Towards Consensus on the Reporting of Core Outcome Domains in Total Joint Replacement Clinical Trials: The Derivation of the Preliminary Core Outcome Domain Set

There is no consensus on how to report total joint replacement (TJR) trials. To our knowledge, core outcome domains for TJR clinical trials have not been defined. Our objective was to develop data-driven, consensus-based, preliminary recommendations for core outcome domains for TJR clinical trials.

We surveyed two groups of experts/stakeholders, who rated potential core outcome domains (mapped to Outcome Measures in Rheumatology Trials (OMERACT) filter 2.0 framework) for their relevance to TJR clinical trials during the 2014 American Academy of Orthopaedic Surgeons [AAOS].

Outcome Research Interest Group of the Orthopaedic Research Society (ORS) annual meeting and the 2014 OMERACT meeting. Ratings were on a 1-9 scale, 1-3 indicating domain of limited importance, 4-6 being important domain, and 7-9 being critically important domain.

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