Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

Since 2006, some Italian Regions introduced the active offer of measles, mumps, rubella, and varicella (MMRV) vaccine for all newborns during the second years of life. In 2011, Italian Drug Authority (AIFA) recommended the discontinuation of the MMRV use for an increased risk of febrile seizures following vaccination; furthermore, some Regions (such as Apulia, that introduced MMRV offer in 2009) chose to continue the use of MMRV and Ministry of Health recommended to guarantee supplemental monitoring of safety of the vaccine. In Italy, the surveillance of Adverse Events following immunization (AEFIs) is currently carried out by AIFA and Regional Health Authorities; this paper aims to summarize the results of MMRV-vaccine surveillance of AEFIs program carried out in Apulia. From the AIFA database, we selected MMRV AEFIs that occurred in Apulia (about 4,000,000 inhabitants) from 2009 to 2017. For serious AEFIs, we applied the WHO causality assessment algorithm, using for cases hospitalized information from individual medical records. In the 8 years of observation, 155 MMRV-AEFIs (reporting rate: 37.9×100,000 doses) occurred of which 26 were classified as serious (6.3×100,000 doses) and 22 led to hospitalization. Performing causality assessment, for 10 the classification was "consistent causal association to immunization" (reporting rate: 2.4×100000 doses), for 2 indeterminate, for 13 "inconsistent causal association to immunization" and for 1 not-classifiable. No case of febrile seizure resulted consistent to vaccination. All consistent serious AEFIs were completely resolved at subsequent follow-up.

Telemedicine services can be classified into the macro-categories of specialist Telemedicine, Tele-health and Tele-assistance. From a regulatory perspective, in Italy, the first provision dedicated to the implementation of Telemedicine services is represented by the Agreement between the Government and the Regions on the document bearing “Telemedicine—National guidelines,” approved by the General Assembly of the Superior Health Council in the session of 10th July 2012 and by the State Regions Conference in the session of 20th February 2014. Scientifically, several studies in the literature state that information and communication technologies have great potential to reduce the costs of health care services in terms of planning and making appropriate decisions that provide timely tools to patients. Another clear benefit is the equity of access to health care. The evolution of telemedicine poses a series of legal problems ranging from the profiles on the subject of authorization and accreditation to those concerning the protection of patient confidentiality, the definition and solution of which, in the absence of specific regulatory provisions, is mainly left to the assessment of compatibility of the practices adopted so far, with the general regulatory framework. In terms of professional liability, it is necessary to first clarify that the telemedicine service is comparable to any diagnostic-therapeutic health service considering that the telemedicine service does not replace the traditional health service, but integrates the latter to improve its effectiveness, efficiency and appropriateness.

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-related infection has a major impact on public health, and healthcare workers (HCWs) are exposed to high biological risk. This paper describes the prevention procedures introduced at the University Hospital of Bari, Italy to reduce the risk to HCWs, consisting of enhanced preventive measures and activation of a report system to collect HCWs' contacts. Twenty-three confirmed cases of infection (0.4% of all HCWs) were reported in the 30-day observation period following implementation of the protocol. This shows that correct management of HCWs' contacts is essential to avoid nosocomial clusters.

Mounting evidence has linked the metabolic disease to neurovascular disorders and cognitive decline. Using a murine model of a high‐fat high‐sugar diet mimicking obesity‐induced type 2 diabetes mellitus (T2DM) in humans, we show that pro‐inflammatory mediators and altered immune responses damage the blood‐brain barrier (BBB) structure, triggering a proinflammatory metabolic phenotype. We find that disruption to tight junctions and basal lamina due to loss of control in the production of matrix metalloproteinases (MMPs) and their inhibitors (TIMPs) causes BBB impairment. Together the disruption to the structural and functional integrity of the BBB results in enhanced transmigration of leukocytes across the BBB that could contribute to an initiation of a neuroinflammatory response through activation of microglia. Using a humanized in vitro model of the BBB and T2DM patient post‐mortem brains, we show the translatable applicability of our results. We find a leaky BBB phenotype in T2DM patients can be attributed to a loss of junctional proteins through changes in inflammatory mediators and MMP/TIMP levels, resulting in increased leukocyte extravasation into the brain parenchyma. We further investigated therapeutic avenues to reduce and restore the BBB damage caused by HFHS‐feeding. Pharmacological treatment with recombinant annexin A1 (hrANXA1) or reversion from a high‐fat high‐sugar diet to a control chow diet (dietary intervention), attenuated T2DM development, reduced inflammation, and restored BBB integrity in the animals. Given the rising incidence of diabetes worldwide, understanding metabolic‐disease‐associated brain microvessel damage is vital and the proposed therapeutic avenues could help alleviate the burden of these diseases.

