A Retrospective Database Analysis to Estimate the Burden of Acute Otitis Media in Children Aged <15 Years in the Veneto Region (Italy).

This study aimed to assess trends in the incidence of acute otitis media (AOM), a common childhood condition, following the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) in the Veneto region of Italy in 2010. AOM episodes (overall, simple, and recurrent (≥3 or ≥4 episodes in 6 or 12 months, respectively, with ≥1 episode in the preceding 6 months)) in children <15 years of age were identified in Pedianet from 2010-2017. Interrupted time series analyses were conducted to assess changes in the annual incidence rates (IRs) in early (2010-2013) and late (2014-2017) PCV13 periods. In total, 72,570 children (402,868 person-years) were identified; 21,048 had 41,683 AOM episodes. Mean annual AOM IR was 103/1000 person-years (95% confidence interval: 102-104), decreasing from 126 to 79/1000 person-years. AOM IRs were highest in children 2-4 years of age, followed by <2 and 5-14 years of age. Overall and simple AOM IRs decreased among children 0-14 years of age, including 2-4 and 5-14 years of age, while recurrent AOM IRs decreased in children <2 years of age. Following PCV13 introduction, AOM IRs decreased substantially in children <15 years of age, with the greatest benefit observed in older children, driven by a reduction in simple AOM IRs. AOM disease burden remains substantial.