Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
OBJECTIVE: Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments. METHODS: The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement. RESULTS: Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%). CONCLUSION: An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.

Authors:
Singh, J. A. Dowsey, M. M. Dohm, M. Goodman, S. M. Leong, A. L. Scholte Voshaar, Mmjh Choong, P. F.

Publication

Journal:
J Rheumatol
Volume:
44
Issue:
11
Pages:
1723 - 1726
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Arthritis

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Semi structured discussion

Stakeholders Involved

Unknown

Study Type

COS for clinical trials or clinical research

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