TY - JOUR T1 - The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders JF - The Journal of Rheumatology JO - J Rheumatol SP - 969 LP - 975 DO - 10.3899/jrheum.181070 VL - 46 IS - 8 AU - Sofia Ramiro AU - Matthew J. Page AU - Samuel L. Whittle AU - Hsiaomin Huang AU - Arianne P. Verhagen AU - Dorcas E. Beaton AU - Pamela Richards AU - Marieke Voshaar AU - Beverley Shea AU - Danielle A. van der Windt AU - Christian Kopkow AU - Mario Lenza AU - Nitin B. Jain AU - Bethan Richards AU - Catherine Hill AU - Tiffany K. Gill AU - Bart Koes AU - Nadine E. Foster AU - Philip G. Conaghan AU - Toby Smith AU - Peter Malliaras AU - Yngve Roe AU - Joel J. Gagnier AU - Rachelle Buchbinder Y1 - 2019/08/01 UR - http://www.jrheum.org/content/46/8/969.abstract N2 - Objective. To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process.Methods. At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants.Results. The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set.Conclusion. OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain. ER -