Reliability and sensitivity to change of the Bristol Rheumatoid Arthritis Fatigue scales.

OBJECTIVE To examine the reliability (stability) and sensitivity of the Bristol Rheumatoid Arthritis Fatigue scales (BRAFs) and patient-reported outcome measures (PROMs) developed to capture the fatigue experience. The Multi-Dimensional Questionnaire (BRAF-MDQ) has a global score and four subscales (Physical Fatigue, Living with Fatigue, Cognitive Fatigue and Emotional Fatigue), while three numerical rating scales (BRAF-NRS) measure fatigue Severity, Effect and Coping. METHODS RA patients completed the BRAFs plus comparator PROMs. Reliability (study 1): 50 patients completed questionnaires twice. A same-day test-retest interval (minimum 60 min) ensured both time points related to the same 7 days, minimizing the capture of fatigue fluctuations. Reliability (study 2): 50 patients completed the same procedure with a re-worded BRAF-NRS Coping. Sensitivity to change (study 3): 42 patients being given clinically a single high dose of i.m. glucocorticoids completed questionnaires at weeks 0 and 2. RESULTS The BRAF-MDQ, its subscales and the BRAF-NRS showed very strong reliability (r = 0.82-0.95). BRAF-NRS Coping had lower moderate reliability in both wording formats (r = 0.62, 0.60). The BRAF-MDQ, its subscales and the BRAF-NRS Severity and Effect were sensitive to change, with effect sizes (ESs) of 0.33-0.56. As hypothesized, the BRF-NRS Coping was not responsive to the pharmaceutical intervention (ES 0.05). Preliminary exploration suggests a minimum clinically important difference of 17.5% for improvement and 6.1% for fatigue worsening. CONCLUSION The BRAF scales show good reliability and sensitivity to change. The lack of BRAF-NRS Coping responsiveness to medication supports the theory that coping with fatigue is a concept distinct from severity and effect that is worth measuring separately.

[1]  Sarah Hewlett,et al.  Fatigue in rheumatoid arthritis: time for a conceptual model. , 2011, Rheumatology.

[2]  R. Geenen,et al.  Longitudinal association between coping and psychological distress in rheumatoid arthritis: a systematic review , 2011, Annals of the rheumatic diseases.

[3]  J. Kirwan,et al.  The Impact Triad (Severity, Importance, Self-management) as a Method of Enhancing Measurement of Personal Life Impact of Rheumatic Diseases , 2011, The Journal of Rheumatology.

[4]  J. Kirwan,et al.  Collaboration with patients in the design of patient‐reported outcome measures: Capturing the experience of fatigue in rheumatoid arthritis , 2010, Arthritis care & research.

[5]  J. Kirwan,et al.  Measuring fatigue in rheumatoid arthritis: A cross‐sectional study to evaluate the Bristol Rheumatoid Arthritis Fatigue Multi‐Dimensional questionnaire, visual analog scales, and numerical rating scales , 2010, Arthritis care & research.

[6]  E. Taal,et al.  New insights into the experience of fatigue among patients with rheumatoid arthritis: a qualitative study , 2009, Annals of the rheumatic diseases.

[7]  C. Kelly,et al.  Fatigue in rheumatoid arthritis. , 2009, Rheumatology.

[8]  R. Hays,et al.  The Minimally Important Difference for the Fatigue Visual Analog Scale in Patients with Rheumatoid Arthritis Followed in an Academic Clinical Practice , 2008, The Journal of Rheumatology.

[9]  Sarah Hewlett,et al.  Fatigue in musculoskeletal conditions , 2008 .

[10]  Han Repping-Wuts,et al.  Fatigue as experienced by patients with rheumatoid arthritis (RA): a qualitative study. , 2008, International journal of nursing studies.

[11]  Ron D Hays,et al.  What is sufficient evidence for the reliability and validity of patient-reported outcome measures? , 2007, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[12]  D. Patrick,et al.  Patient-reported outcomes to support medical product labeling claims: FDA perspective. , 2007, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[13]  J. Connor-Smith,et al.  Relations between personality and coping: a meta-analysis. , 2007, Journal of personality and social psychology.

