Dr. Sean Tunis , CMTP President and CEO, was involved in the development of an extension to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org/) to improve the reporting of pragmatic features of clinical trials in the peer reviewed literature. Statement is part of a larger movement to enhance the quality and reporting of different types of health services research that contribute to real-world healthcare decision-making. The original CONSORT Statement provides a checklist to investigators, with the goal of improving the consistency of reporting of randomized control trials.
In addition to this main checklist, the CONSORT group has developed a number of extensions to the original CONSORT Statement to provide guidance on the reporting of study designs and study interventions. Dr. Sean Tunis, CMTP President and CEO, was involved in the development of one of these extensions to the original CONSORT Statement designed to improve the reporting of pragmatic features of clinical trials in the peer reviewed literature. The extension is the result of two two-day long meetings held in Toronto, Canada. These meetings were attended by experts in the area of trial design as well as individual who had expertise in developing clinical guidelines. Based on the outcomes of these meetings, specific recommendations regarding the reporting of pragmatic clinical trials were developed by who attended the meetings.
The peer-reviewed journal article describing the CONSORT extension was published in the British Medical Journal in 2008 and can be viewed via this link, Zwarenstein CONSORT PCTs (pdf) (262.81 kB)
For more information on this extension to the CONSORT Statement, please see: http://www.consort-statement.org/extensions/designs/pragmatic-trials/.