[Medical assistance in dying in Italy: a bill of law or just a political compromise?] / La morte volontaria medicalmente assistita in Italia: un disegno di legge o solo un compromesso politico?

INTRODUCTION: After two judgements by the Italian constitutional Court (the first one - No. 242/2019 - related to the decriminalisation, under well-defined conditions, of the article No. 580 of the penal code: support or incitement to commit suicide, and, the second - No. 50/2022 - related to the referendum held in regard to the partial repeal of article No. 579 of the penal code: murder of the consenting party), the issue of the physician assisted suicide (PAS) has been recently regulated by the bill of law No. 3101, approved by the Italian Chamber of Deputies, currently before the Senate and registered with the No. 2553. PURPOSE: To assess from the healthcare ethics perspective whether the bill of law can be considered an helpful legal tool to address the problems of both sick people who request PAS and the health professionals caring for them. FINDINGS: A systematic analysis of the bill of law has highlighted four critical issues: 1) PAS left out from the doctor-patient relationship; 2) the mutual exclusion between PAS and palliative care; 3) the dependency on life-sustaining treatments (DLST) to get PAS procedure as a condition discriminating against sick people not dependent (DLST represents one of the four conditions covered by the Italian constitutional Court judgement No. 242/2019 in order to exempt someone for the crime of aiding or inciting someone else to commit suicide); 4) the conscientious objection setting the rights of the doctor and the sick person against each other. Meaning. The bill of law does not take into account both the concrete problems of the sick people asking for hasten their death through the PAS procedure and those of the health professionals caring for them; it seems rather that the legislator's primary concern was to provide the follow-up to the solicitations of the Constitutional Court, only guaranteeing a political compromise. The bill of law therefore goes against the interpretation of the right as a system of rules taking into account the modern complexity of the disease-death paradigm which drawn up the law No. 219/2017.

[The dark price that non-covid patients are paying to covid pandemic: the "chinese boxes" of the public health crisis.] / Il prezzo pagato alla pandemia dai malati non covid: le scatole cinesi della crisi sanitaria.

In Italy, as in the other Western countries, during the different pandemic surges, the health care systems have undergone an unprecedented imbalance between health care resources demand and supply due to the huge number of patients affected by covid-19. In this dramatic scenario the access to the necessary hospital care for non-covid patients has been limited or precluded. Delays in diagnostic procedures or in caring for many acute or chronic diseases can result in a dangerous increase in their severity with a consequent increase in short and long-term related mortality. This is evident both with regard to time-dependent acute diseases, such as coronary artery syndromes or cerebrovascular diseases, and chronic degenerative diseases such as neoplasms. In this case the natural consequence of the interruption of the screening activities will require more complex treatments with a lower probability of a good outcome and higher mortality. Developing policies to promote healthcare access for non-covid patients population is an urgent task for governmental bodies and all decision makers to prevent a health crisis of unpredictable proportions. This narrative review is firstly aimed to set out the findings regarding the comparison between the trends of hospital admissions, surgical interventions, diagnostic and screening procedures for cardiac, cerebrovascular and oncological diseases before and during pandemic around the world; secondly, some public health policies are put forward in order to begin the restoration of medical services for non-covid patients.

Medical assistance in dying: just an ethical or legal issue?

According to current vital statistics suicide appears as a growing public health problem in most Western countries. However, suicide is rarely discussed in scientific journals, possibly because of a persisting moral stigma. As a consequence, the diverse bases of suicidal behavior are little understood while the role of Chronic-Degenerative Terminal Diseases (CDTD) has been poorly investigated. In the present study, the topic of suicidality was addressed in a clinical, holistic, perspective in an attempt to clarify how, in some chronically ill patients, the decision to end their own life is taken independently from mental disorders, being conversely, the expression of a rational psychological pattern which copes with the burden of chronic illnesses to become an integral part of their clinical spectrum. An assisted suicide (AS) request should therefore be considered from a clinical point of view and not only as an ethical or legal issue, in fact a holistic evaluation of the patient's situation must be performed, conferring the decisions making process a further in-depth line of thinking. In this study we first examined the relationship between suicide and CDTD as reported in the medical literature; then we reviewed the psychological theories which allegedly explain suicidal behavior; finally we discussed the possible role of a full-fledged palliative care in preventing suicide and in managing death requests by CDTD patients.

