用于肩部疾病临床试验的初步核心领域集：来自 OMERACT 2016 肩部核心结局集特别兴趣小组的报告。
A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.
机构信息
Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; School of Public Health and Preventive Medicine, Monash University, Melbourne; Department of Rheumatology, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; School of Social and Community Medicine, University of Bristol, Bristol; Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK; Department of Orthopedic Surgery, and Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Department of General Practice, Erasmus Medical Centre University, Rotterdam; Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands; St. Michael's Hospital, Musculoskeletal Health and Outcomes Research, The Li Ka Shing Knowledge Institute, composed of the Keenan Research Center and the Li Ka Shing International Healthcare Education Center of St. Michael's Hospital; Institute for Work and Health, Toronto, Ontario, Canada; University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare, Dresden, Germany; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
R. Buchbinder, PhD, Director, Monash Department of Clinical Epidemiology, Cabrini Institute, and Professor, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; M.J. Page, PhD, Research Fellow, School of Public Health and Preventive Medicine, Monash University, and School of Social and Community Medicine, University of Bristol; H. Huang, MPH, Research Associate, Department of Orthopedic Surgery, University of Michigan; A.P. Verhagen, PhD, Associate Professor, Department of General Practice, Erasmus Medical Centre University; D. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Institute for Work and Health, and Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute of Health Policy Management and Evaluation, University of Toronto; C. Kopkow, MPH, Research Fellow, University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare; M. Lenza, PhD, Coordinator of Orthopaedics of Hospital Israelita Albert Einstein; N.B. Jain, MD, Associate Professor, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center; B. Richards, MMed (Clin Epi), Director Department of Rheumatology, Royal Prince Alfred Hospital, and Senior Lecturer, Sydney Medical School, University of Sydney; P. Richards, Patient Research Partner, University of Bristol, M. Voshaar, MSc, Research Fellow, Department of Psychology, Health and Technology, University of Twente; D. van der Windt, PhD, Professor of Primary Care Epidemiology, Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University; J.J. Gagnier, PhD, Assistant Professor, Departments of Orthopedic Surgery and Epidemiology, and Director, Clinical Epidemiology and Research in Orthopedic Surgery, University of Michigan.
出版信息
J Rheumatol. 2017 Dec;44(12):1880-1883. doi: 10.3899/jrheum.161123. Epub 2017 Jan 15.
OBJECTIVE
The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders.
METHODS
In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps.
RESULTS
There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated.
CONCLUSION
Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.
目的
风湿病结局测量学（OMERACT）肩部核心结局集特别兴趣小组（SIG）的成立旨在为肩部疾病的临床试验制定核心结局集（COS）。
方法
为筹备 2016 年 OMERACT 会议，我们系统性地评估了自 1954 年至 2015 年间发表的 409 项肩部疾病干预措施的随机试验中报告的所有结局领域和测量工具。在此基础上，我们开展了一项国际德尔菲共识研究，包括肩部试验专家、临床医生和患者，以确定应纳入肩部疾病 COS 的关键领域。研究结果在 OMERACT 的利益相关者预会议上进行了讨论。在 2016 年 OMERACT 会议上，我们就初步核心域集达成共识，并就下一步工作征求意见。
结果
预会议和 2016 年 OMERACT SIG 会议的参会人数分别为 13 人和 15 人（9 人同时参加了两次会议）。会上就初步核心域集达成了共识，该域集包括 4 个核心域：疼痛、身体功能/活动、整体感知效果和包括死亡在内的不良事件。一个中级核心域由 3 个领域组成：情感健康、睡眠和参与（娱乐和工作）。还制定了一个需要进行研究的外部核心域，以为最终 COS 提供信息。
结论
我们的下一步工作是：（1）分析参与（娱乐和工作）是否应纳入核心域；（2）进行第三轮德尔菲调查，以最终确定域的定义和措辞，并最终对域表示认可；（3）确定哪些工具符合 OMERACT 测量每个域的标准。
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