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The concurrent administration of COVID-19 and influenza vaccines has arisen as a promising approach to bolster protection against respiratory pathogens and improve vaccination rates. However, there remains a lack of data regarding the prevalence of co-administration across several vaccination campaigns, especially among healthcare workers (HCWs). Therefore, this study aims to shed light on the acceptance of co-administration strategies among HCWs during the two campaigns following the introduction of the anti-SARS-CoV-2 vaccine. A retrospective cohort study was conducted among the HCWs of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, a research hospital in Rome. Hospital administrative databases were accessed to gather information about vaccination for SARS-CoV-2 and influenza during the 2021/2022 and 2022/2023 vaccination campaigns. The study included 7399 HCWs. The co-administration of anti-SARS-CoV-2 and influenza vaccines presented a significant rise in 2022/2023 compared to the previous vaccination campaign (+38%): this was confirmed for every professional category, with the largest increases among resident doctors (+47%) and physicians (+44%), and also for every age category, but it was particularly evident for the youngest health professionals. The probability of co-administration uptake during the 2022/2023 campaign was significantly higher for males, and for those that received co-administration during the 2021/2022 campaign, while the probability was lower for nurses and administrative staff. This study highlights the co-administration procedure as a valuable and effective tool in annual vaccination campaigns for SARS-CoV-2 and influenza. The procedure's safety and streamlined logistics make it increasingly attractive for implementation, particularly among HCWs.

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/purpose: Since a significant proportion of SARS-CoV-2 infections occur within healthcare facilities, a multidisciplinary approach is required for careful and timely assessment of the risk of infection in asymptomatic patients or those whose COVID-19 diagnosis has not yet been made. The aim of this study was to investigate whether an adaptative model based on microbiological testing can represent a valid risk management strategy. Material and methods: We collected data from the risk management unit database of a 1,550-bed tertiary hospital (Fondazione Policlinico Gemelli IRCCS, Rome, Italy) concerning pediatric admissions to the Emergency Department (ED) from 1 March 2020 to 31 December 2021. The study period was subdivided in period A and period B according to the technique used for the microbiological screening, respectively reverse-transcription polymerase chain reaction (RT-PCR) and antigen-detection test. Results: In Period A, 426 children (mean age: 6 years) underwent microbiological screening at the ED. The total number of molecular tests performed was 463. 459/463 tested negative at the molecular test. In Period B, 887 children (mean age: 6 years) underwent microbiological screening in the ED. The total number of molecular tests performed was 1,154. 1,117/1,154 tested negative at the molecular test. Neither in Period A nor in Period B hospital-acquired SARS-CoV-2 infections were reported. Discussion and conclusion: Despite high volumes, no cases of hospital-acquired SARS-CoV-2 infection have been reported. SARS-CoV-2 antigen-based tests can be used as a first-line option as they provide rapid results compared to RT-PCR, reducing the risk of infection in ED waiting rooms.

The efficacy of the first schedule of COVID-19 mRNA vaccines has decreased after the surge of the Delta variant, posing the need to administer a booster dose to enhance the neutralising immune response. This study aims at evaluating the duration of protection given by the booster dose of Pfizer-BioNTech BNT162b2 mRNA vaccine in healthcare workers (HCWs) of a large teaching hospital in Rome and to analyse the factors associated with post-booster vaccination infections. Data about vaccinations of HCWs with the BNT162b2 vaccine and nasal swabs positive for SARS-CoV-2 were extracted from the digital archives of the hospital from 27 September 2021 to 31 May 2022. In total, 5770 HCWs were observed. The cumulative risk of becoming infected by SARS-CoV-2 increased with time (2.5% at 4 weeks, 17% at 12 weeks and 40% at 24 weeks) and was significantly higher for females, younger classes of patients and for those who had developed a hybrid immunity (natural infection plus one dose, namely the primary schedule, added to the booster dose) compared to those who had completed the three doses. This study describes the duration and the determinants of the protection against infections after the booster dose of COVID-19 vaccine, highlighting the need for continuous monitoring of vaccine-induced immunogenicity.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020-3 May 2020 and 3 November 2020-27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (-0.138--0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013-0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013-0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (-0.050--0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

