Assessment of presentation quality of the results of clinical trials in accordance with the standards of CONSORT

• Main Authors: L V Kisar’, A U Ziganshin, L E Ziganshina
• Format: Article
• Language: Russian
• Published: ECO-vector 2019-06-01
• Series: Kazanskij Medicinskij Žurnal
• Subjects: CONSORT; randomized clinical trials; evidence-based medicine
• Online Access: https://kazanmedjournal.ru/kazanmedj/article/viewFile/13345/10518

Randomized clinical trials (RCTs) are currently recognized as the gold standard for evaluating the efficacy and safety of medical interventions. However, often the presentation of the results of RCTs in reports and articles does not give a complete and reliable description of all the results of the test, which often leads to incorrect conclusions and guidelines. In order to comply with certain uniform requirements for reporting documents based on materials of the conducted RCT, a group of authors and editors of medical journals in the early 1990s came out with a proposal to the medical community about using common standards for presenting RCT results, which they called CONSORT (CONsolidated Standards Of Reporting). The first version of CONSORT, however, caused a lot of criticism from both authors and editors of journals. The accumulated critical comments were taken into account by the developers of the revised and published in 2010 version of CONSORT, which is currently accepted as a reference for presenting the results of RCT in the world's leading medical journals. CONSORT 2010 contains a statement, supplemented with a set of questions on the conducted RCT, requiring a clearly formalized answer, and a flowchart for visual presentation of the results. In addition, the CONSORT developers submitted a separate document to clarify the terms in order to clarify the cases of application of this methodology. It is important to understand that CONSORT does not include recommendations for developing, conducting and analyzing the trials. It contains only reports on what and how it was done, what was eventually established, and only indirectly affects the design and conduct of RCT. However, authors who are familiar with the requirements of CONSORT will strive to meet these requirements when planning and conducting RCTs. As an example, the article presents a case of assessing the quality of the presentation of one of the RCTs according to CONSORT 2010 standards.