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Cochrane method for evaluating the efficacy of drugs, national contribution to international Cochrane collaboration

https://doi.org/10.47093/22187332.2019.4.31-39

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Abstract

Modern approaches in medicine are based on the principles of evidence-based and balanced decisions in the age of personalized evidence-based medicine. Cochrane collaboration plays an important role in the development of evidence-based medicine; it’s methodology of meta-analysis, summarizing the scientific evidence from randomized clinical trials (RCTs) to answer the clinical questions about safety and effectiveness of various medical interventions. The article provides a brief historical background on the main milestones in the development of the methodology of evidence-based medicine, on the formation of Cochrane collaboration. The authors explain the concept of meta-analysis and systematic review, their types, methodological features and current requirements. The article defines the sequence of writing a metaanalysis: determing a task, inclusion and exclusion criteria, systematic search for randomized clinical trials, methodological assessment of studies, error risk assessment, meta-analysis models: fixed and random effects; determination of heterogeneity, presentation of meta-analysis results, assessment of confidence level using the GRADE system. The domestic experience of establishing evidence-based medicine in Russia and the contribution to the Cochrane international collaboration are represented separately: the opening of the first branch of the North European Cochrane Cooperation Center in Russia in 1998, the development of educational activities, the work of the Russian clone of the Cochrane Hepatobiliary Group and the appearance of the first qualitative meta-analysis, written by Russian authors, the introduction of an adapted system and the development of a national system for supporting medical decisions. The policy of introducing evidence-based medicine at the state level, legal acts, and the prospects for the development of evidence-based medicine in Russia are reflected.

About the Authors

D. L. Varganova
Sechenov First Moscow State Medical University (Sechenov University); Ulyanovsk State Clinical Hospital
Russian Federation

Daria L. Varganova, MD, junior researcher, Center for Evidence Based Medicine, Technopark of Biomedicine, Sechenov First Moscow State Medical University; gastroenterologist, Ulyanovsk State Clinical Hospital

8/2 Trubetskaya st., Moscow, 119991
Tel.: +7 (903) 339-19-77



C. S. Pavlov
Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Chavdar S. Pavlov, Professor, MD, PhD, DMSc, Head  of Center for Evidence Based Medicine, Technopark of Biomedicine, Head of Internal Diseases Department, Institute of Professional Education

Moscow



A. A. Svistunov
Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation

Andrey A. Svistunov, MD, PhD, DMSc, Professor, Corresponding Member of the RAS, First Vice-rector

Moscow



References

1. Glass GV. Primary, secondary, and meta-analysis of research. Educational Research, 1976; 5: 3–8. DOI: 10.2307/1174772

2. Pearson K. Report on certain enteric fever inoculation statistics. British Medical Journal (BMJ), 1922; 2: 1243–1246. PMID: 20761760

3. Fisher RA. Statistical methods for research workers. Oliver and Boyd. 1925; 239p.

4. Chalmers I. The Cochrane Collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Annals of the New York academy of sciences, 1993; 703: 156-165. DOI:10.1111/j.1749-6632.1993.tb26345.x

5. Chalmers I, Enkin M, Keirse M. Effective care in pregnancy and childbirth: pregnancy. Oxford University Press, 1989; 1516р. DOI: 10.1002/sim.4780110118

6. Bastian H, Glasziou P, Chalmers I. Seventy-five trials and eleven systematic reviews a day: how will we ever keep up? PLOS Medicine, 2010; 7(9): e1000326. DOI: 10.1371/journal.pmed.1000326

7. Murad MH, Asi N, Alsawas M, Alahdab F. New evidence pyramid. Evid Based Med, 2016; 21(4): 125–127. DOI: 10.1136/ebmed-2016-110401

8. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. [Electronic resource]. URL: https://training.cochrane.org/handbook/current, free (accessed: 12.05.2019)

9. Transparency and registration in clinical research in the nordic countries by the nordic trial alliance working group on transparency and registration. Nordfosk, 2015; 111p. [Electronic resource]. URL: https://nta.nordforsk.org/projects/nta_transparency_report.pdf, free (accessed: 12.05.2019)

10. Tudur Smith C, Marcucci M, Nolan SJ et al. Individual participant data meta‐analyses compared with meta‐analyses based on aggregate data. Cochrane Database of Systematic Reviews 2016, Issue 9. Art. No.: MR000007. DOI: 10.1002/14651858.MR000007.pub3

11. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Statistics in medicine (STAT MED) 2002; 21(11): 1539-1558. DOI: 10.1002/sim.1186

12. Deeks JJ, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. [Electronic resource]. URL: https://handbook-5-1.cochrane.org/chapter_9/9_analysing_data_and_undertaking_meta_analyses.htm, free (accessed 12.05.2019)

