Accurate estimation of vaccine effectiveness (VE) in real-world settings is essential for guiding immunization strategies, especially in older populations. However, observational studies are prone to bias due to confounding factors, and the choice of statistical method can significantly influence VE estimates. We compared the performance of a multivariable Cox proportional hazards model with seven propensity score (PS)-based models to estimate the relative vaccine effectiveness (rVE) of the bivalent Original/Omicron BA.4-5 mRNA vaccine as a second or third booster, compared to a first mRNA booster received ≥120 days earlier. Data from 11,879,461 individuals aged ≥60 in Italy (April-June 2023) were analyzed. All models produced consistent rVE estimates, with values ranging from 16.4% to 22.1%. Over time, booster effectiveness declined, with the reference model showing a drop in rVE from 45.6% (15-60 days) to 14.3% (181-265 days). PS-based methods improved covariate balance but did not outperform the Cox model in terms of precision or interpretability. In large, relatively balanced datasets, traditional multivariable models remain a robust and reliable choice for estimating VE. While PS-based methods offer theoretical advantages, their practical benefit may be limited when confounding is well controlled.

Witnessed domestic violence is a widespread yet underrecognized form of childhood trauma, with serious consequences for the emotional, behavioral, and physical development of children and adolescents. In Italy, nearly half of domestic violence incidents occur in the presence of children, yet standardized tools for identifying affected minors remain scarce. This study presents the EpiCHILD assessment tool, designed to support the early identification of psychophysical vulnerabilities in children exposed to domestic violence and to guide targeted prevention and care strategies. Developed within the ESMiVA study, EpiCHILD is a multidimensional electronic questionnaire composed of nine sections, incorporating validated instruments for PTSD (ITQ-CA), depression (CDI-2), and psychosocial functioning (SDQ-Ita). Administered by trained professionals in clinical and social service settings, the tool is GDPR-compliant and allows for flexible, child-centered use. EpiCHILD enables systematic screening and early detection of children at risk due to violence exposure. It standardizes data collection across sectors and lays the groundwork for future research on the biological impact of trauma, including potential epigenetic markers, representing an innovative contribution to precision prevention in child mental health.

Onsite school-based intervention represents a key strategy to increase influenza vaccination uptake and improve knowledge of children, parents and school staff. This study aims to quantitatively describe an intervention in Local Health Authority Roma 1. Vaccination was offered to children aged 2-6 years. A quantitative descriptive analysis of vaccination coverage and population variables was performed. 29 schools were included. Out of 2,424 eligible children, 405 were vaccinated (16.7%). Of these, 218 (53.8%) were male and 187 (46.2%) female, mean age 4.4 years old. 177 (43.7%) received one dose, while 228 (56.3%) were vaccinated for the first time. Of these, 150 students (65.8%) also received the second dose. 148 other people (parents, teachers and older children) decided to join the campaign, thus being vaccinated. Community-based interventions in school settings increase adherence to health promotion campaigns. It is necessary to continue researching and investing in such activities.

The implementation of an innovative psychoeducational group intervention in Italian general hospital psychiatric units started in the years 2000-2001 in two Italian regions. The aim of this contribution is to describe the intervention method and the experience of its application, its spread, the results of evaluation studies and its evolution. The methodology is qualitative/quantitative. The qualitative approach concerns the description of the prevalent clusters of topics in the most used intervention modules. The quantitative approach concerns the analysis of indicators used in the evaluation studies carried out since 2000-2001. Over time, three topics of the intervention have remained constant: "What happened before the crisis"; "Stress-vulnerability-coping model"; "Psychotropic drugs: shared decisions". Other topics have been introduced based on the patients' preferences: "Psychophysical well-being", "Awareness", "Emotions-thoughts-behaviors connection", "Problem-solving" and "Stigma". The intervention has been applied over time in 15% of Italian psychiatric wards with positive results (main result: decrease in readmissions and restraints). Two main topics are discussed: a) the advantages and obstacles in applying the intervention; b) the need for addressing also the issues of substance dependence and antisocial personality.

COVID-19 vaccines have proven effective and safe, enabling the resumption of normal life. However, misinformation has hindered vaccination efforts. This study aimed to investigate perceptions of vaccine safety among Italians through an anonymous online survey. An anonymous online survey was conducted from April to July 2022 and disseminated through social platforms, among adult individuals living in Italy. A total of 1,329 individuals participated. Younger individuals and healthcare professionals showed greater trust in vaccines. Education level was significantly associated with perceived vaccine safety. Most respondents, including many healthcare workers and highly educated individuals, believed vaccines to be safe, with confidence levels of 39.5% for mRNA, 32.9% for viral vector, and 39% for protein subunit vaccines. Younger age and trust in institutions were linked to higher confidence in all vaccine types. These findings may be useful to further investigate the drivers of vaccine safety perceptions and their relationship with vaccine hesitancy and may help to develop more effective communication campaigns in the future.

To describe breastfeeding and associated factors in a large representative sample of children aged 0-2 years in Italy. Data from the 2022 Italian surveillance of children aged 0-2 years, comprised of 35,550 mothers, were analysed to estimate rates of EBF (exclusive breastfeeding), any breastfeeding (BF) and never breastfed (NBF). Logistic regression was used to investigate the association of EBF, BF and NBF with potential predictors. EBF among children aged 2-3 months varied from 36.4% in the South Italy to 54.0% in the North, decreasing respectively to 19.6% and 35.8% at 4-5 months. At 12-15 months BF ranged between 29.2% (South) and about 40% (Centre and North). Women with Italian citizenship, having a lower educational level, those who never attended antenatal classes (AC), and those residing in the South were significantly less likely to exclusively breastfeed or to breastfeed after the first year of life of the child. The data underscore the gap between recommendations and actual breastfeeding practices, offering the first national perspective that highlights territorial disparities. The findings emphasize the need for targeted interventions, particularly in light of identified regional and socio-economic differences.