[14]  M. Suarez‐Almazor,et al.  Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. , 2007, The Journal of rheumatology.

[15]  J. Kirwan,et al.  Measuring fatigue in rheumatoid arthritis: a systematic review of scales in use. , 2007, Arthritis and rheumatism.

[16]  P. Tugwell,et al.  Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. , 2007, The Journal of rheumatology.

[17]  E. Choy,et al.  Fatigue in rheumatoid arthritis reflects pain, not disease activity. , 2006, Rheumatology.

[18]  B. Rintelen,et al.  Lack of agreement between patients' and physicians' perspectives of rheumatoid arthritis disease activity changes , 2006, Scandinavian journal of rheumatology.

[19]  Karen Kitchen,et al.  Patients' perceptions of fatigue in rheumatoid arthritis: overwhelming, uncontrollable, ignored. , 2005, Arthritis and rheumatism.

[20]  D. Cella,et al.  Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. , 2005, The Journal of rheumatology.

[21]  D. Wild,et al.  Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. , 2005, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[22]  J. Kirwan,et al.  The personal impact HAQ: Sensitivity to change of a measure of the impact of disability , 2004 .

[23]  Frederick Wolfe,et al.  Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. , 2004, The Journal of rheumatology.

[24]  C. Kwoh,et al.  Rheumatology patient and physician concordance with respect to important health and symptom status outcomes. , 2001, Arthritis and rheumatism.

[25]  F. Wolfe,et al.  Evaluation and documentation of rheumatoid arthritis disease status in the clinic: which variables best predict change in therapy. , 2001, The Journal of rheumatology.

[26]  C. Bombardier,et al.  "Are you better?" A qualitative study of the meaning of recovery. , 2001, Arthritis and rheumatism.

[27]  C. Bombardier,et al.  Guidelines for the process of cross-cultural adaptation of self-report measures. , 2000, Spine.

[28]  F. Wolfe,et al.  The prevalence and meaning of fatigue in rheumatic disease. , 1996, The Journal of rheumatology.

[29]  B. Belza.  Comparison of self-reported fatigue in rheumatoid arthritis and controls. , 1995, The Journal of rheumatology.

[30]  C. Bombardier,et al.  Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. , 1993, Journal of clinical epidemiology.

[31]  C. Sherbourne,et al.  The MOS 36-Item Short-Form Health Survey (SF-36) , 1992 .

[32]  M. Liang,et al.  The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. , 1988, Arthritis and rheumatism.

[33]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[34]  A. Beckett,et al.  AKUFO AND IBARAPA. , 1965, Lancet.

[35]  S. Richards,et al.  Fatigue in RA. , 2012, Rheumatology.

[36]  M. Suarez‐Almazor,et al.  Lack of congruence in the ratings of patients' health status by patients and their physicians. , 2001, Medical decision making : an international journal of the Society for Medical Decision Making.

[37]  M J Buxton,et al.  Evaluating patient-based outcome measures for use in clinical trials. , 1998, Health technology assessment.

[38]  A. Carr,et al.  Primary total hip replacement surgery: a systematic review of outcomes and modelling of cost-effectiveness associated with different prostheses. , 1998, Health technology assessment.

[39]  Ware J.E.Jr.,et al.  THE MOS 36- ITEM SHORT FORM HEALTH SURVEY (SF- 36) CONCEPTUAL FRAMEWORK AND ITEM SELECTION , 1992 .

[40]  P. Gertman,et al.  Measuring health status in arthritis. The arthritis impact measurement scales. , 1980, Arthritis and rheumatism.

[41]  H. Holman,et al.  Measurement of patient outcome in arthritis. , 1980, Arthritis and rheumatism.

[42]  M. Lorr,et al.  Two EITS Manual for the Profile of Mood States (1971 & 1992) , 1971 .