2013). \"The patient experience with fatigue and content validity of a measure to assess fatigue severity: qualitative research in patients with ankylosing spondylitis (AS).\" Health Qual Life Outcomes 11: 192.","USA",2013,"musculoskeletal","None","BFI",null,null,null,"USA",null,"Musculoskeletal","None",null,null,"BFI","2010:2014"]
[202,"Neuzillet, C., et al. (2015). \"Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.\" Trials 16: 454.",null,"Neuzillet, C., et al.","Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial","BACKGROUND: Exercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). We aim to evaluate the effects of an exercise intervention in this setting. METHODS: This randomized, national, multicenter, interventional study will examine the effectiveness of an unsupervised, home-based, 16-week adapted physical activity (APA) program. Specificities of advanced PDAC for the implementation of the APA program will be taken into account (healthy volunteer as physical activity partner instead of patient groups, nutritional management). The main inclusion criteria are: patients with histologically confirmed, unresectable PDAC; scheduled for chemotherapy; performance status 0-2; age >/= 18; and physical activity partner. In total, 200 patients will be randomized into either the APA program (aerobic and resistance exercises) in addition to usual care (including chemotherapy at the investigator's choice), or usual care. The primary objective will be the effect on fatigue (Multidimensional Fatigue Inventory, MFI-20) and HRQoL (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC-QLQ-C30; co-primary endpoint) at week 16. As secondary objectives, the effects of the exercise intervention on pain, anxiety, depression, nutritional status, insulin resistance, tolerance of chemotherapy, survival, and adherence to the APA program will be evaluated. DISCUSSION: Patients with advanced PDAC are strongly affected by fatigue, and are thus likely to benefit from an exercise intervention. Moreover, exercise may have a potential beneficial effect on tumor outcome by reducing insulin resistance and insulin/insulin-like growth factor-1 (IGF-1) secretion. However, an exercise intervention may appear challenging due to multiple PDAC-related symptoms such as fatigue, depression, pain, and denutrition. We hypothesize that an APA program taking into account specific characteristics of PDAC may improve symptoms and HRQoL. If demonstrated to be feasible and effective, such APA programs will be systematically proposed to patients with advanced PDAC in addition to usual care. TRIAL REGISTRATION: ClinicalTrial.gov REGISTRATION NUMBER: NCT02184663 ; Registration date: 2 July 2014.","Neuzillet, C., et al. (2015). \"Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.\" Trials 16: 454.","France",2015,"Cancer","Psychobehavioural","MFI",null,null,null,"France",null,"Cancer","Psychobehavioural",null,null,"MFI","2015:2018"]
[203,"Newman, M. A., et al. (2007). \"Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study.\" Mult Scler 13(1): 113-119.",null,"Newman, M. A., et al.","Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study","Impaired mobility in multiple sclerosis (MS) is associated with high-energy costs and effort when walking, gait abnormalities, poor endurance and fatigue. This repeated measures trial with blinded assessments investigated the effect of treadmill walking at an aerobic training intensity in 16 adults with MS. The intervention consisted of 12 sessions of up to 30 minutes treadmill training (TT), at 55-85% of age-predicted maximum heart rate. The primary outcome measure was walking effort, measured by oxygen consumption (mL/kg per metre), during treadmill walking at comfortable walking speed (CWS). Associated changes in gait parameters using the 'Gait-Rite' mat, 10-m time and 2-minute distance, and Fatigue Severity Scale were examined. Following training, oxygen consumption decreased at rest (P = 0.008), CWS increased (P = 0.002), and 10-m times (P = 0.032) and walking endurance (P = 0.020) increased. At increased CWS, oxygen consumption decreased (P = 0.020), with a decreased time spent in stance in the weaker leg (P = 0.034), and a greater stride distance with the stronger leg (P = 0.044). Reported fatigue levels remained the same. Aerobic TT presents the opportunity to alter a motor skill and reduce the effort of walking, whilst addressing cardiovascular de-conditioning, thereby, potentially reducing effort and fatigue for some people with MS.","Newman, M. A., et al. (2007). \"Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study.\" Mult Scler 13(1): 113-119.","UK",2007,"Neurological","Psychobehavioural","FSS",null,null,null,"UK",null,"Neurological","Psychobehavioural",null,null,"FSS","2005:2009"]
[204,"Newton, J. L., et al. (2006). \"Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence.\" Hepatology 44(1): 91-98.",null,"Newton, J. L., et al.","Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence","A significant proportion of patients with primary biliary cirrhosis (PBC) suffer from severe fatigue. The aim of this study was to characterize patterns of daytime sleep in patients with PBC (using both objective and subjective assessment approaches) and to study the association between sleep abnormality and fatigue severity. Fatigue severity was assessed in 48 female subjects with PBC (using a disease-specific quality of life instrument (the PBC-40) and a generic fatigue measure (Fatigue Impact Scale [FIS]) as well as 48 case-matched normal controls. All participants also completed the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS, which assesses daytime hypersomnolence). Objective sleep assessment was performed using accelerometry over 7 days. Global sleep quality assessed by the PSQI was significantly lower in the PBC group compared to controls (P < .0001). ESS scores were significantly higher in patients with PBC than controls (P = .0001), suggesting significantly greater daytime somnolence in the patients with PBC. Objective sleep assessment confirmed that subjects with PBC were sleeping on average almost twice as long as controls during the daytime. Both degree of daytime somnolence (ESS) and actual daytime sleep activity (accelerometry) correlated strongly with fatigue severity in the patient group (r2 = 0.5, P < .0001 and r2 = 0.2, P < .01, respectively). In conclusion, Sleep abnormality, in the form of excessive daytime somnolence, is present in a significant proportion of patients with PBC, with the degree of daytime somnolence correlating strongly with the degree of fatigue. Existing agents effective at reducing daytime somnolence (such as modafinil) hold potential for the treatment of fatigue in PBC.","Newton, J. L., et al. (2006). \"Fatigue in primary biliary cirrhosis is associated with excessive daytime somnolence.\" Hepatology 44(1): 91-98.","UK",2006,"Liver Disease","None","FIS",null,null,null,"UK",null,"Liver Disease","None",null,null,"FIS","2005:2009"]
[205,"Nogueira, I. C., et al. (2017). \"Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer.\" J Bras Pneumol 43(3): 169-175.",null,"Nogueira, I. C., et al.","Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer","Objective:: To evaluate the properties of the Identity-Consequence Fatigue Scale (ICFS) in patients with lung cancer (LC), assessing the intensity of fatigue and associated factors. Methods:: This was a cross-sectional study involving LC patients, treated at a teaching hospital in Brazil, who completed the ICFS. Patients with chronic heart disease (CHD) and healthy controls, matched for age and gender, also completed the scale. Initially, a Brazilian Portuguese-language version of the ICFS was administered to 50 LC patients by two independent interviewers; to test for reproducibility, it was readministered to those same patients. At baseline, the LC patients were submitted to spirometry and the six-minute walk test, as well as completing the Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), and Fatigue Severity Scale (FSS). Inflammatory status was assessed by blood C-reactive protein (CRP) levels. To validate the ICFS, we assessed the correlations of its scores with those variables. Results:: The sample comprised 50 patients in each group (LC, CHD, and control). In the LC group, the intraclass correlation coefficients for intra-rater and inter-rater reliability regarding ICFS summary variables ranged from 0.94 to 0.76 and from 0.94 to 0.79, respectively. The ICFS presented excellent internal consistency, and Bland-Altman plots showed good test-retest reliability. The ICFS correlated significantly with FSS, HADS, and SF-36 scores, as well as with CRP levels. Mean ICFS scores in the LC group differed significantly from those in the CHD and control groups. Conclusions:: The ICFS is a valid, reliable instrument for evaluating LC patients, in whom depression, quality of life, and CRP levels seem to be significantly associated with fatigue. Objetivo:: Avaliar as propriedades da Escala de Identificacao e Consequencias da Fadiga (EICF) em pacientes com cancer de pulmao (CP), analisando a intensidade da fadiga e fatores associados. Metodos:: Estudo transversal com pacientes com CP, atendidos em um hospital-escola no Brasil, que preencheram a EICF. Pacientes com doencas cardiacas cronicas (DCC) e controles saudaveis, pareados por idade e sexo, tambem preencheram a escala. Inicialmente, uma versao brasileira da escala foi aplicada a 50 pacientes com CP por dois entrevistadores independentes; para testar a reprodutibilidade, ela foi reaplicada aos mesmos pacientes. No momento basal, os pacientes com CP realizaram espirometria e teste de caminhada de seis minutos, bem como preencheram a Epworth Sleepiness Scale (ESS), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) e Fatigue Severity Scale (FSS). O estado inflamatorio foi avaliado pelos niveis de proteina C reativa (PCR) no sangue. Para validar a EICF, avaliamos as correlacoes entre as pontuacoes na mesma e essas variaveis. Resultados:: A amostra foi composta por 50 pacientes em cada grupo (CP, DCC e controle). No grupo CP, os coeficientes de correlacao intraclasse para confiabilidade intra e interobservador para as variaveis resumidas da EICF variaram de 0,94 a 0,76 e de 0,94 a 0,79, respectivamente. A EICF apresentou excelente consistencia interna, e as disposicoes graficas de Bland-Altman demonstraram boa confiabilidade teste-reteste. A EICF apresentou correlacoes significativas com as pontuacoes na FSS, HADS e SF-36, bem como com os niveis de PCR. As medias das pontuacoes na EICF do grupo CP diferiram significativamente das dos grupos DCC e controle. Conclusoes:: A EICF e um instrumento valido e confiavel para a avaliacao de pacientes com CP, nos quais depressao, qualidade de vida e niveis de PCR parecem estar significativamente associados a fadiga.","Nogueira, I. C., et al. (2017). \"Assessment of fatigue using the Identity-Consequence Fatigue Scale in patients with lung cancer.\" J Bras Pneumol 43(3): 169-175.","Unknown",2017,"CVD","None","FSS",null,null,null,"Unknown",null,"CVD","None",null,null,"FSS","2015:2018"]
[206,"Noonan, V. K., et al. (2012). \"Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form.\" Qual Life Res 21(7): 1123-1133.",null,"Noonan, V. K., et al.","Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form","PURPOSE: To create cross-walk tables to associate scores for the Modified Fatigue Impact Scale (MFIS) with scores for the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) in persons with Multiple Sclerosis (MS). METHODS: Cross-walk tables were created using equipercentile linking and based on data collected at one time point in a longitudinal study of persons with MS (N = 458). Validation of the tables was conducted using data collected at a subsequent time point (N = 444). Deviations between estimates and actual scores were compared across levels of fatigue. The impact of sample size on the precision of sample mean estimates was evaluated using bootstrapping. RESULTS: Correlations between deviations and fatigue level for the PROMIS Fatigue SF and MFIS were (-0.31) and (-0.30), respectively, indicating moderately greater deviations with lower fatigue scores. Estimated sample means were impacted by sample size. CONCLUSIONS: Cross-walk tables allow data from studies using different measures of fatigue to be combined to achieve larger sample sizes and to compare results. These tables are valid for group-level analyses with sample sizes of 150 or greater.","Noonan, V. K., et al. (2012). \"Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Short Form.\" Qual Life Res 21(7): 1123-1133.","USA",2012,"Neurological","None","PROMIS-F",null,null,null,"USA",null,"Neurological","None",null,null,"PROMIS-F","2010:2014"]
[207,"Nostdahl, T., et al. (2016). \"Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS).\" J Psychosom Res 84: 1-7.",null,"Nostdahl, T., et al.","Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS)","OBJECTIVE: Postoperative fatigue is a common problem after otherwise uncomplicated surgery. It may defer patients from resuming their daily activities and is often reported to be among their most severe symptoms. There are few validated instruments for assessing postoperative fatigue. Our aim was to translate into Norwegian and explore a Short Form of the Identity-Consequences Fatigue Scale; a fatigue questionnaire specifically developed to assess postoperative fatigue. METHODS: The fatigue scale was translated to Norwegian through a forward-backward process, and subsequently validated in a large, mixed surgical population. We performed Principal Component Analyses on the complete 31-item scale and on the 10-item Short Form. The analyses were performed separately on pre- and postoperative data (n=422 and n=315, respectively). RESULTS: The factor analyses confirmed that the translation was valid and revealed three defined dimensions in the 10-item scale. There was no statistically significant difference between means of reported fatigue when measured with the 31- or 10-item scale. Ninety-eight% of change in fatigue from pre- to postoperative status was retained when using the 10-item scale as compared to the 31-item scale. CONCLUSION: The abridged, 10-item Short Form performed equal to the 31-item scale and may replace the complete 31-item ICSF scale in exploring the incidence of pre- and post-operative fatigue.","Nostdahl, T., et al. (2016). \"Postoperative fatigue; translation and validation of a revised 10-item short form of the Identity-Consequence Fatigue Scale (ICFS).\" J Psychosom Res 84: 1-7.","Norway",2016,"none","None","Identity Consequences Fatigue Scale",null,null,null,"Norway",null,"None","None",null,null,"Identity Consequences Fatigue Scale","2015:2018"]
[208,"Oechsle, K., et al. (2014). \"Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial.\" Support Care Cancer 22(1): 63-69.",null,"Oechsle, K., et al.","Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial","PURPOSE: Cancer and its treatment-related side effects induce loss of physical performance. This study evaluated the effects of multimodal aerobic and strength exercises on physical performance in hospitalized cancer patients while receiving myeloablative chemotherapy. METHODS: In this prospective pilot study, 48 evaluable patients were randomly assigned to a training (TG, n = 24) or control (CG, n = 24) group. The TG performed an individually supervised exercise program five times a week with ergometer training and strength exercises for 20 min each during the hospitalization period for chemotherapy. The CG received standard physiotherapy. Physical performance was evaluated using spiroergometry, lung function, and muscle strength testing. Treatment-related side effects were assessed by daily interviews, quality of life by EORTC-QLQ-C30, and fatigue using the Modified Fatigue Impact Scale (MFIS) questionnaire. RESULTS: Physical performance significantly increased in the TG (8.96 +/- 24 W) and decreased in the CG (-7.24 +/- 20 W, p = 0.02). At 2-mmol/ml blood lactate concentration, the TG achieved significantly increased oxygen consumption (p = 0.03) and expiratory minute ventilation (p = 0.04) compared to the CG. Furthermore, physical functioning increased significantly in the TG (p = 0.04). Patients in the TG required less antiemetics (p = 0.01) and experienced significantly less fatigue (p = 0.04), although MFIS analysis was not able to detect this beneficial effect. Patients of the CG displayed higher impairments of cognitive (p = 0.02) and psychosocial function (p = 0.03) after chemotherapy. No adverse events due to the study intervention were observed. CONCLUSIONS: Multimodal exercise has beneficial effects on physical performance, physical functioning, and treatment-related symptoms even during myeloablative chemotherapy. We suggest an enhanced physical activity intervention program during hospitalization of cancer patients.","Oechsle, K., et al. (2014). \"Multimodal exercise training during myeloablative chemotherapy: a prospective randomized pilot trial.\" Support Care Cancer 22(1): 63-69.","Germany",2014,"Cancer","Psychobehavioural","MFI",null,null,null,"Germany",null,"Cancer","Psychobehavioural",null,null,"MFI","2010:2014"]
[209,"Oken, B. S., et al. (2004). \"Randomized controlled trial of yoga and exercise in multiple sclerosis.\" Neurology 62(11): 2058-2064.",null,"Oken, B. S., et al.","Randomized controlled trial of yoga and exercise in multiple sclerosis","OBJECTIVE: To determine the effect of yoga and of aerobic exercise on cognitive function, fatigue, mood, and quality of life in multiple sclerosis (MS). METHODS: Subjects with clinically definite MS and Expanded Disability Status Score less than or equal to 6.0 were randomly assigned to one of three groups lasting 6 months: weekly Iyengar yoga class along with home practice, weekly exercise class using a stationary bicycle along with home exercise, or a waiting-list control group. Outcome assessments performed at baseline and at the end of the 6-month period included a battery of cognitive measures focused on attention, physiologic measures of alertness, Profile of Mood States, State-Trait Anxiety Inventory, Multi-Dimensional Fatigue Inventory (MFI), and Short Form (SF)-36 health-related quality of life. RESULTS: Sixty-nine subjects were recruited and randomized. Twelve subjects did not finish the 6-month intervention. There were no adverse events related to the intervention. There were no effects from either of the active interventions on either of the primary outcome measures of attention or alertness. Both active interventions produced improvement in secondary measures of fatigue compared to the control group: Energy and Fatigue (Vitality) on the SF-36 and general fatigue on the MFI. There were no clear changes in mood related to yoga or exercise. CONCLUSION: Subjects with MS participating in either a 6-month yoga class or exercise class showed significant improvement in measures of fatigue compared to a waiting-list control group. There was no relative improvement of cognitive function in either of the intervention groups.","Oken, B. S., et al. (2004). \"Randomized controlled trial of yoga and exercise in multiple sclerosis.\" Neurology 62(11): 2058-2064.","USA",2004,"Neurological","None","MFI",null,null,null,"USA",null,"Neurological","None",null,null,"MFI","2000:2004"]
[210,"Oken, B. S., et al. (2006). \"Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life.\" Altern Ther Health Med 12(1): 40-47.",null,"Oken, B. S., et al.","Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life","CONTEXT: There are potential benefits of mind-body techniques on cognitive function because the techniques involve an active attentional or mindfulness component, but this has not been fully explored. OBJECTIVE: To determine the effect of yoga on cognitive function, fatigue, mood, and quality of life in seniors. DESIGN: Randomized, controlled trial comparing yoga, exercise, and wait-list control groups. PARTICIPANTS: One hundred thirty-five generally healthy men and women aged 65-85 years. INTERVENTION: Participants were randomized to 6 months of Hatha yoga class, walking exercise class, or wait-list control. Subjects assigned to classes also were asked to practice at home. MAIN OUTCOME MEASURES: Outcome assessments performed at baseline and after the 6-month period included a battery of cognitive measures focused on attention and alertness, the primary outcome measures being performance on the Stroop Test and a quantitative electroencephalogram (EEG) measure of alertness; SF-36 health-related quality of life; Profile of Mood States; Multi-Dimensional Fatigue Inventory; and physical measures related to the interventions. RESULTS: One hundred thirty-five subjects were recruited and randomized. Seventeen subjects did not finish the 6-month intervention. There were no effects from either of the active interventions on any of the cognitive and alertness outcome measures. The yoga intervention produced improvements in physical measures (eg, timed 1-legged standing, forward flexibility) as well as a number of quality-of-life measures related to sense of well-being and energy and fatigue compared to controls. CONCLUSIONS: There were no relative improvements of cognitive function among healthy seniors in the yoga or exercise group compared to the wait-list control group. Those in the yoga group showed significant improvement in quality-of-life and physical measures compared to exercise and wait-list control groups.","Oken, B. S., et al. (2006). \"Randomized, controlled, six-month trial of yoga in healthy seniors: effects on cognition and quality of life.\" Altern Ther Health Med 12(1): 40-47.","USA",2006,"none","Psychobehavioural","MFI",null,null,null,"USA",null,"None","Psychobehavioural",null,null,"MFI","2005:2009"]
[211,"Olson, L. G., et al. (2003). \"A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome.\" Psychosomatics 44(1): 38-43.",null,"Olson, L. G., et al.","A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome","This study determined whether dexamphetamine improved symptoms and quality of life in patients with chronic fatigue syndrome. The setting was a specialized clinic within a tertiary referral hospital. This was a 6-week parallel-group, placebo-controlled trial with random allocation. There was a 2-week dose-adjustment phase and a 4-week stable treatment period. Outcome measures were the Fatigue Severity Scale, the Medical Outcomes Study 36-item Short-Form Health Survey, and two patient-determined outcomes. Ten patients were randomly assigned to dexamphetamine, and 10 were assigned to placebo. Fatigue Severity Scale scores improved in nine of 10 dexamphetamine and four of 10 placebo patients. The change in mean score was statistically significant. There were large but statistically nonsignificant changes in scores for the Short-Form Health Survey domains vitality and physical functioning. Dexamphetamine may be useful in the management of chronic fatigue syndrome; a larger and longer trial is justified by these results.","Olson, L. G., et al. (2003). \"A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome.\" Psychosomatics 44(1): 38-43.","Australia",2003,"Chronic Fatigue","Other Drugs","FSS",null,null,null,"Australia",null,"Chronic Fatigue","Other Drugs",null,null,"FSS","2000:2004"]
[212,"Oncu, J., et al. (2013). \"A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis.\" Rheumatol Int 33(12): 3031-3037.",null,"Oncu, J., et al.","A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis","This study was performed to compare the impact of fatigue on different aspects of quality of life in patients with rheumatoid arthritis (RA) and fibromyalgia syndrome (FM). This study involved subjects with FM (n = 45) and RA (n = 44). Impact of fatigue on physical, cognitive, and psychosocial status was measured with Fatigue Impact Scale (FIS) and health-related quality of life (HRQoL) with the Medical Outcome Study Short Form 36 (SF-36). Multiple regression analyses were used to evaluate impact of fatigue on quality of life by taking into account clinical symptoms and disease activity scores in these two patient groups. Although the severity of fatigue assessed by FSS was the same in FM and RA; according to Fatigue Impact Scale, fatigue has higher impact on cognitive function in FM (mean +/- SD; 28.8 +/- 19.9), and on the other hand, it has higher impact on mainly physical component (mean +/- SD; 26.3 +/- 4.9) in RA. Regarding all the clinical symptoms and disease activity scores, multiple regression models showed that fatigue together with pain affected the HRQoL (SF-36) in both patient groups. Fatigue has different impacts on QoL in FM and RA, respectively. Together with pain, fatigue lead FM patients to see disease as having worse health in terms of mental function, whereas it leads to poor health in terms of physical function in RA.","Oncu, J., et al. (2013). \"A comparison of impact of fatigue on cognitive, physical, and psychosocial status in patients with fibromyalgia and rheumatoid arthritis.\" Rheumatol Int 33(12): 3031-3037.","Turkey",2013,"Musculoskeletal","None","FIS",null,null,null,"Turkey",null,"Musculoskeletal","None",null,null,"FIS","2010:2014"]
[213,"Ong, S. Y., et al. (2015). \"Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).\" BMJ Open 5(8): e008938.",null,"Ong, S. Y., et al.","Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron)","INTRODUCTION: HFE p.C282Y homozygosity is the most common cause of hereditary haemochromatosis. There is currently insufficient evidence to assess whether non-specific symptoms or hepatic injury in homozygotes with moderately elevated iron defined as a serum ferritin (SF) of 300-1000 microg/L are related to iron overload. As such the evidence for intervention in this group is lacking. We present here methods for a study that aims to evaluate whether non-specific symptoms and hepatic fibrosis markers improve with short-term normalisation of SF in p.C282Y homozygotes with moderate elevation of SF. METHODS AND ANALYSIS: Mi-iron is a prospective, multicentre, randomised patient-blinded trial conducted in three centres in Victoria and Queensland, Australia. Participants who are HFE p.C282Y homozygotes with SF levels between 300 and 1000 mug/L are recruited and randomised to either the treatment group or to the sham treatment group. Those in the treatment group have normalisation of SF by 3-weekly erythrocytapheresis while those in the sham treatment group have 3-weekly plasmapheresis and thus do not have normalisation of SF. Patients are blinded to all procedures. All outcome measures are administered prior to and following the course of treatment/sham treatment. Patient reported outcome measures are the Modified Fatigue Impact Scale (MFIS-primary outcome), Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study 36-item short form V.2 (SF36v2) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF). Liver injury and hepatic fibrosis are assessed with transient elastography (TE), Fibrometer and Hepascore, while oxidative stress is assessed by measurement of urine and serum F2-isoprostanes. ETHICS AND DISSEMINATION: This study has been approved by the Human Research Ethics Committees of Austin Health, Royal Melbourne Hospital and Royal Brisbane and Women's Hospital. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: Trial identifier: NCT01631708; Registry: ClinicalTrials.gov.","Ong, S. Y., et al. (2015). \"Should HFE p.C282Y homozygotes with moderately elevated serum ferritin be treated? A randomised controlled trial comparing iron reduction with sham treatment (Mi-iron).\" BMJ Open 5(8): e008938.","Australia",2015,"Hematological","None","MFI",null,null,null,"Australia",null,"Hematological","None",null,null,"MFI","2015:2018"]
[214,"Pallis, A. G. and I. A. Mouzas (2004). \"Instruments for quality of life assessment in patients with gastrointestinal cancer.\" Anticancer Res 24(3b): 2117-2121.",null,"Pallis, A. G. and I. A. Mouzas","Instruments for quality of life assessment in patients with gastrointestinal cancer","Health-related quality of life (HRQoL) is a multi-dimensional concept, encompassing all aspects of patient health and used widely as an outcome measure in clinical trials. In this review, the current status of HRQoL assessment in clinical studies of gastrointestinal cancer is examined and the various instruments proposed for this purpose are considered and compared. The cancer-specific questionnaires, among them the Spitzer Quality of Life Index, the Rotterdam Symptom Check List, the Functional Living Index-Cancer, the Functional Assessment of Cancer Therapy General (FACT-G) and the Quality of Life Questionnaire of the European Organization for Research and Treatment in Cancer (EORTC), provide essential information about particular concerns of cancer patients and are most sensitive in detecting changes over time. The domain-specific questionnaires, among them the Multidimensional Fatigue Inventory, the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale and the Anorectal Sphincter-Conservative Treatment Questionnaire, are designed to assess one specific domain of quality of life. The core-module cancer-specific questionnaires combine a core questionnaire for use in any type of cancer with a module questionnaire which assesses specific issues in cancer patient subgroups. Such core-module instruments have been evaluated for colorectal, pancreatic, hepatobiliary, oesophageal and gastric cancer. The most valid and standardized instruments for HRQoL assessment in cancer patients are the EORTC and the FACT questionnaires, which are widely used in Europe and around the world. Data provided by these specific instruments complement clinical outcomes and may help to evaluate the costs and benefits of different treatment options, thus being essential to further improvement of treatment and care of cancer patients.","Pallis, A. G. and I. A. Mouzas (2004). \"Instruments for quality of life assessment in patients with gastrointestinal cancer.\" Anticancer Res 24(3b): 2117-2121.","Greece",2004,"Cancer","None","MFI",null,null,null,"Greece",null,"Cancer","None",null,null,"MFI","2000:2004"]
[215,"Parameswaran, R., et al. (2013). \"Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.\" Ann Surg Oncol 20(6): 1970-1977.",null,"Parameswaran, R., et al.","Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers","BACKGROUND: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE). METHODS: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery. RESULTS: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group. CONCLUSIONS: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.","Parameswaran, R., et al. (2013). \"Assessment and comparison of recovery after open and minimally invasive esophagectomy for cancer: an exploratory study in two centers.\" Ann Surg Oncol 20(6): 1970-1977.","UK",2013,"Cancer","Surgery","MFI",null,null,null,"UK",null,"Cancer","Surgery",null,null,"MFI","2010:2014"]
[216,"Pashos, C. L., et al. (2013). \"Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.\" Support Care Cancer 21(10): 2853-2860.",null,"Pashos, C. L., et al.","Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia","PURPOSE: This analysis examined associations between gender and health-related quality of life (HRQOL) in patients with B-cell chronic lymphocytic leukemia (CLL) as they initiate therapy for CLL outside the clinical trial setting. METHODS: Baseline data were collected as part of Connect(R) CLL Registry, a prospective observational study initiated in community, academic, and government centers. Patient demographics and clinical characteristics were provided by clinicians. Patients reported HRQOL using the Brief Fatigue Inventory (BFI), EQ-5D, and Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Mean scores were analyzed, with statistical significance of differences determined by ANOVA. Multivariate analysis also considered age and line of therapy. RESULTS: Baseline HRQOL data were available for 1,140 patients: 710 (62 %) men and 430 (38 %) women from 161 centers. Patients were predominantly white (89 %) with mean age 69 +/- 11 years. Women reported significantly worse global fatigue (P <0.0001), fatigue severity (P <0.0001), and fatigue-related interference (P = 0.0005) versus men (BFI). Pain/discomfort (P = 0.0077), usual activities (P = 0.0015), and anxiety/depression (P = 0.0117) were significantly worse in women than in men (EQ-5D). With women reporting a better social/family score (P = 0.0238) and men reporting a better physical score (P = 0.0002), the mean FACT-G total score did not differ by gender. However, the mean FACT-Leu total score was better among men versus women (P = 0.0223), primarily because the mean leukemia subscale score was significantly better among men (P <0.0001). Multivariate analysis qualitatively confirmed these findings. CONCLUSIONS: Connect(R) CLL Registry results indicate that significant differences exist in certain HRQOL domains, as women reported greater levels of fatigue and worse functioning in physical domains.","Pashos, C. L., et al. (2013). \"Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia.\" Support Care Cancer 21(10): 2853-2860.","USA",2013,"Cancer","None","BFI",null,null,null,"USA",null,"Cancer","None",null,null,"BFI","2010:2014"]
[217,"Patti, F., et al. (2002). \"The impact of outpatient rehabilitation on quality of life in multiple sclerosis.\" J Neurol 249(8): 1027-1033.",null,"Patti, F., et al.","The impact of outpatient rehabilitation on quality of life in multiple sclerosis","It is well accepted that rehabilitative treatment can be effective in reducing disability and optimizing quality of life (QoL) of people with multiple sclerosis (MS). The aim of this study was to evaluate the effects of a comprehensive outpatient rehabilitative treatment on QoL in patients suffering from MS. We selected 111 patients from a sample of 407 patients who had consecutively entered the MS Center of Catania (which is located in southern Italy) in 1998. Fifty-eight were randomly assigned to the study treatment and 53 to a waiting list (control treatment). Kurtzke's EDSS and quality of Life (QoL)were the primary endpoints. QoL was measured with the generic multi-item SF-36 scales. We also used: the Beck Depression Inventory (BDI) for depression, the Tempelaar Social Experience Check-list (SET) for social activities and the Fatigue Impact Scale (FIS). The study treatment group was treated for 6 consecutive weeks, 6 days a week with a comprehensive rehabilitative outpatient model. The control treatment group was in a waiting list and was trained to self-exercises at home. EDSS remained unchanged in both groups. All health related QoL domains significantly improved in the study treatment (p < 0.001 in physical functioning, role physical, bodily pain, general health, and social functioning; p < 0.05 in vitality, role emotional and mental health). FIS, SET and BDI also improved significantly after the rehabilitative treatment in the study group (p < 0.001). The results of this study confirm the effectiveness of a short comprehensive outpatient model of rehabilitative treatment in people with MS and in particular in their QoL.","Patti, F., et al. (2002). \"The impact of outpatient rehabilitation on quality of life in multiple sclerosis.\" J Neurol 249(8): 1027-1033.","Italy",2002,"Neurological","None","FIS",null,null,null,"Italy",null,"Neurological","None",null,null,"FIS","2000:2004"]
[218,"Pavsic, K., et al. (2015). \"Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients.\" Clin Neurol Neurosurg 139: 35-40.",null,"Pavsic, K., et al.","Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients","OBJECTIVE: Previous studies have predominantly investigated the effect of fampridine on lower extremities motor functions while data on its impact on other symptoms of multiple sclerosis (MS) are scarce. The aim of our study was to assess the impact of fampridine on walking, arm/hand function, fatigue, cognitive function, mood and quality of life among responders. METHODS: Our prospective non-randomized study included 30 patients with different types of MS, aged 35-70, EDSS value 3.5-6.5. They were treated with 10mg of fampridine twice daily. The examinations were performed before the treatment, after 14 days, when responders were defined by T25FW (Timed 25-Foot Walk) and 2-min walk test (2MWT) was performed, and after 28 days of treatment, when only the responders were examined. Standardized protocols and questionnaires were used to evaluate the impact of fampridine on walking speed (T25FW, 2MWT), arm/hand function (9-HPT - Nine-Hole Peg Test), cognitive function (PASAT - Paced Auditory Serial Addition Test), total MSFC score (Multiple Sclerosis Functional Composite), fatigue (MFIS - Modified Fatigue Impact Scale), mood (BDI - Beck Depression Inventory) and quality of life (EQ-5D index, EQ-VAS - Euro Quality of Life - 5 Dimension questionnaire and visual analogue scale) in responders. RESULTS: Response rate was 56.7%. Average improvement of T25FW and 2MWT after 14 days of treatment in responders was 3.6s (34.5%) and 37.4m (42.3%), respectively. This improvement persisted after 28 days of treatment. In non-responders there was no significant improvement of T25FW after 14 days (p=0.689), but there was improvement of 2MWT for 13.4m (14.3%) (p=0.000). After 28 days of treatment significant improvement among responders occurred in total MSFC score (p=0.001), 9-HPT (p=0.002), BDI (p=0.005), MFIS total score (p=0.003), physical (p=0.001), cognitive (p=0.008) MFIS subscales, and EQ-5D index (p=0.012). There were implied trends towards improvement in EQ-VAS and psychosocial MFIS subscale, yet not significant (p=0.057 and p=0.127, respectively). There was no statistically significant improvement of PASAT (p=0.432). CONCLUSIONS: The results of our study highlight the potential of fampridine for improving not only walking speed but also arm/hand function, physical and cognitive fatigue, mood and quality of life. There was no objective improvement of cognitive function. Further placebo-controlled studies will be needed for precise definition of fampridine's action beyond its impact on walking.","Pavsic, K., et al. (2015). \"Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients.\" Clin Neurol Neurosurg 139: 35-40.","Slovenia",2015,"Neurological","Other Drugs","MFI",null,null,null,"Slovenia",null,"Neurological","Other Drugs",null,null,"MFI","2015:2018"]
[219,"Penttinen, H. M., et al. (2011). \"Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments.\" Psychooncology 20(11): 1211-1220.",null,"Penttinen, H. M., et al.","Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments","OBJECTIVE: The study aimed at investigating the quality of life (QoL) and physical performance and activity, and their interrelations, in Finnish female breast cancer patients shortly after adjuvant treatments. METHODS: A total of 537 disease-free breast cancer survivors aged 35-68 years were surveyed at the beginning of a one year randomized exercise intervention. The patients were interviewed using EORTC QLQ-C30, FACIT-F, RBDI, and WHQ (for vasomotor symptoms) questionnaires. Physical performance was tested by a 2 km walking test. Physical activity was measured by a questionnaire and a prospective two-week diary. Multivariate analysis was used to study the factors associated with QoL. RESULTS: About 26% of the patients were rated as depressed, 20.4% as fatigued, and 82% suffered from menopausal symptoms. The global QoL was lower than in general population (69.4 vs 74.7, p<0.001). About 62% of the walking test results were below the population average. Fatigue (p<0.001), depression (p<0.001), body mass index (p = 0.016) and comorbidity (p = 0.032) impaired, and physical activity (p = 0.003) improved QoL. Physical activity level correlated positively to physical performance (r = -0.274, p<0.0001). CONCLUSIONS: The QoL of the patients shortly after adjuvant treatments was impaired and the physical performance poor as compared to general population. In particular, depression and fatigue were related to impaired QoL. Physical performance and activity level were the only factors that correlated positively to QoL. Thus, physical exercise could be useful in rehabilitation of cancer survivors, especially for depressed and fatigued patients.","Penttinen, H. M., et al. (2011). \"Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments.\" Psychooncology 20(11): 1211-1220.","Finland",2011,"Cancer","None","FACIT-F",null,null,null,"Finland",null,"Cancer","None",null,null,"FACIT-F","2010:2014"]
[220,"Petri, M. A., et al. (2004). \"Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus.\" Arthritis Rheum 50(9): 2858-2868.",null,"Petri, M. A., et al.","Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus","OBJECTIVE: To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. METHODS: Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (</=10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for >/=6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). RESULTS: A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5%) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5%) (P = 0.017). Acne and hirsutism were reported in 33% and 16%, respectively, of the prasterone group and in 14% and 2%, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22% and 15%, respectively) than in the placebo group (36% and 23%, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. CONCLUSION: In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.","Petri, M. A., et al. (2004). \"Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus.\" Arthritis Rheum 50(9): 2858-2868.","USA",2004,"Inflamatory Systemic Disease","Other Drugs","KFSS",null,null,null,"USA",null,"Inflamatory Systemic Disease","Other Drugs",null,null,"KFSS","2000:2004"]
[221,"Petty, T. L., et al. (2006). \"Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease.\" J Cardiopulm Rehabil 26(2): 112-117.",null,"Petty, T. L., et al.","Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease","PURPOSE: To compare the impact of a library of pulmonary rehabilitation videotapes versus an older videotape and usual care on quality of life and ability to perform activities of daily living in persons with chronic obstructive pulmonary disease. METHODS: Two hundred fourteen patients diagnosed with chronic obstructive pulmonary disease, emphysema, or chronic bronchitis were recruited and randomized to receive customized videotapes, standard videotapes, or usual care. Outcome measures included the Fatigue Impact Scale, Seattle Obstructive Lung Disease Questionnaire, and the SF-36(R) Health Survey. RESULTS: Differences in coping skills and emotional functioning on the Seattle Obstructive Lung Disease Questionnaire were found among the 174 subjects who completed the study. The customized videotape group improved by 8.6 and 4.8 points, respectively, whereas the score of the other groups decreased by less than 1 point for the coping skills, and the scores of the standard video and the control groups decreased by 3.0 and 2.1 points, respectively, for emotional functioning (P < .05, all comparisons). The scores using the Fatigue Impact Scale also improved for the customized videotape group, whereas the scores of the others remained unchanged. Videotape users demonstrated better conversion to and retention of exercise habits, with over 80% of customized videotape subjects who reported exercise habits at baseline continuing the habits as compared with 40% in the usual care group. Sedentary subjects at baseline were more likely to begin and maintain exercise if randomized to videotapes. CONCLUSIONS: These findings demonstrate increased quality of life, lower fatigue, and better compliance with a prescribed exercise regimen among subjects using the customized videotapes. There was a significant improvement in emotional functioning and coping skills among customized videotape subjects.","Petty, T. L., et al. (2006). \"Impact of customized videotape education on quality of life in patients with chronic obstructive pulmonary disease.\" J Cardiopulm Rehabil 26(2): 112-117.","USA",2006,"Respiratory Disease","Psychobehavioural","FIS",null,null,null,"USA",null,"Respiratory Disease","Psychobehavioural",null,null,"FIS","2005:2009"]
[222,"Piche, T., et al. (2010). \"Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome.\" Neurogastroenterol Motil 22(6): 626-e174.",null,"Piche, T., et al.","Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome","BACKGROUND: Patients with irritable bowel syndrome (IBS) and Crohn disease (CD) have impaired quality of life (Qol) associated with fatigue. Whether IBS-like symptoms have a similar impact on Qol and fatigue in quiescent CD than in IBS is currently unknown. Our aims were (i) to evaluate the prevalence of IBS-like symptoms in quiescent CD and (ii) to compare the impact of IBS-like symptoms on Qol and fatigue in both diseases. METHODS: A total of 92 quiescent CD, 40 IBS and 20 healthy subjects similar in age were included prospectively in five French academic centers. IBS symptoms were evaluated through the Rome III criteria. The severity of IBS symptoms, Qol, fatigue, depression and anxiety was measured using questionnaires (Francis Score, Likert scales, Fatigue Impact Scale, short-form Beck and Hospital Anxiety and Depression Scale). KEY RESULTS: Irritable bowel syndrome-like symptoms were found in 42/92 (45.6%) patients with quiescent CD. The presence of IBS-like symptoms was associated with significant more profound alterations of Qol, high scores of fatigue, depression, but similar levels of anxiety. Compared to CD patients with IBS-like symptoms, IBS patients had more severe gastrointestinal symptoms and alterations of Qol, but similar scores of fatigue, depression and anxiety. In quiescent CD patients, fatigue was independently associated with the presence of IBS-like symptoms (OR = 1.018, 95% CI: 1.002-1.034, P = 0.02). CONCLUSIONS & INFERENCES: The prevalence of IBS-like symptoms is elevated in quiescent CD. The presence of IBS-like symptoms in quiescent CD is probably associated with the range of fatigue/depression disorders. The mechanism underlying the occurrence of IBS-like symptoms in quiescent CD needs to be further explored.","Piche, T., et al. (2010). \"Impact of functional bowel symptoms on quality of life and fatigue in quiescent Crohn disease and irritable bowel syndrome.\" Neurogastroenterol Motil 22(6): 626-e174.","France",2010,"Gastrointestinal","None","FIS",null,null,null,"France",null,"Gastrointestinal","None",null,null,"FIS","2010:2014"]
[223,"Plow, M., et al. (2012). \"Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol.\" BMC Neurol 12: 122.",null,"Plow, M., et al.","Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol","BACKGROUND: Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels. METHODS/DESIGN: A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12 weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy). DISCUSSION: The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS. TRIAL REGISTRATION: NCT01572714.","Plow, M., et al. (2012). \"Randomized controlled trial of a teleconference fatigue management plus physical activity intervention in adults with multiple sclerosis: rationale and research protocol.\" BMC Neurol 12: 122.","USA",2012,"Neurological","Psychobehavioural","FIS",null,null,null,"USA",null,"Neurological","Psychobehavioural",null,null,"FIS","2010:2014"]
[224,"Poulsen, M. B., et al. (2015). \"Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.\" Stroke 46(12): 3470-3477.",null,"Poulsen, M. B., et al.","Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial","BACKGROUND AND PURPOSE: Poststroke fatigue is common and reduces quality of life. Current evidence for intervention is limited, and this is the first placebo-controlled trial to investigate treatment of poststroke fatigue with the wakefulness promoting drug modafinil. METHODS: The trial was randomized, double-blinded, and placebo-controlled. Patients were treated with 400-mg modafinil or placebo for 90 days. Assessments were done at inclusion, 30, 90, and 180 days. The primary end point was fatigue at 90 days measured by the Multidimensional Fatigue Inventory-20 general fatigue domain. Secondary end points included the Fatigue Severity Scale, the Montreal Cognitive Assessment, the modified Rankin Scale and the Stroke-specific quality of Life questionnaire. Adult patients with a recent stroke achieving a score of >/=12 on the Multidimensional Fatigue Inventory-20 general fatigue domain were consecutively included. Exclusion criteria were severe cognitive disabilities and contraindications for modafinil treatment. RESULTS: One thousand one hundred twenty-one patients with stroke were screened and 41 patients included, 21 received modafinil. The primary end point, the Multidimensional Fatigue Inventory-20 general fatigue score, did not differ between groups. Patients in the modafinil group obtained better scores on the Fatigue Severity Scale (P=0.02) and in some subscales of the stroke-specific quality of life questionnaire (0.001<P<0.05), which were secondary outcomes. No serious adverse reactions were observed and there was no difference in blood pressure between groups. CONCLUSIONS: There were no significant differences between the 2 groups with regard to the primary end point. There were secondary significant outcomes that should be explored in future trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800097.","Poulsen, M. B., et al. (2015). \"Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial.\" Stroke 46(12): 3470-3477.","Denmark",2015,"CVD","Other Drugs","FSS,MFI",null,null,null,"Denmark",null,"CVD","Other Drugs",null,null,"FSS,MFI","2015:2018"]
[225,"Prick, B. W., et al. (2015). \"Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage.\" Bjog 122(13): 1789-1797.",null,"Prick, B. W., et al.","Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage","OBJECTIVE: To determine clinical predictors of escape red blood cell (RBC) transfusion in postpartum anaemic women, initially managed expectantly, and the additional predictive value of health-related quality of life (HRQoL) measures. DESIGN: Secondary analysis of women after postpartum haemorrhage, either randomly allocated to, or opting for expectant management. SETTING: Thirty-seven hospitals in the Netherlands. POPULATION: A total of 261 randomised and 362 nonrandomised women. METHODS: We developed prediction models to assess the need for RBC transfusion: one using clinical variables (model 1), and one extended with scores on the HRQoL-measures Multidimensional Fatigue Inventory (MFI) and EuroQol-5D (model 2). Model performance was assessed by discrimination and calibration. Models were internally validated with bootstrapping techniques to correct for overfitting. MAIN OUTCOME MEASURES: Escape RBC transfusion. RESULTS: Seventy-five women (12%) received escape RBC transfusion. Independent predictors of escape RBC transfusion (model 1) were primiparity, multiple pregnancy, total blood loss during delivery and haemoglobin concentration postpartum. Maternal age, body mass index, ethnicity, education, medical indication of pregnancy, mode of delivery, preterm delivery, placental removal, perineal laceration, Apgar score and breastfeeding intention had no predictive value. Addition of HRQoL-scores (model 2), significantly improved the model's discriminative ability: c-statistics of model 1 and 2 were 0.65 (95% CI 0.58-0.72) and 0.72 (95% CI 0.65-0.79), respectively. The calibration of both models was good. CONCLUSIONS: In postpartum anaemic women, several clinical variables predict the need for escape RBC transfusion. Adding HRQoL-scores improves model performance. After external validation, the extended model may be an important tool for counselling and decision making in clinical practice.","Prick, B. W., et al. (2015). \"Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage.\" Bjog 122(13): 1789-1797.","Netherlands",2015,"Hematological","None","MFI",null,null,null,"Netherlands",null,"Hematological","None",null,null,"MFI","2015:2018"]
[226,"Prick, B. W., et al. (2010). \"Well being of obstetric patients on minimal blood transfusions (WOMB trial).\" BMC Pregnancy Childbirth 10: 83.",null,"Prick, B. W., et al.","Well being of obstetric patients on minimal blood transfusions (WOMB trial)","BACKGROUND: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. METHODS/DESIGN: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). DISCUSSION: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.","Prick, B. W., et al. (2010). \"Well being of obstetric patients on minimal blood transfusions (WOMB trial).\" BMC Pregnancy Childbirth 10: 83.","Netherlands",2010,"Hematological","Various","MFI",null,null,null,"Netherlands",null,"Hematological","Various",null,null,"MFI","2010:2014"]
[227,"Purcell, A., et al. (2010). \"Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.\" Support Care Cancer 18(3): 307-315.",null,"Purcell, A., et al.","Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population","PURPOSE: The Multidimensional Fatigue Inventory (MFI) is a commonly used cancer-related fatigue assessment tool. Unlike other fatigue assessments, there are no published minimal clinically important difference (MCID) criteria for the MFI in cancer populations. MCID criteria determine the smallest change in scores that can be regarded as important, allowing clinicians and researchers to interpret the meaning of changes in patient's fatigue scores. This research aims to improve the clinical utility of the MFI by establishing MCID criteria for the MFI sub-scales in a radiotherapy population. MATERIALS AND METHODS: Two hundred ten patients undergoing radiotherapy were recruited to a single-centre prospective cohort study. Patients were assessed at three time points, at the start of radiotherapy, the end of radiotherapy and 6 weeks after radiotherapy completion. Assessment consisted of four clinically relevant constructs: (1) treatment impact on fatigue, (2) health-related quality of life, (3) performance status and (4) occupational productivity. These constructs were used as external or anchor-based measures to determine MCIDs for each sub-scale of the MFI. RESULTS: Multiple MCIDs were identified, each from a different perspective based on the constructs cited. Researchers seeking to use a generic MCID may wish to use a two-point reference for each MFI sub-scale as it was consistent across the pre- and post-radiotherapy comparison and occupational productivity anchors. CONCLUSIONS: MCIDs validated in this study allow better interpretation of changes in MFI sub-scale scores and allow effect size calculations for determining sample size in future studies.","Purcell, A., et al. (2010). \"Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population.\" Support Care Cancer 18(3): 307-315.","Australia",2010,"Cancer","None","MFI",null,null,null,"Australia",null,"Cancer","None",null,null,"MFI","2010:2014"]
[228,"Qin, Z., et al. (2009). \"Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort.\" Parkinsonism Relat Disord 15(10): 767-771.",null,"Qin, Z., et al.","Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort","OBJECTIVE: To identify the motor and non-motor factors that are associated with health related quality of life (HR-QOL) in a subgroup of Parkinson's disease (PD) patients with Levodopa therapy in early clinical stages. METHODS: 391 Levodopa exposed patients were evaluated during the baseline assessment of a clinical trial in China. HR-QOL was measured by the Short Form 36 (SF-36). Motor and non-motor variables were determined during a structured interview and by clinical examination by movement disorder specialists. Multiple regression analyses were used to determine which variables were associated with low levels of HR-QOL. RESULTS: Even if excluding non-motor variables from the regression model, motor factors, particularly motor deficits (measured by motor score of UPDRS), rigidity (measured by item 22 of UPDRS), and disease severity (measured by Hoehn&Yahr scale), explained only 18.9% of the variance of total SF-36 score. Whereas, when non-motor variables were included in the model, especially depression (measured by CES-D), sleep disturbances (measured by PSQ-I), and fatigue (measured by FSS), 61.7% of the variance of SF-36 score could be explained. Two motor variables, UPDRS motor score and Hoehn&Yahr score, were also contributed to the model, however, the 95% confidence intervals (CIs) of these two motor factors were wide and included the null value (CIs -0.282, 0.019 for UPDRS motor score, and CIs -4.043, 0.856 for Hoehn&Yahr score). Neither, did higher daily levodopa dose contribute significantly to both models predicting SF-36 score. CONCLUSIONS: In our sample patients with levodopa therapy, motor disability and severity of parkinsonism contributed to a lesser extent to patients' self-report distress, within the first 5 years of disease onset. The clinical factors that showed the highest predictive value for worsen HR-QOL were non-motor symptoms, such as depression, sleep disorders, and fatigue. Great effort should be made to recognize and treat those conditions, thus improving all aspects of PD and giving these patients as a good HR-QOL as possible.","Qin, Z., et al. (2009). \"Health related quality of life in early Parkinson's disease: impact of motor and non-motor symptoms, results from Chinese levodopa exposed cohort.\" Parkinsonism Relat Disord 15(10): 767-771.","China",2009,"Neurological","None","FSS",null,null,null,"China",null,"Neurological","None",null,null,"FSS","2005:2009"]
[229,"Racciatti, D., et al. (2011). \"An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences.\" Int J Immunopathol Pharmacol 24(3): 673-681.",null,"Racciatti, D., et al.","An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences","Severe fatigue and a significantly reduced health-related quality of life (HRQoL) have been described in patients with chronic fatigue syndrome (CFS) in comparison with patients affected by chronic hepatitis C (CHC) and other chronic medical conditions. We examined 39 CFS and 49 CHC patients to explore whether fatigue and a poor HRQoL represent a greater medical and social problem in CFS than in CHC. The severity of fatigue and the HRQoL were assessed using the Fatigue Impact Scale (FIS) and the Health Status Questionnaire Short Form-36 (SF-36), respectively. The statistical analysis showed both a higher score of fatigue and a lower HRQoL in CFS than in CHC patients. Furthermore, in CHC patients the FIS evaluation showed a significantly reduced score of the psychosocial domain in comparison with the other domains. Multivariate linear regression analysis revealed female gender as the most important positive variable in chronic hepatitis C patients for total score of FIS. In conclusion, CFS was associated with a severe and disabling fatigue and an impaired HRQOL. In particular, both fatigue and all aspects of HRQOL perceived by CFS patients were significantly impaired compared to CHC patients. Consequently, management of fatigue should be considered a priority in order to improve HRQOL in CFS patients. In CHC patients the impact of fatigue on HRQoL was less significant than in CFS patients, even though the FIS evaluation showed a significant impairment of the psychosocial domain.","Racciatti, D., et al. (2011). \"An Italian study on health-related quality of life and fatigue in patients with chronic fatigue syndrome and patients with chronic HCV virus infection: similarities and differences.\" Int J Immunopathol Pharmacol 24(3): 673-681.","Italy",2011,"Chronic Fatigue","None","FIS",null,null,null,"Italy",null,"Chronic Fatigue","None",null,null,"FIS","2010:2014"]
[230,"Radbruch, L., et al. (2003). \"Validation of the German version of the brief fatigue inventory.\" J Pain Symptom Manage 25(5): 449-458.",null,"Radbruch, L., et al.","Validation of the German version of the brief fatigue inventory","Sedation and tiredness are among the most frequent symptoms among cancer patients. A detailed assessment of these symptoms is necessary to evaluate therapeutic effects, such as the use of methylphenidate or comparison of different opioids. The Brief Fatigue Inventory (BFI) has been validated as a short and comprehensive instrument to assess severity of fatigue and fatigue-related impairment in cancer patients. We validated the German version of the BFI in patients with chronic cancer-related and noncancer-related pain treated in a tertiary pain center. Patients treated in the Pain Clinic of the Department of Anesthesiology completed the BFI, the minimal documentation system (MIDOS) and the short form SF-36 quality-of-life questionnaire (SF-36). Test-retest reliability was assessed with a second BFI immediately after the consultation and in a subgroup of patients after 3 to 7 days. Nineteen percent of the 117 patients were treated for cancer-related pain (C); the other patients suffered from chronic severe pain of nonmalignant origin (NC). Patients reported mean values for average fatigue of 3.9 (C) and 4.9 (NC), and for worst fatigue of 5.5 (C) and 6.2 (NC). The mean score of the 6 impairment items was 4.3 in both groups. Factor analysis led to a solution with one common factor for all nine items. Fatigue on the BFI correlated highly with 'feeling tired' in the SF-36 and with 'sedation' in MIDOS, and less with 'being worn out' in SF-36 and 'weakness' in MIDOS. Internal consistency was high, as was test-retest reliability, with a correlation of the intensity, mean scores of 0.93 and the impairment mean scores of 0.87. In conclusion, we found the German version of the BFI to be reliable and valid for cancer and noncancer patients. Minor differences were seen in the validation compared to the original version.","Radbruch, L., et al. (2003). \"Validation of the German version of the brief fatigue inventory.\" J Pain Symptom Manage 25(5): 449-458.","Germany",2003,"Cancer","None","BFI",null,null,null,"Germany",null,"Cancer","None",null,null,"BFI","2000:2004"]
[231,"Rasenack, J., et al. (2003). \"Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.\" Pharmacoeconomics 21(5): 341-349.",null,"Rasenack, J., et al.","Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C","BACKGROUND: Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a. OBJECTIVES: To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon]. DESIGN: A randomised, international, multicentre, open-label, parallel group study. SETTING: 36 centres worldwide. PATIENTS: Interferon-naive patients (n = 531) with chronic hepatitis C. INTERVENTIONS: Peginterferon alpha-2a (40kD) 180 mirog once a week (n = 267) for 48 weeks or unmodified interferon alpha-2a 6 million IU three times a week for 12 weeks followed by 36 weeks of 3 million IU three times a week (n = 264). MEASUREMENTS: Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36). RESULTS: At weeks 2 and 12, differences favouring peginterferon alpha-2a (40kD) were seen on seven of eight domains and both summary scores of the SF-36 (p < 0.05 to p < 0.01). At weeks 2, 12 and 24, patients receiving peginterferon alpha-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon alpha-2a. CONCLUSION: Treatment with peginterferon alpha-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon alpha-2a. In addition to safety and efficacy, the impact on health-related quality of life may be an important consideration for physicians when selecting an optimal treatment regimen.","Rasenack, J., et al. (2003). \"Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.\" Pharmacoeconomics 21(5): 341-349.","Germany",2003,"Infectious disease","Other Drugs","FSS",null,null,null,"Germany",null,"Infectious Disease","Other Drugs",null,null,"FSS","2000:2004"]
[232,"Ray, A. D., et al. (2013). \"A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis.\" Arch Phys Med Rehabil 94(10): 1964-1970.",null,"Ray, A. D., et al.","A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis","OBJECTIVE: To determine the effects of a short-duration, combined (inspiratory and expiratory), progressive resistance respiratory muscle training (RMT) protocol on respiratory muscle strength, fatigue, health-related quality of life, and functional performance in individuals with mild-to-moderate multiple sclerosis (MS). DESIGN: Quasi-experimental before-after trial. SETTING: University rehabilitation research laboratory. PARTICIPANTS: Volunteers with MS (N=21) were divided into 2 groups: RMT (n=11; 9 women, 2 men; mean age +/- SD, 50.9 +/- 5.7y, mean Expanded Disability Status Scale score +/- SD, 3.2 +/- 1.9) and a control group that did not train (n=10; 7 women, 3 men; mean age +/- SD, 56.2 +/- 8.8y, mean Expanded Disability Status Scale score +/- SD, 4.4 +/- 2.1). Expanded Disability Status Scale scores ranged from 1 to </=6.5. No patients withdrew from the study. INTERVENTION: Training was a 5-week combined progressive resistance RMT program, 3d/wk, 30 minutes per session. MAIN OUTCOME MEASURES: The primary outcome measures were maximal inspiratory pressure and expiratory pressure and the Modified Fatigue Impact Scale. All subjects completed secondary measures of pulmonary function, the six-minute walk test, the timed stair climb, the Multiple Sclerosis Self-Efficacy Scale, the Medical Outcomes Study 36-Item Short-Form Health Survey, and the Physical Activity Disability Scale. RESULTS: Maximal inspiratory pressure and expiratory pressure (mean +/- SD) increased 35% +/- 22% (P<.001) and 26% +/- 17% (P<.001), respectively, whereas no changes were noted in the control group (12% +/- 23% and -4% +/- 17%, respectively). RMT improved fatigue (Modified Fatigue Impact Scale, P<.029), with no change or worsening in the control group. No changes were noted in the six-minute walk test, stair climb, Multiple Sclerosis Self-Efficacy Scale, or Physical Activity Disability Scale in the RMT group. The control group had decreases in emotional well-being and general health (Medical Outcomes Study 36-Item Short-Form Health Survey). CONCLUSIONS: A short-duration, combined RMT program improved inspiratory and expiratory muscle strength and reduced fatigue in patients with mild to moderate MS.","Ray, A. D., et al. (2013). \"A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis.\" Arch Phys Med Rehabil 94(10): 1964-1970.","USA",2013,"Neurological","Psychobehavioural","MFI",null,null,null,"USA",null,"Neurological","Psychobehavioural",null,null,"MFI","2010:2014"]
[233,"Reich, K., et al. (2009). \"Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis.\" Dermatology 219(3): 239-249.",null,"Reich, K., et al.","Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis","OBJECTIVE: To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administered etanercept 50 mg once weekly (QW). METHODS: Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits. RESULTS: At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms. CONCLUSIONS: Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated.","Reich, K., et al. (2009). \"Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis.\" Dermatology 219(3): 239-249.","Germany",2009,"Inflamatory Systemic Disease","Etanercept","FACIT-F",null,null,null,"Germany",null,"Inflamatory Systemic Disease","Etanercept",null,null,"FACIT-F","2005:2009"]
[234,"Revicki, D. A., et al. (2011). \"Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis.\" Health Qual Life Outcomes 9: 36.",null,"Revicki, D. A., et al.","Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis","BACKGROUND: We evaluated the psychometric characteristics of the Short Form 36 (SF-36) Health Survey and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale in patients with ankylosing spondylitis (AS). METHODS: We analyzed clinical and patient-reported outcome (PRO) data collected during 12-week, double-blind, placebo-controlled periods of two randomized controlled trials comparing adalimumab and placebo for the treatment of active AS. The Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and other clinical measures were collected during the clinical trial. We evaluated internal consistency/reliability, construct validity, and responsiveness to change for the SF-36 and FACIT-Fatigue. RESULTS: The SF-36 (Cronbach alpha, 0.74-0.92) and FACIT-Fatigue (Cronbach alpha, 0.82-0.86) both had good internal consistency/reliability. At baseline, SF-36 and FACIT-Fatigue scores correlated significantly with Ankylosing Spondylitis Quality of Life scores (r = -0.36 to -0.66 and r = -0.70, respectively; all p < 0.0001). SF-36 scores varied by indicators of clinical severity, with greater impairment observed for more severe degrees of clinical activity (all p < 0.0001). FACIT-Fatigue scores correlated significantly with SF-36 scores (r = 0.42 to 0.74; all p < 0.0001) and varied by clinical severity (p < 0.05 to p < 0.0001). CONCLUSIONS: The SF-36 is a reliable, valid, and responsive measure of health-related quality of life and the FACIT-Fatigue is a brief and psychometrically sound measure of the effects of fatigue on patients with AS. These PROs may be useful in evaluating effectiveness of new treatments for AS.","Revicki, D. A., et al. (2011). \"Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis.\" Health Qual Life Outcomes 9: 36.","USA",2011,"Musculoskeletal","None","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","None",null,null,"FACIT-F","2010:2014"]
[235,"Ribas, C. G., et al. (2017). \"Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial.\" Parkinsonism Relat Disord 38: 13-18.",null,"Ribas, C. G., et al.","Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial","Although motor symptoms in Parkinson's disease (PD) are well established, few studies have described the effects of exergaming on the clinical and functional outcomes of PD. OBJECTIVES: To analyze the effectiveness of exergaming in improving functional balance, fatigue, functional exercise capacity and quality of life in PD. METHODS: The study population consisted of 20 patients (12 males and 8 females) aged 61 +/- 9.11 years allocated into two groups: an exergaming group (EGG) (n = 10) and a conventional exercise, or control, group (CG) (n = 10). The following variables were evaluated: functional balance (Berg Scale), fatigue (Fatigue Severity Scale), functional exercise capacity (Six-Minute Walk Test) and quality of life (PDQ-39 Quality of Life Questionnaire). RESULTS: RM-ANOVA showed that balance and fatigue differed significantly between time points: balance [F(1.29, 23.33) = 4.16, p = 0.043] and fatigue [F(2,36) = 5.96, p = 0.006]. In both cases post hoc Bonferroni testing revealed an improvement after 12 weeks of exergaming (p = 0.033 and p = 0.000, respectively). However, this benefit was not sustained after 60 days of follow-up for either outcome. There were no differences in functional exercise capacity or quality of life between the two groups after 12 weeks of treatment. CONCLUSION: Exergaming was effective in enhancing balance and reducing fatigue in PD patients after 12 weeks of treatment, but this benefit was not sustained in the long-term.","Ribas, C. G., et al. (2017). \"Effectiveness of exergaming in improving functional balance, fatigue and quality of life in Parkinson's disease: A pilot randomized controlled trial.\" Parkinsonism Relat Disord 38: 13-18.","Brazil",2017,"Neurological","Psychobehavioural","FSS",null,null,null,"Brazil",null,"Neurological","Psychobehavioural",null,null,"FSS","2015:2018"]
[236,"Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.",null,"Richard, P. O., et al.","Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy","OBJECTIVES: To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale, in men with prostate cancer (PCa) treated with a luteinizing hormone-releasing hormone (LHRH) for a minimum of 6 months, and to assess changes in global fatigue and quality of life (QoL) as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively. PARTICIPANTS AND METHODS: We performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores. RESULTS: The study was closed prematurely because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [sd] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within-group analysis showed a significant improvement in fatigue scores in the methylphenidate arm (P = 0.008) but not in the placebo arm (P = 0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component summary scores than did the use of placebo (P = 0.04 for both component scores). CONCLUSIONS: Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.","Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.","Canada",2015,"Cancer","Other Drugs","GFS",null,null,null,"Canada",null,"Cancer","Other Drugs",null,null,"GFS","2015:2018"]
[237,"Richardson, C. A., et al. (2015). \"Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot.\" J Gerontol A Biol Sci Med Sci 70(4): 487-494.",null,"Richardson, C. A., et al.","Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot","BACKGROUND: Slow gait speed increases morbidity and mortality in older adults. We examined how preferred gait speed is associated with energetic requirements of walking, fatigability, and fatigue. METHODS: Older adults (n = 36, 70-89 years) were categorized as slow or fast walkers based on median 400-m gait speed. We measured VO2peak by graded treadmill exercise test and VO2 during 5-minute treadmill walking tests at standard (0.72 m/s) and preferred gait speeds. Fatigability was assessed with the Situational Fatigue Scale and the Borg rating of perceived exertion at the end of walking tests. Fatigue was assessed by questionnaire. RESULTS: Preferred gait speed over 400 m (range: 0.75-1.58 m/s) averaged 1.34 m/s for fast walkers versus 1.05 m/s for slow walkers (p < .001). VO2peak was 26% lower (18.5 vs 25.1ml/kg/min, p = .001) in slow walkers than fast walkers. To walk at 0.72 m/s, slow walkers used a larger percentage of VO2peak (59% vs 42%, p < .001). To walk at preferred gait speed, slow walkers used more energy per unit distance (0.211 vs 0.186ml/kg/m, p = .047). Slow walkers reported higher rating of perceived exertion during walking and greater overall fatigability on the Situational Fatigue Scale, but no differences in fatigue. CONCLUSIONS: Slow walking was associated with reduced aerobic capacity, greater energetic cost of walking, and greater fatigability. Interventions to improve aerobic capacity or decrease energetic cost of walking may prevent slowing of gait speed and promote mobility in older adults.","Richardson, C. A., et al. (2015). \"Walking energetics, fatigability, and fatigue in older adults: the study of energy and aging pilot.\" J Gerontol A Biol Sci Med Sci 70(4): 487-494.","USA",2015,"none","Psychobehavioural","Situational Fatigue Scale,Borg Fatigue Scale",null,null,null,"USA",null,"None","Psychobehavioural",null,null,"Situational Fatigue Scale,Borg Fatigue Scale","2015:2018"]
