Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

Advanced search

New framework for the development of clinical guidelines in Russia

https://doi.org/10.17749/2070-4909.2019.12.2.125-144

Abstract

Aim - based on the existing regulations and recent documents from the regulatory bodies, determine the methodology for the development of clinical guidelines (CG) that meet the requirements of the legislation in the Russian Federation.

Materials and methods. We analyzed a number of regulatory and subordinate acts confirming the concept and status of the CG, in particular, the Federal Law № 323-ФЗ “On the principles of health care for citizens of the Russian Federation”, Federal Law № 489-ФЗ “On the amendments to article 40 of the Federal Law “On compulsory medical insurance in the Russian Federation” and the Federal Law “On the principles of health care for citizens of the Russian Federation” concerning clinical guidelines, Order № 102н of the Ministry of Health of the Russian Federation dated 28 Feb 2019 “Regulations on the scientific and practical council of the Ministry of Health of Russia” and Order № 103н of the Ministry of Health of the Russian Federation of 28 Feb 2019 “On Approval of the procedure and terms for the development of clinical guidelines and their revision, the model format of clinical guidelines and requirements to their structure, contents and scientific validity of the information included in the clinical guidelines”. In addition, we used the documents of regulatory bodies of the Russian Federation, expert opinions from medical professionals and non-profit organizations as well as leading opinions from public sources.

Results. Order № 102н of the Ministry of Health of the Russian Federation secured the right of the scientific and practical council to consider and decide on the CG. Order № 103н of the Ministry of Health of the Russian Federation approved the procedure and deadlines for the development/revision of the CG; the typical format of CG; the requirements for the structure of CG, its contents and scientific validity of the information included in the CG. A step-by-step algorithm was created for the procedure and timing of CG development and update; the above documents elaborate on the requirements to the structure of CG, the contents and scientific validity of the information included. There are also comments on the development and design of each CG section (title page, table of contents, list of abbreviations, terms and definitions, brief information on the disease, diagnosis, treatment, medical rehabilitation, prevention and follow-up care, organization of medical care, additional information, criteria for assessing the quality of medical care, list of references, composition of the working group on the development and revision of the CG, methodology of the development of the CG, reference materials, algorithms for doctor’s actions, patient information, assessment scales, questionnaires, and other patient assessment tools). The recently adopted requirements for CG registration are compared with the previous methodological recommendations of the regulatory bodies.

Discussion. The unification of treatment strategies and the use of evidence-based reasoning in the updated CG will improve the quality of medical care and have a positive impact on the medical insurance segment and the judicial decisions. However, the presented concept of CG has attracted a number of critical comments from representatives of the medical community and medical lawyers. For example, the updated regulatory acts do not specify the deadlines and algorithms for updating the CG; these acts do not address the coordination between various medical non-profit organizations although such coordination is needed to avoid work duplication; the acts determine no specific resources required for the CG development (the latter flaw may have a negative impact on the quality and timing of the resulting CG). Some experts believe that it would be advisable to implement the system called GRADE. In addition, possible legal risks are analyzed in light of the fact that the CG are not regulatory legal documents.

Conclusion. Periodic improvements in the CG renewing and approving procedure are an integral part of this large-scale process that introduces changes in the regulatory framework and clinical practice. Compulsory adherence to the CG is a due element of today’s high quality medical care.

About the Authors

D. V. Blinov
Institute of Preventive and Social Medicine; Moscow Haass Medical - Social Institute; Lapino Clinic Hospital, MD Medical Group
Russian Federation
Dmitry V. Blinov - MD, PhD, MBA, Head of Medical and Scientific Affairs, IPSM; Faculty Member, Department of Neurology, Psychiatry and Narcology, MHM-SI; Neurologist, Lapino CH, MD Medical Group. Researcher ID: E-8906-2017.4-10 Sadovaya-Triumfalnaya Str., Moscow; 45 p. 1-1a 2nd Brestskaya Str., Moscow 123056; 1st Uspenskoye Highway, 111, Moscow Region, Odintsovo District, Lapino 


E. S. Akarachkova
International society of stress Stress under control; Sechenov University
Russian Federation

Elena S. Akarachkova - MD, PhD, President of International Society of “Stress Under Control”; Neurologist, Leading Researcher, Department of Neurology, SU.

