Protocol for a SPIRIT extension for reporting pragmatic and explanatory trial protocols designed using the PRECIS tool (SPIRIT-PRECIS).

BACKGROUND AND

OBJECTIVE

The need to design randomized controlled trials (RCTs) with explicit intent, either pragmatic or explanatory, and matching design features is well recognized. There is a need for clear, standardized reporting recommendations for protocols for these RCTs to facilitate communication of trialists' intention and trial design choices. This protocol outlines the development process of a Standard Protocol Items: Recommendations for Interventional Trials extension applicable to RCTs where authors explicitly declare their intention for the trial. This will enhance the transparency, reproducibility, and comprehensiveness of RCT protocol reports.

METHODS

Using the Enhancing the QUAlity and Transparency of health Research Network's structured multiphase approach, the study begins with a scoping review to identify existing literature and reporting guidelines for pragmatic and explanatory RCTs designed using the PRECIS tool (PRECIS RCTs), which will inform a draft checklist. An international panel including trialists, trial methodologists, clinicians and policy decision-makers, biostatisticians, regulatory representatives, research funders, journal editors, and patient partners will then participate in a Delphi process to achieve consensus on essential checklist items. This will involve at least two rounds of structured surveys. A consensus meeting with approximately 30 experts will meet to finalize the checklist items, incorporating findings from both the scoping review and the Delphi process. The authors will draft the final SPIRIT-PRECIS checklist and accompanying explanation documents. The checklist will be pilot tested with end users to ensure their clarity and practical utility. The final checklist will be refined based on feedback from pilot testing and disseminated through publications, workshops, and online training opportunities.

RESULTS

The study will produce a consensus-based SPIRIT-PRECIS checklist and accompanying explanation documents for reporting protocols of RCTs in which authors explicitly declare their trial intention.

CONCLUSION

The SPIRIT-PRECIS checklist is expected to enhance the transparency, reproducibility, and comprehensiveness of RCT protocol reports by providing standardized reporting recommendations for protocols of pragmatic and explanatory RCTs.