Abstract
BackgroundThere are no core outcome domain or measurement sets for Total Joint Replacement (TJR) clinical trials. Our objective was to achieve an International consensus by orthopaedic surgeons on the OMERACT core domain/area set for TJR clinical trials.MethodsWe conducted surveys of two orthopaedic surgeon cohorts, which included (1) the leadership of international orthopaedic societies and surgeons (IOS; cohort 1), and (2) the members of the American Academy of Orthopaedic Surgeons’ Outcome Special Interest Group (AAOS-Outcome SIG), and/or the Outcome Research Interest Group of the Orthopaedic Research Society (ORS; cohort 2). Participants rated OMERACT-endorsed preliminary core area set for TJR clinical trials on a 1 to 9 scale, indicating 1–3 as domain of limited importance, 4–6 being important, but not critical, and 7–9 being critical.ResultsEighteen survey participants from the IOS group and 69 participants from the AAOS-Outcome SIG/ORS groups completed the survey questionnaire. The median (interquartile range [IQR]) scores were seven or higher for all six proposed preliminary core areas/domains across both groups, IOS and AAOS-Outcome SIG/ORS, respectively: pain, 8 [8, 9] and 8 [7, 9]; function, 8 [8, 8] and 8 [7, 9]; patient satisfaction, 8 [7, 9] and 8 [7, 8]; revision surgery, 7 [6, 9] and 8 [6, 8]; adverse events, 7 [5, 8] and 7 [6, 9]; and death, 7 [7, 9] and 8 [5, 9]. Respective median scores were lower for two additional optional domains: patient participation, 6.5 [5, 7] and 6 [5, 8]; and cost, 6 [5, 7] and 6 [5, 7].ConclusionsThis study showed that two independent surveys dervied from three groups of orthopaedic surgeons with international representation endorsed a preliminary/draft OMERACT core domain/area set for Joint Replacement clinical trials.
Highlights
There are no core outcome domain or measurement sets for Total Joint Replacement (TJR) clinical trials
A similar approach was planned for the future, in case of lack of complete consensus between surgeon and patient surveys for the draft TJR trial core domain set, leading either to its endorsement or modification
The pattern of endorsement and ratings of both core domains and optional domains for measurement in arthroplasty RCTs were similar across the two diverse groups of orthopaedic surgeons (Table 2)
Summary
There are no core outcome domain or measurement sets for Total Joint Replacement (TJR) clinical trials. Our objective was to achieve an International consensus by orthopaedic surgeons on the OMERACT core domain/area set for TJR clinical trials. Total Joint Replacement (TJR) is one of the most common elective procedures performed in the US and worldwide. Despite the recognition that the measurement of pain and function after TJR is very important and the common practice is to assess these outcomes in clinical practice, there is no consensus as to which domains or outcome measures should be included in every TJR trial. A TJR outcome Working Group (WG) first met at the OMERACT-9 meeting in 2008 where this critical issue was discussed in detail [5]. Based on the strategy outlined, we have continued the work in this area within our WG for the last 8 years
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