Core Outcome Measures in Effectiveness Trials

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

General Information

Abstract:
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. METHODS: In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. RESULTS: There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. CONCLUSION: Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

Authors:
Buchbinder, R. Page, M. J. Huang, H. Verhagen, A. P. Beaton, D. Kopkow, C. Lenza, M. Jain, N. B. Richards, B. Richards, P. Voshaar, M. van der Windt, D. Gagnier, J. J. Shoulder Core Outcome Set Special Interest, Group

Publication

Journal:
J Rheumatol
Volume:
44
Issue:
12
Pages:
1880 - 1883
Year:
2017
DOI:
Further Study Information

Date:
Not stated
Funding source(s):
A Patient-Centered Outcomes Research Institute (PCORI) Engagement Award supported this work (#2072). RB is supported by an Australian National Health and Medical Research Council (NHMRC) Senior Principal Research Fellowship (#1082138). MJP is supported by an Australian NHMRC Early Career Fellowship (#1088535). NJ is supported by funding from National Institute of Arthritis and Musculoskeletal and Skin Diseases 1K23AR059199 and 1U34AR069201.

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Shoulder disorders

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Systematic review

Stakeholders Involved

Consumers (caregivers)
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
Systematic review of outcomes measured in trials

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