Core Outcome Measures in Effectiveness Trials

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

General Information

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.

Aim:
To achieve an International consensus by orthopaedic surgeons on the OMERACT core domain/area set for TJR clinical trials.

Authors:
Jasvinder A. Singh, Michael Dohm and Peter F. Choong

Publication

Journal:
BMC Musculoskeletal Disorders
Volume:
18
Issue:
1
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):
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.

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Arthritis

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Delphi process
Survey

Stakeholders Involved

Clinical experts

Study Type

COS for clinical trials or clinical research
COS for practice

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