• Sarah L Mackie, Helen Twohig, Lorna M Neill, Eileen Harrison, Beverley Shea, Rachel J Black, Tanaz A Kermani, Peter A Merkel, Christian D Mallen, Frank Buttgereit, Chetan Mukhtyar, Lee S Simon, Catherine L Hill, and OMERACT PMR Working Group.
• From the Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, and UK National Institute for Health Research (NIHR), Leeds; Academic Unit of Primary Medical Care, University of Sheffield, Sheffield; PMR-GCA Scotland, Dundee; PMR-GCA North East, Gateshead; Primary Care and Health Sciences, Keele University, Keele; Norfolk and Norwich University Hospital, Norwich, UK; Ottawa Hospital Research Institute and School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Discipline of Medicine, The University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Division of Rheumatology, University of California Los Angeles (UCLA), Los Angeles, California; Division of Rheumatology and Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania; SDG LLC, Cambridge, Massachusetts, USA; Department of Rheumatology and Clinical Immunology, Charite University Hospital Berlin, Berlin, Germany. s.l.mackie@leeds.ac.uk.
• J Rheumatol. 2017 Oct 1; 44 (10): 1515-1521.

ObjectiveTo 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.MethodsDomains 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.ResultsNinety-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.ConclusionThis 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.

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