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
AffiliationUniv Arizona, Dept Orthopaed Surg
MetadataShow full item record
PublisherBIOMED CENTRAL LTD
CitationConsensus 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 2017, 18 (1) BMC Musculoskeletal Disorders
JournalBMC Musculoskeletal Disorders
Rights© The Author(s). 2017 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License.
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AbstractBackground: 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.
NoteOpen access journal
VersionFinal published version
- Patient Endorsement of the Outcome Measures in Rheumatology (OMERACT) Total Joint Replacement (TJR) clinical trial draft core domain set.
- Authors: Singh JA, Dowsey M, Choong PF
- Issue date: 2017 Mar 15
- Patients and surgeons provide endorsement of core domains for total joint replacement clinical trials.
- Authors: Hoang A, Goodman SM, Navarro-Millán IY, Mandl LA, Figgie MP, Bostrom MP, Padgett DE, Sculco PK, McLawhorn AS, Singh JA
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- Issue date: 2015 Dec
- Achieving Consensus on Total Joint Replacement Trial Outcome Reporting Using the OMERACT Filter: Endorsement of the Final Core Domain Set for Total Hip and Total Knee Replacement Trials for Endstage Arthritis.
- Authors: Singh JA, Dowsey MM, Dohm M, Goodman SM, Leong AL, Scholte Voshaar MMJH, Choong PF
- Issue date: 2017 Nov
- Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.
- Authors: Wall PDH, Richards BL, Sprowson A, Buchbinder R, Singh JA
- Issue date: 2017 May 30