Influenza is a contagious respiratory viral infection with significant health and economic impacts, causing millions of cases and hundreds of thousands of deaths annually worldwide. In Italy, annual epidemics affect approximately 8 % of the population. Vaccination remains the most effective prevention strategy, yet coverage in Italy is low and consistently below the WHO-recommended threshold of 75 % in elderly. This study aims to analyze trends in influenza vaccination coverage in Italy from 1999/2000 to 2023/2024 through joinpoint regression analysis. Data on influenza vaccination coverage were obtained from the Italian Ministry of Health, covering the general population and specific age groups. The analysis included data from the 1999/2000 season to the 2023/2024 season. Joinpoint regression was used to identify significant changes in coverage trends over time, calculating Annual Percentage Change (APC) and Average Annual Percent Change (AAPC). Coverages vary between and within age groups over the study period. The pediatric population showed the lowest values, never exceeding 10 % except for the COVID-19 pandemic years. Similar trends, albeit with higher coverage, were observed in the adult population. In the elderly population, the WHO target of 75 % was never reached, obtaining the highest value of 68.3 % in 2005/2006. Trends show increasing AAPC coverages for all groups except 15-17 years. During the pandemic, increases in coverages are observed in all age groups, but these decline towards pre-pandemic values during the following seasons. Our study shows that vaccination coverage in Italy falls below target thresholds, particularly in high-risk age groups, with a significant decreasing trend observed in the years following the pandemic across almost all age groups. Despite the proven efficacy and safety of the vaccine, hesitancy has gained momentum in Italy, resulting in persistently low coverage rates. Our findings highlight the need for a multifaceted approach, including expanding free vaccination programs, implementing school-based initiatives, strengthening healthcare worker engagement, and enhancing public awareness campaigns. A coordinated national effort, led by the Ministry of Health, is essential to achieving higher coverage rates and reducing the burden of influenza.

Background: Molecular Tumor Boards (MTBs) bring together multidisciplinary experts to translate genomic data into clinical decisions in oncology, however, their overall clinical impact remains unclear. The aim of this systematic review is to assess the clinical impact of MTB-recommended therapies on patients with cancer outcomes. Methods and findings: In this systematic review and meta-analysis, we searched PubMed, Embase, Scopus, and CENTRAL up to July 2025. We included studies of any design, both single-arm studies and studies with a comparator group, that reported the clinical impact of MTBs in patients who received MTB-guided therapy. Meta-analyses were performed separately by study design, using hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS), relative risks (RRs) for objective response rate (ORR) and disease control rate (DCR), and pooled proportions for PFS ratio ≥1.3. All meta-analyses were conducted using random-effects models based on the inverse variance method. We evaluated the risk of bias using the RoB 2.0 for RCTs and ROBINS-I for non-randomized studies. From 6,846 records, 78 studies (9,195 patients; 4,569 treated per MTB recommendations) were included. MTB-guided therapies were associated with reduced risk of death (HR 0.87; 95% CI [0.76, 1.01]; p = 0.069; I ² = 0.0% in RCTs; 0.62 in retrospective studies) and disease progression (HR 0.73; 95% CI [0.64, 0.84]; p < 0.001; I ² = 0.0% in RCTs; 0.63 in retrospective studies), as well as improved ORR (RR 1.75; 95% CI [1.24, 2.47]; p = 0.001; I ² = 0.0% in RCTs; 3.32 in retrospective studies) and DCR (RR 1.20; 95% CI [1.03, 1.40]; p = 0.018; I ² = 19.9% in RCTs; 1.65 in retrospective studies). Between 33% and 43% of patients achieved a PFS ratio ≥1.3. While the risk of bias for RCTs was low, except for one study that was rated as having some concerns, the overall risk of bias for non-randomized studies was rated as “serious” in most of the studies ( n = 54). Limitations include substantial heterogeneity, predominance of non-randomized studies with risk of bias, and limitations in data reporting, which restrict causal inference. Conclusions: This meta-analysis provides robust evidence from RCTs supporting the clinical benefit of MTBs, although limited for OS. Methodological heterogeneity and study limitations from observational studies warrant cautious interpretation. Future high-quality RCTs and standardized reporting are needed to confirm these findings and guide the integration of MTBs into routine clinical practice and health system strategies.

Healthcare-associated infections (HAIs) place a significant burden on healthcare systems, leading to increased morbidity, prolonged hospital stays, and elevated costs. Surgical site infections (SSIs) are among the most prevalent HAIs, often surpassing the cost of the surgical procedures themselves. To evaluate the economic impact of a preventive intervention designed to reduce the prevalence of SSIs at Fondazione Policlinico A. Gemelli (FPG) IRCCS. A point prevalence survey (PPS) was conducted in June 2023 and June 2024 at FPG IRCSS, following the protocol of the European Centre for Disease Prevention and Control. The study analysed data from hospitalized patients, comparing the prevalence of SSIs before and after implementation of a preventive intervention (bundle approach). An economic evaluation was performed using a budget impact model, estimating cost savings from the reduction in SSI cases. Sensitivity analysis was conducted to assess variations in the effectiveness of the intervention. The prevalence of SSIs decreased from 2.5% in 2023 to 1.4% in 2024, representing a 44% reduction. The estimated number of SSI cases decreased from 2287 to 1281, resulting in a cost reduction of approximately €31.6 million in direct healthcare expenses. The projected economic benefits for 2025 and 2026 suggest further savings if the downward trend continues. The findings indicate that targeted preventive measures reduce the prevalence and associated costs of SSIs significantly. The reduction rate exceeds previously reported figures in the literature, emphasizing the effectiveness of the intervention, and underline the need for broader implementation of prevention strategies to enhance patient safety and economic sustainability.

