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

Abstract

Background: 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. Method: 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] and 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. Results: Seventeen participants at the AAOS/ORS Outcomes Research Interest Group and 19 at OMERACT meeting completed the survey. At the two meetings, 73% and 36% were arthroplasty researcher/surgeons, 0% and 10% were patients and 58% and 31% were above 54 years, respectively. The following domains were rated as core outcome domains by both groups, with a median score of 7 and above (median score from AAOS/ORS vs. OMERACT): Joint pain (9 vs. 9), functional ability (8 vs. 9), joint-specific quality of life (8 vs. 7), patient satisfaction (7 vs. 8), revision surgery (8 vs. 7), adverse events (9 vs. 8), death (9 vs. 7.5), serious adverse events (8.5 vs. 8), reoperation (8 vs. 8), and cost (7 vs. 7). Conclusion: Stakeholders achieved consensus on preliminary core outcome domain set for TJR clinical trials. This set will be further vetted with multi-stakeholder input to achieve a fully endorsed TJR core outcome domain set.