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Personalized medicine (PM) has the potential to revolutionize healthcare by delivering treatments tailored to individual patients based on their unique characteristics. However, ensuring its effective implementation presents complex challenges, particularly in terms of long-term sustainability. To address these challenges, the IC2PerMed project fosters collaboration between the European Union and China. This study, building on insights from the project, aims to identify key priorities for advancing PM, focusing on Clinical Studies and Funding Systems, with special attention to optimizing resource management, distribution, and protection to support sustainable development. A two-round Delphi survey was conducted to achieve consensus on common priorities among China and Europe related to Clinical Studies and Funding Systems. Consensus was measured using the Content Validity Index, requiring an agreement level of 80% or higher for item inclusion. The survey identified 20 key priorities in PM research, split evenly between research initiatives and funding mechanisms. Notable priorities include developing technology for deep phenotyping, standardizing methodological approaches, and fostering public-private collaborations. In funding, the emphasis was placed on involving patient voices in research design and establishing synergies among funders to support larger projects. The findings underscore the importance of structured collaboration between Europe and China in advancing personalised medicine. By addressing identified priorities in research and funding, this initiative can significantly enhance the efficacy of PM, ultimately improving healthcare outcomes globally. The study sets a precedent for future international partnerships aimed at fostering innovation in health sciences., (© The Author(s) 2025. Published by Oxford University Press on behalf of the European Public Health Association.)

Effective leadership is essential in neonatal intensive care units (NICUs), where complex, high-stakes environments require coordinated multidisciplinary teamwork. Strong leadership improves clinical outcomes, team performance, and staff well-being. This systematic review assesses various leadership models and interventions in NICUs to identify best practices and areas for future research. A systematic search was conducted on PubMed, Web of Science, and Scopus, covering studies published from 2010 to October 2024. Articles were screened using the PRISMA guidelines, and inclusion criteria focused on primary studies in NICU settings evaluating leadership interventions. Data extraction and quality assessment were performed using the Newcastle-Ottawa Scale. Nine studies from diverse countries and research designs were included. Leadership interventions varied from simulation-based training programs to co-leadership models. High-fidelity simulation boot camps significantly improved self-perceived skills, teamwork, and leadership confidence among trainees. While most studies reported positive impacts on team performance and patient safety, one large-scale quality improvement program showed no significant improvement in clinical outcomes for very-low-birth-weight infants., Conclusion: The findings emphasize that leadership interventions, including structured training and co-leadership, enhance team dynamics and clinical outcomes in NICUs. However, variability in study designs and reliance on self-reported data highlight the need for standardized evaluation methods. Future research should focus on long-term impacts, cross-context comparisons, and refining leadership frameworks to address the unique challenges of NICU settings. Promoting effective leadership not only improves patient care but also fosters a resilient and collaborative work environment., What Is Known: • Leadership is crucial in NICUs, where complex, high-stakes environments demand coordinated, multidisciplinary teamwork. Strong leadership enhances clinical outcomes, team performance, and staff well-being. • No systematic review of leadership interventions in neonatal care has been conducted to date., What Is New: • Recent studies highlight a range of tools, including simulation-based training programs and co-leadership models. • High-fidelity simulations have been shown to significantly improve participants' self-perceived skills, teamwork, and leadership confidence., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

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.)

Introduction: Limited data are available comparing the interposition and transposition techniques for microvascular decompression (MVD) in patients with trigeminal neuralgia (TN) secondary to vertebrobasilar dolichoectasia (VBD); this study aims to review current findings on TN associated with VBD and compare the interposition and transposition techniques in terms of surgical morbidity and patient outcomes., Methods: Following the PRISMA guidelines, PubMed/Medline, Web of Science, and SCOPUS databases were searched to identify studies reporting patients undergoing MVD for TN secondary to VBD. The studies were divided into two groups, interposition and transposition, based on the microvascular decompression technique used. Studies not reporting the diagnostic criteria, included less than five cases, or were not available in English were excluded., Results: Fourteen eligible papers were retrieved, of which five studies reported cases undergoing the interposition technique, eight studies for the transposition technique, and one study reported cases from both groups. Data including preoperative and postoperative BNI class, comorbidities, and postoperative complications were retrieved to analyze and compare the two techniques in terms of efficacy and long-term outcomes in treating TN secondary to VBD., Conclusion: Both interposition and transposition techniques for MVD yield high rates of pain relief in patients with TN secondary to VBD. While both approaches demonstrate similar efficacy, the interposition method is associated with a lower rate of long-term complications. Further research, preferably through randomized prospective studies, is needed to refine surgical strategies and improve patient 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 Signorelli, Zeoli, Rastegar, Beccia, Caronna and Visocchi.)

