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CONSORT2025更新要点实例解读

Interpretation and Examples: Key Updates in CONSORT 2025

  • 摘要: 规范化的临床试验报告是确保报告结果科学性、可重复性及临床转化价值的关键。临床试验报告统一标准(Consolidated Standards of Reporting Trials, CONSORT)声明(又称“临床试验报告规范”)作为国际公认的随机对照试验(randomised controlled trials, RCTs)指南,自2010版发布以来已成为医学论文写作的重要参考标准。随着科学研究方法的进展和新形式临床试验的涌现,CONSORT工作组于2025年4月,在BMJ等期刊发布了更新版规范。本文旨在通过系统解读CONSORT 2025的核心修订内容,并对比分析其与CONSORT 2010的关键差异;通过实例解读为研究者提供高效应用该规范的实操建议,以提升国内研究者撰写临床试验报告质量。

     

    Abstract: 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.

     

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