[238,"Riesenberg, H. and A. S. Lubbe (2010). \"In-patient rehabilitation of lung cancer patients--a prospective study.\" Support Care Cancer 18(7): 877-882.",null,"Riesenberg, H. and A. S. Lubbe","In-patient rehabilitation of lung cancer patients--a prospective study","PURPOSE: It has not previously been shown whether there is any benefit to multi-morbid patients with lung cancer who participate in complex interdisciplinary rehabilitation programmes after primary therapy. The purpose of this prospective study was to assess changes in exercise capacity and quality of life before and after an in-patient training programme. PATIENTS AND METHODS: Forty-five patients with lung cancer (WHO I-III after surgery and/or radiotherapy and/or chemotherapy) were enrolled in a 28-day in-patient rehabilitation programme that included standardised aerobic training. Functional status and health-related quality of life (QLQ-C30, QLQ-LC13, SF-36, and MFI-20) were examined at the beginning of the study and at day 28. RESULTS: A substantial increase in work performance (bicycle ergometry from 68 +/- 3 to 86 +/- 4 W, p < 0.001, and 6-minute walk test from 322 +/- 11 to 385 +/- 13 m, p < 0.001) was registered. In addition, heart rate at rest was reduced (from 84 +/- 2 to 80 +/- 1 beats per minute, p < 0.05) and heart rate variability (indicator of the efficacy of endurance training) was significantly increased (from 9.7 +/- 1 to 12.9 +/- 1 root mean square of successive differences, p < 0.001). Moreover, there was also a significant improvement in quality of life (48 +/- 3 to 62 +/- 2, p < 0.001) while fatigue was reduced from 66 +/- 3 to 41 +/- 4, p < 0.001. CONCLUSION: A standardised, aerobic endurance training programme as part of the in-patient oncological rehabilitation of patients with lung cancer results in improvements in both physiological and psychological parameters after therapy. A follow-on study in order to determine to what extent this benefit persists over the long-term, particularly, in comparison with patients who have not participated in a rehabilitation programme, is currently being conducted.","Riesenberg, H. and A. S. Lubbe (2010). \"In-patient rehabilitation of lung cancer patients--a prospective study.\" Support Care Cancer 18(7): 877-882.","Germany",2010,"Cancer","Psychobehavioural","MFI",null,null,null,"Germany",null,"Cancer","Psychobehavioural",null,null,"MFI","2010:2014"]
[239,"Rigby, W., et al. (2011). \"Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate.\" Arthritis Care Res (Hoboken) 63(5): 711-720.",null,"Rigby, W., et al.","Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate","OBJECTIVE: To assess the effect of rituximab plus methotrexate (MTX) compared with MTX alone on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in patients with active early rheumatoid arthritis (RA) previously untreated with MTX. METHODS: Patients with active early RA were randomized to groups receiving placebo, rituximab 500 mg, or rituximab 1,000 mg. Rituximab was given by intravenous infusion on days 1 and 15. From week 24, patients with a Disease Activity Score in 28 joints-erythrocyte sedimentation rate of >/=2.6 were eligible for retreatment. Physical function was assessed by Health Assessment Questionnaire (HAQ) disability index (DI) and Short Form 36 (SF-36) scores. Patients achieving a minimal clinically important difference (MCID) for PROs were determined. Additional PROs, including fatigue and pain, were assessed. RESULTS: A total of 748 patients were randomized and received the study drug. Patient characteristics were well balanced. At week 52, treatment with rituximab in both dose groups showed significant improvements in the HAQ DI compared to the MTX alone group (-0.905 and -0.916 in the rituximab 500 mg plus MTX and 1,000 mg plus MTX groups, respectively, versus -0.628 in the MTX alone group; P < 0.0001). Higher proportions of patients achieved MCID in the HAQ DI in the rituximab plus MTX groups compared to MTX alone. Treatment with rituximab plus MTX led to a significant reduction in the SF-36 physical component summary for both rituximab dose groups, but did not show statistically significant differences in the SF-36 mental component summary. Compared to the MTX alone group, both doses of rituximab plus MTX were associated with significant reductions in the patient global assessment of disease activity and pain, and a significantly higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores from baseline to 52 weeks. CONCLUSIONS: Rituximab plus MTX was associated with significant improvement in physical function and HRQOL outcomes compared with MTX alone in patients previously untreated with MTX.","Rigby, W., et al. (2011). \"Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate.\" Arthritis Care Res (Hoboken) 63(5): 711-720.","USA",2011,"Musculoskeletal","Rituximab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Rituximab",null,null,"FACIT-F","2010:2014"]
[240,"Rios Romenets, S., et al. (2013). \"Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study.\" Parkinsonism Relat Disord 19(7): 670-675.",null,"Rios Romenets, S., et al.","Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study","INTRODUCTION: Although a variety of pharmacologic and non-pharmacologic treatments are effective for insomnia in the general population, insomnia in Parkinson's disease differs in important ways and may need different treatments. No studies have conclusively demonstrated effective insomnia treatments in Parkinson's disease. METHODS: We conducted a three-arm six-week randomized pilot study assessing non-pharmacologic treatment (cognitive behavioural therapy with bright light therapy) or doxepin (10 mg daily), compared to an inactive placebo in Parkinson's patients with insomnia. Sleep outcomes included insomnia scales, clinical global impression, sleep diaries and actigraphy. Secondary outcomes included motor severity, fatigue, depression and quality of life. RESULTS: 18 patients were randomized, 6 to each group. Compared to placebo, doxepin improved the Insomnia Severity Index (-9 +/- 5.4 vs. -2 +/- 3.9, p = 0.03), the SCOPA-night score (-5.2 +/- 1.5 vs. -2.3 +/- 2.8, p = 0.049), the Pittsburgh Sleep Quality Index-sleep disturbances subscale (-0.5 +/- 0.5 vs 0.2 +/- 0.4, p = 0.02), and both patient and examiner-rated clinical global impression of change (1.7 +/- 0.8 vs. 0.5 +/- 0.8, p = 0.03 and 1.4 +/- 0.5 vs. 0.3 +/- 0.5, p = 0.003). On secondary outcomes doxepin reduced the fatigue severity scale (p = 0.02) and improved scores on the Montreal Cognitive Assessment (p = 0.007). Non-pharmacological treatment reduced the Insomnia Severity Index (-7.8 +/- 3.8 vs. -2.0 +/- 3.9, p = 0.03), and the examiner-reported clinical global impression of change (p = 0.006), but was associated with decline in Parkinson Disease Questionnaire-39. There were no changes in other primary and secondary outcomes, including actigraphy outcomes. Adverse events were comparable in all groups. CONCLUSION: Doxepin and non-pharmacologic treatment substantially improved insomnia in Parkinson's disease. These potential benefits must be replicated in a full confirmatory randomized controlled trial.","Rios Romenets, S., et al. (2013). \"Doxepin and cognitive behavioural therapy for insomnia in patients with Parkinson's disease -- a randomized study.\" Parkinsonism Relat Disord 19(7): 670-675.","Canada",2013,"Various","Psychobehavioural","FSS",null,null,null,"Canada",null,"Various","Psychobehavioural",null,null,"FSS","2010:2014"]
[241,"Rizzo, M. A., et al. (2004). \"Prevalence and treatment of spasticity reported by multiple sclerosis patients.\" Mult Scler 10(5): 589-595.",null,"Rizzo, M. A., et al.","Prevalence and treatment of spasticity reported by multiple sclerosis patients","The objective of this study was to characterize the population of multiple sclerosis (MS) patients suffering from spasticity and to evaluate treatment patterns, including intrathecal baclofen (ITB) delivery, related to patient quality of life (QOL). We conducted a cross-sectional, two-level study using data from the Patient Registry of the North American Research Committee on MS (NARCOMS). In addition, we surveyed a subgroup of 198 preselected patients who are using ITB (ITBG) and a random sample of 315 oral drug users (ORALG). Among the registrants, 16% reported no spasticity, 31% minimal, 19% mild, 17% moderate (frequently affects activities), 13% severe (daily forced to modify activities) and 4% total (prevents daily activities). Patients experiencing greater severity included by proportion males, and those older and with longer duration of MS. QOL scores decreased inversely with severity. In the focused survey, ITBG reported lower levels of spasticity than ORALG, less stiffness in the legs, less pain and fewer spasms at any time. They scored significantly lower in the SF-36 physical component, yet reported less fatigue on the MFIS scale. Prevalence data reveal that one third of MS patients modify or eliminate daily activities as a result of spasticity. Treatment of spasticity can significantly impact QOL parameters by reducing spasms, pain and fatigue.","Rizzo, M. A., et al. (2004). \"Prevalence and treatment of spasticity reported by multiple sclerosis patients.\" Mult Scler 10(5): 589-595.","USA",2004,"Neurological","None","MFI",null,null,null,"USA",null,"Neurological","None",null,null,"MFI","2000:2004"]
[242,"Robinson, D. W., Jr., et al. (2008). \"The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.\" J Support Oncol 6(6): 283-290.",null,"Robinson, D. W., Jr., et al.","The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia","Data from a clinical study of 86 pancreatic cancer patients with involuntary, significant weight loss (cachexia) were used to explore the relationship between patient-reported outcomes (PROs) and survival. In all, 28 pancreatic cancer patients with cachexia were given gemcitabine (Gemzar) plus 3 mg/kg of infliximab (Remicade), 28 were given gemcitabine plus 5 mg/kg of infliximab, and 30 were given gemcitabine plus placebo in a double-blinded, phase II, multicenter trial. PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Anorexia/ Cachexia Therapy (FAACT), Brief Pain Inventory (BPI), and the Short-Form 36 general health survey (SF-36). Population mean scores at baseline indicated fatigue problems (FACIT-F), nutritional health issues (FAACT), and mild-to-moderate pain (BPI \"worst pain\" score). Baseline normalized SF-36 values for physical functioning, vitality, and mental health indicated substantial impairment. Baseline fatigue and physical-functioning scores predicted survival as well as, or better than, baseline Karnofsky Performance Status or hemoglobin level. A cut-point in the FACIT-F score (median < or = 30) strongly predicted mortality; patients with greater fatigue had a lower median overall survival than did those with less fatigue. These findings supported several features of an a priori clinical-benefit model. Patient-reported fatigue provided powerful prognostic information; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia. These results must be confirmed by larger trials.","Robinson, D. W., Jr., et al. (2008). \"The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.\" J Support Oncol 6(6): 283-290.","USA",2008,"Cancer","Other Drugs,Infliximab","FACIT-F",null,null,null,"USA",null,"Cancer","Other Drugs,Infliximab",null,null,"FACIT-F","2005:2009"]
[243,"Romito, F., et al. (2014). \"Patients attitudes towards sleep disturbances during chemotherapy.\" Eur J Cancer Care (Engl) 23(3): 385-393.",null,"Romito, F., et al.","Patients attitudes towards sleep disturbances during chemotherapy","Sleep disturbances are among the most distressing symptoms in cancer: they often co-occur with fatigue, pain and psychological distress. Despite the negative impact on quality of life, patients rarely seek help for managing their sleep disturbances. This paper presents the results of a multicentre observational study on patients' attitudes towards their sleep problems. The study also investigates symptom correlates. Patients responded to a semi-structured interview and completed the following questionnaires: Pittsburgh Sleep Quality Index; Brief Fatigue Inventory; Hospital Anxiety and Depression Scale; and European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life QLQ-C30 Questionnaire (QLQ-C30). Four hundred and three cancer patients were enrolled in the study. Bad sleepers constituted 66% of the sample. Thirty-eight per cent of them had not turned to any professional to solve their sleep disturbances because they had various beliefs about the importance of the problem and the possibility to be treated. The main correlates of sleep disturbances were psychological distress, reduced physical functioning and reduced overall quality of life. In conclusion, there is a need to sensitise patients to actively search for a solution to their sleep disturbances so they can be solved along with other co-occurring symptoms. Doctors could also be encouraged to dedicate more attention to routinely asking cancer patients about eventual sleep disturbances.","Romito, F., et al. (2014). \"Patients attitudes towards sleep disturbances during chemotherapy.\" Eur J Cancer Care (Engl) 23(3): 385-393.","Italy",2014,"Cancer","None","BFI",null,null,null,"Italy",null,"Cancer","None",null,null,"BFI","2010:2014"]
[244,"Roncella, A., et al. (2009). \"Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction).\" J Cardiovasc Med (Hagerstown) 10(12): 947-452.",null,"Roncella, A., et al.","Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction)","OBJECTIVE: A number of previous studies addressed the effect of psychological interventions in patients after acute myocardial infarction (AMI), but it is not known whether psychotherapy might be beneficial after medical and interventional therapy of AMI. We designed a randomized, controlled study to assess the effects of a short-term psychotherapy (STP) on the clinical outcomes of patients who underwent an emergency percutaneous coronary intervention after AMI. METHODS: One hundred consecutive patients undergoing an emergency percutaneous coronary intervention will be randomized 1 week after AMI to medical therapy (control group, C group) or to medical therapy and STP (STP group). Clinical follow-up visits are scheduled at 6 months, 1 and 5 years, whereas psychometric tests (Self-Evaluation test, Modified Maastricht Questionnaire, Social Support Questionnaire, Recent Life Change Questionnaire, Beck Depression Inventory, the MacNew Heart Disease Health-Related Quality of Life Questionnaire, Type D Personality test) are scheduled 1 week after AMI and at 1 year. The primary outcome measures of the study are the cumulative incidence of new cardiological events (myocardial reinfarction, death, stroke, life-threatening ventricular arrhythmias, and recurrence of angina) and the occurrence of new medical disorders. Secondary outcome measures are the incidence of rehospitalizations due to cardiological problems, the prevalence of patients with New York Heart Association class > or = II, left ventricular function, as assessed by echocardiography, and mean score of psychometric tests in the two groups at follow-up. CONCLUSION: Our study has been planned to obtain an insight into how a STP influences clinical outcomes after interventional and medical treatment of AMI.","Roncella, A., et al. (2009). \"Rationale and trial design of a randomized, controlled study on short-term psychotherapy after acute myocardial infarction: the STEP-IN-AMI trial (Short Term Psychotherapy in Acute Myocardial Infarction).\" J Cardiovasc Med (Hagerstown) 10(12): 947-452.","Italy",2009,"CVD","Psychobehavioural","Maastricht questionnaire",null,null,null,"Italy",null,"CVD","Psychobehavioural",null,null,"Maastricht questionnaire","2005:2009"]
[245,"Rosen, C. F., et al. (2012). \"Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone.\" Rheumatology (Oxford) 51(3): 571-576.",null,"Rosen, C. F., et al.","Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone","OBJECTIVE: PsA is an inflammatory arthritis present in approximately 30% of people with psoriasis (PsC). Both conditions have a significant impact on quality of life (QoL). Our objective was to test the hypothesis that people with PsA have poorer QoL than patients with PsC because of the added burden of arthritis, age and comorbidities. METHODS: Consecutive patients with PsA (CASPAR criteria) and PsC were approached to participate in this study. Patients with PsC were examined by a rheumatologist using a standardized protocol to exclude PsA. Patients completed the HAQ, Medical Outcome Study 36-item Short Form Health Survey, Dermatology Life Quality Index (DLQI), EuroQoL 5 domains (EQ-5D) and Fatigue Severity Scale (FSS). Mean scores were compared and multivariate analyses were conducted to compare the QoL measures between the two patient groups. RESULTS: Two hundred and one patients with PsC and 201 patients with PsA were studied. A significant decrease in QoL for patients with PsA compared with those with PsC was identified by all questionnaires except for the DLQI. This skin-specific questionnaire revealed a lower QoL in patients with PsC. Multivariate analyses for each QoL measure confirmed the results of these analyses. After adjusting for age, sex, duration of PsC, comorbidities, DMARDs and biologic therapy, HAQ and DLQI were independently associated with PsA in a logistic regression. CONCLUSION: Patients with PsA have a poorer QoL compared with those with PsC as measured by all questionnaires except the DLQI.","Rosen, C. F., et al. (2012). \"Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone.\" Rheumatology (Oxford) 51(3): 571-576.","Canada",2012,"Musculoskeletal","None","FSS",null,null,null,"Canada",null,"Musculoskeletal","None",null,null,"FSS","2010:2014"]
[246,"Rotonda, C., et al. (2011). \"Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study.\" Contemp Clin Trials 32(2): 244-249.",null,"Rotonda, C., et al.","Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study","INTRODUCTION: Breast cancer is by far the most common form of cancer diagnosis in women. Cancer treatments are long, complex and often cumbersome with numerous side effects. Fatigue is now considered as the most distressing side effect of treatment. Fifty-eight percent to 94% of breast cancer patients experience fatigue during treatment with adjuvant chemotherapy. OBJECTIVE: The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effects of the different adjuvant treatments will be explored. RESEARCH DESIGN: A prospective longitudinal study in women diagnosed for the first time with stage I-IIIA breast cancer and who have undergone surgery, has been designed to meet the study aims. Recruitment began in September 2008 and target enrollment completion date is December 2010. (clinicaltrials.gov number, NCT01064427). The MFI-20 (Multidimensional Fatigue Inventory) and the EORTC QLQ-C30 (European Organization for Research and Treatment Quality of Life Questionnaire) will be completed, at several times. The follow-up is planned over a 24-month period. We studied adjuvant chemotherapy regimens with anthracyclines or with anthracycline/taxane combination. The LOR (Life Orientation Test) will be completed only at baseline to estimate the level of optimism of the patient and the STAI (State-Trait Anxiety Questionnaire) will be filled to measure a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening. OUTCOMES: The knowledge of determinants should facilitate screening of fatigue, and its evaluation on consequences on the patients' quality of life would allow physicians better help patients cope with the management of fatigue according to the adjuvant regimen.","Rotonda, C., et al. (2011). \"Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study.\" Contemp Clin Trials 32(2): 244-249.","France",2011,"Cancer","Cancer treatments","MFI",null,null,null,"France",null,"Cancer","Cancer treatments",null,null,"MFI","2010:2014"]
[247,"Ruffer, J. U., et al. (2003). \"Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG).\" Eur J Cancer 39(15): 2179-2186.",null,"Ruffer, J. U., et al.","Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG)","Although treatment regimens for Hodgkin's lymphoma have become more sophisticated, little is known about the prevalence of fatigue in long-term survivors. Therefore, we investigated the fatigue status of long-term survivors of Hodgkin's lymphoma and a control group using a pre-validated questionnaire. In 1995/1996, we contacted 1981 patients, who were enrolled in the German Hodgkin Studies HD 1-6. All patients were treated according to the treatment protocols HD1-3 (1981-1988) and HD 4-6 (1988-1993). The patients with a current status of complete remission were asked to complete a quality-of-life (QoL) questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ C-30)) and a fatigue questionnaire (Multidimensional Fatigue Inventory (MFI)). The results were compared with the data from 935 controls, matched for age, gender and living area. Eight-hundred and eighteen questionnaires from the patients were available for analysis. The median time between the end of treatment and completing the questionnaire is 5.2 years. Fatigue levels of patients with Hodgkin's lymphoma are high, even years after treatment. Fatigue dimensions are significantly influenced by several clinical and non-clinical factors. Fatigue levels of Hodgkin's lymphoma patients are significantly higher than those of the control group. Further investigations are warranted to explore the effectiveness of treatment strategies for fatigue.","Ruffer, J. U., et al. (2003). \"Fatigue in long-term survivors of Hodgkin's lymphoma; a report from the German Hodgkin Lymphoma Study Group (GHSG).\" Eur J Cancer 39(15): 2179-2186.","Germany",2003,"Cancer","None","MFI",null,null,null,"Germany",null,"Cancer","None",null,null,"MFI","2000:2004"]
[248,"Rupp, I., et al. (2004). \"Impact of fatigue on health-related quality of life in rheumatoid arthritis.\" Arthritis Rheum 51(4): 578-585.",null,"Rupp, I., et al.","Impact of fatigue on health-related quality of life in rheumatoid arthritis","OBJECTIVE: To multidimensionally assess fatigue in rheumatoid arthritis (RA) and to evaluate the impact of fatigue on health-related quality of life (HRQOL). METHODS: The study was conducted in 1999 among 490 RA patients with varying disease duration. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and HRQOL with a validated Dutch version of the RAND 36-Item Health Survey. We evaluated the impact of fatigue on HRQOL by multiple linear regression analyses taking into account RA-related pain and depressive symptoms. RESULTS: Different aspects of fatigue selectively explained different dimensions of HRQOL. The MFI-20 was entered last to the linear regression models, resulting in an additional increase of explained variance of 1% (mental health) to 14% (vitality). CONCLUSION: The multidimensional portrayal of RA-related fatigue can be used to develop intervention strategies targeted to specific aspects of fatigue. Fatigue, supplementary to RA-related pain and depressive symptoms, appears to be a feasible and treatable target in the clinical management of RA to increase HRQOL.","Rupp, I., et al. (2004). \"Impact of fatigue on health-related quality of life in rheumatoid arthritis.\" Arthritis Rheum 51(4): 578-585.","Netherlands",2004,"Musculoskeletal","None","MFI",null,null,null,"Netherlands",null,"Musculoskeletal","None",null,null,"MFI","2000:2004"]
[249,"Sabapathy, N. M., et al. (2011). \"Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study.\" Clin Rehabil 25(1): 14-24.",null,"Sabapathy, N. M., et al.","Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study","OBJECTIVE: The purpose of this study was to compare adaptations in functional and quality of life measures following endurance- and resistance-exercise training in people with multiple sclerosis. DESIGN: Cross-over design with an eight-week washout period. SETTING: Community health centre. SUBJECTS: Sixteen individuals with multiple sclerosis. INTERVENTION: Subjects completed both an eight-week endurance- and an eight-week resistance-exercise training programme in a randomized order. The exercise training comprised individualized progressive programmes that were completed twice weekly in a supervised group setting. MAIN MEASURES: Grip strength, functional reach, four step square, timed up and go and six-minute walk tests, Multiple Sclerosis Impact and Modified Fatigue Impact Scales, Becks Depression Inventory and the Health Status Questionnaire Short Form-36. RESULTS: Sixteen of 21 (76%) subjects completed the study. Subjects attended 13.2 +/- 1.6 endurance- and 15.8 +/- 1.9 resistance-exercise training sessions. No adverse events were reported. No significant differences (P < 0.05) in any outcome measures were observed between the two exercise training programmes either at baseline or following the completion of both training programmes. CONCLUSION: Both endurance- and resistance-exercise training were well tolerated and appear to provide similar effects for people with multiple sclerosis, but larger studies are required to confirm these findings.","Sabapathy, N. M., et al. (2011). \"Comparing endurance- and resistance-exercise training in people with multiple sclerosis: a randomized pilot study.\" Clin Rehabil 25(1): 14-24.","Australia",2011,"Neurological","Psychobehavioural","MFI",null,null,null,"Australia",null,"Neurological","Psychobehavioural",null,null,"MFI","2010:2014"]
[250,"Salsman, J. M., et al. (2015). \"Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.\" Support Care Cancer 23(5): 1355-1364.",null,"Salsman, J. M., et al.","Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia","PURPOSE: Cancer anorexia-cachexia syndrome (CACS) is common in advanced cancer patients and associated with weight loss, fatigue, impaired quality of life (QoL), and poor prognosis. The goal of this project was to identify the most responsive items from two QoL measures in the ROMANA 2 (NCT01387282) phase III global study evaluating anamorelin HCl in the treatment of non-small cell lung cancer (NSCLC) cachexia: the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). METHODS: In the ROMANA 2 trial, 477 patients with unresectable stage III or IV NSCLC and cachexia were to be enrolled and randomized (2:1) to receive anamorelin HCl or placebo once daily for 12 weeks. All 203 patients who reached the week 12 visit at the time of data analysis were included. Co-primary endpoints were change from baseline in lean body mass and handgrip strength. QoL was a secondary outcome with FACIT-F and FAACT questionnaires administered at baseline and at weeks 3, 6, 9, and 12. RESULTS: Two 4-item scales (fatigue/activity and appetite/eating) from the FACIT-F and FAACT questionnaires, respectively, demonstrated good internal consistency reliability, validity, and responsiveness (also referred to as the Simplified Evaluation of Fatigue (SEF) and Simplified Evaluation of Appetite (SEA), respectively). The estimated important difference for each scale was 1-2 points. CONCLUSIONS: These brief scales provide the psychometric properties necessary to promote future research in NSCLC patients with CACS. Additional work should examine the clinical utility of these scales and their impact on treatment decision-making.","Salsman, J. M., et al. (2015). \"Brief versions of the FACIT-fatigue and FAACT subscales for patients with non-small cell lung cancer cachexia.\" Support Care Cancer 23(5): 1355-1364.","USA",2015,"Cancer,Various","None","FACIT-F",null,null,null,"USA",null,"Cancer,Various","None",null,null,"FACIT-F","2015:2018"]
[251,"Samuels, N., et al. (2012). \"Acupuncture for symptoms of Gaucher disease.\" Complement Ther Med 20(3): 131-134.",null,"Samuels, N., et al.","Acupuncture for symptoms of Gaucher disease","OBJECTIVE: The purpose of this study was to examine the effect of acupuncture on bone/joint pain, headache and fatigue, as well as quality of life in patients with Gaucher disease (GD), within the framework of an integrated treatment programme. METHODS: Patients with GD suffering from any of the above symptoms were offered a series of 10-12 weekly acupuncture treatment sessions. Prior to initiation of treatment, participants were asked to score the severity of pain, as well as to complete the Functional Assessment of Chronic Illness Therapy-Fatigue measure (FACIT-F) and the Medical Outcomes Study (MOS) Short-Form (SF) questionnaire. These tools were evaluated again at the end of the treatment period. RESULTS: A total of 12 patients were evaluated. While the only pain outcome reduced by acupuncture was knee pain, a significant improvement was observed with respect to nearly all FACIT-Fatigue measures, including the Physical Well Being (PWB) subscales and the SF-12 Physical Composite Score (PCS), though not for the Mental Composite Score (MCS). Patients reported satisfaction with the treatment process, and no significant side effects were reported. CONCLUSION: Acupuncture may play a beneficial role for patients with GD when used in conjunction with conventional therapy, reducing fatigue and improving physical function. The preliminary finding of this observational study should encourage further research.","Samuels, N., et al. (2012). \"Acupuncture for symptoms of Gaucher disease.\" Complement Ther Med 20(3): 131-134.","Israel",2012,"Various","Complementary","FACIT-F",null,null,null,"Israel",null,"Various","Complementary",null,null,"FACIT-F","2010:2014"]
[252,"Sancho, A., et al. (2015). \"Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.\" BMC Cancer 15: 40.",null,"Sancho, A., et al.","Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial","BACKGROUND: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. DESIGN/METHODS: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. DISCUSSION: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.","Sancho, A., et al. (2015). \"Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial.\" BMC Cancer 15: 40.","Spain",2015,"Cancer","Psychobehavioural","FACIT-F",null,null,null,"Spain",null,"Cancer","Psychobehavioural",null,null,"FACIT-F","2015:2018"]
[253,"Sandi, D., et al. (2015). \"The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life.\" Mult Scler Relat Disord 4(6): 499-504.",null,"Sandi, D., et al.","The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life","BACKGROUND: Multiple Sclerosis (MS) causes not only somatic, but also cognitive impairment regardless of the patients age or the course of the disease. The Brief International Cognitive Assessment for MS (BICAMS) test, published in 2011, is a short cognitive questionnaire: a fast, reliable, sensitive and specific tool for the evaluation of the patients cognitive state. OBJECTIVES: Our primary objective was to assess the validity of the Hungarian version of the BICAMS test. Our secondary objective was to evaluate the impact of the cognitive impairment on the patients quality of life and fatigues impact on the patients cognitive state. METHODS: 65 RR-MS patients and 65 age, sex and education matched healthy control (HC) subjects completed the test and were retested after 3 weeks. The patients also completed the MS Quality of Life 54 (MSQoL54) and the Fatigue Impact Scale (FIS) assessments. Group differences were calculated by paired sample T-tests. The test-retest reliability was measured by intraclass correlation coefficients. To analyze the difference between the test-retest performances of the two groups we used two-way repeated measures ANOVA where the BICAMS battery was the single composite outcome and one-way repeated measures ANOVA. To assess the impact of the cognitive decline on the patients quality of life and fatigues impact on the cognitive state, we examined the correlations between results in the BICAMS and the MSQoL54 and FIS. RESULTS: We found significant difference (p </= 0.001, p = 0.017 in the first CVLT-II assessment) between MS patients and members of the HC group in all four evaluated parameters of BICAMS test in both sessions. The correlation coefficients were very strong between the tests and retests (r > 0.8; p < 0.001; r = 0.678, p < 0.001 between the CVLT-II assessments). We found that the HC group performed significantly (p = 0.020) better in the retest sessions as compared to their original performance than the patients did and this difference is solely due to the difference between the CVLT-II performances. We have found significant negative correlation between the patients cognitive function and the fatigue score (r < -0.3, p < 0.05). Seven of the MSQoL-54 subscales correlated with the BICAMS performance (r > 0.3; < 0 .05). CONCLUSIONS: The Hungarian version of the BICAMS test is a valid and reliable method for the evaluation of MS patients cognitive function. It seems that because of the short retest period, the members of the HC group remembered the CVLT-II words thus performed better than the patients did. Also apparently fatigue can have a negative impact on the patients cognitive state, and cognitive impairment could worsen the patients quality of life.","Sandi, D., et al. (2015). \"The Hungarian validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery and the correlation of cognitive impairment with fatigue and quality of life.\" Mult Scler Relat Disord 4(6): 499-504.","UK,Hungary",2015,"Neurological","None","FIS",null,null,null,"UK,Hungary",null,"Neurological","None",null,null,"FIS","2015:2018"]
[254,"Scherber, R., et al. (2011). \"The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.\" Blood 118(2): 401-408.",null,"Scherber, R., et al.","The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients","Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF], coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English [25%], Italian [46%], and Swedish [28%]) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P < .001) and highly reproducible (intraclass correlation coefficient > 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally.","Scherber, R., et al. (2011). \"The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF): international prospective validation and reliability trial in 402 patients.\" Blood 118(2): 401-408.","USA",2011,"Hematological","None","BFI",null,null,null,"USA",null,"Hematological","None",null,null,"BFI","2010:2014"]
[255,"Schneider, R. A. (2004). \"Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers.\" J Clin Nurs 13(2): 219-225.",null,"Schneider, R. A.","Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers","BACKGROUND: Quality of life for caregivers of end-stage renal disease patients has not been well addressed yet the physical and psychological status of this overlooked group can be important in the recovery or adaptation of patients with chronic renal failure, not to mention the caregivers themselves. One particular feature of the overall quality of life of such caregivers is that of fatigue. AIMS AND OBJECTIVES: The purpose of the study was to test the Fatigue Severity Scale for potential usefulness in assessing fatigue among a non-medical population, caregivers of end-stage renal disease patients. METHODS: Subjects completed a short battery of measures at either a dialysis centre or at home. RESULTS: The Short Form-12 of the Short Form-36 and the Center for Epidemiologic Studies Depression Scale accounted for 56% of the variance on the Fatigue Severity Scale. The results suggest that physical fatigue may be more prominent than mental fatigue as a feature of caregiver quality of life. CONCLUSIONS: The Fatigue Severity Scale which has been used for multiple sclerosis patients may prove to be useful as a short assessment of fatigue among the non-medical population of end-stage renal disease caregivers. This may result in improved interventions for the population of caregivers. RELEVANCE TO CLINICAL PRACTICE: Physicians, nurses and allied health professionals will be called on more frequently to assess and intervene with fatigued and overburdened caregivers in addition to patients themselves. A more thorough understanding of the nature of caregiver fatigue may drive changes or innovations with caregivers who are too often overlooked in the current era of scarce resources. Accordingly results of the study suggest that the direction in intervention may focus more on rest and respite as opposed to a need for psychosocial support or counselling. While there are various modes for assessing end-stage renal disease caregivers' fatigue, a simple measure like the Fatigue Severity Scale is brief enough to be administered without undue demand on practitioners or caregivers.","Schneider, R. A. (2004). \"Chronic renal failure: assessing the Fatigue Severity Scale for use among caregivers.\" J Clin Nurs 13(2): 219-225.","USA",2004,"Kidney Disease","None","FSS",null,null,null,"USA",null,"Kidney Disease","None",null,null,"FSS","2000:2004"]
[256,"Schneider, S. M. and L. E. Hood (2007). \"Virtual reality: a distraction intervention for chemotherapy.\" Oncol Nurs Forum 34(1): 39-46.",null,"Schneider, S. M. and L. E. Hood","Virtual reality: a distraction intervention for chemotherapy","PURPOSE/OBJECTIVES: To explore virtual reality (VR) as a distraction intervention to relieve symptom distress in adults receiving chemotherapy treatments for breast, colon, and lung cancer. DESIGN: Crossover design in which participants served as their own control. SETTING: Outpatient clinic at a comprehensive cancer center in the southeastern United States. SAMPLE: 123 adults receiving initial chemotherapy treatments. METHODS: Participants were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and then received no intervention (control) during an alternate matched chemotherapy treatment. The Adapted Symptom Distress Scale-2, Revised Piper Fatigue Scale, and State Anxiety Inventory were used to measure symptom distress. The Presence Questionnaire and an open-ended questionnaire were used to evaluate the subjects' VR experience. The influence of type of cancer, age, and gender on symptom outcomes was explored. Mixed models were used to test for differences in levels of symptom distress. MAIN RESEARCH VARIABLES: Virtual reality and symptom distress. FINDINGS: Patients had an altered perception of time (p < 0.001) when using VR, which validates the distracting capacity of the intervention. Evaluation of the intervention indicated that patients believed the head-mounted device was easy to use, they experienced no cyber-sickness, and 82% would use VR again. However, analysis demonstrated no significant differences in symptom distress immediately or two days following chemotherapy treatments. CONCLUSIONS: Patients stated that using VR made the treatment seem shorter and that chemotherapy treatments with VR were better than treatments without the distraction intervention. However, positive experiences did not result in a decrease in symptom distress. The findings support the idea that using VR can help to make chemotherapy treatments more tolerable, but clinicians should not assume that use of VR will improve chemotherapy-related symptoms. IMPLICATIONS FOR NURSING: Patients found using VR during chemotherapy treatments to be enjoyable. VR is a feasible and cost-effective distraction intervention to implement in the clinical setting.","Schneider, S. M. and L. E. Hood (2007). \"Virtual reality: a distraction intervention for chemotherapy.\" Oncol Nurs Forum 34(1): 39-46.","USA",2007,"Cancer","Psychobehavioural","PFS",null,null,null,"USA",null,"Cancer","Psychobehavioural",null,null,"PFS","2005:2009"]