Background: To evaluate, in patients undergoing macula-off rhegmatogenous retinal detachment surgery (RRD), the correlation between preoperative optical coherence tomography (OCT) morphological features and postoperative visual acuity., Methods: Retrospective interventional non-randomised clinical trial on 89 eyes of 89 patients undergoing pars plana vitrectomy for macula-off primary RRD at Policlinico Universitario Agostino Gemelli from 2020 to 2023. Preoperative 6×6 mm OCT B scans with Nidek Mirante (Nidek, Gamagori, Japan) were performed, collecting the following features: foveal involvement (fovea-on vs fovea-off), subretinal hyper-reflective points (HRPs), outer retinal corrugations (ORCs) and intraretinal cystic spaces (ICS) in the outer nuclear layer. The patients were followed in a 6-month follow-up to evaluate best-corrected visual acuity (BCVA) outcomes., Results: Preoperative mean BCVA was 0.15±0.22 and improved to 0.29±0.3 decimals at 6 months (p<0.001). The presence of subretinal HRPs showed a significant negative impact on BCVA improvement in the univariate regression analysis (r=-0.264, p=0.024), as well as the presence of foveal detachment (r=-0.355, p=0.012). The other OCT features did not show a significant correlation with BCVA improvement: ORCs (r=0.072, p=0.257) and ICS (r=-0.020, p=0.734). In the multivariate regression analysis, the negative impact of foveal detachment was confirmed (r=-0.199, p=0.05) while the statistical significance of subretinal HRPs was lost (r=-0.135, p=0.105)., Conclusions: The negative impact of foveal involvement in a macula-off RRD was confirmed. Moreover, the presence of subretinal HRPs, as a possible indirect marker of inflammatory response extent, may act as a negative predictor for postoperative visual recover., Trial Registration Number: NCT05747144., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: This study aimed to assess students' knowledge, awareness, and attitudes regarding forensic-medicine concepts taught during a Medicine and Surgery degree program at eight Italian universities. Additionally, the study aimed to evaluate the impact of the course on students' knowledge and attitudes toward choosing medical residency., Materials and Methods: A cross-sectional study was conducted through an anonymous web-based survey of medical students at eight italian universities. Descriptive, univariate, and logistic regression analyses were performed for the selected questions., Results: The survey was completed by 1022 students. Forensic medicine appears to be important for providing training in the fundamental concepts of forensic medicine, especially professional liability, defensive medicine, and forensic pathology. The descriptive and univariate analyses demonstrate that the course can assist students in choosing their specialisation school. The multivariate analysis highlighted the impact of the forensic medicine course on orienting students' choice of medical residency, increasing it by nine times after attending the course. In the logistic regression analysis of the influence of medical liability on the choice of medical residency, students recognised a doubled effect after attending the course. Finally, the perceived usefulness of the course was significantly higher after attendance., Conclusions: Forensic medicine courses have the task of defining the duties and responsibilities of forensic physicians, providing indispensable tools for future medical practitioners regardless of their future specialisation, and limiting the increasing use of defensive medicine. In conclusion, it is imperative for governments to implement measures directed at diminishing the risk of burnout arising from the ongoing pressure associated with the fear of medicolegal litigation, encompassing both criminal and civil contexts., Competing Interests: Declarations Ethical approval The study protocol was approved by the Ethics Committee of the Policlinico Universitario A. Gemelli IRCCS (ID 4974). Conflict of interest The authors declare they have no conflict of interest., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution., Methods: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document., Results: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR., Conclusions: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues., Competing Interests: Disclosures None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP., Methods: BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions., Results: Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06-2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk., Conclusions: The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP., Trial Registration: Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212., (© 2024. The Author(s).)

Background: Acute respiratory infections (ARIs) are a major healthcare issue in children. The SARS-CoV-2 pandemic changed the epidemiology of ARIs; the aims of this study are to characterize the epidemiological trend of ARI emergency hospitalizations and virology results and to estimate the association of ARI emergency hospitalizations with respiratory viruses from January 2018 to June 2023., Methods: This study was carried out in an Italian tertiary care children's hospital (Bambino Gesù Children's Hospital). The demographic and clinical information of children who accessed the Emergency Department (ED) with ARI and were hospitalized were retrospectively extracted from the electronic health records. Multivariate linear regression model was used to compare the number of ARI hospital admissions with the reported temporal trends in viruses diagnosed from respiratory samples throughout the same time period., Results: During the study period, there were 92,140 ED visits and 10,541 hospitalizations due to ARIs, reflecting an admission rate of 11.4%. The highest proportion of hospitalizations occurred in infants ≤ 1 year of age (n = 4840, 45.9% of total admissions), with a hospitalization rate of 22.6%. Emergency hospitalizations aligned closely with the predictions made by the multivariate regression model; peaks in hospitalizations reflected Respiratory Syncytial Virus (RSV) circulation., Conclusions: ARI hospital urgent admissions are a relevant component of ARI disease burden in children. RSV prevention and control are crucial to limit the risk of urgent hospitalizations due to ARIs., (© 2024 The Author(s). Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.)

Introduction: This study aims to analyze the clinical characteristics, demographic features, and injury circumstances of patients admitted to the Emergency Department (ED) at Fondazione Policlinico Universitario A. Gemelli (IRCCS) in Rome, Italy, due to bicycle accidents., Methods: Data on clinical characteristics, accident timing, injury circumstances, and helmet use were collected for ED patients involved in bicycle accidents from January 2019 to December 2022. Subsequently, Abbreviated Injury Scale codes of all diagnoses were recorded and the Injury Severity Score was calculated., Results: Over the study period, 763 patients were admitted to the ED following bicycle accidents, with a 0.3 % fatality rate and a 30.4 % frequency of multitrauma. Multivariate analysis revealed that collisions with other vehicles increased trauma severity and the risk of ICU admission. Conversely, helmet use was associated with reduced severity of head trauma and a lower likelihood of ICU admission. Notably, toxicological investigations were not conducted for any ED-admitted patients., Conclusions: Although a low mortality rate and a low incidence of multi-trauma have been shown in comparison to other nations, it is necessary to adopt prevention strategies like safety devices, more cycle paths, and better infrastructures on the one hand, and stricter laws on the other. It is essential to require toxicological testing in Italy for all accidents involving this means of transport, and to make helmet use compulsory for all ages., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: The advent of Personalized Medicine (PM) holds significant promise in revolutionizing healthcare by tailoring treatments to individual patients based on their data. However, its successful implementation requires the seamless integration of innovative technologies and presents formidable challenges in terms of sustainability. To tackle these challenges head-on, the International Consortium for Personalized Medicine (ICPerMed) was established, and the IC2PerMed project, as part of this consortium, seeks to foster collaboration between the European Union (EU) and China in the field of Personalized Medicine. Based on the results collected by the project, the objective of this study is to discern the key priorities for the implementation of Personalised Medicine concerning Information and Communication Technologies (ICT) and Big Data and digital solutions, with a particular emphasis on data management and protection., Methods: A Delphi survey was conducted to gather expert's consensus on the main priorities for actions on Information and Communication Technologies (ICT) and Big Data and digital solutions in the field of Personalized Medicine., Results: The survey identified seven priorities in the area of Big Data and digital solutions, including data interoperability, standards, security measures, and international partnerships. Additionally, twelve priorities were identified for the innovation-to-market process, emphasizing cost-effectiveness, need assessment, and value definition in resource allocation., Conclusions: The effective implementation of new technologies in Personalized Medicine research and practice is essential for the advancement of healthcare systems in both the European and Chinese contexts. The identified priorities play a pivotal role in promoting the sustainability of health systems and driving innovation in the implementation of Personalized Medicine. Addressing challenges related to data interoperability, standards, security, international collaboration, cost-effectiveness, and value assessment is of utmost importance in order to propel the progress of Personalized Medicine in healthcare systems., (© 2024. The Author(s).)

