title: The Reporting of Patient-reported Outcomes in Studies of Patients with Rheumatoid Arthritis: A Systematic Review of 250 Articles.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: From the Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.L. Kilic, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; A. Erden, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; C.O. Bingham III, MD, Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University; L. Gossec, MD, Professor, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital; U. Kalyoncu, MD, Associate Professor, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, and Division of Rheumatology, Department of Medicine, Johns Hopkins University. drleventkilic@yahoo.com.
authors.forename: Levent
authors.initials: L
authors.lastname: Kilic
authors.affiliation: From the Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.L. Kilic, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; A. Erden, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; C.O. Bingham III, MD, Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University; L. Gossec, MD, Professor, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital; U. Kalyoncu, MD, Associate Professor, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, and Division of Rheumatology, Department of Medicine, Johns Hopkins University.
authors.forename: Abdulsamet
authors.initials: A
authors.lastname: Erden
authors.affiliation: From the Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.L. Kilic, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; A. Erden, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; C.O. Bingham III, MD, Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University; L. Gossec, MD, Professor, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital; U. Kalyoncu, MD, Associate Professor, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, and Division of Rheumatology, Department of Medicine, Johns Hopkins University.
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.affiliation: From the Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.L. Kilic, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; A. Erden, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; C.O. Bingham III, MD, Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University; L. Gossec, MD, Professor, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital; U. Kalyoncu, MD, Associate Professor, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, and Division of Rheumatology, Department of Medicine, Johns Hopkins University.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: From the Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.L. Kilic, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; A. Erden, MD, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; C.O. Bingham III, MD, Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University; L. Gossec, MD, Professor, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital; U. Kalyoncu, MD, Associate Professor, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Hacettepe University, and Division of Rheumatology, Department of Medicine, Johns Hopkins University.
authors.forename: Umut
authors.initials: U
authors.lastname: Kalyoncu
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D006801:Humans; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D018501:Antirheumatic Agents
keywords: OUTCOMES MEASURES; PATIENT-REPORTED; RHEUMATOID ARTHRITIS; SYSTEMATIC REVIEW