Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians' knowledge, attitudes and practices in four northern Italian health care facilities.

BACKGROUND: On December 2017 the Italian Parliament approved law n. 219/2017 "Provisions for informed consent and advance directives" regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person's autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law. METHODS: A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation). RESULTS: Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians' opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered. CONCLUSIONS: Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations.

The SARS-CoV-2 pandemic as a source of unprecedented bioethical and biolaw issues: lessons for intensivists.

The following article presents the relevant and unprecedented bioethical and biolaw issues posed by the SARS-COV-2 pandemic and summarizes the initiatives adopted by the Italian Society of Anesthesia and Resuscitation (SIAARTI) as well as by the Veneto Region ICU Network. Since the initial phase of the pandemic, in March 2020, there has been a strong appeal from both SIAARTI and the Veneto Region ICU Network to consider "the appropriate intensive treatment." During the pandemic, the principle of proportionality must be applied, in compliance with the main principle in bioethics. This encompasses the concept of clinical appropriateness, based on the efficacy of the treatment in specific case and context, as well as the concept of ethical appropriateness, which refers to ethical and juridical principles of acceptance of health care. The "appropriate treatment" must never interfere with the withdrawal of patients, who are not eligible for intensive treatments since they would not benefit from them and who are eligible for ordinary treatments that must be maintained, and, where necessary, palliative treatments were initiated. On the other hand, it must not encroach on unreasonable obstinacy. At the end of 2020, the SIAARTI-SIMLA (Italian Society of Insurance and Legal Medicine) document provides healthcare professionals with a tool for responding appropriately to the emergency of the pandemic, in the event of an imbalance between healthcare demand and available resources. The document states that the ICU triage should be based on global evaluation of each patient, taking into account well-defined parameters and stresses that each person potentially eligible for intensive care should have a shared care planning (SCP) stipulated, and, when necessary, a proxy should be nominated. This has illustrated how the biolaw issues encountered by intensivists during the pandemic, such as those relating to consent and refusal to medical treatment, even when it is lifesaving, as well as requests for treatment of unproven clinical efficacy, were subject to appropriate guidelines and solutions through the application of Law 219/2017 (provisions for informed consent and advance directives treatment). Communication with family members and the management of sensitive personal data; the evaluation of "legal capacity" of comprehension and informed decision-making regarding the proposed treatment plan; and the need for emergency medical intervention in the absence of consent are all addressed in light of the relevant regulations and the particular conditions of social isolation induced by the pandemic. The collaborative ICUs network sustained by the Veneto Region has given great prominence to clinical bioethics issues, and as a result, multidisciplinary integration with the help of legal and juridical experts was developed. This has led to an increase in skills in the bioethical field, as well as providing a valuable lesson for the improvement of therapeutic relationships with critically ill patients and their families.

[The Italian National Healthcare System and the SARS-CoV-2 pandemic: a foretold debacle? Reflections for changing.] / Il Sistema Sanitario Nazionale e la pandemia da SARS-CoV-2: un disastro annunciato? Riflessioni per un cambiamento.

Almost two years after the first official report from World Health Organization (WHO), the SARS-CoV-2 pandemic (covid-19) outreached 200 mln of cases around the world with an overall mortality equal to 2% (more than 4.5 mln of cases). In many countries, when the surge in cases of severe covid-19 respiratory failure has exceeded the availability of intensive healthcare resources (intensive care beds, respirators, human resources) clinicians were forced to triage intensive care unit (ICU) admissions. In order to support these difficult decisions, many scientific societies and national regulatory bodies developed guidelines to prioritize patients entitled to receive mechanical ventilation and other life support treatments. From an ethical point of view two main theoretical approaches - the egalitarian and the utilitarian one - have been suggested to identify the criteria to be adopted for triaging the ICU patients. In regard, there is a limited consensus until now and in many cases these different theoretical approaches gave rise to a clash of opinions contributing to additional difficulties for doctors. In Italy, the National Committee for Bioethics is the only public institution that, through an official document, has expressly taken a position on the issue of triage and rationing of resources, admitting its lawfulness in particular conditions as long as it is based on common clinical criteria of clinical appropriateness and ethical proportionality, underlining however the fundamental role of "preparedness". As the covid-19 crisis seems slowing down, the need to debate the triage criteria and the allocation of the scarce ICU resources it seems less pressing. Instead, it seems more useful to dwell on two aspects with respect to the choice of regulatory criteria for allocating resources: 1) the necessary interconnection between macro- and micro-allocation choices which ends up conditioning the decision-making processes relating to individual patients; 2) the opportunity for decision-makers and healthcare professionals to maintain a right level of "honesty" towards citizens and patients regarding the causes of the lack of resources and the decision-making processes that involve the need to make "tragic choices" at both levels.