Background and Objectives: The first clusters of SARS-CoV-2 infection were identified in an occupational setting, and to date, a significant portion of the cases may result from occupational exposure; thus, COVID-19 should also be considered a new occupational risk that both directly and indirectly impacts the health of workers. Given the significance of occupational-exposure-related infections and deaths, this study aims to assess the roles and tasks of occupational physicians (OPs) in countering the spread of the infection. Indeed, despite the OP’s centrality in risk management in the workplace, its activity in the current epidemic context has rarely been mentioned. Materials and Methods: Three different databases (PubMed, Google Scholar, and Embase) were questioned using the main keywords “COVID-19” and “SARS-CoV-2” that were crossed, according to different needs, with the terms “occupational medicine”, “occupational physician”, “workplace”, and “risk assessment” using, when possible, the MeSH database research. Additionally, a systematic research of the regulatory changes of workplaces health surveillance was performed on reference sites of international, European, and Italian authorities. Results: Fundamental tasks and duties of OPs in the current COVID-19 outbreak are highlighted by examining their clinical activity and technical action. A risk assessment and management workflow is proposed, and medico-legal implications in case of infection at work are also discussed in the light of recent regulatory changes that clearly attribute to OPs an important role in safeguarding public health. Conclusion: The proposed approach can provide new instruments to contrast the spread of the infection as part of a comprehensive system response to the current pandemic, for which OPs are called to assume full responsibility.

BackgroundAlthough surgery is essential in healthcare, a significant number of patients suffer unfair harm while undergoing surgery. Many of these originate from failures in non-technical aspects, especially communication among operators. A surgical safety checklist is a simple tool that helps to reduce surgical adverse events, but even if it is fast to fill out, its compilation is often neglected by the healthcare workers because of unprepared cultural background. The present study aims to value the efficacy of a free intervention, such as a short training about risk management and safety checklist, to improve checklist adherence.MethodsIn March 2019, the medical and nursing staff of the General Surgical Unit attended a two-lesson theoretical training concerning surgical safety and risk management tools such as the surgical safety checklist. The authors compared the completeness of the surgical checklists after and before the training, considering the same period (2 months) for both groups.ResultThe surgical safety checklists were present in 198 cases (70.97%) before the intervention and 231 cases (96.25%) after that. After the training, the compilation adherence increased for every different type of healthcare worker of the unit (surgeons, nurses, anesthetists, and scrab nurses). Furthermore, a longer hospitalization was associated with a higher surgical checklist adherence by the operators.ConclusionsThe results showed that a free and simple intervention, such as a two-lesson training, significantly stimulated the correct use of the surgical safety checklist. Moreover, the checklist adherence increased even for the operators who did not attend the training, maybe because of the positive influence of the colleagues' positive behaviors. As the results were promising with only two theoretical lessons, much more can be done to build a new safety culture in healthcare.

Clinical risk management constitutes a central element in the healthcare systems in relation to the reverberation that it establishes, and as regards the optimization of clinical outcomes for the patient. The starting point for a right clinical risk management is represented by the identification of non-conforming results. The aim of the study is to carry out a systematic analysis of all data received in the first three years of adoption of a reporting system, revealing the strengths and weaknesses. The results emerged showed an increasing trend in the number of total records. Notably, 86.0% of the records came from the medical category. Moreover, 41.0% of the records reported the possible preventive measures that could have averted the event and in 30% of the reports are hints to be put in place to avoid the repetition of the events. The second experimental phase is categorizing the events reported. Implementing the reporting system, it would guarantee a virtuous cycle of learning, training and reallocation of resources. By sensitizing health workers to a correct use of the incident reporting system, it could become a virtuous error learning system. All this would lead to a reduction in litigation and an implementation of the therapeutic doctor–patient alliance.