Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III

Nicholas Bellamy*, John Kirwan, Maarten Boers, Peter Brooks, Vibeke Strand, Peter Tugwell, Roy Altman, Kenneth Brandt, Maxime Dougados, Michel Lequesne

*Corresponding author for this work

    Research output: Contribution to journalArticle (Academic Journal)peer-review

    596 Citations (Scopus)

    Abstract

    Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials, and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Oganization/International League of Associations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further international harmonization of measurement procedures used to establish beneficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique). These evidence based preferences, achieved with a high degree of consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborative Project goals.

    Original languageEnglish
    Pages (from-to)799-802
    Number of pages4
    JournalJournal of Rheumatology
    Volume24
    Issue number4
    Publication statusPublished - 1 Apr 1997

    Keywords

    • Core set
    • Endpoints
    • Osteoarthritis
    • Outcome measures

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