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Telemedicine allows for the effective delivery of health care to patients at a distance through the application of information technology to the field of medicine. This is optimal during the COVID-19 pandemic to reduce interpersonal contact to mitigate contagion. Among the possible Telemedicine applications, there is Telesurgery, which involves more and more surgical specialties thanks to the numerous benefits in quality and cost containment. In the growing field of Telesurgery, its technical and legal implications must be considered. In this study, a traditional review of the scientific literature was carried out to identify the most relevant issues of interest in Telesurgery. The problematic legal aspects identified are mainly related to the difference in legislation between different geographical areas, which is critical in the case of malpractice. In addition, there is the possibility of a malicious hacker attack on the transmitted data stream either to steal sensitive data or to harm the patient. Finally, there are inherent difficulties with the technology used, such as latency issues in data transmission. All these critical issues are currently not adequately addressed by current legislation. Therefore, one can only hope for a legislative action to allow Telesurgery to be used safely.

Autopsy examination, the gold standard for defining causes of death, is often difficult to apply in certain health care settings, especially in developing countries. The COVID-19 pandemic and its associated difficulties in terms of implementing autopsy examinations have made the need for alternative means of determining causes of death even more evident. One of the most interesting alternatives to the conventional autopsy is the verbal autopsy, a tool that originated in Africa and Asia in the 1950s and consists of a structured interview with the deceased’s family members concerning the symptoms manifested by the person and the circumstances of death. In the early 1990s, the first doubts emerged about the validity of verbal autopsies, especially about the real reliability of the cause of death identified through this tool. The objective of the review was to identify studies that had assayed the validity of verbal autopsies through a rigorous comparison of the results that emerged from it with the results of conventional autopsies. When starting from an initial pool of 256 articles, only 2 articles were selected for final review. These are the only two original research articles in which a verbal autopsy validation process was performed by employing the full diagnostic autopsy as the gold standard. The two papers reached opposite conclusions, one suggesting adequate validity of verbal autopsy in defining the cause of death and the other casting serious doubts on the real applicability of this tool. Verbal autopsy undoubtedly has extraordinary potential, especially in the area of health and demographic surveillance, even considering the implementation that could result from the use of artificial intelligence and deep learning. However, at present, there appears to be a lack of solid data to support the robust reliability of this tool in defining causes of death.

A new, rapid, sensitive, and comprehensive ultra‐high‐performance liquid chromatography tandem mass spectrometry (UHPLC–MS/MS) method for quantifying diuretics (acetazolamide, brinzolamide, dorzolamide, and their metabolites) in human urine and hair was developed and fully validated. Twenty‐five milligrams of hair were incubated with 500‐μl M3® buffer reagent at 100°C for 1 h for complete digestion. After cooling, 1‐μl supernatant was injected onto chromatography system. Urine samples were simply diluted before injection. The chromatographic run time was short (8 min) through a column with a mobile phase gradient. The method was linear (determination coefficients always higher than 0.99) from limit of quantification (LOQ) to 500 ng/ml in urine and from LOQ to 10 ng/mg in hair. LOQs ranged from 0.07 to 1.16 ng/ml in urine and from 0.02 to 0.15 ng/mg in hair. No significant ion suppression due to matrix effect was observed, and process efficiency was always higher than 80%. Intra‐ and inter‐assay precision was lower than 15%. The suitability of the methods was tested with six urine and hair specimens from patients treated with acetazolamide, dorzolamide, or brinzolamide for ocular diseases or systemic hypertension. Average urine concentrations were 266.32 ng/ml for dorzolamide and 47.61 ng/ml for N‐deethyl‐dorzolamide (n = 3), 109.27 ng/ml for brinzolamide and 1.02 ng/ml for O‐desmethyl‐brinzolamide (n = 2), and finally, 12.63 ng/ml for acetazolamide. Average hair concentrations were 5.94 ng/mg for dorzolamide and 0.048 ng/mg for N‐deethyl‐dorzolamide (n = 3), 3.26 ng/mg for brinzolamide (n = 2), and 2.3 ng/mg for acetazolamide (n = 1). The developed method was simple and fast both in the extraction procedures making it eligible in high‐throughput analysis for clinical forensic and doping purposes., A new, rapid, sensitive, and comprehensive UHPLC–MS/MS method for determining acetazolamide, brinzolamide, dorzolamide, and their metabolites in human urine and hair was developed and fully validated.

