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-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).


CONCLUSIONS
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.
INSERM, Université Paris Diderot, France. florence.tubach@bch.aphp.fr
F
F
Tubach
P
P
Ravaud
E
E
Martin-Mola
H
H
Awada
N
N
Bellamy
C
C
Bombardier
D T
DT
Felson
N
N
Hajjaj-Hassouni
M
M
Hochberg
I
I
Logeart
M
M
Matucci-Cerinic
M
M
van de Laar
D
D
van der Heijde
M
M
Dougados
D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D001416:Back Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D059350:Chronic Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D015331:Cohort Studies; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D011446:Prospective Studies; D012216:Rheumatic Diseases / Q000175:diagnosis* / Q000523:psychology* / Q000628:therapy; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D016896:Treatment Outcome