Patient safety implications of wearing a face mask for prevention in the era of COVID-19 pandemic: a systematic review and consensus recommendations.

In the past, the use of face masks in western countries was essentially limited to occupational health. Now, because of the COVID-19 pandemic, mask-wearing has been recommended as a public health intervention. As potential side effects and some contraindications are emerging, we reviewed the literature to assess the impact of them in daily life on patient safety and to provide appropriate guidelines and recommendations. We performed a systematic review of studies investigating physiological impact, safety, and risk of masks in predefined categories of patients, which have been published in peer-reviewed journals with no time and language restrictions. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. Wearing a N95 respirator is more associated with worse side effects than wearing a surgical mask with the following complications: breathing difficulties (reduced FiO2, SpO2, PaO2 increased ETCO2, PaCO2), psychiatric symptoms (panic attacks, anxiety) and skin reactions. These complications are related to the duration of use and/or disease severity. Difficulties in communication is another issue to be considered especially with young children, older person and people with hearing impairments. Even if benefits of wearing face masks exceed the discomfort, it is recommended to take an "air break" after 1-2 h consecutively of mask-wearing. However, well-designed prospective studies are needed. The COVID-19 pandemic could represent a unique opportunity for collecting large amount of real-world data.

When COVID-19 Is Not All: Femicide Conducted by a Murderer with a Narcissistic Personality "Masked" by a Brief Psychotic Disorder, with a Mini-Review.

Several cases of COVID-19-related mental disorders have emerged during the pandemic. In a case of femicide that occurred in Italy during the first phase of the pandemic, coinciding with a national lockdown, a discrepancy arose among forensic psychiatry experts, particularly toward the diagnosis of Brief Psychotic Disorder (BPD) related to COVID-19. We aimed to discuss the evaluation of the case through an integration of information and a literature review on comparable reported cases. An analysis of the diagnosis of brief acute psychosis was then performed, as well as a mini-review on cases of COVID-19-related psychosis. Results showed that psychotic symptomatology was characterized by polythematic delusions that always involved a SARS-CoV-2 infection. To a lesser extent, the delusions were accompanied by hallucinations, bizarre cognitive and associative alterations, insomnia, hyporexia, dysphoria, and suicidal behavior. No particularly violent acts with related injury or death of the victim were described. Finally, we could hypothesize that our case was better represented by a diagnosis of personality with predominantly narcissistic and partly psychopathic traits. The present case highlighted the importance, in the context of forensic psychiatry, of integrating assessments with the crime perpetrators, namely through accurate clinical interviews, neuropsychological tests, diachronic observations, and comparison with similar cases present in the literature. Such an integrated approach allows precise evaluation and reduces the odds of errors in a field, such as forensic psychiatry, where a diagnostic decision can be decisive in the judgment of criminal responsibility. Moreover, discerning forensics from health cases represents an important issue in risk management.

From COVID-19 Pandemic to Patient Safety: A New "Spring" for Telemedicine or a Boomerang Effect?

During the Covid-19 health emergency, telemedicine was an essential asset through which health systems strengthened their response during the critical phase of the pandemic. According to the post-pandemic economic reform plans of many countries, telemedicine will not be limited to a tool for responding to an emergency condition but it will become a structural resource that will contribute to the reorganization of Healthcare Systems and enable the transfer of part of health care from the hospital to the home-based care. However, scientific evidences have shown that health care delivered through telemedicine can be burdened by numerous ethical and legal issues. Although there is an emerging discussion on patient safety issues related to the use of telemedicine, there is a lack of reseraches specifically designed to investigate patient safety. On the contrary, it would be necessary to determine standards and specific application rules in order to ensure safety. This paper examines the telemedicine-risk profiles and proposes a position statement for clinical risk management to support continuous improvement in the safety of health care delivered through telemedicine.

Mental Health Consequences of COVID-19 Pandemic Period in the European Population: An Institutional Challenge.

The worldwide spread of SARS-CoV-2 has been responsible for an infectious pandemic, with repercussions on socio-economic aspects and on the physical and mental health of the general population. The present systematic review aimed to evaluate the data belonging to the European framework, analyzing the population by age group. Original articles and reviews on the state of mental health of the general European population have been researched starting from 2021. Initially, a total of 1764 studies were found, among which a total of 75 were selected. Youth were the age group most affected by pandemic consequences on mental health, with emotional and behavioral alterations observed from a third to more than a half of children and adolescents examined. Among both adolescents and adults, the female gender had a higher prevalence of psychopathological symptoms. The main risk factors were poor social support, economic difficulties, and, in particular, unemployment or job changes. Additional individual risk factors were the perception of loneliness, the presence of pre-pandemic mental illness/distress, and some personality traits, such as neuroticism, impulsiveness, and the use of maladaptive coping strategies. Unexpectedly, the elderly maintained good resilience towards change, even if a stress factor was represented by the feeling of loneliness and poor social contact. As regards suicidal behaviors, among adolescents, there was an increase in attempts of 25%, with a greater risk for the female gender. This risk increased also among adults, in association with symptoms of anxiety and depression, and poor socio-environmental conditions. In conclusion, some population groups were found to be at greater risk of psychological burden during pandemic waves, thus representing priority targets for socio-health interventions.

