Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: outcomes of importance for patients with PMR.
We worked toward developing a core outcome set for clinical research studies in polymyalgia rheumatica (PMR) by conducting (1) patient consultations using modified nominal group technique; (2) a systematic literature review of outcome measures in PMR; (3) a pilot observational study of patients presenting with untreated PMR, and further discussion with patient research partners; and (4) a qualitative focus group study of patients with PMR on the meaning of stiffness, using thematic analysis. (1) Consultations included 104 patients at 4 centers. Symptoms of PMR included pain, stiffness, fatigue, and sleep disturbance. Function, anxiety, and depression were also often mentioned. Participants expressed concerns about diagnostic delay, adverse effects of glucocorticoids, and fear of relapse. (2) In the systematic review, outcome measures previously used for PMR include pain visual analog scores (VAS), morning stiffness, blood markers, function, and quality of life; standardized effect sizes posttreatment were large. (3) Findings from the observational study indicated that asking about symptom severity at 7 AM, or "on waking," appeared more relevant to disease activity than asking about symptom severity "now" (which depended on the time of assessment). (4) Preliminary results were presented from the focus group qualitative study, encompassing broad themes of stiffness, pain, and the effect of PMR on patients' lives. It was concluded that further validation work is required before a core outcome set in PMR can be recommended. Nevertheless, the large standardized effect sizes suggest that pain VAS is likely to be satisfactory as a primary outcome measure for assessing response to initial therapy of PMR. Dissection of between-patient heterogeneity in the subsequent treatment course may require attention to comorbidity as a potential confounding factor.
From UK National Institute for Health Research (NIHR)-Leeds Biomedical Research Unit, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; Polymyalgia Rheumatica Giant Cell Arteritis (PMRGCA) UK, Bristol; Department of Rheumatology Ashford and St Peter's Hospitals National Health Service (NHS) Foundation Trust, Chertsey, Surrey; Centre for Health and Clinical Research, Faculty of Health and Life Sciences, University of the West of England, Bristol; Department of Rheumatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; Horizon Pharma Inc., Deerfield, Illinois; SDG LLC, Boston, Massachusetts, USA; Department of Rheumatology, Katholieke Universiteit Leuven, Leuven, Belgium; Academic Rheumatology Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.
Sarah L
SL
Mackie
Seher
S
Arat
Jose
J
da Silva
Catia
C
Duarte
Sue
S
Halliday
Rod
R
Hughes
Marianne
M
Morris
Colin T
CT
Pease
Jeffrey W
JW
Sherman
Lee S
LS
Simon
Maggie
M
Walsh
René
R
Westhovens
Samy
S
Zakout
John R
JR
Kirwan
D003245:Consensus Statements as Topic; D005260:Female; D017144:Focus Groups; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010147:Pain Measurement; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011111:Polymyalgia Rheumatica / Q000175:diagnosis* / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012720:Severity of Illness Index; D013256:Steroids / Q000009:adverse effects / Q000627:therapeutic use*
D013256:Steroids
CORE SET; OMERACT; OUTCOME AND PROCESS ASSESSMENT; PAIN; POLYMYALGIA RHEUMATICA; STIFFNESS