Telemedicine in diabetic ulcer management: A pilot study with exploration of medico-legal aspects.

BACKGROUND AND AIMS: This study aimed to evaluate the quality and efficiency of telemedicine in managing patients with chronic diabetic ulcers and provide an overview of the main medico-legal implications associated with telemedicine management of diabetic foot complications. METHODS AND RESULTS: A total of 50 patients with type 2 diabetes mellitus were enrolled from a diabetic foot outpatient clinic in Cyprus between March and May 2022. Participants completed a survey concerning telemedicine services, and the demographic variables and average responses to the PACIC (Patient Assessment of Chronic Illness Care) questions were examined using descriptive analysis. The majority of patients (84%) were male, with a mean age of 60.9 ± 13.05 years. The average PACIC score was 4.42 (min. 2.7 and max. 5.0). Voice calls were the most preferred method of telemedicine delivery, accounting for 53% of all services. CONCLUSION: Telemedicine can effectively manage chronic patients, such as those with diabetic ulcers, by reducing the burden on resources and maintaining service quality. However, healthcare professionals must be well-versed in medico-legal implications to adhere to legal and ethical guidelines, protect patient privacy, and maintain high standards of care while using telemedicine for chronic condition treatment.

The contributing factors to suicide in Italian prisons: An 11-year analysis (2010-2020).

BACKGROUND: Suicide is a leading cause of death globally, with approximately 800,000 deaths annually and accounting for 1.5% of all deaths. Risk factors are multifaceted, encompassing individual factors (such as genetics, family history and mental illnesses) and environmental factors (such as economic conditions, social support and life events). In prisons, suicide rates are markedly higher than in the general population, particularly in Italy, where the prisoner suicide rate is approximately 20 times that of the non-incarcerated population. There is, however, little research on suicide in Italian prisons. AIMS: To analyse the characteristics of all people who died by suicide in Italian prisons between 2010 and 2020. METHODS: We carried out a records-based cohort study analysing official data from the Italian Ministry of Justice on prison suicides between 2010 and 2020. The data were cross-referenced and, when required, supplemented with information from Ristretti Orizzonti, a journal specialising in health and living conditions in prisons, as well as from the website of ISTAT (Italian National Statistical Institute), newspapers, radio broadcasts and news agencies. RESULTS: Factors associated with an increased risk of suicide in prisons were nighttime periods, the months of June, July and October, a relatively brief duration of detention (<6 months), having been convicted of murder, male gender, being about 40 years old, having access to hanging materials and being interned (i.e. subjected to the execution of custodial security measures) or awaiting trial. Prison overcrowding was not a risk factor for suicide. CONCLUSION: Our findings hold substantial implications for suicide prevention in Italian prisons as they suggest both characteristics of individuals and characteristics of the institutions that could be taken as risk indicators. This knowledge can inform the development of targeted interventions to manage both individual and environmental factors better, leading to improved prison conditions and reduced suicide rates. Furthermore, our research establishes a foundation for more systematic and in-depth investigations that could further improve suicide prevention strategies in Italian prisons, ultimately influencing policy changes in both practice and research, including perhaps establishing a national database on every completed suicide in prisons.

Ethical and Legal Challenges of Telemedicine in the Era of the COVID-19 Pandemic.

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.

Telemedicine Practice: Review of the Current Ethical and Legal Challenges.

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.

Telepharmacy Services: Present Status and Future Perspectives: A Review.

Background and Objectives: The term "telepharmacy" indicates a form of pharmaceutical care in which pharmacists and patients are not in the same place and can interact using information and communication technology (ICT) facilities. Telepharmacy has been adopted to provide pharmaceutical services to underserved areas and to address the problem of pharmacist shortage. This paper has reviewed the multi-faceted phenomenon of telepharmacy, summarizing different experiences in the area. Advantages and limitations of telepharmacy are discussed as well. Materials and Methods: A literature analysis was carried out on PubMed, using as entry term "telepharmacy" and including articles on the topic published between 2012 and 2018. Results: The studies reviewed were divided into three categories of pharmacy practice, namely (1) support to clinical services, (2) remote education and handling of "special pharmacies", and (3) prescription and reconciliation of drug therapies. In general, different telepharmacy services were effective and accompanied by a satisfaction of their targets. Conclusions: Nowadays, the shortage of health personnel, and in particular pharmacists, is a challenging issue that the health systems have to face. The use of a new technology such as telepharmacy can represent a possible option to solve these problems. However, there are unsolved limitations (e.g., legal implications) that make greater diffusion of telepharmacy difficult. Stronger data on the effectiveness of this area of pharmacy care, together with a critical evaluation of its limits, can make actors involved aware about the potentialities of it and could contribute to a larger diffusion of telepharmacy services in the interest of communities and citizens.

