Guidelines "Medical registries. Role in evidence-based medicine. Recommendations for creation": a brief review
https://doi.org/10.15829/1728-8800-2023-3615
EDN: RPDYDF
Abstract
The article provides a brief review of the guidelines on medical registries. The methodological recommendations are based on the accumulated clinical and scientific experience, data from domestic and foreign literature, expert consensus on the management of medical registers. The main types and goals of medical registers are described in detail. The issues of planning, management, development of documentation, conducting registers, preliminary preparation of data for statistical analysis are considered. The problems of quality and limitations of registries are highlighted, and the role of registries in the assessment of real clinical practice is defined.
About the Authors
S. Yu. Martsevich
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
Yu. V. Lukina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
N. P. Kutishenko
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
S. N. Tolpygina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
M. M. Lukyanov
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
O. M. Drapkina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation
Russian Federation
Moscow
References
1. Martsevich SYu, Lukina YuV, Kutishenko NP, et al. Medical registers. Role in evidence-based medicine. Guidelines for creation. Methodological guidelines. M.: ROPNIZ, Silicea-Poligraf, 2023. 44 p. (In Russ.) doi:10.15829/ROPNIZ-m1-2023. EDN OCKJVC.
2. Harris M, Taylor G, Jackson D. Clinical evidence made easy. Banbury, 2014. 212 p. (ISBN-10: 1907904204; ISBN-13: 978-1907904202).
3. Wang D, Bakhai A, eds. Clinical trials. A practical guide to design, analysis and reporting. London, 2006. 480 p. 6(6): 619-20. doi:10.7861/clinmedicine.6-6-619a.
4. Gliklich RE, Leavy MB, Dreyer NA. Registries for Evaluating Patient Outcomes: A User’s Guide. 4th ed. AHRQ Publication No. 19(20)-EHC020. Rockville, MD: Agency for Healthcare Research and Quality; September 2020. doi:10.23970/AHRQEPCREGISTRIES4.
5. Belenkov YN, Arutunov GP, Barbarash OL, et al. Value of comparative studies of "real clinical practice" in modern cardiology. Position paper based on the expert council discussion dated 12/18/2020. Kardiologiia. 2021;61(5):79-81. (In Russ.) doi:10.18087/cardio.2021.5.n1646.
6. 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.
7. 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.
8. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;301(8):831-41. doi:10.1001/jama.2009.205.
9. Pedersen E. Some uses of the cancer registry in cancer control. Br J Prev Soc Med. 1962;16:105-10.
10. ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008;17(2):200-8. doi:10.1002/pds.1471.
11. Ruseckaite R, Maharaj AD, Dean J, et al. Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries. BMC Health Serv Res. 2022;22(1):276. doi:10.1186/s12913-022-07657-4.
12. Pogones S, Mullins A, Guerrero-Tucker G. Put Your Clinical Data to Work with a Registry. Fam Pract Manag. 2021;28(6):21-4. PMID: 34751548.
13. McGettigan P, Alonso Olmo C, Plueschke K, et al. Patient Registries: An Underused Resource for Medicines Evaluation. Drug Saf. 2019;42:1343-51. doi:10.1007/s40264-019-00848-9.
14. Pop B, Fetica B, Blaga ML, et al. The role of medical registries, potential applications and limitations. Medicine and pharmacy reports 2019;92(1):7-14. doi:10.15386/cjmed-1015.
15. Dawson LP, Biswas S, Lefkovits J, et al. Characteristics and Quality of National Cardiac Registries: A Systematic Review. Circ Cardiovasc Qual Outcomes. 2021;14(9):e007963. doi:10.1161/CIRCOUTCOMES.121.007963.
16. Peacock JL, Peacock PJ. Oxford Handbook of Medical Statistics. Oxford University Press. 2nd edition. 640 p. ISBN: 9780198743583.
Supplementary files
Review
For citations:
Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Tolpygina S.N., Lukyanov M.M., Drapkina O.M. Guidelines "Medical registries. Role in evidence-based medicine. Recommendations for creation": a brief review. Cardiovascular Therapy and Prevention. 2023;22(6):3615. (In Russ.) https://doi.org/10.15829/1728-8800-2023-3615. EDN: RPDYDF
Views:
1136
Email this article 
