Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria.
Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed.
Pham
Thao
T
René Descartes University, AP-HP, Rheumatology B Department, Cochin Hospital, Paris, France.
Van Der Heijde
Désirée
D
Lassere
Marissa
M
Altman
Roy D
RD
Anderson
Jennifer J
JJ
Bellamy
Nicholas
N
Hochberg
Marc
M
Simon
Lee
L
Strand
Vibeke
V
Woodworth
Thasia
T
Dougados
Maxime
M
D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D006305:Health Status Indicators; D006801:Humans; D015207:Osteoarthritis, Hip / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D020370:Osteoarthritis, Knee / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D012955:Societies, Medical; D016896:Treatment Outcome