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.

Objective. The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). Methods. A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. Results. A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. Conclusion. Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age-and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.

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