Minimum Clinically Important Improvement and Patient Acceptable Symptom State in Pain and Function in Rheumatoid Arthritis, Ankylosing Spondylitis, Chronic Back Pain, Hand Osteoarthritis, and Hip and Knee Osteoarthritis: Results From a Prospective Multinational Study

F. Tubach, P. Ravaud, E. Martin-Mola, H. Awada, N. Bellamy, C. Bombardier, D.T. Felson, N. Hajjaj-Hassouni, M. Hochberg, I. Logeart, M. Matucci-Cerinic, Mart A F J van de Laar, D. van der Heijde, M. Dougados

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Abstract

Objective To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries. Methods We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs 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. Results For the whole sample, the estimated MCII values for absolute change at 4 weeks were −17 (95% confidence interval [95% CI] −18, −15) for pain; −15 (95% CI −16, −14) for patient global assessment; −12 (95% CI −13, −11) for functional disability assessment; and −14 (95% CI −15, −14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups ≥20 patients). Conclusion This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 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
Original languageUndefined
Pages (from-to)1699-1707
JournalArthritis care & research
Volume64
Issue number11
DOIs
Publication statusPublished - 2012

Keywords

  • METIS-291293
  • IR-83841

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