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

Buchbinder, Rachelle; Page, Matthew J.; Huang, Hsiaomin; Verhagen, Arianne P.; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B.; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J.; Set Special Interest Group, The Shoulder Core Outcome

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.

Citation

Buchbinder, R., Page, M. J., Huang, H., Verhagen, A. P., Beaton, D., Kopkow, C., …Set Special Interest Group, T. S. C. O. (2017). A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group. Journal of Rheumatology, 44(12), 1880-1883

• Journal Article Type: Conference Paper
• Conference Name: OMERACT 2016 — International Consensus Conference on Outcome Measures in Rheumatology (May 2016)
• Conference Location: Whistler, British Columbia, Canada
• Acceptance Date: Dec 9, 2016
• Online Publication Date: Dec 1, 2017
• Publication Date: Dec 1, 2017
• Deposit Date: Mar 1, 2024
• Journal: Journal of Rheumatology
• Print ISSN: 0315-162X
• Publisher: Journal of Rheumatology
• Peer Reviewed: Peer Reviewed
• Volume: 44
• Issue: 12
• Pages: 1880-1883
• Publisher URL: https://www.jrheum.org/content/44/12/1880