使用队列和常规收集数据开展随机对照试验的报告清单(CONSORT-ROUTINE 2021)解读

Interpretation of reporting checklist(CONSORT-ROUTINE 2021) for trials using cohorts and routinely collected data

近年来使用队列和常规收集数据(例如,电子健康记录、行政数据库和注册登记来源的数据)开展随机对照试验的数量正在增加,这种随机对照试验设计能够降低研究的实施难度,节约经费和时间成本。为规范此类随机对照试验和增加研究报告的透明度与完整性,2021年BMJ发表了CONSORT-ROUTINE(2021)报告规范。为方便理解和规范应用该报告规范,提高该类型研究的整体质量,本文对该报告规范的制订过程和CONSORT-ROUTINE清单进行介绍和解读。

In recent years, the number of randomized controlled trials using cohorts and routinely collected data(e.g., electronic health records, administrative databases, and health registries) has increased. Such trials can ease the challenges of conducting research and save cost and time. Accordingly, to standardize such trials and increase the transparency and completeness of research reports, an international panel of experts developed the CONSORT-ROUTINE(2021) reporting guideline. The reporting guideline was published in 2021 in the BMJ. To help understand and formally apply the reporting guideline and improve the overall quality of this type of study, the present paper introduced and interpreted the development process and reporting checklist of the CONSORT-ROUTINE.