RT Journal Article
SR Electronic
T1 Feasibility and Face Validity of Outcome Measures for Use in Future Studies of Polymyalgia Rheumatica: An OMERACT Study
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.190575
DO 10.3899/jrheum.190575
A1 Max Yates
A1 Claire E.  Owen
A1 Sara Muller
A1 Karly Graham
A1 Lorna Neill
A1 Helen Twohig
A1 Maarten Boers
A1 Mar  Pujades Rodriguez
A1 Susan Goodman
A1 Jonathan Cheah
A1 Christian Dejaco
A1 Chetan Mukhtyar
A1 Berit  Dalsgaard  Nielsen
A1 Joanna Robson
A1 Lee S.  Simon
A1 Beverley Shea
A1 Sarah L.  Mackie
A1 Catherine L.  Hill
YR 2020
UL http://www.jrheum.org/content/early/2020/07/27/jrheum.190575.abstract
AB 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.