Savović Jelena, Weeks Laura, Sterne Jonathan A C, Turner Lucy, Altman Douglas G, Moher David, Higgins Julian P T
School of Social and Community Medicine, University of Bristol, Bristol, UK.
Syst Rev. 2014 Apr 15;3:37. doi: 10.1186/2046-4053-3-37.
In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials.
To assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool.
The survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway.
Overall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation.
2008年，Cochrane协作网推出了一种用于评估Cochrane系统评价中所纳入临床试验偏倚风险的工具。偏倚风险（RoB）工具基于对已知会增加试验偏倚风险的循证方法学特征的叙述性描述。
为评估该工具的可用性，我们通过焦点小组、在线调查和一次面对面会议进行了评估。我们从Cochrane协作网内的一系列利益相关者那里获得了关于他们使用RoB工具及相关指导材料的经验和看法的反馈。然后，我们在一次专家和利益相关者的面对面会议上评估了这些反馈，并就RoB工具的改进和进一步开发提出了建议。
该调查共收到380份回复。受访者报告称，每项研究完成RoB评估平均耗时10至60分钟，83%的人认为这是可以接受的。大多数受访者（87%的作者和95%的编辑人员）认为RoB评估比以往评估试验质量的方法有所改进。大多数作者喜欢标准化方法（81%）以及能够提供引用来支持判断的功能（74%）。三分之一的参与者不喜欢工作量增加，并且发现描述RoB判断的措辞令人困惑。据报告最难评估的RoB领域是不完整的结局数据和结局的选择性报告。作者们表示需要更多关于如何将RoB评估纳入Meta分析和系统评价结论的指导。基于此次评估，针对RoB工具及其相关指导提出了改进建议。这些建议目前正在实施中。
总体而言，受访者对RoB工具给出了积极的体验和看法。针对此次评估对该工具及其相关指导进行的修订，以及改进培训的提供，可能会改善其应用情况。
