SPIRIT 2025 statement: updated guideline for protocols of randomised trials.

ABSTRACT:

Importance

The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users.

Objective

To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial.

Design

We completed a scoping review and developed a project specific database of empirical and

SUBMITTER: Chan AW 

PROVIDER: S-EPMC12035670 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature