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1.
Vaccines ; 10(5):635, 2022.
Article in English | MDPI | ID: covidwho-1792362

ABSTRACT

Italy, like other European countries, has produced a series of regulations during the COVID-19 pandemic. Compulsory vaccination has been introduced for the Italian population. Meanwhile, the Decree-Law 27 January 2022 n. 4 provided for the compensation mechanism for those who have received damage of the psycho-physical integrity due to the anti-SARS-CoV-2 vaccination recommended by the Italian Health Authority. Law 1992 no. 210 already provided for the indemnity system for persons damaged by irreversible complications due to compulsory vaccinations, transfusions, and the administration of blood products. The legislator intended to attribute the right to an indemnity that is not compensatory in order to repair a wrong connected to some hypothesis of liability, but it rather has a welfare character in the broad sense, being attributable to Constitutional fundamentals. In the Italian panorama, although the vaccination damages have been fully included in the already existing law no. 210/1992, to date, no precise indications have been provided regarding the ascertainment of the causal link and the extent of the compensable damage. In the near future, the interest of the scientific community will focus on the evaluation of applications for access to the benefit.

2.
Vaccines (Basel) ; 10(2)2022 Feb 16.
Article in English | MEDLINE | ID: covidwho-1703957

ABSTRACT

More than eight billion doses of COVID-19 vaccines have been administered globally so far and 44.29% of people are fully vaccinated. Pre-authorization clinical trials were carried out and the safety of vaccines is still continuously monitored through post-commercialization surveillance. However, some people are afraid of vaccine side effects, claiming they could lead to death, and hesitate to get vaccinated. Herein, a literature review of COVID-19-vaccine-related deaths has been carried out according to the PRISMA standards to understand if there is a causal relationship between vaccination and death and to highlight the real extent of such events. There have been 55 cases of death after COVID-19 vaccination reported and a causal relationship has been excluded in 17 cases. In the remaining cases, the causal link between the vaccine and the death was not specified (8) or considered possible (15), probable (1), or very probable/demonstrated (14). The causes of deaths among these cases were: vaccine-induced immune thrombotic thrombocytopenia (VITT) (32), myocarditis (3), ADEM (1), myocardial infarction (1), and rhabdomyolysis (1). In such cases, the demonstration of a causal relationship is not obvious, and more studies, especially with post-mortem investigations, are needed to deepen understanding of the possible pathophysiological mechanisms of fatal vaccine side effects. In any event, given the scarcity of fatal cases, the benefits of vaccination outweigh the risks and the scientific community needs to be cohesive in asserting that vaccination is fundamental to containing the spread of SARS-CoV-2.

3.
Vaccines (Basel) ; 10(2)2022 Jan 30.
Article in English | MEDLINE | ID: covidwho-1677719

ABSTRACT

At the end of 2020, a vaccination campaign against COVID-19 was launched. In 2021, legal obligations for health workers, as well as specific regulations for all workers, were introduced. The global SARS-CoV-2 pandemic was followed by epochal changes in life, school, and work habits in Italy. Therefore, the pharmacovigilance work currently being conducted in Italy by the AIFA concerning the recording and analysing of adverse reactions related to the use of vaccines has proved to be very important. The latest report, including a period of 10 months from December 2020 to September 2021, has allowed us to combine the results received so far, and to compare the safety of all vaccines currently available in Italy. The results of this analysis are highly encouraging and reveal the statistical reliability of the safety of the COVID-19 vaccines currently used in Italy. The dissemination of these findings could increase the public's awareness of vaccines and their ability to make free and informed choices concerning vaccination. The potential increase in the Italian population's adherence to the vaccination campaign could ultimately be a decisive factor in achieving herd immunity and the final resolution of the pandemic.

