OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis

T. E. McAlindon, J. B. Driban, Y. Henrotin, D. J. Hunter, G. L. Jiang, S. T. Skou, S. Wang, T. Schnitzer

    Publikation: Bidrag til tidsskriftReviewForskningpeer review

    Abstrakt

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA).To develop recommendations for the design, conduct, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the members voted we calculated the median score among the nine members of the working group who completed the score.The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations.In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA.

    OriginalsprogEngelsk
    Sider (fra-til)747-760
    Antal sider14
    TidsskriftOsteoarthritis and Cartilage
    Vol/bind23
    Udgave nummer5
    DOI
    StatusUdgivet - 1 jan. 2015

    Fingeraftryk Udforsk hvilke forskningsemner 'OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis' indeholder.

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