The NIH Collaboratory has developed a tool to assist authors in the complete and transparent reporting of their pragmatic clinical trials (PCTs). In the PCT Reporting Template, users will find descriptions of reporting elements based on CONSORT guidance as well as on expertise from the NIH Collaboratory Demonstration Projects and Core working groups.

Particularly relevant to PCTs are recommendations on how to report the use of data from electronic health records. Other elements of importance to PCTs include reporting wider stakeholder engagement, monitoring for unanticipated changes in study arms, and specific approaches to human subjects protection. The template contains numerous links to online material in the Living Textbook, CONSORT, and the Pragmatic–Explanatory Continuum Indicator Summary tool known as PRECIS-2.

This resource is intended to assist authors in developing primary journal publications. It will be updated over time as new best practices emerge for the transparent reporting of PCTs.

Download the PCT Reporting Template.

Please note: this document opens as an Adobe PDF. If you do not have software that can open a PDF, click here to download a free version of Adobe Acrobat Reader.

This work was supported by a cooperative agreement (U54 AT007748) from the NIH Common Fund for the NIH Health Care Systems Research Collaboratory. The views presented in this document are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Originally published on September 1, 2016.

• Questions or comments can be submitted via email. Please add “Living Textbook” to the Subject line of the email.