5.
Diagnostics (Basel) ; 11(9)2021 Sep 08.
Article in English | MEDLINE | ID: covidwho-1649974

ABSTRACT

Coronavirus disease 2019 (COVID-19) can potentially affect all organs owing to the ubiquitous diffusion of the angiotensin-converting enzyme II (ACE2) receptor-binding protein. Indeed, the SARS-CoV-2 virus is capable of causing heart disease. This systematic review can offer a new perspective on the potential consequences of COVID-19 through an analysis of the current literature on cardiac involvement. This systematic review, conducted from March 2020 to July 2021, searched the current literature for postmortem findings in patients who were positive for SARS-CoV-2 by combining and meshing the terms "COVID-19", "postmortem", "autopsy", and "heart" in titles, abstracts, and keywords. The PubMed database was searched following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Sixteen papers met the inclusion criteria (case reports and series, original research, only English-written). A total of 209 patients were found (mean age (interquartile range (IQR)), 60.17 years (IQR, 54.75-70.75 years); 122 men (58.37%, ratio of men to women of 1:0.7%)). Each patient tested positive for SARS-CoV-2. Death was mainly the result of respiratory failure. The second most common cause of death was acute heart failure. Few patients specifically died of myocarditis. Variables such as pathological findings, immunohistochemical data, and previous clinical assessments were analyzed. Main cardiac pathological findings were cardiac dilatation, necrosis, lymphocytic infiltration of the myocardium, and small coronary vessel microthrombosis. Immunohistochemical analyses revealed an inflammatory state dominated by the constant presence of CD3+ and CD8+ cytotoxic lymphocytes and CD68+ macrophages. COVID-19 leads to a systemic inflammatory response and a constant prothrombotic state. The results of our systematic review suggest that SARS-CoV-2 was able to cause irreversible changes in several organs, including the heart; this is reflected by the increased cardiac risk in patients who survive COVID-19. Postmortem analysis (including autopsy, histologic, and immunohistochemical examination) is an indispensable tool to better understand pathological changes caused by emerging diseases such as COVID-19. Our results may provide more information on the involvement of the heart in COVID-19 patients.

7.
Front Med (Lausanne) ; 8: 787805, 2021.
Article in English | MEDLINE | ID: covidwho-1581283

ABSTRACT

The pandemic from COVID-19 causes a health threat for many countries and requires an internationally coordinated response due to the high spread of the infection. The current local and international situation gives rise to logistical and ethical considerations regarding the imbalance between needs for assistance and availability of health resources in the continuation of the emergency. A shortage condition will require healthcare professionals to choose between patients who will have access to respiratory support and those who will have to continue without. The sharing of criteria for the introduction of patients to the different therapeutic paths is fundamental to prevent the onset of ethical issues. The present paper analyzes the critical issues related to the scarcity of healthcare resources and the limitation of access to intensive care with the aim of proposing ethically sustainable principles for the management of the current pandemic situation.

8.
Int J Environ Res Public Health ; 19(1)2021 Dec 21.
Article in English | MEDLINE | ID: covidwho-1580863

ABSTRACT

The syndemic framework proposed by the 2021-2030 World Health Organization (WHO) action plan for patient safety and the introduction of enabling technologies in health services involve a more effective interpretation of the data to understand causation. Based on the Systemic Theory, this communication proposes the "Systemic Clinical Risk Management" (SCRM) to improve the Quality of Care and Patient Safety. This is a new Clinical Risk Management model capable of developing the ability to observe and synthesize different elements in ways that lead to in-depth interventions to achieve solutions aligned with the sustainable development of health services. In order to avoid uncontrolled decision-making related to the use of enabling technologies, we devised an internal Learning Algorithm Risk Management (LARM) level based on a Bayesian approach. Moreover, according to the ethics of Job Well Done, the SCRM, instead of giving an opinion on events that have already occurred, proposes a bioethical co-working because it suggests the best way to act from a scientific point of view.


Subject(s)
COVID-19 , Bayes Theorem , Humans , Pandemics/prevention & control , Risk Management , SARS-CoV-2 , Syndemic
9.
Int J Environ Res Public Health ; 18(22)2021 11 13.
Article in English | MEDLINE | ID: covidwho-1512364

ABSTRACT

Nowadays only a few studies on biological and environmental risk among healthcare workers are available in literature. The present study aims to assess the health operator's risk of contact with microorganisms during necropsy activities, to evaluate the efficiency of current protections, to identify possible new sources of contact, and to point out possible preventive measures. In addition, considering the current pandemic scenario, the risk of transmission of SARS-CoV-2 infection in the dissection room is assessed. The objectives were pursued through two distinct monitoring campaigns carried out in different periods through sampling performed both on the corpses and at the environmental level.


