Response to the letter by Meng-jun Zhan et al. regarding the paper \u201cA technical report from the Italian SARS-CoV-2 outbreak. Postmortem sampling and autopsy investigation in cases of suspected or probable COVID-19\u201d

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Cytokine storm and histopathological findings in 60 cases of COVID-19-related death: from viral load research to immunohistochemical quantification of major players IL-1\u3b2, IL-6, IL-15 and TNF-\u3b1

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-1\u3b2, IL-6, IL-10, IL-15, TNF-\u3b1, and MCP-1), inflammatory cells (CD4, CD8, CD20, and CD45), and fibrinogen. Immunohistochemical staining showed that endothelial cells expressed IL-1\u3b2 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-\u3b1 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

Fibrin Sealants and Axillary Lymphatic Morbidity. A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Background: use of fibrin sealants following pelvic, paraaortic, and inguinal lymphadenec- tomy may reduce lymphatic morbidity. The aim of this meta-analysis is to evaluate if this finding applies to the axillary lymphadenectomy. Methods: randomized trials evaluating the efficacy of fibrin sealants in reducing axillary lymphatic complications were included. Lymphocele, drainage output, surgical-site complications, and hospital stay were considered as outcomes. Results: twenty-three randomized studies, including patients undergoing axillary lymphadenectomy for breast cancer, melanoma, and Hodgkin’s disease, were included. Fibrin sealants did not affect axillary lymphocele incidence nor the surgical site complications. Drainage output, days with drainage, and hospital stay were reduced when fibrin sealants were applied (p &lt; 0.0001, p &lt; 0.005, p = 0.008). Conclusion: fibrin sealants after axillary dissection reduce the total axillary drainage output, the duration of drainage, and the hospital stay. No effects on the incidence of postoperative lymphocele and surgical site complications rate are found

Evaluation of appendicitis risk prediction models in adults with suspected appendicitis

Background Appendicitis is the most common general surgical emergency worldwide, but its diagnosis remains challenging. The aim of this study was to determine whether existing risk prediction models can reliably identify patients presenting to hospital in the UK with acute right iliac fossa (RIF) pain who are at low risk of appendicitis. Methods A systematic search was completed to identify all existing appendicitis risk prediction models. Models were validated using UK data from an international prospective cohort study that captured consecutive patients aged 16–45 years presenting to hospital with acute RIF in March to June 2017. The main outcome was best achievable model specificity (proportion of patients who did not have appendicitis correctly classified as low risk) whilst maintaining a failure rate below 5 per cent (proportion of patients identified as low risk who actually had appendicitis). Results Some 5345 patients across 154 UK hospitals were identified, of which two‐thirds (3613 of 5345, 67·6 per cent) were women. Women were more than twice as likely to undergo surgery with removal of a histologically normal appendix (272 of 964, 28·2 per cent) than men (120 of 993, 12·1 per cent) (relative risk 2·33, 95 per cent c.i. 1·92 to 2·84; P < 0·001). Of 15 validated risk prediction models, the Adult Appendicitis Score performed best (cut‐off score 8 or less, specificity 63·1 per cent, failure rate 3·7 per cent). The Appendicitis Inflammatory Response Score performed best for men (cut‐off score 2 or less, specificity 24·7 per cent, failure rate 2·4 per cent). Conclusion Women in the UK had a disproportionate risk of admission without surgical intervention and had high rates of normal appendicectomy. Risk prediction models to support shared decision‐making by identifying adults in the UK at low risk of appendicitis were identified

Risk management, patient safety and quality in health care

The formulation of a correct diagnosis and the prescription of adequate therapies represent key aspects in planning healthcare. Diagnostic and therapeutic errors constitute a significant and unrecognized threat to patient safety. In such a context, the management of clinical risk represents a privileged observatory on healthcare since the successful implementation of these activities involves the search for preventive actions adequate to overcome the critical issues. The implementation of a virtuous litigation management system as well as a culture of safety for citizens and health professionals cannot be guaranteed by sectoral interventions but must derive from the integrated action of different skills. With this in mind, the integration of activities must aim at improving quality and safety with clinical risk management. These activities must be guaranteed through the most appropriate organizational methods based on the peculiarities of the individual health systems. Therefore, in the current state of knowledge, the acquisition of data from the different institutions is fundamental in order to adopt a shared methodology and design appropriate strategies for the reduction of errors in medicine. The need to generate evidence and recommendations useful for competitively addressing problems related to error requires the identification and use of evaluation criteria and performance indicators that can contribute to the continuous updating of technologies. Furthermore, the reduction of the knowledge gap and the implementation of surveillance systems at a multicenter level can contribute to defining methodological standards for the development of preventive strategies. Understanding the error represents the main effort to be made to improve the quality and safety of care. In fact, it is widely known that error is the most common and preventable cause of patient harm. The costs of medical errors are significant and include expenses due to morbidity, mortality, additional treatments, and prolonged hospital stay. On the other hand, the costs of prevention and surveillance are relatively low and sustainable [1-8]. The aim of the papers collected in the present issue is to provide relevant information about healthcare quality and patient safety, focusing attention on the adequacy of diagnostic procedures, medication errors, litigation management, risk management, and performance measurement. This special international issue of ‘Current Pharmaceutical Biotechnology’, entitled “Risk management, patient safety and quality in health care” compiles valuable research articles on subjects concerning the quality and safety of care, the evaluation of healthcare activities, and the processes of elaboration, development, and implementation of health policies

