Jørgensen Lars, Paludan-Müller Asger S, Laursen David R T, Savović Jelena, Boutron Isabelle, Sterne Jonathan A C, Higgins Julian P T, Hróbjartsson Asbjørn
The Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Syst Rev. 2016 May 10;5:80. doi: 10.1186/s13643-016-0259-8.
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.
随机临床试验的Cochrane偏倚风险工具于2008年推出，在系统评价中经常受到评论和使用。我们希望通过回顾已发表的关于其优势和挑战的评论，并描述和分析该工具如何应用于Cochrane和非Cochrane系统评价来评估该工具。
对已发表的评论进行回顾（在PubMed、Cochrane方法学注册库和谷歌学术中检索）以及一项观察性研究（2014年的100篇Cochrane综述和100篇非Cochrane综述）。
我们的综述纳入了68条评论，其中15条被归类为主要评论。该工具的主要优势被认为是其目的（评估试验实施情况而非报告情况）、其发展基础（广泛咨询、实证和理论证据）以及其透明的程序。该工具的挑战主要被认为是其核心偏倚领域的选择（例如不涉及资金/利益冲突）以及与实施相关的问题（即评分者间一致性一般）和术语问题。我们的观察性研究发现，该工具在所有Cochrane综述中均有使用（100/100），并且是非Cochrane综述中首选的工具（31/100）。两种类型的综述都经常以非推荐的方式使用该工具。大多数Cochrane综述计划将偏倚风险评估用作敏感性分析的基础（70%），但只有少数进行了此类分析（19%），因为在许多情况下，很少有试验在所有标准领域被评估为具有“低”偏倚风险（6%）。在纳入的随机临床试验中，89%（1103/1242）的试验至少有一个偏倚风险领域的判断为“不清楚”。
Cochrane工具已成为评估随机临床试验偏倚风险的标准方法，但经常以非推荐的方式使用。基于已发表的评论以及其在系统评价实践中的应用方式，该工具可能通过修订结构和更具针对性的指导得到进一步改进。
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