Vaccinations generate health, economic and social benefits in both vaccinated and unvaccinated populations. The aim of this study was to conduct a cost–benefit analysis to estimate the costs and benefits associated with the COVID-19 vaccination campaign for health workers in Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The analysis included 5152 healthcare workers who voluntarily received the Pfizer–BioNTech COVID-19 vaccine, divided into physicians, nurses and other health workers. Data about vaccine cost, administration and materials were derived from administrative databases of the FPG from 28 December 2020 to 31 March 2021. The costs associated with the COVID-19 vaccination campaign amounted to EUR 2,221,768, while the benefits equaled EUR 10,345,847. The benefit-to-cost ratio resulted in EUR 4.66, while the societal return on investment showed a ratio of EUR 3.66. The COVID-19 vaccination campaign for health workers in FPG has high social returns and it strengthens the need to inform and update decision-making about the economic and social benefits associated with a vaccination campaign. Health economic evaluations on vaccines should always be considered by decision-makers when considering the inclusion of a new vaccine into the national program.

Alcohol is a significant public health issue, according to the World Health Organization. Our study aims to analyze the correlation between blood alcohol concentrations (BACs) of drivers, their demographic features, and the possible underestimation of BACs due to the time elapsed between hospital admission and blood sampling. Methods: This study includes patients evaluated for BAC levels in the emergency department (ED) of Fondazione Policlinico Universitario A. Gemelli IRCCS from January 2013 to December 2016. BAC levels were compared in patients involved in road crashes according to age group, sex, and time of the accident. The delays in blood sampling and BAC measurement in the ED were recorded for each patient. The time between the accident and access to the hospital in most cases was unknown. Results: A total of 398 patients were included in the analysis, 107 of them had BACs more than 0.05 g/L., and 86 of these individuals had BAC levels more than 0.5 g/L. Road accident patients had higher rates of positive BAC readings at night and on weekends. A significant delay in blood sampling for BAC determination was observed. Discussion: This study demonstrates a critical bias due to the arrival time at the ED and the delay in blood sampling that inevitably influences and underestimates the BAC, resulting in possible false negative results (BAC values below the cutoff). Zero tolerance or a retrospective BAC calculation could mitigate this bias. It is necessary to implement preventive strategies to reduce instances of driving under the influence (DUI) of alcohol.

This study reports the detection of a set of 35 peptide fragments and 7 intact proteins in the vitreous humour using a top-down proteomic platform based on high-resolution HPLC-MS and MS/MS analysis. The concentrations of thymosin b4 (R = 0.932) and two peptide fragments (i.e., vimentin fragment (Fr.) 443-465 (R = 0.998) and polyubiquitin Fr. 1-73 (R = 0.968)) were observed to have very strong linear correlations with postmortem intervals. Data are available via ProteomeXchange with identifier PXD037095. These preliminary results suggest that some biochemical molecular events are linearly related to the postmortem interval and that the concentrations of these peptides and fragments can be clinically useful in establishing the time of death if measured within the first 160 h postmortem. (c) 2022 Elsevier B.V. All rights reserved.

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Discussing border areas in Head and Neck pathologies means addressing diseases’ convergence point of different specialities and professionalisms guided by a common goal: patient health. Starting from the concept of a border, it becomes possible to define the content of a new model of team responsibility: no longer that of the team leader who, as a new Agamemnon, takes on the role of scapegoat when things go wrong, even for errors not directly attributable to his supervision, but that of a primus inter pares, a King Arthur with the Knights of the Round Table, committed like the others, each with his wealth of experience and knowledge, to pursue the same goal. A member of this team assumes the role of spokesperson for diagnostic and therapeutic solutions within a process of acquiring consent that recovers the dimension of verbal and non-verbal communication with the patient. In such a context, in which criminal liability can be challenging to identify based on the principle of in dubio pro reo and civil liability in some countries has already transferred the burden of compensation from the professional to the healthcare facility. In most, no-fault compensation systems appear consistent.

