Psychiatric advance directives (Ulysses Contract): the need for a specific law and a criteria proposal for its introduction.

AIM: Advance healthcare directives in the psychiatric field raise more concerns and controversies compared to their use in other medical branches. We discuss the role of advance directives in this field and suggest a criteria proposal for the settlement of a comprehensive regulation on the matter. METHODS: We analyse the existing law and discuss the ethical points in the Italian context and, in comparison, with the United Kingdom context. RESULTS: Numerous studies have highlighted that psychiatric patients experience advance directives as an instrument to participate in therapeutic decision-making. Regarding the usefulness of advance directives, Italy and the United Kingdom did not approve deontological rules or laws. The United Nations Commission states that, based on the principles of the Convention on the Rights of Persons with Disabilities, it is necessary to respect the spatient's will, even if it is biased by psychic disorders. CONCLUSIONS: The Convention does not consider advance directives; instead, they just suggest using some support to have the patient regain their competence. In case this is unsuccessful, it is necessary to appoint a substitute decision-maker to express, even in the light of the advance directives, the will that the patient would have expressed if he had been competent.

The choice of Caesarean section between clinical indication and patient autonomy: The physician between rock and hard place.

RATIONALE, AIMS AND OBJECTIVES: Caesarean delivery carries a higher risk of short- and long-term complications for both mother and baby than vaginal delivery. However, over the past two decades, data show a considerable increase in requests for Caesarean sections. This manuscript analyses the case of Caesarean Section on maternal request without a clinical indication from a medico-legal and ethical perspective. METHOD: Medical associations and bodies databases were searched for published guidelines and recommendations on the use of caesarean sections on maternal requests. As derived from the literature, medical risks, attitudes, and reasons for this choice have also been summarized. RESULTS: International guidelines and medical associations recommend strengthening the doctor-patient relationship by setting up an information process to make the pregnant woman understand the danger of Caesarean delivery without clinical indications and to make her consider whether she can survive natural childbirth. CONCLUSION: Caesarean section on maternal request and without clinical indications is an emblematic case of how the physician could be between two opposing interests. Our analysis shows that if the woman's rejection of natural birth persists and clinical indications for Caesarean delivery are lacking, the physician must respect the patient's choice.

In Vitro Fertilisation with Reception of Oocytes from Partner: A Transnational Case of Female Shared Biological Motherhood.

The social evolution of the concept of "the family" and changes in attitudes towards homosexual couples have expanded the range of people permitted to gain access to assisted reproduction technologies, encouraging the creation of blended families. "Reception of Oocytes from Partner" (ROPA) is a treatment that permits female couples to become active participants in the reproductive process and have a biological connection to their child. This article reports a case of transnational shared motherhood, in which the Italian Supreme Court (Application no 19599, Supreme Court of Cassation, First Civil Chamber, 2016), dealt for the first time with a same-sex couple's request concerning the recognition of a legal child-relationship with a child conceived through in vitro fertilisation with ROPA. Although Italian law bans assisted reproduction technologies for same-sex couples, the Court acceded to the request of the couple on the basis of its evaluation of what was in the best interests of the child.

Late termination of pregnancy in case of congenital CMV infection: ethics, medicine and law.

This paper provides a recent legal case which calls into discussion the women's safe access to voluntary termination of pregnancy (VTP) after the first 90 days. On 15 January 2021, the Italian Supreme Court sentenced a physician to damage compensation because he did not correctly inform the patient, in her 22nd week of pregnancy, about the risks to the fetus relating to an infection from cytomegalovirus (CMV). The option for VTP was not offered since, at the time of the woman's request, medical investigations did not show the evidence of fetal malformations, neither there were concrete risks for the life of the mother, as Italian law requires. The baby was born with severe brain injuries. The case is noteworthy because it offers a new precedent to extend legal requirements for late VTP. The impact of this decision must be tested in the clinical practice. Further studies are necessary to evaluate possible law amendments extending access conditions for this practice and new policies promoting the strengthening of informative and assistance procedures, including psychological help, to the pregnant woman are needed, as well.