[257,"Schwartz, T. L., et al. (2004). \"An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy.\" J Clin Psychiatry 65(9): 1223-1227.",null,"Schwartz, T. L., et al.","An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy","OBJECTIVE: In patients with major depressive disorder (MDD), excessive sleepiness and fatigue not only are major components of the disorder, but also may occur as side effects of antidepressant therapy. In addition, sedation may be a consequence of antidepressant regimens. The novel wake-promoting agent modafinil improves wakefulness and reduces fatigue across a variety of clinical disorders. This study assessed the use of modafinil as an adjunctive treatment in patients with MDD who reported sedation related to serotonergic antidepressant therapy. METHOD: Data were collected between September 2001 and December 2003. Twenty men and women with DSM-IV-defined MDD were enrolled in this 3-week, open-label, single-center study. In addition to ongoing and stable treatment with selective serotonin reuptake inhibitors (SSRIs), clinic patients received modafinil once daily. Efficacy assessments were conducted at 1-week intervals. RESULTS: Sixteen patients (80%) completed the study. Modafinil plus SSRIs significantly improved overall depressive symptoms, as shown by reductions in mean Hamilton Rating Scale for Depression total scores (p <.001 vs. baseline). Adjunctive modafinil significantly improved subjective estimates of wakefulness on the Epworth Sleepiness Scale (p <.001, all weeks) and reduced fatigue on the Fatigue Severity Scale (p =.009). At the final visit, modafinil had improved overall health status and health-related quality of life, as shown by significant improvements in mean Medical Outcomes Study Short-Form 12-Item Health Survey total scores (p =.007) and in physical health (p =.04) and mental health (p =.006) subscores. CONCLUSION: In patients with MDD who experience sedation as a side effect of antidepressant therapy, adjunctive modafinil improved wakefulness and reduced fatigue. Modafinil plus SSRIs also improved mood and quality of life.","Schwartz, T. L., et al. (2004). \"An open-label study of adjunctive modafinil in patients with sedation related to serotonergic antidepressant therapy.\" J Clin Psychiatry 65(9): 1223-1227.","USA",2004,"Mental health","Other Drugs","FSS",null,null,null,"USA",null,"Mental Health","Other Drugs",null,null,"FSS","2000:2004"]
[258,"Schwarz, R., et al. (2003). \"Fatigue in the general population.\" Onkologie 26(2): 140-144.",null,"Schwarz, R., et al.","Fatigue in the general population","BACKGROUND: Fatigue symptoms are often found in cancer patients. One test to assess fatigue is the Multidimensional Fatigue Inventory (MFI-20). It has been successfully applied to specific groups of cancer patients. However, until now population-based norm values are missing. METHODS: We conducted an investigation on a representative sample of the adult German population, which comprised 2,037 subjects aged 14-92 years. RESULTS: The reliability of the 5 MFI-20 subscales (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) is satisfying. The correlations between MFI-20 subscales and the fatigue scale of the quality-of-life questionnaire EORTC indicate convergent validity. As an important result we found that all subscales of the MFI-20 showed a clear and nearly linear dependency on age with higher fatigue values for older subjects (p < 0.0001). Females as compared with males are characterized by higher mean values in all MFI-20 subscales (p < 0.001). CONCLUSIONS: The results show that it is necessary to take into account age and sex when different groups of cancer patients have to be compared.","Schwarz, R., et al. (2003). \"Fatigue in the general population.\" Onkologie 26(2): 140-144.","Germany",2003,"Cancer","None","MFI",null,null,null,"Germany",null,"Cancer","None",null,null,"MFI","2000:2004"]
[259,"Scott, J., et al. (2014). \"Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection.\" BMC Infect Dis 14: 465.",null,"Scott, J., et al.","Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection","BACKGROUND: Fatigue is a common symptom of chronic hepatitis C virus (HCV) infection and a frequent side-effect of peginterferon/ribavirin (PR) therapy for HCV. This study evaluated the impact of adding the oral HCV NS3/4A protease inhibitor simeprevir to PR on patient-reported fatigue and health status among patients with chronic HCV genotype 1 infection enrolled in the Phase IIb PILLAR and ASPIRE trials [NCT00882908; NCT00980330]. METHODS: Treatment-naive patients (PILLAR, n = 386) and treatment-experienced patients (ASPIRE, n = 462) were randomized to simeprevir plus PR (simeprevir/PR) or placebo plus PR (placebo/PR). In PILLAR, duration of PR treatment in the simeprevir/PR groups was determined using response-guided therapy (RGT) criteria. PR could be terminated at Week 24, instead of Week 48, if HCV RNA was <25 IU/mL by Week 4 and then undetectable at Weeks 12, 16, and 20. In both studies, patients completed the Fatigue Severity Scale (FSS) and EQ-5D quality-of-life questionnaire in their native language at baseline and throughout the studies up until Week 72. RESULTS: During the first 24 weeks of treatment, mean FSS total score was increased to a similar degree compared with baseline among patients receiving simeprevir/PR or placebo/PR in both studies indicating increased fatigue severity. Mean FSS scores returned to values comparable with baseline among patients receiving simeprevir/PR after Week 24 in PILLAR (after treatment completion for the majority of patients) and in ASPIRE (after Week 48), consistent with RGT enabling early termination of all treatment at Week 24 in 82.2% of simeprevir/PR-treated patients in the PILLAR study. Similar results were observed for EQ-5D, with simeprevir/PR-treated patients experiencing less time with worse health problems according to EQ-5D scores compared with placebo/PR groups in both studies, and more rapid improvement in health status associated with shorter treatment duration in the PILLAR study. CONCLUSIONS: Combination of simeprevir with PR did not increase patient-reported fatigue severity or health status impairments beyond that reported by patients treated with PR alone. Many patients treated with simeprevir/PR returned to pretreatment fatigue and health status levels sooner due to increased treatment efficacy that enabled shorter duration of all therapy, compared with PR alone.","Scott, J., et al. (2014). \"Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection.\" BMC Infect Dis 14: 465.","UK",2014,"Infectious disease","Simeprevir","FSS",null,null,null,"UK",null,"Infectious Disease","Simeprevir",null,null,"FSS","2010:2014"]
[260,"Seyidova-Khoshknabi, D., et al. (2011). \"Review article: a systematic review of cancer-related fatigue measurement questionnaires.\" Am J Hosp Palliat Care 28(2): 119-129.",null,"Seyidova-Khoshknabi, D., et al.","Review article: a systematic review of cancer-related fatigue measurement questionnaires","PURPOSE: Cancer-related fatigue (CRF) is a common symptom experienced by patients in all stages and in cancer survivors. The main objectives of this review were to identify validated CRF instruments, and populations in whom these tools have been validated. METHODS: We used a systematic review methodology. Three separate searches were performed using different MeSH terms in Pub Med and Ovid databases. Articles were analyzed for validation and reliability. RESULTS: A total of 1453 papers from 3 different searches identified 40 instruments (3 unidimensional and 37 multidimensional). Instruments varied by psychometric properties, items, scale, dimension, cancer site, and population. Five were optimally tested for validity and reliability. Completion rates, sensitivity to change, and test-retest reliability were reported for a few. DISCUSSION: Most tools had been validated in mixed populations and are relatively insensitive to differences in fatigue to cancer stage. Most instruments are burdensome for those with advanced cancer. The Brief Fatigue Inventory and 3 fatigue items of the European Organization for Research and Treatment Quality of Life Questionnaire Fatigue Scale (EORTC QLQ-C30) are optimal instruments in advanced cancer. CONCLUSIONS: In all, 40 CRF instruments were identified. Validity and reliability varied by questionnaire. The ideal item numbers, scale, and domains are not established and may be population dependent.","Seyidova-Khoshknabi, D., et al. (2011). \"Review article: a systematic review of cancer-related fatigue measurement questionnaires.\" Am J Hosp Palliat Care 28(2): 119-129.","USA",2011,"Cancer","None","BFI",null,null,null,"USA",null,"Cancer","None",null,null,"BFI","2010:2014"]
[261,"Shinto, L., et al. (2008). \"A randomized pilot study of naturopathic medicine in multiple sclerosis.\" J Altern Complement Med 14(5): 489-496.",null,"Shinto, L., et al.","A randomized pilot study of naturopathic medicine in multiple sclerosis","BACKGROUND: Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. OBJECTIVE: To assess quality of life in MS subjects who received interventions designed to \"model\" the \"whole practice\" of naturopathy. DESIGN: A pilot, randomized, controlled study with a 6-month intervention period. PARTICIPANTS: Participants who met criteria for clinically definite MS. INTERVENTIONS: The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. OUTCOME MEASURES: The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. RESULTS: Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. CONCLUSIONS: Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.","Shinto, L., et al. (2008). \"A randomized pilot study of naturopathic medicine in multiple sclerosis.\" J Altern Complement Med 14(5): 489-496.","USA",2008,"Neurological","Complementary","MFI",null,null,null,"USA",null,"Neurological","Complementary",null,null,"MFI","2005:2009"]
[262,"Simmonds, M. J., et al. (2005). \"The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus.\" Clin J Pain 21(3): 200-206.",null,"Simmonds, M. J., et al.","The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus","OBJECTIVES: The purposes of this study were to: 1) characterize physical performance in individuals with human immunodeficiency virus; and 2) examine group differences by pain and fatigue on a multivariate profile of disease, physical, and psychologic symptoms. METHODS: One hundred outpatients, 78 men and 22 women (mean age 40.70 +/- 7.49 years) participated. Patients completed a battery of physical performance tests in which the time taken or the distance reached or walked was measured. Self-report questionnaires included measures of pain (0-10 numerical rating scale), fatigue (Brief Fatigue Inventory), and perceived health status (Medical Outcomes Survey-HIV scale). RESULTS: Physical performance was compromised in a task specific manner. Patients took twice as long as healthy individuals on a belt-tie and 4 times as long on a sit-to-stand task and in 6 minutes walked 75% of the distance covered by healthy individuals. Fifty percent of patients (n = 50) had pain at the time of testing (mean 6.3 +/- 2.4), and 98% had fatigue (mean 5.4 +/- 2.3). Multivariate analysis of variance showed pain had a greater influence on performance than fatigue. Pain, distance walked in 6 minutes, and unloaded forward reach accounted for 26% of the variability in quality of life (r = 0.51, P < or = 0.0001). DISCUSSION: Pain has a substantial impact on physical performance and quality of life among ambulatory human immunodeficiency virus patients. Fatigue also impacts physical performance. Compromised ability to perform certain physical tasks affects quality of life. Further investigation of the roles of these relevant variables should be investigated in path analyses.","Simmonds, M. J., et al. (2005). \"The differential influence of pain and fatigue on physical performance and health status in ambulatory patients with human immunodeficiency virus.\" Clin J Pain 21(3): 200-206.","UK",2005,"Infectious disease","None","BFI",null,null,null,"UK",null,"Infectious Disease","None",null,null,"BFI","2005:2009"]
[263,"Small, S. P. and M. Lamb (2000). \"Measurement of fatigue in chronic obstructive pulmonary disease and in asthma.\" Int J Nurs Stud 37(2): 127-133.",null,"Small, S. P. and M. Lamb","Measurement of fatigue in chronic obstructive pulmonary disease and in asthma","Despite recognition of a high prevalence of fatigue in individuals with chronic airflow obstruction conditions, including chronic obstructive pulmonary disease and asthma, and its importance from a quality of life perspective, no research was found in which fatigue was measured directly in these populations. This may be due to a seeming lack of appropriate instruments for measuring fatigue in these populations. The purpose of this study, therefore, was to pretest an instrument, the Piper Fatigue Scale, which was developed to measure chronic fatigue in clinical populations. The outpatient sample consisted of 17 persons with chronic obstructive pulmonary disease and 19 with asthma. Findings revealed that the visual analogue scale version of the Piper Fatigue Scale may not be appropriate for measuring fatigue in these populations. Instruments with validity and reliability for fatigue in chronic obstructive pulmonary disease and asthma need to be developed.","Small, S. P. and M. Lamb (2000). \"Measurement of fatigue in chronic obstructive pulmonary disease and in asthma.\" Int J Nurs Stud 37(2): 127-133.","Canada",2000,"Respiratory Disease","None","PFS",null,null,null,"Canada",null,"Respiratory Disease","None",null,null,"PFS","2000:2004"]
[264,"Smith, S. K., et al. (2015). \"Evaluation of Pillars4life: a virtual coping skills program for cancer survivors.\" Psychooncology 24(11): 1407-1415.",null,"Smith, S. K., et al.","Evaluation of Pillars4life: a virtual coping skills program for cancer survivors","OBJECTIVE: Pillars4Life is an educational program that teaches coping skills to cancer patients in a virtual group setting; it was recently implemented at 17 hospitals across the USA. The cost-effective, scalable, and assessable Pillars4Life curriculum targets psychosocial resources (e.g., self-efficacy and coping skills) as a means to reduce symptoms (e.g., depression, anxiety, and posttraumatic stress) and enhance quality of life. METHODS: Cancer patients were recruited from hospitals that received the LIVESTRONG Community Impact Project Award to enroll in a pilot study of Pillars4Life. Consenting participants met with a certified instructor weekly for 10 weeks in a virtual environment; the manualized intervention trained participants in personal coping skills. Longitudinal assessments over 6 months were assessed using validated instruments to determine changes in Pillars4Life targeted resources and outcomes. Multiple linear regression models examined the relationship between changes in targeted resources and changes in outcome from baseline to 3 months post-intervention. RESULTS: Participants (n = 130) had the following characteristics: mean age of 56 +/- 11 years, 87% women, 11% non-Caucasian, and 77% with college degree. At 3- and 6-month follow-up, mean scores improved on all key outcome measures such as depression (Patient Health Questionnaire), anxiety (Generalized Anxiety Disorder), posttraumatic stress (Posttraumatic Stress Disorder Checklist), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and well-being (Functional Assessment of Cancer Therapy-General) from baseline (all p < 0.01); results were most pronounced among participants who reported >/=4/10 on the Distress Thermometer at baseline (all p < 0.001). Changes in each targeted resource were associated with 3-month improvements in at least one outcome. CONCLUSIONS: Participation in the Pillars4Life program was associated with statistically and clinically significant improvements in scores on pre-specified outcomes and targeted resources.","Smith, S. K., et al. (2015). \"Evaluation of Pillars4life: a virtual coping skills program for cancer survivors.\" Psychooncology 24(11): 1407-1415.","USA",2015,"Cancer","Psychobehavioural","FACIT-F",null,null,null,"USA",null,"Cancer","Psychobehavioural",null,null,"FACIT-F","2015:2018"]
[265,"Snel, M., et al. (2012). \"Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise.\" Eur J Intern Med 23(2): 143-149.",null,"Snel, M., et al.","Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise","OBJECTIVE: To evaluate whether the addition of exercise to a very low calorie diet (VLCD) has beneficial short- and long-term effects on health-related quality of life (QoL) in obese patients with type 2 diabetes mellitus (T2DM). METHODS: We included 27 obese, insulin-dependent T2DM patients in a 16-week VLCD study, of whom 13 participated simultaneously in an exercise program (VLCD+E). Before, immediately after and 18 months after the intervention anthropometric measurements, glucoregulation and QoL (SF-36, HADS, NHP and MFI-20) were assessed. Patients were compared to healthy lean and obese (matched for body mass index) controls matched for gender and age. RESULTS: At baseline, T2DM patients had significantly worse QoL scores in 18 and 14 of the 22 subscales of the QoL questionnaires, compared to lean and obese controls, resp. The 16-week VLCD (n=27) decreased bodyweight (-25.4+/-1.3 kg, p<0.0001, p=0.179 between groups), and improved glucoregulation (HbA1c -1.3+/-0.3%, p<0.0001, p=0.488 between groups) and 9 (VLCD-only) and 11 (VLCD+E) of the 22 subscales of QoL. After 18 months, in the VLCD+E group the QoL subscales did not differ from those in obese controls and only 4 of the 22 subscales were significantly worse compared to lean controls. However, in the VLCD-only group 17 and 13 of the 22 QoL subscales were significantly worse compared to the lean and obese controls, resp. CONCLUSION: A 16-week VLCD induces considerable weight loss, metabolic amelioration, and major improvements in QoL in obese T2DM patients. The addition of exercise is of paramount importance for the maintenance of better QoL.","Snel, M., et al. (2012). \"Quality of life in type 2 diabetes mellitus after a very low calorie diet and exercise.\" Eur J Intern Med 23(2): 143-149.","Netherlands",2012,"Various","Psychobehavioural","MFI",null,null,null,"Netherlands",null,"Various","Psychobehavioural",null,null,"MFI","2010:2014"]
[266,"So, W. K., et al. (2003). \"Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation.\" Cancer Nurs 26(3): 211-219; quiz 220-211.",null,"So, W. K., et al.","Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation","Fatigue is reported to be a major symptom for many patients with cancer. However, little is known about this symptom among Chinese people who have cancer. A cross-sectional design was used to examine the intensity of fatigue in patients who underwent bone marrow transplantation for a hematologic malignancy, and to determine whether fatigue affected the quality of life in a Chinese sample (N = 157). The Revised Piper Fatigue Scale-Chinese Version was used to measure fatigue, and the Chinese version of the SF-36 Health Survey was used to measure quality of life. Overall, the subjects perceived a moderate level of fatigue (mean total fatigue score, 4.7 +/- 1.7). More than 15% reported experiencing a high level of fatigue. Subjects more likely to perceive a high level of fatigue were older, married, not employed, and on lower incomes. On post hoc tests, the group with a high level of fatigue scored significantly lower on quality-of-life domains than the other two groups (P <.05). The results may help nurses working with Chinese populations in identifying patients at risk for increased fatigue and in planning fatigue-relieving strategies.","So, W. K., et al. (2003). \"Fatigue and quality of life among Chinese patients with hematologic malignancy after bone marrow transplantation.\" Cancer Nurs 26(3): 211-219; quiz 220-211.","China",2003,"Cancer","Cancer treatments","PFS",null,null,null,"China",null,"Cancer","Cancer treatments",null,null,"PFS","2000:2004"]
[267,"So, W. K., et al. (2009). \"The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study.\" Oncol Nurs Forum 36(4): E205-214.",null,"So, W. K., et al.","The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study","PURPOSE/OBJECTIVES: To examine the symptom cluster of fatigue, pain, anxiety, and depression and its effect on the quality of life (QOL) of women receiving chemotherapy or radiotherapy for breast cancer. DESIGN: Descriptive. SETTING: Oncology outpatient sections of four public hospitals in Hong Kong. SAMPLE: 215 ethnic Chinese women who were midway through treatment for breast cancer. METHODS: Chinese versions of the Brief Fatigue Inventory, Hospital Anxiety and Depression Scale, Brief Pain Inventory, Functional Assessment of Chronic Illness Therapy for Breast Cancer, and Medical Outcomes Study Social Support Survey were used. Spearman rho correlation and structural equation modeling were used to examine the relationships among the study variables. MAIN RESEARCH VARIABLES: Breast cancer, fatigue, pain, anxiety, depression, and QOL. FINDINGS: Most participants reported mild-to-moderate levels of fatigue and pain. Twenty-one percent and 36% of patients might have had an anxiety or depression disorder, respectively. Significant correlations among the four symptoms supported the existence of the symptom cluster. The participants receiving chemotherapy had inadequate social support, experienced higher levels of symptoms, and were more likely to have a poorer QOL. CONCLUSIONS: The findings supported the existence of the symptom cluster that had detrimental effects on QOL. IMPLICATIONS FOR NURSING: This study shed light on a contemporary approach of grouping several related symptoms together. The findings enhance nurses' clinical sensitivity when identifying patients in high-risk groups and provide useful information for designing and prioritizing symptom-management strategies to meet patients' needs.","So, W. K., et al. (2009). \"The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study.\" Oncol Nurs Forum 36(4): E205-214.","China",2009,"Cancer","None","BFI,FACIT-F",null,null,null,"China",null,"Cancer","None",null,null,"BFI,FACIT-F","2005:2009"]
[268,"Srisurapanont, M., et al. (2013). \"Clinical features of depression in Asia: results of a large prospective, cross-sectional study.\" Asia Pac Psychiatry 5(4): 259-267.",null,"Srisurapanont, M., et al.","Clinical features of depression in Asia: results of a large prospective, cross-sectional study","INTRODUCTION: The objective of this study was to investigate the clinical features of depression in Asian patients. METHODS: It was a cross-sectional, observational study of depression in China, Korea, Malaysia, Singapore, Taiwan, and Thailand. Participants were drug-free outpatients with depressed mood and/or anhedonia. Symptoms and clinical features were assessed using the Montgomery-Asberg Depression Rating Scale, Symptoms Checklist 90-Revised (SCL-90-R), and the Fatigue Severity Scale. Other measures included the Medical Outcome Survey 36-Item Short-Form Health Survey (SF-36), the Sheehan Disability Scale, and the Multidimensional Scale of Perceived Social Support (MSPSS). RESULTS: A total of 547 outpatients with major depressive disorder were included in the analyses. Among the Montgomery-Asberg Depression Rating Scale symptoms, \"reported sadness\" and \"reduced sleep\" had the highest severity, with means (SDs) of 3.4 (1.2) and 3.4 (1.6), respectively. Apart from the SCL-90-R depression and anxiety domains, the SCL-90-R obsession-compulsion syndrome had the highest domain score, with a mean (SD) of 1.9 (0.9). Among eight domains, the mean (SD) SF-36 pain subscale score of 58.4 (27.7) was only second to that for the SF-36 physical function. In comparison to other disability domains, the Sheehan Disability Scale work/school had the highest subscale score, with a mean (SD) of 6.5 (2.9). The mean (SD) MSPSS \"family\" subscale score of 4.7 (1.7) was higher than the MSPSS \"friends\" and \"significant others\" subscale scores. DISCUSSION: This study suggests that pain has a minimal impact on the quality of life in Asian patients with depression. Noteworthy issues in this population may include insomnia, obsessive-compulsive symptoms, working/school disability, and family support.","Srisurapanont, M., et al. (2013). \"Clinical features of depression in Asia: results of a large prospective, cross-sectional study.\" Asia Pac Psychiatry 5(4): 259-267.","Thailand",2013,"Mental health","None","FSS",null,null,null,"Thailand",null,"Mental Health","None",null,null,"FSS","2010:2014"]
[269,"Stachler, R. J., et al. (2014). \"PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool.\" Laryngoscope 124(6): 1368-1376.",null,"Stachler, R. J., et al.","PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool","OBJECTIVES/HYPOTHESIS: The objective of this study was to evaluate the Patient-Reported Outcomes Measure Information System (PROMIS) in a head and neck cancer patient cohort by assessing the associations of the PROMIS instruments with the responses to the European Oncology Research and Treatment of Cancer (EORTC) general measures, EORTC head and neck (H&N) measures, and Voice Handicap Index (VHI-10). We hypothesized that PROMIS scores are related to the other measures and may be used as assessment tools to help determine quality-of-life outcomes in head and neck cancer patients. STUDY DESIGN: Prospective baseline assessment of quality-of-life outcomes. METHODS: Thirty-nine head and neck cancer patients were included in the study. PROMIS (domains of fatigue, physical functioning, sleep disturbance, sleep-related impairment, and negative perceived cognitive function, EORTC (general), EORTC H&N, and the VHI-10 were given to all patients at the onset of their cancer diagnosis. Spearman correlation coefficients were computed to assess relationships between the measures. Correlations with corresponding P values <.0083 (Bonferroni adjustment) were considered statistically significant. Descriptive statistics of means, standard deviations, medians, and ranges were computed for all the instruments and measures. RESULTS: Significant correlations between the PROMIS instruments and EORTC functional scales were observed. The PROMIS instruments were also associated with some of the EORTC symptom scales, as well as some of the EORTC H&N symptoms measures. PROMIS fatigue instrument was significantly correlated with the VHI-10 measure. CONCLUSIONS: PROMIS instruments are reasonable measures to determine quality-of-life outcomes in head and neck cancer patients. Computerized adaptive testing devices can be effectively utilized in this patient population. LEVEL OF EVIDENCE: 2c.","Stachler, R. J., et al. (2014). \"PROMIS evaluation for head and neck cancer patients: a comprehensive quality-of-life outcomes assessment tool.\" Laryngoscope 124(6): 1368-1376.","USA",2014,"Cancer","None","PROMIS-F",null,null,null,"USA",null,"Cancer","None",null,null,"PROMIS-F","2010:2014"]
[270,"Sterkenburg, A. S., et al. (2015). \"Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes.\" Neuro Oncol 17(7): 1029-1038.",null,"Sterkenburg, A. S., et al.","Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes","BACKGROUND: Quality of life (QoL) and long-term prognosis are frequently, and often severely, impaired in craniopharyngioma (CP) patients. Knowledge of risk factors for long-term outcome is important for optimization of treatment. METHODS: Overall survival (OS) and progression-free survival (PFS), body mass index (BMI), neuropsychological status (EORTCQLQ-C30, MFI-20), and psychosocial status were analyzed in 261 patients with childhood-onset CP diagnosed before 2000 and longitudinally observed in HIT-Endo. RESULTS: Twenty-year OS was lower (P = .006) in CP with hypothalamic involvement (HI) (n = 132; 0.84 +/- 0.04) when compared with CP without HI (n = 82; 0.95 +/- 0.04). OS was not related to degree of resection, sex, age at diagnosis, or year of diagnosis (before/after 1990). PFS (n = 168; 0.58 +/- 0.05) was lower in younger patients (<5 y at diagnosis) (n = 30; 0.39 +/- 0.10) compared with patients aged 5-10 years (n = 66; 0.52 +/- 0.08) and older than 10 years (n = 72; 0.77 +/- 0.06) at diagnosis. PFS was not associated with HI, degree of resection, or sex. HI led to severe weight gain during the first 8-12 years of follow-up (median BMI increase: +4.59SD) compared with no HI (median increase: +1.20SD) (P = .00). During >12 years of follow-up, patients with HI presented no further increase in BMI. QoL in CP patients with HI was impaired by obesity, physical fatigue, reduced motivation, dyspnea, diarrhea, and nonoptimal psychosocial development. CONCLUSIONS: OS and QoL are impaired by HI in long-term survivors of CP. HI is associated with severe obesity, which plateaus after 12 years. OS/PFS are not related to degree of resection, but gross-total resection should be avoided in cases of HI to prevent further hypothalamic damage, which exacerbates sequelae.","Sterkenburg, A. S., et al. (2015). \"Survival, hypothalamic obesity, and neuropsychological/psychosocial status after childhood-onset craniopharyngioma: newly reported long-term outcomes.\" Neuro Oncol 17(7): 1029-1038.","Germany",2015,"Various","None","MFI",null,null,null,"Germany",null,"Various","None",null,null,"MFI","2015:2018"]
[271,"Sternberg, C. N., et al. (2013). \"Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.\" Ann Oncol 24(4): 1017-1025.",null,"Sternberg, C. N., et al.","Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy","BACKGROUND: Fatigue is a common, debilitating side-effect of prostate cancer and its treatment. Patient-reported fatigue was evaluated as part of COU-AA-301, a randomized, placebo-controlled, phase III trial of abiraterone acetate and prednisone versus placebo and prednisone in metastatic castration-resistant prostate cancer (mCRPC) patients after docetaxel chemotherapy. This is the first phase III study in advanced prostate cancer to evaluate fatigue outcomes using a validated fatigue-specific instrument. PATIENTS AND METHODS: The Brief Fatigue Inventory (BFI) questionnaire was used to measure patient-reported fatigue intensity and fatigue interference with activities of daily life. All analyses were conducted using prespecified responder definitions of clinically meaningful changes. RESULTS: A total of 797 patients were randomized to abiraterone acetate and prednisone, and 398 were randomized to placebo and prednisone. Compared with prednisone alone, in patients with clinically significant fatigue at baseline, abiraterone acetate and prednisone significantly increased the proportion of patients reporting improvement in fatigue intensity (58.1% versus 40.3%, P = 0.0001), improved fatigue interference (55.0% versus 38.0%, P = 0.0075), and accelerated improvement in fatigue intensity (median 59 days versus 194 days, P = 0.0155). CONCLUSIONS: In patients with mCRPC progressing after docetaxel chemotherapy, abiraterone acetate and prednisone yielded clinically meaningful improvements in patient-reported fatigue compared with prednisone alone.","Sternberg, C. N., et al. (2013). \"Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy.\" Ann Oncol 24(4): 1017-1025.","Italy",2013,"Cancer","Other Drugs","BFI",null,null,null,"Italy",null,"Cancer","Other Drugs",null,null,"BFI","2010:2014"]
[272,"Stobaus, N., et al. (2015). \"Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy.\" Nutr Cancer 67(5): 818-824.",null,"Stobaus, N., et al.","Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy","Cancer patients, in general, suffer from anorexia hence diminished nutritional intake. In a prospective observational study, we investigated the impact of recent energy and protein intake on cancer-related fatigue and 6-month mortality in patients undergoing chemotherapy. Recent protein and energy intake was assessed by 24-h recall in 285 patients. Cancer-related fatigue was determined by Brief Fatigue Inventory, and fat free mass index (FFMI) was assessed with bioelectrical impedance analysis. Symptoms with the validated German version of European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (30 questions) and 6-month mortality was documented. Risk factors of cancer-related fatigue and predictors of mortality were investigated with logistic regression analysis and stepwise Cox regression analysis, respectively. Low protein intake (<1 g/kg body weight) was found in 66% of patients, who were characterized by higher age, weight, and body mass index. Recent protein intake emerged as the strongest contributor to cancer-related fatigue followed by nausea/vomiting, insomnia, and age. Reduced protein intake, male sex, number of comorbidities, and FFMI were identified as significant predictors for increased 6-month mortality. In conclusion, a low recent protein intake assessed by 24-h recall is associated with a more than twofold higher risk of cancer-related fatigue and 6-month mortality. Every effort should be taken to assess and guarantee proper nutritional intake in patients undergoing chemotherapy.","Stobaus, N., et al. (2015). \"Low Recent Protein Intake Predicts Cancer-Related Fatigue and Increased Mortality in Patients with Advanced Tumor Disease Undergoing Chemotherapy.\" Nutr Cancer 67(5): 818-824.","Germany",2015,"Cancer","None","BFI",null,null,null,"Germany",null,"Cancer","None",null,null,"BFI","2015:2018"]
[273,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.","UK",2001,"Cancer","Cancer treatments","Bidimensional Fatigue Scale,FSS",null,null,null,"UK",null,"Cancer","Cancer treatments",null,null,"Bidimensional Fatigue Scale,FSS","2000:2004"]
[274,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.","UK",2001,"Cancer","Cancer treatments","FSS,Bidimensional Fatigue Scale",null,null,null,"UK",null,"Cancer","Cancer treatments",null,null,"FSS,Bidimensional Fatigue Scale","2000:2004"]
[275,"Strand, V., et al. (2012). \"Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.\" Rheumatology (Oxford) 51(10): 1860-1869.",null,"Strand, V., et al.","Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study","OBJECTIVE: To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis). METHODS: In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed. RESULTS: At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P=0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P<0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P=0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P=0.0100), HAQ-DI (P=0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9-84.9% vs 35.0-51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2-51.2% vs 10-20.7% and 10.7-37.5% vs 0.0-3.4%, respectively). CONCLUSION: Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports. Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522.","Strand, V., et al. (2012). \"Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.\" Rheumatology (Oxford) 51(10): 1860-1869.","USA",2012,"Musculoskeletal","Tocilizumab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Tocilizumab",null,null,"FACIT-F","2010:2014"]
[276,"Strand, V., et al. (2015). \"Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial.\" Arthritis Care Res (Hoboken) 67(4): 475-483.",null,"Strand, V., et al.","Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial","OBJECTIVE: To assess patient-reported outcomes (PROs) for tofacitinib, an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA), in a 6-month, phase III, randomized controlled trial. METHODS: Patients ages >/=18 years with active RA with an inadequate response to >/=1 tumor necrosis factor inhibitor (TNFi) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily, or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3. PROs measured at month 3 included patient global assessment of disease activity (PtGA), pain, Health Assessment Questionnaire (HAQ) disability index (DI), Medical Outcomes Study (MOS) Short Form 36 Health Survey version 2 (SF-36v2; acute), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and MOS Sleep Scale. RESULTS: Patients received tofacitinib 5 mg (n = 133) or 10 mg (n = 134) or placebo advanced to tofacitinib 5 mg (n = 66) or 10 mg (n = 66). HAQ DI (reported previously), PtGA (P < 0.0001), and SF-36v2 physical and mental component summary (P < 0.05) scores were improved for both tofacitinib doses versus placebo. Furthermore, improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib-treated patients versus placebo for PtGA (P < 0.05), pain (P < 0.0001), HAQ DI (P < 0.05), SF-36v2 physical and mental component summary scores (P < 0.05), and FACIT-F (P < 0.001 for 5 mg twice daily). No statistical differences were observed in the MOS Sleep Scale. CONCLUSION: Tofacitinib treatment resulted in significant, clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi.","Strand, V., et al. (2015). \"Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial.\" Arthritis Care Res (Hoboken) 67(4): 475-483.","USA",2015,"Musculoskeletal","Tofactinib","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Tofactinib",null,null,"FACIT-F","2015:2018"]
