350 rub
Journal Biomedical Radioelectronics №3 for 2019 г.
Article in number:
Development of requirements for information system for auto-mathization of the process of methodological quality of scientific publications on clinical studies assessment
Type of article: scientific article
DOI: 10.18127/j15604136-201903-02
UDC: 534.6 303.8, 614
Authors:

S.S. Otstavnov – Ph.D. (Econ.), Chairman of the Committee for the comprehensive assessment of medical devices and information technology, Health Technology Assessment Association; Lecturer, Chair of technological entrepreneurship,  Moscow Institute of Physics and Technology (State University)

E-mail: oss@htaa.ru

A.N. Briko – Member of the Committee for the Comprehensive Assessment of Medical Devices and Information Technology, Health Technology Assessment Association, Assistant, “Medical and technical information technology” (BMT-2), Bauman Moscow State Technical University E-mail: briko@bmstu.ru

G.R. Khachatryan – MD, Chairman of the Committee for the Comprehensive Assessment of drugs, Health Technology Assessment  Association, Research Officer at the Laboratory for Health Technology Assessment at the Institute of Applied  Economic Re-search of the Presidential Academy

E-mail: khachatryan-gr@rane.ru 

N.Z. Musina – Ph. D. (Pharm.), Associate Professor, Executive Director, Health Technology Assessment Association, Chief of the Department of the Development and External Affairs, The Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation; Lecturer, Department of Pharmacology,  Faculty of Pharmacy, I.M. Sechenov First Moscow State Medical University

E-mail: nuriyamusina@gmail.com

V.V. Omelyanovsky – Ph.D. (Med.), Professor, Director of the Center for Technology Assessment in Healthcare, Institute of Applied Economic Research of RANEPA, Member of the Health Technology Assessment Association

E-mail: vitvladom@gmail.com

Abstract:

According to the principles of evidence-based medicine, decisions about the use of various medical technologies should be based on a comprehensive analysis of all available scientific evidence of their effectiveness and safety. This principle is used in the preparation of clinical guidelines, which are systematically developed documents, on the basis of which decisions are made to ensure proper medical care in a particular clinical situation.

To indicate the degree of confidence in the reliability of scientific evidence and the validity of clinical recommendations, special assessment systems and grades (confidence grades of evidence and confidence grades of recommendations) are designed, making it possible to ensure the unification of clinical recommendations, as well as a uniform interpretation by their end users. To carry out these assessment systems, separate systematic reviews of evidence of efficacy and safety, including an assessment of the methodological quality of clinical trials, which are currently carried out manually by experts and are a rather laborious process, should be performed.

The implementation of the information system considered in the article into the practice of professional communities will allow quickly collect information about promising innovative technologies for health care, whose effectiveness, reliability and safety will be confirmed by scientific research results, which will reduce the burden on experts involved in the actualization of clinical research and speed up described process.

The article contains key requirements to ensure the development of a software product for the methodological quality assessment of scientific articles about clinical trials. The process of actualization of clinical guidelines taking into account the assessment of materials containing data on clinical trials of innovative technologies for healthcare, the algorithm of the software product based on the semantic search technology, as well as the key requirements for the software product and the company- developer are described in the article.