Subject(s)
COVID-19 , Autopsy , Health Personnel , Humans , Pandemics , SARS-CoV-2
10.
Panminerva Med ; 63(3): 324-331, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1504553

ABSTRACT

BACKGROUND: New messenger RNA (mRNA) and adenovirus-based vaccines (AdV) against Coronavirus disease 2019 (COVID-19) have entered large scale clinical trials. Since healthcare professionals (HCPs) and armed forces personnel (AFP) represent a high-risk category, they act as a suitable target population to investigate vaccine-related side effects, including headache, which has emerged as a common complaint. METHODS: We investigated the side-effects of COVID-19 vaccines among HCPs and AFP through a 38 closed-question international survey. The electronic link was distributed via e-mail or via Whatsapp to more than 500 contacts. Responses to the survey questions were analyzed with bivariate tests. RESULTS: A total of 375 complete surveys have been analyzed. More than 88% received an mRNA vaccine and 11% received AdV first dose. A second dose of mRNA vaccine was administered in 76% of individuals. No severe adverse effects were reported, whereas moderate reactions and those lasting more than 1 day were more common with AdV (P=0.002 and P=0.024 respectively). Headache was commonly reported regardless of the vaccine type, but less frequently, with shorter duration and lower severity that usually experienced by participants, without significant difference irrespective of vaccine type. CONCLUSIONS: Both mRNA and AdV COVID-19 vaccines were safe and well tolerated in a real-life subset of HCPs and AFP subjects.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Headache/chemically induced , Vaccination/adverse effects , Adolescent , Adult , Aged , COVID-19/transmission , Cross-Sectional Studies , Female , Headache/diagnosis , Headache/epidemiology , Health Care Surveys , Health Personnel , Humans , Incidence , Male , Middle Aged , Occupational Health , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Young Adult
11.
Vaccines (Basel) ; 9(10)2021 Sep 30.
Article in English | MEDLINE | ID: covidwho-1444353

ABSTRACT

Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In many countries, a no-fault program was established to compensate individuals who experienced serious vaccine-related injuries. The impressive number of administrations worldwide and the legal indemnity afforded to manufacturers of approved vaccines that cannot be pursued for compensation fed the debate about the availability of a compensation model for COVID-19 vaccine-related injuries. Several European countries have long introduced a system, Vaccine Injury Compensation Programs, to compensate people who suffer physical harm because of vaccination. In Europe, COVID-19 vaccination is strongly recommended for the general population and in many states is declared mandatory for healthcare workers. In 1992, Italy edited Law no. 210 providing legal protection for individuals who reported injuries after mandatory and recommended vaccinations as a no-fault alternative to the traditional tort system. Despite its recommended nature, COVID-19 vaccination is excluded from the no-fault model in several European states, and the Italian government is called to provide clear and firm instructions for the management of the many requests for compensation. The authors provide an overview of the existing compensation models in Europe and analyse available legislative proposals.

12.
Forensic Sci Med Pathol ; 18(1): 4-19, 2022 03.
Article in English | MEDLINE | ID: covidwho-1391995

ABSTRACT

This study involves the histological analysis of samples taken during autopsies in cases of COVID-19 related death to evaluate the inflammatory cytokine response and the tissue localization of the virus in various organs. In all the selected cases, SARS-CoV-2 RT-PCR on swabs collected from the upper (nasopharynx and oropharynx) and/or the lower respiratory (trachea and primary bronchi) tracts were positive. Tissue localization of SARS-CoV-2 was detected using antibodies against the nucleoprotein and the spike protein. Overall, we tested the hypothesis that the overexpression of proinflammatory cytokines plays an important role in the development of COVID-19-associated pneumonia by estimating the expression of multiple cytokines (IL-1ß, IL-6, IL-10, IL-15, TNF-α, and MCP-1), inflammatory cells (CD4, CD8, CD20, and CD45), and fibrinogen. Immunohistochemical staining showed that endothelial cells expressed IL-1ß in lung samples obtained from the COVID-19 group (p < 0.001). Similarly, alveolar capillary endothelial cells showed strong and diffuse immunoreactivity for IL-6 and IL-15 in the COVID-19 group (p < 0.001). TNF-α showed a higher immunoreactivity in the COVID-19 group than in the control group (p < 0.001). CD8 + T cells where more numerous in the lung samples obtained from the COVID-19 group (p < 0.001). Current evidence suggests that a cytokine storm is the major cause of acute respiratory distress syndrome (ARDS) and multiple organ failure and is consistently linked with fatal outcomes.


Subject(s)
COVID-19 , Cytokine Release Syndrome , Viral Load , COVID-19/mortality , COVID-19/pathology , Endothelial Cells , Humans , Interleukin-15 , Interleukin-1beta , Interleukin-6 , SARS-CoV-2 , Tumor Necrosis Factor-alpha
13.
Int J Environ Res Public Health ; 18(7)2021 03 25.
Article in English | MEDLINE | ID: covidwho-1378236