Background: Telemedicine involves medical practice and information and communications technology. It has been proven to be very effective for remote health care, especially in areas with poor provision of health facilities. However, implementation of these technologies is often hampered by various issues. Among these, ethical and legal concerns are some of the more complex and diverse ones. In this study, an analysis of scientific literature was carried out to identify the ethical and legal challenges of telemedicine. Materials and Methods: English literature, published between 2010 and 2019, was searched on PubMed, Scopus, and Web of Science by using keywords, including “Telemedicine,” “Ethics,” “Malpractice,” “Telemedicine and Ethics,” “Telemedicine and Informed consent,” and “telemedicine and malpractice.” Different types of articles were analyzed, including research articles, review articles, and qualitative studies. The abstracts were evaluated according to the selection criteria, using the Newcastle–Ottawa Scale criteria, and the final analysis led to the inclusion of 22 articles. Discussion: From the aforementioned sample, we analyzed elements that may be indicative of the efficacy of telemedicine in an adequate time frame. Ethical aspects such as informed consent, protection data, confidentiality, physician's malpractice, and liability and telemedicine regulations were considered. Conclusions: Our objective was to highlight the current status and identify what still needs to be implemented in telemedicine with respect to ethical and legal standards. Gaps emerged between current legislation, legislators, service providers, different medical services, and most importantly patient interaction with his/her data and the use of that data.

Objectives Merchant ships represent a peculiar working environment with several challenges and risks. The specific situation on board of ships may affect the mental health of seafarers more remarkably than ashore workers. Content A systematic review of the literature has been carried out to identify the main causes of mood disorders among seafarers and the impact that these disorders have on their health. This review has analyzed the scientific literature published between January 2006 and December 2021 using the search engines PubMed, Web of Science (WoS) and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Summary Social isolation, distance from families, fatigue, stress and long work shifts represent the main causes of mood disorders among seafarers. Outlook Strategies aimed at improving conditions of cohabitation on board, and a greater consideration of these problems are key for improving the mental health of workers at sea.

Background: Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite “hostile” anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this “inconsistency” between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the “best interest” of the patient can be set. Materials and Methods: A literature review on currently available evidence on standard EVAR using commercially available endografts in patients with hostile aortic neck anatomies was conducted. Medline using the PubMed interface and The Cochrane Library databases were searched from 1 January 2000 to 6 May 2021, considering the following outcomes: technical success; need for additional procedures; conversion to OR; reintervention; migration; the presence of type I endoleaks; AAA-related mortality rate. Results: A total of 52 publications were selected by the investigators for a detailed review. All studies were either prospective or retrospective observational studies reporting the immediate, 30-day, and/or follow-up outcomes of standard EVAR procedures in patients with challenging neck anatomies. No randomized trials were identified. Fourteen different endo-grafts systems were used in the selected studies. A total of 45 studies reported a technical success rate ranging from 93 to 100%, and 42 the need for additional procedures (mean value of 9.04%). Results at 30 days: the incidence rate of type Ia endoleak was reported by 37 studies with a mean value of 2.65%; 31 studies reported a null migration rate and 32 a null conversion rate to OR; in 31 of the 35 studies that reported AAA-related mortality, the incidence was null. Mid-term follow-up: the incidence rate of type Ia endoleak was reported by 48 studies with a mean value of 6.65%; 30 studies reported a null migration rate, 33 a null conversion rate to OR, and 28 of the 45 studies reported that the AAA-related mortality incidence was null. Conclusions: Based on the present analysis, EVAR appears to be a safe and effective procedure—and therefore recommendable—even in the presence of hostile anatomies, in patients deemed unfit for OR. However, in order to identify and pursue the patient’s best interest, particular attention must be paid to the management of the patient’s informed consent process, which—in addition to being an essential ethical-legal requirement to legitimize the medical act—ensures that clinical data can be integrated with the patient’s personal preferences and background, beyond the therapeutic potential of the proposed procedures and what is generically stated in the guidelines.