8-2 Trubetskaya Str., Moscow 119048



A. S. Orlova
Sechenov University
Russian Federation


E. V. Kryukov
Burdenko Main Military Clinical Hospital
Russian Federation

Evgeniy V. Kryukov - MD, PhD, Professor, corresponding member of Russian Academy of Sciences, Head.

3, Gospitalnaya square, Moscow 105229



D. I. Korabelnikov
Moscow Haass Medical - Social Institute
Russian Federation

Daniil I. Korabelnikov- M.D., Ph.D., Professor at the Department of Internal Diseases, General practice, Functional Diagnostics and Infectious Diseases, Rector, RSCI: 7380-7790.

5 p. 1-1a 2nd Brestskaya Str., Moscow 123056



References

1. Yakovlev V.M. et al. Dysplasia of the connective tissue in the practice of primary care physicians: a guide for physicians (in Russ.). Moscow. 2016; T. 520.

2. Serov V.N. et al. Guidelines for outpatient care in obstetrics and gynecology (in Russ.). Moscow. 2016.

3. Ivashkin V.T. et al. Clinical recommendations of the Russian Society for the Study of the Liver on the management of adult patients with alcoholic liver disease. Rossiiskiizhurnalgastroenterologii, gepa-tologii, koloproktologii (in Russ.). 2017; 27 (6): 20-40.

4. Moshetova L.K., Nesterova A.P., Egorova E.A. Clinical guidelines. Ophthalmology (in Russ.). Moscow. 2007; 204.

5. Federal Law № 323 “On the Principles of Health Protection of Citizens in the Russian Federation”, approved on November 21, 2011. Meeting of the legislation of the Russian Federation. 2018; No. 53 (in Russ.).

6. Federal Law of December 25, 2018 № 489-ФЗ “On Amendments to Article 40 of the Federal Law“ On Compulsory Health Insurance in the Russian Federation ”and the Federal Law“ On the Basics of the Protection of Citizens’ Health in the Russian Federation ”on clinical recommendations” (in Russ.).

7. Order of the Ministry of Health of Russia dated February 28, 2019 № 102n “Regulations on the Scientific and Practical Council of the Ministry of Health of Russia” (in Russ.).

8. Order of the Ministry of Health of the Russian Federation of February 28, 2019 No. 103n “On approval of the procedure and terms for the development of clinical guidelines, their revision, the standard form of clinical guidelines and requirements for their structure, composition and scientific validity of the information included in clinical guidelines” (in Russ.).

9. Rubricator of clinical recommendations (in Russ.) [Electronic resource]. URL: http://cr.rosminzdrav.ru/clin_recomend.html. Accessed: 05.03.2019.

10. Federal State Budgetary Institution “Center for Expertise and Control of Quality of Medical Care” (CECKMP) of the Ministry of Health of the Russian Federation (in Russ.). [Electronic resource]. URL: https://rosmedex.ru/. Accessed: 05.03.2019.

11. Requirements for the design of clinical guidelines for placement in the Rubricator. (in Russ.). [Electronic resource]. URL: https://ros-medex.ru/wp-content/uploads/2017/09/Trebovaniya-k-KR.pdf. Accessed: 19.03.2019.

12. The State Duma adopted a law on clinical guidelines, which gives them mandatory status. Group “VKontakte” “Accreditation of doctors.” (in Russ.) [Electronic resource]. URL: http://vrachi-spb.ru/novosti/prinyat-zakon-o-klin-rekomend. Accessed: 13.03.2019.

