With the rapid development of artificial intelligence (AI) and machine learning technologies, the development of AI-based prediction models has become increasingly prevalent in the medical field. However, the PROBAST tool, which is used to evaluate prediction models, has shown growing limitations when assessing models built on AI technologies. Therefore, Moons and colleagues updated and expanded PROBAST to develop the PROBAST+AI tool. This tool is suitable for evaluating prediction model studies based on both artificial intelligence methods and regression methods. It covers four domains: participants and data sources, predictors, outcomes, and analysis, allowing for systematic assessment of quality in model development, risk of bias in model evaluation, and applicability. This article interprets the content and evaluation process of the PROBAST+AI tool, aiming to provide references and guidance for domestic researchers using this tool.
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 with 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.
The consolidated standards of reporting trials (CONSORT) is an internationally recognized guideline for reporting randomized controlled trials (RCTs), aiming to enhance the transparency, completeness, and reliability of trial findings. In response to the ongoing evolution of clinical trial methodology, the CONSORT group has issued updates to the CONSORT statement in 2001, 2010, and most recently in 2025. This article provides an applied interpretation of the background and key components of the CONSORT 2025 statement through the lens of a representative randomized controlled trial, with the aim of offering practical guidance and reference for domestic researchers utilizing this reporting tool.