ABSTRACT

Over the past two decades, health litigation has followed an exponentially incremental trend. As insurance companies tend to limit their interest because of the high risk of loss, health facilities increasingly need to internalize dispute management. This study was conducted through a retrospective analysis of existing files concerning the civil litigation of the Sant'Andrea Hospital in Rome. All claims from 1 June 2010 to 30 June 2019 were included. Paid claims were further classified according to the areas of health care inappropriateness found. Authors indexed 567 different claims along the study period, with an average number of 59 per year (range 38-77). The total litigation involved 47 different units; more than 40% concerned 5 high-incidence wards or services. Concerning the course of disputes, 91 cases were liquidated before a judicial procedure was instituted, while 177 cases landed in a civil court. Globally, 131 different claims hesitated in compensation, for a total of 16 million 625 thousand euros, 41% of which was related to the internal medicine area. Dealing with the inappropriateness analysis, clinical performance alone involved 76 cases, for a total of 10 million 320 thousand euros, while organization defects involved 20 disputes equivalent to 1 million 788 thousand euros. The aim of this study was to enhance the clinical risk management at our facility through a litigation analysis.


Subject(s)
Liability, Legal , Malpractice , Compensation and Redress , Hospitals , Retrospective Studies
14.
Vaccines (Basel) ; 9(9)2021 Aug 29.
Article in English | MEDLINE | ID: covidwho-1374555

ABSTRACT

The European Convention on Human Rights (ECHR) judgement no. 116(2021) of 8 April 2021 establishes the principle of mandatory vaccination, indicating the criteria that national legislation must comply with, following the principle of non-interference in the private life of the individual. Vaccination for the prevention of SARS-CoV-2 infection appears to be an essential requirement for providing healthcare assistance. The European experience with compulsory vaccinations, offers a composite panorama, as the strategy of some European countries is to make vaccinations compulsory, including financial penalties for non-compliance. As in other countries, there is a clear need for Italy to impose compulsory vaccination for healthcare workers, in response to a pressing social need to protect individual and public health, and above all as a defense for vulnerable subjects or patients, for whom health workers have a specific position of guarantee and trust. The Italian Republic provided for mandatory vaccinations for health professionals by Decree-Law of 1 April 2021 no. 44, to guarantee public health and adequate safety conditions. As stated by ECHR, the Italian State, despite having initially opted for recommendation as regards to SARS-CoV-2 vaccination, had to adopt the mandatory system to achieve the highest possible degree of vaccination coverage among health professionals to guarantee the safety of treatments and protection of patients' health. We present the Italian situation on vaccine hesitation in healthcare workers, with updated epidemiological data as well as the doctrinaire, social, and political debate that is raging in Italy and Europe.

15.
Brain Pathol ; 31(6): e13013, 2021 11.
Article in English | MEDLINE | ID: covidwho-1354468

ABSTRACT

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the new coronavirus responsible for the pandemic disease in the last year, is able to affect the central nervous system (CNS). Compared with its well-known pulmonary tropism and respiratory complications, little has been studied about SARS-CoV-2 neurotropism and pathogenesis of its neurological manifestations, but also about postmortem histopathological findings in the CNS of patients who died from COVID-19 (coronavirus disease 2019). We present a systematic review, carried out according to the Preferred Reporting Items for Systematic Review standards, of the neuropathological features of COVID-19. We found 21 scientific papers, the majority of which refer to postmortem examinations; the total amount of cases is 197. Hypoxic changes are the most frequently reported alteration of brain tissue, followed by ischemic and hemorrhagic lesions and reactive astrogliosis and microgliosis. These findings do not seem to be specific to SARS-CoV-2 infection, they are more likely because of systemic inflammation and coagulopathy caused by COVID-19. More studies are needed to confirm this hypothesis and to detect other possible alterations of neural tissue. Brain examination of patients dead from COVID-19 should be included in a protocol of standardized criteria to perform autopsies on these subjects.


Subject(s)
Brain/physiology , Brain/virology , COVID-19/pathology , Nervous System Diseases/virology , SARS-CoV-2/metabolism , Brain/physiopathology , COVID-19/metabolism , COVID-19/virology , Central Nervous System/physiology , Central Nervous System/virology , Humans , Inflammation/pathology , Inflammation/virology , Nervous System Diseases/etiology , Nervous System Diseases/pathology , Pandemics
16.
Healthcare (Basel) ; 9(7)2021 Jun 28.
Article in English | MEDLINE | ID: covidwho-1323201

