The CONSORT Statement: development, use, and new challenges

The importance of complete and transparent reporting of clinical trials cannot be overstated, as published reports are used by healthcare providers to inform patient care. The CONSORT (Consolidated Standards of Reporting Trials) statement published in 1996 was an initiative by scientists and medical journal editors to improve the reliability and reproducibility of randomized clinical trials (RCTs).[1]

CONSORT provides a checklist of items that ensure the trial design and analysis are clearly described. In addition, CONSORT provides a flow diagram to account for all participants and the rationale for their inclusion or exclusion throughout each phase of the study. An updated statement and guide were published in 2010, to provide rationale and examples to help authors understand and comply with the statement.[2,3] CONSORT was intended to provide guidance for all RCTs; however, the 2010 update focused on the most commonly used two-group parallel design. Extensions of CONSORT have been developed to address the unique characteristics of other study designs such as noninferiority, cluster, and crossover trials.[4] Other recommendations, including those for reporting patient-reported outcomes, have also been published.[5] CONSORT was not intended to instruct trial design, conduct, or analysis; however, its use can reveal study deficiencies, thus encouraging best practices and ultimately improving trial design and conduct. CONSORT has been endorsed by over 500 journals, the Council of Science Editors, the World Association of Medical Editors, and the International Committee of Medical Journal Editors.[6,7]

A review published in 2012 suggested that RCT reporting was improved in journals that endorsed CONSORT; however, compliance remained suboptimal overall.[8] This has recently been underscored by the rapid onslaught of both preprints and peer-reviewed publications of COVID-19-related clinical trials. A review of COVID-19 therapy trials published during the first year of the pandemic found inadequate transparency, completeness, and consistency in many reports.[9] Ongoing initiatives to improve CONSORT include modifications to streamline recommendations and provide consistent guidance to improve usability and adherence. Updates to the CONSORT guidelines will expand stakeholder diversity and geographical representation, and include the views of trial participants.[7]

Artificial intelligence (AI) tools are now able to generate text that reads as informative and even persuasive. In particular, the chatbot ChatGPT has generated research abstracts so convincing that scientists could not detect that they were produced using AI.[10] The impact of AI on scientific communications presents a new challenge for the transparent reporting of RCTs that will undoubtedly need to be addressed by CONSORT stakeholders.

References

1. 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.

2. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.

3. 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.

4. Extensions of the CONSORT Statement. Published May 30, 2009. Accessed January 30, 2022. https://www.consort-statement.org/extensions

5. 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.

6. CONSORT Transparent Reporting of Trials - Endorsers. Published May 9, 2022. Accessed January 30, 2023. https://www.consort-statement.org/about-consort/endorsers#w

7. 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.

8. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. 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.

9. Kapp P, Esmail L, Ghosn L, Ravaud P, Boutron I. Transparency and reporting characteristics of COVID-19 randomized controlled trials. BMC Med. 2022;20(1):363.

10. Tools such as ChatGPT threaten transparent science; here are our ground rules for their use. Nature. 2023;613(7945):612.

 © 2023 Sandra Munro. All rights reserved.