Protocol for a CONSORT extension for reporting Pragmatic and Explanatory trials designed using the PRECIS tool. (CONSORT-PRECIS)

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 on mechanism of action often under tightly controlled conditions, which are often contrived in comparison with usual care conditions for that condition and intervention. 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. This protocol is an update to the previous CONSORT statement extension for pragmatic trials and involves five key steps; conducting a scoping review to identify relevant literature, engaging an international panel including trialists, trial methodologists, clinicians and policy decision-makers, biostatisticians, regulatory representatives, research funders, journal editors, and patient partners in a Delphi process to achieve consensus on necessary updates, to finalize the revised guidelines, develop and pilot test the product. The updated CONSORT extension for randomized trials (RCTs) with declared pragmatic or explanatory intention designed using the PRECIS tool (CONSORT-PRECIS) will emphasize the clear reporting of trial intention, design choices, settings, delivery, and outcomes and analysis, to enhance the understanding and applicability of findings to clinical practice and decision-making or, alternatively to testing mechanistic hypotheses. By improving the transparency and completeness of reporting for both pragmatic and explanatory trials, this updated CONSORT extension aims to support informed healthcare decisions, promote trust in trial results, and advance scientific knowledge.