Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.
Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials: overview of published comments and analysis of user practice in Cochrane and non-Cochrane reviews.
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DOI：
10.1186/s13643-016-0259-8
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发表时间：
2016-05-10
影响因子：
3.7
通讯作者：
Hróbjartsson A
中科院分区：
文献类型：
--
作者：
Jørgensen L;Paludan-Müller AS;Laursen DR;Savović J;Boutron I;Sterne JA;Higgins JP;Hróbjartsson A
随机临床试验的科克伦偏倚风险工具于2008年引入，并经常在系统评价中得到评论和使用。我们希望通过回顾已发表的关于其优势和挑战的评论以及描述和分析该工具如何应用于科克伦和非科克伦系统评价来评估该工具。对已发表评论的综述（检索PubMed、科克伦方法学注册库和Google Scholar）和一项观察性研究（2014年的100篇科克伦和100篇非科克伦综述）。我们的评论包括68条评论，其中15条被归类为主要评论。该工具的主要优点被认为是其目的（评估审判的进行而不是报告）、其发展基础（广泛协商、经验和理论证据）及其透明的程序。这一工具的挑战主要被认为是它对核心偏向领域的选择（例如不涉及供资/利益冲突）以及与执行有关的问题（即评级者之间的一致性不大）和术语。我们的观察性研究发现，该工具用于所有科克伦综述（100/100），是非科克伦综述的首选工具（31/100）。这两种类型的审查经常以非推荐的方式实施该工具。大多数科克伦综述计划使用偏倚风险评估作为敏感性分析的基础（70%），但只有少数进行了此类分析（19%），因为在许多情况下，很少有试验被评估为所有标准领域的偏倚风险“低”（6%）。89%的随机临床试验（1103/1242）将至少一个偏倚风险域判断为“不清楚”。科克伦工具已成为随机临床试验中评估偏倚风险的标准方法，但经常以非推荐的方式实施。根据已发表的评论及其在系统评价实践中的应用情况，该工具可能会通过修订结构和更有针对性的指导来进一步改进。本文的在线版本（doi：10.1186/s13643-016-0259-8）包含补充材料，可供授权用户使用。
The Cochrane risk of bias tool for randomized clinical trials was introduced in 2008 and has frequently been commented on and used in systematic reviews. We wanted to evaluate the tool by reviewing published comments on its strengths and challenges and by describing and analysing how the tool is applied to both Cochrane and non-Cochrane systematic reviews. A review of published comments (searches in PubMed, The Cochrane Methodology Register and Google Scholar) and an observational study (100 Cochrane and 100 non-Cochrane reviews from 2014). Our review included 68 comments, 15 of which were categorised as major. The main strengths of the tool were considered to be its aim (to assess trial conduct and not reporting), its developmental basis (wide consultation, empirical and theoretical evidence) and its transparent procedures. The challenges of the tool were mainly considered to be its choice of core bias domains (e.g. not involving funding/conflicts of interest) and issues to do with implementation (i.e. modest inter-rater agreement) and terminology. Our observational study found that the tool was used in all Cochrane reviews (100/100) and was the preferred tool in non-Cochrane reviews (31/100). Both types of reviews frequently implemented the tool in non-recommended ways. Most Cochrane reviews planned to use risk of bias assessments as basis for sensitivity analyses (70 %), but only a minority conducted such analyses (19 %) because, in many cases, few trials were assessed as having “low” risk of bias for all standard domains (6 %). The judgement of at least one risk of bias domain as “unclear” was found in 89 % of included randomized clinical trials (1103/1242). The Cochrane tool has become the standard approach to assess risk of bias in randomized clinical trials but is frequently implemented in a non-recommended way. Based on published comments and how it is applied in practice in systematic reviews, the tool may be further improved by a revised structure and more focused guidance. The online version of this article (doi:10.1186/s13643-016-0259-8) contains supplementary material, which is available to authorized users.