Two sides of the same coin: educational and professional pathway for surgical residents.

AIM: To provide a review of medical malpractice cases ruled by the Italian Supreme Court with the aims at identifying lawsuits targeting involved with surgical residents. MATERIAL AND METHODS: Legal cases ruled by the Italian Supreme Court, from September 2020 to October 2020, pertaining to medical claims involving surgical residents were examined, using the main online databases. RESULTS: Of a total of eleven (n=11; 100%) cases identified, four (n= 4; 36,4%) cases addressed the standard of care pertaining to the surgical residents' medical activity. The legal reasoning of the Italian Supreme Court does not focus on the manual skill in the resident's medical performance, but rather on the choice to accept to treat the patient, regardless of the participation of the tutor. CONCLUSIONS: The performance of the surgical residents is made more difficult due to their peculiar nature, characterized by the complex interactions between the directives given by the tutor and the need to guarantee patients' needs. KEY WORDS: Surgical Residents, Tutor, Educational Pathway, Medical Malpractice, Standard of Care.

Physical Restraint in Psychiatric Care: Soon to Fall Out of Use?

International directives all recommend that using restraints on psychiatric patients should be avoided, yet scientific literature shows that such practices are still largely in use. This article aims to lay out strategies that could be put in place in order to gradually discard the use of restraints, particularly through a "restraint-free" approach, nursing, logistic-environmental pathways, and locally centered health care provision. All such tools have proven valuable for the purpose of safeguarding the health of psychiatric patients. Hence, the failure to put in place such measures may lead to litigation and lawsuits against physicians and particularly health care facilities. Undoubtedly, the ability to effectively implement such methods largely depends on the financial resources available, which in countries such as Italy are poorer than in others. Still, the risk of being sued and held professionally liable may constitute a factor in raising awareness among operators, facilities, and public health care management, leading to the implementation of policy changes aimed at minimizing the use of restraints.

Euthanasia and physician-assisted suicide for patients with depression: thought-provoking remarks.

Euthanasia and medical assistance in dying entail daunting ethical and moral challenges, in addition to a host of medical and clinical issues, which are further complicated in cases of patients whose decision-making skills have been negatively affected or even impaired by psychiatric disorders. The authors closely focus on clinical depression and relevant European laws that have over the years set firm standards in such a complex field. Pertaining to the mental health realm specifically, patients are required to undergo a mental competence assessment in order to request aid in dying. The way psychiatrists deal and interact with decisionally capable patients who have decided to end their own lives, on account of sufferings which they find to be unbearable, may be influenced by subjective elements such as ethical and cultural biases on the part of the doctors involved. Moreover, critics of medical aid in dying claim that acceptance of such practices might gradually lead to the acceptance or practice of involuntary euthanasia for those deemed to be nothing more than a burden to society, a concept currently unacceptable to the vast majority of observers. Ultimately, the authors conclude, the key role of clinicians should be to provide alternatives to those who feel so hopeless as to request assistance in dying, through palliative care and effective social and health care policies for the weakest among patients: lonely, depressed or ill-advised people.

Sex reassignement with or without surgery. New ethical and juridical pathways.

INTRODUCTION: The access to sex-reassignment surgery is based on the existence of an unequivocal dyscrasia between the morphological sex and the objective evidence that emerges from in-depth analysis of the individual's personality. In Italy, such type of surgical intervention is subject to the authorization of a judge. MATERIAL OF STUDY: Authors examine the recent Italian Constitutional judgement which has addressed the right to change legal sex status without the need for sex-reassignment surgery. DISCUSSION: The Italian approach is in line with scientific evidence that the physical and mental well-being of an individual does not always require the surgical rectification of primary sexual features. Thus, sex reassignment surgery is not to be considered mandatory; rather, it should be aimed at ensuring the transsexual individual's stable psychological and physical good. From an ethical point of view, the Court's decision is very important, since it does not subordinate such fundamental rights as gender identity, healthcare and equality to prior, highly invasive surgery. CONCLUSIONS: The authors point out that critical issues and obstacles to the full implementation of the right to gender identity remain, in that this right is still subject to the authorization of a judge. This approach does not seem to be in line with the recent World Health Organization (WHO) decision to remove the "gender incongruity" from the list of mental and behavioural disorders (as it is in the current International Classification of Diseases-10, so far), to decrease the stigma surrounding such a condition. KEY WORDS: Gender identity, Sex reassignment, Surgery, Stigma, Transsexualism, Transgender.

