1.Interpretation and Examples:Key Updates in CONSORT 2025
Zelei DAI ; Renjie ZHAO ; Kefan LI ; Yonggang ZHANG ; Nian LI ; Wenjie YANG ; Lei LIU ; Lingmin CHEN
Journal of Sichuan University (Medical Sciences) 2025;56(3):678-685
Standardized clinical trial reporting is crucial for ensuring the scientific validity,reproducibility,and clinical translational value of reported results.The Consolidated Standards of Reporting Trials(CONSORT)statement,an internationally recognized guideline for randomized controlled trials(RCTs),has become an important reference standard for writing research papers in medicine since the 2010 version of CONSORT was published.With advancements in scientific research methodologies and the emergence of new forms of clinical trials,the CONSORT working group released an updated version in April 2025,published in journals such as The BMJ.Herein,we provide a systematic interpretation of the core revisions of CONSORT 2025,as well as a comparison with CONSORT 2010 to highlight the key differences.By providing practical,example-based recommendations,we aim to help domestic researchers apply the new guidelines efficiently,thereby improving the quality of clinical trial reports authored by domestic researchers.
2.Interpretation and Examples:Key Updates in SPIRIT 2025 Statement
Zelei DAI ; Renjie ZHAO ; Kefan LI ; Yonggang ZHANG ; Nian LI ; Wenjie YANG ; Lei LIU ; Lingmin CHEN
Journal of Sichuan University (Medical Sciences) 2025;56(3):686-696
A high-quality clinical trial protocol is the cornerstone for ensuring the scientific integrity and ethical compliance of a study.The Standard Protocol Items:Recommendations for Interventional Trials(SPIRIT)has become the international benchmark for developing clinical trial protocols since its release in 2013.To adapt to the developing trends of open science and patient-centered principles,the SPIRIT group completed a comprehensive update in 2025.While retaining its core structure,this updated guideline introduces a new open science module and incorporates several new elements,including patient and public involvement,trial monitoring,and data sharing,alongside substantial revisions of five pre-existing items.In this article,we critically examine the core revisions in SPIRIT 2025 and,through analysis of representative case studies,illustrate the practical application of the new reporting guideline in drafting trial protocols.Our goal is to to provide Chinese researchers with a valuable reference for understanding and implementing this new reporting guideline,thereby enhancing the quality and rigor of clinical trial protocols developed in the country.

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