中国循证儿科杂志 ›› 2025, Vol. 20 ›› Issue (2): 81-86.DOI: 10.3969/j.issn.1673-5501.2025.02.001

• 循证医学方法学 •    下一篇

2025版临床试验报告规范(CONSORT)条目详细说明解读

张萍1,王伟2,张崇凡3   

  1. 1 复旦大学附属儿科医院《中国循证儿科杂志》编辑部 上海,201102;2 上海市公共卫生临床中心泌尿外科 上海,201508;
    3 复旦大学GRADE中心 上海,201102
  • 收稿日期:2025-05-06 修回日期:2025-01-23 出版日期:2025-04-25 发布日期:2025-04-25
  • 通讯作者: 王伟,张崇凡

Interpretation of CONSORT 2025 checklist of detailed information

ZHANG Ping1, WANG Wei2, ZHANG Chongfan   

  1. 1 Children's Hospital of Fudan University, Editorial Office of Chinese Journal of Evidence-based Pediatrics, Shanghai 201102, China; 2 Department of Urology, Shanghai Public Health Clinical Center, Shanghai 201508, China; 3 Fudan University GRADE Center, Shanghai 201102, China

  • Received:2025-05-06 Revised:2025-01-23 Online:2025-04-25 Published:2025-04-25
  • Contact: WANG Wei, email: ericwang79@126.com; ZHANG Chongfan, email: chongfan_zhang@fudan.edu.cn

摘要: 临床试验报告统一标准(CONSORT)推动了临床试验报告规范的透明性和可重复性,1996年首次发布后于2001和2010年更新,2025年4月发布了最新版本。2025版CONSORT声明在2010版的基础上新增了7个条目,修订了3个条目,删除了1个条目。本文对2025版CONSORT清单条目及其细节进行描述,同时对新增、修订和删除条目进行解读。

关键词: CONSORT 2025, 随机对照试验, 解读

Abstract: Consolidated Standards of Reporting Trials (CONSORT) has significantly enhanced the transparency and reproducibility of clinical trial reporting. Initially published in 1996, it underwent updates in 2001 and 2010, with the latest version released in April 2025. CONSORT 2025 statement introduces 7 new items, modifies 3 items, and removes 1 item. This article details the checklist items in CONSORT 2025, along with an interpretation of the newly added, revised, and deleted items.

Key words: CONSORT 2025, Randomized controlled trial, Interpretation