Bioethics in Italian Medical and Healthcare Education. A Pilot Study.

BACKGROUND AND AIM OF THE WORK: Bioethics is relevant in healthcare and medical schools. However, unlike other foreign countries, its teaching in Italy has only been recently introduced, it is less extensively offered and no academic standards for bioethics education have been established. This research aims at understanding whether university bioethics courses attendees appreciate and consider teaching strategies to be effective with the objective of validating a coherent didactic approach to the discipline and stimulate further discussion on ways to improve it. METHODS: A standardized survey was administered to 1590 students attending undergraduate degree programs in medicine and healthcare at four Italian universities. RESULTS: The majority of interviewees (92.5%) had an interest in bioethics, considered it to be important for any life-sciences-related program (73.5%) and most healthcare (77.2%) and medical students (69.2%) suggested its teaching should be included in their curricula and made mandatory (66.3%) and continuous (57.7%), given its usefulness in clinical practice. Students consider bioethics as a care-integrated practice and appreciate teaching methods where it is integrated into clinical cases. Conceptual specificity and interdisciplinarity may affect the learning process and contribute to enhance students' analytical skills. CONCLUSIONS: Italian bioethics education should be revised to meet students' expectations and preferences. Its complex, multi-disciplinary and transversal nature suggests bioethical education to be flexible and integrated among different disciplines, thus stimulating a broader critical capacity through cases studies and other interactive teaching methods for helping students better deal with bioethics-inherent difficulties and improve the learning process.

Limitation of professional medical liability in case of emergency medical treatment according to the joint criminal divisions of the Supreme Court of Cassazione.

Judgement no. 8770 released on February 22, 2018 by the joint criminal divisions of the Supreme Court of Cassazione innovatively established that emergency medical conditions represent "problem of special complexity" and, therefore, it is mandatory to apply art. 2236 of the Italian Civil Code. This article provides that health care professional may be convicted only in case of willful misconduct or gross negligence. The authors analyze the jurisprudential evolution of all those elements that are fundamental to assess health care professional liability: a) special complexity of the performance b) relation between imprudence and carelessness c) conditions that may make the healthcare liability gross. The principles approved by the joint criminal division within the above mentioned judgment significantly expand special complexity cases' range and, therefore, the corresponding liability's limitation range is extended. Due to the solidity of the reasons on which it is based, this sentence could permanently influence the orientation of the Courts and, therefore, dramatically diminish the risk of professional liability for healthcare staff. There is, however, a lack of clarity in the practical applications of the distinction between unskillfulness, on the one hand, and imprudence and negligence on the other. This event risks to nullify the usefulness of the joint criminal divisions' intervention. In fact, if the Court considers the health care professional behavior to be imprudent or negligent (rather than unskilled), no limitation of liability can be applied. KEY WORDS: Carelessness, Criminal and civil medical liability limitation, Emergency medical treatments, Gross negligence, Problems of special complexity, Unskillfulness, imprudence.

The Italian law on informed consent and advance directives: New rules of conduct for the autonomy of doctors and patients in end-of-life care.

