Interpretation of the CONSORT 2025 Statement: Updated guideline for reporting randomised trials_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YANG Geliang ¹ , ZHOU Xiaoqin ² , LEI Fang ³ , DONG Min ³ , FENG Tianxing ⁴ , ZHENG Li ⁵ ,  LIU Lunxu ⁶ ,  ZHU Yunpeng ⁷ ,  LIU Xuemei ³

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;

Corresponding author：

LIU Lunxu, Email: lunxu_liu@aliyun.com; ZHU Yunpeng, Email: zyp12220@rjh.com.cn; LIU Xuemei, Email: l_xm20@263.net

Keywords：

Clinical trial; randomized controlled trial; guideline; CONSORT 2025; interpretation

DOI：

10.7507/1007-4848.202504067

Video：

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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 for RCT reporting. 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.

1.	Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 2012, 1: 60.
2.	Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276.
3.	Savović J, Jones HE, Altman DG, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med, 2012, 157(6): 429-438.
4.	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.
5.	Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
6.	Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
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.	Dechartres A, Trinquart L, Atal I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: Research on research study. BMJ, 2017, 357: j2490.
9.	Moher D, Jones A, Lepage L; CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. JAMA, 2001, 285(15): 1992-1995.
10.	Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 2001, 357(9263): 1191-1194.
11.	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.
12.	Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA, 2006, 295(10): 1152-60.
13.	Campbell MK, Elbourne DR, Altman DG, et al. CONSORT statement: Extension to cluster randomised trials. BMJ, 2004, 328(7441): 702-708.
14.	Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
15.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
16.	Hopewell S, Boutron I, Chan AW, et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med, 2022, 28(9): 1740-1743.
17.	Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 2012, 11(11): MR000030.
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.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
20.	Tunn R, Boutron I, Chan AW, et al. Methods used to develop the SPIRIT 2024 and CONSORT 2024 statements. J Clin Epidemiol, 2024, 169: 111309.
21.	Nejstgaard CH, Boutron I, Chan AW, et al. A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010. J Clin Epidemiol, 2023, 155: 48-63.
22.	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: e12057.
23.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 Statement: Updated guideline for reporting randomized trials. JAMA, 2025. doi: 10.1001/jama.2025.4347. Epub ahead of print.
24.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. Nat Med, 2025, doi: 10.1038/s41591-025-03635-5. Epub ahead of print.
25.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: Updated guideline for reporting randomised trials. Lancet, 2025, S0140-6736(25): 00672-5.
26.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med, 2025, 22(4): e1004587.

1. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 2012, 1: 60.
2. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet, 2014, 383(9913): 267-276.
3. Savović J, Jones HE, Altman DG, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med, 2012, 157(6): 429-438.
4. 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.
5. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
6. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
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. Dechartres A, Trinquart L, Atal I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: Research on research study. BMJ, 2017, 357: j2490.
9. Moher D, Jones A, Lepage L; CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. JAMA, 2001, 285(15): 1992-1995.
10. Moher D, Schulz KF, Altman DG. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 2001, 357(9263): 1191-1194.
11. 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.
12. Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA, 2006, 295(10): 1152-60.
13. Campbell MK, Elbourne DR, Altman DG, et al. CONSORT statement: Extension to cluster randomised trials. BMJ, 2004, 328(7441): 702-708.
14. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
15. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ, 2010, 340: c869.
16. Hopewell S, Boutron I, Chan AW, et al. An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nat Med, 2022, 28(9): 1740-1743.
17. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 2012, 11(11): MR000030.
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. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7(2): e1000217.
20. Tunn R, Boutron I, Chan AW, et al. Methods used to develop the SPIRIT 2024 and CONSORT 2024 statements. J Clin Epidemiol, 2024, 169: 111309.
21. Nejstgaard CH, Boutron I, Chan AW, et al. A scoping review identifies multiple comments suggesting modifications to SPIRIT 2013 and CONSORT 2010. J Clin Epidemiol, 2023, 155: 48-63.
22. 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: e12057.
23. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 Statement: Updated guideline for reporting randomized trials. JAMA, 2025. doi: 10.1001/jama.2025.4347. Epub ahead of print.
24. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomized trials. Nat Med, 2025, doi: 10.1038/s41591-025-03635-5. Epub ahead of print.
25. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: Updated guideline for reporting randomised trials. Lancet, 2025, S0140-6736(25): 00672-5.
26. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med, 2025, 22(4): e1004587.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Latest ArticlesInterpretation of the CONSORT 2025 Statement: Updated guideline for reporting randomised trials

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