Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

Abstract

Objectives: The OMERACT Polymyalgia Rheumatica Working Group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previously-reported work from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. Methods:A three-round Delphi survey of clinicians and PMR patients 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 in order 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 that took part in round 1, 46 and 35 took part in subsequent rounds. 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. Conclusions:A provisional core domain set is presented for clinical trials in PMR, comprising: 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.

Development and testing of candidate items for inclusion in a new rheumatoid arthritis stiffness patient-reported outcome measure

“…However, patient descriptions of stiffness not being exclusively experienced in the morning period challenge this biomedical interpretation in relation to patient-reported assessment of stiffness. This finding is supported by work with patients with PMR who similarly reported that stiffness is not purely experienced in the morning [46] and a recent Delphi study in the development of a core domain set for PMR where patients expressed a preference for 'stiffness' rather than 'morning stiffness' [47]. Work in PMR has also questioned the adequacy of duration as part of stiffness assessment [46].…”

Incidence, prevalence and treatment burden of polymyalgia rheumatica in the UK over two decades: a population-based study

“…Its impact on patients’ lives can be devastating, causing stiffness, severe pain and significant impairment to daily activities 1. Glucocorticoids (GCs) remain the mainstay of treatment 2…”

Perspectives and unmet needs in polymyalgia rheumatica. Providing the fundamental framework for the development of new treatment regimes in polymyalgia rheumatica

“…Such a study will clarify the contribution of other imaging modalities such as FDG PET-CT towards verification of PMR inflammatory lesions. Besides from validation of the 2012 provisional classification criteria for PMR, the outlined prospective observational study will also provide the essential information needed to establish the reproducibility, redundancy and validity of previously proposed measures for defining remission and response in PMR (2,4,5). Taken together, the framework for high quality clinical trials in PMR will then be available.…”

“…Immense efforts have been devoted to provide the best of knowledge for both clinical decision making and future studies considering classification (1), outcome measures (2)(3)(4)(5), therapeutic interventions and prognosis (6). Recommendations for the management of PMR have been developed, and serve to standardise clinical practice and improve patient care (7).…”