Assessment of quality of presentation of clinical trial results in Russia in accordance with CONSORT standards

The gold standard for presenting evidence of the effectiveness and safety of medical procedures is randomized controlled trials (RCTs). For the research results to be available to other specialists and have potential weight in the scientific community, they must be described and published in accordance with generally accepted international standards, CONSORT, or Consolidated standards of reporting trials.

Objective: to analyze the quality of presenting the results of clinical trials in the Russian Federation in accordance with CONSORT standards.

Materials and methods. The following Russian journals were selected for the study: "Scientific and Practical Rheumatology", "Good Clinical Practice", "Social and Clinical Psychiatry", "S. S. Korsakov Journal of Neurology and Psychiatry". The selection of target journals was based on two main indicators of the journal rating in the Russian Science Citation Index; according to the SCIENCE INDEX rating and the rating of psychiatric journals by the impact factor RSCI 2016. Journals in the fields of biomedicine (Scientific and Practical Rheumatology), clinical pharmacology (Good Clinical Practice), and journals in the fields of psychology and psychiatry (Social and Clinical Psychiatry, S. S. Korsakov Journal of Neurology and Psychiatry) were selected. Each article was assessed according to the CONSORT checklist items, and the presence or absence of data on the presented items was noted. When studying the articles, the presence or absence of a flowchart in the article was also analyzed, which significantly improves the quality of the written article and compliance with international standards for the design of articles for medical journals.

Results. The articles analyzed with the results of RCTs in journals met most of the necessary criteria. The authors paid the least attention to such details of the methodology when publishing a description of the sample calculation (2 out of 5 publications), the type of randomization (2 out of 5 publications), the mechanism of blinding participants (3 out of 5 publications), and implementation and masking (1 out of 5 publications). The inaccessibility of this information may have distorted the reader’s perception and trust in the results.

Conclusion. The results show that the reviewed Russian medical journals declare requirements and recommendations for the publication of articles in accordance with the CONSORT standards. To increase readers' confidence in the practical and scientific significance of RCTs, it is necessary to consider the CONSORT requirements and strive to follow them.

1. Kisar’ L.V., Ziganshin A.U., Ziganshina L.E. Assessment of presentation quality of the results of clinical trials in accordance with the standards of CONSORT. Kazan medical journal. 2019;100(3):469–475 (In Russ.)].

2. Trusova AV, Klimanova SG. Presentation of the results of the study of psychological and psychosocial interventions: the consort-spi 2018 standard. Review of Psychiatry and Medical Psychology named after V.M. Bekhterev. 2020;(3):41-49. (In Russ.)].

3. Cuschieri S. The CONSORT statement. Saudi journal of anaesthesia. 2019;13(1):27-30. https://doi.org/10.4103/sja.SJA_559_18

4. CONSORT (Consolidated Standards of Reporting Trials). 2010. Available at: http://www.consort-statement.org/

5. Shah J, Shah A, Pietrobon R. Scientific writing of novice researchers: what difficulties and encouragements do they encounter? Academic Medicine. 2009;84(4):511-516. https://doi.org/10.1097/ACM.0b013e31819a8c3c

6. Sereda AP, Andrianova MA. Study Design Guidelines. Travmatologiya i ortopediya Rossii [Traumatology and orthopedics of Russia]. 2019;25(3):165-184. (In Russ.).].

7. ICMJE. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (Updated December 2016). Available at: https://www.icmje.org/recommendations/

8. Rennie D. CONSORT revised - improving the reporting of randomized trials. JAMA. 2001;285(15): 2006-7. https://doi.org/10.1001/jama.285.15.2006

9. Mazurov V.I., Lila A.M., Korolev M.A., Prystrom A.M., Kundzer A.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Plaksina T.V., Antipova O.V., Krechikova D.G., Smakotina S.A., Tciupa O.A., Puntus E.V., Raskina T.A., Shilova L.N., Kropotina T.V., Nesmeyanova O.B., Popova 7T.A., Vinogradova I.B., Dokukina E.A., Plotnikova A.V., Pukhtinskaia P.S., Zinkina-Orikhan A.V., Linkova Yu.N., Eremeeva A.V., Lutckii A.A., Nasonov E.L. Efficacy and safety of levilimab in combination with methotrexate in patients with active rheumatoid arthritis: 56-week results of phase III randomized double-blind placebo-controlled trial SOLAR. Rheumatology Science and Practice. 2023;61(1):87-99. (In Russ.)].

10. Nasonov E.L., Lisitsyna T.A., Zonova E.V., Kuzkina S.M. The effect of olokizumab on rheumatoid arthritis patient’s reported outcomes: results of a double-blind randomized placebo-controlled multicenter phase III trial (CREDO 1). Rheumatology Science and Practice. 2021;59(1):62-69. (In Russ.)].

11. Karateev A.E., Pogozheva E.Yu., Filatova E.S., Lila A.M., Amirdjanova V.N., Nesterenko V.A. Is there an alternative to diclofenac i/m injections for rapid relief of severe pain? Results of randomized controlled and partially blind forsage study. Rheumatology Science and Practice. 2020;58(4):387394. (In Russ.)].

12. Karateev A.E., Pogozheva E.Yu., Sukhareva M.L., Lila A.M., Ivanov A.V., Osnovina I.P., Shchashkova O.V., Borisova S.V., Larinsky N.Е., Israelyan Yu.A., Afoshin S.А., Bondarenko T.P., Repchanskaya E.А., Chernyavskaya L.A., Pupina S.P., Darmova T.V. Evaluation of the efficiency and safety of magnet therapy for osteoarthritis. Results of the multicenter blind placebo-controlled study COSMO (Clinical Evaluation of Current Magnet Therapy for Osteoarthritis). Rheumatology Science and Practice. 2020;58(1):55-61. (In Russ.)].

13. Zalevskaya A.G., Mosikian A.A., Afonkina O.V., Drai R.V. Evaluation of immunogenicity, efficacy and safety of GP40041 compared to Humulin® NPH in patients with type 2 diabetes mellitus. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(1):53-64. (In Russ.)].

14. Krupitskiĭ EM, Rybakova KV, Skurat EP, Semenova NV, Neznanov NG. A double blind placebo controlled randomized clinical trial of the efficacy and safety of pregabalin in induction of remission in patients with alcohol dependence. S.S. Korsakov Journal of Neurology and Psychiatry. 2020;120(1):33-43. (In Russ.)].

15. Piatoikina A.S., Zhilyaeva T.V., Kostina O.V., Mazo G.E. The double-blind randomized placebo-controlled trial of N-acetylcysteine use in schizophrenia. Social and clinical psychiatry. 2022;32(1):61-68.].

16. Mozenzadeh E., Bayanati S., Ziafat K., Rezaei F., Mesgarpour B., Akhondzadeh Sh. Vortioxetine as adjunctive therapy to risperidone for treatment of patients with chronic schizophrenia: a randomised, double-blind, placebo-controlled clinical trial. Social and clinical psychiatry. 2020;30(2):47-50.].

17. Schastny E.D., Polezhaev P.K., Yurchenko A.O., Shmykova N.A., Leonov K.A., Larchenko V.V., Semenyuk E.V. Results of a clinical study of a new form of atypical antipsychotic Azaleptin®Retard. Social and clinical psychiatry. 2021;31(3):54-59.].