Oxidative stress (OS) is implicated in several chronic diseases. Extra-cellular superoxide dismutase (ec-SOD) catalyses the dismutation of superoxide anions with a protective role in endothelial cells. In chronic kidney disease (CKD), OS and thyroid dysfunction (low fT3 syndrome) are frequently present, but their relationship has not yet been investigated. This cohort study evaluated ec-SOD activity in CKD patients during haemodialysis, divided into "acute haemodialytic patients" (AH, 1-3 months of treatment) and "chronic haemodialytic patients" (CH, treated for a longer period). We also evaluated plasmatic total antioxidant capacity (TAC) and its relationships with thyroid hormones. Two basal samples ("basal 1", obtained 3 days after the last dialysis; and "basal 2", obtained 2 days after the last dialysis) were collected. On the same day of basal 2, a sample was collected 5 and 10 min after the standard heparin dose and at the end of the procedure. The ec-SOD values were significantly higher in CH vs. AH in all determinations. Moreover, the same patients had lower TAC values. When the CH patients were divided into two subgroups according to fT3 levels (normal or low), we found significantly lower ec-SOD values in the group with low fT3 in the basal, 5, and 10 min samples. A significant correlation was also observed between fT3 and ec-SOD in the basal 1 samples. These data, confirming OS and low fT3 syndrome in patients with CKD, suggest that low fT3 concentrations can influence ec-SOD activity and could therefore potentially contribute to endothelial oxidative damage in these patients.

In the transformative landscape of healthcare, personalized medicine emerges as a pivotal shift, harnessing genetic, environmental and lifestyle data to tailor medical treatments for enhanced outcomes and cost efficiency. Central to its success is public engagement and consent to share health data amidst rising data privacy concerns. To investigate European public opinion on this paradigm, we executed a comprehensive cross-sectional survey to capture the general public's views on personalized medicine and data-sharing modalities, including digital tools and electronic records. The survey was distributed in eight major European Union countries and the results aim at guiding future policymaking and trust-building measures for secure health data exchange. This article delineates our methodological approach, whereby survey findings will be expounded in subsequent publications.

Introduction: Over the last decade, the emergence and spread of personalized medicine (PM) have defined a substantial revolution in healthcare. In principle, healthcare system sustainability is challenged by the investments required for research and development, as well as the adoption of PM techniques in routine clinical care. The "Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) EU-funded project aims to integrate China into the "International Consortium for Personalized Medicine" (ICPerMed). IC2PerMed aims to align the EU and China's research agendas in this field to enable a swift development of approaches in the EU and China with strong leverage upon EU-Chinese collaborations., Methods: Within this project, we first mapped relevant policies on PM in both the EU and China, and then we involved European and Chinese experts in PM in workshops and Delphi surveys in order to identify relevant priorities for the implementation of PM in sustainable healthcare., Results: As a result of this process, we identified nine overarching priorities, each addressing specific aspects of the sustainability of healthcare systems and PM implementation, with the main goal of supporting policymakers in integrating PM approaches in the EU and China., Discussion/conclusion: The implementation of PM in health systems is appealing in terms of improved accuracy in diagnostics, treatment, and prevention of disease, as well as reduction of the side effects resulting from inefficient use of drugs. Research, development, and implementation of needed techniques require time and resources that can slow the adoption of PM in healthcare systems. The nine priorities we identified address some of the most critical points, trying to lay the foundations for a comprehensive approach., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

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.

Importance: Repeated transfusions in preterm neonates with anemia of prematurity replace fetal hemoglobin (HbF) with adult Hb (HbA), which has a low oxygen affinity. The reduction of HbF is associated with a higher incidence of retinopathy of prematurity (ROP)., Objective: To assess whether HbF and HbA are differently associated with cerebral tissue oxygenation in preterm neonates., Design, Setting, and Participants: This cohort study was a single-center, pilot study on cerebral oxygenation kinetics in preterm neonates with a gestational age between 24.0 weeks and 27.9 weeks who were admitted to the neonatal intensive care unit of Policlinico Universitario A. Gemelli IRCCS from December 27, 2021, to May 15, 2023. This study was ancillary to the ongoing, double-blind, multicenter Umbilical or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN) randomized clinical trial. The BORN trial outcome was ROP severity in neonates randomized to receive standard packed red blood cell (PRBC) transfusions obtained from RBCs of adult donors (A-RBCs) or from cord blood (CB-RBCs). According to standard procedures at the institute's neonatal intensive care unit, patients concurrently received continuous cerebral near-infrared spectroscopy (NIRS) monitoring. This cohort study was not prespecified in the trial protocol., Exposure: Transfusion with A-RBCs or CB-RBCs., Main Outcomes and Measures: The main outcome was the kinetics of cerebral regional oxygen saturation (crSO2) and cerebral fraction of tissue oxygen extraction (cFTOE) associated with A-RBC or CB-RBC transfusions. Cerebral NIRS monitoring was performed by neonatologists and nurses, who were blinded to the PRBC type. The NIRS monitoring was conducted starting with the blood product order, during transfusion, and for the subsequent 24 hours after transfusion completion. The mean treatment effects of A-RBCs or CB-RBCs were quantified using a linear mixed model for repeated measures., Results: Of 23 randomized neonates, 17 (11 male [64.7%]; median gestational age at birth, 25.6 weeks [IQR, 25.3-26.1 weeks]) with a median birth weight of 840 g (IQR, 580-900 g) were included in the study; NIRS was evaluated for 42 transfusion episodes, of which 22 were A-RBCs and 20 were CB-RBCs. Globally considering all posttransfusion time points, the overall crSO2 covariate-adjusted mean after CB-RBC transfusions was 5.27% lower (95% CI, 1.20%-9.34%; P = .01) than that after A-RBC transfusions, while the cFTOE after CB-RBC transfusions was 6.18% higher (95% CI, 1.66%-10.69%; P = .009) than that after A-RBCs., Conclusions and Relevance: The findings of this cohort study suggest that A-RBC transfusions may be associated with more oxygen delivery to cerebral tissues of preterm neonates than transfusions from CB-RBCs. This finding may explain the previously observed association between low HbF and high ROP risk. It also suggests that use of CB to meet the RBC transfusion needs of neonates with a gestational age of less than 28 weeks may protect cerebral tissues from overexposure to oxygen.

