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
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...
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Published in | Arthritis care & research (2010) Vol. 64; no. 11; pp. 1699 - 1707 |
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Main Authors | , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken, USA
John Wiley & Sons, Inc
01.11.2012
Wiley-Blackwell |
Subjects | |
Online Access | Get full text |
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Summary: | 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. |
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Bibliography: | Dr. Hochberg has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Covidien, Eli Lilly, EMD Serono, Merck, Genentech, VCB, Theralogix, and Teva Pharmaceuticals, and (more than $10,000 each) from Bioiberica, NicOx, and Pfizer. Dr. Ravaud has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck, Sharp, & Dohme. Dr. Bombardier holds a Pfizer Research Chair and a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care. Dr. Awada has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Ipsen and Novartis. Dr. van der Heijde has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Centocor, Chugai, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi‐Aventis, Schering Plough, UCB, and Wyeth. Dr. Matucci‐Cerinic has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Bristol Myers Squibb, Pfizer, and Actelion. Dr. Dougados has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Merck. Dr. Bombardier has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott Canada, AstraZeneca, BioGen, Pfizer, Merck (Schering), and Janssen (Merck), (more than $10,000) from Abbott International, and served on the advisory boards for Bristol Myers Squibb, Pfizer, Pfizer (Wyeth), Merck (Schering), Janssen (Merck), and Takeda. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 2151-464X 2151-4658 |
DOI: | 10.1002/acr.21747 |