Clinical guidelines or similar documents in members of Commonwealth Independent States: normative status and development experience
Аннотация
Objective. To analyze development of clinical guidelines (CG) or similar documents and their normative status in the Commonwealth Independent States (CIS). Material and methods. We reviewed regulatory legal documents and surveyed experts from 5 CIS countries (the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Uzbekistan). Survey was based on original questionnaire devoted to development of CGs and their status. Results. Three types of documents similar in meaning are being developed in 5 countries: clinical protocols (the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Uzbekistan), clinical guidelines (the Kyrgyz Republic) and CGs (the Russian Federation). In all countries, development of CGs/protocols/guidelines is a structured multi-stage process. The rules for developing CGs are unified and approved within the country. At the same time, the structures responsible for developing CGs vary from country to country. Expertise and/or review of CGs are present in all countries with different mechanism. In 2 countries (the Russian Federation and the Kyrgyz Republic), documents contain items intended for medical care quality control (criteria for medical care quality in the Russian Federation, indicators for assessing the quality of medical care in the Kyrgyz Republic). In the Russian Federation and the Republic of Belarus, inclusion of unregistered medicinal products is not provided, but inclusion of medicines off-label is allowed. In other 3 countries, inclusion of unregistered medicinal products is possible, while medicines off-label are not included in CGs. Conclusion. Development of clinical guidelines or similar documents is very important in 5 CIS members. Despite the general trend to unify the requirements for creation of clinical guidelines/protocols, there are differences in the status of documents, their content, development and approval.