From COVID-19 Pandemic to Patient Safety: A New “Spring” for Telemedicine or a Boomerang Effect?

During the Covid-19 health emergency, telemedicine was an essential asset through which health systems strengthened their response during the critical phase of the pandemic. According to the post-pandemic economic reform plans of many countries, telemedicine will not be limited to a tool for responding to an emergency condition but it will become a structural resource that will contribute to the reorganization of Healthcare Systems and enable the transfer of part of health care from the hospital to the home-based care. However, scientific evidences have shown that health care delivered through telemedicine can be burdened by numerous ethical and legal issues. Although there is an emerging discussion on patient safety issues related to the use of telemedicine, there is a lack of reseraches specifically designed to investigate patient safety. On the contrary, it would be necessary to determine standards and specific application rules in order to ensure safety. This paper examines the telemedicine-risk profiles and proposes a position statement for clinical risk management to support continuous improvement in the safety of health care delivered through telemedicine.

COVID-19 and H1N1-09: A Systematic Review of Two Pandemics with a Focus on the Lung at Autopsy.

BACKGROUND: The purpose of this manuscript is to provide a comparative overview of the two global pandemics: the first on June 11th 2009 due to influenza A H1N1 (H1N1-09); the second and current pandemic caused by coronavirus 2019 (COVID-19) on March 11th 2020, focusing on how autopsy can contribute to the definition of cellular pathology, to clinical pathology and, more generally, to public health. METHODS: A systematic literature search selection was conducted on PubMed database on June 5, 2021, with this search strategy: (COVID-19) AND (H1N1 influenza) showing 101 results. The following inclusion criteria were selected: English language; published in a scholarly peer-reviewed journal; full-length articles were further elected. To further refine the research was to focus on the type of manuscript: review, systematic review, and meta-analysis. A critical appraisal of the collected studies was conducted, analyzing titles and abstracts, excluding the following topics: treatment, public health measures and perception of the general population or healthcare personnel about their quality of life. According to these procedures, 54 eligible studies were included in the present review. RESULTS: Histopathological findings play a key role in understanding the pathophysiological mechanisms of diseases and, thus possible therapeutic approaches. The evidence on the thrombo-inflammatory mechanism underlying COVID-19 is growing to a much greater magnitude than the diffuse alveolar damage in common with H1N1-09; our study appears to be in line with these results. The prevailing scientific thinking to explain the morbidity and mortality of COVID-19 patients is that it elicits an exuberant immune reaction characterized by dysregulated cytokine production, known as a "cytokine storm". CONCLUSIONS: The histological and immunohistochemical pattern demonstrated similarities and differences between the infectious manifestations of the two pathogens, which justify empirical therapeutic approaches, in the first phase of the COVID-19 pandemic. Therefore, the previous pandemic should have taught us to promote a culture of clinical and forensic autopsies in order to provide timely evidence from integration among autopsy and clinical data for early adopting adequate therapies.

No-Fault Compensation and Anti-COVID-19 Compulsory Vaccination: The Italian Context in a Broad View.

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.

Death after the Administration of COVID-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?

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.

Myocardial Pathology in COVID-19-Associated Cardiac Injury: A Systematic Review.

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.

Supporting Decision Making in Intensive Care: Ethical Principles for Managing Access to Care During the COVID-19 Pandemic.

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.

From Syndemic Lesson after COVID-19 Pandemic to a "Systemic Clinical Risk Management" Proposal in the Perspective of the Ethics of Job Well Done.

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.

Mapping Biological Risks Related to Necropsy Activities: Old Concerns and Novel Issues for the Safety of Health Professionals.

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.

"First Do No Harm". No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy.

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.

Cytokine storm and histopathological findings in 60 cases of COVID-19-related death: from viral load research to immunohistochemical quantification of major players IL-1ß, IL-6, IL-15 and TNF-α.

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.

Analysis of Inadequacies in Hospital Care through Medical Liability Litigation.

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.

Compulsory Vaccination for Healthcare Workers in Italy for the Prevention of SARS-CoV-2 Infection.

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.

SARS-CoV-2 and the brain: A review of the current knowledge on neuropathology in COVID-19.

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.

Aggressions on Social Networks: What Are the Implications for Healthcare Providers? An Exploratory Research.

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.