[What if my life is not worth living?] / Cosa fare se la mia vita non è più degna di essere vissuta?

In the culture of the Western countries suicide remains a taboo subject. Some of the risk factors for suicide are known, but the connections between non-communicable conditions (chronic-degenerative terminal diseases - CDTD) and suicide have been poorly explored until now. In contrast, the increasing legalization and public support for euthanasia (E) and physician assisted suicide (PAS) in Western countries make it important to understand this topic. Palliative care (PC) is a useful measure to counteract suicidal ideation, but many chronically sick people chose nevertheless to hasten death through E or PAS. In Western countries, where E and PAS are not legalized, "suicide tourism" started from 2001 towards Switzerland. This is the case of an Italian patient (dj Fabo) suffering from a severe post-traumatic disability. He recently died through PAS in that country supported by Mr. Marco Cappato, a member of Luca Coscioni Association who then incriminated himself, declaring he helped the patient reach Switzerland (in Italy violation of Criminal Code Art. 580). In October 24, 2018 the Italian Constitutional Court held that the absolute ban on assisted suicide provided for in Art. 580 of the Italian Criminal Code is unconstitutional under specific conditions such as a terminal illness causing physical and/or psychological unbearable suffering, requiring life supports being the patient still able to make decisions (ordinance n. 207/2018). The Court has asked Parliament to pass legislation before ruling on unconstitutionality of Art. 580. The Parliament has not passed a law on assisted suicide to date, then the Court will decide on September 24, 2019. Taking into account the content of the ordinance n. 207/2018, legal scholars and physicians, pooled in a Working Group, decided to open an interdisciplinary discussion on the physician assisted suicide issues drawing up the document entitled "Medical assistence to die, and law" (see the document in this issue of the journal) aimed to contribute to the public debate.

The prognostic importance of chronic end-stage diseases in geriatric patients admitted to 163 Italian ICUs.

BACKGROUND: The number of elderly patients undergoing major surgical interventions and then needing admission to intensive care unit (ICU) grows steadily. We investigated this issue in a cohort of 232,278 patients admitted in five years (2011-2015) to 163 Italian general ICUs. METHODS: Surgical patients older than 75 registered in the GiViTI MargheritaPROSAFE project were analyzed. The impact on hospital mortality of important chronic conditions (severe COPD, NYHA class IV, dementia, end-stage renal disease, cirrhosis with portal hypertension) was investigated with two prognostic models developed yearly on patients staying in the ICU less or more than 24 hours. RESULTS: 44,551 elderly patients (19.2%) underwent emergency (47.3%) or elective surgery (52.7%). At least one severe comorbidity was present in 14.6% of them, yielding a higher hospital mortality (32.4%, vs. 21.1% without severe comorbidity). In the models for patients staying in the ICU 24 hours or more, cirrhosis, NYHA class IV, and severe COPD were constant independent predictors of death (adjusted odds ratios [ORs] range 1.67-1.97, 1.54-1.91, and 1.34-1.50, respectively), while dementia was statistically significant in four out of five models (adjusted ORs 1.23-1.28). End-stage renal disease, instead, never resulted to be an independent prognostic factor. For patients staying in the ICU less than 24 hours, chronic comorbidities were only occasionally independent predictors of death. CONCLUSIONS: Our study confirms that elderly surgical patients represent a relevant part of all ICUs admissions. About one of seven bear at least one severe chronic comorbidity, that, excluding end-stage renal disease, are all strong independent predictors of hospital death.

Palliative sedation: the position statement of the Italian National Committee for Bioethics.

In January 2016 the Italian National Bioethics Committee (NBC) published a position statement entitled Deep and continuous palliative sedation in the imminence of death, related to the use of sedation and analgesia for relief from pain and psychological distress in dying patients. In this statement the Committee points out the clinical and ethical appropriateness of palliative sedation as a therapeutic procedure. As a result, today palliative sedation has to be considered useful, scientifically safe and reliable, and acknowledged as an integral part of good clinical practice. At the same time, the position statement, once and for all, makes clear that palliative sedation cannot and must not be equated with the practice of euthanasia. Thus, this document should be known by health professionals caring for dying patients not only in palliative as well as in intensive care settings, but it should be also considered as a milestone aimed to encourage and ease a widespread implementation of this procedure in all health care settings.

