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The Assessment of Potential Benefit and Risk Balance in the Process of Clinical Practice Guidelines Development and Grading the Evidence

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.008-017 meta


Aim of the study. A review of international practice of “benefit-risk” ratio assessment in the process of clinical practice guidelines (CPG) development; assessment of its acceptability for Russian Federation.

Material and methods. We analyzed official methodological guides of the GRADE working group and information from the websites of the professional associations, indicated on the official GRADE website. Additionally, the review of methods of quantitative assessment of risk-benefit ratio was conducted. The search was performed in Pubmed and Embase in April 2019, according to the queries “benefit-risk guidelines”, “balance of benefits and harm”, “risk-benefit guidelines”.

Results. The “benefit-risk” ratio assessment is an important component in the development of CPG, however, there were no universal transparent methods for it: in foreign CPG, the “benefit-risk” ratio for medical interventions is determined by the expert group consensus. There were also identified quantitative methods for assessing this ratio, currently not used in the process of the CPG development.

Conclusion. We have not identified universal transparent validated quantitative methods for assessing the “benefit-risk” ratio for medical interventions in CPG. Still many quantitative, semi-quantitative and qualitative methods for analyzing this ratio were found in the literature. Thus it seems appropriate to analyze international experience further, to evaluate the advantages and disadvantages of all assessment systems and to test their acceptability for the development of CPG in the Russian Federation.


clinical practice guidelines, evidence-based medicine, health technology assessment, «benefit-risk» ratio.

For citation

Kovalyova MY, Fedyaeva VK. The Assessment of potential benefit and risk balance in the process of clinical practice guidelines development and grading the evidence. Medical Technologies Assessment and Choice. 2019;(4):8–17. DOI: 10.31556/2219-0678.2019.38.4.008-017