Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
- VernacularTitle:CONSORT 2025声明：随机试验报告指南更新解读
- Author:
Geliang YANG
1
;
Xiaoqin ZHOU
2
;
Fang LEI
3
;
Min DONG
3
;
Tianxing FENG
4
;
Li ZHENG
5
;
Lunxu LIU
6
;
Yunpeng ZHU
7
;
Xuemei LIU
3
Author Information
1. Department of Clinical Research, Shanghai Clinical Research and Trial Center, Shanghai, 201210, P. R. China
2. Center of Biostatistics, Design, Measurement and Evaluation (CBDME), Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
3. West China Journal Press, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
4. Department of Medical Affairs, Shanghai Clinical Research and Trial Center, Shanghai, 201210, P. R. China
5. Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
6. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
7. Department of Cardiovascular Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, P. R. China
- Publication Type:Journal Article
- Keywords:
Clinical trial;
randomized controlled trial;
guideline;
CONSORT 2025;
interpretation
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2025;32(06):752-759
- CountryChina
- Language:Chinese
-
Abstract:
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
