INTERNATIONAL EPIDEMIOLOGICAL STUDY OF NONCOMMUNICABLE DISEASES IN RUSSIA: PROTOCOL

The article presents the general description of the epidemiological study program in the Kemerovo region in accordance with the protocol, methodical approaches to sampling, characteristics of the questionnaires for collecting the detailed information, as well as instrumental and laboratory research methods. The study program in the Kemerovo region is based on the unifed principles of an international study, which provides four stages: preparatory stage, screening, assessment of morbidity/mortality (follow-up period), survival status assessment and work with the study database. Prospective observation with assessment of fatal and nonfatal endpoints is performed once in three years, starting from the next year after the completion of the frst stage of the study. The phase of participants’ involvement includes performing of the doorto-door visits – more than 6000 households, among which there were 5660 urban and 460 rural households. The study is planned to involve 1600 participants. The participants will be fully examined according to the protocol: ECG (interpretation by Minnesota code), spirometry, anthropometry, dynamometry, bioimpedansometry, measuring of arterial blood pressure and heart rate; blood test – total cholesterol, HDL, LDL, triglycerides, plasma glucose; uranalysis – creatinine, sodium, potassium. Data collection will be performed at three levels (community, household and individual). These levels include 4 social determinants (artifcial environment, diet, tobacco use, socioeconomic/psychosocial determinants). The obtained information will be entered into the database with its subsequent statistical processing. It is planned to perform follow-up examinations of the participants within three years in order to record the clinical events. Additional data on diet, physical activity, blood tests and ECG will be collected in all the participants. The newly received data will be entered into the database and statistically processed. Within the study, for the frst time the mutual influence of social, family, individual and genetic determinants of non-communicable diseases will be studied depending on the residence place, which will allow to estimate the effcacy of state and regional healthcare policy, to develop and implement into the medical practice new individual and population prevention programs which contribute to the implementation of the program for mortality reduction from cardiovascular diseases, improvement of the quality of life and prognosis.

1. Yusuf, S. INTER-HEART: a study of risk factors for frst myocardial infarction in 52 countries and over 27,000 subjects. Paper presented at the European Society for Cardiology Congress 2004, 29 August-1 September, Munich, Germany. Summary prepared by Murphy M.S.A. Available at: www.cardiosource.com.

2. Yusuf S., Hawken S., Ounpuu S., Dans T., Avezum A., Lanas F. et al. Effect of potentially modi.able risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 1117;364(9438):937-52. DOI: 10.1016/S0140-6736(04)17018-9

3. O’Riordan M. INTER-HEART: Nine modifable risk factors predict 90% of acute MI. Available at: www.theheart.org.

4. Kish L. Survey Sampling. New York: John Wiley and Sons; 1965.

5. Diagnostika i lechenie arterial'noj gipertenzii: klinicheskie rekomendacii 2013. Available at: http://minzdrav.med04.ru/Clinical_recommendations/ (In Russian)

6. Klinicheskie rekomendacii po diagnostike i korrekcii narushenij pishchevogo statusa. Nacional'naya associaciya klinicheskogo pitaniya. Moscow; 2013. (In Russian)

7. Orlov V.N. Rukovodstvo po ehlektrokardiografi. Moscow; 1984. (In Russian)

8. Prinears R.J., Crow R.S., Zhu-Ming Zhang. The Minnesota Code Manual of Electrocardiographic Findings. Standards and Procedures of ECG Measurement in Epidemiologic and Clinical Trials. 2-nd ed.. Springer-Verlag London. 2010. DOI 10.1007/978-1-84882-778-3

9. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects Available at: http://www.wma.net/en30publications/10policcies/b3/17c.pdf.

10. Nadlezhashchaya klinicheskaya praktika. Nacional'nyj standart Rossijskoj Federacii. GOST 52379-2005. Available at: http://standard.gost.ru. (In Russian)