Ramiro, S, Page, MJ, Whittle, SL et al. (21 more authors) (2019) The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders. Journal of Rheumatology, 46 (8). pp. 969-975. ISSN 0315-162X
Abstract
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 withbshoulder 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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2019 The Journal of Rheumatology. This is an author produced version of a paper published in Journal of Rheumatology. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | OMERACT; Shoulder; Core outcome set; Trials; Outcome measurement |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Musculoskeletal Medicine & Imaging (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 21 Jan 2019 15:02 |
Last Modified: | 15 Aug 2019 08:40 |
Status: | Published |
Publisher: | Journal of Rheumatology |
Identification Number: | 10.3899/jrheum.181070 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:140944 |