Towards a Transversal Definition of Psychological Resilience: A Literature Review.

Background and objectives: This paper addresses psychological resilience, a multidisciplinary theoretical construct with important practical implications for health sciences. Although many definitions have been proposed in several contexts, an essential understanding of the concept is still lacking up to now. This negatively affects comparisons among research results and makes objective measurement difficult. The aim of this review is to identify shared elements in defining the construct of resilience across the literature examined in order to move toward a conceptual unification of the term. Materials and methods: A literature review was performed using the electronic databases 'PubMed' and 'PsycINFO'. Scientific studies written in English between 2002 and May 2019 were included according to the following key terms: 'Psychological', 'resilience', and 'definition'. Results: The review identifies five macro-categories that summarize what has been reported in the recent literature concerning the resilience phenomenon. They serve as a preliminary and necessary step toward a conceptual clarification of the construct. Conclusions: We propose a definition of psychological resilience as the ability to maintain the persistence of one's orientation towards existential purposes. It constitutes a transversal attitude that can be understood as the ability to overcome the difficulties experienced in the different areas of one's life with perseverance, as well as good awareness of oneself and one's own internal coherence by activating a personal growth project. The conceptual clarification proposed will contribute to improving the accuracy of research on this topic by suggesting future paths of investigation aimed at deeply exploring the issues surrounding the promotion of resilience resources.

A Proposed Road Map for the Ethical Evaluation of Sham (Placebo) Surgery.

OBJECTIVE: The study proposes a possible roadmap for the ethical assessment of sham surgery clinical trials (CTs), focusing on methodological aspects, as a result of the lack of this type of practical tool in the literature/practice. BACKGROUND: Surgical procedures are frequently conducted without closely controlled studies. For this reason, these procedures are less rigorous than those for drug/device clinical trials. The aim of a sham (placebo) surgery CT is to carry out a surgical CT with a legitimate control group. The use of sham surgery is controversial from an ethical point of view. METHODS: This evaluation system is set up according to ICH/GCP, World Medical Association Declaration of Helsinki, CONSORT 2010 standards. The proposed roadmap is based on the following 4 steps/levels: safety/clinical indications; adequacy of trial methodology/design adopted for a sham surgery CT; specific informed consent, and economic issues. RESULTS: A flowchart is proposed which can be used at two levels: as a basic guideline for the design of a surgical protocol representing a benchmark level of care; and a multiaxial assessment considering the first two sources of morality of human acts according to Aristotelian ethics: the object of the act (step 1) and some of its circumstances (steps 2-4). CONCLUSIONS: The use of a placebo and of double-blind control groups in surgery CTs would improves the quality of results, providing that an accurate ethical assessment procedure is in place, firstly to ensure patient safety and secondly to prevent abuses/procedural biases. Future testing of the proposed flowchart is outlined.

Metabolic syndrome, hypertension, and nervous system injury: Epidemiological correlates.

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. ABBREVIATIONS: 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.

MEDICALLY ASSISTED PROCREATION, A DISCUSSION STILL OPEN IN ITALY.

This article analyses the current situation of medically assisted reproduction in Italy after the issuance of Law 40 in 2004. This law is actually completely different from its first version. In fact, the controversial points, like reproduction for couples with genetic diseases, prohibition of heterologous fertilization, cryoconservation of embryos, obligation to perform just one and simultaneous implant of all the embryos produced, are definitively not in force today. This new situation can be explained not only by rules issued by Italian courts but, in particular, by changes introduced by the European Court of Human Rights and by questions of constitutional legitimacy raised by some Italian Courts. After ten years from the issue of this law, Italy has returned to the pre-existing situation. The old law was only full of prohibitions. Now, heterologous fertilization is possible and this article gives a picture of the present situation in hospitals for assisted procreation in Italy.