The imposition of compulsory health treatments has always been a subject of animated legal and bioethical debate. What is at stake are two opposing interests that are in their own way protected by international treaties and constitutional provisions: the right to individual self-determination and the duty to defend and preserve collective safety. The global health crisis related to the COVID-19 pandemic has placed the issue of the legitimacy of imposing compulsory vaccination at the center of the multifaceted debate on pandemic health policies. Indonesia, Tajikistan, Turkmenistan, and the Federated States of Micronesia are currently the only four countries in the world where the COVID-19 vaccine is mandatory for all citizens. Italy was the first country in the European Union to introduce this obligation, effective from 8 January 2022 by virtue of the decree-law approved on 5 January 2022, which imposed vaccination compulsory for everyone over the age of 50. Similar paths have been undertaken by Greece and Austria, where the obligation will start respectively on 16 January 2022 (for citizens aged over 60) and 1 February 2022 (for citizens of all ages). However, in many civilized countries, “selective” forms of compulsory vaccination, i.e., aimed at specific categories of individuals, especially healthcare professionals, are already provided for. The present work aims to offer a concise and as much as possible exhaustive overview of the main ethical and legal issues related to compulsory COVID-19 vaccination, with reference to both the Italian and the international context, mainly European.

At the dawn of the fourth industrial revolution, the healthcare industry is experiencing a momentous shift in the direction of increasingly pervasive technologization of care. If, up until the 2000s, imagining healthcare provided by robots was a purely futuristic fantasy, today, such a scenario is in fact a concrete reality, especially in some countries, such as Japan, where nursing care is largely delivered by assistive and social robots in both public and private healthcare settings, as well as in home care. This revolution in the context of care, already underway in many countries and destined to take place soon on a global scale, raises obvious ethical issues, related primarily to the progressive dehumanization of healthcare, a process which, moreover, has undergone an important acceleration following the outbreak of the COVID-19 pandemic, which has made it necessary to devise new systems to deliver healthcare services while minimizing interhuman contact. According to leading industry experts, nurses will be the primary users of healthcare robots in the short term. The aim of this study is to provide a general overview, through a scoping review approach, of the most relevant ethical issues that have emerged in the nursing care field in relation to the increasingly decisive role that service robots play in the provision of care. Specifically, through the adoption of the population-concept-context framework, we formulated this broad question: what are the most relevant ethical issues directly impacting clinical practice that arise in nursing care delivered by assistive and social robots? We conducted the review according to the five-step methodology outlined by Arksey and O’Malley. The first two steps, formulating the main research question and carrying out the literature search, were performed based on the population-context-concept (PCC) framework suggested by the Joanna Briggs Institute. Starting from an initial quota of 2,328 scientific papers, we performed an initial screening through a computer system by eliminating duplicated and non-English language articles. The next step consisted of selection based on a reading of the titles and abstracts, adopting four precise exclusion criteria: articles related to a nonnursing environment, articles dealing with bioethical aspects in a marginal way, articles related to technological devices other than robots, and articles that did not treat the dynamics of human-robot relationships in depth. Of the 2,328 titles and abstracts screened, we included 14. The results of the 14 papers revealed the existence of nonnegligible difficulties in the integration of robotic systems within nursing, leading to a lively search for new theoretical ethical frameworks, in which robots can find a place; concurrent with this exploration are the frantic attempts to identify the best ethical design system applicable to robots who work alongside nurses in hospital wards. In the final part of the paper, we also proposed considerations about the Italian nursing context and the legal implications of nursing care provided by robots in light of the Italian legislative panorama. Regarding future perspectives, this paper offers insights regarding robot engagement strategies within nursing.

