Kilic Levent, Erden Abdulsamet, Bingham Clifton O, Gossec Laure, Kalyoncu Umut
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.
J Rheumatol. 2016 Jul;43(7):1300-5. doi: 10.3899/jrheum.151177. Epub 2016 Apr 15.
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.
类风湿关节炎（RA）患者报告的结局（PRO）提供了有关疾病影响的重要信息。本研究的目的是评估近期RA研究中PRO的使用频率，并将结果与2005 - 2007年的一项先前系统评价（SR）进行比较。
于2015年1月在PubMed MEDLINE中进行了一项系统评价。使用以下医学主题词检索出版物：“关节炎，类风湿性”，限定为“人类”、“所有成年人：19岁及以上”、“英语”、“过去2年发表”以及“临床试验”。无论研究设计如何，均对所有研究进行评估。出版物中报告的所有PRO由两名作者根据健康的一般领域进行分类。统计数据为描述性的。
分析了250篇文章。其中，113篇（45.2%）为随机对照试验；报告了138种不同的PRO。与2007年的系统评价相似，最常报告的PRO是功能（68.0%）、疼痛（40.0%）、患者整体评估（49.2%）和健康相关生活质量（18.4%）。疲劳（14.4%）、晨僵（10.0%）、心理状态（9.6%）、生产力损失（6.4%）、效用（5.2%）、睡眠障碍（2.4%）和应对（2.0%）很少被报告。尽管常用领域使用了经过充分验证的问卷进行报告，但其他领域使用的问卷则各不相同。
RA研究中收集和报告的PRO与2005 - 2007年所见的PRO显著一致，并反映了现有的RA核心集指标。患者优先考虑的其他健康领域，包括疲劳、心理状态、生产力损失、睡眠障碍和应对，仍然很少被报告。此外，所使用的结局测量方法的异质性在解释真正的疾病效应和对治疗的反应方面带来了挑战。
