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

Research output: Contribution to journalArticle

590 Scopus citations

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 (US)
Pages (from-to)799-802
Number of pages4
JournalJournal of Rheumatology
Volume24
Issue number4
StatePublished - Apr 1 1997

Keywords

  • Core set
  • Endpoints
  • Osteoarthritis
  • Outcome measures

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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    Bellamy, N., Kirwan, J., Boers, M., Brooks, P., Strand, V., Tugwell, P., Altman, R., Brandt, K., Dougados, M., & Lequesne, M. (1997). 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. Journal of Rheumatology, 24(4), 799-802.