The use of the level of evidence and grade of recommendations scales in developing clinical guidelines in the Russian Federation
Abstract
Aim – analyze the existing systems for assessing the levels of evidence (LE-scales) and grades of recommendation (GR-scales) in the development of clinical guidelines in the Russian Federation.
Materials and Methods. We analyzed the LE- and GR-scales that had been used in developing clinical guidelines up to 01.09.2017; the materials were stored in the Federal Electronic Medical Library. The study included several stages: analysis of the clinical guidelines for the presence and type of LE- and GR-scales; comparison of the LE- and GR-scales between various clinical guidelines including the internationally accepted ones; assessment of using the international scales or their combinations in the development of clinical guidelines in Russia.
Results. More than 150 various LE- and GR-scales used for clinical recommendations were identified; most of them represented modifications of the international assessment systems. The original SIGN technique was found to be most commonly used.
Conclusion. Based on the results of the study, we concluded that at present, there is no unified approach to the assessment of the levels of evidence and grades of recommendation in clinical guidelines developed by professional medical associations in the Russian Federation.
About the Authors
N. I. Zhuravleva
Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
10-5 Khokhlovskii pereulok, Moscow 109028
Natalya I. Zhuravleva – Chief Specialist, Department of Medical Support of Standardization
L. C. Shubina
Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation; Children’s Clinic Medsi
Russian Federation
Russian Federation
Lyubov S. Shubina – Leading Specialist, Department of Medical Support ofr Standardization, Center for Healthcare Quality Assessment and Control, Ministry of Health of the Russian Federation; Physiotherapist, MEDSI Children’s Clinic in Blagoveshchensky Lane.
SCOPUS Author ID: 57201487715
O. A. Sukhorukikh
Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation; Research Financial Institution of the Ministry of Finance of the Russian Federation, Federal State Budget Institution
Russian Federation
Russian Federation
Olga A. Sukhorukikh – Head, Department of Medical Support of Standardization, Center for Healthcare Quality Assessment and Control, Ministry of Health of the Russian Federation; Researcher with the Healthcare Finance Center at the Research Financial Institute, Ministry of Finance of the Russian Federation.
SCOPUS Author ID: 57201486113
References
1. Bashchinskii S. E., Vlasov V. V., Vorob’ev K. P., Zil’ber A. P., Zorin N. A., Van Zuuren Ester, Klimova T. M. Yerevan Declaration on the consistent promotion of the principles of evidence-based medicine. Plasticheskaya khirurgiya i kosmetologiya. Moscow. 2013; 1: 49–51. (in Russ.).
2. Moseley E.T., Hsu D. J., Stone D. J., Celi L. A. Beyond Open Big Data: Addressing Unreliable Research. Eysenbach G., ed. Journal of Medical Internet Research. 2014; 16 (11): e259.
3. Djulbegovic B., Guyatt G. H. Progress in evidence-based medicine: a quarter century on. Lancet. 2017; 390: 415–423.
4. Marjolein A. van der Marck, René J. F. Melis, Marcel G. M. Olde Rikkert. On evidence-based medicine. The Lancet Journal. 2017; 390 (18, ISSUE 10109): 2244–2245.
5. Andreeva N. S. et. al. Systems for assessing the reliability of scientific evidence and the soundness of guidelines: comparison and prospects for unificatio. Meditsinskie tekhnologii. Otsenka i vybor. 2012; 4 (10): 10–24. (in Russ.).
6. Draft Guidelines for the development and updating of clinical guidelines (version 1.1). (in Russ.). [Electronic resource]. URL: https://rosmedex.ru/wp-content/uploads/2017/09/Trebovaniya-k-KR.pdf. Accessed: 26.01.2019.
7. Omeljanovskij V.V., Avksent’eva M.V., Zhelezniakova I. A., Sukhorukih O. A., Hachatrian G. R., Galeeva Z. A., Vlasov V. V., Lukjanceva D. V., Fediaeva V. K., Rykov M. Y. Clinical Guidelines as a Tool for Improving the Quality of Medical Care Delivery. Oncopediatrics. 2017; 4 (4): 246–259. (In Russ.). https://doi.org/10.15690/onco.v4i4.1811.
8. OCEBM Levels of Evidence. [Electronic resource]. URL: http:// www.cebm.net/ocebm-levels-of-evidence. Accessed: 26.01.2019.
9. Juni P., et al. The hazards of scoring the quality of clinical trials for meta-analysis. AMA. 1999 Sep 15; 282 (11): 1054–1060.
10. Scheunemann H., Brozek J., Guyatt G., Oxman A. Grade handbook for grading quality of evidence and strength of recommendation, 2010.
11. SIGN 50: A guideline developer’s handbook Quick reference guide November 2015. [Electronic resource]. URL: https://www.sign.ac.uk/assets/sign_grading_system_1999_2012.pdf. Accessed: 26.01.2019.
12. OCEBM Levels of Evidence Working Group «The Oxford 2011 Levels of Evidence» Oxford Centre for Evidence-Based Medicine. [Electronic resource]. URL: http://www.cebm.net/index.aspx?o=5653. Accessed: 26.01.2019.
13. Guyatt G. H., Oxman A. D., Kunz R., Falck-Ytter Y., Vist G. E., Liberati A., et al. Going from evidence to recommendations. BMJ. 2008; 336: 1049.
14. The NCBI Handbook, 2nd Edition. [Electronic resource]. URL: https://www.ncbi.nlm.nih.gov/books/NBK20542/table/A5857/?report=objectonly. Accessed: 26.01.2019.
15. NHMRC levels of evidence and grade of recommendations. 2009. [Electronic resource]. URL: https://www.mja.com.au/sites/default/files/NHMRC.levels.of.evidence.2008-09.pdf. Accessed: 26.01.2019.
16. NCCN Categories of Evidence and Consensus. [Electronic resource]. URL: https://www.nccn.org/professionals/physician_gls/categories_of_consensus.aspx. Accessed: 26.01.2019.
17. Draft guidelines for assessing the reliability of evidence and credibility of recommendations (version 1.1). (In Russ.). [Electronic resource]. URL: https://rosmedex.ru/wp-content/uploads/2018/05/MR-po-shkalam_v1.pdf. Accessed: 26.01.2019.
18. Applying the GRADE methodology to SIGN guidelines: core principles. [Electronic resource]. URL: http://www.sign.ac.uk/pdf/gradeprinciples.pdf. Accessed: 26.01.2019.
19. Guidelines for guideline developers: a systematic review of grading systems for medical tests Gopalakrishna et al. Implementation Science 2013, 8: 78. [Electronic resource]. URL: http://www.implementationscience.com/content/8/1/78. Accessed: 26.01.2019.
For citation:
Zhuravleva N.I., Shubina L.C., Sukhorukikh O.A. The use of the level of evidence and grade of recommendations scales in developing clinical guidelines in the Russian Federation. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(1):34-41. (In Russ.) https://doi.org/10.17749/2070-4909.2019.12.1.34-41
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