[Forgoing treatments: a kind of euthanasia? A scientific approach to the debate about end of life decisions]. / La limitazione dei trattamenti: una forma di eutanasia? Un approccio scientifico al dibattito sulle decisioni alla fine della vita.

In the last decade an extensive debate on the topic of end of life decisions has developed in western countries, obtaining a worldwide media relevance. Philosophers, theologians, legal experts and doctors, focus their attention on the three thorny issues of the topic: forgoing treatments, euthanasia and assisted suicide. A thorough and respectful discussion on these issues should include all stakeholders - above all palliative care physicians - and should be encouraged in order to understand the views in favor or against the three practices, checking the different moral positions, and analyzing the cultural, social and legal aspects in the background on one hand, and, on the other, their impact on the health care systems. At present, in the fields of communications and politics, the debate related to the topic of these end of life practices is characterized by a confusion of terms and meanings. As an outcome, the term "euthanasia" is misused as a "container" including forgoing treatments, euthanasia and assisted suicide, while palliative sedation is wrongly considered as a procedure to cause death. This confusing approach does not permit to understand the real issues at the stake, keeping the debate at the tabloid level. Conversely, sharing the precise meaning of the words is the only way to provide tools to make rational, autonomous and responsible decisions, allowing individual informed choices in compliance with the principle of autonomy. This article is not aimed to take a moral stand in favor or against forgoing treatments, euthanasia and assisted suicide. Through an analysis based on scientific criteria, the authors firstly review the definitions of these three practices, examining the concepts enclosed in each term; secondly, they offer a glance on the legal approach to end of life issues in western countries; lastly, they investigate the relationship between these practices and palliative care culture in light of the medical societies official statements. The authors chosen to examine the topic of forgoing treatments, euthanasia and assisted suicide from a scientific point of view, because the clinical approach, taking into account the biological context of disease related to the human and social domains, seems to be able to better gather all the aspects of end of life practices, providing useful information to deal with them also in a philosophical or juridical perspective.

[A position paper on end of life shared between those who believe and those who don't believe: a dialogue is possible]. / Un documento condiviso tra credenti e non credenti sulla fine della vita: il dialogo è possibile.

In the modern medicine a sound evidence is available today supporting the four fundamental principles representing the best scientific and ethical approach to end of life issues: shared decision making process in a doctor-patient relationship centered care; rejection of dying process marked by the suffering and disproportionate treatments; withholding/withdrawing these treatments and palliative sedation as main contributions to suppress the patients' suffering and pain at the end of life; clear-cut difference between these clinical and ethical options and euthanasia. In some European countries, such as Germany, France, UK, and Spain, these principles are included in a well set legislation regarding the end of life issue, but this is not the case of our country. Despite this failure, in Italy, doctors, patients, and their families, need a law aimed to deal with the complex issues of end of life care as a whole. Therefore, the Italian Society of Anesthesia, Analgesia and Intensive Care (SIAARTI) together with Italian Society of Palliative Care (SICP), shared with the Foundation "Courtyard of the Gentiles" - Department of the Pontifical Council for the Culture - the project to appoint a panel of religious and non-religious experts (physicians, philosophers, legal experts, and politicians) in order to draw up and offer to the political consideration a shared position paper, containing all the ethical and legal principles aimed to outline a more complete regulation of end of life in our country. The "Courtyard of the Gentiles" - whose aim is to promote the dialogue in regard to the issues of contemporary society between those who believe and those who don't believe, with a view to connect political and cultural institutions - appointed the panel in April 2014 and the shared position paper was formally presented on 17 September 2015, in a public conference in the Senate. The physicians who have been part of the panel, affirmed that all the problems related to the legal approach to the decision making process at the end of life may be solved only through a regulation of the doctor-patient relationship centered care. The aim of this regulation will be to set goals, rules, and limits of therapies, patients and doctors rights, procedures able to support and safeguard the good clinical practice, giving to patients and doctors an ethic reference point in the context of a law's guarantee. The fundamental principles of the regulation of the doctor-patient relationship centered care will rest on the contents of code of medical ethics, the safeguard of dignity, autonomy, and health of human beings. In conclusion, we hope to have supplied a useful contribution to draw up in the next future a law able to guarantee the autonomy of doctor-patient relationship, respecting different cultures and religious or non-religious approaches to life and death, as well as the different biography and biology of everyone. Our first goal was to comprehensively address the issue of end of life, understanding the concerns of patients and their families in a very problematic stage of their life, and offering to the doctors a valuable tool for dealing with the increasing complex connection between disease, death and modern medical practice on one hand, and related human fortunes on the other hand.