Background and aim: COVID-19 is an extremely challenging disease, both from a clinical and forensic point of view, and performing autopsies of COVID-19 deceased requires adequately equipped sectorial rooms and exposes health professionals to the risk of contagion. Among one of the categories that are most affected by SARS-Cov-2 infection are the elderly residents. Despite the need for prompt diagnoses, which are essential to implement all isolation measures necessary to contain the infection spread, deceased subjects in longterm care facilities are still are often diagnosed post-mortem. In this context, our study focuses on the use of post-mortem computed tomography for the diagnosis of COVID-19 infection, in conjunction with post-mortem swabs. The aim of this study was to assess the usefulness of post-mortem whole CT-scanning in identifying COVID-19 pneumonia as a cause of death, by comparing chest CT-findings of confirmed COVID-19 fatalities to control cases. Materials and methods: The study included 24 deceased subjects: 13 subjects coming from long-term care facility and 11 subjects died at home. Whole body CT scans were performed within 48 h from death in all subjects to evaluate the presence and distribution of pulmonary abnormalities typical of COVID-19-pneumonia, including: ground-glass opacities (GGO), consolidation, and pleural effusion to confirm the post-mortem diagnosis. Results: Whole-body CT scans was feasible and allowed a complete diagnosis in all subjects. In 9 (69%) of the 13 cases from long-term care facility the cause of death was severe COVID 19 pneumonia, while GGO were present in 100% of the study population. Conclusion: In the context of rapidly escalating COVID-19 outbreaks, given that laboratory tests for the novel coronavirus is time-consuming and can be falsely negative, the post-mortem CT can be considered as a reliable and safe modality to confirm COVID-19 pneumonia. This is especially true for specific postmortem chest CT-findings tha

Incident reporting is an important method to identify risks because learning from the reports is crucial in developing and implementing effective improvements. A medical malpractice claims analysis is an important tool in any case. Both incident reports and claims show cases of damage caused to patients, despite incident reporting comprising near misses, cases where no event occurred and no-harm events. We therefore compare the two worlds to assess whether they are similar or definitively different. From 1 January 2014 to 31 December 2021, the claims database of Policlinico Universitario A. Gemelli IRCCS collected 843 claims. From 1 January 2020 to 31 December 2021, the incident-reporting database collected 1919 events. In order to compare the two, we used IBNR calculation, usually adopted by the insurance industry to determine loss to a company and to evaluate the real number of adverse events that occurred. Indeed, the number of reported adverse events almost overlapped with the total number of events, which is indicative that incurred-but-not-reported events are practically irrelevant. The distribution of damage events reported as claims in the period from 1 January 2020 to 31 December 2021 and related to incidents that occurred in the months of the same period, grouped by quarter, was then compared with the distribution of damage events reported as adverse events and sentinel events in the same period, grouped by quarter. The analysis of the claims database showed that the claims trend is slightly decreasing. However, the analysis of the reports database showed that, in the period 2020–2021, the reports trend was increasing. In our study, the comparison of the two, malpractice claims and incident reporting, documented many differences and weak areas of overlap. Nevertheless, this contribution represents the first attempt to compare the two and new studies focusing on single types of adverse events are, therefore, desirable.

Artificial intelligence needs big data to develop reliable predictions. Therefore, storing and processing health data is essential for the new diagnostic and decisional technologies but, at the same time, represents a risk for privacy protection. This scoping review is aimed at underlying the medico-legal and ethical implications of the main artificial intelligence applications to healthcare, also focusing on the issues of the COVID-19 era. Starting from a summary of the United States (US) and European Union (EU) regulatory frameworks, the current medico-legal and ethical challenges are discussed in general terms before focusing on the specific issues regarding informed consent, medical malpractice/cognitive biases, automation and interconnectedness of medical devices, diagnostic algorithms and telemedicine. We aim at underlying that education of physicians on the management of this (new) kind of clinical risks can enhance compliance with regulations and avoid legal risks for the healthcare professionals and institutions.