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Clinical Guidelines

The CONSORT Statement: A Standard Clinical Trial Requirement


Shujun Xia, MD, PhD, LetPub Editor

May 2021

Key Takeaways

• A CONSORT statement is required to transparently and accurately report the results from a clinical trial.

• A 25-item checklist and a flow diagram are included in the CONSORT statement.

• Authors should adhere to the CONSORT requirements when developing their research protocols and presenting their study results.

An increasing number of journals have adopted the CONSORT statement as a guideline to report a clinical trial. Importantly, authors who perform clinical trials should fully understand the CONSORT statement when designing and presenting their studies.

What is CONSORT?

CONSORT stands for Consolidated Standards of Reporting Trials. Its main purpose is to improve the transparency and accuracy of reporting and interpreting the study results from a clinical trial. The initial version was proposed in 1996, and the most updated version was published in 2010. Several extensions of the CONSORT statement have also been developed for the different types of clinical trials. The CONSORT statement has also been translated into different languages, such as Chinese, French, and German. At present, 585 journals and organizations, such as the The Lancet, The New England Journal of Medicine, American Diabetes Association, and the American Medical Association, have endorsed the CONSORT statement as a standard publication guideline.

What is required for CONSORT?

The CONSORT statement includes a checklist and a flow diagram. The CONSORT checklist includes 25 items that outline the key instructions on the study rationale, trial design, data analysis, results presentation, and outcome interpretations. The CONSORT flow diagram provides a schematic illustration for the allocation and sequential flow of participants from the study enrollment to the clinical trial analysis.

The CONSORT checklist and flow diagram can be found on the official CONSORT website. This website also includes the CONSORT extensions, translations, endorsers, examples from real clinical trials, and a document with a detailed explanation of the statement. In addition, a modified checklist and a flow diagram with comments can be downloaded for reference at the end of this article (Table 1 and Figure 1).

Authors are strongly encouraged to carefully read the CONSORT statement not only when presenting their results but also when designing their research. The CONSORT statement can assist scholars in developing their research protocols, ensuring they avoid missing critical steps in their clinical trials. Lastly, authors should always read the instructions from the target journal website, as some journals may have specific requirements for reporting the CONSORT statement.

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