Improving the quality of randomized controlled trial reporting: the role and impact of the CONSORT statement and its extended version_Chinese Journal of Evidence-Based Medicine

Authors：

WU Jingling ¹ , XU Caihua ² , ZHOU Yongjia ² , CUI Yating ² , WANG Junfei ² ,  TIAN Jinhui ²

1. Department of Ultrasound, PLA 96604 Military Hospital, Lanzhou University, Lanzhou 730000, P. R. China;
2. Center for Evidence-based Medicine, School of Basic Medicine, Lanzhou University, Lanzhou 730000, P. R. China;

Corresponding author：

TIAN Jinhui, Email: tjh996@163.com

Keywords：

CONSORT; Randomized controlled trial; Reporting standardization; History

DOI：

10.7507/1672-2531.202506020

Video：

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Randomized controlled trials (RCT) are the gold standard for evaluating the effectiveness of medical interventions, and the quality of their reporting is critical to clinical practice and scientific research. Consolidated standards of reporting trials (CONSORT) statements and their extended tools are the core standards for reporting quality of RCT. Since its first publication in 1996, it has been updated and expanded several times, and has become the authoritative guideline in the field of clinical research worldwide. This paper systematically reviews the evolution of CONSORT from its foundation version in 1996 to the latest version in 2025, and analyzes the classification and application scenarios of five categories of CONSORT extension tools (research design/analysis type oriented, subject domain oriented, reporting process-oriented, research focus oriented, and interdisciplinary integration oriented) in detail. CONSORT has significantly improved the transparency, reproducibility, and scientific rigor of RCT reporting, especially in reducing the risk of bias, standardizing data sharing, and promoting open science. However, its implementation still faces challenges such as concept misuse, insufficient cross-cultural adaptation, resource limitation, and mechanization. The CONSORT system needs to be promoted into high-quality practice worldwide through the development of multilingual resources, the application of intelligent tools and international cooperation, so as to provide continuous support for the standardization and evidence transformation of clinical research.

1.	Zabor EC, Kaizer AM, Hobbs BP. Randomized controlled trials. Chest, 2020, 158(1S): S79-S87.
2.	Msaouel P, Lee J, Thall PF. Interpreting randomized controlled trials. Cancers (Basel), 2023, 15(19): 4674.
3.	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.
4.	Moher D, Cook DJ, Eastwood S, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Onkologie, 2000, 23(6): 597-602.
5.	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.
6.	Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses. Lancet, 1998, 352(9128): 609-613.
7.	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.
8.	Meinert CL. Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated standards of reporting trials. JAMA, 1998, 279(18): 1487-1489.
9.	Moher D, Schulz KF, Altman DG, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med, 2001, 134(8): 657-662.
10.	Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2): 100-107.
11.	Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
12.	Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
13.	Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
14.	Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 2012, 308(24): 2594-2604.
15.	Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
16.	Cheng A, Kessler D, Mackinnon R, et al. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. BMJ Simul Technol Enhanc Learn, 2016, 2(3): 51-60.
17.	Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ, 2016, 355: i5239.
18.	Pandis N, Chung B, Scherer RW, et al. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. Br J Dermatol, 2019, 180(3): 534-552.
19.	Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2018, 363: k1614.
20.	Juszczak E, Altman DG, Hopewell S, et al. Reporting of multi-arm parallel-group randomized trials: extension of the CONSORT 2010 statement. JAMA, 2019, 321(16): 1610-1620.
21.	Dwan K, Li T, Altman DG, et al. CONSORT 2010 statement: extension to randomised crossover trials. BMJ, 2019, 366: l4378.
22.	Dimairo M, Pallmann P, Wason J, et al. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 2020, 369: m115.
23.	Kwakkenbos L, Imran M, McCall SJ, et al. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 2021, 373: n857.
24.	Yap C, Solovyeva O, de Bono J, et al. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT dose-finding extension (CONSORT-DEFINE) guidance. BMJ, 2023, 383: e076387.
25.	Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement. JAMA, 2023, 330(21): 2106-2114.
26.	McKenzie JE, Taljaard M, Hemming K, et al. Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2025, 388: e080472.
27.	Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med, 2006, 144(5): 364-367.
28.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范(征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
29.	MacPherson H, Altman DG, Hammerschlag R, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med, 2010, 28(2): 83-93.
30.	Cheng CW, Fu SF, Zhou QH, et al. Extending the CONSORT Statement to moxibustion. J Integr Med, 2013, 11(1): 54-63.
31.	Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167(1): 40-47.
32.	Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
33.	Montgomery P, Grant S, Mayo-Wilson E, et al. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 extension. Trials, 2018, 19(1): 407.
34.	Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
35.	Zhang X, Tian R, Lam WC, et al. Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement. Chin Med, 2020, 15: 10.
36.	Liu X, Rivera SC, Moher D, et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ, 2020, 370: m3164.
37.	Zhang X, Liang F, Lau CT, et al. Standards for reporting interventions in clinical trials of tuina/massage (STRICTOTM): extending the CONSORT statement. J Evid Based Med, 2023, 16(1): 68-81.
38.	Duarte RV, Bresnahan R, Copley S, et al. Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension. EClinicalMedicine, 2024, 78: 102932.
39.	Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
40.	Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension. JAMA, 2022, 328(22): 2252-2264.
41.	Manyara AM, Davies P, Stewart D, et al. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ, 2024, 386: e078524.
42.	Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
43.	Welch VA, Norheim OF, Jull J, et al. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ, 2017, 359: j5085.
44.	Junqueira DR, Zorzela L, Golder S, et al. CONSORT harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials. J Clin Epidemiol, 2023, 158: 149-165.
45.	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.

