Test-retest reliability of pain VAS/NRS, stiffness VAS/NRS, HAQ-DI and mHAQ in polymyalgia rheumatica: An OMERACT study.

OBJECTIVE: To examine the test-retest reliability of four measurement instruments in polymyalgia rheumatica (PMR): pain severity visual analogue scale (VAS) / numerical rating score (NRS), stiffness severity VAS/NRS, the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the modified Health Assessment Questionnaire (mHAQ). METHOD: Two prospectively collected datasets were used. All participants had a diagnosis of PMR and only those with stable disease were included in analyses. Measurement instruments were administered twice, with a testing interval of two to six weeks. The intra-class correlation coefficient (ICC) was calculated using a two-way mixed effects model looking for absolute agreement. ICC values of 0.8-0.9 were deemed representative of good test-retest reliability, whilst values >0.9 were representative of excellent test-retest reliability. RESULTS: From the first dataset, 38 participants were analysed. The ICC between baseline and 2 weeks for pain VAS, stiffness VAS, HAQ-DI and mHAQ were 0.84, 0.82, 0.92 and 0.92 respectively. From the second dataset, 58 participants were included in the analysis for pain NRS, 59 for stiffness NRS and 78 for mHAQ. The ICC between baseline and follow-up for pain NRS, stiffness NRS and mHAQ were 0.80, 0.83 and 0.87 respectively. CONCLUSION: Pain severity VAS/NRS, stiffness severity VAS/NRS, HAQ-DI and mHAQ all demonstrate good to excellent test-retest reliability in a PMR patient population.

Toward a Core Outcome Measurement Set for Polymyalgia Rheumatica: Report from the OMERACT 2018 Special Interest Group.

OBJECTIVE: To report the progress of the Outcome Measures in Rheumatology (OMERACT) Polymyalgia Rheumatica (PMR) Working Group in selecting candidate instruments for a core outcome measurement set. METHODS: A systematic literature review identified outcomes measured and instruments used in PMR studies, and a respondent survey and raw data analysis assessed their domain match and feasibility. RESULTS: Candidate instruments were identified for pain [visual analog scale/numerical rating scale (VAS/NRS)], stiffness (VAS/NRS and duration), and physical function (Health Assessment Questionnaire-Disability Index/modified Health Assessment Questionnaire). Domain match and feasibility assessments were favorable; however, validation in PMR was lacking. CONCLUSION: Further assessment of candidate instruments is required prior to recommending a PMR core outcome measurement set.

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

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.

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

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.