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Feasibility and Face Validity of Outcome Measures for Use in Future Studies of Polymyalgia Rheumatica: An OMERACT
Max Yates1,2, Claire E Owen3,4, Sara Muller3,4
1From the Epidemiology Centre Versus Arthritis, Norwich Medical School, University of East Anglia, Norwich, UK; Department of Rheumatology, East Suffolk and North Essex Foundation Trust, Ipswich, UK; Department of Rheumatology, Austin Health; Department of Medicine, University of Melbourne, Melbourne, Australia; Primary Care Centre Versus Arthritis, Research Institute for Primary Care and Health Sciences, Keele University, Keele; PMRGCA Scotland, Scotland, UK; Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands; Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Department of Rheumatology, and Department of Medicine, Hospital for Special Surgery, New York, New York, USA; Department of Rheumatology and Immunology, Medical University Graz, Graz, Austria; Department of Rheumatology, Hospital of Bruneck, Bruneck, Italy; Department of Rheumatology, Norfolk and Norwich University Hospital, Norwich, UK; Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark; Department of Rheumatology, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK; SDG LLC, Cambridge, Massachusetts, USA; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals National Health Service (NHS) Trust, Leeds, UK; Discipline of Medicine, The University of Adelaide; the Rheumatology Unit, The Queen Elizabeth and Royal Adelaide Hospitals, Adelaide, Australia. maxyates@doctors.org.uk.
Objective:
To survey participants with polymyalgia rheumatica (PMR) to evaluate the face validity, acceptability, and domain match of proposed candidate outcome measures.
Methods:
A structured, online, anonymous survey was disseminated by patient support groups through their networks and online forums. The candidate outcome measures comprised (1) visual analog scale (VAS) and numerical rating score (NRS) to assess pain; (2) VAS, NRS, and duration to assess stiffness; (3) the modified Health Assessment Questionnaire and Health Assessment Questionnaire Disability Index to assess physical function; and (4) C-reactive protein and erythrocyte sedimentation rate to assess inflammation. Free-text answers were analyzed using descriptive thematic analysis to determine respondents' views of the candidate instruments.
Results:
Seventy-eight people with PMR from 6 countries (UK, France, USA, Canada, Australia, and New Zealand) participated in the survey. Most respondents agreed candidate instruments were acceptable or "good to go." Free-text analysis identified 5 themes that participants considered inadequately covered by the proposed instruments. These related to (1) the variability, context, and location of pain; (2) the variability of stiffness; (3) fatigue; (4) disability; and (5) the correlation of inflammatory marker levels and severity of symptoms, sometimes reflecting disease activity and other times not.
Conclusion:
Participants reported additional aspects of their experience that are not covered by the proposed instruments, particularly for the experience of stiffness and effect of fatigue. New patient-reported outcome measures are required to increase the relevance of results from clinical trials to patients with PMR.