Introduction: Food insecurity represents a public health issue that has been associated with poor birth outcomes. We describe the methodological steps followed to structure and validate a questionnaire, which has the potential to contribute to the planning and conduction of future studies investigating the possible association between maternal food insecurity and fetal structural anomalies., Methods: We first conducted a literature review to structure and validate the questionnaire. Subsequently, we drafted the questionnaire based on the results of this review, further refined through two focus groups. Afterward, the questionnaire was submitted using the Delphi Method to a panel of experts for validation. We conducted a pilot study prior to recruiting the final sample., Results: The questionnaire consisted of sections covering information about socio-demographic characteristics, women's health and lifestyle, pregnancy, and food security status. After the first Delphi round, the Content Validity Index (CVI) for each section ranged 0.81-0.85, while after the second round all items had a CVI of 1. The final version of the questionnaire, consisting of 87 items, was pilot tested among 20 participants. Cronbach's Alpha for each section resulted in values higher than 0.6. The response rate ranged from 78 to 100%. A situation of food security was present in 85% of the participants, while 5% were in a situation of mild food insecurity and 10% of moderate food insecurity., Conclusion: The questionnaire has appropriate measurement properties, and is an adequate instrument to evaluate the association between maternal food insecurity and fetal structural anomalies., (© 2023. The Author(s).)

Objectives: The aim of this umbrella review of systematic reviews and meta-analyses was to address workplace violence (WPV) against healthcare workers (HCWs). Several systematic reviews exist in the literature, but the diversity of settings, population considered, and type of violence investigated make it difficult to gain insight and use the vast amount of available data to implement policies to tackle WPV. With this in mind, we conducted an umbrella review of systematic reviews and meta-analyses on WPV against HCWs to examine the global prevalence of the phenomena and its features., Study Design and Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, PubMed, Scopus, and ISI Web of Science were searched for relevant systematic reviews and meta-analyses published in English up to November 2022. Data on authors, year, country, violence type, prevalence (pooled and not), setting, population, and specific considerations were extracted., Results: A total of 32 systematic reviews were included, 19 of which performed a meta-analysis, investigating overall, physical, and non-physical violence. Even considering the variability of the data, the COVID-19 pandemic has exacerbated the scale of the problem. From our review, we found that overall violence prevalence among HCWs was reported to be as high as 78.9%, and nurses working in psychiatric wards were the professionals most impacted., Conclusion: In conclusion, this umbrella review revealed a high prevalence of WPV among HCWs, which varies between countries, population subgroups, and detection methods. Strengthening recognition of the problem could lead to appropriate local and international strategies to address it., (Copyright © 2023 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

The COVID-19 vaccination campaign in Italy started in December 2020, and, due to the Omicron variant's emergence, a second booster dose was recommended for high-risk individuals and healthcare workers from July 2022. The aim of the study was to evaluate the vaccination coverages for the COVID-19 second booster dose and to identify predictors of its acceptance within the population of medical residents (MRs) of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS (FPG) University Hospital. The study was conducted at FPG from October 4th to December 21st, 2022, and COVID-19 second booster dose and influenza vaccines were administered. The study analyzed collected data and conducted multivariate logistic regressions to explore potential predictors of vaccination adherence. The analyses performed were compared with the sample enrolled in FPG residency programs at the start of the COVID-19 vaccination campaign. 1968 MRs were involved in the 2022-2023 vaccination campaign (mean age 28.97, SD 3.44), and the second booster dose of COVID-19 vaccination coverage was low (18.80%). Almost all participants opted for co-administration of COVID-19 and influenza vaccinations, leading to a similar rate of influenza vaccination coverage (16.26%). Being a frontline resident, meaning a direct involvement in managing COVID-19 patients and vaccination campaigns, was the main predictor of vaccination adherence (OR 1.72, 95% CI 1.25-2.17). The dropping in influenza vaccination coverage in 2022-2023 and the low adherence to COVID-19 second booster dose among young physicians is concerning, calling for tailored vaccination campaigns and interventions.