Preserving Patient Stories: Bioethical and Legal Implications Related to the Shift from Traditional to Digital Anamnesis.

It is since the beginning of the so-called 'digital revolution' in the 1950s that technological tools have been developed to simplify and optimise traditional, time-consuming, and laborious anamnestic collection for many physicians. In recent years, more and more sophisticated 'automated' anamnestic collection systems have been developed, to the extent that they can actually enter daily clinical practice. This article not only provides a historical overview of the evolution of such tools, but also explores the ethical and medico-legal implications of the transition from traditional to digital anamnesis, including the protection of data confidentiality, the preservation of the communicative effectiveness of the doctor-patient dialogue and the safety of care in patients with poor digital and health literacy.

Physician-Modified Endografts for Repair of Complex Abdominal Aortic Aneurysms: Clinical Perspectives and Medico-Legal Profiles.

Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.

Long-term care insurance in Italy: medico-legal and socio-economic profiles.

Long-term care insurance (LTCI) plays a crucial role in providing substantial aid in non-self-sufficient situations and complementing existing state protection mechanisms. With an aging population and increasing demand for healthcare services LTC policies have become indispensable. While individual LTCI policies face adoption challenges, group insurances offer a more streamlined alternative. However, realizing the full potential of these insurances necessitates targeted legislative intervention to improve accessibility and ensure sustainability. This article explores the evolution of LTCI policies in Italy, offering an overview of the current landscape and highlighting the socio-economic and medico-legal factors shaping the present scenario. By providing this analysis, we seek to offer insights into the dynamic evolution of LTCI policies and the crucial role of legislative measures in enhancing their effectiveness and accessibility.

Self-reported diabetes mellitus among seafarers: occupational and sociodemographic predictors.

BACKGROUND: Seafarers are at increased risk of diabetes due to their lifestyle and working conditions on board ships. There is, however, limited evidence regarding the magnitude of diabetes and its risk factors. In this study, we aimed to assess the prevalence of self-reported diabetes among seafarers on board ships and identify risk factors associated with it. MATERIALS AND METHODS: A cross-sectional epidemiological survey was conducted among seafarers aboard ships between November and December 2022. The study enrolled a total of 4,500 seafarers aged 18 and older. Data were collected using anonymous, standardized questionnaires. The association between the outcome variable and the independent variables was assessed using binary logistic regression models. RESULTS: In total, 2,986 participants were included in the study. The prevalence of self-reported diabetes among seafarers was found to be 8.2% (95% CI: 7.2-9.2). Self-reported diabetes prevalence among officers and non-officers was 7% and 9%, respectively. The mean age of study participants was 37.96 ± 10.22, while the mean age of participants with diabetes was 47.5 ± 9.46. Independent predictors of self-reported diabetes mellitus were age (51+ years) [adjusted odds ratio (AOR): 3.52, 95% confidence interval (CI): 1.46-8.95], rank (non-officer) [AOR: 1.65; 95% CI: 1.14-2.40], worksites (engine) (AOR: 2.08, 95% CI: 1.19-3.77), work experience (10-20 years) (AOR: 4.66, 95% CI: 2.33-10.05), work experience (21+ years) (AOR: 5.01, 95% CI: 2.32-11.55), working hours per week (57-70 hours) (AOR: 1.57, 95% CI: 1.08-2.31), working hours per week (71+ hours) (AOR: 1.80, 95% CI: 1.17-2.80), self-reported hypertension (AOR: 1.44, 95% CI: 1.03-1.99), overweight (AOR: 1.74; 95% CI: 1.24-2.47), and obesity (AOR: 2.93; 95% CI: 1.84-4.65). CONCLUSIONS: This study revealed that one in twelve seafarers between the ages of 19 and 70 have self-reported diabetes. The present study identified significant risk factors associated with diabetes. Risk factor mitigation strategies aimed at high-risk groups should be implemented on board ships.

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study.

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.

3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?