13. Makatsariya A.D., Bitsadze V.O., Khizroeva D.Kh., Vikulov G.Kh., Gomberg M.A., Khryanin A.A. Efficacy and safety of glucosaminylmuramyl dipeptide in the treatment of diseases associated with human papillomavirus: a systematic review. Akusherstvo, Ginekologiya i Reproduktsiya / Obstetrics, Gynecology and Reproduction (in Russ.). 2019; 13 (2): 132-154. DOI: 10.17749/2313-7347.2019.13.2.132-154.

14. State Register of Medicines. (in Russ.) [Electronic resource]. URL: http://www.grls.rosminzdrav.ru. Accessed: 24.05.2019.

15. Order of the Government of the Russian Federation of December 31, 2018 № 3053-p “On approval of the lists of medical products implanted into the human body when providing medical care under the program of state guarantees of free medical care to citizens and prescriptions for medical products when providing social services". (Meeting of the legislation of the Russian Federation, 2019, № 2, Art. 196) (in Russ.).

16. Order of the Government of the Russian Federation № 2273-p dated October 22, 2018 “List of specialized therapeutic food products for children with disabilities for 2019”. Meeting of the legislation of the Russian Federation. 2018; № 44, art. 6786 (in Russ.).

17. Order of the Ministry of Health of Russia dated 12/20/2012 № 1183n (ed. Dated 08/01/2014) “On approval of the Nomenclature of positions of medical workers and pharmaceutical workers” (in Russ.) [Electronic resource]. URL: https://legalacts.ru/doc/prikaz-minzdrava-rossii-ot-20122012-n-1183n/. Accessed: 14.03.2019.

18. Changes in the requirements for the development and execution of clinical guidelines, taking into account the entry into force of the Order of the Ministry of Health of Russia dated February 28, 2019 № 103n compared with the “Requirements for the design of clinical guidelines for placement in the Rubricator”. (in Russ.) [Electronic resource]. URL: https://rosmedex.ru/wp-content/uploads/2019/05/Izme-neniya-Trebovaniy.pdf. Accessed: 19.03.2019.

19. Перечень медицинских изделий, имплантируемых в организм человека при оказании медицинской помощи в рамках программы государственных гарантий бесплатного оказания гражданам медицинской помощи, утвержденный распоряжением Правительства Российской Федерации от 31 декабря 2018 г. № 3053-р (Собрание законодательства Российской Федерации, 2019, № 2, ст. 196). (in Russ.)

20. Draft Guidelines for the development and updating of clinical guidelines (version 1.1) (in Russ.) [Electronic resource]. URL: https://rosmedex.ru/wp-content/uploads/2018/05/MR-po-razrab.-KR_v1.pdf . Accessed: 19.03.2019.

21. 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: 19.03.2019.

22. Andreeva N.S., Rebrova O.Yu., Zorin N.A., Avksentyeva M.V., Omelyanovskiy V.V. Systems for assessing the reliability of scientific evidence and the credibility of recommendations: a comparative description and prospects for unification. Meditsinskie Tekhnologii. Otsenka i vybor (in Russ.). 2012; 4: 10-24.

23. Systems to Rate the Strength of Scientifi c Evidence. Evidence Report/Technology Assessment Number 47. Prepared for: Agency for Healthcare Research and Quality. AHRQ Publication № 02-E016, April 2002, 199.

24. Staevska M. et al. The effectiveness of levocetirizine and deslo-ratadine in up to 4 times conventional doses in difficult-to-treat urticaria. Journal of Allergy and Clinical Immunology. 2010; 125 (3): 676-682.

25. Sharma V.K. et al. An open-label prospective clinical study to assess the efficacy of increasing levocetirizine dose up to four times in chronic spontaneous urticaria not controlled with standard dose. Journal of Dermatological Treatment. 2017; 28 (6): 539-543.

