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

Area of Science:

• Clinical Trial Methodology
• Health Research Reporting Standards

Background:

• Randomized controlled trials (RCTs) require explicit design intent (pragmatic or explanatory).
• Standardized reporting recommendations for RCT protocols are needed to communicate design choices clearly.
• Existing guidelines lack specific focus on pragmatic versus explanatory RCTs using tools like PRECIS.

Purpose of the Study:

• To develop an extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
• To create a checklist for reporting protocols of pragmatic and explanatory RCTs, explicitly declaring trial intent.
• To enhance the transparency, reproducibility, and comprehensiveness of RCT protocol reporting.

Main Methods:

• A multi-phase approach based on the EQUATOR Network's methodology.
• Scoping review to identify existing literature and guidelines for PRECIS-guided RCTs.
• International Delphi process with diverse stakeholders (trialists, methodologists, clinicians, patients, etc.) to achieve consensus on checklist items.
• Consensus meeting to finalize checklist items.
• Pilot testing of the SPIRIT-PRECIS checklist with end-users.

Main Results:

• Development of a draft checklist informed by a scoping review.
• Consensus achieved on essential checklist items through a multi-round Delphi process and expert meeting.
• Pilot testing planned to ensure clarity and utility of the final SPIRIT-PRECIS checklist.

Conclusions:

• The SPIRIT-PRECIS checklist aims to standardize reporting for pragmatic and explanatory RCT protocols.
• This initiative will improve the clarity and consistency of trial design communication.
• Dissemination through publications and training will support widespread adoption and enhance research quality.