Can We Harmonize Them? An OMERACT Collaborative Initiative Outcome Domains and Measures in Total Joint Replacement Clinical Trials:

ABSTRACT. Objective. To develop a plan for harmonizing outcomes for people undergoing total joint replacement(TJR), to achieve consensus regarding TJR outcome research. Methods. The TJR working group met during the 2014 Outcome Measures in Rheumatology(OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-facemeeting. Brief presentations were made during a 1.5-h meeting, which included an overview ofpublished systematic reviews of TJR trials and the results of a recent systematic review of TJR clinicaltrial outcome domains and measures. This was followed by discussion of potential core setareas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associatedwith the measurement of these domains. Results . Working group participants discussed which TJR clinical trial outcome domains/areas mapto the inner versus outer core for core domain set. Several challenges were identified with TJRoutcomes including how to best measure function after TJR, elucidating the source of the pre- andpost-TJR joint pain being measured, joint-specific versus generic quality of life instruments and theimportance of patient satisfaction and revision surgery as outcomes. A preliminary core domain setfor TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverseevents, and death. This core domain set will be further vetted with a broader audience.