13. Review Manager 5 (RevMan 5) [Software]. [Electronic resource]. Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014. URL: https://community.cochrane.org/help/tools-and-software/revman-5/revman-5-download/installation, free (accessed 12.05.2019)

14. Jakobsen J, Wetterslev J, Winkel P et al. Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods. BMC Medical Research Methodology, 2014; 14: 120. DOI: 10.1186/1471-2288-14-120

15. Gamble C, Hollis S. Uncertainty method improved on best-worst case analysis in a binary meta-analysis. Journal of Clinical Epidemiology, 2005; 58(6): 579-588. DOI: 10.1016/j.jclinepi.2004.09.013

16. Brok J, Thorlund K, Gluud C, Wetterslev J. Trial Sequential Analysis reveals insufficient information size and potentially false positive results in many meta-analyses. Journal of Clinical Epidemiology, 2008; 61(8): 763-9. DOI: 10.1016/j.jclinepi.2007.10.007

17. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in a random-effects meta-analysis. BMC Medical Research Methodology, 2009; 30; 9: 86. DOI: 10.1186/1471-2288-9-86

18. Thorlund K, Anema A, Mills E. Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals. Clinical Epidemiology, 2010; 2: 57–66. DOI: 10.2147/clep.s9242

19. GRADE Handbook. Hamilton (ON): McMaster University (developed by Evidence Prime), 2015. [Electronic resource]. URL: https://gdt.gradepro.org/app/handbook/handbook.html, free (accessed 12.05.2019)

20. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg, 2010; 8(5): 336–341. DOI: 10.1371/journal.pmed.1000097

21. Liberati A, Altman DG, Tetzlaff J et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Journal of Clinical Epidemiology 2009; Oct., 62(10): 1-34. DOI: 10.1136/bmj.b2700

22. Vlasov V.V. Vvedenie v dokazatel'nuiu meditsinu. / An introduction to evidence-based medicine. Moscow: Media Sphera publishing house 2001; 362p. [in Russian]

23. DUODECIM. Evidence-based medicine guidelines. [Electronic resource]. URL: https://www.duodecim.fi/english/products/ebmg/, free (accessed 26.04.2019)

24. ALGOM. Sistema podderzhki vrachebnykh reshenii. / ALGOM. Support system for medical decisions. [Electronic resource]. URL: https://algom.ru/, free (accessed 26.04.2019) [in Russian]

25. Ziganshina L.E., Abakumova T.R. Tserebrolizin v lechenii ostrogo ishemicheskogo insul'ta. Vestnik Rossiiskoi akademii meditsinskikh nauk. / Cerebrolysin for acute ischemic stroke. Annals of the Russian Academy of Medical Sciences. Moscow: Publishing House of the Union of Pediatricians of Russia Pediatr. 2013; 68(1): 21-29. DOI: 10.15690/vramn.v68i1.533 [in Russian]

26. Pavlov Ch.S., Varganova D.L., Semenistaia M.Ch. i dr. Ursodezoksikholevaia kislota: effektivnost' i bezopasnost' v lechenii nealkogol'noi zhirovoi bolezni pecheni (meta-analiz). Vestnik Rossiiskoi akademii meditsinskikh nauk. / Ursodeoxycholic Acid: Efficacy and Safety in the Treatment of Nonalcoholic Fatty Liver Disease (Meta-Analysis). Annals of the Russian Academy of Medical Sciences. Moscow: Publishing House of the Union of Pediatricians of Russia «Pediatrician». 2018; 73(5): 294-305. DOI: 10.15690/vramn975 [in Russian]

27. Postanovleniye Pravitel'stva RF ot 28.08.2014 N 871 «Ob utverzhdenii Pravil formirovaniya perechney lekarstvennykh preparatov dlya meditsinskogo primeneniya i minimal'nogo assortimenta lekarstvennykh preparatov, neobkhodimykh dlya okazaniya meditsinskoy pomoshchi» / Decree of the Government of the Russian Federation of 08.28.2014 N 871 “On approval of the Rules for the formation of lists of drugs for medical use and the minimum range of drugs required for the provision of medical care” [Electronic resource], 2014; 51p. URL: http://static.government.ru/media/files/myBXVUxYbiU.pdf, free (accessed 26.04.2019). [ in Russian]

28. Metodicheskiye rekomendatsii po otsenke dostovernosti dokazatel'stv i ubeditel'nosti rekomendatsii. / Guidelines for assessing the reliability of evidence and the credibility of recommendations. [Electronic resource]. https://rosmedex.ru/wp-content/uploads/2018/05/MR-po-shkalam_v1.pdf, free (accessed 26.04.2019) [in Russian]


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ISSN 2218-7332 (Print)
ISSN 2658-3348 (Online)