School of Health Sciences, Faculty of Medicine and Health, UNSW Sydney, Sydney, Australia.
Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
JAMA Netw Open. 2023 Sep 5;6(9):e2336023. doi: 10.1001/jamanetworkopen.2023.36023.
Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice.
To assess the reporting of observational studies that explicitly aimed to emulate a target trial.
We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation.
A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation.
In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.
旨在模拟随机试验（即目标试验）的观察性（非实验性）研究越来越多地为医疗和决策提供信息，但这些研究在文献中的报告方式尚不清楚。一致的报告对于质量评估、证据综合以及将证据转化为政策和实践至关重要。
评估明确旨在模拟目标试验的观察性研究的报告情况。
我们在 2012 年 3 月至 2022 年 10 月期间在 Medline、Embase、PsycINFO 和 Web of Science 中搜索了明确旨在模拟健康或医疗干预目标试验的观察性研究。两名审查员对研究特征、目标试验方案及其模拟的关键预设组成部分（纳入标准、治疗策略、治疗分配、结局、随访、因果对比和分析计划）以及与目标试验模拟相关的其他项目进行了双屏幕筛选和提取数据。
共纳入 200 项明确旨在模拟目标试验的研究。这些研究涵盖了 26 个医学子领域，其中 168 项（84%）发表于 2020 年 1 月至 2022 年 10 月。70 项研究标题（35%）明确表示旨在模拟目标试验。43 项研究（22%）报告了使用已发表的报告指南（例如，《加强观察性研究的报告：流行病学》）。85 项研究（43%）未描述如何模拟目标试验的所有关键项目，113 项研究（57%）未描述目标试验的方案及其模拟。
在这项对 200 项明确旨在模拟目标试验的研究的系统评价中，报告如何模拟目标试验的情况不一致。针对明确旨在模拟目标试验的研究的报告指南可能会提高目标试验方案和这些模拟尝试的其他方面的报告质量。