Background/objectives. Emerging viral diseases represent an increasing threat to global health security, driven by environmental change, globalization, and intensified human–animal–environment interactions. The COVID-19 pandemic exposed critical weaknesses in preparedness systems but also demonstrated the transformative potential of recombinant vaccine technologies, which enable rapid, scalable, and safe responses to novel pathogens. We aim to examine the role of recombinant vaccine platforms in the management of emerging viral diseases, emphasizing their contribution to health system preparedness and exploring strategies for their integration into preparedness frameworks. Methods. We synthesized the current evidence on recombinant vaccine platforms (viral vector, protein subunit, DNA, and mRNA) through a targeted review of the scientific literature, regulatory documents, and global health policy reports. Drawing from experiences like COVID-19 (mRNA vaccines) and Ebola (rVSV-ZEBOV), we analyzed the advantages, challenges, and lessons from initiatives such as the CEPI, BARDA, HERA, and WHO frameworks. Results. Recombinant vaccine platforms offer significant advantages for epidemic preparedness through rapid adaptability, standardized production, and strong safety profiles. Nonetheless, challenges remain in manufacturing scalability, cold-chain logistics, regulatory harmonization, and equitable global access. Global initiatives such as the CEPI, WHO-led programs, BARDA, and regional manufacturing networks exemplify this collaborative approach, while regulatory mechanisms have proven to be essential to timely vaccine deployment. Conclusions. Recombinant vaccines have redefined preparedness by coupling scientific innovation with operational agility. Strengthening global coordination, regional production capacity, and public trust is essential to ensure that technological progress translates into equitable and effective public health impacts.

Importance: Genetics and other -omics’ technologies have long been proposed for medical research use. Objective: To assess how genetics and other -omics information’ are used in the most cited recent clinical trials, and to evaluate industry involvement and transparency patterns. Design, Setting, Participants: Meta-research evaluation using a previously constructed database of the 600 most cited clinical trials published from 2019 to 2022. Main Outcome(s) and Measure(s): Utilization of genetic or other -omics information in the trial design, analysis, and results; industry involvement and transparency. Results: 132 (22%) trials used genetic or other -omics information, predominantly for detection of cancer mutations (n=101). Utilization included eligibility criteria (n=59), subgroup analysis (n=82), and stratification factor in randomization (n=14). Authors addressed the relevance in the conclusions in 82 studies (62%). 102 studies (77%) provided data availability statements and 6 had data already available. Most studies had industry funding (n=111 [84.0%]). Oncology trials were more likely to be industry-funded (90.1% vs 64.5%, p=0.001), to have industry-affiliated analysts (43.6% vs 22.6%, p=0.036) and to favor industry-sponsored interventions (83.2% vs 58.1% p=0.004). When compared to other trials, genetic and other -omics trials were more likely to be funded by industry (84% vs 63.9%, p<0.001) and tended to be less likely to have full protocols (p=0.018) and statistical plans (p=0.04) available. Conclusions and Relevance: Our study highlights the current underutilization of genetic and other-omics technologies beyond testing for cancer mutations. Industry involvement in these trials appears to be more substantial and transparency is more limited, raising concerns about potential bias. Key Points: Question: How are genetics and other -omics information used in highly impactful clinical trials, and what is the involvement of the industry in their development? Findings: 22% of the trials employed genetic or -omics information, with the vast majority being oncology-related and focusing on testing for mutations. Industry was more heavily involved in the funding and in the design of these trials, in particular for oncology trials. Meaning: The use of genetics and -omics is limited and needs to become more common in non-oncology trials. Industry involvement is intense in this context, highlighting the need for improvements in transparency and independence.

Background: Polygenic Risk Score (PRS) represents a promising advancement in personalized medicine, enabling the inherited risk assessment for disease outcomes based on the effect of various common genetic variants. The utilization of PRS information to promote the adoption of healthier behaviors has witnessed an increase interest in recent years, but its full potential still needs to be fully addressed. Methods: This systematic review aims to assess the efficacy of disclosing PRS information on individuals’ engagement in risk-reducing interventions. CENTRAL database has been searched up to December 2023 to identify randomized controlled trials (RCTs) comparing the disclosure of PRS results, with scenarios where other or no information is provided. We performed a preliminary meta-analysis on the mean difference of clinical and psychological outcomes between the two arms. Results: Out of 4419 results, we included 12 studies. Trials focused on primary (83%), secondary (8%) and tertiary (8%) preventive interventions. As for the possible diseases predicted by the PRS, cardiovascular diseases (33%) were the most common (n = 4), along with cancers (33%), diabetes (25%) and metabolic disease (8%). PRS result disclosure was compared to standard care (n = 7), no information provided (n = 4), and family risk (n = 1). By pooling data from four comparable studies, we report a reduction in the mean difference for LDL cholesterol in the intervention group of -6.39mg/dL (95%CI -10.09, -2.70, I²=0%, p < 0.001). No significant changes were observed for systolic and diastolic blood pressure, and weight, in 3 studies and 4 analyzed studies, respectively. An increase in anxiety levels was observed towards the PRS group in 4 studies (SMD 0.24, 95%CI 0.02, 0.46, I² = 66%, p = 0.03). Conclusions: Preliminary analysis show small or no effects of PRS disclosure on intermediate health or psychological outcomes. Larger trials assessing the potentiality of PRS disclosure are still needed. Key messages: • From the analysis of twelve preventive trials on the efficacy of PRS on behavior change, we report a positive effect on LDL cholesterol reduction. • Larger well conducted trials are needed to integrate PRS-based information into future preventive strategies.