The Reporting of Patient-reported Outcomes in Studies of Patients with Rheumatoid Arthritis: A Systematic Review of 250 Articles

Objective. Patient-reported outcomes ( PRO) in rheumatoid arthritis ( RA) provide important information regarding disease effect. The study objective was to assess the frequency of PRO use in recent RA studies and compare results with a previous systematic review ( SR) in 2005-2007. Methods. An SR was performed in PubMed MEDLINE ( January 2015). Publications were identified using these MEdical Subject Headings terms: arthritis, rheumatoid with a limitation to humans, all adults: 19+ years, English, published in the last 2 years, and clinical trials. All studies were assessed, whatever their designs. All PRO reported in publications were classified according to general domains of health by 2 authors. Statistics were descriptive. Results. Two hundred fifty articles were analyzed. Of them, 113 ( 45.2%) were randomized controlled trials; 138 different PRO were reported. The most frequent PRO, similar to the 2007 SR, were function ( 68.0%), pain ( 40.0%), patient's global assessment ( 49.2%), and health-related quality of life ( 18.4%). Fatigue ( 14.4%), morning stiffness ( 10.0%), psychological status ( 9.6%), productivity losses ( 6.4%), utility ( 5.2%), sleep disturbance ( 2.4%), and coping ( 2.0%) were rarely reported. Although frequent domains were reported using well-validated questionnaires, the others were reported using heterogeneous questionnaires. Conclusion. The PRO collected and reported in RA studies are remarkably consistent with those seen in 2005-2007, and reflect the existing RA Core Set measures. Other domains of health prioritized by patients including fatigue, psychological status, productivity losses, sleep disturbance, and coping remain rarely reported. Further, heterogeneity in outcome measures used presents challenges in interpreting true disease effect and response to therapy.