更新银屑病关节炎（PsA）核心领域集：来自 2016 年 OMERACT 会议上的 PsA 研讨会的报告。
Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016.
机构信息
From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Department of Dermatology, University of Utah, Salt Lake City, Utah; Quintiles, Duke University School of Medicine, Durham, North Carolina; Division of Immunology, Stanford University, Palo Alto, California; Cleveland Clinic, Cleveland, Ohio; University of Pennsylvania, Philadelphia, Pennsylvania, USA; VU Medical Centre, Amsterdam; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; Royal National Hospital for Rheumatic Diseases; Royal National Hospital for Rheumatic Diseases, Bath; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals UK National Health Service (NHS) Trust, Leeds, UK; Toronto Western Hospital; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network; Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto; Ottawa Hospital Research Institute, School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey.
A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center, and University of Washington School of Medicine; K. Callis Duffin, MD, Department of Dermatology, University of Utah; M. Elmamoun, MBBS, MRCPI, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; W. Tillett, BSc, MB ChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; W. Campbell, BEd LLB, Patient Research Partner, Toronto Western Hospital; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network; N. Goel, MD, Patient Research Partner, Quintiles, Duke University School of Medicine; L. Gossec, MD, PhD, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; P. Hoejgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; C.A. Lindsay, PharmD, Patient Research Partner; V. Strand, MD, Division of Immunology, Stanford University; D.M. van der Heijde, MD, PhD, Department of Rheumatology, Leiden University Medical Center; B. Shea, MSc, PhD, Senior Methodologist, Ottawa Hospital Research Institute, Adjunct Professor, School of Epidemiology, Public Health and Preventative Medicine, Faculty of Medicine, University of Ottawa; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L. Coates, MB ChB, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; L. Eder, MD, PhD, Women's College Research Institute, Women's College Hospital, University of Toronto; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; U. Kalyoncu, MD, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; I. Steinkoenig, BA, Patient Research Partner, Cleveland Clinic; A. Ogdie, MD, MSCE, University of Pennsylvania.
出版信息
J Rheumatol. 2017 Oct;44(10):1522-1528. doi: 10.3899/jrheum.160904. Epub 2017 Feb 1.
OBJECTIVE
To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS).
METHODS
At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants.
RESULTS
We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda.
CONCLUSION
The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.
目的
根据疗效测量在风湿病学（OMERACT）过滤器 2.0 纳入患者观点，更新用于随机对照试验（RCT）和纵向观察研究（LOS）的银屑病关节炎（PsA）核心领域集。
方法
在 OMERACT 2016 年，展示并讨论了更新 PsA 核心领域集的研究。OMERACT 参与者对更新的 PsA 核心领域集进行了投票和认可。
结果
我们对 PsA RCT 和 LOS 中测量的领域进行了系统文献回顾，确定了 24 个领域。我们进行了 24 次焦点小组讨论，有来自 7 个国家的 130 名患者参加，代表了 5 个大洲。我们通过 2 轮独立的患者和医生调查（分别有 50 名患者和 75 名医生参加）以及 12 名患者和 12 名医生的名义小组技术会议达成了共识。我们在 OMERACT 2016 年举行了研讨会和分组讨论，介绍和讨论了研究结果。更新的 PsA 核心领域集获得了 90%的 OMERACT 2016 参与者的认可，包括肌肉骨骼疾病活动、皮肤疾病活动、疲劳、疼痛、患者整体评估、身体功能、健康相关生活质量和全身炎症，这些都建议用于所有 RCT 和 LOS。这些是重要的，但不是所有 RCT 和 LOS 都必需的：经济成本、情感健康、参与和结构损伤。独立性、睡眠、僵硬和治疗负担被列入研究议程。
结论
更新的 PsA 核心领域集在 OMERACT 2016 年获得认可。PsA 工作组的下一步包括评估 PsA 结局测量和开发 PsA 核心结局测量集。
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