Background and Objective: The capacity to promote and disseminate the best evidence-based practices in terms of digital health innovations and technologies represents an important goal for countries and governments. To support the digital health maturity across countries the Global Digital Health Partnership (GDHP) was established in 2019. The mission of the GDHP is to facilitate global collaboration and knowledge-sharing in the design of digital health services, through the administration of surveys and white papers., Objective: The scope of this study is to critically analyze and discuss results from the Evidence and Evaluation GDHP Work Stream's survey, understand how governments and countries intend to address main obstacles to the digital health implementation, identify their strategies for a communication of effective digital health services, and promote the sharing of international based best practices on digital health., Methods: This survey followed a cross-sectional study approach. A multiple-choice questionnaire was designed to gather data. Choices were extracted from research publications retrieved through a rapid review., Results: Out of 29 countries receiving the survey, 10 returned it. On a scale from 1 to 5, eHealth systems/platforms (mean = 3.56) were indicated as the most important tool for centralized infrastructure to collect information on digital health, while primary care (mean = 4.0) represented the most voted item for healthcare services to collect information on digital health. Seven Countries out of 10 identified lack of organization, skepticism of clinicians, and accessibility of the population as a barriers to adopt digital health implementation, resulting to be the most voted items. Finally, the most endorsed priorities in digital health for Countries were the adoption of data-driven approaches (6 Countries), and telehealth (5 Countries)., Conclusion: This survey highlighted the main tools and obstacles for countries to promote the implementation of evidence-based digital health innovations. Identifying strategies that would communicate the value of health care information technology to healthcare professionals are particularly imperative. Effective communication programs for clinicians and the general population in addition to improved digital health literacy (both for clinicians and citizens) will be the key for the real implementation of future digital health technologies., 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 © 2023 Cascini, Gentili, Causio, Altamura, Melnyk, Beccia, Pappalardo, Lontano and Ricciardi.)

Background: Personalised medicine (PM) has been fostered by technological and medical advances, but all stakeholders, including healthcare professionals, citizens and policy makers, should achieve adequate health literacy to promote PM implementation. The "Integrating China in the International Consortium for Personalised Medicine" (IC2PerMed) project, funded by the International Consortium for Personalised Medicine, focuses on this issue by highlighting the need to educate healthcare professionals and empower citizens. Within the aforementioned project, building on a mapping of European and Chinese policies in PM, experts in the field of PM participated in an online workshop and a following two-round Delphi survey, in order to identify the priority areas of intervention for healthcare professionals' education and curricula, engagement and empowerment of citizens and patients., Results: Nine experts completed the survey and reached a consensus on seventeen priorities: seven were related to health professionals' education and curricula, whereas ten on citizen and patients' awareness and empowerment., Conclusion: These priorities emphasized the importance of education and health literacy, multidisciplinary and international collaboration, public trust, and consideration of ethical, legal, and social issues. The present experience highlights the relevance of the involvement of stakeholders in informing decision-makers, developing appropriate national plans, strategies, and policies, and ensuring the adequate implementation of PM in health systems., (© 2023. The Author(s).)

Introduction: Personalized Medicine (PM) is one of the main priorities of the research agenda of the European Commission and the focus of the European Coordination and Support Action titled "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed). Similar to the European focus, PM is a current priority of the Chinese Government, through dedicated policies and its five-year investment plans. In the context of IC2PerMed, we implemented a survey to understand the state of the art of the implementation of PM related policies in EU and China, and to identify opportunities for future Sino-European collaborations., Methods: The survey was elaborated by the IC2PerMed consortium and validated by a focus group of experts. The final version, in English and Chinese, was administered online to a pool of accurately selected experts. Participation was anonymous and voluntary. The survey consists of 19 questions in 3 sections: (1) personal information; (2) policy in PM; (3) facilitating and hindering factors for Sino-European collaboration in PM., Results: Forty-seven experts completed the survey, 27 from Europe and 20 from China. Only four participants were aware of the implementation of PM-related policies in their working country. Expert reported that PM areas with greatest policy impact so far were: Big Data and digital solutions; citizen and patient literacy; and translational research. The main obstacles found were the lack of shared investment strategies and the limited application of scientific developments in clinical practice. Aligning European and Chinese efforts, finding common ground across cultural, social, and language barriers, were considered as actions needed to enhance efforts in applying PM strategies internationally., Conclusion: To achieve efficiency and sustainability of health systems, it remains crucial to transform PM into an opportunity for all citizens and patients with the commitment of all the stakeholders involved. The results obtained aim to help define common research and development approaches, standards and priorities and increase collaboration at international level, as well as provide key solutions to enable convergence towards a common PM research, innovation, development and implementation approach between Europe and China., (© 2023. The Author(s).)

Aim: Research and innovation (R&I) actors are fundamental in shortening the translational gap of personalized medicine in health systems. In the context of the 'Integrating China in the International Consortium for Personalized Medicine' project, we aimed to map the current landscape of R&I actors in the field of personalized medicine in the EU and China. Methods: A two-phase desk research study was conducted. Results: We identified 78 R&I actors. Research and technology organizations were the most frequent in both the EU and China. The identified R&I actors were active in a wide range of fields. The EU and China have many different R&I actors addressing personalized medicine-related issues, with few characteristics in common. Conclusion: More efforts are needed to ensure these R&I actors are encouraged to work together to bridge each other's gaps.

Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman's correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine's safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.

Background: The increasing availability of Direct-to-Consumer Genetic Tests (DTC-GTs) has great implications for public health (PH) and requires literate healthcare professionals to address the challenges they pose. We designed and conducted a survey to assess the state of knowledge, attitudes and behaviours of PH professionals members of the European Public Health Association (EUPHA) towards DTC-GTs., Methods: EUPHA members were invited to participate and fill in the survey. We performed multivariable logistic regression to evaluate associations between selected covariates and knowledge, attitudes and behaviours of healthcare professionals towards DTC-GT., Results: Three hundred and two professionals completed the survey, 66.9% of whom were not involved in genetics or genomics within their professional activities. Although 74.5% of respondents were aware that DTC-GTs could be purchased on the web, most of them reported a low level of awareness towards DTC-GTs applications and regulatory aspects. The majority did not approve the provision of DTC-GTs without consultation of a healthcare professional (91.4%), were doubtful about the test utility and validity (61%) and did not feel prepared to address citizens' questions (65.6%). Predictors of knowledge on DTC-GT were the involvement in genetics/genomics and receiving training during the studies (P < 0.0001 and P = 0.043). Predictors of attitudes were medical degree and knowledge about DTC-GTs (P = 0.006 and P = 0.027)., Conclusions: Our results revealed a high level of awareness of DTC-GT web purchasing and a moderate to low level of awareness towards their applications. Despite the overall positive attitudes, PH professionals reported a high need for strengthening regulatory aspects of DTC-GTs provision process., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Public Health Association.)

