Interpretation of the CONSORT 2025 statement: guidelines for reporting randomized controlled trials_Chinese Journal of Evidence-Based Medicine

Authors：

ZHAO Wenshuo ^1,2 , LIU Ming ^3,4,5 , GE Long ^6,7 , LI Lun ^8,9 , SHI Jiyuan ¹⁰ , YANG Fengwen ^11,12 , TIAN Jinhui ^4,5 , XUE Fuzhong ^1,2,13 ,  GAO Ya ^1,2

1. Department of Medical Dataology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan 250012, P. R. China;
2. National Institute of Health and Medical Big Data, Jinan 250003, P. R. China;
3. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore;
4. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University,Lanzhou 730000, P. R. China;
5. Key Laboratory of Evidence-Based Medicine of Gansu Province, Lanzhou 730000, P. R. China;
6. Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
7. Center for Evidence-Based Social Science, Lanzhou University, Lanzhou 730000, P. R. China;
8. Department of General Surgery, The Second Xiangya Hospital, Central South University, Changsha 410010, P. R. China;
9. Clinical Research Center of Hunan Province, Changsha 410011, P. R. China;
10. School of Nursing, Beijing University of Traditional Chinese Medicine, Beijing 100029, P. R. China;
11. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
12. Key Laboratory of Evidence-Based Evaluation of Traditional Chinese Medicine, National Medical Products Administration, Tianjin 301617, P. R. China;
13. Qilu Hospital of Shandong University, Jinan 250012, P. R. China;

Corresponding author：

GAO Ya, Email: gaoy2021@163.com

Keywords：

Randomized controlled trial; CONSORT 2025; Reporting guideline; Interpretation

DOI：

10.7507/1672-2531.202504182

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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.

1.	Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Ann Intern Med, 1994, 121(11): 894-895.
2.	Andrew E, Anis A, Chalmers T, et al. A proposal for structured reporting of randomized controlled trials. JAMA, 1994, 272(24): 1926-1931.
3.	Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
4.	Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694.
5.	Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c332.
6.	Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet, 2005, 365(9465): 1159-1162.
7.	Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials. A systematic review. Med J Aust, 2006, 185(5): 263-267.
8.	花放, 贺红. 个体内临床试验报告规范(CONSORT for WPT)解读. 中国循证医学杂志, 2018, 18(9): 1001-1006.
9.	耿朝辉, 吴傅蕾, 王佳姝, 等. CONSORT-EHEALTH报告规范的解读与应用现状分析. 中国循证医学杂志, 2019, 19(6): 748-754.
10.	杨文杰, 王丹丹, 黄利弢, 等. 健康公平相关随机对照试验的报告规范(CONSORT-Equity)扩展声明与解读. 中国循证医学杂志, 2019, 19(2): 238-247.
11.	王瑞平, 李斌. 随机对照临床试验CONSORT声明解读. 上海医药, 2022, 43(5): 58-62.
12.	庞博, 张晨瑶, 马毓聪, 等. 临床试验报告中的结局报告规范(CONSORT-Outcomes)2022扩展声明解读. 中国循证医学杂志, 2024, 24(11): 1337-1346.
13.	王巍巍, 朱雪泉, 丰雷, 等. 析因随机试验报告CONSORT 2010扩展声明条目解读. 中国循证医学杂志, 2025, 25(1): 111-117.
14.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. Nat Med, 2025, 31(6): 1776-1783.
15.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. JAMA, 2025, 333(22): 1998-2005.
16.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet, 2025, 14: S0140-6736.
17.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
18.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081124.
19.	Østengaard L, Barrientos A, Boutron I, et al. Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010. Cochrane Evid Synth Methods, 2024, 2(5): e12057.
20.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
21.	Aaron SD, Vandemheen KL, Whitmore GA, et al. Early diagnosis and treatment of COPD and asthma - a randomized, controlled trial. N Engl J Med, 2024, 390(22): 2061-2073.
22.	Ye H, Chu LH, Xie GH, et al. Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial. BMJ, 2025, 390: e084539.
23.	Scott S. How to report statistics in medicine: annotated guidelines for authors, editors, and reviewers. Philadelphia PA: American College of Physicians, 1997: 364.
24.	Schulz KF. Subverting randomization in controlled trials. JAMA, 1995, 274(18): 1456-1458.

1. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Ann Intern Med, 1994, 121(11): 894-895.
2. Andrew E, Anis A, Chalmers T, et al. A proposal for structured reporting of randomized controlled trials. JAMA, 1994, 272(24): 1926-1931.
3. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA, 1996, 276(8): 637-639.
4. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694.
5. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c332.
6. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet, 2005, 365(9465): 1159-1162.
7. Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials. A systematic review. Med J Aust, 2006, 185(5): 263-267.
8. 花放, 贺红. 个体内临床试验报告规范(CONSORT for WPT)解读. 中国循证医学杂志, 2018, 18(9): 1001-1006.
9. 耿朝辉, 吴傅蕾, 王佳姝, 等. CONSORT-EHEALTH报告规范的解读与应用现状分析. 中国循证医学杂志, 2019, 19(6): 748-754.
10. 杨文杰, 王丹丹, 黄利弢, 等. 健康公平相关随机对照试验的报告规范(CONSORT-Equity)扩展声明与解读. 中国循证医学杂志, 2019, 19(2): 238-247.
11. 王瑞平, 李斌. 随机对照临床试验CONSORT声明解读. 上海医药, 2022, 43(5): 58-62.
12. 庞博, 张晨瑶, 马毓聪, 等. 临床试验报告中的结局报告规范(CONSORT-Outcomes)2022扩展声明解读. 中国循证医学杂志, 2024, 24(11): 1337-1346.
13. 王巍巍, 朱雪泉, 丰雷, 等. 析因随机试验报告CONSORT 2010扩展声明条目解读. 中国循证医学杂志, 2025, 25(1): 111-117.
14. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. Nat Med, 2025, 31(6): 1776-1783.
15. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. JAMA, 2025, 333(22): 1998-2005.
16. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet, 2025, 14: S0140-6736.
17. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
18. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081124.
19. Østengaard L, Barrientos A, Boutron I, et al. Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010. Cochrane Evid Synth Methods, 2024, 2(5): e12057.
20. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
21. Aaron SD, Vandemheen KL, Whitmore GA, et al. Early diagnosis and treatment of COPD and asthma - a randomized, controlled trial. N Engl J Med, 2024, 390(22): 2061-2073.
22. Ye H, Chu LH, Xie GH, et al. Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial. BMJ, 2025, 390: e084539.
23. Scott S. How to report statistics in medicine: annotated guidelines for authors, editors, and reviewers. Philadelphia PA: American College of Physicians, 1997: 364.
24. Schulz KF. Subverting randomization in controlled trials. JAMA, 1995, 274(18): 1456-1458.

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