[Advance directives in Italy: a goal not yet reached but already passed?]. / Direttive anticipate in Italia: un obiettivo non ancora raggiunto ma già superato?

The advance directives (ADs) have been adopted in many countries to defend patients' autonomy. In Italy, in the past, this topic gave rise to a heated debate involving philosophers, theologians, and politicians. In 2009, the government presented a bill of law on ADs firmly criticized from a scientific, moral and juridical point of view because the bill's content is against the principles of Italian Constitution, Italian Code of Medical Ethics, Oviedo Convention, and official statements of many scientific societies. Although the bill has passed the Low Chamber it lies, even since, in the Senate, lacking in regard any agreement among the political parties. The purpose of this article is to highlight that, in our country, patients, relatives and doctors deserve a law not only related to the specific topic of ADs, but - as in other European countries (Germany, Spain, France, UK) - aimed to deal with the complex issue of end of life care as a whole. This law should take into account the sound evidence existing in regard to the four fundamental principles supporting the best scientific and ethical approaches to the end of life issues: shared decision making process between doctors and patients/relatives; rejection of dying process marked by the suffering; withholding/withdrawing futile treatments together with palliative sedation as two crucial contributions to suppress the patient suffering and pain; clear-cut difference between these clinical/ethical options and euthanasia. At the same time, this law should be able to provide physicians with a legal coverage to make all the clinical and ethical decisions more and more complex because of the continuous evolution of medical science on one hand, and the impressive development of biotechnology on the other hand.

[Chronic uremia and palliative care]. / Insufficienza renale cronica "end stage": cure intensive e cure palliative.

Nowadays the choice to start with a renal replacement therapy (or its withdrawal once begun) is a critical issue leading to review the paradigm of constantly treating terminal uremia by means of dialysis technologies, without caring for effective prognosis nor for patients preferences, in a more affordable physician-patient relationship. Furthermore dialysis patients mean age is increasing and such population bears the burden of comorbidities that seriously affect survival and quality of life. In any case, dialysis withdrawing does not mean neglecting the patient: the start, or continuation of a very low protein diet program may represent a reasonable alternative, not only for uremic symptoms control but also providing a slowing of disease progression (at least postponing further the start of renal replacement therapy). Basically, in our opinion, the decision to start dialysis in an eligible patient, mainly in the elderly or frails, it should be driven by an adequate balance among all the factors. These factors play a role not only concerning survival, but also in life quality issues and patients preferences. Thus, we argue that ethical issues must be taken into account as well as compelling clinical factors which usually nephrologists refer to. To pursue this goal, it could be useful to set up specific educational pathways addressed to physicians, nurses and technicians of renal units. It also could be instrumental in developing new strategies to manage end stage renal failure, considering not only hospital facilities,but also nursing and patients homes. Incoming guidelines could help nephrologists in improving their behaviors to face these new issues.

[Part I. End-stage chronic organ failures: a position paper on shared care planning. The Integrated Care Pathway]. / Parte I. Il percorso clinico e assistenziale nelle insufficienze croniche d'organo "end-stage".Documento di consenso per una pianificazione condivisa delle scelte di cura.

In Italy the birth rate decrease together with the continuous improvement of living conditions on one hand, and the health care progress on the other hand, led in recent years to an increasing number of patients with chronic mono- or multi-organ failures and in an extension of their life expectancy. However, the natural history of chronic failures has not changed and the inescapable disease's worsening at the end makes more rare remissions, increasing hospital admissions rate and length of stay. Thus, when the "end-stage" get close clinicians have to engage the patient and his relatives in an advance care planning aimed to share a decision making process regarding all future treatments and related ethical choices such as patient's best interests, rights, values, and priorities. A right approach to the chronic organ failures end-stage patients consists therefore of a careful balance between the new powers of intervention provided by the biotechnology and pharmacology (intensive care), both with the quality of remaining life supplied by physicians to these patients (proportionality and beneficence) and the effective resources rationing and allocation (distributive justice). However, uncertainty still marks the criteria used by doctors to assess prognosis of these patients in order to make decisions concerning intensive or palliative care. The integrated care pathway suggested in this position paper shared by nine Italian medical societies, has to be intended as a guide focused to identify end-stage patients and choosing for them the best care option between intensive treatments and palliative care.