Aim of this paper is to report an unusual case of iliac artery acute thrombosis following a laparoscopic elective surgery for hiatal hernia repair and observed during a medical malpractice litigation. A 69-year-old woman submitted to laparoscopic hiatal hernia repair developed a lower limb ischemia in 5th postoperative day due to common iliac and popliteal arteries acute occlusion. Patient was urgently treated with iliac embolectomy with Fogarty's catheter, and femoral endarterectomy, followed on 1st post-operative day by external iliac artery stenting and multiple attempts of popliteal artery recanalization. After 4 years of follow-up, despite symptoms at rest were disappeared, a severe (, Highlights • Although rare, retrospective studies and surveys report an incidence ranging from 0.04% to 0.5%, direct major vascular injuries are well-known potential complications of laparoscopic surgery. • In the great majority of cases, iliac lesion become clinically evident as haemorrhagic lesions. • This is the first case of acute limb ischemia due to laparoscopic surgery related iliac lesion evaluated during a medical malpractice litigation.

Violence against women emerges with tragic regularity in the daily news. It is now an evident trace of a dramatic social problem, the characteristics of which are not attributable to certain economic, cultural, or religious conditions of the people involved but affect indiscriminately, in a unanimous way, our society. The study is a survey about the number of hospital admissions due to episodes attributable to violence against women, recorded by the Niguarda Hospital in Milan in the period 1 March–30 May from 2017 to 2020. This period, in 2020, corresponds to the coronavirus Lockdown in Italy. All the medical records of the Emergency department were reviewed, and the extracted data classified in order to identify the episodes of violence against women and the features of the reported injuries and the characteristics of the victims. The data did not show an increase in the number of cases in 2020 compared to previous years, but we did find a notable increase in the severity of injuries.

Background and objective: Telemedicine or telehealth services has been increasingly practiced in the recent years. During the COVID-19 pandemic, telemedicine turned into and indispensable service in order to avoid contagion between healthcare professionals and patients, involving a growing number of medical disciplines. Nevertheless, at present, several ethical and legal issues related to the practice of these services still remain unsolved and need adequate regulation. This narrative review will give a synthesis of the main ethical and legal issues of telemedicine practice during the COVID-19 pandemic. Material and Methods: A literature search was performed on PubMed using MeSH terms: Telemedicine (which includes Mobile Health or Health, Mobile, mHealth, Telehealth, and eHealth), Ethics, Legislation/Jurisprudence, and COVID-19. These terms were combined into a search string to better identify relevant articles published in the English language from March 2019 to September 2021. Results: Overall, 24 out of the initial 85 articles were considered eligible for this review. Legal and ethical issues concerned important aspects such as: informed consent (information about the risks and benefits of remote therapy) and autonomy (87%), patient privacy (78%) and confidentiality (57%), data protection and security (74%), malpractice and professional liability/integrity (70%), equity of access (30%), quality of care (30%), the professional–patient relationship (22%), and the principle of beneficence or being disposed to act for the benefit of others (13%). Conclusions: The ethical and legal issues related to the practice of telehealth or telemedicine services still need standard and specific rules of application in order to guarantee equitable access, quality of care, sustainable costs, professional liability, respect of patient privacy, data protection, and confidentiality. At present, telemedicine services could be only used as complementary or supplementary tools to the traditional healthcare services. Some indications for medical providers are suggested.

The COVID-19 pandemic has shocked the world causing more victims than the latest global epidemics such as Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) in 2003, and the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in 2012. Italy has been one of the most affected countries, and it had to deal with an already weak economic condition and cuts to public health services due to budgetary requirements from the last decade—something that made the situation even more dramatic. Deaths have exceeded 600.000 worldwide. During the emergency, regulatory measures were taken to counter the situation. This study highlights the main anti-COVID-19 government measures to support doctors and healthcare professionals, and it analyzes how to respond to the many requests complaining about neglectful healthcare professionals during the spread of the infection. For all those healthcare workers who died on duty, a compensation plan is assumed through a solidarity fund. The same solution cannot be granted to all patients, given the difficulty in assessing the responsibility of the doctor not only during an emergency but with insufficient instruments to cope with it as well.