Synthetic cathinones represent one of the largest and most abused new psychoactive substance classes, and have been involved in numerous intoxications and fatalities worldwide. Methcathinone analogues like 3-methylmethcathinone (3-MMC), 3-chloromethcathinone (3-CMC), and 4-CMC currently constitute most of synthetic cathinone seizures in Europe. Documenting their consumption in clinical/forensic casework is therefore essential to tackle this trend. Targeting metabolite markers is a go-to to document consumption in analytical toxicology, and metabolite profiling is crucial to support investigations. We sought to identify 3-CMC, 4-CMC, and 4-bromomethcathinone (4-BMC) human metabolites. The substances were incubated with human hepatocytes; incubates were screened by liquid chromatography-high-resolution tandem mass spectrometry and data were mined with Compound Discoverer (Themo Scientific). 3-CMC-positive blood, urine, and oral fluid and 4-CMC-positive urine and saliva from clinical/forensic casework were analyzed. Analyses were supported by metabolite predictions with GLORYx freeware. Twelve, ten, and ten metabolites were identified for 3-CMC, 4-CMC, and 4-BMC, respectively, with similar transformations occurring for the three cathinones. Major reactions included ketoreduction and N-demethylation. Surprisingly, predominant metabolites were produced by combination of N-demethylation and ω-carboxylation (main metabolite in 3-CMC-positive urine), and combination of ß-ketoreduction, oxidative deamination, and O-glucuronidation (main metabolite in 4-CMC-positive urine). These latter metabolites were detected in negative-ionization mode only and their non-conjugated form was not detected after glucuronide hydrolysis; this metabolic pathway was never reported for any methcathinone analogue susceptible to undergo the same transformations. These results support the need for comprehensive screening strategies in metabolite identification studies, to avoid overlooking significant metabolites and major markers of consumption.

Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review.

Three-dimensional bioprinting is a rapidly evolving technology that holds the promise of addressing the increasing demand for organs, tissues, and personalized medicine. By employing computer-aided design and manufacturing processes, 3D bioprinting allows for the precise deposition of living cells, biomaterials, and biochemicals to create functional human tissues and organs. The potential applications of this technology are vast, including drug testing and development, disease modeling, regenerative medicine, and ultimately, organ transplantation. However, as with any groundbreaking technology, 3D bioprinting presents several ethical, legal, and regulatory concerns that warrant careful consideration. As the technology progresses towards clinical applications, it is essential to address these challenges and establish appropriate frameworks to guide the responsible development of 3D bioprinting. This article, utilizing the Arksey and O'Malley scoping review model, is designed to scrutinize the bioethical implications, legal and regulatory challenges, and medico-legal issues that are intertwined with this rapidly evolving technology.

Telemedicine as a Strategic Tool to Enhance the Effectiveness of Care Processes: Technological and Regulatory Evolution over the Past Two Decades.

Digital innovation represents one of the largest areas of investment in healthcare [...].

Informed Consent in Paediatric Telemedicine: Challenge or Opportunity? A Scoping Review.

The fundamental importance of informed consent as a prerequisite for the lawfulness of the medical act is an indisputable cornerstone of clinical practice. However, the provision of effective information and the collection of informed consent presents important critical issues in the underage patient, even considering that in general terms he or she does not have the power to directly express consent, which must be provided by parents or legal guardians. These critical issues are amplified in the context of telemedicine. The present study aims, through a scoping review of the literature of the past 10 years, to outline the operational practices adopted in the collection of informed consent from children in the context of telemedicine and to identify solutions devised to address the critical issues related to the provision of adequate information to the child in this particular care setting. The results of the research show that the activity of delivering adequate information to the child, itself complex, is made even more complex by the particular setting of telemedicine, which, however, could be effectively exploited to facilitate communication with the child patient.

The role of digital literacy in achieving health equity in the third millennium society: A literature review.

Healthcare in the third millennium is largely delivered through systems involving the use of the technological devices and services, foremost among them telemedicine. For the adequate delivery of digital medicine services, however, it is necessary for users to be digitally literate, that is, able to consciously make use of technology. In order to understand how relevant digital literacy is in determining the effectiveness of e-Health services, we performed a traditional literature review on 3 major databases by combining the terms "Digital Literacy" and "Computer Literacy" with the terms "Telemedicine" and "Telehealth". Starting from an initial library of 1,077 papers, we selected 38 articles. At the outcome of the search, we found that digital literacy is a pivotal element in conditioning the effectiveness of telemedicine and digital medicine services in general, however, with some limitations.