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

Abstract

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.

Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review

“…Pain was the most commonly assessed patient-reported outcome with a VAS being the most frequently used measurement instrument. However, as noted in previous reviews (Duarte et al, 2015;Huang and Castrejon, 2016), there is little consistency in the question and scales used or on the time frame being considered. Each measurement property of pain VAS has been evaluated in PMR but there is only sufficient evidence on its test-retest reliability.…”

Sleep Impairment at the Time of First Diagnosis in Patients with Seronegative Elderly-Onset Rheumatoid Arthritis and in Patients with Polymyalgia Rheumatica    

“…Higher prevalence of depressive and anxiety symptoms was highlighted in early arthritis patients in comparison to the normal population [25,26]. Similarly, anxiety and depression are present in patients with PMR [27] even if they seem less assessed as patient-reported outcomes [28].…”

Depression and depressive symptoms in patients with polymyalgia rheumatica: discussion points, grey areas and unmet needs emerging from a systematic review of published literature

“…The Visual Analogue Scale (VAS) of pain by the patient remains the only PRO in PMR activity score. This is another critical point, because, even if pain is the most frequent PRO, its correlation with depressive symptoms was infrequently reported in published literature [34,38]. Therefore, whether depressive symptoms or depression are related to pain rather than -for example -GC therapy or other different conditions is still unclear.…”

“…In other previous studies on quality of life in PMR, short form (SF) questionnaires were used and although these questionnaires contain depression-related domains, they do not directly address depression [38,39].…”