Mackie, S.L., Twohig, H., Neill, L.M. et al. (10 more authors) (2017) The OMERACT core domain set for outcome measures for clinical trials in polymyalgia rheumatica. The Journal of Rheumatology, 44 (10). pp. 1515-1521. ISSN 0315-162X
Abstract
Objective. To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies.
Methods. Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary.
Results. Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patient’s global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life.
Conclusion. This core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent “deeper dive” into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2017 The Journal of Rheumatology. This is an author-produced version of a paper subsequently published in The Journal of Rheumatology. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | POLYMYALGIA RHEUMATICA; OUTCOMES; OMERACT |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > The Medical School (Sheffield) > Academic Unit of Medical Education (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 15 Aug 2019 11:28 |
Last Modified: | 15 Aug 2019 11:28 |
Status: | Published |
Publisher: | The Journal of Rheumatology Publishing Co. Ltd |
Refereed: | Yes |
Identification Number: | 10.3899/jrheum.161109 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:149739 |