Goldstein Cory E, du Toit Jessica, Murphy Nicholas B, Nicholls Stuart G, Shaw Julia F, Althabe Fernando, Binik Ariella, Brehaut Jamie, Eldridge Sandra, Ferrand Rashida A, Gillies Katie, Giraudeau Bruno, van der Graaf Rieke, Hemkens Lars G, Hemming Karla, Johri Mira, Kim Scott Y H, Largent Emily, London Alex John, Mbuagbaw Lawrence, Mitchell Susan L, Smith Maureen, Tugwell Peter, Treweek Shaun, Welch Vivian A, Taljaard Monica, Weijer Charles
Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Res Integr Peer Rev. 2025 Jun 18;10(1):10. doi: 10.1186/s41073-025-00166-y.
Although commonly used to evaluate health interventions, cluster randomized trials raise difficult ethical issues. Recognizing this, the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues across seven domains. But due to several developments in the design and implementation of cluster randomized trials, there are new issues requiring guidance. To inform the forthcoming update of the Ottawa Statement, we aimed to identify any gaps in the Ottawa Statement discussed within the literature.
We searched Google Scholar, Scopus, and Web of Science using the 'cited by' function on 11 November 2022.We included all types of publications, including articles, book chapters, commentaries, editorials, ethics guidelines, theses and trial-related publications (i.e., primary reports, protocols, and secondary analyses), that cited and engaged with the Ottawa Statement, the Ottawa Statement précis, or one or more of its four background papers. Data were extracted by four reviewers working in rotating pairs. Reviewers captured relevant text verbatim and recorded whether it reflected a gap relating to one or more of the Ottawa Statement domains. Using a thematic analysis approach, semantic coding was used to summarize the content of the data into distinct gaps within the Ottawa Statement domains, which was subsequently expanded in an inductive manner through discussion.
The qualitative analysis of the text from 53 articles resulted in the identification of 24 distinct gaps in the Ottawa Statement: 4 gaps about justifying the cluster randomized design; 2 gaps about research ethics committee review; 3 gaps about identifying research participants; 4 gaps about obtaining informed consent; 3 gaps about gatekepeers; 6 gaps about assessing benefits and harms; 1 gap about protecting vulnerable participants; and 1 gap about equity-related issues in cluster randomized trials.
Identifying 24 gaps reveals a need to update the Ottawa Statement. Alongside additional gaps identified in ongoing empirical work and through engagement with our patient and public partners, the gaps identified through this citation analysis should be considered in the forthcoming Ottawa Statement update.
尽管整群随机试验常用于评估健康干预措施，但它引发了棘手的伦理问题。认识到这一点，2012年发表的《渥太华整群随机试验伦理设计与实施声明》提出了15项建议，以解决七个领域的伦理问题。但由于整群随机试验在设计和实施方面的一些发展，出现了需要指导的新问题。为了为即将更新的《渥太华声明》提供参考，我们旨在确定文献中讨论的《渥太华声明》存在的任何差距。
我们于2022年11月11日使用“被引用”功能在谷歌学术、Scopus和科学网进行搜索。我们纳入了所有类型的出版物，包括文章、书籍章节、评论、社论、伦理指南、论文以及与试验相关的出版物（即主要报告、方案和二次分析），这些出版物引用并涉及了《渥太华声明》、《渥太华声明摘要》或其四份背景文件中的一份或多份。数据由四名审查员以轮流配对的方式提取。审查员逐字记录相关文本，并记录其是否反映了与《渥太华声明》的一个或多个领域相关的差距。采用主题分析方法，使用语义编码将数据内容总结为《渥太华声明》各领域内不同的差距，随后通过讨论以归纳方式进行扩展。
对53篇文章的文本进行定性分析后，确定了《渥太华声明》中24个不同的差距：关于整群随机设计合理性的4个差距；关于研究伦理委员会审查的2个差距；关于确定研究参与者的3个差距；关于获得知情同意的4个差距；关于把关人的3个差距；关于评估益处和危害的6个差距；关于保护脆弱参与者的1个差距；以及关于整群随机试验中与公平相关问题的1个差距。
识别出24个差距表明有必要更新《渥太华声明》。除了在正在进行的实证工作中以及通过与我们的患者和公众伙伴合作发现的其他差距外，在即将进行的《渥太华声明》更新中应考虑通过此次引文分析确定的差距。
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