Moore Theresa H M, Higgins Julian P T, Dwan Kerry
Cochrane Editorial and Methods Department London UK.
NIHR Applied Research Collaboration West (ARC West) University Hospitals Bristol and Weston NHS Foundation Trust Bristol UK.
Cochrane Evid Synth Methods. 2023 Dec 3;1(10):e12031. doi: 10.1002/cesm.12031. eCollection 2023 Dec.
RoB 2 is a tool used by systematic reviewers to assess risk of bias in randomized trials. Over a period of 19 months working as editors for Cochrane, we saw many instances where users of RoB 2 frequently applied the tool in ways the developers had not intended, despite availability of detailed guidance, webinars and FAQs.
In this paper we highlight the ten main issues that we observed, with the aims of optimising the application of the RoB 2 tool, avoiding some of the frequent misapplications of the tool.
Issues noted included failure to state an effect of interest, applying the tool to an entire study rather than to a specific numerical result, omitting key signaling questions and relying on outdated views of causes of bias.
Such omissions and misapplications can lead to overly harsh or lenient assessments of bias with potential to change the confidence we have in an evidence base of randomized trials. We recommend that teams planning to use RoB 2 include at least one member familiar with the RoB 2 detailed guidance and that they use the free resources, such as webinars and FAQs, from the developers of RoB 2 and Cochrane. Our ten tips should be useful to non-Cochrane systematic reviewers as well as to peer reviewers and editors in Cochrane and other journals.
RoB 2是系统评价者用于评估随机试验偏倚风险的工具。在担任Cochrane编辑的19个月里，我们看到许多情况，尽管有详细的指南、网络研讨会和常见问题解答，但RoB 2的使用者经常以开发者未曾预期的方式应用该工具。
在本文中，我们突出了观察到的十个主要问题，目的是优化RoB 2工具的应用，避免该工具的一些常见误用情况。
注意到的问题包括未说明感兴趣的效应、将该工具应用于整个研究而非特定的数值结果、遗漏关键的信号问题以及依赖过时的偏倚原因观点。
此类遗漏和误用可能导致对偏倚的评估过于严苛或宽松，有可能改变我们对随机试验证据基础的信心。我们建议计划使用RoB 2的团队至少包括一名熟悉RoB 2详细指南的成员，并使用RoB 2和Cochrane开发者提供的免费资源，如网络研讨会和常见问题解答。我们的十条提示对非Cochrane系统评价者以及Cochrane和其他期刊的同行评审者和编辑应该会有所帮助。
