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

Jasvinder A. Singh, Michael Dohm, Peter F. Choong

Research output: Contribution to journalArticlepeer-review

Abstract

Background: 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. Methods: We 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. Results: Eighteen 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]. Conclusions: This 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.

Original languageEnglish (US)
Article number45
JournalBMC Musculoskeletal Disorders
Volume18
Issue number1
DOIs
StatePublished - Jan 26 2017
Externally publishedYes

Bibliographical note

Funding Information:
There is no direct funding for this study. This study was supported by the resources and use of facilities at Birmingham VA Medical Center at Birmingham, Alabama, USA.

Publisher Copyright:
© 2017 The Author(s).

Keywords

  • Clinical trails
  • Core domain
  • OMERACT
  • TJR
  • Total Joint Arthroplasty

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