title: 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.
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 Organization/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.
authors.affiliation: London Health Sciences Centre, Canada.
authors.forename: N
authors.initials: N
authors.lastname: Bellamy
authors.forename: J
authors.initials: J
authors.lastname: Kirwan
authors.forename: M
authors.initials: M
authors.lastname: Boers
authors.forename: P
authors.initials: P
authors.lastname: Brooks
authors.forename: V
authors.initials: V
authors.lastname: Strand
authors.forename: P
authors.initials: P
authors.lastname: Tugwell
authors.forename: R
authors.initials: R
authors.lastname: Altman
authors.forename: K
authors.initials: K
authors.lastname: Brandt
authors.forename: M
authors.initials: M
authors.lastname: Dougados
authors.forename: M
authors.initials: M
authors.lastname: Lequesne
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D006225:Hand; D006621:Hip Joint; D006801:Humans; D007719:Knee Joint; D010003:Osteoarthritis / Q000175:diagnosis*; D017063:Outcome Assessment, Health Care / Q000592:standards*