RT Journal Article
SR Electronic
T1 The Omeract Core Domain Set for Clinical Trials of Shoulder Disorders
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.181070
DO 10.3899/jrheum.181070
A1 Sofia Ramiro
A1 Matthew J.  Page
A1 Samuel L.  Whittle
A1 Hsiaomin Huang
A1 Arianne P.  Verhagen
A1 Dorcas Beaton
A1 Pamela Richards
A1 Marieke Scholte-Voshaar
A1 Beverley Shea
A1 Danielle van der Windt
A1 Christian Kopkow
A1 Mario Lenza
A1 Nitin Jain
A1 Bethan Richards
A1 Catherine L.  Hill
A1 Tiffany K.  Gill
A1 Bart Koes
A1 Nadine Foster
A1 Philip G.  Conaghan
A1 Toby O.  Smith
A1 Peter Malliaras
A1 Yngve Roe
A1 Joel J  Gagnier
A1 Rachelle Buchbinder
YR 2019
UL http://www.jrheum.org/content/early/2019/01/23/jrheum.181070.abstract
AB Objective To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the OMERACT Filter 2.1 Core Domain Set process. Methods At OMERACT 2018, the Outcome Measures in Rheumatology (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 an international Delphi 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 break-out 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 four ‘mandatory’ trial domains: pain, function, patient global - shoulder and adverse events including death; and four ‘important but optional’ domains: participation (recreation/work), sleep, emotional wellbeing 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.