PURPOSE: Italy has long lacked a law regulating patients' informed consent and advance directives (ADs). All previous attempts to introduce a law on this matter failed to reach positive outcomes, and aroused heated ideological debate over the exact meaning of life and death. We report on the new law on informed consent and ADs approved by the Italian Parliament on 14th December 2017. MATERIALS AND METHODS: We analyse the new law and discuss the main ethical points connected with it, in the Italian context and in comparison with the international situation. RESULTS: The law provides for fundamental ethical principles and important guidelines: respect for patients' self-determination in all phases of life, option to refuse or interrupt life-sustaining treatments, including artificial nutrition and hydration, the legitimacy of end-of-life decisions, and the implementation of palliative care to ease suffering and pain. CONCLUSIONS: The effects of the new law must be tested in the field. Its objectives will be achieved if, in clinical practice, ADs are able to satisfactorily represent informed personal preferences through patients' relationships with their physicians, as part of personalized advance care planning. Future studies are necessary to assess the impact of the new law in Italy.

A Survey on the Knowledge and Attitudes of Italian Medical Students toward Body Donation: Ethical and Scientific Considerations.

Post mortem body donation (PMBD) for medical training and research plays a key role in medical-surgical education. The aim of this study is to evaluate Italian medical students’ awareness and attitudes regarding this practice. A questionnaire was sent to 1781 Italian medical students (MS). A total of 472 MS responded: 406 (92.91%) had a strongly positive attitude to PMBD, while 31 (7.09%) were not in favor. The majority of subjects were Catholic (56.36%), while 185 and 21 subjects, said that they did not hold any religious beliefs, or were of other religions, respectively. Multivariate analysis showed significant associations (p-values < 0.05) between PMBD and religion, as well as perceptions of PMBD as an act of altruism, a tool for learning surgical practices, body mutilation, and an act contrary to faith. Although Italian MS believed cadaver dissection to be an important part of their education, they did not know much about it and had not received training on this altruistic choice. As future doctors, MS can play an important role in raising public awareness of the importance of PMBD for medical education and research. Specific educational programs to improve knowledge of this topic among MS are needed.

The "Canone Inverso": when tobacco was not so bad. A Look Back at the Primordial Debate on the tobacco effects in the Occupational Medicine.

AIM: The article provides an overview on the beginning and evolutions of medical observations on tobacco induced diseases between Eighteenth and Nineteenth century. METHODS: By searching for historical medical literature, first studies on tobacco-induced diseases focused on production risks rather than on adverse effects that the use of tobacco has for the human health. RESULTS: The approach induced first eighteenth-century authors to define this substance as a non-pathogenic and, consequently, not to consider tobacco factories dangerous for health workers. In those years, tobacco was employed in therapy as a stimulant treatment and it was considered harmless and even healthy and preventive of several acute diseases. CONCLUSIONS: Authors will show that studies on pathogenic effects of smoking will only start around late nineteenth century, when the idea of the healthiness of tobacco industry was already supported.

[New italian law about end of life: self-determination and shared care pathway.] / La nuova normativa italiana sul fine vita: l'autodeterminazione e la condivisione del percorso di cura.

The Italian Parliament has recently approved the Law n. 219/2017 concerning "Rules on informed consent and advance directives". The manuscript points out the main key points of the new law, in order to clarify the role of the advance directives and to provide clear operational guidelines for healthcare personnel. Taking into consideration the Italian deontological and juridical context, along with the main jurisprudential judgements, the law has been analysed. The Authors discussed the new rules and the bioethical issues also in relation to the provisions stated by the Convention on Human Rights and Biomedicine (Convention of Oviedo). The new law deals with relevant issues that were confined to jurisprudential rulings so far, such as the informed consent, the withdrawal/withholding of medical treatment (including artificial nutrition and hydration), the content of medical information, including the modalities, the medical responsibility and, finally, the value of advance directives. In the Authors' opinion this law provides essential rules to expressly strengthen the patients' autonomy, eliminating the juridical uncertainty on many central issues (such us, for example, the refusal of life-sustainment treatments) that have been the subject of contradictory judgments ruled by the Italian Courts. Nevertheless, advance directives should be regarded as a dynamic tools of relationship between physicians and assisted person and, thus, as an essential integrant part of the advance care planning. The education of health professionals and citizens about end of life issues is the basis for the successful implementation of this legislation.

