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  • Guidelines for the reporting of randomized controlled trial protocols: interpretation of SPIRIT 2025

    Since its initial publication in 2013, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines have received widespread international attention. The guidelines aim to enhance the standardization and transparency of clinical trial protocol reporting. With continuous advancements in clinical trial methodologies, the SPIRIT group released an updated version, SPIRIT 2025, in 2025. The SPIRIT 2025 reporting guideline comprises 34 items; compared to the 2013 version, 2 items were added, 5 were revised, 2 were merged, and 3 were deleted. Its core updates are reflected in: The addition of an "open science" section, which emphasizes trial registration, accessibility of the trial protocol and statistical analysis plan, a data sharing statement, and a dissemination policy for research findings; The addition of a "patient and public involvement" item, which requires the protocol to describe the participation of patients or the public in the trial's design, conduct, and reporting phases; Structural optimization, which reorganizes the original items into five major sections for clearer logic and strongly recommends the use of a schedule diagram to present the trial timeline. This article provides an illustrative interpretation of the items contained in the SPIRIT 2025 statement using a randomized controlled trial protocol, aiming to offer guidance and convenience for domestic researchers utilizing this tool.

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