Objective Sham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors. Materials and methods For the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present. Results The analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects. Conclusions The validity of sham surgery should be reconsidered., Highlights • In sham surgery literature there's no assessment on confounding factors effect. • Even if sham surgery has been used as control for over 30 years it isn't a standard. • The validity of sham surgery is not completely supported by available literature.

BACKGROUND: Our previous studies have investigated the psychological consequences of kidnapping in a group of Italian seafarers assaulted by sea pirates and held in captivity and in their family members by the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-4. These studies have shown that both the victims and the family members showed significant psychological disturbances, corresponding to a chronic Post-Traumatic Stress Disorder (PTSD), in the victims, and a pattern of anxiety and depression in their family members. After publication of these studies, an updated edition of the DSM became available, namely, the DSM-5. The DSM-5 redefines some diagnostic criteria, including those related to the PTSD. This work was focused on the re-evaluation of the results of our previous studies in the light of the DSM-5 diagnostic criteria. MATERIALS AND METHODS: Sixteen Italians including 4 kidnapped seafarers and 12 family members were examined by a semi-structured interview followed by Clinician-Administered PTSD Scale (CAPS-DX) and the Cognitive Behaviour al Assessment (CBA 2.0) for victims and by State-Trait Anxiety Inventory (STAI) X-1 and X-2 of CBA 2.0 and the Hamilton Depression Rating Scale (HDRS) for family members. Data already obtained were reviewed and re-analysed according to the DSM-5 criteria and the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). RESULTS: The use of the CAPS-5 did not modify the diagnosis for the victims' group: 3 of 4 had a PTSD diagnosis performed through the CAPS-5. Seven of 12 family members had PTSD diagnosis performed through the CAPS-5, with negative cognitions and mood symptoms being those obtaining the highest score. CONCLUSIONS: Using DSM-5 criteria, the diagnosis of PTSD in the direct victims of piracy was confirmed. The same diagnosis could apply to a group of their family members. Besides anxiety and fear, in fact, we found in 7 out 12 subjects the presence of symptoms included by the DSM-5 in the PTSD spectrum. These symptoms were: avoidance, negative alterations in mood and cognition, blame of self or others. The use of updated diagnostic criteria may enable more correct assessment of the consequences of piracy acts. This may be also useful for establishing proper compensations for the damage suffered by seafarers, depending on the degree of disability resulting from the criminal acts they suffered. Language: en

Metabolic syndrome (MetS) is a common and complex disorder combining hypertension, obesity, dyslipidemia, and insulin resistance. MetS represents a risk factor for changes in cognitive functions in older age, and several studies have suggested that MetS may be linked to dementia. This article reviews the main evidences about the relationship between MetS and neurodegenerative disease. Starting from an epidemiological point of view, the article analyzes medico-social aspects related to MetS, considering the reduction of work capacity and the condition of disability that it involves. Some authors affirm that on the basis of current Italian legislation, it is possible to consider the syndrome as a disability. This is because all the diseases that make up MetS are high-risk clinical pathological conditions. For these reasons, a joint action is required to contain the incidence of MetS, the high social costs, and the loss of productivity related to the syndrome. In conclusion, healthcare initiatives could be adopted in order to increase the understanding of the pathogenic contributions of each element on MetS and how they can be modified. These actions will be useful to reduce healthcare costs and can lead to more effective prevention of metabolic disease, thus promoting good health.MetS: Metabolic syndrome; WHO: World Health Organization; CVD: cerebrovascular diseases; AD: Alzheimer's Disease; VaD: Vascular Dementia; IDF: International Diabetes Federation; T2DM: type 2 diabetes mellitus; CAD: coronary artery disease; MCI: mild cognitive impairment; NCDs: Non Communicable Diseases; BMI: Body Mass Index; ICIDH: International classification of impairments, disabilities and handicaps.