COVID-19 pandemic in ICU. Limited resources for many patients: approaches and criteria for triaging.

The COVID-19 pandemic has shattered the illusion that healthcare resource shortages that require rationing are problems restricted to low- and middle-income countries. During the pandemic surges, many high-income countries have been confronted with unprecedented demands for healthcare systems that dramatically exceeded available resources. Hospitals capacities were overwhelmed, and physicians working in intensive care units (ICUs) were often forced to deny admissions to patients in desperate need of intensive care. To support these difficult decisions, many scientific societies and governmental bodies have developed guidelines on the triage of patients in need of mechanical ventilation and other life-support treatments. The ethical approaches underlying these guidelines were grounded on egalitarian or utilitarian principles. Thus far, however, consensus on the approaches used, and, above all, on the solutions adopted have been limited, giving rise to a clash of opinions that has further complicated health professionals' ability to respond optimally to their patients' needs. As the COVID-19 crisis moves toward a phase of what some have called "pandemic normalcy," the need to debate the merits and demerits of the individual decisions made in the allocation of ICU resources seems less pressing. Instead, the aims of the authors are: 1) to critically review the approaches and criteria used for triaging patients to be admitted in ICU; 2) to clarify how macro- and micro-allocation choices, in their interdependance, can condition decision-making processes regarding the care of individual patients; 3) to reflect on the need for decision-makers and professionals working in ICUs to maintain a proper degree of "honesty" towards citizens and patients regarding the causes of the resource shortages and the decision-making processes, which, in different ways routinely and in crisis times, involve the need to make "tragic choices" at both levels.

How to communicate with families living in complete isolation.

IMPORTANCE: During the SARS-CoV-2 pandemic, a complete physical isolation has been worldwide introduced. The impossibility of visiting their loved ones during the hospital stay causes additional distress for families: in addition to the worries about clinical recovery, they may feel exclusion and powerlessness, anxiety, depression, mistrust in the care team and post-traumatic stress disorder. The impossibility of conducting the daily meetings with families poses a challenge for healthcare professionals. OBJECTIVE: This paper aims to delineate and share consensus statements in order to enable healthcare team to provide by telephone or video calls an optimal level of communication with patient's relatives under circumstances of complete isolation. EVIDENCE REVIEW: PubMed, Cochrane Database of Systematic Reviews, Database of Abstracts and Reviews of Effectiveness and the AHCPR Clinical Guidelines and Evidence Reports were explored from 1999 to 2019. Exclusion criteria were: poor or absent relevance regarding the aim of the consensus statements, studies prior to 1999, non-English language. Since the present pandemic context is completely new, unexpected and unexplored, there are not randomised controlled trials regarding clinical communication in a setting of complete isolation. Thus, a multiprofessional taskforce of physicians, nurses, psychologists and legal experts, together with some family members and former intensive care unit patients was established by four Italian national scientific societies. Using an e-Delphi methodology, general and specific questions were posed, relevant topics were argumented, until arriving to delineate position statements and practical checklist, which were set and evaluated through an evidence-based consensus procedure. FINDINGS: Ten statements and two practical checklists for phone or video calls were drafted and evaluated; they are related to who, when, why and how family members must be given clinical information under circumstances of complete isolation. CONCLUSIONS AND RELEVANCE: The statements and the checklists offer a structured methodology in order to ensure a good-quality communication between healthcare team and family members even in isolation, confirming that time dedicated to communication has to be intended as a time of care.

