The need to design randomized controlled trials (RCTs) with explicit intent, either pragmatic or explanatory, and matching design features is well recognised. There is a need for clear, standardised 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 SPIRIT (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. Registered: 16 June 2026
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Contact: David Moher Email: [email protected]