Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria.

Authors: Pham T (1) , van der Heijde D , Lassere M , Altman R , Anderson JJ , Bellamy N , Hochberg M , Simon L , Strand V , Woodworth T , Dougados M , OMERACT-OARSI

Affiliations:

(1) René Descartes University, AP-HP, Rheumatology B Department, Cochin Hospital

Source: J Rheumatol. 2003 Jul;30(7):1648-54.

DOI: Not specified Publication date: 2003 Jul E-Publication date: Not specified Availability: abstract Copyright: Not specified

Language: English Countries: Not specified Location: Not specified Correspondence address: Not specified

Keywords

Article abstract

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.

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