[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".] / Considerazioni etiche, deontologiche e giuridiche sul Documento SIAARTI "Raccomandazioni di etica clinica per l'ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili".

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.

The Italian law on informed consent and advance directives: its impact on intensive care units and the European legal framework.

The Italian Parliament has recently approved a law on informed consent, advance directives and advance care planning. The law also deals with health care proxy and health care decisions for minors and adults who are not able to give consent. The Italian law arrived quite late in comparison with other European countries. After several years of debate on the need to approve such a law, the focus has now shifted to the assessment of the legislative provisions and their impact on clinical practice. In this article, the authors firstly offer an overview of the findings from the empirical research regarding the use of the different legal tools in the field of intensive care medicine; secondly, they present the tools now provided by law no. 219/2017 particularly with regard to the decision-making processes in the Intensive Care Unit (ICU); thirdly, the authors offer a comparison between the new Italian law and other European legal orders, with special reference to France, Spain, Germany and England. The aim of the article is to assess the degree of innovation of the law vis-à-vis the previous framework.

How to protect incompetent clinical research subjects involved in critical care or emergency settings.

Clinical research is an essential component of medical activity, and this is also true in intensive care. Adequate information and consent are universally considered necessary for the protection of research subjects. However, in emergency situations, the majority of critical patients are unable to consent and a valid legal representative is often unavailable. The situation is even more complex in Italy, where the relevant legislation fails to specify how investigators should manage research in emergency or critical care setting when it involves incompetent patients who do not have an appointed legal representative. While special measures for the protection of incompetent subjects during emergency research are necessary, not allowing such research at all dooms critically ill patients to receive non-evidence-based treatments without the prospect of improvement. The recently-issued EU Regulation n. 536/2014 will probably help shed light on this situation. Indeed, it specifically addresses the issue of "research in emergency situations" and introduces detailed rules aimed at protecting patients while allowing research. In this article, we argue that obtaining informed consent during emergency research on incompetent subjects in unrealistic, and that in most cases substituted judgment on the part of a proxy carries major flaws. Strict criteria in evaluating the risk-benefit ratio of proposed intervention and a careful evaluation of the trial by a local or national Research Ethics Committee are perhaps the most practicable solution.

[Parte III. Ethical and juridical aspects in end-stage chronic organ failures. A position paper on a shared care planning]. / Parte III. Aspetti etici e giuridici nelle insufficienze croniche d'organo "end-stage". Documento di consenso per una pianificazione condivisa delle scelte di cura.

The specific target of an experts panel was to assess in terms of law and ethics the compliance of a new specific decision making algorithm described in the position paper proposed by the Gruppo di Lavoro Insufficienze Croniche d'Organo, with the main goal of the position paper consisting in the shared care planning process. The following specific aspects were assessed by the experts: a) the impact on case law and statute law of a new clinical pathway shared by scientific societies in light of good clinical practice and scientific evidence; b) the relevance of all tools useful to identify the appropriateness of care pathways, recognizing responsibilities and decision-making skills related to the end of life choices made by all stakeholders involved (healthcare professionals, patients and their beloved ones); c) the consistency of the healthcare professionals duties proposed in the position paper with the Italian legal order; d) the opportunity to take into account the role of all healthcare providers involved in care relationship; e) the consistency of the definition of patient rights at the end of life as proposed in the position paper with the Italian legal order and the relevance in this context of simultaneous palliative care; f) the relevance of shared care planning and its consistency with the proposed operative tools; g) the relevance of the conscientious objection issue and the compliance of management tools proposed in the position paper with the results of ethical and legal considerations; h) considerations about available resources allocation.