OBJECTIVES: Until recently authors of clinical guidelines in Russia had no unified approach for assessment of levels of evidence (LOE) and grades of recommendations (GOR). Professional associations used different systems from international practice. Furthermore, considerable proportion of Russian clinical guidelines was not based on systematic reviews of evidence. The aim of this research was to develop unified scales for the assessment of LOE and GOR for Russia in accordance with the directive of the Ministry of Health to standardize and improve quality of clinical guidelines.

METHODS: Systematic literature review (SR) was conducted to identify LOE and GOR scales used in international practice. The working group of multidisciplinary experts (physicians, specialists in evidence-based medicine, healthcare decision-makers) was created to discuss the SR results and establish a common understanding of advantages and challenges of existing scales. Finally, experts pointed out key elements of international systems to be used in the unified scales for Russia.

RESULTS: The working group selected different aspects from widely recognized GRADE and Oxford Centre for Evidence-based Medicine systems to create unified scales (taking into account experts skills, limited time and budget for clinical guidelines development). Main priorities when developing unified system were robust methodology, its transparency and feasibility in Russia. Two types of scales were made: 1) for medicines, rehabilitation, preventive and surgical interventions; 2) for diagnostic methods. The LOE scales are based on the hierarchy of designs of clinical trials (CT) identified by SR which is mandatory for every recommendation; GOR scales include assessment of methodological quality of CTs, consistency of their results (if several) and clinical significance of outcomes used in CTs. The proposed scales are being implemented presently.

CONCLUSIONS: Expert opinion based on SR helped to create unified scales for LOE and GOR assessment suitable for the process of clinical guidelines development in Russia.