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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.
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Sangre Fetal , Retinopatía de la Prematuridad , Humanos , Retinopatía de la Prematuridad/prevención & control , Recién Nacido , Femenino , Masculino , Método Doble Ciego , Transfusión de Eritrocitos , Recien Nacido Extremadamente Prematuro , Edad Gestacional , Resultado del Tratamiento , Índice de Severidad de la EnfermedadRESUMEN
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.
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Pruebas Genéticas , Difusión de la Información , Medicina de Precisión , Opinión Pública , Humanos , Medicina de Precisión/métodos , Pruebas Genéticas/métodos , Difusión de la Información/métodos , Estudios Transversales , Encuestas y Cuestionarios , Europa (Continente) , Masculino , Femenino , Adulto , Persona de Mediana Edad , Registros Electrónicos de Salud , AncianoRESUMEN
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.
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COVID-19 , Servicio de Urgencia en Hospital , Hospitalización , Hospitales Pediátricos , Infecciones del Sistema Respiratorio , SARS-CoV-2 , Centros de Atención Terciaria , Humanos , Italia/epidemiología , COVID-19/epidemiología , Lactante , Hospitalización/estadística & datos numéricos , Preescolar , Centros de Atención Terciaria/estadística & datos numéricos , Femenino , Masculino , Niño , Estudios Retrospectivos , Infecciones del Sistema Respiratorio/epidemiología , Infecciones del Sistema Respiratorio/virología , Servicio de Urgencia en Hospital/estadística & datos numéricos , Hospitales Pediátricos/estadística & datos numéricos , Adolescente , Recién NacidoRESUMEN
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.
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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.
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Traumatismos Craneocerebrales , Traumatismo Múltiple , Humanos , Accidentes de Tránsito/prevención & control , Ciudad de Roma/epidemiología , Ciclismo/lesiones , Traumatismos Craneocerebrales/epidemiología , Traumatismos Craneocerebrales/prevención & control , Traumatismos Craneocerebrales/etiología , Traumatismo Múltiple/complicaciones , Dispositivos de Protección de la Cabeza , Evaluación de Resultado en la Atención de Salud , DemografíaRESUMEN
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.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Consenso , Técnica Delphi , Procedimientos Endovasculares , Humanos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/normas , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/normas , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Valor Predictivo de las Pruebas , Factores de Tiempo , Aortografía/normas , Angiografía por Tomografía Computarizada/normas , Reparación Endovascular de AneurismasRESUMEN
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.
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Atención a la Salud , Medicina de Precisión , Humanos , Unión Europea , ChinaRESUMEN
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.
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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.
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Atención a la Salud , Medicina de Precisión , Humanos , ChinaRESUMEN
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.
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Transfusión de Eritrocitos , Retinopatía de la Prematuridad , Adulto , Humanos , Lactante , Recién Nacido , Masculino , Estudios de Cohortes , Sangre Fetal , Oxígeno , Proyectos Piloto , FemeninoRESUMEN
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.
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COVID-19 , Vacunas contra la Influenza , Gripe Humana , Internado y Residencia , Humanos , Adulto , Centros de Atención Terciaria , Vacunas contra la COVID-19 , Gripe Humana/prevención & control , Estaciones del Año , COVID-19/prevención & control , SARS-CoV-2 , Vacunación , Italia/epidemiologíaRESUMEN
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.
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Salud Global , Personal de Salud , Humanos , Estudios Transversales , Encuestas y Cuestionarios , Encuestas EpidemiológicasRESUMEN
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.
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Curriculum , Medicina de Precisión , Humanos , Escolaridad , China , Atención a la SaludRESUMEN
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.
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Abastecimiento de Alimentos , Ultrasonografía Prenatal , Embarazo , Humanos , Femenino , Proyectos Piloto , Reproducibilidad de los Resultados , Primer Trimestre del Embarazo , Encuestas y Cuestionarios , Inseguridad AlimentariaRESUMEN
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.
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Medicina de Precisión , Tecnología , Humanos , ChinaRESUMEN
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.
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Medicina de Precisión , Humanos , China , Unión EuropeaRESUMEN
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.
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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.