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Influenza is an important public health issue given its significant burden of disease. In Italy, the unsatisfactory coverage rate in people ≥65 years underlines the need to improve the current vaccination pathway. This study aims to define an integrated pathway across primary and secondary care, facilitated by a digital clinical decision support system (CDSS), to enhance vaccination coverage in people ≥65 years by actively recruiting patients in hospitals and administering vaccination. Moreover, the study seeks to gauge the potential epidemiological and economic impact of this approach. The methodology consisted of two main phases: definition of the integrated pathway and CDSS and estimation of the potential epidemiological and economic impact resulting from the implementation of the pathway in the whole Lazio region. Assuming an increase of influenza vaccination coverage from the current rate of 60% to 65% in ≥65 years old population in the Lazio region thanks to the pathway implementation, an increase of 8% in avoided influenza cases, avoided influenza- or pneumonia-related hospitalizations and avoided influenza-related outpatient visits was estimated with a relative increase in savings for hospitalizations and outpatient visits of up to 11.85%. Setting the vaccination coverage at 70%, the impact is doubled. Alongside offering a predictive estimate of the pathway's potential impact, both epidemiological and economic, this project, with its robust methodology, may serve as a scalable and transferable model for enhancing vaccination coverage at national and international level., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Public Health Association.)

Background: Cardiovascular diseases (CVDs) pose a significant global health challenge, necessitating innovative approaches for primary prevention. Personalized prevention, based on genetic risk scores (PRS) and digital technologies, holds promise in revolutionizing CVD preventive strategies. However, the clinical efficacy of these interventions requires further investigation. This study presents the protocol of the INNOPREV randomized controlled trial, aiming to evaluate the clinical efficacy of PRS and digital technologies in personalized cardiovascular disease prevention., Methods: The INNOPREV trial is a four-arm RCT conducted in Italy. A total of 1,020 participants, aged 40-69 with high 10-year CVD risk based on SCORE 2 charts, will be randomly assigned to traditional CVD risk assessment, genetic testing (CVD PRS), digital intervention (app and smart band), or a combination of genetic testing and digital intervention. The primary objective is to evaluate the efficacy of providing CVD PRS information, measured at baseline, either alone or in combination with the use of an app and a smart band, on two endpoints: changes in lifestyle patterns, and modification in CVD risk profiles. Participants will undergo a comprehensive assessment and cardiovascular evaluation at baseline, with follow-up visits at one, five, and 12 months. Lifestyle changes and CVD risk profiles will be assessed at different time points beyond the initial assessment, using the Life's Essential 8 and SCORE 2, respectively. Blood samples will be collected at baseline and at study completion to evaluate changes in lipid profiles. The analysis will employ adjusted mixed-effect models for repeated measures to assess significant differences in the data collected over time. Additionally, potential moderators and mediators will be examined to understand the underlying mechanisms of behavior change., Discussion: As the largest trial in this context, the INNOPREV trial will contribute to the advancement of personalized cardiovascular disease prevention, with the potential to positively impact public health and reduce the burden of CVDs on healthcare systems. By systematically examining the clinical efficacy of PRS and digital interventions, this trial aims to provide valuable evidence to guide future preventive strategies and enhance population health outcomes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Pastorino, Pezzullo, Agodi, de Waure, Mazzucco, Russo, Bianchi, Maio, Farina, Porcelli, Tona, Di Pumpo, Amore, Wachocka, Pasciuto, Barchitta, Magnano San Lio, Favara, Tuttolomondo, Tramuto, Morello, De Bella, Fruscione, Severino, Liuzzo and Boccia.)