[277,"Strand, V., et al. (2016). \"Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial.\" Arthritis Res Ther 18: 198.",null,"Strand, V., et al.","Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial","BACKGROUND: Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR). These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT. METHODS: Patients (n = 1197) were randomized to receive placebo, sarilumab 150 or 200 mg subcutaneously + MTX every 2 weeks for 52 weeks; after 16 weeks, patients without >/=20 % improvement from baseline in swollen or tender joint counts on two consecutive assessments were offered open-label treatment. PROs included patient global assessment of disease activity (PtGA), pain, health assessment questionnaire disability index (HAQ-DI), Short Form-36 Health Survey (SF-36), and functional assessment of chronic illness therapy-fatigue (FACIT-F). Changes from baseline at weeks 24 and 52 were analyzed using a mixed model for repeated measures. Post hoc analyses included percentages of patients reporting improvements equal to or greater than minimal clinically important differences (MCID) and normative values in the FACIT-F and SF-36. Pearson correlation between observed PRO scores and clinical measures of disease activity was tested at week 24. RESULTS: Both doses of sarilumab + MTX vs placebo + MTX resulted in improvement from baseline by week 24 in PtGA, pain, HAQ-DI, SF-36 and FACIT-F scores (p < 0.0001) that was clinically meaningful, and persisted until week 52. In post hoc analyses, the percentages of patients with improvement equal to or greater than the MCID across all PROs were greater with sarilumab than placebo (p < 0.05), with differences ranging from 11.6 to 26.2 %, as were those reporting equal to or greater than normative scores. CONCLUSIONS: In this RCT in patients with MTX-IR RA, sarilumab + MTX resulted in sustained improvement in PROs that were clinically meaningful, greater than placebo + MTX, and complement the previously reported clinical efficacy and safety of sarilumab. TRIAL REGISTRATION: ClinicalTrials.gov. NCT01061736 . February 2, 2010.","Strand, V., et al. (2016). \"Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial.\" Arthritis Res Ther 18: 198.","USA",2016,"Musculoskeletal","Sarilumab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Sarilumab",null,null,"FACIT-F","2015:2018"]
[278,"Strand, V., et al. (2014). \"Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.\" Health Qual Life Outcomes 12: 31.",null,"Strand, V., et al.","Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds","BACKGROUND: The primary aim of rheumatoid arthritis (RA) treatment is to induce remission, the absence of disease activity. The objective of this study was to explore the association between clinical endpoints used to gauge RA treatment efficacy and patient-reported outcomes of health-related quality of life, fatigue, and physical function in RA patients treated with secukinumab in a phase 2 randomized controlled trial (RCT). METHOD: Adult RA patients (n = 237) with incomplete responses to methotrexate were randomized equally to receive monthly s.c. injections of secukinumab 25 mg, 75 mg, 150 mg, 300 mg or placebo. Clinical endpoints used in this study included the ACR response criteria and its components and simplified disease activity score. Patient-reported outcomes (PRO) included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study Short Form-36 [SF-36] Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Patients were categorized into mutually exclusive groups according to the magnitude and direction of change from baseline to week 16 in each clinical endpoint. Definitions of minimal important differences [MID] in each clinical endpoint were used to categorize patients, as well as thresholds beyond MID. Mean changes from baseline to week 16 were computed for each PRO and analyses of variance to test the differences in PRO changes observed across groups of patients that differed in each clinical endpoint. Analyses were limited to patients randomized to secukinumab treatment. All dose groups were combined (n = 187). RESULTS: Mean changes from baseline in each PRO differed significantly across groups of patients in the expected direction. With few exceptions, there was considerable agreement between clinical endpoints and PROs concerning the magnitude of change defined as clinically meaningful. More importantly, results demonstrated that greater improvements in clinical endpoints were associated with incrementally better improvements in HRQoL, fatigue, and physical function. CONCLUSION: Results of this study show considerable agreement between minimal thresholds of improvement established for PROs and clinical outcome measures used in RA treatment studies and provide thresholds to be considered in gauging the importance of a treatment effect that goes beyond what is considered as minimally important for PRO measures.","Strand, V., et al. (2014). \"Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds.\" Health Qual Life Outcomes 12: 31.","USA",2014,"Musculoskeletal","Secukinumab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Secukinumab",null,null,"FACIT-F","2010:2014"]
[279,"Strand, V., et al. (2015). \"Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.\" Arthritis Res Ther 17: 307.",null,"Strand, V., et al.","Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs","INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. METHOD: In this 6-month, phase 3, randomized, placebo-controlled trial, 611 patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR) were randomized 4:4:1:1 to receive: tofacitinib 5 mg BID or tofacitinib 10 mg BID for the duration of the study, or placebo for 3 months followed by tofacitinib 5 mg BID or tofacitinib 10 mg BID. Patient-reported outcomes (PROs) included: Patient Global Assessment of Disease Activity (PtGA); Patient Assessment of Pain (Pain); Health Assessment Questionnaire-Disability Index (HAQ-DI); Medical Outcomes Survey (MOS) Short Form-36 (SF-36); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and MOS Sleep Scale. Time-to-event data (PtGA and Pain) were collected using an interactive voice response system daily diary (baseline through day 14). RESULTS: At month 3, tofacitinib 5 and 10 mg BID demonstrated statistically significant improvements versus placebo in PtGA (both p < 0.0001), Pain (both p < 0.0001), HAQ-DI (both p < 0.0001), SF-36 Physical (p < 0.0001) and Mental (p < 0.05 [5 mg BID] and p < 0.0001 [10 mg BID]), Component Summary scores and all domain scores (p < 0.05-p < 0.0001) and FACIT-F (both p < 0.0001). Statistically significant changes from baseline in MOS Sleep Scale were reported for 10 mg BID (p < 0.05). Benefits of tofacitinib treatment were rapid in onset and significant improvements were reported at week 2 for PtGA, Pain and HAQ-DI, and differentiation from baseline was seen as early as 3 days after treatment initiation for interactive voice response system (IVRS) PtGA and IVRS Pain. The numbers needed to treat for patients to report changes greater than or equal to the minimum clinically important difference in PtGA, Pain, HAQ-DI, SF-36 Physical Component Summary score and FACIT-F ranged between 4.0-6.1 (5 mg BID) and 3.2-5.0 (10 mg BID). CONCLUSION: Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months. TRIAL REGISTRATION: Clinicaltrials.gov registration NCT00814307 , registered 22 December 2008.","Strand, V., et al. (2015). \"Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.\" Arthritis Res Ther 17: 307.","USA",2015,"Musculoskeletal","Tofactinib","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Tofactinib",null,null,"FACIT-F","2015:2018"]
[280,"Strand, V., et al. (2017). \"Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.\" Arthritis Care Res (Hoboken) 69(4): 592-598.",null,"Strand, V., et al.","Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial","OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). METHODS: In a 12-month, phase III randomized controlled trial (ORAL Sync), patients (n = 795) with active RA and previous inadequate response to therapy with >/=1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included patient global assessment of arthritis (PtGA), patient assessment of arthritis pain (Pain), physical function (Health Assessment Questionnaire disability index [HAQ DI]), health-related quality of life (Short Form 36 health survey [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). RESULTS: At month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ DI, all 8 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ DI, 7 SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to month 12. Significantly more tofacitinib-treated patients reported improvements of greater than or equal to the minimum clinically important differences at month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). CONCLUSION: Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo.","Strand, V., et al. (2017). \"Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial.\" Arthritis Care Res (Hoboken) 69(4): 592-598.","USA",2017,"Musculoskeletal","Tofactinib","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Tofactinib",null,null,"FACIT-F","2015:2018"]
[281,"Strand, V., et al. (2014). \"Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.\" Ann Rheum Dis 73(5): 838-844.",null,"Strand, V., et al.","Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials","OBJECTIVE: Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE. METHODS: Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks' duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D. RESULTS: Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses. CONCLUSIONS: The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials. CLINICALTRIALSGOV NUMBER: NCT00424476, NCT00410384.","Strand, V., et al. (2014). \"Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.\" Ann Rheum Dis 73(5): 838-844.","USA",2014,"Inflamatory Systemic Disease","Belimumab","FACIT-F",null,null,null,"USA",null,"Inflamatory Systemic Disease","Belimumab",null,null,"FACIT-F","2010:2014"]
[282,"Strand, V., et al. (2012). \"Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study.\" J Rheumatol 39(1): 63-72.",null,"Strand, V., et al.","Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study","OBJECTIVE: Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA. METHODS: PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged >/= 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient's global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3). RESULTS: Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p <0.0001), vitality (p = 0.0139), role limitations-physical (p = 0.0005)], SF-6D (p = 0.0152), VAS-PtGA (p < 0.0001), VAS-pain (p < 0.0001), FACIT-F (p < 0.0001), and HUI-3 (p = 0.0034) scores versus patients treated with MTX monotherapy. Both SF-6D and HUI-3 were found to be sensitive preference-based measures for assessing the effects of treatment on multidimensional function. No clinically meaningful differences between adalimumab and MTX monotherapy groups were observed for most measures. For each measure, there was significant association between HRQOL improvement and ACR clinical response. CONCLUSION: Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).","Strand, V., et al. (2012). \"Health-related quality of life outcomes of adalimumab for patients with early rheumatoid arthritis: results from a randomized multicenter study.\" J Rheumatol 39(1): 63-72.","USA",2012,"Musculoskeletal","Adalimumab","FACIT-F",null,null,null,"USA",null,"Musculoskeletal","Adalimumab",null,null,"FACIT-F","2010:2014"]
[283,"Strand, V., et al. (2013). \"Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study.\" J Rheumatol 40(7): 1158-1165.",null,"Strand, V., et al.","Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study","OBJECTIVE: Apremilast, a specific inhibitor of phosphodiesterase 4, modulates proinflammatory and antiinflammatory cytokine production. A phase IIb randomized, controlled trial (RCT) evaluated the effect of apremilast on patient-reported outcomes (PRO) in psoriatic arthritis (PsA). METHODS: In this 12-week RCT, patients with active disease (duration > 6 mo, >/= 3 swollen and >/= 3 tender joints) received apremilast (20 mg BID or 40 mg QD) or placebo. PRO included pain and global assessment of disease activity [visual analog scale (VAS)], Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Medical Outcomes Study Short-Form 36 Health Survey (SF-36) assessing health-related quality of life (HRQOL). Percentages of patients reporting improvements >/= minimum clinically important differences (MCID) and correlations between SF-36 domains and pain VAS, HAQ-DI, and FACIT-F were determined. RESULTS: Among the 204 randomized patients (52.5% men; mean age 50.6 yrs), baseline SF-36 scores reflected large impairments in HRQOL. Apremilast 20 mg BID resulted in statistically significant and clinically meaningful improvements in physical and mental component summary scores and 7 and 6 SF-36 domains, respectively, compared with no change/deterioration in placebo group. Patients receiving apremilast 20 mg BID and 40 mg QD reported significant improvements >/= MCID in global VAS scores and FACIT-F versus placebo, and significant improvements in pain VAS scores. Moderate-high, significant correlations were evident between SF-36 domains and other PRO. CONCLUSION: Apremilast resulted in statistically significant and clinically meaningful improvements in HRQOL, pain and global VAS, and FACIT-F scores.","Strand, V., et al. (2013). \"Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study.\" J Rheumatol 40(7): 1158-1165.","USA",2013,"Musculoskeletal","Other Drugs","FACIT-F,VAS-F",null,null,null,"USA",null,"Musculoskeletal","Other Drugs",null,null,"FACIT-F,VAS-F","2010:2014"]
[284,"Strand, V., et al. (2016). \"Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.\" Rheumatology (Oxford) 55(6): 1031-1041.",null,"Strand, V., et al.","Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis","OBJECTIVE: To evaluate effects of tofacitinib or adalimumab on patient-reported outcomes (PROs) in patients with moderate to severe RA and inadequate responses to MTX. METHODS: In this 12-month, phase 3, randomized controlled trial (ORAL Standard), patients (n = 717) receiving background MTX were randomized to tofacitinib 5 or 10 mg twice daily (BID), adalimumab 40 mg once every 2 weeks or placebo. PROs included HAQ-Disability Index, Patient Global Assessment of Arthritis, Patient Assessment of Arthritis Pain, health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) and sleep (Medical Outcomes Study-Sleep). RESULTS: At month 3, tofacitinib 10 mg BID treatment resulted in significant changes from baseline vs placebo across all PROs, sustained to month 12, with the highest number of patients reporting improvements minimum clinically important differences vs placebo (P < 0.05). Changes from baseline at month 3 with tofacitinib 5 mg BID and adalimumab were similar and statistically significant vs placebo across most PROs, excluding SF-36 Mental Component Score and Social Functioning, Role Emotional, and Mental Health domains, with significantly more patients reporting improvements minimum clinically important differences. Numbers Needed to Treat were lowest for tofacitinib 10 mg BID and similar between tofacitinib 5 mg BID and adalimumab. CONCLUSION: Patients with moderate to severe RA and inadequate responses to MTX reported improvements across a broad range of PROs with tofacitinib 5 and 10 mg BID and adalimumab that were significantly superior to placebo.","Strand, V., et al. (2016). \"Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis.\" Rheumatology (Oxford) 55(6): 1031-1041.","Sweden,Korea,USA",2016,"Musculoskeletal","Tofactinib,Adalimumab","FACIT-F",null,null,null,"Sweden,Korea,USA",null,"Musculoskeletal","Tofactinib,Adalimumab",null,null,"FACIT-F","2015:2018"]
[285,"Straudi, S., et al. (2016). \"The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial.\" Mult Scler 22(3): 373-384.",null,"Straudi, S., et al.","The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial","BACKGROUND: Gait and mobility impairments are common in progressive multiple sclerosis (MS), leading to reduced quality of life (QoL). OBJECTIVE: In this randomized controlled study, we tested the effects of robot-assisted gait training (RAGT) and compared it to conventional physiotherapy, measuring walking ability, depression, fatigue, and QoL in patients with progressive MS and severe gait disability. METHODS: Fifty-two participants (Expanded Disability Status Scale score 6-7) completed the study protocol. They received two sessions/week over 6 weeks of RAGT or conventional walking therapy. Outcome measures were Six-Minute Walk Test, Ten-Meter Walk Test, Timed Up and Go Test, Berg Balance Scale, Fatigue Severity Scale, Patient Health Questionnaire, and Short Form 36. They were performed pre-treatment, post-treatment, and at 3 months. RESULTS: Walking endurance (p < 0.01) and balance (p < 0.01) were improved among those in the RAGT group. Positive effects on depression in both treatment groups were highlighted. However, only among those in the RAGT group was perceived physical functioning QoL increased. No significant effects on fatigue were found. CONCLUSION: RAGT is a treatment option in progressive MS patients with severe gait impairments to induce short-lasting effects on mobility and QoL.","Straudi, S., et al. (2016). \"The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial.\" Mult Scler 22(3): 373-384.","Italy",2016,"Neurological","Psychobehavioural","FSS",null,null,null,"Italy",null,"Neurological","Psychobehavioural",null,null,"FSS","2015:2018"]
[286,"Straudi, S., et al. (2014). \"A task-oriented circuit training in multiple sclerosis: a feasibility study.\" BMC Neurol 14: 124.",null,"Straudi, S., et al.","A task-oriented circuit training in multiple sclerosis: a feasibility study","BACKGROUND: The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training (TOCT) in a sample of multiple sclerosis (MS) subjects on walking competency, mobility, fatigue and health-related quality of life (HRQoL). METHODS: 24 MS subjects (EDSS 4.89 +/- 0.54, 17 female and 7 male, 52.58 +/- 11.21 years, MS duration 15.21 +/- 8.68 years) have been enrolled and randomly assigned to 2 treatment groups: (i) experimental group received 10 TOCT sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program, whereas control group did not receive any specific rehabilitation intervention. A feasibility patient-reported questionnaire was administered after TOCT. Functional outcome measures were: walking endurance (Six Minute Walk Test), gait speed (10 Meter Walk Test), mobility (Timed Up and Go test) and balance (Dynamic Gait Index). Furthermore, self-reported questionnaire of motor fatigue (Fatigue Severity Scale), walking ability (Multiple Sclerosis Walking Scale - 12) and health-related quality of life (Multiple Sclerosis Impact Scale - 29) were included. Subjects' assessments were delivered at baseline (T0), after TOCT (T1) and 3 months of home-based exercise program (T2). RESULTS: After TOCT subjects reported a positive global rating on the received treatment. At 3 months, we found a 58.33% of adherence to the home-exercise program. After TOCT, walking ability and health-related quality of life were improved (p < 0.05) with minor retention after 3 months. The control group showed no significant changes in any variables. CONCLUSIONS: This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments; moreover it might improve walking abilities. TRIAL REGISTRATION: NCT01464749.","Straudi, S., et al. (2014). \"A task-oriented circuit training in multiple sclerosis: a feasibility study.\" BMC Neurol 14: 124.","Italy",2014,"Neurological","Psychobehavioural","FSS",null,null,null,"Italy",null,"Neurological","Psychobehavioural",null,null,"FSS","2010:2014"]
[287,"Strickland, G., et al. (2012). \"Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools.\" Clin Rheumatol 31(8): 1215-1222.",null,"Strickland, G., et al.","Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools","This study evaluates predictors of health-related quality of life (HRQoL) and fatigue in systemic sclerosis (SSc) using two novel self-report indices. A cross-sectional study of patients with SSc was undertaken using a postal questionnaire including the EuroQol-5Domain health questionnaire (EQ-5D), Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F) and the Scleroderma Health Assessment Questionnaire (SHAQ). The EQ-5D assesses five domains of health quality and is quantified as a time trade-off (TTO) value and patient global assessment (0-100 visual analogue scale [VAS]). The FACIT-F is a 13-item questionnaire (0-52 scale). Higher scores for both the EQ-5D and FACIT-F indicate better health. Case notes were scrutinised for patient demographics, disease duration, serology and clinical phenotype. Sixty-eight patients (60 females, mean age 62.6 years) completed the questionnaires. Fatigue correlated closely with HRQoL (r (s) = 0.78 and 0.77 for FACIT-F vs. EQ-5D VAS and TTO respectively, p < 0.01) and disability (r (s) = -0.74 for FACIT-F vs. HAQ-DI, p < 0.01). Pain was the most frequently reported health problem (80 %) in the EQ-5D. HRQoL also correlated closely with disability (r (s) = 0.83 for EQ-5D vs. HAQ-DI, p < 0.01). SHAQ-VAS scores correlated well with the FACIT-F, EQ-5D and HAQ-DI scores (p < 0.05 for all comparisons). Of the patient demographics and clinical disease associations, only the absence of upper gastrointestinal complications was associated with better levels of fatigue, HRQoL and function. There is a strong correlation between disability, fatigue and HRQoL measured using self-reports, possibly reflecting similarly perceived health beliefs amongst patients across outcomes. There was little association between self-report indices and patient demographics and/or clinical phenotype.","Strickland, G., et al. (2012). \"Predictors of health-related quality of life and fatigue in systemic sclerosis: evaluation of the EuroQol-5D and FACIT-F assessment tools.\" Clin Rheumatol 31(8): 1215-1222.","UK",2012,"Inflamatory Systemic Disease","None","FACIT-F",null,null,null,"UK",null,"Inflamatory Systemic Disease","None",null,null,"FACIT-F","2010:2014"]
[288,"Suzuki, Y., et al. (2008). \"Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy.\" Jpn J Clin Oncol 38(3): 214-221.",null,"Suzuki, Y., et al.","Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy","OBJECTIVE: This study was aimed at investigating the effectiveness and safety of once-weekly epoetin beta for anaemic cancer patients receiving chemotherapy. METHODS: A total of 104 patients with a haemoglobin level of </=11.0 g/dL were enrolled. Patients received a once-weekly subcutaneous dose of 36 000 IU epoetin beta for 12 weeks. If the increase in the haemoglobin level was <1.0 g/dL after 6 weeks, or a red blood cell transfusion was required between days 15 and 42, the dose of epoetin beta was increased to 54 000 IU from the subsequent week. The primary endpoint was the percentage of patients who achieved a haemoglobin increase of >/=2.0 g/dL; the haemoglobin response rate. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anaemia (FACT-An) questionnaire. RESULTS: The haemoglobin response rate was 66.3% among the 98 patients (breast cancer: n = 25; malignant lymphoma: n = 21; ovarian cancer: n = 20; lung cancer: n = 15; other cancers: n = 17) assessable for a haemoglobin response. Thirty-nine patients (39.8%) required a dose escalation to 54 000 IU. At the end of the study, QOL assessable patients (n = 96) showed a mean improvement in the FACT-An total fatigue subscale score (FSS) of 0.3 points from baseline. Patients with a haemoglobin response had a mean change in the total FSS of +3.2, compared with -3.4 for patients without a haemoglobin response. No serious adverse event of epoetin beta was observed. CONCLUSIONS: Epoetin beta administered at an initial dose of 36 000 IU once-weekly was well tolerated, with increased haemoglobin levels and improved QOL in anaemic cancer patients receiving myelosuppressive chemotherapy.","Suzuki, Y., et al. (2008). \"Weekly epoetin beta maintains haemoglobin levels and improves quality of life in patients with non-myeloid malignancies receiving chemotherapy.\" Jpn J Clin Oncol 38(3): 214-221.","Japan",2008,"Cancer","Cancer treatments","FSS",null,null,null,"Japan",null,"Cancer","Cancer treatments",null,null,"FSS","2005:2009"]
[289,"Svenningsson, A., et al. (2013). \"Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.\" PLoS One 8(3): e58643.",null,"Svenningsson, A., et al.","Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting","Fatigue is a significant symptom in multiple sclerosis (MS) patients. First-generation disease modifying therapies (DMTs) are at best moderately effective to improve fatigue. Observations from small cohorts have indicated that natalizumab, an antibody targeting VLA-4, may reduce MS-related fatigue. The TYNERGY study aimed to further evaluate the effects of natalizumab treatment on MS-related fatigue. In this one-armed clinical trial including 195 MS patients, natalizumab was prescribed in a real-life setting, and a validated questionnaire, the Fatigue Scale for Motor and Cognitive functions (FSMC), was used both before and after 12 months of treatment to evaluate a possible change in the fatigue experienced by the patients. In the treated cohort all measured variables, that is, fatigue score, quality of life, sleepiness, depression, cognition, and disability progression were improved from baseline (all p values<0.0001). Walking speed as measured by the six-minute walk-test also increased at month 12 (p = 0.0016). All patients were aware of the nature of the treatment agent, and of the study outcomes. CONCLUSION: Natalizumab, as used in a real-life setting, might improve MS-related fatigue based on the results from this one-armed un-controlled stud. Also other parameters related to patients' quality of life seemed to improve with natalizumab treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT00884481.","Svenningsson, A., et al. (2013). \"Natalizumab treatment reduces fatigue in multiple sclerosis. Results from the TYNERGY trial; a study in the real life setting.\" PLoS One 8(3): e58643.","Sweden",2013,"Neurological","Natalizumab","Fatigue Scale for Motor and Cognitive functions",null,null,null,"Sweden",null,"Neurological","Natalizumab",null,null,"Fatigue Scale for Motor and Cognitive functions","2010:2014"]
[290,"Takemoto, M. L., et al. (2015). \"Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study.\" Health Qual Life Outcomes 13: 119.",null,"Takemoto, M. L., et al.","Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study","BACKGROUND: Multiple sclerosis (MS) is a chronic disease associated with several impacts; especially regarding patients' health-related quality of life (HRQL). EuroQol 5 Dimensions questionnaire (EQ-5D) provides self-reported analysis of HRQL and utility scores. Although the British algorithm to convert EQ-5D responses into utility is the most used in the literature, national settings is more appropriate for health policy decision makers. A Brazilian algorithm is available, but not used in MS patients yet. Primarily, this study aimed to address potential differences in utility scores obtained through Brazilian and British value sets. Secondary objective was to determine the role of disability, fatigue and patients socio-demographic and clinical characteristics relevant to MS on the utility scores reported by Brazilian patients. METHODS: Cross-sectional study with MS patients treated in 8 Brazilian sites. Patients were interviewed about socio-demographic and clinical characteristics, self-reported disability level, HRQL and impact of fatigue on daily living. Disability level, HRQL and impact of fatigue were assessed using the Expanded Disability Status Scale (EDSS) and the Brazilian versions of EQ-5D-3 L and Modified Fatigue Impact Scale (MFIS-BR), respectively. Patients were classified in subgroups according to EDSS (mild: 0-3; moderate: 4-6.5; severe: >7) and the self-perceived impact of fatigue (absent: </= 38 points; low: 39-58; high: >/= 59). EQ-5D-3 L data was converted into a utility index using an algorithm developed by a Brazilian research group (QALY Brazil) and also the UK algorithm. Differences between utility scores were analysed through Wilcoxon test. RESULTS: Two hundred and ten patients were included in the study. Utility index mean scores of 0.59 (SD = 0.22) and 0.56 (SD = 0.32) for the Brazilian and UK algorithms were observed, respectively, without statistically significant difference for the distribution of data (p = 0.586). However, when utility scores were lower than 0.5, Brazilian algorithm provided higher estimates than UK with a better agreement between the scores found closer to 1. The same trend was observed when data was stratified for EDSS and impact of fatigue, with statistically significant difference between scores in categories of mild/severe disabilities and absent/high impact of fatigue. CONCLUSIONS: Results suggest that Brazilian value set provided higher utility scores than the UK, particularly for measures below 0.5.","Takemoto, M. L., et al. (2015). \"Differences in utility scores obtained through Brazilian and UK value sets: a cross-sectional study.\" Health Qual Life Outcomes 13: 119.","Brazil",2015,"Neurological","None","MFI",null,null,null,"Brazil",null,"Neurological","None",null,null,"MFI","2015:2018"]
[291,"Tang, S., et al. (2004). \"Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia.\" Rheumatology (Oxford) 43(5): 609-614.",null,"Tang, S., et al.","Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia","OBJECTIVE: Fibromyalgia (FM) is a major determinant of poor health status in systemic lupus erythematosus (SLE). FM has been shown to be associated with neurally mediated hypotension (NMH) in the general population, in which effective treatments exist. We explored whether NMH was more common in SLE patients with FM than those without. METHODS: Seventy-six SLE patients (4 male, 72 female; 1 ethnic Indian, 28 African American, 47 Caucasian; mean age 40.2 +/- 9.4 yr) were recruited and their FM status ascertained using American College of Rheumatology (ACR) classification criteria. Patients who were pregnant or deconditioned were excluded. A two-stage tilt-table test was used to detect NMH. All patients completed the SF-36 Heath Status Inventory (SF-36) and the Krupp Fatigue Severity Scale (KFSS) to evaluate their quality of life. Serological markers and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) were recorded. Medications that might interfere with testing were temporarily withheld before the tilt-table test. RESULTS: The prevalence of NMH (first stage) in SLE patients was 47.9%. Seven patients had both NMH and postural orthostatic tachycardia syndrome. Two patients had borderline results with symptoms reproduced but an inadequate drop in systolic blood pressure by definition (a drop of at least 25 mmHg defines an abnormal response). Eighteen (23.7%) SLE patients had FM and 51 (67.1%) had at least one tender point (TP). The frequency of NMH (first or second stage) in SLE with FM was 58.3% compared with 69.4% in SLE without FM (odds ratio 0.62, 95% CI 0.16-2.37). SF-36 and KFSS scores were not significantly different in SLE patients with and without NMH. However, both scores were found to be associated with FM status (P<0.001 and P = 0.014), reflecting poor health status in the FM group. No confounding variable was found to be significantly associated with both NMH and FM. CONCLUSION: NMH is common in SLE patients with a high prevalence rate. The large increase in NMH, a form of autonomic neuropathy, in SLE, has not been explained. However, NMH has no impact on quality of life above that determined by FM, and has no statistically significant association with FM status. Identification of NMH may be important in selected patients with SLE who have chronic fatigue, but NMH cannot explain the increased prevalence of FM in SLE.","Tang, S., et al. (2004). \"Neurally mediated hypotension in systemic lupus erythematosus patients with fibromyalgia.\" Rheumatology (Oxford) 43(5): 609-614.","China",2004,"Inflamatory Systemic Disease","None","KFSS",null,null,null,"China",null,"Inflamatory Systemic Disease","None",null,null,"KFSS","2000:2004"]
[292,"ter Borg, P. C., et al. (2004). \"Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634].\" BMC Gastroenterol 4: 13.",null,"ter Borg, P. C., et al.","Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634]","BACKGROUND: Fatigue is a major clinical problem in many patients with primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). An effective treatment has not been defined. Recently, a large proportion of patients with these diseases was found to have symptoms of depression. Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia, we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC. METHODS: Fatigued patients were randomised to receive fluvoxamine (75 mg BID) or placebo for a six-week period. Fatigue and quality of life were quantified using a visual analogue scale, the Fisk Fatigue Severity Scale, the Multidimensional Fatigue Inventory and the SF-36. RESULTS: Seventeen and 16 patients were allocated to fluvoxamine and placebo, respectively. There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life. The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0, 6.9 and 7.15 at day 14, 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation. CONCLUSION: We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.","ter Borg, P. C., et al. (2004). \"Fluvoxamine for fatigue in primary biliary cirrhosis and primary sclerosing cholangitis: a randomised controlled trial [ISRCTN88246634].\" BMC Gastroenterol 4: 13.","Netherlands",2004,"Liver Disease","Other Drugs","Fisk Fatigue Severity Scale,VAS-F,MFI",null,null,null,"Netherlands",null,"Liver Disease","Other Drugs",null,null,"Fisk Fatigue Severity Scale,VAS-F,MFI","2000:2004"]
[293,"Teuber, G., et al. (2008). \"Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis.\" J Hepatol 49(6): 923-929.",null,"Teuber, G., et al.","Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis","BACKGROUND/AIMS: Health-related quality of life (HRQoL) is impaired in patients with chronic hepatitis C. We investigated HRQoL and fatigue in patients with chronic hepatitis C virus (HCV) infection in relation to the degree of fibrosis and inflammation, and controlled for the influence of relevant demographic and medical variables. METHODS: We conducted a cross-sectional two-center study including 215 outpatients with chronic hepatitis C applying the Short-Form Health Survey (SF-36) and the Fatigue Impact Scale (FIS-D). The contribution to the variability of these psychometric scores was evaluated for the degree of fibrosis as well as viremia, gender, age, mode of transmission, genotype, and ALT. RESULTS: There was a strong negative association between the degree of liver fibrosis and the physical SF-36 summary score (p=0.016). This was independent of the covariate age, also significantly predicting physical HRQoL (p=0.001). The absolute FIS score was significantly increased in patients with advanced fibrosis (p=0.043). In females, mental SF-36 summary score (p=0.007) and fatigue (p=0.017) were significantly more impaired. CONCLUSIONS: Our study suggests a significant association of physical aspects of HRQoL and fatigue with the extent of fibrosis. Fibrosis stage should be considered for the identification and management of HCV patients at risk for reduced physical HRQoL.","Teuber, G., et al. (2008). \"Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis.\" J Hepatol 49(6): 923-929.","Germany",2008,"Inflamatory Systemic Disease","None","FIS",null,null,null,"Germany",null,"Inflamatory Systemic Disease","None",null,null,"FIS","2005:2009"]
[294,"Thaci, D., et al. (2014). \"Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial.\" J Eur Acad Dermatol Venereol 28(7): 900-906.",null,"Thaci, D., et al.","Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial","BACKGROUND: Impaired sleep in patients with moderate-to-severe psoriasis and improvement on therapy has not been widely studied. OBJECTIVE: Quantify baseline aspects of sleep and improvement in patients with psoriasis receiving etanercept (ETN) when allowed concomitant topical medications (PRISTINE study). METHODS: Patients with moderate-to-severe psoriasis were randomized to 50 mg ETN once weekly (QW/QW) or 50 mg ETN twice weekly (BIW/QW) for weeks 1-12, followed by 50 mg QW for weeks 13-24; a broad range of topical therapies were permitted during weeks 13-24. Sleep impairment was measured by the Medical Outcomes Study (MOS) sleep questionnaire Index II (population norm = 25.8; minimum clinically important difference = 5.1); quality of life (QoL) measures included Dermatology Life Quality Index (DLQI), EuroQoL 5 Dimension (EQ-5D) Utility Index and Visual Analogue Scale (VAS) and Functional Activity in Chronic Therapy-Fatigue (FACIT-Fatigue). ancova and Fisher's exact test or chi-squared tests were used for between-group testing. RESULTS: Mean baseline MOS-Sleep scores were 34.0 for both groups indicating impairment (N = 270; QW/QW n = 137; BIW/QW n = 133, approximately 64% had impaired sleep). At week 12 of treatment, MOS-Sleep scores improved to 30.8 and 30.1, and at week 24, to 28.4 and 28.2 respectively. Poor sleep was significantly associated with clinically important problems in EQ-5D utility, VAS and FACIT-Fatigue; sleep improvement was associated with improved EQ-5D utility and FACIT-Fatigue (P < 0.001). CONCLUSION: This study confirms that most patients with moderate-to-severe psoriasis have impaired sleep which is associated with impaired QoL. Treatment with etanercept significantly improved sleep, with most improvement occurring before a broad range of topicals were allowed. Sleep improvement was associated with improved QoL.","Thaci, D., et al. (2014). \"Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial.\" J Eur Acad Dermatol Venereol 28(7): 900-906.","Germany",2014,"Inflamatory Systemic Disease","Etanercept","VAS-F,FACIT-F",null,null,null,"Germany",null,"Inflamatory Systemic Disease","Etanercept",null,null,"VAS-F,FACIT-F","2010:2014"]
