Patient-reported outcomes in trials of patients with polymyalgia rheumatica: a systematic literature review.

Patient-reported outcomes (PROs) are being increasingly recognized as important measures by rheumatologists. The objective of this review was to evaluate the frequency of use of PROs in studies of patients with polymyalgia rheumatica (PMR). A systematic literature search was performed in PubMed (up to April 2015) to identify any type of clinical studies reporting any type of PROs in patients with PMR. Articles were excluded if they did not include adults with PMR or did not report any PROs. Characteristics of each study such as study design, follow-up, treatment assessed if any, number of patients, mean age, gender, and a description of PROs used were collected to perform a descriptive analysis. From 118 initial studies captured, 28 articles met the predefined criteria, and 20 were finally included in this review. Ten studies (50 %) were randomized clinical trials (RCTs), and 8 (40 %) were cohorts. The most frequently reported domains were: pain (90 %), being the most frequent tool using a visual analogue scale; morning stiffness in minutes (85 %); and function (25 %), evaluated through the Health Assessment Questionnaire. Other domains such as patient global assessment, fatigue, quality of life, and anxiety and depression were infrequently reported. A larger proportion of PROs were included in cohorts in comparison with RCT. Pain and morning stiffness are the most frequently reported PROs. Other domains that may appear relevant for patients are infrequently reported, especially function.