ABSTRACT

Incidents of violence by healthcare users against staff have been considered as sentinel events. New forms of aggression, i.e., cyberbullying, have emerged with the advent of social networks. Medical literature includes some reports about workplace cyberbullying on nurses and young doctors by colleagues/supervisors, but not by users. To investigate cyberbullying on healthcare providers via social networks, we carried out an exploratory quali-quantitative study, researching and analyzing posts and comments relating to a local Health Trust (ASL5) in Italy, published from 2013 until May 2020 on healthcare worker aggressions on social networks on every local community's Facebook page. We developed a thematic matrix through an analysis of the most recurring meaning categories (framework method). We collected 217 texts (25 posts and 192 comments): 26% positive and 74% negative. Positive posts were shared about ten times more than negative ones. Negative comments received about double the "Likes" than the positive ones. Analysis highlighted three main meaning categories: 1. lack of adequate and functional structures; 2. negative point of view (POV) towards some departments; 3. positive POV towards others. No significant differences were observed between the various categories of healthcare workers (HCW). Geriatric, medical wards and emergency department were the most frequent targets of negative comments. All the texts referred to first-line operators except for one. Online violence against HCW is a real, largely unknown, problem that needs immediate and concrete attention for its potentially disastrous consequences. Compared to traditional face-to-face bullying, it can be more dangerous as it is contagious and diffusive, without spatial, temporal or personal boundaries.

17.
Pathologica ; 112(2): 64-77, 2020 06.
Article in English | MEDLINE | ID: covidwho-1052586
18.
Forensic Sci Med Pathol ; 17(2): 279-296, 2021 06.
Article in English | MEDLINE | ID: covidwho-834059

ABSTRACT

Although many clinical reports have been published, little is known about the pathological post-mortem findings from people who have died of the novel coronavirus disease. The need for postmortem information is urgent to improve patient management of mild and severe illness, and treatment strategies. The present systematic review was carried out according to the Preferred Reporting Items for Systematic Review (PRISMA) standards. A systematic literature search and a critical review of the collected studies were conducted. An electronic search of PubMed, Science Direct Scopus, Google Scholar, and Excerpta Medica Database (EMBASE) from database inception to June 2020 was performed. We found 28 scientific papers; the total amount of cases is 341. The major histological feature in the lung is diffuse alveolar damage with hyaline membrane formation, alongside microthrombi in small pulmonary vessels. It appears that there is a high incidence of deep vein thrombosis and pulmonary embolism among COVID-19 decedents, suggesting endothelial involvement, but more studies are needed. A uniform COVID-19 post-mortem diagnostic protocol has not yet been developed. In a time in which international collaboration is essential, standardized diagnostic criteria are fundamental requirements.


Subject(s)
Autopsy , COVID-19/pathology , Lung/pathology , Alveolar Epithelial Cells/pathology , Brain/pathology , Fibrin/metabolism , Fibroblasts/pathology , Humans , Kidney/pathology , Leukocytes, Mononuclear/pathology , Myositis/pathology , Respiratory Mucosa/pathology , Thrombosis/pathology
19.
Int J Qual Health Care ; 33(1)2021 Mar 05.
Article in English | MEDLINE | ID: covidwho-684625

ABSTRACT

BACKGROUND: Nursing homes provide long-term care and have residential-oriented hospitalizations characterized by medical, nursing and social-care treatments for a typically geriatric population. In the current emergency phase, the problem of infections in residential structures for the elderly is taking on considerable importance in relation to the significant prevalence rates of coronavirus disease 2019 (COVID-19). SAFETY IMPROVEMENT STRATEGIES: Prevention and control measures for severe acute respiratory syndrome coronavirus 2 infection in nursing homes should be planned before a possible outbreak of COVID-19 occurs and should be intensified during any exacerbation of the same. Each facility should identify a properly trained contact person-also external-for the prevention and control of infections, who can refer to a multidisciplinary support committee and who is in close contact with the local health authorities. The contact person should collaborate with professionals in order to prepare a prevention and intervention plan that considers national provisions and scientific evidence, the requirements for reporting patients with symptoms compatible with COVID-19 and the indications for the management of suspected, probable or confirmed cases of COVID-19. DISCUSSION: Adequate risk management in residential structures implies the establishment of a coordination committee with dedicated staff, the implementation of a surveillance program for the rapid recognition of the outbreaks, the identification of suitable premises and equipment, the application of universal precautions, the adaptation of care plans to reduce the possibility of contagion among residents and the protection of operators and staff training initiatives.


Subject(s)
COVID-19/epidemiology , Homes for the Aged/organization & administration , Infection Control/organization & administration , Nursing Homes/organization & administration , Safety Management/organization & administration , COVID-19/prevention & control , Homes for the Aged/standards , Humans , Infection Control/standards , Nursing Homes/standards , Pandemics , Quality Improvement/organization & administration , SARS-CoV-2 , Safety Management/standards
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