Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
BMJ Open. 2024 Sep 17;14(9):e087724. doi: 10.1136/bmjopen-2024-087724.
Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time.
A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews.
We searched MEDLINE between 1 January 2017 and 17 August 2022.
We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022.
Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year.
Among 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time.
Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.
整群随机试验（cluster randomised trials，CRTs）常用于评估中低收入国家（low-income and middle-income countries，LMICs）的卫生相关干预措施，但引发了复杂的伦理问题。为了为未来的伦理指南制定提供信息，我们旨在通过检查集群类型、设置、作者隶属关系和主要临床重点来描述仅在 LMIC 中进行的 CRTs，并评估随着时间的推移对试验注册和伦理报告要求的遵守情况。
使用系统评价和荟萃分析扩展的首选报告项目进行的系统范围审查。
我们在 2017 年 1 月 1 日至 2022 年 8 月 17 日期间检索了 MEDLINE。
我们纳入了在 2017 年至 2022 年期间发表的、仅在 LMIC 中进行的、评估卫生相关干预措施的 CRTs 的主要报告。
由一名审查员提取数据，另一名审查员从 10%的报告中提取数据，以验证准确性。结果按国家经济水平或出版年份进行总体总结和分类。
在 800 项确定的 CRTs 中，400 项（50.0%）随机分配地理区域，373 项（46.6%）在非洲进行。30 项（3.7%）没有作者来自 LMIC，246 项（30.8%）既没有第一作者也没有最后一位作者来自 LMIC。第一或最后一位作者来自 LMIC 的相对频率随着国家经济水平的提高而增加。大多数 CRTs 侧重于减少产妇和新生儿疾病（106 项，13.3%）。670 项（83.8%）CRTs 报告了试验注册情况，786 项（98.2%）报告了研究伦理委员会审查情况，757 项（94.6%）报告了同意声明。在 757 项 CRTs 中，有 46 项（6.1%）报告了豁免或不同意，其中 10 项（21.7%）没有提供理由。在 403 项 CRTs 中确定了把关人。随着时间的推移，没有观察到试验注册或伦理报告要求的遵守情况有任何有意义的趋势。
我们的研究结果表明，作者群体的组成存在不平等现象。对试验注册和伦理报告要求的遵守程度很高，尽管需要更加注意报告使用同意豁免的理由。