[295,"Thomas, P. W., et al. (2014). \"One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.\" BMC Neurol 14: 109.",null,"Thomas, P. W., et al.","One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis","BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. METHODS: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). RESULTS: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. CONCLUSIONS: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. TRIAL REGISTRATION: ISRCTN76517470.","Thomas, P. W., et al. (2014). \"One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.\" BMC Neurol 14: 109.","UK",2014,"Neurological","None","FAI,GFS",null,null,null,"UK",null,"Neurological","None",null,null,"FAI,GFS","2010:2014"]
[296,"Tillmann, H. L., et al. (2011). \"Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment.\" J Viral Hepat 18(4): 252-261.",null,"Tillmann, H. L., et al.","Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment","Little is known comparing and contrasting quality of life (QoL) in patients with hepatitis C, compared to patients with other liver diseases. We performed two independent prospective cross-sectional studies including 511 and 284 patients with different forms of liver diseases. SF-36 was used in both studies. Fatigue Impact Score, WHO-BREF and Hospital Anxiety and Depression Scale (HADS) were used in either study only. In both studies, HCV-positive patients scored worse in the mental aspects of health-related QoL compared to other liver diseases, except for HBV in one study. Surprisingly, in both studies, quality of life was also significantly impaired in patients with viral clearance after interferon therapy but not after spontaneous clearance. Furthermore, patients with primary biliary cirrhosis showed significantly better mental health but significantly worse physical well-being. Liver diseases differ in their form of impaired QoL. In HCV, this impairment might not always return to normal after treatment-induced viral clearance. This may suggest that HCV either may not be involved in QoL impairment or may induce a process which persists after viral clearance in some patients.","Tillmann, H. L., et al. (2011). \"Quality of life in patients with various liver diseases: patients with HCV show greater mental impairment, while patients with PBC have greater physical impairment.\" J Viral Hepat 18(4): 252-261.","Germany",2011,"Infectious disease","None","FIS",null,null,null,"Germany",null,"Infectious Disease","None",null,null,"FIS","2010:2014"]
[297,"Trojan, D. A., et al. (2001). \"Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome.\" J Neurol Sci 182(2): 107-115.",null,"Trojan, D. A., et al.","Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome","OBJECTIVES AND BACKGROUND: To determine if serum insulin-like growth factor-I (IGF-I) levels are associated with strength, body mass index (BMI), fatigue, or quality of life in post-poliomyelitis syndrome (PPS). PPS is likely due to a distal disintegration of enlarged post-polio motor units as a result of terminal axonal sprouting. Age-related decline in growth hormone and IGF-I (which support terminal axonal sprouts) is proposed as a contributing factor. METHODS: As part of the North American Post-Poliomyelitis Pyridostigmine Study (NAPPS), baseline data on maximum voluntary isometric contraction (MVIC), BMI, subjective fatigue (fatigue severity scale, Hare fatigue symptom scale), health-related quality of life (short form health survey-36; SF-36), and serum IGF-I levels were gathered on 112 PPS patients. Pearson correlation coefficients were calculated to evaluate the association between serum IGF-I and MVIC in 12 muscles, BMI, two fatigue scales, and SF-36 scale scores. RESULTS: There is a significant inverse correlation of IGF-I levels with MVIC in left ankle dorsiflexors (r=-0.30, P<0.01), and left and right knee extensors (r=-0.22, -0.25, P=<0.01, 0.01), but no significant correlations in other muscles. When men and women were evaluated separately, inverse correlations of IGF-I levels with MVIC were found only in men. IGF-I correlated inversely with BMI (r=-0.32, P=0006) and age (r=-0.32, P=0.0005). IGF-I did not correlate with the fatigue or SF-36 scales. CONCLUSIONS: In this exploratory study, we found that contrary to our expectations, IGF-I did not correlate positively with strength. IGF-I correlated negatively with strength in several lower extremity muscles, BMI, and age. IGF-I is likely not an important factor in the pathogenesis of fatigue and in determining quality of life in PPS, but its role on strength should be studied further.","Trojan, D. A., et al. (2001). \"Serum insulin-like growth factor-I (IGF-I) does not correlate positively with isometric strength, fatigue, and quality of life in post-polio syndrome.\" J Neurol Sci 182(2): 107-115.","Canada",2001,"Neurological","Various","FSS,Hare Fatigue Symptom scale",null,null,null,"Canada",null,"Neurological","Various",null,null,"FSS,Hare Fatigue Symptom scale","2000:2004"]
[298,"Tsuboi, M., et al. (2009). \"Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study.\" Jpn J Clin Oncol 39(3): 163-168.",null,"Tsuboi, M., et al.","Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study","OBJECTIVE: The efficacy and safety of weekly administration of epoetin beta (EPO) for chemotherapy-induced anemia (CIA) patients was evaluated. METHODS: One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were randomized to the EPO 36 000 IU group or the placebo group. Hematological response and red blood cell (RBC) transfusion requirement were assessed. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. RESULTS: Mean change in hemoglobin level with EPO increased significantly over placebo (1.4 +/- 1.9 g/dl versus -0.8 +/- 1.5 g/dl; P < 0.001). The proportion of patients with change in hemoglobin level > or =2.0 g/dl was higher for EPO than those for placebo (P < 0.001). After 4 weeks of administration, the proportion of RBC transfusion or hemoglobin level <8.0 g/dl was significantly lower for EPO than those for placebo (P = 0.046). The changes in the FACT-An total Fatigue Subscale Score (FSS) were less deteriorated with EPO than those with placebo. Progressive disease (PD) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients. No significant differences in adverse events were observed. Thrombovascular events and pure red cell aplasia related to EPO were not observed. Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94. CONCLUSION: Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period.","Tsuboi, M., et al. (2009). \"Weekly administration of epoetin beta for chemotherapy-induced anemia in cancer patients: results of a multicenter, Phase III, randomized, double-blind, placebo-controlled study.\" Jpn J Clin Oncol 39(3): 163-168.","Japan",2009,"Hematological","Cancer treatments","FSS",null,null,null,"Japan",null,"Hematological","Cancer treatments",null,null,"FSS","2005:2009"]
[299,"Turner, J., et al. (2004). \"Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention.\" J Surg Oncol 86(3): 141-146.",null,"Turner, J., et al.","Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention","BACKGROUND AND OBJECTIVES: This pilot project assessed the acceptability of a mixed-type, moderate-intensity exercise programme following breast cancer treatment, and the impact on presence of lymphoedema, fitness, body composition, fatigue, mood and quality of life. METHODS: Ten women completed the programme and measures of fitness (sub-maximal ergometer test), body composition (bio-electrical impedance), lympoedema (bio-electrical impedance and arm circumferences), fatigue (revised Piper Fatigue Scale), mood (Hospital Anxiety and Depression Scale), quality of life (FACT-B) and general well-being, at baseline, completion of the programme, and 6-week and 3-month follow-up. RESULTS: Participation in the programme caused no adverse effect on the presence of lymphoedema. There was a trend towards reduction in fatigue and improved quality of life across the testing phases. Women rated the programme extremely favourably, citing benefits of the support of other women, trained guidance, and the opportunity to experience different types of exercise. CONCLUSIONS: A mixed-type, moderate-intensity exercise program in a group format is acceptable to women following breast cancer treatment, with the potential to reduce fatigue and improve quality of life, without exacerbating or precipitating lymphoedema. This pilot work needs to be confirmed in larger randomised studies.","Turner, J., et al. (2004). \"Improving the physical status and quality of life of women treated for breast cancer: a pilot study of a structured exercise intervention.\" J Surg Oncol 86(3): 141-146.","Australia",2004,"Cancer","Psychobehavioural","PFS",null,null,null,"Australia",null,"Cancer","Psychobehavioural",null,null,"PFS","2000:2004"]
[300,"Twiss, J., et al. (2010). \"Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS).\" Health Qual Life Outcomes 8: 117.",null,"Twiss, J., et al.","Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS)","BACKGROUND: The PRIMUS is a Multiple Sclerosis (MS)-specific suite of outcome measures including assessments of QoL (PRIMUS QoL, scored 0-22) and activity limitations (PRIMUS Activities, scored 0-30). The U-FIS is a measure of fatigue impact (scored 0-66). These measures have been fully validated previously using an MS sample with mixed diagnoses. The aim of the present study was to validate the measures further in a specifically Relapse Remitting MS (RRMS) sample and to provide preliminary evidence of the responder definitions (RD; also known as minimal important difference) for these instruments. METHODS: Data were derived from a multi-country efficacy trial of MS patients with assessments at baseline and 12 months. Baseline data were used to assess the internal reliability and validity of the measures. Both anchor-based and distribution-based approaches were employed for estimating RD. Anchor-based estimates were based on published RD values for the EQ-5D and were assessed for those improving and deteriorating separately. Distribution-based estimates were based on standard error of measurement (SEM), change score equivalent to 0.30, and change score equivalent to 0.50, effect sizes (ES). RESULTS: The sample included 911 RRMS patients (67.3% female, age mean (SD) 36.2 (8.4) years, duration of MS mean (SD) 4.8 (5.2) years). Results showed that the PRIMUS and U-FIS had good internal consistency. Appropriate correlations were observed with comparator instruments and both measures were able to distinguish between participants based on Expanded Disability Status Scale scores and time since diagnosis. The anchor-based and distribution-based RD estimates were: PRIMUS Activities range = 1.2-2.3, PRIMUS QoL range = 1.0-2.2, and U-FIS range = 2.4-7.0. CONCLUSIONS: The results show that the PRIMUS and U-FIS are valid instruments for use with RRMS patients. The analyses provide preliminary information on how to interpret scores on the scales. These data will be useful for assessing treatment efficacy and for powering clinical studies. TRIAL REFERENCE NUMBER: ClinicalTrials.gov Identifier NCT00340834.","Twiss, J., et al. (2010). \"Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS).\" Health Qual Life Outcomes 8: 117.","UK",2010,"Neurological","None","U-FIS",null,null,null,"UK",null,"Neurological","None",null,null,"U-FIS","2010:2014"]
[301,"Unal, G., et al. (2001). \"A psychometric comparison of health-related quality of life measures in chronic liver disease.\" J Clin Epidemiol 54(6): 587-596.",null,"Unal, G., et al.","A psychometric comparison of health-related quality of life measures in chronic liver disease","Four generic [the Sickness Impact Profile (SIP-68), Short-Form Health Survey (SF-36), EuroQol instrument (EQ-5D), COOP/WONCA charts], two domain-specific health-related quality of life measures [the sexuality scale of the HIV Overview Problems Evaluating System (HOPES), Multi-dimensional Fatigue Index (MFI-20)], and a self-developed 12-item symptom index were compared in terms of feasibility, test-retest reliability, internal consistency reliability, construct validity, and known groups validity in patients with chronic liver disease. All instruments could be completed within 10 min and exhibited a good psychometric performance in patients with chronic liver disease. The SF-36 and the MFI-20 performed relatively best in terms of reliability, construct validity, and discriminative ability. The sexuality scale of the HOPES demonstrated a relatively poor performance, as the missing value rate was higher than 5%. Further research is needed into the sensitivity to important clinical changes of the instruments.","Unal, G., et al. (2001). \"A psychometric comparison of health-related quality of life measures in chronic liver disease.\" J Clin Epidemiol 54(6): 587-596.","Netherlands",2001,"Various","None","MFI",null,null,null,"Netherlands",null,"Various","None",null,null,"MFI","2000:2004"]
[302,"Valko, P. O., et al. (2008). \"Validation of the fatigue severity scale in a Swiss cohort.\" Sleep 31(11): 1601-1607.",null,"Valko, P. O., et al.","Validation of the fatigue severity scale in a Swiss cohort","BACKGROUND: Fatigue is highly prevalent and has a negative impact on quality of life and performance in a variety of disorders. The 9-item Fatigue Severity Scale (FSS) is one of the most commonly used self-report questionnaires to measure fatigue, but has only been validated in small sample-sized studies and in single disorders. OBJECTIVE: To validate the FSS in healthy subjects and different disorders known to be commonly associated with fatigue. MATERIAL AND METHODS: The FSS was administered to 454 healthy subjects, 188 patients with multiple sclerosis (MS), 235 patients with recent ischemic stroke, and 429 patients with sleep-wake disorders including narcolepsy with cataplexy (n=22), restless legs syndrome (RLS) (n=79), sleep apnea (n=108), insomnia (n=62), parasomnia (n=25), excessive daytime sleepiness/hypersomnia of other origin (n=84, and other sleep-wake disorders (n=49. RESULTS: FSS scores were 4.66 +/- 1.64 (mean +/- SD) in patients with MS, 3.90 +/- 1.85 in patients after ischemic stroke, and 4.34 +/- 1.64 in patients with sleep-wake disorders. Compared to patients, values were significantly lower in healthy subjects (3.00 +/- 1.08, P < 0.01). Scores did not correlate with gender, age, or education. Item analysis showed an excellent internal consistency and reliability (Cronbach alpha = 0.93). Test-retest variability was assessed in 104 healthy subjects, showing stable values over time (2.94 +/- 0.90 vs. 2.90 +/- 0.74; P = 0.27). CONCLUSIONS: This first validation of a fatigue scale in a large sample size demonstrates that the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.","Valko, P. O., et al. (2008). \"Validation of the fatigue severity scale in a Swiss cohort.\" Sleep 31(11): 1601-1607.","Switzerland",2008,"Neurological,CVD","None","FSS",null,null,null,"Switzerland",null,"Neurological,CVD","None",null,null,"FSS","2005:2009"]
[303,"Vallejo, M. A., et al. (2010). \"Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF).\" Health Qual Life Outcomes 8: 2.",null,"Vallejo, M. A., et al.","Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF)","BACKGROUND: Fibromyalgia is a syndrome with heterogeneous symptoms. The evaluation in the clinical setting usually fails to cover the complexity of the syndrome. This study aims to determine how different aspects of fibromyalgia are inter-related when measured by means of a self-reporting tool. The objective is to develop a more complete evaluation model adjusted to the complexity and multi-dimensional nature of the syndrome. METHODS: Application was made of the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory, the Fatigue Assessment Scale, the Health Assessment Questionnaire, the General Health Questionnaire (GHQ-28), the Chronic Pain Coping Inventory, the Arthritis Self-efficacy Scale and the Sleep Quality Scale. An assessment was made, on the basis of clinical interviews, case histories and specific tests, of the patient sociodemographic data, comorbidity, physical exploration and other clinical indexes. An exploratory factor analysis was made, with comparisons of the clinical index scores in extreme groups of patients. RESULTS: The ICAF composed of 59 items was obtained, offering four factors that explain 64% of the variance, and referred to as Emotional Factor (33.7%), Physical-Activity (15%), Active Coping (9%) and Passive Coping (6.3%). A t-test between the extreme scores of these factors in the 301 patients revealed statistically significant differences in occupational status, medically unexplained syndromes, number of tender points, the six-minutes walk test, comorbidity and health care costs. CONCLUSIONS: This study offers a tool allowing more complete and rapid evaluation of patients with fibromyalgia. The test intrinsically evaluates the emotional aspects: anxiety and depression, and their impact upon social aspects. It also evaluates patient functional capacity, fatigue, sleep quality, pain, and the way in which the patient copes with the disease. This is achieved by means of a self-assessment questionnaire based on elements from well known tests.","Vallejo, M. A., et al. (2010). \"Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF).\" Health Qual Life Outcomes 8: 2.","Spain",2010,"Musculoskeletal","None","FAS",null,null,null,"Spain",null,"Musculoskeletal","None",null,null,"FAS","2010:2014"]
[304,"van Aken, M. O., et al. (2005). \"Quality of life in patients after long-term biochemical cure of Cushing's disease.\" J Clin Endocrinol Metab 90(6): 3279-3286.",null,"van Aken, M. O., et al.","Quality of life in patients after long-term biochemical cure of Cushing's disease","To evaluate the long-term impact of cured Cushing's disease on subjective well-being, we assessed quality of life by validated health-related questionnaires in 58 patients cured from Cushing's disease by transsphenoidal surgery (n = 58), some of whom received additional radiotherapy (n = 11) and/or bilateral adrenalectomy (n = 3). The mean duration of remission was 13.4 +/- 6.7 yr (range of 2-25 yr). Patient data were compared with a control group of 98 healthy subjects with the same age and sex distribution and with age-adjusted reference values available from the literature. General perceived well-being, measured by the Nottingham Health Profile and the Short Form, was reduced compared with controls for all subscales (P < 0.001). Patients with Cushing's disease had worse scores on subscales of fatigue Multidimensional Fatigue Index and anxiety and depression (Hospital Anxiety and Depression Scale). Compared with reference values from the literature, quality of life was also reduced in the patients according to all questionnaires and all items, except pain (Short Form), sleep (Nottingham Health Profile), and reduced activity (Multidimensional Fatigue Index). Despite conventional hormone replacement therapy, hypopituitarism was an important independent predictor of reduced quality of life. Patients without hypopituitarism (n = 28) showed reduced scores on physical items but normal scores on mental items compared with controls. In conclusion, despite long-term cure of Cushing's disease, patients experience a considerable decrease in quality of life, with physical and psychosocial impairments, especially in the presence of hypopituitarism.","van Aken, M. O., et al. (2005). \"Quality of life in patients after long-term biochemical cure of Cushing's disease.\" J Clin Endocrinol Metab 90(6): 3279-3286.","Netherlands",2005,"Endocrine","Surgery","MFI",null,null,null,"Netherlands",null,"Endocrine","Surgery",null,null,"MFI","2005:2009"]
[305,"Van Breugel, H. N., et al. (2010). \"A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery.\" J Cardiovasc Electrophysiol 21(5): 511-520.",null,"Van Breugel, H. N., et al.","A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery","INTRODUCTION: This is a multicenter, prospective, randomized controlled trial to determine the effect of add-on arrhythmia surgery on health-related quality of life during 1-year follow-up of cardiac surgery patients with atrial fibrillation. METHODS: 150 patients with documented atrial fibrillation were randomly assigned to undergo cardiac surgery with or without add-on surgery. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6, and 12 months following operation. RESULTS: 132 patients completed the questionnaires at a minimum of one time-point during follow-up. At baseline patient characteristics, operative data and health-related quality of life were comparable. At 12-month follow-up 62 patients were free of atrial fibrillation without significant differences between groups (P = 0.28). Conversion to SR occurred in 69.8% (37/53) of patients with paroxysmal AF, in 28.2% (11/39) of patients with permanent AF and in 44.4% (12/27) of patients in persistent AF. Cardiac surgery in general resulted in an overall improvement of the RAND SF-36 and the MFI-20. However, the EQ-5D showed a significant deterioration in the subscale Pain/Discomfort for both groups (P < 0.001), with a significant worse outcome for the control group (P = 0.006). CONCLUSIONS: Health-related quality of life in patients with paroxysmal, permanent and persistent atrial fibrillation improves after cardiac surgery regardless of giving add-on surgery or not, but this improvement is presumably more affected by treating the underlying heart disease than by restoring sinus rhythm.","Van Breugel, H. N., et al. (2010). \"A prospective randomized multicenter comparison on health-related quality of life: the value of add-on arrhythmia surgery in patients with paroxysmal, permanent or persistent atrial fibrillation undergoing valvular and/or coronary bypass surgery.\" J Cardiovasc Electrophysiol 21(5): 511-520.","Netherlands",2010,"CVD","Surgery","MFI",null,null,null,"Netherlands",null,"CVD","Surgery",null,null,"MFI","2010:2014"]
[306,"van Breugel, H. N., et al. (2016). \"Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?\" J Cardiothorac Surg 11(1): 75.",null,"van Breugel, H. N., et al.","Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?","BACKGROUND: We investigated the impact and the predictive value of sinus rhythm at 12 months (SR12) on subscales of three different HrQoL questionnaires: SF-36., EuroQoL and MFI 20. METHODS: Data of 125 cardiac surgery patients with pre-operative AF from our previous randomized trial were used. Based on their rhythm outcome patients were divided in two groups: SR12 or AF at 12 months follow up (non-SR12). All questionnaires were self-administered pre-operatively and at 3 months, 6 months and 12 months after surgery. RESULTS: Synus rhytm at 12 months was predictive of improvement of SF36- mental score (MS, p = 0.021), Euro-QoL-MS (p = 0.009), VAS (p = 0.006), and MFI 20-MS (p = 0.009). We failed to find any significant interactions between SR12 and any of the other significant risk factors: age <65 years, paroxysmal type of AF and preoperative AF duration <12 months. In contrast, SR12 was not significant in predicting physical score (PS) subscales of any of the questionnaires (all, p > 0.05) which were predicted by age <65 years (SF36-PS, p = 0.029) by paroxysmal type of AF and age <65 years (Euro-QoL-PS, p = 0.017 and p = 0.04, respectively) and by AF duration <12 months, paroxysmal type of AF and age < 65 years (MFI 20-PS, p = 0.019, p = 0.020 and p = 0.015, respectively). CONCLUSIONS: Specific mental-related HrQoL scales are much more sensitive to sinus rhythm conversion. Sinus rithm mantainance shows significant effects on mental scores independently of other cofactors. Successful conversion to sinus rhythm after surgical ablation during cardiac surgery does not significantly affect phisical health related quality of life during 1 year follow up.","van Breugel, H. N., et al. (2016). \"Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?\" J Cardiothorac Surg 11(1): 75.","Netherlands",2016,"CVD","Surgery","MFI",null,null,null,"Netherlands",null,"CVD","Surgery",null,null,"MFI","2015:2018"]
[307,"van der Klaauw, A. A., et al. (2008). \"Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly.\" Clin Endocrinol (Oxf) 69(1): 123-128.",null,"van der Klaauw, A. A., et al.","Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly","OBJECTIVE: Cross-sectional studies have shown impaired quality of life (QoL) in patients in biochemical control of acromegaly. The aim of this study was to assess longitudinal changes in QoL in a homogenous cohort of patients with sustained biochemical control of acromegaly. DESIGN: Prospective follow-up study. PATIENTS AND METHODS: QoL was assessed using four health-related QoL questionnaires (HADS, Hospital Anxiety and Depression Scale; MFI-20, Multidimensional Fatigue Index; NHP, Nottingham Health Profile; and SF-36, Short Form-36) and one disease-specific acromegaly quality of life (ACRO-QOL) questionnaire in 82 patients (43 men) with strict biochemical control of acromegaly, aged 56 years (range 29-84 years) at baseline and after 4 years of follow-up. The mean duration of controlled disease was 12 years (range 1-26 years). RESULTS: During follow-up, scores in 5 of 26 QoL subscales significantly worsened: physical and social functioning (SF-36), physical fatigue (MFI-20), and psychological well-being and personal relations (ACRO-QOL). Using linear regression analysis, baseline item scores predicted the follow-up scores, indicating individual stability over time. Previous radiotherapy (n = 27, 33%) negatively influenced several QoL subscales at follow-up: energy, pain and social isolation (NHP), physical fatigue and reduction in activity and motivation (MFI-20), depression and total anxiety and depression scores (HADS) and physical performance (ACRO-QOL). CONCLUSION: During 4 years of follow-up in patients with long-term biochemical control of ACRO-QOL is subtly, but progressively impaired. Radiotherapy was the predominant indicator of progressive impairment in QoL.","van der Klaauw, A. A., et al. (2008). \"Previous radiotherapy negatively influences quality of life during 4 years of follow-up in patients cured from acromegaly.\" Clin Endocrinol (Oxf) 69(1): 123-128.","Netherlands",2008,"Endocrine","Cancer treatments","MFI",null,null,null,"Netherlands",null,"Endocrine","Cancer treatments",null,null,"MFI","2005:2009"]
[308,"van der Plas, S. M., et al. (2004). \"The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire.\" Qual Life Res 13(8): 1469-1481.",null,"van der Plas, S. M., et al.","The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire","The available liver disease-specific questionnaires do address severity of symptoms but hardly evaluate how patients experience these specific symptoms during daily activities. The Liver Disease Symptom Index 2.0 (LDSI) includes 18 items that measure symptom severity and symptom hindrance in the past week. In a large survey (n = 1175) conducted in collaboration with the Dutch liver patient association, convergent and divergent construct validity and the surplus value of including symptom severity and symptom hindrance items in the LDSI were examined. The LDSI items showed expected convergent and divergent correlations with Short Form-36 (SF-36) and Multidimensional Fatigue Index-20 (MFI-20) scales. Correlations revealed only a slight to moderate overlap between LDSI items and SF-36 and MFI-20 scales. The impact of symptom severity and symptom hindrance on generic health related quality of life (HRQoL) varied in a different way across liver patients, which indicated that symptom severity items and the symptom hindrance items measure different aspects of HRQoL. We conclude that the LDSI provides information complementary to the information given by the SF-36 and the MFI-20 and that it is psychometrically sound to include both symptom severity items and symptom hindrance items in the LDSI.","van der Plas, S. M., et al. (2004). \"The Liver Disease Symptom Index 2.0; validation of a disease-specific questionnaire.\" Qual Life Res 13(8): 1469-1481.","Netherlands",2004,"Liver Disease","None","MFI",null,null,null,"Netherlands",null,"Liver Disease","None",null,null,"MFI","2000:2004"]
[309,"van der Plas, S. M., et al. (2007). \"Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey.\" Qual Life Res 16(3): 375-388.",null,"van der Plas, S. M., et al.","Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey","Most studies on health related quality of life (HRQoL) of chronic liver patients were done in small clinical populations or restricted to one aetiology or disease stage. There is still a need for a study in a large liver patient population with various aetiologies and disease stages, approaching a population-based study. We evaluated the impact of liver disease aetiology on generic HRQoL, disease-specific HRQoL and fatigue and we compared HRQoL and fatigue between aetiological groups and healthy Dutch controls. Members of the Dutch liver patient association completed the Liver Disease Symptom Index, Short Form-36, and Multidimensional Fatigue Index-20. We compared the HRQoL between patients with viral hepatitis, autoimmune hepatitis, cholestatic diseases, hemochromatosis and other liver diseases by linear, ordinal and logistic regression, corrected for disease stage and other significant factors. Viral hepatitis patients showed a worse mental health than other aetiological groups. Hemochromatosis patients demonstrated 17% more bodily pain than viral hepatitis patients and the strongest decrease in role emotional health with increasing age. Aetiological groups showed a worse generic HRQoL and more fatigue than controls. In conclusion, viral hepatitis and hemochromatosis patients have a more impaired HRQoL than patients of other liver disease aetiological groups.","van der Plas, S. M., et al. (2007). \"Generic and disease-specific health related quality of life of liver patients with various aetiologies: a survey.\" Qual Life Res 16(3): 375-388.","Netherlands",2007,"Liver Disease","None","MFI",null,null,null,"Netherlands",null,"Liver Disease","None",null,null,"MFI","2005:2009"]
[310,"van Rhee, F., et al. (2015). \"Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.\" Patient 8(2): 207-216.",null,"van Rhee, F., et al.","Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab","BACKGROUND: Multicentric Castleman's disease (MCD) is a rare lymphoproliferative disorder driven by dysregulated interleukin-6 production. MCD has a poor prognosis, and treatment is generally noncurative and aimed at symptom relief. Siltuximab is a novel, monoclonal interleukin-6 antibody recently shown to be effective in a registration clinical trial. MCD symptoms, such as fatigue, pain, and weakness, are most appropriately quantified using patient-reported outcome (PRO) measures. We assessed the effect of siltuximab on patient perception of symptoms, functional status, and wellbeing using PRO instruments. METHODS: We analyzed results of a randomized, double-blind trial comparing siltuximab 11 mg/kg every 3 weeks with placebo to treat MCD. Subjects (N = 79) completed the recently developed MCD-Symptom Scale (MCD-SS), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale, and the Short Form (SF)-36 at predetermined time points throughout the treatment period. Scores were compared at baseline and over time between the treatment arms and PRO instruments. RESULTS: At baseline, the mean number of symptoms reported was 9.2 (standard deviation 3.76) out of 16 total, as measured by the MCD-SS. Fatigue was a key symptom across all PRO instruments. Siltuximab-treated subjects reported early improvements in symptoms compared with subjects in the placebo arm on both the MCD-SS and FACIT-Fatigue scale. Statistically significant improvements in five SF-36 domains were observed in siltuximab-treated patients, namely role physical, role emotional, vitality, bodily pain, and mental health. CONCLUSIONS: Patients with MCD commonly report impairments in functioning, wellbeing, and fatigue at baseline. Siltuximab-treated patients reported significant improvements in these outcomes after treatment.","van Rhee, F., et al. (2015). \"Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.\" Patient 8(2): 207-216.","USA",2015,"Hematological","Siltuximab","FACIT-F",null,null,null,"USA",null,"Hematological","Siltuximab",null,null,"FACIT-F","2015:2018"]
[311,"van Tubergen, A., et al. (2002). \"Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis.\" Arthritis Rheum 47(1): 8-16.",null,"van Tubergen, A., et al.","Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis","OBJECTIVES: To investigate whether the single-item fatigue question of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Multidimensional Fatigue Inventory (MFI) are appropriate instruments to measure fatigue in ankylosing spondylitis (AS); to identify factors that influence fatigue in AS; and to assess how fatigue in all its aspects is associated with quality of life in AS. METHODS: A total of 812 patients with AS were included. Patients completed questionnaires on disease activity (BASDAI), functional ability (Bath Ankylosing Spondylitis Functional Index [BASFI]), global well-being (Bath Ankylosing Spondylitis Global Score [BAS-G]), overall perceived health (EuroQoL visual analog scale), and quality of life (Ankylosing Spondylitis Quality of Life questionnaire, and Short Form 36 [SF-36]). Patients were dichotomized into a F+ group (fatigue = major symptom) if the BASDAI fatigue score was > 5.0 and a F- group (fatigue = minor symptom) if the fatigue score was < 5.0. Reproducibility was assessed with intraclass correlation coefficients, and responsiveness was calculated according to 3 different methods. Logistic regression analysis was used to determine which factors were associated with fatigue. Multiple regression analysis was used to investigate whether fatigue contributes in explaining quality of life. RESULTS: Fifty-three percent of the patients were assigned to the F+ group. They scored significantly worse compared with the F- group with respect to each dimension of the MFI and to all other questionnaires studied (all P < 0.001). The BASDAI fatigue question, as well as each separate dimension of the MFI, showed moderate to good reproducibility (0.57-0.75) and responsiveness (0.23-0.96). Fatigue was, in the opinion of the patients, highly associated with pain (70% of patients) and stiffness (54% of patients). Logistic regression analysis showed that scores on BASDAI, BASFI, BAS-G, and mental health status (SF-36) were independently associated with fatigue (R(2) = 0.52). Multiple regression analysis showed that scores on the BASDAI fatigue question were significantly associated with quality of life. With the 5 MFI dimensions as explanatory variables, different aspects of fatigue were associated with different domains of quality of life. CONCLUSIONS: Fatigue as a major symptom of AS can effectively be measured with either a single-item question on the intensity of fatigue or with the MFI. The MFI, however, provides more insight into specific dimensions of fatigue. Fatigue appears to be associated with the level of disease activity, functional ability, global well-being, and mental health status. In addition, fatigue negatively influences different aspects of quality of life.","van Tubergen, A., et al. (2002). \"Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis.\" Arthritis Rheum 47(1): 8-16.","Netherlands",2002,"Musculoskeletal","None","MFI",null,null,null,"Netherlands",null,"Musculoskeletal","None",null,null,"MFI","2000:2004"]
[312,"Vasconcelos, O. M., et al. (2007). \"Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.\" Neurology 68(20): 1680-1686.",null,"Vasconcelos, O. M., et al.","Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial","OBJECTIVE: To determine if modafinil can improve fatigue in patients with post-polio syndrome. METHODS: We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects. RESULTS: Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments. CONCLUSION: Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population.","Vasconcelos, O. M., et al. (2007). \"Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial.\" Neurology 68(20): 1680-1686.","USA",2007,"Neurological","Other Drugs","FSS,VAS-F,FIS",null,null,null,"USA",null,"Neurological","Other Drugs",null,null,"FSS,VAS-F,FIS","2005:2009"]