La discrezionalità degli street-level bureaucrats a confronto in diversi contesti organizzativi: evidenze da una survey in un’area metropolitana italiana

In recent years studies on Street Level Bureaucracy (SLB) have increased in number and diversified their approaches. In 2011 Brodkin suggested extending the analysis to organizations, to also include those non-public actors who implement public policies and work front-line. The dimension of discretion has remained central, declined in a conflictual way between management and workers, and put to the test by new organizational practices, such as accountability and digitization, and work practices, such as multi-professional teams. The main perspective on discretionality, however, has been and continues to be subjective. In this paper we propose an analysis which instead considers discretion as a specific dimension, that finds its application at an organizational level. We have chosen an urban case study (Rome) and distinguished the sample organizations between public institutions, specifically Local Health Authorities (ASL) and Local Government Districts (social assistance branches of the City Municipality), and Third Sector institutions (Cooperatives that manage the service after winning the bidding process) and administered a semi-structured questionnaire to 75 social workers. The main research hypothesis, confirmed by the results, is that discretion depends on the type of organization in which the worker is inserted: that is, discretionality can be defined as organizational-led and not just predominantly subjective-led

A technical report from the Italian SARS-CoV-2 outbreak. Postmortem sampling and autopsy investigation in cases of suspected or probable COVID-19

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is a coronavirus responsible for COVID-19 (coronavirus disease 2019) which resulted in a cluster of cases of pneumonia that originated in China around 31 December 2019 and has subsequently spread across the globe. Currently, COVID-19 represents a health emergency worldwide, leading, in severe cases, to pneumonia, severe acute respiratory syndrome, multiorgan dysfunction or failure, and death. In the context of limited scientific knowledge and evidence of SARS-CoV-2 infection, guidance is becoming increasingly necessary for pathologists who have to perform postmortem investigations on COVID-19 cases. The aim of the present report is to share a procedure applicable to cases of COVID-19-related death, particularly in cases of death without medical intervention and in the absence of an ascertained SARS-CoV-2 infection and/or COVID-19 diagnosis, therefore providing support for diagnostic activity in the present COVID-19 pandemic. For this purpose, a standard operating procedure for correct swab collection, autopsy investigation and tissue sampling is provided

Attitudes of Italian Infertile Women Toward Ethical and Regulatory Limits of Medically Assisted Procreation (MAP)

Objective: Outline the views of Italian women, with fertility problems, on Medically Assisted Procreation. Methods: We have collected the opinions of 448 infertile women. The items used in the questionnaire were created with a qualitative method based on the Medically Assisted Procreation's most important bioethics issues and on the basis of the limits imposed by Law. The questions of the first part of the questionnaire were open; in the second part was closed ("Yes/No"); for each method they were asked whether they would introduce a legal limit to prohibit it. The tests have been standardized with test-retest method. Results: We found that much of the disputes that have, over time, been made to Law 40 of 2004 by Italian Courts, are shared by patients with infertility problems. Italian women do not share the legal limit for Medically Assisted Procreation in over 43 women, heterologous in-semination with seed donation and egg donation. Moreover, our sample show that Italian women do not share legal limit to pre-implantation genetic diagnosis and cryopreservation of embryos. Moreover, it emerges that many Italian infertile patients disagree with the Medically Assisted Procreation for homosexual couples. Conclusion: It will be important, in the event of a legislative reform in Italy on the Medically Assisted Procreation, also consider the point of view of women with infertility problems

Fatal food-induced anaphylaxis: determination of tryptase and specific IgE on cadaveric blood samples. What else for a better methodological standard?

Post-mortem investigation in cases of fatal anaphylaxis is required to provide clarifications on the presence of macroscopic pathological changes, histological features, and immunohistochemical positivity suggestive of the diagnosis, on biochemical evidence of anaphylaxis and on the presence of serological data indicative of the allergen responsible for the anaphylactic reaction. We describe the case of a 16-year-old boy with a medical history of allergic asthma, celiac disease, and known food-induced allergy for fish, fresh milk, peanuts, hazelnuts, walnuts, apples, kiwis, and peaches. Acute onset of dyspnea followed by cyanosis of the lips and respiratory failure was described immediately after having an ice cream sandwich. Unsuccessful rescues were immediately attempted with oral administration of betamethasone, intramuscular injection of adrenaline, and cardiopulmonary resuscitation. A complete post-mortem examination was performed. Serum dosage of mast cell beta-tryptase from femoral blood detecting serum values of 41.4 mg/l. Determination of specific IgE on cadaveric blood samples confirmed the anamnestic data related to sensitization for several food allergens, including cod parvalbumin, tropomyosin, brazil nut, omega-5-gliadin of foods derived from wheat and gluten. The cause of death was identified in a cardiorespiratory failure due to anaphylactic shock in a poly-allergic subject and anaphylaxis was ascribed to the wheat contained in the ice cream sandwich eaten immediately before the onset of respiratory symptoms. The need is to implement an interdisciplinary approach capable to ascertain the sensitivity and specificity of the diagnostic tests currently in use as well as to evaluate the possibility of introducing new biomarkers in practice