Congratulations on CONSORT Team's New Publication

by Mahrukh Imran & Lydia Tao | Oct 29, 2018

Recently, CONSORT Extension project team's study protocol titled "Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data" has been officially published in BioMed Central (BMC). This study protocol can be accessed by using the following link:

The health-care system is most effective when it is able to provide evidence-based care that is informed by research on the benefits and harms of interventions, as well as patients’ values and preferences. Randomized controlled trials (RCTs), when well-designed and conducted, represent the gold standard to evaluate intervention benefits and harms. Large-scale RCTs, however, are often complex and expensive to perform. Alternative trial models have been sought to overcome some of these challenges, including trial designs that utilize existing data structures to facilitate recruitment of participants and to access routinely collected outcome data. Trials conducted in existing data structures include trials embedded in researcher-generated cohorts and routinely collected health data, including registries, electronic health records, and administrative databases.


These designs, however, are relatively recent innovations, and published trial reports often do not adequately describe important aspects of trials. Reporting guidelines increase the reporting quality and utility of research, but there is no guideline for trials embedded in observational cohorts and routinely collected health data. Our team was recently funded by the Canadian Institutes of Health Research (CIHR) to develop a consensus-driven guideline for trials embedded in observational cohorts and routinely collected health data as an extension of the Consolidated Standards of Reporting Trials (CONSORT) statement.


The CONSORT Extension project is led by Dr. Brett Thombs (Principal Investigator), Dr. Linda Kwakkenbos (Co-Principal Investigator) and Mahrukh Imran (Research Coordinator). This project is a collaboration between Dr. Thombs and an international network of experts involved in conducting RCTs using these novel designs. A two day face-to-face meeting involving members of the Project Team and key stakeholders will be held in London, UK in May 2019 to finalize items in our CONSORT extension and disseminate findings.

The team has also previously published a paper, which is a protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data in BMJ Open. You could read the full-text paper by accessing the following link: