RT Journal Article
SR Electronic
T1 Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2496
OP 2502
DO 10.3899/jrheum.141201
VO 42
IS 12
A1 Jasvinder A. Singh
A1 Michael Dohm
A1 Andrew P. Sprowson
A1 Peter D. Wall
A1 Bethan L. Richards
A1 Laure Gossec
A1 Gillian A. Hawker
A1 Daniel L. Riddle
A1 Rachelle Buchbinder
YR 2015
UL http://www.jrheum.org/content/42/12/2496.abstract
AB 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-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains.Results. Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience.Conclusion. An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.