The recent guideline from the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) on observational studies prompts a broader reflection on the impact of regulations on clinical research and real-world evidence. While regulations are necessary to ensure ethical and scientific standards, their effectiveness in improving research quality is unclear. It is also uncertain whether these regulations strengthen clinical research or create bureaucratic obstacles. This quantitative, "before and after" study investigates the impact of the 2008 AIFA guideline and the 2018 General Data Protection Regulation (GDPR) on the complexity of ethical evaluation processes. As a secondary outcome, we also aimed to investigate whether the duration and probability of suspensions were influenced by intrinsic study characteristics (study design, rare disease, genetic data, post-authorization safety study). The study analyzed the ethical evaluation process of 112 observational multicenter studies with 2,875 submissions from 2002 to 2022, included in the database of Medineos srl. The number of suspensions observed in each evaluation process was a surrogate endpoint of complexity of evaluation process. Descriptive analyses and survival analysis were used to evaluate the total evaluation time, and a logistic model was applied to assess the probability of receiving a suspension. The median (and interquartile range) evaluation time for "pre-AIFA" submissions was 70 (41-133) days, whereas it was 75 (45-122) days for "post-AIFA" submissions. The median evaluation time was 68 (41-113) days without suspension and 127 (84-180) days with suspension. Post-AIFA submissions had a higher likelihood of suspension. The median evaluation time for "pre-GDPR" submissions was 70 (42-123) days, whereas it was 90 (63-140) days for "post-GDPR" submissions. AIFA guidelines slightly increased evaluation time and the likelihood of suspension, suggesting improved quality control. GDPR increased evaluation time due to privacy evaluations but did not affect suspension probability. Intrinsic study factors did not impact evaluation duration or suspension probability. Although more extensive analyses are necessary, this study suggests that past changes in Italian regulations have affected the evaluation by the Ethics Committee (EC) and have also impacted the conduct of the observational studies. The data generated can be useful for monitoring the future impact of the recently published new AIFA guideline.

Intimate partner violence (IPV) profoundly impacts women's health, increasing the risk of chronic and non-communicable diseases. Recent findings underscore the promise of epigenetic indicators to uncover the enduring effects of trauma on the human genome, especially concerning stress-related conditions such as post-traumatic stress disorder (PTSD). To evaluate the lasting health impacts of violence against women, developing a digital tool specifically structured to consolidate crucial details about the contexts of violence, the relationship between victim and perpetrator, and health outcomes. A Microsoft Forms-based questionnaire was developed, organized into nine sections addressing socio-personal information, external conditions of violence, health statuses, and psychological evaluations, incorporating PTSD assessment via the International Trauma Questionnaire and depression measurement through the Center for epidemiologic studies depression scale revised (CESD-R) module. Data is securely archived, and participation includes optional consent for epigenetic analysis through blood samples. The assessment tool presents a thorough tool for gathering information on IPV, evaluating health outcomes, and identifying PTSD and depression in survivors. It also aids in the collection of biological specimens for epigenetic exploration. This instrument could enhance intervention strategies and contribute to precision medicine methodologies, facilitating early detection of chronic health risks in women who have experienced violence.

In health impact assessment, relative excess measures of effect are used in combination with exposure and outcome data to estimate the health impacts under an alternative exposure scenario. The aim of this study is to propose: a classification of relative excess measures of effect functional for health impact assessment; a standard and general framework for calculating health impacts; different approaches when using data at different spatial resolutions. A classification of the relative excess measures of effect was presented, introducing a new measure. A standard framework for calculating attributable and preventable cases based on the nature of the exposure and the imagined change in exposure was described. The marginal and conditional approaches to calculate health impacts using data at different spatial resolutions were illustrated. The proposed methods and frameworks are designed to be applicable to a range of different situations. As health impact assessment continues to evolve, the insights and tools provided in this paper could help guide effective and equitable assessments, ultimately contributing to better public health decisions and outcomes.

During summer, beach authorities are charged with ensuring the safety of beach visitors, which includes promoting safe behaviour via educational efforts. The purpose of this study was to describe the processes of development and implementation of a promotional project for beach safety. A multidisciplinary task force developed the informational material and the content to be provided following the principles of the Health Belief Model (HBM). The health promotion addressed a wide range of topics and was delivered at 65 bathing facilities along the Lazio coast (Central Italy) from June 2, 2023, to September 10, 2023. To evaluate the feedback of the promotion activities, the attendees were asked to answer a post-event self-evaluation survey. 1,032 people responded to the questionnaire about satisfaction and utility levels. Participants' overall satisfaction scores (98% rated "excellent" or "good") and utility (88%) were high, with higher satisfaction levels for the women, those with higher education, and Italian citizens. Most participants reported that the material was easy to understand; the contents were comprehensive; and the healthcare professionals were prepared, engaging, and available. This project showed that approaching the summer visitors in the place time is a feasible and well-accepted strategy for summer health-related education.