26. Akarachkova E.S., Veselova A.N., Blinov D.V., Kotova O.V., Lebedeva D.I., Tsareva E.V., Travnikova E.V. Stress in children and adolescents. Causes and effects, treatment and prevention. Methodical recommendations for doctors. Moscow. 2018; 83 s.

27. Gabai P. Clinical Non-Recommendations of the Ministry of Health (in Russ.) [Electronic resource]. URL: https://www.kormed.ru/baza-znaniy/kontrol-kachestva-medicinskoi-pomoschi/kliniches-kie-nerekomendatsii-minzdrava/#hcq=DBXzotr. Accessed: 26.03.2019.

28. Brand P. Clinical guidelines (KR). Brief analysis (in Russ.) [Electronic resource]. URL: https://www.facebook.com/100002993238093/posts/1773718619404562/. Accessed: 26.03.2019.

29. Doctors criticized the clinical guidelines bill. Vademecum. 10.07.2018 (in Russ.) [Electronic resource]. URL: https://vademec.ru/news/2018/07/10/vrachi-raskritikovali-zakonoproekt-o-klinicheski-kh-rekomendatsiyakh/. Accessed: 26.03.2019.

30. New status of clinical recommendations: opinions. Vademecum. (in Russ.) [Electronic resource]. URL: https://vademec.ru/news/2018/05/04/novyy-status-klinicheskikh-rekomendatsiy-mneni-ya/. Accessed: 26.03.2018.

31. 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. Modern Pharmacoeco-nomics and Pharmacoepidemiology [FARMAKOEKONOMIKA. Sovre-mennaya farmakoekonomika i farmakoepidemiologiya]. 2019; 12 (1): 34-41 (in Russ.). DOI: 10.17749/2070-4909.2019.12.1.34-41.

32. SIGN 50: A guideline developer’s handbook. Quick reference guide November 2015. [Electronic resource]. URL: https://www.sign.ac.uk/as-sets/sign_grading_system_1999_2012.pdf. Accessed: 28.03.2019.

33. 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: 28.03.2019.

34. Guyatt G.H. et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336 (7650): 924-926.

35. 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.

36. The NCBI Handbook, 2nd Edition. [Electronic resource]. URL: https://www.ncbi.nlm.nih.gov/books/NBK20542/table/A5857/Pre-port=objectonly. Accessed: 28.03.2019.

37. 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.

38. NCCN Categories of Evidence and Consensus. [Electronic resource]. URL: https://www.nccn.org/professionals/physician_gls/cate-gories_of_consensus.aspx. Accessed: 26.01.2019.

39. Applying the GRADE methodology to SIGN guidelines: core principles. [Electronic resource]. URL: http://www.sign.ac.uk/pdf/grade-principles.pdf. Accessed: 29.03.2019.

40. The level of GPP is not included in the requirements for clinical guidelines (in Russ) [Electronic resource]. URL: https://rosmedex.ru/uroven-gpp-ne-voshel-v-trebovaniya-k-klinicheskim-rekomendaci-yam/. Accessed: 17.03.2019.

41. Order of the Ministry of Healthcare and Social Development of the Russian Federation of August 9, 2005 № 494 “On the Procedure for Using Medicinal Products in Patients for Life Conditions” (in Russ).

42. The Ministry of Health will consider how to compare clinical recommendations and compulsory health insurance tariffs. Vademecum (in Russ). [Elektronnyi resurs]. URL https://vademec.ru/news/2018/07/30/minzdrav-produmaet-kak-sopostavit-kliniches-kie-rekomendatsii-i-tarify-oms/. Accessed: 14.03.2019.


For citation:


Blinov D.V., Akarachkova E.S., Orlova A.S., Kryukov E.V., Korabelnikov D.I. New framework for the development of clinical guidelines in Russia. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(2):125-144. (In Russ.) (In Russ.) https://doi.org/10.17749/2070-4909.2019.12.2.125-144

Views: 199


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)