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

Abstract


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.


L V Kisar’

Department of drug supply and information technologies

Email: lezign@gmail.com
Kaliningrad, Russia

A U Ziganshin

Kazan State Medical University

Email: lezign@gmail.com
Kazan, Russia

L E Ziganshina

Cochrane Russia, Research and Education Center for Evidence-Based Medicine, Kazan Federal University

Author for correspondence.
Email: lezign@gmail.com
Kazan, Russia

  1. Association of Clinical Research Organizations. http://acto-russia.org/index.php?option=com_content&task=view&id=184 (access date: 17.04.2019). (In Russ.)
  2. Clinical trials in Russian Federation. http://clinical-rials.ru/about_trials.html (access date: 17.04.2019). (In Russ.)
  3. Jüni P., Altman D.G., Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. Brit. Med. J. 2001; 323: 42–46. doi: 10.1136/bmj.323.7303.42.
  4. Chan A.W., Altman D.G. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005; 365: 1159–1162. doi: 10.1016/S0140-6736(05)71879-1.
  5. Glasziou P., Meats E., Heneghan C., Shepperd S. What is missing from descriptions of treatment in trials and reviews? Brit. Med. J. 2008; 336: 1472–1474. doi: 10.1136/bmj.39590.732037.47.
  6. Dwan K., Altman D.G., Arnaiz J.A. et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE. 2008; 3: e3081. doi: 10.1371/journal.pone.0003081.
  7. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994; 272: 1926–1931. doi: 10.1001/jama.272.24.1926.
  8. Call for comments on a proposal to improve repor­ting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann. Intern. Med. 1994; 121: ­894–895. doi: 10.7326/0003-4819-121-11-199412010-00015.
  9. Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA. 1995; 273: 1054–1055. doi: 10.1001/jama.273.13.1054.
  10. Begg C., Cho M., Eastwood S. et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996; 276: 637–639. doi: 10.1001/jama.1996.03540080059030.
  11. Altman D.G. Better reporting of randomized controlled trials: the CONSORT statement. Brit. Med. J. 1996; 313: 570–571. doi: 10.1136/bmj.313.7057.570.
  12. A standard method for reporting randomized me­dical scientific research; the Consolidation of the standards of reporting trials (CONSORT). Ned. Tijdschr. Geneeskd. 1998; 142: 1089–1091. PMID: 9623225.
  13. Huston P., Hoey J. CMAJ endorses the CONSORT statement. CONsolidation of Standards for Reporting Trials. CMAJ. 1996; 155: 1277–1282. PMID: 8911294.
  14. Ausejo M., Saenz A., Moher D. CONSORT: an attempt to improve the quality of publication of clinical trials. Aten. Primaria. 1998; 21: 351–352. PMID: 9633133.
  15. Davidoff F. News from the International Committee of Medical Journal Editors. Ann. Intern. Med. 2000; 133: 229–231. doi: 10.7326/0003-4819-133-3-200008010-00017.
  16. Meinert C.L. Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials. JAMA. 1998; 279: 1487–1489. doi: 10.1001/jama.279.18.1487.
  17. Moher D., Jones A., Lepage L. Use of the ­CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001; 285: 1992–1995. doi: 10.1001/jama.285.15.1992.
  18. Moher D., Schulz K.F., Altman D. The ­CONSORT statement: revised recommendations for improving the qua­lity of reports of parallel-group randomized trials. JAMA. 2001; 285: 1987–1991. doi: 10.1001/jama.285.15.1987.
  19. Egger M., Juni P., Bartlett C. Value of flow diagrams in reports of randomized controlled trials. JAMA. 2001; 285: 1996–1999. doi: 10.1001/jama.285.15.1996.
  20. Moher D., Schulz K.F., Altman D.G. The ­CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. Ann. Intern. Med. 2001; 134: 657–662. doi: 10.7326/0003-4819-134-8-200104170-00011.
  21. Moher D., Schulz K.F., Altman D.G. The ­CONSORT statement: revised recommendations for improving the qua­lity of reports of parallel-group randomised trials. Lancet. 2001; 357: 1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
  22. Campbell M.K., Elbourne D.R., Altman D.G. ­CONSORT statement: extension to cluster randomised trials. Brit. Med. J. 2004; 328: 702–708. doi: 10.1136/bmj.328.7441.702.
  23. CONSORT Transparent reporting of trials. http://www.consort-statement.org/about-consort (access date: 17.04.2019).
  24. Schulz K.F., Altman D.G., Moher D. ­CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Int. J. Surg. 2012; 9 (8): 672–677. doi: 10.1016/j.ijsu.2011.09.004.
  25. Schulz K.F., Altman D.G., Moher D. ­CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J. Clin. Epidemiol. 2010; 63 (8): 834–840. doi: 10.1016/j.jclinepi.2010.02.005.
  26. Schulz K.F., Altman D.G., Moher D., Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet. 2010; 375: 1144–1146. doi: 10.1016/S0140-6736(10)60413-8.
  27. Moher D., Hopewell S., Schulz K.F. et al. ­CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int. J. Surg. 2012; 10 (1): 28–55. doi: 10.1016/j.ijsu.2011.10.001.
  28. Sologub T.V., Goryacheva L.G., Sukhanov D.S. et al. Study of pharmacotherapeutic efficacy, safety with an assessment of the risk of adverse outcomes of inclusion of remaxol in the treatment of chronic liver da­mage (based on multicenter randomized clinical trials). Vestnik Sankt-Peterburgskoy gosudarstvennoy meditsinskoy aka­demii im. I.I. Mechnikova. 2009; (2): 116–124. (In Russ.)
  29. CONSORT Transparent reporting of trials. http://www.consort-statement.org/downloads/translations (access date: 17.04.2019).

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© 2019 Kisar’ L.V., Ziganshin A.U., Ziganshina L.E.

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