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The application of the Italian law No. 24/2017, which focused on patient safety and medical liability, in the Italian National Health Service has been evaluated by a survey conducted five years after the promulgation of the law. The law required the establishment of healthcare risk management and patient safety centers in all Italian regions and the appointment of a Clinical Risk Manager (CRM) in all Italian public and private healthcare facilities. This study demonstrates that five years after the approval of the law, it has not yet been fully implemented. The survey revealed a lack of adequate permanent staff in all the Regional Centers, with two employees on average per Center. Few meetings were held with the Regional Healthcare System decision-makers with less than four meetings per year. This reduces the capacity to carry out functions. In addition, the role of the CRMs is weak in most healthcare facilities. More than 20% of CRMs have other roles in the same organization. Some important tasks have reduced application, e.g., assessment of the inappropriateness risk (reported only by 35.3% of CRM) and use of patient safety indicators for monitoring hospitals (20.6% of CRM). The function of the Regional Centers during the COVID-19 pandemic was limited despite the CRMs being very committed. The CRMs units undertake limited research and have reduced collaboration with citizen associations. Despite most of the CRMs believing that the law has had an important role in improving patient safety, 70% of them identified clinicians' resistance to change and lack of funding dedicated to implementing the law as the main barriers to the management of risk. [ABSTRACT FROM AUTHOR]

Objectives: The objective of the present policy analysis was to understand how a disinvestment approach to the process of health technology assessment (HTA), applied to the field of medical devices, might help Italian policymakers to properly spend the resources in healthcare. Methods: Previous international and national experiences in disinvestment for medical devices were reviewed. Precious insights for the rational expenditure of the resources were derived by assessing the evidence available. Results: The disinvestment of ineffective or inappropriate technologies or interventions with an inadequate value-for-money ratio has become a growing priority for National Health Systems. Different international disinvestment experiences of medical devices were identified and described through a rapid review. Although most of them have a strong theoretical framework, their practical application remains difficult. In Italy, there are no examples of large and complex HTA-based disinvestment practices, but their importance is becoming increasingly acknowledged, especially given the need to prioritize the funds provided by Recovery and Resilience Plan. Conclusions: Anchoring decisions on health technologies without reassessing the current technological landscape through a robust HTA model might expose to the risk of not ensuring the best employment of the resources available. Thus, it is necessary to develop a strong HTA ecosystem in Italy through adequate consultation with stakeholders to enable a data-driven and evidence-based prioritization of resources toward choices characterized by high value for both patients and society as a whole. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The May 2022 proposal from the European commission for a 'European health data space' envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come. [ABSTRACT FROM AUTHOR]

History of neck trauma should be promptly investigated in patients with severe infections of the chest as mediastinitis. We present a forensic case of a death due to a mediastinitis in a patient with an undetected fracture of the superior horn of the thyroid cartilage that was exclusively revealed at autopsy examination. Histological analyses of the neck tissues showed signs of pharyngeal mucosal microperforation caused by the fracture and surrounded by an inflammatory reaction. The fracture was caused by a not declared manual strangulation attempt, happened several days before medical evaluations. We share our experience to emphasize the importance of revealing the etiologies of fatal infections of the mediastinum both for clinical and forensic purposes. [ABSTRACT FROM AUTHOR]

In this paper we describe analyses performed by Real-Time Reverse-Transcriptase Polymerase Chain Reaction (real-time RT-PCR) on RNA of 12 samples, carried out for forensic purposes to investigate a correlation between tetrahydrocannabinol (THC) concentration in Cannabis and the tetrahydrocannabi- nol acid synthase (THCAS) gene expression. Samples were obtained from an experimental cultivation of declared potency Cannabis variety seeds and from seizures. The Rubisco gene and the 26S ribosomal RNA gene were used as internal control genes for their constant expression and stability. As results we found minor gene expression in samples from leaves of young plants. Further, grouping results for cannabis samples with similar characteristics, we have found an increased relative expression in samples with the highest percentage of THC coming from seized sample and adult plants. [ABSTRACT FROM AUTHOR]

Abstract: In this study, we wanted to investigate whether or not the tetrahydrocannabinolic acid (THCA) synthase gene, which codes for the enzyme involved in the biosynthesis of THCA, influences the production and storage of tetrahydrocannabinol (THC) in a dose-dependent manner. THCA is actually decarboxylated to produce THC, the main psychoactive component in the Cannabis plant. Assuming as the research hypothesis a correlation between the gene copy number and the production of THC, gene quantification could be useful in forensics in order to complement or replace chemical analysis for the identification and classification of seized Cannabis samples, thus distinguishing the drug-type from the fibre-type varieties. A real-time PCR assay for the relative quantification of the THCA synthase gene was then validated on Cannabis samples; some were seized from the illegal drug market and others were derived from experimental cultivation. In order to determine the gene copy number to compare high vs. low potency plants, we chose the ΔΔCt method for TaqMan reactions. The assay enabled single plants with zero, one, and two copies of the gene to be distinguished. As a result of this first part of the research on the THCA synthase gene (the second part will cover a study of gene expression), we found no correlation between THCA synthase gene copy number and the content of THC in the herbal Cannabis samples tested. [Copyright &y& Elsevier]

