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Observational studies and registers. Their quality and role in modern evidence-based medicine

https://doi.org/10.15829/1728-8800-2021-2786

Abstract

The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.

About the Authors

S. Yu. Martsevich
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow



N. P. Kutishenko
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow



Yu. V. Lukina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow



M. M. Lukyanov
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow



O. M. Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Moscow



References

1. Harris M, Taylor G, Jackson D. Clinical evidence made easy. Banbury. 2014;1-212.

2. Wang D, Bakhai A. Clinical trials. A practical guide to design, analysis and reporting. London. 2006;1-480.

3. Gliklich RE, Dreyer NA, Leavy MB. Registries for Evaluating Patient Outcomes: A User’s Guide. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US);2014 Apr. Report No.: 13(14)-EHC111.

4. Tricoci P, Allen JM, Kramer JM, et al. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;301(8):831-41. doi: 10.1001/jama.2009.205.

5. Gitt AK, Bueno H, Danchin N, et al. The role of cardiac registries in evidence-based medicine. Eur Heart J. 2010;31:525-9. doi:10.1093/eurheartj/ehp596.

6. Pass HI. Medical registries. Continued attempts for robust quality data. J Thorac Oncol. 2010;5:S198-9. doi: 10.1097/JTO.0b013e3181dcf957.

7. Boytsov SA, Martsevich SYu, Kutishenko NP, et al. Registers in cardiology: their principles, rules, and real-word potential. Cardiovascular Therapy and Prevention. 2013;12(1):4-9. (In Russ.) doi:10.15829/1728-8800-2013-1-4-9.

8. Steg PG. Heart rate management in coronary artery disease: the CLARIFY registry. Eur Heart J. 2009;11(Suppl. D):D13-8.

9. Little R, Kang S. Intention-to-treat analysis with treatment discontinuation and missing data in clinical trials. Stat Med. 2015;34(16):2381-90. doi:10.1002/sim.6352.

10. Siddique J, Brown CH, Hedeker D, et al. Missing Data in Longitudinal Trials — Part B, Analytic Issues. Psychiatr Ann. 2008;38(12):793-801. doi:10.3928/00485713-20081201-09.

11. Martsevich SYu, Kutishenko NP, Sichinava DP, et al. Prospective outpatient registry of myocardial infarction patients (PROFILE-MI): study design and first results. Cardiovascular Therapy and Prevention. 2018;17(1 ):81-6. (In Russ.) doi:10.15829/1728-8800-2018-1-81-86.

12. Voronina VP, Zagrebelnyi AV, Lukina YuV, et al. Features of cerebral stroke course in patients with diabetes mellitus according to the REGION-M register. Cardiovascular Therapy and Prevention. 2019;18(5):60-5. (In Russ.) doi:10.15829/1728-8800-2019-5-60-65.

13. Zagrebelny AV, Lukina YuV, Kutishenko NP, et al. Associated with in-hospital mortality in patients after acute cerebrovascular accident (according to the REGION-M REGISTER). Cardiovascular Therapy and Prevention. 2020;19(1):62-9. (In Russ.) doi:10.15829/1728-8800-2020-1-2443.

14. Bhatt DL, Drozda JP, Shahian DM. ACC/AHA/STS statement on the future of registries and the performance measurement enterprise. J Am Coll Cardiol. 2015;66(20):2230-45. doi:10.1016/j.jacc.2015.07.010.

15. ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008;17(2):200-8. doi:10.1002/pds.1471.

16. Glybochko P, Fomin V, Avdeev S, et al. Clinical characteristics of 1007 intensive care unit patients with SARS-CoV-2 pneumonia. Clinical Pharmacology and Therapy. 2020;29(2):21-9. (In Russ.) doi:10.32756/0869-5490-2020-2-21-29.

17. 17 Martsevich SYu, Ginsburg ML, Kutishenko NP, et al. LIS study (Lyubertsy study of mortality in patients after acute myocardial infarction): the patients’ portrait. Cardiovascular Therapy and Prevention. 2011; 10(6):89-93. (In Russ.)

18. Drapkina OM, Karpov OE, Lukyanov MM, et al. Prospective inhospital registry of patients with suspected or documented COVID-19 infection and community acquired pneumonia (TARGET-VIP): characteristics of patients and assessment of in-hospital outcomes. Cardiovascular Therapy and Prevention. 2020;19(6):79-88. (In Russ.) doi:10.15829/1728-8800-2020-2727

19. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021-104. doi:10.1093/eurheartj/ehy339.

20. Hanssen M, Cottin Y, Khalife K, et al. French registry on acute ST-elevation and non ST-elevation myocardial infarction 2010. FAST-MI 2010. Heart. 2012;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

21. Holt A, Blanche P, Zareini B, et al. Effect of long-term beta-blocker treatment following myocardial infarction among stable, optimally treated patients without heart failure in the reperfusion era: a Danish, nationwide cohort study. Eur Heart J. 2021;00:1-8. doi:10.1093/eurheart/ehaa1058.

22. IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomized trial. Lancet. 2002;359(9314): 1269-75. doi:10.1016/S0140-6736(02)08265-X.

23. Horinaka S, Yabe A, Yagi H, et al. Effects of nicorandil on cardiovascular events in patients with coronary artery disease in the Japanese Coronary Artery Disease (JCAD) study. Circ J. 2010;74(3):503-9. doi:10.1253/circj.cj-09-0649.

24. Lukina YV, Kutishenko NP, Martsevich SY. Efficacy, Safety and Long-term Outcomes of Nicorandil Use in Patients with Stable Ischemic Heart Disease According to the Results of Randomized and Observational Studies. Rational Pharmacotherapy in Cardiology. 2019;15(5):641-8. (In Russ.) doi:10.20996/1819-6446-2019-15-5-641-648.

25. Jones CW, Keil LG, Weaver MA, et al. Clinical trials registries are under-utilized in the conduct of systematic reviews: a crosssectional analysis. Syst Rev. 2014;3:126-32. doi:10.1186/2046-4053-3-126.


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For citations:


Martsevich S.Yu., Kutishenko N.P., Lukina Yu.V., Lukyanov M.M., Drapkina O.M. Observational studies and registers. Their quality and role in modern evidence-based medicine. Cardiovascular Therapy and Prevention. 2021;20(2):2786. (In Russ.) https://doi.org/10.15829/1728-8800-2021-2786

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ISSN 1728-8800 (Print)
ISSN 2619-0125 (Online)