Consensus on draft OMERACT core domains for clinical trials of Total Joint Replacement outcome by orthopaedic surgeons: a report from the International consensus on outcome measures in TJR trials (I-COMiTT) group

BMC Musculoskeletal Disorders

Research Article

Michael Dohm¹  Peter F. Choong²  Jasvinder A. Singh³ 

[1] Department of Orthopaedic Surgery, University of Arizona, Tucson, AZ, USA;Department of Surgery, University of Melbourne, Melbourne, Australia;Department of Surgery, St. Vincent’s Hospital, Melbourne, Australia;University of Alabama at Birmingham, Birmingham, AL, USA;Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA;

关键词: OMERACT;    Core domain;    Clinical trails;    Total Joint Arthroplasty;    TJR;   

DOI  :  10.1186/s12891-017-1409-4

 received in 2016-10-10, accepted in 2017-01-16,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017