1. Zabor EC, Kaizer AM, Hobbs BP. Randomized controlled trials. Chest, 2020, 158(1S): S79-S87.
2. Msaouel P, Lee J, Thall PF. Interpreting randomized controlled trials. Cancers (Basel), 2023, 15(19): 4674.
3. 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.
4. Moher D, Cook DJ, Eastwood S, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Onkologie, 2000, 23(6): 597-602.
5. 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.
6. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses. Lancet, 1998, 352(9128): 609-613.
7. 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.
8. Meinert CL. Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated standards of reporting trials. JAMA, 1998, 279(18): 1487-1489.
9. Moher D, Schulz KF, Altman DG, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med, 2001, 134(8): 657-662.
10. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother, 2010, 1(2): 100-107.
11. Hopewell S, Chan AW, Collins GS, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ, 2025, 389: e081123.
12. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ, 2008, 337: a2390.
13. Campbell MK, Piaggio G, Elbourne DR, et al. Consort 2010 statement: extension to cluster randomised trials. BMJ, 2012, 345: e5661.
14. Piaggio G, Elbourne DR, Pocock SJ, et al. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA, 2012, 308(24): 2594-2604.
15. Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
16. Cheng A, Kessler D, Mackinnon R, et al. Reporting guidelines for health care simulation research: extensions to the CONSORT and STROBE statements. BMJ Simul Technol Enhanc Learn, 2016, 2(3): 51-60.
17. Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ, 2016, 355: i5239.
18. Pandis N, Chung B, Scherer RW, et al. CONSORT 2010 statement: extension checklist for reporting within person randomised trials. Br J Dermatol, 2019, 180(3): 534-552.
19. Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2018, 363: k1614.
20. Juszczak E, Altman DG, Hopewell S, et al. Reporting of multi-arm parallel-group randomized trials: extension of the CONSORT 2010 statement. JAMA, 2019, 321(16): 1610-1620.
21. Dwan K, Li T, Altman DG, et al. CONSORT 2010 statement: extension to randomised crossover trials. BMJ, 2019, 366: l4378.
22. Dimairo M, Pallmann P, Wason J, et al. The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, 2020, 369: m115.
23. Kwakkenbos L, Imran M, McCall SJ, et al. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration. BMJ, 2021, 373: n857.
24. Yap C, Solovyeva O, de Bono J, et al. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT dose-finding extension (CONSORT-DEFINE) guidance. BMJ, 2023, 383: e076387.
25. Kahan BC, Hall SS, Beller EM, et al. Reporting of factorial randomized trials: extension of the CONSORT 2010 statement. JAMA, 2023, 330(21): 2106-2114.
26. McKenzie JE, Taljaard M, Hemming K, et al. Reporting of cluster randomised crossover trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ, 2025, 388: e080472.
27. Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med, 2006, 144(5): 364-367.
28. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范(征求意见稿). 中国循证医学杂志, 2007, 7(8): 601-605.
29. MacPherson H, Altman DG, Hammerschlag R, et al. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med, 2010, 28(2): 83-93.
30. Cheng CW, Fu SF, Zhou QH, et al. Extending the CONSORT Statement to moxibustion. J Integr Med, 2013, 11(1): 54-63.
31. Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167(1): 40-47.
32. Cheng CW, Wu TX, Shang HC, et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): 112-121.
33. Montgomery P, Grant S, Mayo-Wilson E, et al. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 extension. Trials, 2018, 19(1): 407.
34. Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM): recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
35. Zhang X, Tian R, Lam WC, et al. Standards for reporting interventions in clinical trials of cupping (STRICTOC): extending the CONSORT statement. Chin Med, 2020, 15: 10.
36. Liu X, Rivera SC, Moher D, et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ, 2020, 370: m3164.
37. Zhang X, Liang F, Lau CT, et al. Standards for reporting interventions in clinical trials of tuina/massage (STRICTOTM): extending the CONSORT statement. J Evid Based Med, 2023, 16(1): 68-81.
38. Duarte RV, Bresnahan R, Copley S, et al. Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension. EClinicalMedicine, 2024, 78: 102932.
39. Hopewell S, Clarke M, Moher D, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med, 2008, 5(1): e20.
40. Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for reporting outcomes in trial reports: the CONSORT-outcomes 2022 extension. JAMA, 2022, 328(22): 2252-2264.
41. Manyara AM, Davies P, Stewart D, et al. Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ, 2024, 386: e078524.
42. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
43. Welch VA, Norheim OF, Jull J, et al. CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ, 2017, 359: j5085.
44. Junqueira DR, Zorzela L, Golder S, et al. CONSORT harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials. J Clin Epidemiol, 2023, 158: 149-165.
45. 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.

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