Abstract: Placental Site Trophoblastic Tumor (PSTT) is a rare form of Gestational Trophoblastic Disease (GTD). Approximately 200 cases have been reported in the literature. This disease has unpredictable biological behavior, whereas approximately 10–15% have clinically malignant evolution. We present the case of a 21-year old woman at first pregnancy without known previous abortion at 25 weeks of amenorrhea who was admitted to the hospital for hyperemesis, hepatic problems and important weight loss registered during the last few months. Few days after the admission, the patient suddenly died before the doctors can reach a diagnosis. A forensic investigation for medical malpractice was initiated. Samples collected from uterus at the autopsy revealed large trophoblastic cells with eosinophilic cytoplasm. Deposition of fibrinoid material was noticed between trophoblastic cells. Tumor cells dissected through the myometrium and invaded into the vascular spaces. Specimens of the lungs revealed numerous small neoplastic emboli into the vessels. We show autopsy and histological findings of PSTT in a young woman, which are very rarely described in the literature and we discuss the medico-legal implications related to the great difficulties of the gynecologists who faced this rare condition in term of diagnosis and prediction of biological behavior, outlining effective therapeutic approaches. [Copyright &y& Elsevier]

This case concerns an unusual suicidal plastic bag suffocation. An elderly white man was found dead and partially disrobed in his apartment lying supine on a sofa with a plastic bag closed by a rope over the head and the upper and lower extremities tightly tied with two other ropes, the end of both arranged into slipknots (self-rescue mechanism). Police investigations found no pornography in the apartment, and circumstantial data alleged no psychiatric disorders or suicidal intentions. The autopsy excluded signs of struggle and sexual intercourse as well as any type of injury or physical illness. Chemical analyses on the peripheral blood excluded acute drugs and/or alcohol intoxication. A differential diagnosis of the manner of death was performed, including scenarios of accidental autoerotic asphyxiation, homicide during either sexual activity or ritualistic, elderly suicide. The collected data most strongly supported the hypothesis of a suicidal asphyxiation simulating homicide to devolve a life insurance to the victim's sons because of economic difficulties. [ABSTRACT FROM AUTHOR]

Genetic markers can be used in seeds and in plants to distinguish drug-type from fiber-type Cannabis Sativa L. varieties even at early stages, including pre-germination when cannabinoids are not accumulated yet. With this aim, this paper reports sequencing results for tetrahydrocannabinolic acid synthase (THCAS) and cannabidiolic acid synthase (CBDAS) genes from 21 C. sativa L. varieties. Taking into account that THCAS- and CBDAS-derived enzymes compete for the same substrate, the novelty of this work relies in the identification of markers based on both THCAS and CBDAS rather than THCAS alone. Notably, in our panel, we achieved an adequate degree of discrimination (AUC 100%) between drug-type and fiber-type cannabis samples. Our sequencing approach allowed identifying multiple genetic markers (single-nucleotide polymorphisms—SNPs—and a deletion/insertion) that effectively discriminate between the two subgroups of cannabis, namely fiber type vs. drug type. We identified four functional SNPs that are likely to induce decreased THCAS activity in the fiber-type cannabis plants. We also report the finding on a deletion in the CBDAS gene sequence that produces a truncated protein, possibly resulting in loss of function of the enzyme in the drug-type varieties. Chemical analyses for the actual concentration of cannabinoids confirmed the identification of drug-type rather than fiber-type genotypes. Genetic markers permit an early identification process for forensic applications while simplifying the procedures related to detection of therapeutic or industrial hemp. [ABSTRACT FROM AUTHOR]

Abstract: Foreign body ingestion frequently occurs accidentally in the paediatric population as well as intentionally in prisoners to achieve hospitalisation, but is relatively uncommon in forensic cases and extremely rare as a method of inducing death in complex suicide. The reasons for this infrequency are many, not least the slowness of action and the lack of effectiveness in terms of lethality, regardless of the object used. In this article, we show an unplanned complex suicide carried out by ingestion of four plastic knives before hanging. Other complex suicides involving foreign body ingestion reported in the forensic literature are reviewed. [Copyright &y& Elsevier]