Introduction: This study aims to assess students' knowledge of forensic medicine concepts and their opinions regarding the course taught during the degree course in Medicine and Surgery in an Italian university. Consequently, the study aims to assess the impact of the course on the students' knowledge and attitude in choosing a medical residency., Materials and Methods: A cross-sectional study was conducted through an anonymous web-based survey of medical students at the Università Cattolica del Sacro Cuore. Descriptive and univariate analysis were conducted., Results: 1166 students completed the survey. The forensic medicine course appears to be extremely important in providing training in the fundamental concepts of forensic medicine, especially professional liability, defensive medicine, and forensic pathology. Attending autopsies is important during the course, and their number should be more than ten. Additionally, univariate analysis demonstrates that students' awareness of forensic medicine topics, such as the function of the forensic physicians, professional liability, and defensive medicine, improves in the fifth or sixth year of the course. After the course, more students would choose to pursue a nonclinical and nonsurgical specialty, and forensic medicine specifically, for their residency., Conclusions: The forensic medicine course has the task of defining the duties and responsibilities of forensic physicians, providing indispensable tools for future medical practitioners, regardless of their future specialisation, and limiting the increasing use of defensive medicine. In conclusion, we recommend further multicenter studies to evaluate the role and direct effect of undergraduate forensic medicine courses on students and on the quality of practice., (Copyright © 2023. Published by Elsevier Ltd.)

To maintain safety conditions in the provision of care and assistance, and to protect healthcare workers (HCWs) and patients, the Italian government required compulsory COVID-19 vaccination for HCWs, including medical residents (MRs). The aim of this study was to assess COVID-19 vaccination coverage in MRs in a large tertiary hospital in Italy, before and after the introduction of compulsory vaccination, according to demographic characteristics and specific residency. A database on COVID-19 vaccination status and infection of resident medical doctors was created. Descriptive statistics and logistic regressions were carried out on the data. A total of 1894 MRs were included in the study. Being vaccinated in the same hospital as the residency program was significantly related to the year of residency and being enrolled in a frontline residency. A significant association between compliance with the compulsory primary cycle vaccination and vaccination in the hospital residency was observed. Being enrolled in the second, third, and last years of residency, and in a frontline residency, were predictive of being vaccinated in the residency hospital. Almost 100% of the MRs participating in the study were vaccinated against COVID-19. Compulsory vaccination of HCWs, alongside greater and clearer information about the risks and benefits of vaccination, represents an important booster to ensure public health and to promote quality and safety of care.

Colorectal cancer (RC) is the third most common cancer, with an increasing incidence in recent years. Digital health solutions supporting multidisciplinary tumor boards (MTBs) could improve positive outcomes for RC patients. This paper describes the implementation process of a digital solution within the RC-MTB and its impact analysis in the context of the Fondazione Policlinico 'A. Gemelli' in Italy. Adopting a two-phase methodological approach, the first phase qualitatively describes each phase of the implementation of the IT platform, while the second phase quantitatively describes the analysis of the impact of the IT platform. Descriptive and inferential analyses were performed for all variables, with a p -value < 0.05 being considered statistically significant. The implementation of the platform allowed more healthcare professionals to attend meetings and resulted in a decrease in patients sent to the RC-MTB for re-staging and further diagnostic investigations and an increase in patients sent to the RC-MTB for treatment strategies. The results could be attributed to the facilitated access to the platform remotely for specialists, partly compensating for the restrictions imposed by the COVID-19 pandemic, as well as to the integration of the platform into the hospital's IT system. Furthermore, the early involvement of healthcare professionals in the process of customizing the platform to the specific needs of the RC-MTB may have facilitated its use and contributed to the encouraging quantitative results.

Italy was the first country in the western world to be affected by the COVID-19 pandemic, arguably among the worst-affected ones, counting 12 million cases and 150 thousand deaths two years since the first case. Facing new challenges, Italy has enacted different strategies and policies to limit the spread of the SARS-CoV-2 virus and treat those affected by COVID-19. This narrative review provided an overview of factors, measures, and actions that shaped Italy's first two years of the COVID-19 pandemic by investigating epidemiological data and using a mixed-method approach. This narrative review aimed to summarize the most relevant aspects and measures and analyze available data to provide policymakers and healthcare providers with the instruments to learn from this pandemic and improve their preparedness for future pandemic events. The first two years of the pandemic differ in that, during the first year, significant necessary changes to the way health systems were organized were implemented, increasing healthcare spending and adopting social and physical distancing measures that were stricter than the ones adopted in the second year. However, as the pandemic progressed, increased knowledge of the virus and related variants, as well as the introduction of highly effective vaccines, which were not equally available to the whole population, resulted in a stratification of COVID-19 infections and deaths based on factors such as age, vaccination status, and individual susceptibility to the virus.

To reduce vaccine-preventable diseases in workers, workplace vaccination campaigns can be implemented on-site. The aim of this systematic review was to evaluate adherence to workplace vaccination campaigns. Three databases, PubMed, ISI Web of Science, and Scopus, were screened systematically for articles in English or Italian addressing participation in an on-site vaccination program by employees. The following data was extracted: authors, year, country, type of vaccine, type of workplace, sample size, vaccination rate. Data on the prevalence of flu vaccination were calculated and pooled using a random-effects model. Thirteen articles were included in the review, ten in the meta-analysis. Most studies were conducted in the USA (30.7%) and most vaccination campaigns were against influenza (69.2%), with a pooled estimate of 42% (95% CI: 0.25-0.60%); participation rate was highly variable, ranging from 88.9% for an influenza vaccination campaign to 5.7% for a Lyme disease vaccination campaign. Offering free on-site vaccination can be a successful tool to ensure adherence to vaccination campaigns and administration of all required doses according to the vaccine administration scheme. The occupational physician can play a key role in implementing workplace campaigns for employee mandatory vaccinations.