Pages: 16-25
References
  1. Otstavnov S.S., Briko A.N. Informacionnye tekhnologii kak innovacii na puti k berezhlivomu zdravoohraneniyu // Trudy 4-j Mezhdunar. nauch.-prakt. konf. molodyh uchenyh, aspirantov i studentov «Zdorov'e naseleniya i razvitie» (20–21 aprelya 2018 g.; Moskva). M.: Nacional'nyj issledovatel'skij universitet «Vysshaya shkola ekonomiki». 2018. S. 255–261.
  2. National Science Board. Science & Engineering Indicators 2018. Outputs of S&E Research: Publications [Electronic resource], URL: https://www.nsf.gov/statistics/2018/nsb20181/report/sections/academic-research-and-development/outputs-of-s-e-research-publications (accessed March, 2018). 
  3. Orlov A.I. CHislo citirovanij – klyuchevoj pokazatel' effektivnosti nauchnoj deyatel'nosti issledovatelya i organizacii // Politematicheskij setevoj elektronnyj nauchnyj zhurnal Kubanskogo gosudarstvennogo agrarnogo universiteta. 2016. № 124. S. 984–1009.  
  4. Metodicheskie rekomendacii po ocenke dostovernosti dokazatel'stv i ubeditel'nosti rekomendacij. M.: FGBU «CEKKMP» Minzdrava Rossii, 2017 (http://rosmedex.ru/wpcontent/uploads/2018/05/MR-po-shkalam_v1.pdf
  5. OCEBM Levels of Evidence [Electronic resource], URL: http://www.cebm.net/ocebm-levels-of-evidence/ (accessed March, 2018).
  6. Guyatt G. et al, GRADE guidelines: 1. Introduction – GRADE evidence profiles and summary of findings tables // J. Clin. Epidemiol. April 2011. № 64(4). P. 383–94.
  7. Schlessman J.J. Case-Control Studies; Design, Conduct, Analysis. New York: Oxford University Press, 1982.
  8. Temple R.J. A regulatory authority’s opinion about surrogate endpoints // In: Nimmo W.S., Tucker G.T., eds. Clinical Measurement in Drug Evaluation. New York: J Wiley. 1995.
  9. Reitsma J.B., Rutjes A.W.S., Whiting P. et al. Chapter 9: Assessing methodological quality // In: Deeks J.J., Bossuyt P.M., Gatsonis C. (editors), Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0.0. The Cochrane Collaboration, 2009 [Electronic resource], URL: http://srdta.cochrane.org (accessed March, 2018).
  10. Shea B.J., Grimshaw J.M., Wells G.A. et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews // BMC Med. Res. Methodol. 2007. V. 7. № 10. Feb. 15.
  11. Cochrane handbook, Chapter 8: Assessing risk of bias in included studies [Electronic resource], URL: http://handbook.cochrane.org/ (accessed March, 2018).
  12. Wells G.A., Shea B., O'Connell D. et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in me-ta-analyses,URL: http://ohri.ca/programs/clinical_epidemiology/oxford.asp (accessed March, 2018).
  13. Rebrova O.Yu., Fedyaeva V.K. Ocenka riska sistematicheskih oshibok v odnomomentnyh issledovaniyah diagnosticheskih testov: russkoyazychnaya versiya voprosnika QUADAS // Medicinskie tekhnologii. Ocenka i vybor. 2017. № 1. S. 11–14.
  14. Rebrova O.Yu., Fedyaeva V.K. Voprosnik dlya ocenki dostovernosti setevogo meta-analiza (v tom chisle nepryamyh i smeshannyh sravnenij) // Medicinskie tekhnologii. Ocenka i vybor. 2016. № 2 (24). S. 9–15.
  15. Rebrova O.Yu., Fedyaeva V.K. Meta-analizy i ocenka ih metodologicheskogo kachestva. Russkoyazychnaya versiya voprosnika AMSTAR // Medicinskie tekhnologii. Ocenka i vybor. 2016. № 1. S. 10–16.
  16. Rebrova O.Yu., Fedyaeva V.K., Hachatryan G.R. Adaptaciya i validizaciya voprosnika dlya ocenki riska sistematicheskih oshibok v randomizirovannyh kontroliruemyh ispytaniyah // Medicinskie tekhnologii. Ocenka i vybor. 2015. № 1 (19). S. 9–17.
  17. Rebrova O.Yu., Fedyaeva V.K. Voprosnik dlya ocenki riska sistematicheskih oshibok v nerandomizirovannyh sravnitel'nyh issledovanij: russkoyazychnaya versiya shkaly N'yukasl-Ottava // Medicinskie tekhnologii. Ocenka i vybor. 2016. № 3. S. 14–19.
  18. Metodicheskie rekomendacii po sostavu i tekhnicheskim trebovaniyam k setevomu telekommunikacionnomu oborudovaniyu uchrezhdenij sistemy zdravoohraneniya dlya regional'nogo urovnya edinoj gosudarstvennoj informacionnoj sistemy v sfere zdravoohraneniya, a takzhe funkcional'nye trebovaniya k nim. M.: Minzdrav Rossii. 2011. (https://static1.rosminzdrav.ru/system/attachments/attaches/000/016/621/original/Metodicheskie_materialy_po_telekommunikationnomu_oborudovaniu.rtf?1389768808) 19. GOST IEC 60950-1-2014. Oborudovanie informacionnyh tekhnologij. Trebovaniya bezopasnosti. CH/ 1. Obshchie trebovaniya. M.: Standartinform. 2015. 228 s.
Date of receipt: 20 февраля 2019 г.