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The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica

Mackie, SL; Neill, LM; Harrison, E; Black, RJ; Kermani, TA; Simon, LS; Shea, B; Merkel, PA; Mallen, CD; Buttgereit, F; Mukhtyar, C; Hill, CL; PMR Working Group, OMERACT; Twohig, H

The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica Thumbnail


Authors

SL Mackie

LM Neill

E Harrison

RJ Black

TA Kermani

LS Simon

B Shea

PA Merkel

F Buttgereit

C Mukhtyar

CL Hill

OMERACT PMR Working Group



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.

Acceptance Date May 12, 2017
Publication Date Oct 1, 2017
Journal Journal of Rheumatology
Print ISSN 0315-162X
Publisher Journal of Rheumatology
Pages 1515-1521
DOI https://doi.org/10.3899/jrheum.161109
Keywords Polymyalgia Rheumatica; Outcomes; Omeract
Publisher URL http://www.jrheum.org/content/44/10/1515.tab-article-info

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