关于为膝关节骨关节炎试验的荟萃分析制定患者报告疼痛结果分层列表必要性的共识：OMERACT目标。
Consensus on the Need for a Hierarchical List of Patient-reported Pain Outcomes for Metaanalyses of Knee Osteoarthritis Trials: An OMERACT Objective.
作者信息
Christensen Robin, Maxwell Lara J, Jüni Peter, Tovey David, Williamson Paula R, Boers Maarten, Goel Niti, Buchbinder Rachelle, March Lyn, Terwee Caroline B, Singh Jasvinder A, Tugwell Peter
机构信息
From the Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital; Bispebjerg and Frederiksberg, Denmark; Institute of Population Health, and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Institute of Social and Preventive Medicine and Clinical Trials Unit Bern, Department of Clinical Research, University of Bern, Bern, Switzerland; Cochrane Collaboration, London; Department of Biostatistics, University of Liverpool, Liverpool, UK; departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; Quintiles Inc.; Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Monash Department of Clinical Epidemiology, Cabrini Health, Melbourne; Northern Clinical School, Institute of Bone and Joint Research, University of Sydney, Department of Rheumatology, Sydney, Australia; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center Amsterdam, Amsterdam, The Netherlands; Birmingham Veterans Affairs (VA) Medical Center and University of Alabama at Birmingham, Birmingham, Alabama, USA.
R. Christensen, BSc, MSc, PhD, Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital; L.J. Maxwell, Institute of Population Health, University of Ottawa; P. Jüni, MD, Institute of Social and Preventive Medicine and Clinical Trials Unit Bern, Department of Clinical Research, University of Bern; D. Tovey, Cochrane Collaboration; P.R. Williamson, Department of Biostatistics, University of Liverpool; M. Boers, MD, PhD, Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center; N. Goel, Quintiles Inc., Division of Rheumatology, Department of Medicine, Duke University School of Medicine, and Patient Research Partner; R.S. Buchbinder, MBBS (Hons), MSc, PhD, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Monash Department of Clinical Epidemiology, Cabrini Health; L. March, MD, PhD, Northern Clinical School, Institute of Bone and Joint Research, University of Sydney, Department of Rheumatology; C.B. Terwee, Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, VU University Medical Center; J.A. Singh, MBBS, MPH, Birmingham VA Medical Center and University of Alabama at Birmingham; P. Tugwell, MD, MSc, The Department of Medicine, University of Ottawa.
出版信息
J Rheumatol. 2015 Oct;42(10):1971-1975. doi: 10.3899/jrheum.141384. Epub 2015 May 1.
OBJECTIVE
Although protocol registration for systematic reviews is still not mandatory, reviewers should be strongly encouraged to register the protocol to identify the methodological approach, including all outcomes of interest. This will minimize the likelihood of biased decisions in reviews, such as selective outcome reporting. A group of international experts convened to address issues regarding the need to develop hierarchical lists of outcome measurement instruments for a particular outcome for metaanalyses.
METHODS
Multiple outcome measurement instruments exist to measure the same outcome. Metaanalysis of knee osteoarthritis (OA) trials, and the assessment of pain as an outcome, was used as an exemplar to assess how Outcome Measures in Rheumatology (OMERACT), the Cochrane Collaboration, and other international initiatives might contribute in this area. The meeting began with formal presentations of background topics, empirical evidence from the literature, and a brief introduction to 2 existing hierarchical lists of pain outcome measurement instruments recommended for metaanalyses of knee OA trials.
RESULTS
After discussions, most participants agreed that there is a need to develop a methodology for generation of hierarchical lists of outcome measurement instruments to guide metaanalyses. Tools that could be used to steer development of such a prioritized list are the COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement Instruments) and the OMERACT Filter 2.0.
CONCLUSION
We list meta-epidemiological research agenda items that address the frequency of reported outcomes in trials, as well as methodologies to assess the best measurement properties (i.e., truth, discrimination, and feasibility).
目的
尽管系统评价的方案注册仍非强制要求，但应大力鼓励评价者注册方案，以确定方法学途径，包括所有感兴趣的结局。这将最大限度地减少评价中出现偏倚决策的可能性，如选择性报告结局。一组国际专家召开会议，讨论为特定结局制定分层的结局测量工具列表以用于荟萃分析的必要性相关问题。
方法
存在多种测量同一结局的结局测量工具。以膝关节骨关节炎（OA）试验的荟萃分析以及将疼痛作为结局的评估为例，来评估风湿病结局测量（OMERACT）、Cochrane协作网及其他国际倡议在该领域可能做出的贡献。会议首先正式介绍了背景主题、文献中的实证证据，以及为膝关节OA试验荟萃分析推荐的2个现有的疼痛结局测量工具分层列表。
结果
经过讨论，大多数参与者一致认为有必要制定一种方法来生成结局测量工具的分层列表，以指导荟萃分析。可用于指导制定此类优先列表的工具是COSMIN清单（基于共识的健康状况测量工具选择标准）和OMERACT过滤器2.0。
结论
我们列出了元流行病学研究议程项目，这些项目涉及试验中报告结局的频率，以及评估最佳测量属性（即真实性、区分度和可行性）的方法。
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