Dissemination of the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomized controlled trails (RCTs) using cohorts and routinely collected health data

Randomized controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, are increasingly used in health care intervention research. However, relatively little guidance has been published on the methods and reporting such RCTs. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data was undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. As part of the development of the CONSORT extension, a face-to-face meeting will be held to finalize items in the checklist, and disseminate findings to key stakeholders including potential users of the checklist. The meeting will be organised in conjunction with the "Trials Within Cohorts and Routinely Collected Data" symposium which brings together international stakeholders, including patients, clinicians and researchers who use these types of trial design, and during which we can effectively disseminate our reporting guideline. The development and dissemination of this CONSORT extension will help inform clinical practice and ultimately promote transparency, clarity, reduce research waste and provide guidance to researchers on appropriate and consistent reporting of RCTs using cohorts and routinely collected health data.