Patient-reported Outcomes in Polymyalgia Rheumatica

Abstract

Objective. To prospectively evaluate the disease course and the performance of clinical, patient-reported outcome (PRO) and musculoskeletal ultrasound measures in patients with polymyalgia rheumatica (PMR). Methods. The study population included 85 patients with new-onset PMR who were initially treated with prednisone equivalent dose of 15 mg daily tapered gradually, and followed for 26 weeks. Data collection included physical examination findings, laboratory measures of acute-phase reactants, and PRO measures. Ultrasound evaluation was performed at baseline and Week 26 to assess for features previously reported to be associated with PMR. Response to corticosteroid treatment was defined as 70% improvement in PMR on visual analog scale (VAS). Results. At baseline, 77% had hip pain in addition to shoulder pain and 100% had abnormal C-reactive protein or erythrocyte sedimentation rate. On ultrasound, 84% had shoulder findings and 32% had both shoulder and hip findings. Response to corticosteroid treatment occurred in 73% of patients by Week 4 and was highly correlated with percentage improvement in other VAS measures. Presence of ultrasound findings at baseline predicted response to corticosteroids at 4 weeks. Factor analysis revealed 6 domains that sufficiently represented all the outcome measures: PMR-related pain and physical function, an elevated inflammatory marker, hip pain, global pain, mental function, and morning stiffness. Conclusion. PRO measures and inflammatory markers performed well in assessing disease activity in patients with PMR. A minimum set of outcome measures consisting of PRO measures of pain and function and an inflammatory marker should be used in practice and in clinical trials in PMR. (First Release March 152012; J Rheumatol 2012;39:795-803; doi:10.3899/jrheum.110977

Outcome Measures in Polymyalgia Rheumatica. A Systematic Review

“…The electronic search strategy yielded 868 articles, 43 of which were selected, on the basis of title and abstract, for further assessment/detailed review. Ultimately, 35 studies [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41]42,43,44,45,46 met inclusion criteria for this systematic review (Figure 1). Agreement between the 2 reviewers was 96.6% and 100% for the first and second steps of article selection, respectively.…”

“…Pain. Pain was used as an outcome in 17 studies 12,13,14,15,16,18,19,22,25,34,36,39,40,43,44,45,46 . A visual analog scale (VAS)…”

“…Three are nonrandomized interventional studies or ones without clear information about randomization 24,25,26 . Longitudinal observational studies represent more than one-half of selected articles (20 of 35) [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] . One of these observational studies 36 is a longterm followup of an already included RCT 20 .…”

“…The description of pain localization varies: "shoulder and pelvic girdle pain," 15 "proximal pain," 34 "proximal muscle pain," 14,16 or "joint or muscle pain." 13 Matteson and colleagues evaluated pain considering different locations including shoulder, limbs, and global 44 . None of the published reports specified the period of time under evaluation when asking patients about their "pain."…”

“…Morning stiffness. Stiffness, more commonly morning stiffness, was considered in almost all the included studies 13,14,15,16,18,19,20,21,22,24,25,26,27,28,30,33,34,35,36,37,38,40,43,44,45,46 . It was evaluated as an independent outcome in 11 studies 13,14,15,16,18,19,25,27,34,40,44 , and was included as a variable in composite disease activity scores or in the definition of relapse/recurrence/remission in an additional 15 studies 19,20,22,24,26,28,33,35,36,37,38,43,…”