大血管血管炎结局指标核心集的制定：来自 OMERACT 2016 的报告。
Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016.
机构信息
From the Division of Rheumatology, and Department of Family Medicine and Community Health, and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA; Fatih Sultan Mehmet Training and Research Hospital; Division of Rheumatology, Department of Internal Medicine, Istanbul University Faculty of Medicine; Division of Rheumatology, Marmara University, School of Medicine, Istanbul, Turkey; Division of Rheumatology, University of Ottawa; Division of Rheumatology, The Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Internal Medicine, University Paris Diderot, Paris, France; University of the West of England; University of Bristol; University Hospitals Bristol National Health Service (NHS) Trust, Bristol, UK; Department of Public Health Sciences, University of Iceland, Reykjavik, Iceland.
A.G. Sreih, MD, Assistant Professor of Medicine, Division of Rheumatology, University of Pennsylvania; F. Alibaz-Oner, MD, Associate Professor of Rheumatology, Fatih Sultan Mehmet Training and Research Hospital; T.A. Kermani, MD, MS, Assistant Professor of Medicine, Division of Rheumatology, University of California at Los Angeles; S.Z. Aydin, Associate Professor in Rheumatology, Division of Rheumatology, University of Ottawa; P.F. Cronholm, MD, MSCE, Associate Professor of Family Medicine, Department of Family Medicine and Community Health, University of Pennsylvania; T. Davis, Department of Family Medicine and Community Health, University of Pennsylvania; E. Easley, MPH, Department of Family Medicine and Community Health, University of Pennsylvania; A. Gul, MD, Professor of Rheumatology, Division of Rheumatology, Department of Internal Medicine, Istanbul University, Faculty of Medicine; A. Mahr, MD, PhD, Professor of Internal Medicine, Department of Internal Medicine, University Paris Diderot; C.A. McAlear, MA, Division of Rheumatology, University of Pennsylvania; N. Milman, MD, Assistant Professor, Division of Rheumatology, University of Ottawa, and Division of Rheumatology, The Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; J.C. Robson, MRCP, PhD, Consultant Senior Lecturer, University of the West of England, and Honorary Senior Lecturer, University of Bristol, and Honorary Consultant in Rheumatology, University Hospitals Bristol NHS Trust; G. Tomasson, MD, PhD, Assistant Professor of Epidemiology, Department of Public Health Sciences, University of Iceland; H. Direskeneli, MD, Professor of Rheumatology, Division of Rheumatology, Marmara University, School of Medicine; P.A. Merkel, MD, MPH, Professor of Medicine and Epidemiology, Division of Rheumatology and Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania.
出版信息
J Rheumatol. 2017 Dec;44(12):1933-1937. doi: 10.3899/jrheum.161467. Epub 2017 Sep 1.
OBJECTIVE
Among the challenges in conducting clinical trials in large-vessel vasculitis (LVV), including both giant cell arteritis (GCA) and Takayasu arteritis (TA), is the lack of standardized and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group initiated an international effort to develop and validate data-driven outcome tools for clinical investigation in LVV.
METHODS
An international Delphi exercise was completed to gather opinions from clinical experts on LVV-related domains considered important to measure in trials. Patient interviews and focus groups were completed to identify outcomes of importance to patients. The results of these activities were presented and discussed in a "Virtual Special Interest Group" using telephone- and Internet-based conferences, discussions through electronic mail, and an in-person session at the 2016 OMERACT meeting. A preliminary core set of domains common for all forms of LVV with disease-specific elements was proposed.
RESULTS
The majority of experts agree with using common outcome measures for GCA and TA, with the option of supplementation with disease-specific items. Following interviews and focus groups, pain, fatigue, and emotional effect emerged as health-related quality of life domains important to patients. Current disease assessment tools, including the Birmingham Vasculitis Activity Score, were found to be inadequate to assess disease activity in GCA and standardized assessment of imaging tests were felt crucial to study LVV, especially TA.
CONCLUSION
Initial data from a clinician Delphi exercise and structured patient interviews have provided themes toward an OMERACT-endorsed core set of domains and outcome measures.
目的
在大血管血管炎（LVV）的临床试验中，包括巨细胞动脉炎（GCA）和 Takayasu 动脉炎（TA），面临的挑战之一是缺乏标准化和有意义的结局测量指标。风湿病结局测量（OMERACT）血管炎工作组发起了一项国际努力，旨在开发和验证用于 LVV 临床研究的数据驱动结局工具。
方法
完成了一项国际 Delphi 研究，以收集临床专家对在试验中认为重要的与 LVV 相关领域的意见。对患者进行访谈和焦点小组讨论，以确定对患者重要的结局。这些活动的结果在一个“虚拟特别兴趣小组”中进行了介绍和讨论，使用电话和互联网会议、电子邮件讨论以及在 2016 年 OMERACT 会议上的现场会议。提出了一个初步的核心组，其中包含所有形式的 LVV 的共同领域，并有疾病特异性元素。
结果
大多数专家同意使用 GCA 和 TA 的共同结局测量指标，并可选择补充疾病特异性项目。经过访谈和焦点小组讨论，疼痛、疲劳和情绪影响成为患者健康相关生活质量的重要领域。当前的疾病评估工具，包括伯明翰血管炎活动评分，被认为不足以评估 GCA 的疾病活动，并且认为标准化评估成像测试对研究 LVV 至关重要，特别是 TA。
结论
来自临床医生 Delphi 研究和结构化患者访谈的初步数据提供了 OMERACT 认可的核心组域和结局测量的主题。
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