[313,"Velthuis, M. J., et al. (2010). \"Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial.\" BMC Cancer 10: 272.",null,"Velthuis, M. J., et al.","Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial","BACKGROUND: Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. METHODS/DESIGN: The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term) and after 9 months (long term). Validated questionnaires will be used. PRIMARY OUTCOME: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List) and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey), impact on functioning and autonomy (Impact on functioning and autonomy questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), physical fitness (aerobic peak capacity, muscle strength), body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level will be measured using the Short Questionnaire to Assess Health-Enhancing Physical Activity and will be monitored with an exercise log and a pedometer. DISCUSSION: This study investigates the (cost)-effectiveness of exercise during adjuvant treatment of patients with breast or colon cancer. If early physical exercise proves to be (cost) effective, establishing standardised physical exercise programmes during cancer treatment will be planned. TRIAL REGISTRATION: Current Controlled trials ISRCTN43801571, Dutch Trial Register NTR2138.","Velthuis, M. J., et al. (2010). \"Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial.\" BMC Cancer 10: 272.","Netherlands",2010,"Cancer","Psychobehavioural","MFI",null,null,null,"Netherlands",null,"Cancer","Psychobehavioural",null,null,"MFI","2010:2014"]
[314,"Visser, M. R. and E. M. Smets (1998). \"Fatigue, depression and quality of life in cancer patients: how are they related?\" Support Care Cancer 6(2): 101-108.",null,"Visser, M. R. and E. M. Smets","Fatigue, depression and quality of life in cancer patients: how are they related?","In a study concerning a group of cancer patients undergoing radiotherapy three research questions were addressed. (1) Is fatigue a valid criterion for depression in these somatically ill patients? (2) What is the 'cause-and-effect' relation between fatigue and depression? (3) To what extent are fatigue and depression related to patients' quality of life. A heterogeneous sample of cancer patients (n = 250) were interviewed before treatment, 2 weeks after treatment and 9 months later. Fatigue was measured using the MFI, a self-report instrument covering five dimensions of fatigue. Depression was assessed with the non-somatic items of the CES-D. Quality of life had to be indicated on a Cantrill ladder. Fatigue and depression do not follow the same course over time. Just after radiotherapy, fatigue had either increased or remained stable, depending on the dimension under consideration. Depression, in contrast, decreased. Nine months later fatigue had decreased, whereas levels of depression remained stable. Concurrent relations between fatigue and depression were mostly moderate. There was no strong evidence for a cause-and-effect relationship between depression and fatigue. Depression showed highest concurrent relationships with quality of life, especially before treatment. Prospectively, depression and the dimension of physical fatigue were the main predictors for quality of life. Fatigue is not a valid criterion for depression in these patients. Nor is there a strong cause-and-effect relationship. Both depression and physical fatigue are relevant to patients' quality of life.","Visser, M. R. and E. M. Smets (1998). \"Fatigue, depression and quality of life in cancer patients: how are they related?\" Support Care Cancer 6(2): 101-108.","Netherlands",1998,"Cancer","None","MFI",null,null,null,"Netherlands",null,"Cancer","None",null,null,"MFI","1960:1999"]
[315,"Vogelaar, L., et al. (2014). \"Fatigue management in patients with IBD: a randomised controlled trial.\" Gut 63(6): 911-918.",null,"Vogelaar, L., et al.","Fatigue management in patients with IBD: a randomised controlled trial","OBJECTIVE: To assess the effectiveness of solution-focused therapy (SFT) on fatigue and quality of life (QoL) in patients with fatigued inflammatory bowel disease (IBD). DESIGN: Randomised controlled trial in two Dutch hospitals. Patients with IBD with quiescent IBD and with a Checklist Individual Strength--Fatigue (CIS--fatigue) score of >/= 35 were enrolled. Patients were 1:1 randomised to receive SFT or care as usual (CAU) for 3 months. Patients were followed for a further 6 months after the SFT. Primary endpoint was defined as changes in fatigue and QoL during follow-up. Secondary endpoints included change in anxiety and depression, medication use, side effects to medication, disease activity, laboratory parameters (C-reactive protein, leucocytes and haemoglobin) and sleep quality. RESULTS: Ninety-eight patients were included, of whom 63% were women, mean age was 40.1 years. After the SFT course, 17 (39%) patients in the SFT group had a CIS-fatigue score below 35 compared with eight (18%) of patients in the CAU group (p=0.03). The SFT group also showed a greater reduction in fatigue across the first 6 months compared with the CAU group (CIS-fatigue: p=<0.001 and CIS-total: p=0.001). SFT was associated with a significant higher mean IBD questionnaire change at 3 months (p=0.020). At 9 months, no significant differences between the two groups were observed. CONCLUSIONS: SFT has a significant beneficial effect on the severity of fatigue and QoL in patients with quiescent IBD. However, this effect diminished during follow-up.","Vogelaar, L., et al. (2014). \"Fatigue management in patients with IBD: a randomised controlled trial.\" Gut 63(6): 911-918.","Netherlands",2014,"Gastrointestinal","Psychobehavioural","CIS-F",null,null,null,"Netherlands",null,"Gastrointestinal","Psychobehavioural",null,null,"CIS-F","2010:2014"]
[316,"Wallymahmed, M. E., et al. (1996). \"The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency.\" Clin Endocrinol (Oxf) 44(4): 403-411.",null,"Wallymahmed, M. E., et al.","The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency","OBJECTIVE: Adults with GH deficiency frequently complain of lack of energy, fatigue, social isolation and problems with sexual relationships resulting in a low perceived quality of life. Previous studies of quality of life (QOL) in GH deficient adults have involved small numbers of patients and used measures not specifically designed for this patient population. We have devised a health related QOL model specifically designed for use in adults with GH deficiency and to assess the impact of future GH replacement therapy. DESIGN: Six measurements were chosen for inclusion in the model. Two were adapted for use after clinical interviews with 12 adult GH deficient patients: the Impact and the Life Fulfilment scales. The others were the Nottingham Health Profile, the Hospital Anxiety and Depression Scale, the Self-Esteem Scale and the Mental Fatigue Questionnaire. The reliability of the 6 measures was assessed by 2 methods: test re-test correlation and internal consistency (Cronbach's alpha). The validity of the Impact and Life Fulfilment scales was assessed by correlation with the other 4 scales. PATIENTS: Questionnaires were completed by 32 adults with hypothalamic pituitary disorders and GH deficiency (11 male, mean age 35.1 years), with a stimulated maximum serum GH response less than 10 mU/l (mean 2.96). Two had previously received GH injections in childhood. The questionnaires were also completed by 32 age and sex matched control subjects. RESULTS: The 6 scales had test re-test correlations of 0.70-0.92 indicating reliability over time. The Impact and Life Fulfilment Scales and the Mental Fatigue Questionnaire had Cronbach's alpha scores of greater than 0.6 indicating their potential for use in clinical trials. The Impact and Life Fulfilment scales correlated significantly with many physical and psychological domains from the other 4 scales indicating these were valid in the assessment of health related QOL in GH deficient adults. Compared to the controls the patients with GH deficiency were significantly psychosocially disadvantaged in terms of depression, self-esteem, mental fatigue and life fulfilment. CONCLUSION: The results of the reliability and validity studies indicate that this health related quality of life model for use with adults with GH deficiency is a potentially valid and reliable tool that could be used to assess the effect of GH treatment.","Wallymahmed, M. E., et al. (1996). \"The development, reliability and validity of a disease specific quality of life model for adults with growth hormone deficiency.\" Clin Endocrinol (Oxf) 44(4): 403-411.","UK",1996,"Endocrine","None","MFQ",null,null,null,"UK",null,"Endocrine","None",null,null,"MFQ","1960:1999"]
[317,"Wallymahmed, M. E., et al. (1999). \"The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects.\" Clin Endocrinol (Oxf) 51(3): 333-338.",null,"Wallymahmed, M. E., et al.","The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects","OBJECTIVE: Adults with GH deficiency (GHD) frequently report a poor quality of life (QOL). Whether this poor QOL is specifically due to hormone deficiency or a non specific effect of a chronic condition is not known. We therefore assessed QOL in adults with hypopituitarism and GHD and compared scores with a group of patients with diabetes mellitus, another life-long condition with potentially serious complications and a group of healthy controls. PATIENTS: We studied 57 patients with hypopituitarism and GHD (peak stimulated GH response < 9 mU/l) (23 male, mean age 36.4 years, mean stimulated GH response 2.3 mU/l), secondary to a variety of hypothalamic-pituitary disorders. Fifty had been treated surgically (39 cranial surgery, 11 transsphenoidal) and 37 had received external cranial irradiation involving the hypothalamic region. Fifty-seven age and sex matched patients with diabetes mellitus (31 insulin treated, 18 on oral hypoglycaemic agents, 8 on diet alone) and 57 matched healthy controls were also studied. DESIGN AND MEASUREMENTS: We assessed and compared health related QOL in the 3 groups using 4 self rating questionnaires: Hospital Anxiety and Depression Scale, Self Esteem Scale, Mental Fatigue Questionnaire and Life Fulfilment Scale. In addition the GHD and diabetic groups also completed the Disease Impact Scale. RESULTS: The GHD group reported significantly more depression (P < 0.05) and mental fatigue (P < 0.05) and significantly less self esteem (P < 0.05) and life fulfilment (P < 0. 05) than either the group with diabetes or the controls. Patients with GHD reported significantly higher anxiety scores (P < 0.05) than the controls. Within the GHD group there were no differences in QOL scores between patients with pituitary tumours (n = 24), craniopharyngiomas/hypothalamic tumours (n = 18) or other brain tumours. In addition there were no significant differences according to surgical treatment modality or radiotherapy. However subgroup analysis revealed that the patients who had undergone transsphenoidal surgery (n = 11) differed significantly from the control group in life fulfillment and depression (P < 0.01) only and did not differ from the DM group in any of the questionnaires used. There were no significant differences between the group with diabetes and the control group in any of the measures except depression (P < 0.05). CONCLUSIONS: This study revealed a significant impairment of QOL in adults with GHD, particularly those who had undergone cranial surgery, when compared to matched patients with diabetes and healthy controls.","Wallymahmed, M. E., et al. (1999). \"The quality of life of adults with growth hormone deficiency: comparison with diabetic patients and control subjects.\" Clin Endocrinol (Oxf) 51(3): 333-338.","UK",1999,"Endocrine","None","MFQ",null,null,null,"UK",null,"Endocrine","None",null,null,"MFQ","1960:1999"]
[318,"Wallymahmed, M. E., et al. (1997). \"Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years.\" Clin Endocrinol (Oxf) 47(4): 439-446.",null,"Wallymahmed, M. E., et al.","Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years","OBJECTIVE: Adults with GH deficiency complain frequently of low energy levels, emotional lability and mental fatigue resulting in a low perceived quality of life (QOL). Body composition is altered with increased fat mass and decreased lean body mass and muscle strength is reduced. The aims of this study were to determine the effects of replacement GH treatment on: (a) body composition and muscle strength and (b) QOL, using specifically selected and adapted measures. DESIGN: A 12-month study (double-blind placebo-controlled for the first 6 months and open for the second 6 months) of GH replacement injections (0.125 iu/kg/week for the first month and 0.25 iu/kg/week for the following 5 months of each study period) in GH deficient adults on QOL, body composition and muscle strength. This was followed by an open study of a further 12 months' GH treatment assessing QOL and muscle strength. Finally, QOL was assessed after up to 3 years of GH replacement treatment. PATIENTS: Thirty of the 32 adult patients with GH deficiency enrolled completed the initial 12-month study (10 male, mean age 33.5 years, mean (SD) stimulated serum GH response 3.0 mU/l (2.86)). Nineteen patients then opted to continue GH treatment. Of these, 13 patients were available for assessment after a further 12 months' and 24 months' treatment. MEASUREMENTS: Health-related QOL was assessed using 2 specifically adapted scales for adults with GH deficiency: the Life Fulfillment Scale and the Impact Scale. In addition 4 other self-rating questionnaires were used: Nottingham Health Profile, Hospital Anxiety and Depression Scale, Self Esteem Scale and Mental Fatigue Scale. Body composition was assessed by DEXA and quadriceps muscle strength by measuring maximum voluntary contractions. RESULTS: In the initial 12 months' placebo-controlled study perceived energy levels increased after 6 and 12 months of GH treatment (P < 0.01 compared with baseline) in the patients receiving GH for the full 12-month period. There were no changes in energy levels throughout the study in the group receiving placebo for the first 6 months. Also small improvements in impact scores were found after 6 months of GH treatment (P < 0.05) but this was not sustained at 12 months. In both GH and placebo groups life fulfillment worsened after 6 months, but then improved to baseline values after 12 months. In the patients who persisted with GH replacement, energy levels continued to improve (at 2 years, P < 0.01 compared with baseline) but then fell (at 3 years, P = NS compared with baseline). A similar pattern was observed in emotional reaction scores. However, improvements in self-esteem were maintained (at 3 years, P < 0.05 compared with baseline). Body composition altered favourably over the initial 12-month study period with a significant increase in lean mass and decrease in fat mass in both groups after 6-12 months of GH. There were no changes in muscle strength in either group during the initial 12-month study. However, in the patients who were available for assessment after a further 12 months of GH treatment, muscle strength increased significantly (P < 0.02 compared with baseline). CONCLUSION: GH replacement treatment for 6-12 months leads to significant improvements in body composition (DEXA) but longer-term treatment may be needed to increase muscle strength. Self-esteem scores improve and are maintained after 3 years of treatment. Energy levels and emotional reaction improve during treatment for up to 2 years but decline thereafter.","Wallymahmed, M. E., et al. (1997). \"Quality of life, body composition and muscle strength in adult growth hormone deficiency: the influence of growth hormone replacement therapy for up to 3 years.\" Clin Endocrinol (Oxf) 47(4): 439-446.","UK",1997,"Endocrine","Various","MFS",null,null,null,"UK",null,"Endocrine","Various",null,null,"MFS","1960:1999"]
[319,"Wang, S. Y., et al. (2016). \"Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study.\" Ren Fail 38(3): 442-450.",null,"Wang, S. Y., et al.","Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study","BACKGROUD: Fatigue is considered as a common symptom in patients with end-stage renal disease (ESRD) and can significantly decrease patients' quality of life. This study aimed to assess fatigue in hemodialysis patients and to investigate risk factors of fatigue in Chinese patients receiving maintenance hemodialysis (MHD) in China. METHODS: Eligible patients completed questionnaires including demographic information, a Chinese version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Family APGAR Index (APGAR), the medical outcomes study health status-Social Functioning subscale (SF-36,SocF), and the Pittsburgh sleep quality index (PSQI). Laboratory parameters were abstracted by medical records review. The multiple linear regression model was used to relate parameters with the FACIT-Fatigue score. RESULTS: A total of 345 MHD patients (216 men and 129 women, age 55.6 +/- 12.8) were recruited in this study. The score of FACIT-Fatigue was 39 (Interquartile Range, 31-44). Fatigue was correlated with PSQI scores (p < 0.001), SocF scores (p < 0.001), comorbidity (p = 0.006), exercise time <1 hour per day (p = 0.003), adequacy of dialysis (Kt/V) < 1.2 (p = 0.016), APGAR scores (p = 0.014), and high Scr (p = 0.043). CONCLUSIONS: Fatigue is related to sleep disturbance, social and family functioning, taking physical exercise time, comorbidity condition, Kt/V and serum creatinine level in Chinese MHD patients. Future studies and interventions should focus on developing strategies and improving the quality of life in patients by addressing these significant contributing factors.","Wang, S. Y., et al. (2016). \"Factors related to fatigue in Chinese patients with end-stage renal disease receiving maintenance hemodialysis: a multi-center cross-sectional study.\" Ren Fail 38(3): 442-450.","China",2016,"Kidney Disease","None","FACIT-F",null,null,null,"China",null,"Kidney Disease","None",null,null,"FACIT-F","2015:2018"]
[320,"Wang, Y. Y., et al. (2014). \"Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials.\" Complement Ther Med 22(4): 826-833.",null,"Wang, Y. Y., et al.","Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials","BACKGROUND: There is no curative treatment for chronic fatigue syndrome (CFS). Traditional Chinese medicine (TCM) is widely used in the treatment of CFS in China. OBJECTIVE: To evaluate the effectiveness and safety of TCM for CFS. METHODS: The protocol of this review is registered at PROSPERO. We searched six main databases for randomized clinical trials (RCTs) on TCM for CFS from their inception to September 2013. The Cochrane risk of bias tool was used to assess the methodological quality. We used RevMan 5.1 to synthesize the results. RESULTS: 23 RCTs involving 1776 participants were identified. The risk of bias of the included studies was high. The types of TCM interventions varied, including Chinese herbal medicine, acupuncture, qigong, moxibustion, and acupoint application. The results of meta-analyses and several individual studies showed that TCM alone or in combination with other interventions significantly alleviated fatigue symptoms as measured by Chalder's fatigue scale, fatigue severity scale, fatigue assessment instrument by Joseph E. Schwartz, Bell's fatigue scale, and guiding principle of clinical research on new drugs of TCM for fatigue symptom. There was no enough evidence that TCM could improve the quality of life for CFS patients. The included studies did not report serious adverse events. CONCLUSIONS: TCM appears to be effective to alleviate the fatigue symptom for people with CFS. However, due to the high risk of bias of the included studies, larger, well-designed studies are needed to confirm the potential benefit in the future.","Wang, Y. Y., et al. (2014). \"Traditional Chinese medicine for chronic fatigue syndrome: a systematic review of randomized clinical trials.\" Complement Ther Med 22(4): 826-833.","China",2014,"Chronic Fatigue","Complementary","CFS,FSS,FAI,Bells Fatigue Scale",null,null,null,"China",null,"Chronic Fatigue","Complementary",null,null,"CFS,FSS,FAI,Bells Fatigue Scale","2010:2014"]
[321,"Weitz, I., et al. (2013). \"Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria.\" Intern Med J 43(3): 298-307.",null,"Weitz, I., et al.","Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria","BACKGROUND: Paroxysmal nocturnal haemoglobinuria (PNH) is a rare, acquired, clonal haemopoietic stem cell disorder that causes chronic intravascular haemolysis, increases the risk of thrombosis and results in significant patient morbidity and mortality. The symptoms of PNH may have a major impact on patient quality of life. AIMS: To assess patient fatigue and health-related quality of life in 29 patients with PNH using the Functional Assessment of Chronic Illness Therapy Fatigue subscale version 4 (FACIT-Fatigue) and the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30, version 3 (EORTC QLQ-C30). METHODS: Following completion of the questionnaires, patients were interviewed to assess the validity, clarity, relevance and comprehensiveness of the assessments. RESULTS: Overall, patients considered both the FACIT-Fatigue and EORTC QLQ-C30 instruments to be relevant and adequate in assessing the level of PNH-associated fatigue and other quality-of-life measures. The FACIT-Fatigue questionnaire was considered to be clear and to comprehensively cover PNH-related fatigue. The EORTC QLQ-C30 instrument was considered to be easy to understand, but of an overall lower relevance, although some differences between countries were observed. Patients suggested additional questions that could be incorporated into future EORTC QLQ-C30 versions to make it more relevant to PNH. CONCLUSIONS: This study confirms the validity of the FACIT-Fatigue and the EORTC QLQ-C30 questionnaires in this patient population and their routine use should be considered in the management of patients with PNH.","Weitz, I., et al. (2013). \"Cross-sectional validation study of patient-reported outcomes in patients with paroxysmal nocturnal haemoglobinuria.\" Intern Med J 43(3): 298-307.","USA",2013,"Hematological","None","FACIT-F",null,null,null,"USA",null,"Hematological","None",null,null,"FACIT-F","2010:2014"]
[322,"Werumeus Buning, J., et al. (2016). \"Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial.\" Neuroendocrinology 103(6): 771-778.",null,"Werumeus Buning, J., et al.","Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial","BACKGROUND: There is a major lack of randomized controlled trials (RCTs) evaluating the effects of hydrocortisone (HC) substitution therapy in patients with secondary adrenal insufficiency. Therefore, we evaluated the effects of two different replacement doses of HC on health-related quality of life (HRQoL) in a RCT. METHODS: This RCT with a double-blind cross-over design was performed at the University Medical Center Groningen. Forty-seven patients (29 men, age 51 +/- 14 years, range 19-73 years) with secondary adrenal insufficiency participated. Patients received both a lower and a higher dose of HC (0.2-0.3 and 0.4-0.6 mg/kg body weight/day) for 10 weeks in random order. HRQoL was assessed with a daily mood and symptom checklist (Patient Health Questionnaire-15 [PHQ-15], Generalized Anxiety Disorder-7 [GAD-7], Patient Health Questionnaire-9 [PHQ-9]) and with questionnaires assessing general well-being (RAND 36-Item Health Survey [RAND-36]), mood (Hospital Anxiety and Depression Scale [HADS]) and fatigue (Multidimensional Fatigue Inventory-20 [MFI-20]). ClinicalTrials.gov identifier: NCT01546922. RESULTS: Patients receiving the higher dose of HC reported significantly fewer symptoms of depression (p = 0.016 and p = 0.045 for HADS and PHQ-9, respectively), less general and mental fatigue (p = 0.004 and p = 0.003, respectively, both MFI-20), increased motivation (p = 0.021, MFI-20), better physical functioning (p = 0.041), better general health (p = 0.013) and more vitality (p = 0.025) (all RAND-36). In addition, while on the higher dose, fewer somatic symptoms (p = 0.022) and less pain (p < 0.001) (both PHQ-15) were experienced. CONCLUSIONS: On the higher dose of HC, patients reported a better HRQoL on various domains as compared to the lower dose of HC. The fact that a higher dose of HC may improve patient well-being should be taken into consideration when individualizing the HC substitution dose.","Werumeus Buning, J., et al. (2016). \"Hydrocortisone Dose Influences Pain, Depressive Symptoms and Perceived Health in Adrenal Insufficiency: A Randomized Controlled Trial.\" Neuroendocrinology 103(6): 771-778.","Netherlands",2016,"Endocrine","Other Drugs","MFI",null,null,null,"Netherlands",null,"Endocrine","Other Drugs",null,null,"MFI","2015:2018"]
[323,"Wesselius, T., et al. (2005). \"A randomized crossover study of bee sting therapy for multiple sclerosis.\" Neurology 65(11): 1764-1768.",null,"Wesselius, T., et al.","A randomized crossover study of bee sting therapy for multiple sclerosis","BACKGROUND: Bee sting therapy is increasingly used to treat patients with multiple sclerosis (MS) in the belief that it can stabilize or ameliorate the disease. However, there are no clinical studies to justify its use. METHODS: In a randomized, crossover study, we assigned 26 patients with relapsing-remitting or relapsing secondary progressive MS to 24 weeks of medically supervised bee sting therapy or 24 weeks of no treatment. Live bees (up to a maximum of 20) were used to administer bee venom three times per week. The primary outcome was the cumulative number of new gadolinium-enhancing lesions on T1-weighted MRI of the brain. Secondary outcomes were lesion load on T2*-weighted MRI, relapse rate, disability (Expanded Disability Status Scale, Multiple Sclerosis Functional Composite, Guy's Neurologic Disability Scale), fatigue (Abbreviated Fatigue Questionnaire, Fatigue Impact Scale), and health-related quality of life (Medical Outcomes Study 36-Item Short Form General Health Survey). RESULTS: During bee sting therapy, there was no significant reduction in the cumulative number of new gadolinium-enhancing lesions. The T2*-weighted lesion load further progressed, and there was no significant reduction in relapse rate. There was no improvement of disability, fatigue, and quality of life. Bee sting therapy was well tolerated, and there were no serious adverse events. CONCLUSIONS: In this trial, treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity, disability, or fatigue and did not improve quality of life.","Wesselius, T., et al. (2005). \"A randomized crossover study of bee sting therapy for multiple sclerosis.\" Neurology 65(11): 1764-1768.","Netherlands",2005,"Neurological","Complementary","FQ,FIS",null,null,null,"Netherlands",null,"Neurological","Complementary",null,null,"FQ,FIS","2005:2009"]
[324,"Wilburn, J., et al. (2015). \"Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).\" Qual Life Res 24(9): 2279-2288.",null,"Wilburn, J., et al.","Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ)","PURPOSE: Despite the significant impact of Crohn's disease (CD) on patients' physical and emotional well-being, no CD-specific patient-reported outcome (PRO) measure is available for determining the efficacy of interventions. The objective of the study was to develop and validate the Crohn's Life Impact Scale (CLIQ), the first such measure. METHODS: Questionnaire content was derived from qualitative interviews with CD patients and face and content validity assessed by cognitive debriefing interviews (CDIs) with patients. A postal survey was conducted to identify the final scale, confirm its unidimensionality and determine reproducibility and construct validity. A subset of the respondents was sent a second questionnaire package 2 weeks after the first. The survey included the CLIQ, Nottingham Health Profile (NHP) and Unidimensional Fatigue Impact Scale (U-FIS). RESULTS: Content analysis was conducted on the 30 interview transcripts and a draft scale produced. The CDIs indicated that the draft scale was relevant, clear and easy to use. The questionnaire package was completed by 273 CD patients (65.6 % male; aged 16-79 (mean 43.9; SD 15.1) years). Of these, 104 also completed the second package. Rasch analysis confirmed a 27-item unidimensional QoL scale (p < 0.05). Both internal consistency and test-retest reliability were high (0.91). Scores on the CLIQ were related to both physical and emotional impairments (NHP) and to fatigue (U-FIS). CONCLUSION: The CLIQ, the first CD-specific PRO, is unidimensional and has excellent psychometric properties. It should prove to be a valuable tool for evaluating the impact of CD and its treatment from the patients' perspective.","Wilburn, J., et al. (2015). \"Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).\" Qual Life Res 24(9): 2279-2288.","UK",2015,"Gastrointestinal","None","U-FIS",null,null,null,"UK",null,"Gastrointestinal","None",null,null,"U-FIS","2015:2018"]
[325,"Williams, J. E., et al. (2010). \"Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study).\" Am J Cardiol 105(12): 1661-1665.",null,"Williams, J. E., et al.","Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study)","Vital exhaustion, defined as excessive fatigue, feelings of demoralization, and increased irritability, has been identified as a risk factor for incident and recurrent cardiac events, but there are no population-based prospective studies of this association in US samples. We examined the predictive value of vital exhaustion for incident myocardial infarction or fatal coronary heart disease in middle-aged men and women in 4 US communities. Participants were 12,895 black or white men and women enrolled in the Atherosclerosis Risk In Communities (ARIC) study cohort and followed for the occurrence of cardiac morbidity and mortality from 1990 through 2002 (maximum follow-up 13.0 years). Vital exhaustion was assessed using the 21-item Maastricht Questionnaire and scores were partitioned into approximate quartiles for statistical analyses. High vital exhaustion (fourth quartile) predicted adverse cardiac events in age-, gender-, and race-center-adjusted analyses (1.69, 95% confidence interval 1.40 to 2.05) and in analyses further adjusted for educational level, body mass index, plasma low-density lipoprotein and high-density lipoprotein cholesterol levels, systolic and diastolic blood pressure levels, diabetes mellitus, cigarette smoking status, and pack-years of cigarette smoking (1.46, 95% confidence interval 1.20 to 1.79). Risk for adverse cardiac events increased monotonically from the first through the fourth quartile of vital exhaustion. Probabilities of adverse cardiac events over time were significantly higher in people with high vital exhaustion compared to those with low exhaustion (p = 0.002). In conclusion, vital exhaustion predicts long-term risk for adverse cardiac events in men and women, independent of established biomedical risk factors.","Williams, J. E., et al. (2010). \"Vital exhaustion as a risk factor for adverse cardiac events (from the Atherosclerosis Risk In Communities [ARIC] study).\" Am J Cardiol 105(12): 1661-1665.","USA",2010,"CVD","None","Maastricht questionnaire",null,null,null,"USA",null,"CVD","None",null,null,"Maastricht questionnaire","2010:2014"]
[326,"Yadav, V., et al. (2016). \"Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.\" Mult Scler Relat Disord 9: 80-90.",null,"Yadav, V., et al.","Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial","BACKGROUND: The role that dietary interventions can play in multiple sclerosis (MS) management is of huge interest amongst patients and researchers but data evaluating this is limited. Possible effects of a very-low-fat, plant-based dietary intervention on MS related progression and disease activity as measured by brain imaging and MS related symptoms have not been evaluated in a randomized-controlled trial. Despite use of disease modifying therapies (DMT), poor quality of life (QOL) in MS patients can be a significant problem with fatigue being one of the common disabling symptoms. Effective treatment options for fatigue remain limited. Emerging evidence suggests diet and vascular risk factors including obesity and hyperlipidemia may influence MS disease progression and improve QOL. OBJECTIVES: To evaluate adherence, safety and effects of a very-low-fat, plant-based diet (Diet) on brain MRI, clinical [MS relapses and disability, body mass index (BMI)] and metabolic (blood lipids and insulin) outcomes, QOL [Short Form-36 (SF-36)], and fatigue [Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS)], in relapsing-remitting MS (RRMS). METHODS: This was a randomized-controlled, assessor-blinded, one-year long study with 61 participants assigned to either Diet (N=32) or wait-listed (Control, N=29) group. RESULTS: The mean age (years) [Control-40.9+/-8.48; Diet-40.8+/-8.86] and the mean disease duration (years) [Control -5.3+/-3.86; Diet-5.33+/-3.63] were comparable between the two groups. There was a slight difference between the two study groups in the baseline mean expanded disability status scale (EDSS) score [Control-2.22+/-0.90; Diet-2.72+/-1.05]. Eight subjects withdrew (Diet, N=6; Control, N=2). Adherence to the study diet based on monthly Food Frequency Questionnaire (FFQ) was excellent with the diet group showing significant difference in the total fat caloric intake compared to the control group [total fat intake/total calories averaged ~15% (Diet) versus ~40% (Control)]. The two groups showed no differences in brain MRI outcomes, number of MS relapses or disability at 12 months. The diet group showed improvements at six months in low-density lipoprotein cholesterol (Delta=-11.99mg/dL; p=0.031), total cholesterol (Delta=-13.18mg/dL; p=0.027) and insulin (Delta=-2.82mg/dL; p=0.0067), mean monthly reductions in BMI (Rate=-1.125kg/m2 per month; p<0.001) and fatigue [FSS (Rate=-0.0639 points/month; p=0.0010); MFIS (Rate=-0.233 points/month; p=0.0011)] during the 12-month period. CONCLUSIONS: While a very-low fat, plant-based diet was well adhered to and tolerated, it resulted in no significant improvement on brain MRI, relapse rate or disability as assessed by EDSS scores in subjects with RRMS over one year. The diet group however showed significant improvements in measures of fatigue, BMI and metabolic biomarkers. The study was powered to detect only very large effects on MRI activity so smaller but clinically meaningful effects cannot be excluded. The diet intervention resulted in a beneficial effect on the self-reported outcome of fatigue but these results should be interpreted cautiously as a wait-list control group may not completely control for a placebo effect and there was a baseline imbalance on fatigue scores between the groups. If maintained, the improved lipid profile and BMI could yield long-term vascular health benefits. Longer studies with larger sample sizes are needed to better understand the long-term health benefits of this diet.","Yadav, V., et al. (2016). \"Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.\" Mult Scler Relat Disord 9: 80-90.","USA",2016,"Neurological","Psychobehavioural","FSS,MFI",null,null,null,"USA",null,"Neurological","Psychobehavioural",null,null,"FSS,MFI","2015:2018"]
[327,"Yang, M., et al. (2009). \"Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference.\" Curr Med Res Opin 25(10): 2487-2494.",null,"Yang, M., et al.","Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference","OBJECTIVE: To estimate the minimally important difference (MID) for the Insomnia Severity Index (ISI) by examining the association of score differences of the ISI with health-related outcomes including health-related quality of life, productivity, and fatigue. METHODS: Data came from a randomized, placebo-controlled clinical trial evaluating the long-term efficacy of eszopiclone for primary insomnia (N = 828). Logistic regression models were used to characterize the relationship between ISI change scores (from baseline to 6 months post-treatment) and outcomes/anchors from the SF-36 Health Survey, Work Limitations Questionnaire (WLQ), and Fatigue Severity Scale (FSS). Odds ratios were derived from the regression coefficients to calculate the probability of a given outcome being associated with different ISI change scores. Convergence between anchor- and distribution-based estimates was assessed. RESULTS: Higher ISI scores (indicating more severe insomnia) were significantly associated with higher probabilities of negative outcome in all models. Individuals with a 6-point score reduction in ISI scores (which corresponded to 1(1/2) standard deviations) were 48% less likely to report 'feeling worn out' (SF-36) at 6 months, 46% less likely to be 'unable to think clearly' (WLQ), and 52% less likely to report 'feeling fatigued' (FSS). Similar results were found across a broad spectrum of all selected anchors. CONCLUSIONS: Based on results of the study, a 6-point reduction is recommended to represent a clinically meaningful improvement in individuals with primary insomnia. Research on generalizability of the recommended MID in this study to other patient populations and other type of treatment interventions is needed.","Yang, M., et al. (2009). \"Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference.\" Curr Med Res Opin 25(10): 2487-2494.","USA",2009,"Various","Eszopiclone","FSS",null,null,null,"USA",null,"Various","Eszopiclone",null,null,"FSS","2005:2009"]
[328,"Yates, P., et al. (2005). \"Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer.\" J Clin Oncol 23(25): 6027-6036.",null,"Yates, P., et al.","Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer","PURPOSE: To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue. PATIENTS AND METHODS: This randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy-Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value. RESULTS: Compared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy-Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life. CONCLUSION: Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.","Yates, P., et al. (2005). \"Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer.\" J Clin Oncol 23(25): 6027-6036.","Australia",2005,"Cancer","Psychobehavioural","FACT-F,PFS",null,null,null,"Australia",null,"Cancer","Psychobehavioural",null,null,"FACT-F,PFS","2005:2009"]
