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Minimal clinically important improvement and patient acceptable symptomatic state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: The reflect multinational study
Arthritis Care & Research , 06/07/2012
Tubach F et al. – This work allows for promoting the use of values of Minimum Clinically Important Improvement (MCII) (15/100 for absolute improvement, 20% for relative improvement) and Patient Acceptable Symptomatic State (PASS) (40/100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function or physician global assessment used as outcome criteria.
Methods- The authors conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, The Netherlands), 4–week cohort study involving 1,532 patients which were prescribed NSAISDs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis or rheumatoid arthritis.
- The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability and physician global assessment, all normalized to a 0–100 score.
- For the whole sample, the estimated MCII values for absolute change at 4 weeks (95% confidence interval [95% CI]) were –17 (–18, –15) for pain; –15 (–16, –14) for patient global assessment; –12 (–13, –11) for functional disability assessment; and –14 (–15, –14) for physician global assessment.
- For the whole sample, the estimated PASS values were 42 (40, 44) for pain; 43 (41, 45) for patient global assessment; 43 (41, 44) for functional disability assessment; and 39 (37, 40) for physician global assessment.
- Estimates were consistent across diseases and countries (for subgroups ≥20 patients).