关于聚类随机试验的伦理设计和行为的渥太华声明中的空白:引用分析显示需要更新伦理指南。

IF 10.7 Q1 ETHICS
Cory E Goldstein, Jessica du Toit, Nicholas B Murphy, Stuart G Nicholls, Julia F Shaw, Fernando Althabe, Ariella Binik, Jamie Brehaut, Sandra Eldridge, Rashida A Ferrand, Katie Gillies, Bruno Giraudeau, Rieke van der Graaf, Lars G Hemkens, Karla Hemming, Mira Johri, Scott Y H Kim, Emily Largent, Alex John London, Lawrence Mbuagbaw, Susan L Mitchell, Maureen Smith, Peter Tugwell, Shaun Treweek, Vivian A Welch, Monica Taljaard, Charles Weijer
{"title":"关于聚类随机试验的伦理设计和行为的渥太华声明中的空白:引用分析显示需要更新伦理指南。","authors":"Cory E Goldstein, Jessica du Toit, Nicholas B Murphy, Stuart G Nicholls, Julia F Shaw, Fernando Althabe, Ariella Binik, Jamie Brehaut, Sandra Eldridge, Rashida A Ferrand, Katie Gillies, Bruno Giraudeau, Rieke van der Graaf, Lars G Hemkens, Karla Hemming, Mira Johri, Scott Y H Kim, Emily Largent, Alex John London, Lawrence Mbuagbaw, Susan L Mitchell, Maureen Smith, Peter Tugwell, Shaun Treweek, Vivian A Welch, Monica Taljaard, Charles Weijer","doi":"10.1186/s41073-025-00166-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":74682,"journal":{"name":"Research integrity and peer review","volume":"10 1","pages":"10"},"PeriodicalIF":10.7000,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12175472/pdf/","citationCount":"0","resultStr":"{\"title\":\"Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines.\",\"authors\":\"Cory E Goldstein, Jessica du Toit, Nicholas B Murphy, Stuart G Nicholls, Julia F Shaw, Fernando Althabe, Ariella Binik, Jamie Brehaut, Sandra Eldridge, Rashida A Ferrand, Katie Gillies, Bruno Giraudeau, Rieke van der Graaf, Lars G Hemkens, Karla Hemming, Mira Johri, Scott Y H Kim, Emily Largent, Alex John London, Lawrence Mbuagbaw, Susan L Mitchell, Maureen Smith, Peter Tugwell, Shaun Treweek, Vivian A Welch, Monica Taljaard, Charles Weijer\",\"doi\":\"10.1186/s41073-025-00166-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":74682,\"journal\":{\"name\":\"Research integrity and peer review\",\"volume\":\"10 1\",\"pages\":\"10\"},\"PeriodicalIF\":10.7000,\"publicationDate\":\"2025-06-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12175472/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Research integrity and peer review\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s41073-025-00166-y\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Research integrity and peer review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41073-025-00166-y","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0

摘要

背景:虽然通常用于评估健康干预措施,但聚类随机试验引起了困难的伦理问题。认识到这一点,2012年发表的《关于聚类随机试验的伦理设计和行为的渥太华声明》提供了15条建议,以解决七个领域的伦理问题。但是由于在设计和实施集群随机试验方面的一些发展,有一些新的问题需要指导。为了为即将更新的渥太华声明提供信息,我们旨在找出文献中讨论的渥太华声明中的任何空白。方法:我们于2022年11月11日使用‘cited by’功能检索谷歌Scholar、Scopus和Web of Science。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、论文和与试验相关的出版物(即主要报告、协议和二次分析),这些出版物引用并涉及渥太华声明、渥太华声明的修订,或其四篇背景论文中的一篇或多篇。数据由四名审稿人轮流抽取。审稿人逐字捕获相关文本,并记录它是否反映了与渥太华声明的一个或多个领域有关的差距。使用主题分析方法,使用语义编码将数据的内容总结为渥太华声明域中的不同空白,随后通过讨论以归纳的方式扩展。结果:对53篇文献的定性分析发现渥太华声明中有24个明显的空白:4个空白是关于证明聚类随机设计的;2研究伦理委员会审查的空白;识别研究参与者的3个空白;4获取知情同意的差距;关于门节点的3个缺口;6 .效益和危害评估方面的差距;1 .弱势参与者保护差距;在分组随机试验中,公平相关问题的差距为1。结论:确定24个差距表明需要更新渥太华声明。除了在正在进行的实证工作中发现的其他差距以及通过与患者和公共合作伙伴的接触发现的差距外,通过引用分析发现的差距应在即将发布的渥太华声明更新中予以考虑。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
审稿时长
5 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信