RT Journal Article
SR Electronic
T1 Polymyalgia Rheumatica (PMR) Special Interest Group at OMERACT 11: Outcomes of Importance for Patients with PMR
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.131254
DO 10.3899/jrheum.131254
A1 Sarah L.  Mackie
A1 Seher Arat
A1 Jose da  Silva
A1 Catia Duarte
A1 Sue Halliday
A1 Rod Hughes
A1 Marianne Morris
A1 Colin T.  Pease
A1 Jeffrey W.  Sherman
A1 Lee S.  Simon
A1 Maggie Walsh
A1 René Westhovens
A1 Samy Zakout
A1 John R.  Kirwan
YR 2014
UL http://www.jrheum.org/content/early/2014/01/29/jrheum.131254.abstract
AB 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.