[329,"Yennurajalingam, S., et al. (2012). \"The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study.\" J Palliat Med 15(10): 1059-1064.",null,"Yennurajalingam, S., et al.","The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study","OBJECTIVES: To determine the effects of thalidomide and placebo on anorexia-cachexia and its related symptoms, body composition, resting metabolic rate, and serum cytokines and their receptors in patients with advanced cancer. METHODS: Included in the study were patients with advanced cancer with weight loss greater than 5% in 6 months and who reported anorexia, fatigue, and one of the following: anxiety, depression, or sleep disturbances. Patients on chemotherapy within 2 weeks prior or during the study were excluded from the study. Patients were randomly assigned to either 100 mg thalidomide or placebo once a day for 14 days. The Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Functional Assessment of Cancer Illness Therapy (FACIT-F), Hospital Anxiety Depression Scale (HADS) Pittsburgh Sleep Quality Index (PSQI) were utilized, and in addition body composition, Resting Energy Expenditure (REE), and serum cytokine levels were assessed. RESULTS: Of the 31 patients entered in the study, 15 were assigned to the thalidomide group and 16 to the placebo group. However only 21/31 patients were able to complete the study. Compared with their baseline values, both the thalidomide and the placebo groups showed significant reduction in cytokines. Tumor necrosis factor (TNF)-alpha (p=0.04) and its receptors TNFR1 (p=0.04), TNFR2 (p=0.04), and interleukin (IL)-8 (p=0.04) were statistically significant in the thalidomide group. In the placebo group, TNF-alpha (p=0.008), TNFR1 (p=0.005), TNFR2 (p=0.005), IL-RA (p=0.005), IL-6 (p=0.005), and IL-8 (p=0.005) were statistically significant. However, improvement in these symptoms and cytokine levels were not significantly different in the thalidomide group compared with the placebo group. None of the patients withdrew from the study because of toxicity of either thalidomide or placebo. CONCLUSIONS: Based on the poor accrual rate and attrition observed in this study, it is important that future research on thalidomide as a treatment for cancer-related anorexia-cachexia symptoms (ACS) in patients with advanced cancer use less stringent entry criteria and less exhaustive outcome measures.","Yennurajalingam, S., et al. (2012). \"The role of thalidomide and placebo for the treatment of cancer-related anorexia-cachexia symptoms: results of a double-blind placebo-controlled randomized study.\" J Palliat Med 15(10): 1059-1064.","USA",2012,"Cancer","Thalidomide","FACIT-F",null,null,null,"USA",null,"Cancer","Thalidomide",null,null,"FACIT-F","2010:2014"]
[330,"Yeo, T. P., et al. (2012). \"A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients.\" J Am Coll Surg 214(4): 463-475; discussion 475-467.",null,"Yeo, T. P., et al.","A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients","BACKGROUND: As patients with pancreas and periampullary cancer (PPC) experience improved survival rates and longevity, the focus shifts toward living life while surviving cancer. Fatigue is the most commonly reported symptom in all cancer patients. Exercise has been found to effectively decrease fatigue levels and improve physical functioning in cancer patients. STUDY DESIGN: One hundred two patients with resected PPC consented to participate in this study and were randomized to either an intervention group (IG) or a usual care group (UCG). Subjects completed visual analog scales, the FACIT-Fatigue Scale and the Short Form-36v2 after surgery and again 3 to 6 months after hospital discharge. RESULTS: Patients in the IG and UCG were comparable with regard to demographics, comorbidities, cancer type and staging, type of resection, preoperative fatigue and pain levels, adjuvant therapy, and baseline walking distance. Patients in the IG had significantly improved scores on the FACIT-Fatigue Scale at study completion, improved fatigue and pain scores, as well as overall physical functioning and mental health composite scores. At study completion, participants in the IG were walking twice as far and were significantly more likely to have continued walking or another form of exercise as compared with the UCG. Using hierarchical cluster analysis, 3 mutually exclusive symptom groupings were identified in the cohort. Kaplan-Meier survival analysis did not indicate an overall survival benefit for the IG. CONCLUSIONS: This is the first prospective, randomized controlled trial to report that participation in a home walking program confers a significant benefit in resected PPC patients with regard to fatigue levels, physical functioning, and health-related quality of life.","Yeo, T. P., et al. (2012). \"A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients.\" J Am Coll Surg 214(4): 463-475; discussion 475-467.","USA",2012,"Cancer","None","FACIT-F",null,null,null,"USA",null,"Cancer","None",null,null,"FACIT-F","2010:2014"]
[331,"Yorke, J., et al. (2015). \"Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.\" Support Care Cancer 23(11): 3373-3384.",null,"Yorke, J., et al.","Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial","BACKGROUND: Breathlessness, cough and fatigue are distressing symptoms for patients with lung cancer. There is evidence that these three symptoms form a discreet symptom cluster. This study aimed to feasibly test a new non-pharmacological intervention for the management of the Respiratory Distress Symptom Cluster (breathlessness-cough-fatigue) in lung cancer. METHOD: This was a multi-centre, randomised controlled non-blinded parallel group feasibility trial. Eligible patients (patients with primary lung cancer and 'bothered' by at least two of the three cluster symptoms) received usual care plus a multicomponent intervention delivered over two intervention training sessions and a follow-up telephone call or usual care only. Follow-up was for 12 weeks, and end-points included six numerical rating scales for breathlessness severity, Dyspnoea-12, Manchester Cough in Lung Cancer scale, FACIT-Fatigue scale, Hospital Anxiety and Depression scale, Lung Cancer Symptom Scale and the EQ-5D-3L, collected at baseline, week 4 and week 12. RESULTS: One hundred seven patients were randomised over 8 months; however, six were removed from further analysis due to protocol violations (intervention group n = 50 and control group n = 51). Of the ineligible patients (n = 608), 29 % reported either not experiencing two or more symptoms or not being 'bothered' by at least two symptoms. There was 29 % drop-out by week 4, and by week 12, a further two patients in the control group were lost to follow-up. A sample size calculation indicated that 122 patients per arm would be needed to detect a clinically important difference in the main outcome for breathlessness, cough and fatigue. CONCLUSIONS: The study has provided evidence of the feasibility and acceptability of a new intervention in the lung cancer population and warrants a fully powered trial before we reach any conclusions. The follow-on trial will test the hypothesis that the intervention improves symptom cluster of breathlessness, cough and fatigue better than usual care alone. Full economic evaluation will be conducted in the main trial.","Yorke, J., et al. (2015). \"Management of the respiratory distress symptom cluster in lung cancer: a randomised controlled feasibility trial.\" Support Care Cancer 23(11): 3373-3384.","UK",2015,"Cancer","Various","FACIT-F",null,null,null,"UK",null,"Cancer","Various",null,null,"FACIT-F","2015:2018"]
[332,"Younossi, Z. M., et al. (2016). \"Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir.\" Medicine (Baltimore) 95(9): e2702.",null,"Younossi, Z. M., et al.","Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir","Prevalence of chronic hepatitis C (CH-C) infection in patients of Asian ancestry ranges between 1% and 20%. Interferon (IFN)- and ribavirin (RBV)-containing regimens for CH-C have a negative impact on patient-reported outcomes (PROs) during treatment. The aim of this study was to assess the impact of IFN-free RBV-free sofosbuvir (SOF)-based regimens on PROs in CH-C patients of Asian ancestry. In this observational retrospective study, the PRO data from 12 multicenter multinational phase 3 clinical trials (2012-2015, conducted in Europe, North America, Australia, and New Zealand) of SOF-based regimens with and without IFN, ledipasvir (LDV), and/or RBV were used. At baseline, during treatment, and post-treatment, patients completed 4 validated PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, and WPAI:SHP). The resulting PROs in Asian patients were compared across the treatment regimens. Of 4485 of the trials' participants, 106 patients were of Asian ancestry (55.7% male, 69.8% treatment-naive, 17.0% cirrhotic). In comparison with other patients, the Asian CH-C cohort was younger, had lower BMI, and lower rates of pre-treatment psychiatric comorbidities (anxiety, depression, sleep disorders) (all P < .05). At baseline, Asian patients also had lower SF-36 physical functioning scores (on average, by -5.6% on a normalized 0-100% PRO scale, P = .001). During treatment, Asian CH-C patients experienced a decline in their PRO scores while receiving IFN and/or RBV-containing regimens (up to -19.6%, P < .001). In contrast, patients receiving LDV/SOF experienced no PRO decrement and improvement of some PRO scores during treatment (+9.0% in general health of SF-36, P = .03). After achieving SVR-12, some of the PRO scores in Asian patients improved regardless of the regimen (up to +9.3%, P < .001). In multivariate analysis of Asian patients, the use of LDV/SOF was independently associated with higher PRO scores during and soon after the end of treatment (betas +15.0% to +29.3%, all P < .05). Other predictors of PRO impairment included depression, type 2 diabetes mellitus, and cirrhosis. The use of IFN- and RBV-free LDV/SOF regimens leads to PRO improvement in Asian patients with CH-C during treatment. Achieving SVR-12 results in improvement of PRO scores.","Younossi, Z. M., et al. (2016). \"Patient-reported Outcomes in Asian Patients With Chronic Hepatitis C Treated With Ledipasvir and Sofosbuvir.\" Medicine (Baltimore) 95(9): e2702.","China",2016,"Infectious disease","Other Drugs","FACIT-F",null,null,null,"China",null,"Infectious Disease","Other Drugs",null,null,"FACIT-F","2015:2018"]
[333,"Younossi, Z. M., et al. (2017). \"Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity.\" Medicine (Baltimore) 96(7): e5914.",null,"Younossi, Z. M., et al.","Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity","Patient-reported outcomes (PROs) such as quality of life and work productivity are important for measuring patient's experience. We assessed PROs during and after treatment of hepatitis C virus (HCV) patients.Data were obtained from a phase 3 open label study of sofosbuvir and ribavirin (SOF + RBV) with and without interferon (IFN). Patients completed 4 PRO assessment instruments (SF-36, Functional Assessment of Chronic Illness Therapy-Fatigue, Chronic Liver Disease Questionnaire- HCV, Work Productivity and Activity-Specific Health Problem) before, during, and after treatment.A total of 533 patients with chronic HCV were enrolled; 28.9% treatment-naive, 23.1% cirrhotic, 219 received IFN + SOF + RBV and 314 received IFN-free SOF + RBV. At baseline, there were no differences in PROs between the IFN-free and IFN-containing treatment arms (all P > 0.05). During treatment, patients receiving IFN + SOF + RBV had a substantial impairment in their PROs (up to -24.4% by treatment week 12, up to -8.3% at week 4 post-treatment). The PRO decrements seen in the SOF + RBV arm were smaller in magnitude (up to -7.1% by treatment week 12), and all returned to baseline or improved by post-treatment week 4. By 12 weeks after treatment cessation, patients who achieved sustained viral response-12 showed some improvement of PRO scores regardless of the regimen (up to +7.1%, P < 0.0001) or previous treatment experience. In multivariate analysis, the use of IFN was independently associated with lower PROs.IFN-based regimens have a profoundly negative impact to PROs. By contrast, the impact of RBV on these PROs is relatively modest. Achieving HCV cure is associated with improvement of most of the PRO scores.","Younossi, Z. M., et al. (2017). \"Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity.\" Medicine (Baltimore) 96(7): e5914.","Spain",2017,"Infectious disease","Sofosbuvir,Other Drugs","FACIT-F",null,null,null,"Spain",null,"Infectious Disease","Sofosbuvir,Other Drugs",null,null,"FACIT-F","2015:2018"]
[334,"Younossi, Z. M., et al. (2016). \"Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus.\" J Viral Hepat 23(8): 623-630.",null,"Younossi, Z. M., et al.","Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus","Patients with HCV infection have reduced work productivity (WP), in terms of both presenteeism (impairment in work productivity while working) and absenteeism (productivity loss due to absence from work). The aim of this study was to identify clinical and patient-reported factors that are predictive of WP in HCV-infected patients. HCV-infected patients enrolled in clinical trials completed 3 PRO questionnaires (CLDQ-HCV, SF-36 and FACIT-F) and one work productivity (WPAI:SHP) questionnaire. In employed subjects, work productivity and its absenteeism and presenteeism components were calculated using WPAI:SHP instrument. Of 4121 HCV-infected patients with work productivity data, 2480 (60.2%) reported to be employed, and of those, 2190 had completed all PRO questionnaires before treatment initiation. Of the study cohort, 519/2190 (23.7%) had severe work impairment. In multiple linear regression analysis, work productivity was predicted by lower scores in activity/energy domain of CLDQ-HCV, physical well-being domain of FACIT-F, worry domain of CLDQ-HCV and role physical domain of SF-36 (all P < 0.0005). Furthermore, presenteeism was independently predicted by the activity/energy of CLDQ-HCV, physical well-being of FACIT-F, worry domain of CLDQ-HCV, role physical scale of SF-36 and fatigue scale of FACIT-F (P < 0.002). Finally, absenteeism was independently predicted by physical well-being scale of FACIT-F and role physical scale of SF-36 (all P < 0.002). Clinically, work productivity impairment was predicted by the presence of cirrhosis, anxiety, depression and clinically overt fatigue (P < 0.01). Thus, the most important drivers of WP in HCV are impairment of physical aspects of PROs and clinical history of depression, anxiety, fatigue and cirrhosis.","Younossi, Z. M., et al. (2016). \"Association of work productivity with clinical and patient-reported factors in patients infected with hepatitis C virus.\" J Viral Hepat 23(8): 623-630.","USA",2016,"Infectious disease","None","FACIT-F",null,null,null,"USA",null,"Infectious Disease","None",null,null,"FACIT-F","2015:2018"]
[335,"Younossi, Z. M., et al. (2016). \"The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study.\" Liver Int 36(1): 42-48.",null,"Younossi, Z. M., et al.","The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study","BACKGROUND: Interferon- and ribavirin (RBV)-free regimens can improve patient-reported outcomes (PROs) during treatment. AIM: To compare PROs during treatment with ledipasvir and sofosbuvir (LDV/SOF) to placebo and to LDV/SOF + RBV. METHODS: Treatment-experienced CH-C genotype 1 patients with compensated cirrhosis (N = 154) were randomized to receive 24 weeks of LDV/SOF or 12 weeks of placebo followed by 12 weeks of LDV/SOF + RBV (the SIRIUS clinical trial). While blinded to their HCV RNA level and study treatment, patients completed PRO questionnaires (SF-36, FACIT-F, CLDQ-HCV, WPAI:SHP) at baseline, during and post-treatment. RESULTS: Baseline PRO scores were similar between the two study arms. Patients receiving LDV/SOF showed improvement in a number of PROs (predominantly related to mental health) starting as early as 4 weeks after treatment initiation; no PRO decrement from baseline were noted, and no PRO scores were inferior to placebo (all P > 0.05). In the second 12 weeks, patients who were receiving LDV/SOF continued to improve PROs (up to +9.2% from a 100% maximum possible score, P < 0.05), while patients receiving LDV/SOF + RBV had less gains or no improvement in their PRO scores. However, regardless of the regimen, patients who successfully cleared the virus (N = 149) had significant improvement in all aspects of PROs (up to +12.2% by post-treatment week 12, up to +16.9% by week 24). CONCLUSIONS: Treatment-experienced cirrhotic patients experience a notable improvement of their PROs during treatment with LDV/SOF. Furthermore, achieving SVR-12 is associated with significant PRO improvement, which further improves at post-treatment week 24 in this difficult to treat group of patients with chronic hepatitis C.","Younossi, Z. M., et al. (2016). \"The impact of ledipasvir/sofosbuvir on patient-reported outcomes in cirrhotic patients with chronic hepatitis C: the SIRIUS study.\" Liver Int 36(1): 42-48.","USA",2016,"Infectious disease","Ledipasvir,Sofosbuvir","FACIT-F",null,null,null,"USA",null,"Infectious Disease","Ledipasvir,Sofosbuvir",null,null,"FACIT-F","2015:2018"]
[336,"Younossi, Z. M., et al. (2016). \"Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.\" J Viral Hepat 23(11): 857-865.",null,"Younossi, Z. M., et al.","Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus","A fixed-dose combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for treatment of HCV patients. We assessed the effect of LDV/SOF on patient-reported outcomes (PROs) in HIV-HCV-co-infected patients. Patient-reported outcomes data from HIV-HCV-co-infected patients who were treated with LDV/SOF for 12 weeks were collected as a part of a clinical trial (ION-4). Historical controls were HIV-HCV-co-infected patients treated with SOF and ribavirin (RBV) in PHOTON-1. We included 335 HIV-HCV-co-infected patients (SVR-12 in HCV genotype 1 was 96%) who received LDV/SOF, while 223 patients (SVR-12 in HCV genotype 1 was 76.3%) received SOF/RBV. During treatment, patients receiving LDV/SOF showed improvement in all of their PRO scores (+6.0% in activity/energy of CLDQ-HCV, +5.0% in fatigue score of FACIT-F, +6.8% in physical component of SF-36; all P < 0.0001) while those receiving SOF+RBV showed moderate decline in some of their PRO scores (-4.8% in physical functioning of SF-36, -4.4% in fatigue score of FACIT-F, both P < 0.001). Patients who achieved sustained virologic response with LDV/SOF also showed improvement of PROs (average +5.1%) while those treated with SOF/RBV showed less or no improvement (average +1.4%). In a multivariate analysis, in addition to depression and fatigue, receiving SOF+RBV (vs LDV/SOF) was independently associated with more PRO impairment during treatment (beta -6.1 to -12.1%, P < 0.001). Hence, HIV-HCV patients treated with LDV/SOF show significant improvement of their health-related quality of life and other patient-reported outcomes during treatment and after treatment cessation.","Younossi, Z. M., et al. (2016). \"Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus.\" J Viral Hepat 23(11): 857-865.","USA",2016,"Infectious disease","Sofosbuvir,Ledipasvir","FACIT-F",null,null,null,"USA",null,"Infectious Disease","Sofosbuvir,Ledipasvir",null,null,"FACIT-F","2015:2018"]
[337,"Yun, Y. H., et al. (2012). \"Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial.\" J Clin Oncol 30(12): 1296-1303.",null,"Yun, Y. H., et al.","Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial","PURPOSE: To determine whether an Internet-based tailored education program is effective for disease-free cancer survivors with cancer-related fatigue (CRF). PATIENTS AND METHODS: We randomly assigned patients who had completed primary cancer treatment within the past 24 months in any of four Korean hospitals and had reported moderate to severe fatigue for at least 1 week to participate in a 12-week, Internet-based, individually tailored CRF education program or to receive routine care. We based the program on the CRF guidelines of the National Comprehensive Cancer Network (NCCN) and incorporated the transtheoretic model (TTM). At baseline and 12 weeks, we used the Brief Fatigue Inventory (BFI) and Fatigue Severity Scale (FSS) as primary outcomes and the Hospital Anxiety and Depression Scale (HADS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) for secondary outcomes. RESULTS: We recruited 273 participants and randomly assigned 136 to the intervention group. Compared with the control group, the intervention group had an improvement in fatigue as shown by a significantly greater decrease in BFI global score (-0.66 points; 95% CI -1.04 to -0.27) and FSS total score (-0.49; 95% CI, -0.78 to -0.21). In secondary outcomes, the intervention group experienced a significantly greater decrease in HADS anxiety score (-0.90; 95% CI, -1.51 to -0.29) as well as global quality of life (5.22; 95% CI, 0.93 to 9.50) and several functioning scores of the EORTC QLQ-C30. CONCLUSION: An Internet-based education program based on NCCN guidelines and TTM may help patients manage CRF.","Yun, Y. H., et al. (2012). \"Web-based tailored education program for disease-free cancer survivors with cancer-related fatigue: a randomized controlled trial.\" J Clin Oncol 30(12): 1296-1303.","Korea",2012,"Cancer","Psychobehavioural","BFI,FSS",null,null,null,"Korea",null,"Cancer","Psychobehavioural",null,null,"BFI,FSS","2010:2014"]
[338,"Yun, Y. H., et al. (2005). \"Validation study of the korean version of the brief fatigue inventory.\" J Pain Symptom Manage 29(2): 165-172.",null,"Yun, Y. H., et al.","Validation study of the korean version of the brief fatigue inventory","The goal of this study was to evaluate the reliability and validity of the Korean version of the Brief Fatigue Inventory (BFI-K). One hundred seventy-eight cancer patients and the same number of age- and sex-matched control subjects completed the BFI-K, the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30), the Beck Depression Inventory (BDI), and a Brief Pain Inventory (BPI). The Cronbach's alpha coefficient for the BFI-K was 0.956 in the cancer patient group and 0.955 in the control group. The global score and nine of the single item scores for the BFI-K were significantly correlated with the fatigue and global health status/QoL subscale of the EORTC QLQ-C30, BDI, and BPI (coefficient range 0.38-0.66). Discriminant validity showed that BFI-K could distinguish significant differences of performance status between subgroups of patients, and between the cancer patient group and the control group, as expected. Our study has shown that the BFI-K is a reliable, valid self-rating instrument in terms of its psychometric properties.","Yun, Y. H., et al. (2005). \"Validation study of the korean version of the brief fatigue inventory.\" J Pain Symptom Manage 29(2): 165-172.","Korea",2005,"Cancer","None","BFI",null,null,null,"Korea",null,"Cancer","None",null,null,"BFI","2005:2009"]
[339,"Zick, S. M., et al. (2016). \"Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.\" JAMA Oncol 2(11): 1470-1476.",null,"Zick, S. M., et al.","Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial","Importance: Fatigue is a common and debilitating late-term effect of breast cancer that is associated with poor sleep and decreased quality of life, yet therapies remain limited. Acupressure has reduced fatigue in previous small studies, but rigorous clinical trials are needed. Objectives: To investigate if 6 weeks of 2 types of self-administered acupressure improved fatigue, sleep, and quality of life vs usual care in breast cancer survivors and to determine if changes were sustained during a 4-week washout period. Design, Setting, and Participants: Phase 3 randomized, single-blind, clinical trial conducted from March 1, 2011, through October 31, 2014. Women were recruited from the Michigan Tumor Registry. Interventions: Randomization (1:1:1) to 6 weeks of daily self-administered relaxing acupressure, stimulating acupressure, or usual care. Main Outcomes and Measures: The primary outcome was change in the Brief Fatigue Inventory score from baseline to weeks 6 and 10. Secondary analyses were sleep (Pittsburgh Sleep Quality Index) and quality of life (Long-Term Quality of Life Instrument). Results: A total of 424 survivors of stages 0 to III breast cancer who had completed cancer treatments at least 12 months previously were screened, and 288 were randomized, with 270 receiving relaxing acupressure (n = 94), stimulating acupressure (n = 90), or usual care (n = 86). One woman withdrew owing to bruising at the acupoints. At week 6, the percentages of participants who achieved normal fatigue levels (Brief Fatigue Inventory score <4) were 66.2% (49 of 74) in relaxing acupressure, 60.9% (42 of 70) in stimulating acupressure, and 31.3% (26 of 84) in usual care. At week 10, a total of 56.3% (40 of 71) in relaxing acupressure, 60.9% (42 of 69) in stimulating acupressure, and 30.1% (25 of 83) in usual care continued to have normal fatigue. At neither time point were the 2 acupressure groups significantly different. Relaxing acupressure, but not stimulating acupressure, showed significant improvements in sleep quality compared with usual care at week 6, but not at week 10. Only relaxing acupressure significantly improved quality of life vs usual care at weeks 6 and 10. Conclusions and Relevance: Both acupressure arms significantly reduced persistent fatigue compared with usual care, but only relaxing acupressure had significant effects on sleep quality and quality of life. Relaxing acupressure offers a possible low-cost option for managing symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT01281904.","Zick, S. M., et al. (2016). \"Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.\" JAMA Oncol 2(11): 1470-1476.","USA",2016,"Cancer","Complementary","BFI",null,null,null,"USA",null,"Cancer","Complementary",null,null,"BFI","2015:2018"]
[340,"Zick, S. M., et al. (2012). \"Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial.\" BMC Complement Altern Med 12: 132.",null,"Zick, S. M., et al.","Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial","BACKGROUND: Despite high levels of clinically significant persistent cancer related fatigue in breast cancer survivors few treatments are currently available and most pose a significant burden on the part of the woman. Acupressure, a component of Traditional Chinese Medicine, has been shown to decrease fatigue levels by as much as 70% in cancer survivors while being inexpensive, non-toxic and an easy to use intervention. The primary aim of this study was to determine the efficacy of two types of self-administered acupressure (relaxation acupressure and stimulating acupressure), compared to standard of care on fatigue severity. Secondary aims were to evaluate the efficacy of two types of acupressure on sleep and kinetic parameters required for implementation of acupressure in a clinical setting; The purpose of this paper is to share the methodology used including challenges and insights. METHODS/DESIGN: This study is a three group, randomized clinical trial. 375 breast cancer survivors at least 12 months after completion of cancer treatments, with moderate to severe persistent fatigue, are being randomized to one of 3 groups: self-administered relaxation acupressure; self-administered stimulating acupressure; or standard of care. Participants are assessed at baseline, 3 weeks, and 6 weeks followed by a 4-week follow-up period. The primary aim is to examine the effect of 6-weeks of relaxation acupressure compared to stimulatory acupressure or standard of care on fatigue as assessed by: weekly self-report using the Brief Fatigue Inventory; objective daytime physical activity on actigraph; or fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include depression, anxiety, self-efficacy, and sleep quality. DISCUSSION: This study has the potential to develop a low-cost, self-care intervention for the most troubling of late-term effects in breast cancer populations, fatigue. The methods used may lend constructive ideas to other investigators working with this population and/or intervention. TRIAL REGISTRATION: ClinicalTrial.Gov Trials Register NCT01281904.","Zick, S. M., et al. (2012). \"Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial.\" BMC Complement Altern Med 12: 132.","USA",2012,"Cancer","Complementary","BFI,VAS-F",null,null,null,"USA",null,"Cancer","Complementary",null,null,"BFI,VAS-F","2010:2014"]
[341,"Zifko, U. A., et al. (2002). \"Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.\" J Neurol 249(8): 983-987.",null,"Zifko, U. A., et al.","Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study","BACKGROUND: Modafinil is a unique wake-promoting agent that is chemically distinct from traditional stimulants. Results of a placebo-controlled study showed it to improve fatigue in multiple sclerosis (MS) at a dose of 200 mg daily, but not at a dose of 400 mg daily. OBJECTIVE: To establish the efficacy, safety and appropriate dose of modafinil in the treatment of fatigue and sleepiness in patients with multiple sclerosis. METHOD: A total of 50 patients diagnosed with MS (mean age 40.4 +/- 10.3 years, 30 females/20 males; MS type: 36 relapsing remitting, 1 primary progressive, 13 secondary progressive; mean disability level 3.8 +/- 1.5 on the Kurtzke EDSS) and complaining of chronic fatigue were enrolled in a prospective 3-month, two-center, open-label study. Efficacy was evaluated with the Fatigue Severity Scale (FSS, score range 0-42), the Epworth Sleepiness Scale (ESS, score range 0-24) and by subjective patient appraisal of change of fatigue, quality of life and overall satisfaction with treatment. Adverse effects (AEs) were recorded throughout the study. Treatment was started with a single daily dose of 100 mg in all patients. In non-responders the dose was increased by 100 mg increments up to a maximum daily dose of 400 mg. RESULTS: Three patients discontinued modafinil because of AEs (nervousness, dizziness). Two patients (4 %) were treated with 50 mg, 25 (50 %) with 100 mg, 21 (42 %) with 200 mg and 2 (4 %) with 300 mg daily. No patient required 400 mg daily. Mean FSS scores were 30.3 +/- 8.5 at baseline and 25.4 +/- 3.7 at 3 months (p < 0.0001). Mean ESS scores were 9.7 +/- 3.9 at baseline and 4.9 +/- 2.9 at 3 months (p < 0.0001). Self-appraisal of change of fatigue showed clear improvement in 41 patients (87.2 %), some improvement in 4 (8.5 %) and no change in 2 (4.3 %). Overall clinical condition was clearly improved in 43 patients (91.5 %), somewhat improved in 1 patient (2.1 %), and unchanged in 3 patients (6.4 %). No patient reported worsening of overall clinical condition. CONCLUSIONS: Treatment with modafinil significantly improves fatigue and sleepiness and is well tolerated by patients with MS. Unlike the higher dose regimen required in narcolepsy, a low-dose regimen of modafinil is effective in MS.","Zifko, U. A., et al. (2002). \"Modafinil in treatment of fatigue in multiple sclerosis. Results of an open-label study.\" J Neurol 249(8): 983-987.","Austria",2002,"Neurological","Other Drugs","FSS",null,null,null,"Austria",null,"Neurological","Other Drugs",null,null,"FSS","2000:2004"]

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[null,null,"Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," ",null," ",null,null," "]
[null,null,"PRO tools"]
[null,null,"Sub-populations"]
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[null,null,"Study methodologies"]
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[null,"Toggle age cut-offs",null,null,null,null,null,null,7,1,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"This year =",{"$f":"YEAR(NOW())","v":2018},null,"Years","Cut","Selected cut state","Start","End",{"$f":"COUNTA(CF3:CF58)","v":5},{"$f":"OFFSET($CI$2,0,domainChoice)","v":"Study methodologies"},"Locations","Interventions","Diseases","PRO tools","subPopulations","Study types","Study methodologies",null,null,null,null,"selected categories"]
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[null,"From",null,null,"To",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C1","C1","Locations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"OFFSET($BY$5,domainChoice,0)","v":"studymethodCategories"},"High year =",{"$f":"MAX(CG3:$CG$60)","v":2018},null,1961,false,null,2000,2004,{"$f":"IF(CF4<>\"\",_xlfn.CONCAT(CF4,\":\",CG4),\"\")","v":"2000:2004"},{"$f":"OFFSET($CJ$2,0,ROW()-3)","v":"Interventions"},"Austria","Baricitinib","Cancer","Bells Fatigue Scale",null,null,null,null,null,null,null,{"$f":"OFFSET(INDIRECT($CU$1),ROW()-3,0)","v":""}]
[null,{"$f":"IF(CF3=\"\",\"\",CF3)","v":1960},null,null,{"$f":"IF(CG3=\"\",\"\",CG3)","v":1999},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C2","C2","Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1962,false,"Segment count",2005,2009,"2005:2009","Diseases","Brazil","Belimumab","Chronic Fatigue","Bidimensional Fatigue Scale",null,null,null,null,null,null,null,""]
[null,{"$f":"IF(CF4=\"\",\"\",CF4)","v":2000},null,null,{"$f":"IF(CG4=\"\",\"\",CG4)","v":2004},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C3","C3","Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"locationCategories",null,null,null,1963,false,null,2010,2014,"2010:2014","PRO tools","Canada","Cancer treatments","Endocrine","Borg Fatigue Scale",null,null,null,null,null,null,null,""]
[null,2005,null,null,2009,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C4","C4","Sub-populations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"interventionCategories",null,null,null,1964,false,null,2015,2018,"2015:2018","subPopulations","China","Complementary","Gastrointestinal","CFS",null,null,null,null,null,null,null,""]
[null,2010,null,null,2014,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C5","C5","PRO tools",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"diseaseCategories",null,null,null,1965,false,null,null,null,"","Study types","Denmark","Eculizumab","Hematological","CIS-F",null,null,null,null,null,null,null,""]
[null,2015,null,null,2018,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study types",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"protoolCategories",null,null,null,1966,false,null,null,null,"","Study methodologies","Finland","Epoetin Beta","Infectious Disease","DFIS",null,null,null,null,null,null,null,""]
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[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Location categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studytypeCategories",null,null,null,1968,false,null,null,null,"",null,"Germany","Etanercept","Kidney Disease","FACT-F",null,null,null,null,null,null,null,""]
[null,{"$f":"IF(CF10=\"\",\"\",CF10)","v":""},null,null,{"$f":"IF(CG10=\"\",\"\",CG10)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Intervention categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studymethodCategories",null,null,null,1969,false,null,null,null,"",null,"Greece","Fingolimod","Liver Disease","FAI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Disease categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1970,false,null,null,null,"",null,"Hungary","Golimumab","Mental Health","FAS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sub-populations categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1971,false,null,null,null,"",null,"India","Infliximab","Musculoskeletal","FAsD",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PRO tool categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1972,false,null,null,null,"",null,"Iran","Ledipasvir","Neurological","FFS",null,null,null,null,null,null,null,""]
[null,"",null,null,{"$f":"IF(CG14=\"\",\"\",CG14)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study type categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1973,false,null,null,null,"",null,"Ireland","Natalizumab","None","FIS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodology categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1974,false,null,null,null,"",{"$f":"COLUMN()","v":87},"Israel","None","Respiratory Disease","FQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1975,false,null,null,null,"",null,"Italy","Other Drugs","Various","FSS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1976,false,null,null,null,"",null,"Japan","Pazopanib",null,"Fatigue Scale for Motor and Cognitive functions",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1977,false,null,null,null,"",null,"Korea","Psychobehavioural",null,"Fisk Fatigue Severity Scale",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1978,false,null,null,null,"",null,"Netherlands","Rituximab",null,"GFS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1979,false,null,null,null,"",null,"New Zealand","Ruxolitinib",null,"Hare Fatigue Symptom scale",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1980,false,null,null,null,"",null,"Norway","Sarilumab",null,"Identity Consequences Fatigue Scale",null,null,null,null,null,null,null,""]
[null,"",22,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1981,false,null,null,null,"",null,"Poland","Secukinumab",null,"KFSS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1982,false,null,null,null,"",null,"Serbia","Siltuximab",null,"MFI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1983,false,null,null,null,"",null,"Slovenia","Simeprevir",null,"MFQ",null,null,null,null,null,null,null,""]
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