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Development of a provisional core domain set for polymyalgia rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

Pease, Colin T.; Hill, Catherine L.; Neill, Lorna M.; Simon, Lee S.; Mallen, Christian D.; Kirwan, John R.; Mackie, Sarah L.; Pease, Colin; Hill, Catherine; Neill, Lorna; Helliwell, Toby; Simon, Lee; Brouwer, Elisabeth; Mallen, Christian; Hughes, Rodney; Kirwan, John; Mackie, Sarah; Halls, Serena; Boers, Maarten

Authors

Colin T. Pease

Catherine L. Hill

Lorna M. Neill

Lee S. Simon

Christian D. Mallen

John R. Kirwan

Sarah L. Mackie

Colin Pease

Catherine Hill

Lorna Neill

Toby Helliwell

Lee Simon

Elisabeth Brouwer

Christian Mallen

Rodney Hughes

John Kirwan

Sarah Mackie

Maarten Boers



Abstract

The Journal of Rheumatology Copyright © 2016. All rights reserved. Objective. The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. Methods. A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. Results. Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR. Conclusion. A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.

Citation

Mackie, S. L., Kirwan, J. R., Mallen, C. D., Simon, L. S., Neill, L. M., Hill, C. L., …Mackie, S. (2016). Development of a provisional core domain set for polymyalgia rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group. Journal of Rheumatology, 43(1), 182-186. https://doi.org/10.3899/jrheum.141179

Journal Article Type Article
Acceptance Date Nov 15, 2015
Publication Date Jan 1, 2016
Deposit Date Nov 3, 2016
Publicly Available Date Mar 28, 2024
Journal Journal of Rheumatology
Print ISSN 0315-162X
Electronic ISSN 1499-2752
Publisher Journal of Rheumatology
Peer Reviewed Peer Reviewed
Volume 43
Issue 1
Pages 182-186
DOI https://doi.org/10.3899/jrheum.141179
Keywords polymyalgia rheumatica, outcomes, OMERACT
Public URL https://uwe-repository.worktribe.com/output/919602
Publisher URL http://dx.doi.org/10.3899/jrheum.141179