Introduction: Several countries are either planning or implementing national strategies for the development and integration of Personalized Medicine (PM) into their healthcare systems. Personalized Medicine is an undisputed priority of the European Commission (EC), which has funded the project "Integrating China into the International Consortium for Personalized Medicine" (IC2PerMed), in order to ensure a common basis for Sino-European collaborations. By mapping the current PM landscape in the European Union (EU) and in China, IC2PerMed aims to provide key solutions toward a synergistic and coordinated approach in the field of PM., Methods: An extensive desk research was conducted, aimed at identifying documents on PM-related policies, programs, and action plans in the EU and in China, published up to November 2020. The search was conducted by exploring scientific and gray literature, and official institutional repositories. A descriptive summary condensed the information retrieved for both., Results: Since 2013, the year of publication of the first PM policy by the EC "Use of omics technologies in PM development," several documents have been published. PM is a key element of the policy agenda also in China, which in 2016 integrated PM into the 13th National Five-Year Plan, followed by the publication of several policies on technology infrastructure and big data. Both in the EU and China, especially in recent years, these policies addressed in detail the issues of big data, data interoperability and exchange, while defining the standards of information and communication infrastructures., Conclusions: In order to allow optimal collaboration, it is essential to understand similarities and differences between the respective policy strategies, with particular attention to data management and adopted infrastructures. The results of this project may enable the development of joint Sino-European research and innovation initiatives, promoting developments in the field of PM., (© The Author(s) 2022.)

Purpose of the Study: To assess perception, awareness, and attitudes regarding the medico-legal relevance of child maltreatment and management of pediatric patients during the COVID-19 pandemic in a cohort of medicine and surgery students, with a particular focus on child safety and maltreatment., Methods: A cross-sectional, web-based survey was conducted through an anonymous questionnaire on the personal websites of Università Cattolica del Sacro Cuore medical students., Results: The study included 1,166 participants, the majority of whom were experienced with child maltreatment and defensive medicine; only a small percentage was aware of the government's efforts to prevent child maltreatment and safeguard vaccination physicians. Moreover, there was no agreement on the use of telemedicine for non-serious pediatric patients or on the consequences it might have on their health. Finally, the detrimental impacts of lockdown on children's mental health are a major worry., Conclusions: Knowledge of these themes is mainly implemented by deepening these concepts during the undergraduate studies since a high level of knowledge on child maltreatment and on the management of COVID-19 pandemic was significantly associated with clinical years of course. Specific seminars analyzing telemedicine and legislative protections concerning minors and those concerning vaccination doctors should be included in the study plan to raise awareness these concepts., 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 © 2022 Aulino, Beccia, Rega, Siodambro, Capece, Boccia, Lanzone and Oliva.)

Introduction: Physical activity among children and adolescents remains insufficient, despite the substantial efforts made by researchers and policymakers. Identifying and furthering our understanding of potential modifiable determinants of physical activity behaviour (PAB) and sedentary behaviour (SB) is crucial for the development of interventions that promote a shift from SB to PAB. The current protocol details the process through which a series of systematic literature reviews and meta-analyses (MAs) will be conducted to produce a best-evidence statement (BESt) and inform policymakers. The overall aim is to identify modifiable determinants that are associated with changes in PAB and SB in children and adolescents (aged 5-19 years) and to quantify their effect on, or association with, PAB/SB., Methods and Analysis: A search will be performed in MEDLINE, SportDiscus, Web of Science, PsychINFO and Cochrane Central Register of Controlled Trials. Randomised controlled trials (RCTs) and controlled trials (CTs) that investigate the effect of interventions on PAB/SB and longitudinal studies that investigate the associations between modifiable determinants and PAB/SB at multiple time points will be sought. Risk of bias assessments will be performed using adapted versions of Cochrane's RoB V.2.0 and ROBINS-I tools for RCTs and CTs, respectively, and an adapted version of the National Institute of Health's tool for longitudinal studies. Data will be synthesised narratively and, where possible, MAs will be performed using frequentist and Bayesian statistics. Modifiable determinants will be discussed considering the settings in which they were investigated and the PAB/SB measurement methods used., Ethics and Dissemination: No ethical approval is needed as no primary data will be collected. The findings will be disseminated in peer-reviewed publications and academic conferences where possible. The BESt will also be shared with policy makers within the DE-PASS consortium in the first instance., Systematic Review Registration: CRD42021282874., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Clinical trials are essential for bringing new drugs, technologies and procedures to the market and clinical practice. Considering the design and the four-phase development, only 10% of them complete the entire process, partly due to the increasing costs and complexity of clinical trials. This low completion rate has a huge negative impact in terms of population health, quality of care and health economics and sustainability. Automating some of the process' tasks with artificial intelligence (AI) tools could optimize some of the most burdensome ones, like patient selection, matching and enrollment; better patient selection could also reduce harmful treatment side effects. Although the pharmaceutical industry is embracing artificial AI tools, there is little evidence in the literature of their application in clinical trials., Methods: To address this issue, we performed a scoping review. Following the PRISMA-ScR guidelines, we performed a search on PubMed for articles on the implementation of AI in the development of clinical trials., Results: The search yielded 772 articles, of which 15 were included. The articles were published between 2019 and 2022 and the results were presented descriptively. About half of the studies addressed the topic of patient recruitment; 12 articles reported specific examples of AI applications; five studies presented a quantitative estimate of the effectiveness of these tools., Conclusion: All studies present encouraging results on the implementation of AI-based applications to the development of clinical trials. AI-based applications have a lot of potential, but more studies are needed to validate these tools and facilitate their adoption., 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 © 2022 Cascini, Beccia, Causio, Melnyk, Zaino and Ricciardi.)