Noninvasive versus invasive ventilation for acute respiratory failure in patients with hematologic malignancies: a 5-year multicenter observational survey.

BACKGROUND: Mortality is high among patients with hematologic malignancies admitted to intensive care units for acute respiratory failure. Early noninvasive mechanical ventilation seems to improve outcomes. OBJECTIVE: To characterize noninvasive mechanical ventilation use in Italian intensive care units for acute respiratory failure patients with hematologic malignancies and its impact on outcomes vs. invasive mechanical ventilation. DESIGN, SETTING, PARTICIPANTS: Retrospective analysis of observational data prospectively collected in 2002-2006 on 1,302 patients with hematologic malignancies admitted with acute respiratory failure to 158 Italian intensive care units. MEASUREMENTS: Mortality (intensive care unit and hospital) was assessed in patients treated initially with noninvasive mechanical ventilation vs. invasive mechanical ventilation and in those treated with invasive mechanical ventilation ab initio vs. after noninvasive mechanical ventilation failure. Findings were adjusted for propensity scores reflecting the probability of initial treatment with noninvasive mechanical ventilation. RESULTS: Few patients (21%) initially received noninvasive mechanical ventilation; 46% of these later required invasive mechanical ventilation. Better outcomes were associated with successful noninvasive mechanical ventilation (vs. invasive mechanical ventilation ab initio and vs. invasive mechanical ventilation after noninvasive mechanical ventilation failure), particularly in patients with acute lung injury/adult respiratory distress syndrome (mortality: 42% vs. 69% and 77%, respectively). Delayed vs. immediate invasive mechanical ventilation was associated with slightly but not significantly higher hospital mortality (65% vs. 58%, p=.12). After propensity-score adjustment, noninvasive mechanical ventilation was associated with significantly lower mortality than invasive mechanical ventilation. LIMITATIONS: The population could not be stratified according to specific hematologic diagnoses. Furthermore, the study was observational, and treatment groups may have included unaccounted for differences in covariates although the risk of this bias was minimized with propensity score regression adjustment. CONCLUSIONS: In patients with hematologic malignancies, acute respiratory failure should probably be managed initially with noninvasive mechanical ventilation. Further study is needed to determine whether immediate invasive mechanical ventilation might offer some benefits for those with acute lung injury/adult respiratory distress syndrome.

Prone Positioning and Intravenous Zanamivir may Represent Effective Alternatives for Patients with Severe ARDS Virus A (H1N1) Related Pneumonia in Hospitals with no Access to ECMO.

The first patient with influenza A/H1N1-related pneumonia was admitted to an Italian ICU at the end of August 2009. Until then, despite the international alarm, the level of awareness was low and very few Italian hospitals were equipped with ECMOs. Moreover the PCR test for A H1N1 virus was sporadically available and the emergency departments of even the largest institutions could rely only on the rapid test for the urgent screening of patients with pneumonia and respiratory failure. On September 5th, a young and "apparently" previously healthy man, was admitted to our ICU because of a severe ARDS caused by influenza A H1N1 virus. As there was no ECMO available, he was treated with prolonged cycles of prone positioning ventilation. Antiviral treatment was started with Oseltamivir, but as enteral absorption was impaired by paralytic ileus and tube feeding intolerance, Oseltamivir had to be discontinued. Intravenous Zanamivir 1200 mg/day for ten days was therefore prescribed as "off label" antiviral therapy. A bone marrow biopsy allowed the diagnosis of an initial stage of "hairy cells leukaemia." ARDS related to A/H1N1 influenza was the first sign of the disease in our patient. He did well with complete clearance of the infection from the BAL after 10 days of Zanamivir, although the nasopharyngeal swabs remained positive for ten more days. Prone positioning ventilation may be a life-saver strategy in patients with severe ARDS when ECMO is not immediately available. However, prone positioning ventilation is often associated with severe impairment of the absorption of drugs that require enteral administration via the nasogastric tube. In these cases, intravenous Zanamivir may be an effective alternative strategy.