Electrotherapy in the treatment of patients affected by rabies: experiments conducted at the "Maggiore" hospital of Milan in 1865.

During the nineteenth century, the scientific context of rabies treatment was weak due to the lack of the literature on specific nosology of the rabies disease, and unspecific and ineffective therapy approaches. Electrotherapy already represented an important therapeutic approach for nervous system diseases, although not specifically for rabies. In the present paper, the authors discuss the use of electrotherapy in the treatment of humans affected by rabies in an experimental study conducted at the Maggiore Hospital of Milan, with the aim of establishing the discovery of a possible specific therapy. By analyzing the printed scientific sources available in the Braidense Library of Milan, the authors describe four experiments conducted on patients of different ages. Symptoms and effects both during and after the electrotherapy are also highlighted. The experiments demonstrated that electricity is not an effective therapy in the treatment of rabies, being rather able to cause serious functional and organic alterations in all the patients. Analyzing the Milanese experiments, the authors reported specific Italian history of a scientific and medical approach to rabies at the end of the 18th century, which led to the promotion of health education, reinforced prevention strategies and opened the way to the vaccination era.

Does defensive medicine change the behaviors of vascular surgeons? A qualitative review.

Although in literature few successful claims have been shown in comparison with other medical specialties such as gynaecology and orthopaedics, vascular surgery is included among high-risk specialties. The high-risk of receiving medical claims may lead vascular surgeons to practice defensive medicine, as is normal in several other areas of clinical practice. No studies are available to our knowledge of the incidence of defensive medicine in the field of vascular surgery. Taking into consideration the scarce amount of information, the authors provide a critical discussion regarding the application of defensive medicine behaviour among vascular surgeons.

The European Court legitimates access of Italian couples to assisted reproductive techniques and to pre-implantation genetic diagnosis.

On 28 August 2012, the European Court of Human Rights (ECHR) issued a judgment regarding the requirements for the legitimate access of couples to assisted reproductive techniques (ART) and to pre-implantation genetic diagnosis (PGD). This judgment concerns the case of an Italian couple who found out after their first child was born with cystic fibrosis that they were healthy carriers of the disease. When the woman became pregnant again in 2010 and underwent fetal screening, it was found that the unborn child also had cystic fibrosis, whereupon she had the pregnancy terminated on medical grounds. In order to have the embryo genetically screened prior to implantation under the procedure of PGD, the couple sought to use in vitro fertilisation to have another child. Since article 1 of the Italian law strictly limits access to ART to sterile/infertile couples or those in which the man has a sexually transmissible disease, the couple appealed to the European court, raising the question of the violation of articles 8 and 14 of the European Convention on Human Rights. The applicants lodged a complaint that they were not allowed legitimate access to ART and to PGD to select an embryo not affected by the disease. The European Court affirmed that the prohibition imposed by Italian law violated article 8 of the European Convention on Human Rights. Focusing on important regulatory and legal differences among EU Nations in providing ART treatments and PGD, we derived some important similarities and differences.

The evolution of legislation in the field of Medically Assisted Reproduction and embryo stem cell research in European union members.

Medically Assisted Reproduction (MAR), involving in vitro fertilisation (IVF), and research on embryos have created expectation to many people affected by infertility; at the same time it has generated a surplus of laws and ethical and social debates. Undoubtedly, MAR represents a rather new medical field and constant developments in medicine and new opportunities continue to defy the attempt to respond to those questions. In this paper, the authors reviewed the current legislation in the 28 EU member states trying to evaluate the different legislation paths adopted over the last 15 years and highlighting those EU countries with no specific legislation in place and MAR is covered by a general health Law and those countries in which there are no laws in this field but only "guidelines." The second aim of this work has been to compare MAR legislation and embryo research in EU countries, which derive from different origins ranging from an extremely prohibitive approach versus a liberal one, going through a cautious regulatory approach.