The COVID-19 vaccination has proven to be the most effective prevention measure, reducing deaths and hospitalizations and allowing, in combination with non-pharmacological interventions, the pandemic to be tackled. Although most of the adverse reactions to vaccination present mild symptoms and serious effects are very rare, they can be the cause of legal action against the healthcare workers (HCWs) who administered it. To highlight differences in the medical liability systems, we performed a search for the three most populous countries in each continent on vaccine injury compensation programs, new laws or policies to protect HCWs administering vaccinations introduced during the COVID-19 pandemic, and policies on mandatory vaccinations, on literature databases and institutional sites. We found that in seven countries the medical liability system is based on Common Law, while in eleven it is mainly based on Civil Law. Considering the application of specific laws to protect HCWs who vaccinate during the pandemic, only the USA and Canada provided immunity from liability. Among the countries we analyzed, fourteen have adopted compensation funds. From an international perspective, our results highlight that in eleven (61.1%) countries medical liability is mainly based on Civil Law, whilst in seven (38.9%) it is based on Common Law.

The recent progress of genomics research is providing unprecedented insight into human genetic variance, susceptibility to disease and risk stratification. Current trends predict that a massive amount of genomic data will be produced in the upcoming years which, when coupled with the fast-paced development of the field, will create new social, ethical, and legal challenges. In the complex legislative environment of the European Union, genomic data sharing policies will have to weigh the benefits of scientific discovery against the ethical risks posed by the act of sharing sensitive data. In this complex, interconnected environment, blockchain provides a unique and novel solution to accountability, traceability, and transparency issues regarding genomic data sharing. Implementing a distributed ledger technology-based database could empower both patients and citizens to responsibly use genomic data pertaining to them because it allows for a higher degree of control over the recipients of their data and their uses. The blockchain technology will engage both data owners and policymakers to address the multiple issues of genomic data sharing and allow us to redefine the way we look at genomics., (© The Author(s) 2022.)

In 2020, the COVID-19 pandemic exhausted healthcare systems around the world, including European Union countries, with healthcare workers at the frontline. Therefore, new health laws and policies have been introduced at the national level in order to offer greater legal protection for health workers. Since the introduction of COVID-19 vaccination, it has led to the development of specific laws to define the compulsoriness for particular categories. This review aimed to evaluate the system of medical liability, focusing on the ten countries of the European Union with the highest rate of vaccination coverage against SARS-CoV-2. A country-by-country analysis was conducted on the different medical liability systems of individual professionals, in general, and with specific focus on the vaccinating doctors. Additional search was conducted to investigate which European states have introduced specific policies in this field, to identify the implementation of any new laws alongside the COVID-19 vaccination campaigns, and to assess which countries have adopted the European Digital COVID Certificate and funded specific compensation programs for COVID-19 vaccination. Our results highlight an extremely fragmented European scenario; therefore, this work could be a starting point to define a common approach for medical liability and related policies in the COVID-19 pandemic.

The disruptive advances in genomics contributed to achieve higher levels of precision in the diagnosis and treatment of cancer. This scientific advance entails the need for greater literacy for all healthcare professionals. Our study summarizes the training initiatives conducted worldwide in cancer genomics field for healthcare professionals. We conducted a web search of the training initiatives aimed at improving healthcare professionals' literacy in cancer genomics undertaken worldwide by using two search engines (Google and Bing) in English language and conducted from 2003 to 2021. A total of 85,649 initiatives were identified. After the screening process, 36 items were included. The majority of training programs were organized in the United States (47%) and in the United Kingdom (28%). Most of the initiatives were conducted in the last five years (83%) by universities (30%) and as web-based modalities (80%). In front of the technological advances in genomics, education in cancer genomics remains fundamental. Our results may contribute to provide an update on the development of educational programs to build a skilled and appropriately trained genomics health workforce in the future.

Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study was conducted among health staff working at the FPG. Vaccination data were collected from hospital records. The primary end points were vaccine effectiveness and safety. A total of 6649 health workers were included, of whom 5162 received injections. There were 14 cases of COVID-19 with onset at least 14 days after the second dose among vaccinated health workers and 45 cases among unvaccinated ones. BNT162b2 was 91.5% effective against COVID-19 (95% credible interval, 84.7% to 95.3%). The safety profile of BNT162b2 vaccine consisted of short-term, non-serious events. The promotion and boost of the COVID-19 vaccination campaign represents a key public health measure useful to curb the spread of the pandemic especially in vulnerable contexts, such as hospitals, where health workers carry out a paramount role for the entire community, and requires further protection with a possible booster dose in view of autumn-winter 2021.

Summary: The legal responsibility of the vaccinating doctor is one of the central issues in the current setting of the Covid-19 pandemic. The aim of this statement is to outline the profiles of the medical legal liability, with a focus on the figure of the vaccinating physician, in criminal, civil, and disciplinary terms, based on the Italian legislation in force. The vaccinating doctor responds for his work in the field of vaccination in the same way as any other health service should perform (diagnostic, therapeutic, etc.). Helpful in this context is the adoption of the L. 76/2021; it was developed to find a balance between safeguarding the person privacy and greater guarantees for the doctor. This law introduces a criminal shield that can put a limit to litigation, curbing the phenomenon of so-called defensive medicine. The climate of uncertainty and fear of legal repercussions for the doctors, and the constant updating and redefinition of the indications of operability in the vaccination campaigns, underline the need to focus on the knowledge of the responsibilities and the safeguard of the vaccinating doctors. In addition to the regulatory cornerstones, the statement also addresses the issue of informed consent and the role of the occupational doctor as a central figure in the vaccination campaign in the workplace., Competing Interests: The authors of this article have no conflict of interests to disclose., (Copyright© by GIMLE.)