Protocol for a CONSORT extension for reporting pragmatic and explanatory trials designed using the PRECIS tool (CONSORT-PRECIS)

BACKGROUND AND OBJECTIVE: This research protocol outlines a systematic approach to updating the Consolidated Standards of Reporting Trials (CONSORT) extension for pragmatic trials, originally published in 2008. Pragmatic trials, whose intention is to provide evidence for real-world decision-makers choosing between alternative interventions, differ in design from explanatory trials, whose intention is to test hypotheses about mechanisms of action, often under tightly controlled conditions that may be contrived compared with usual care. As the understanding of trials with explanatory and pragmatic intentions has evolved, there is a need to revise the reporting guidelines to better align with current best practices and emerging challenges. METHODS: This protocol updates the previous CONSORT extension for pragmatic trials and involves five key steps: conducting a scoping review to identify relevant literature; engaging an international panel of trialists, trial methodologists, clinicians, policy decision-makers, biostatisticians, regulatory representatives, research funders, journal editors, and patient partners in a Delphi process to achieve consensus on necessary updates; finalizing the revised guidelines; developing the reporting guidance product; and pilot testing the product. RESULTS: The updated CONSORT extension for randomized controlled trials with declared pragmatic or explanatory intentions designed using the PRECIS tool (CONSORT-PRECIS) will emphasize clear reporting of trial intention, design choices, settings, intervention delivery, outcomes, and analyses to enhance understanding of trial findings and their applicability to clinical practice and decision-making or, alternatively, the testing of mechanistic hypotheses. CONCLUSION: By improving the transparency and completeness of reporting for both pragmatic and explanatory trials, the updated CONSORT-PRECIS extension aims to support informed healthcare decisions, promote trust in trial results, and advance scientific knowledge.