Complications of BCG vaccination: modification of the statistical procedure

Abstract

There is no uniform method to conduct the epidemiological monitoring of BCG complications in the Russian Federation, Current indicators of BCG complications include the number of complication cases (cases registered within two years after vaccination) and the total number of the vaccinated children. Our aim is to discover a new indicator of BCG complications and to compare it with the indicators of the existing methods, The comparative analysis of new and existing methods of all complication cases (continuous sampling, n = 110) was conducted in the Irkutsk Region (Eastern Siberia) from 2005 to 2014, The calculating formula included the ratio of the number of children with complications vaccinated in the analyzed year to 100,000 children vaccinated in the same year, The new method shows the advantages over the existing methodological approaches, It demonstrates more adequate assessment, expressed in the highest approximation coefficient of trend model compared to the other methods, and stability of indicator over the years, The incidence of complications in the Irkutsk Region has a steady decreasing linear trend and a significant negative growth rate of the indicator (-17,9 %), The new method offers an adequate assessment and can be used as an epidemiological control system not only in the Russian Federation but in other high TB-burden countries with massive BCG vaccination of children,