Why and how to open intensive care units to family visits during the pandemic.

Since the lockdown because of the pandemic, family members have been prohibited from visiting their loved ones in hospital. While it is clearly complicated to implement protocols for the admission of family members, we believe precise strategic goals are essential and operational guidance is needed on how to achieve them. Even during the pandemic, we consider it a priority to share strategies adapted to every local setting to allow family members to enter intensive care units and all the other hospital wards.

[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.

[Part II. Scientific evidence in end-stage chronic organ failure. A position paper on shared care planning]. / Parte II. Evidenze scientifiche nelle insufficienze croniche d'organo "end-stage". Documento di consenso per una pianificazione condivisa delle scelte di cura.

The therapeutic options related to chronic organ failure are interconnected to the variability of human biological responses and the personal history and choices of the chronically ill patient on one hand, and with the variable human answers to therapies on the other hand. All these aspects may explain the small number and low quality of studies aimed to define the clinical criteria useful in identifying end-stage chronically ill patients, as highlighted through the 2012-2013 Medline survey performed by the task force. These results prevented the grading of scientific evidence. However, taking into account the evidence based medicine definition, the task force believes the clinical reasoning and the individual experience of clinicians as well as the patients and families preferences cannot be replaced "tout court" with a strict methodological research. Accordingly, the working method selected by the task force members was to draw up a set of clinical parameters based on the available scientific literature, submitting it to a peer review process carried out by an expert panel. This paper discusses a set of clinical parameters included in the clinical decision-making algorithm and shared by nine medical societies. For each chronic organ failure these clinical parameters should be intended not as a rigid cutoff system to make a choice between two selected care options (intensive vs palliative), rather as the starting point for a joint and careful consideration regarding the opportunity to adopt the clinical decision-making algorithm care proposed in Part I.

[The banality of evil in the migrants era.] / La banalità del male al tempo dei migranti.

In early November the Italian government, after having prevented two NGO ships with 751 migrants on board from docking in the port of Catania, allowed disembarkation only to migrants in critical health conditions, refusing it to others and ordering then to the ships to set sail. This episode, the latest in a series started in Italy between 2018 and 2019 during the previous right-wing government, is part of a sovereignist ideal and political framework, while the racist tendencies are clearly growing up in the country long ago. The event referred to and the social and political climate in which it took place evokes the theme of banality of evil about which Hannah Arendt and Primo Levi have written after the experience personally lived during the Nuremberg trial by the first author and in the Auschwitz killing field by the second one. The article offers a reflection on this matter and provides an answer to the question whether today it is still possible to speak in regard of the banality of evil and, if so, in what forms and meanings and with what responsibilities compared to those originally given from the two authors to the saying.

[Towards the revision of the Italian code of medical ethics: thoughts of an extremist.] / Verso la revisione del Codice di deontologia medica: riflessioni di un estremista.

In November 2022 the Italian medical council (Federazione nazionale degli ordini dei medici chirurghi e odontoiatri) started the revision of the Italian Code of medical ethics (Cme) with the first race dating back ten years. Since then, the Italian doctors are dealing with the scientific, ethical and economic challenges together with the more recent ones posed by the Sars-CoV-2 pandemic to the National health system underlying the ongoing crisis of the medical profession. Additionally, this critical context requires the doctors to develop new technological skills, a complete and effective adherence to the Ebm principles, a new view regarding the relationship with the other health care professionals and the related changes of clinical practices fostering a responsible use of resources. In brief, what is required nowadays from doctors is to rethink about the meaning of science, ethics, economics and public health and to make new and more appropriate connections between the instances conveyed by these different disciplines. The Cme main aim consists in providing appropriate rules in step with the current transformations of medicine and society to doctors for ethically acting in clinical practice, assuring the citizens, the institutions and law of the scientific competence, the protection of the fundamental rights of the sick person in compliance with the constitutional principles. Under this assumption and in line with the above mentioned professional crisis, at least the overall guidelines aimed to solve it should have been settled before starting the Cme review also in order to ensure the necessary coherence between the new contents drawing the doctors new social function and its codal systemisation. Unfortunately this stepwise approach was not considered.Lastly, to develop the new Cme looking towards the progress of medical profession, systematic and methodologically appropriate consultations would have been necessary to know, value and balance all the different positions of doctors, allowing them to be responsible for the change of their profession. However, such a decision was not made.

[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.

[Task shifting: a derby between doctors and nurses or a resource for patients and health care systems?] / Task shifting: un derby tra medici e infermieri o una risorsa per i malati e i sistemi sanitari?

As proved through a sound evidence, task shifting (TS) - the rational redistribution of tasks among health workforce teams - is an important strategy aimed at improving health of the most vulnerable and disadvantaged populations of the low- and middle-income countries by providing essential services and reducing or eliminating health inequalities. Clinical and epidemiological efficacy of many TS interventions has also been demonstrated in high-income countries. Systematic reviews show that TS can reduce morbidity and mortality by providing essential care for infectious and non-communicable diseases, for maternal and child health, for critically ill and injured patients. The results of some research programs concerning TS interventions offer a conceptualization and an in-depth evaluation of their positive effects on health equity. However, these results are often underestimated, or not considered, by medical institutions in some European countries such as Italy. On the contrary, the TS deserves greater attention and conceptual enhancement as a tool contributing to the development of new health care systems on one hand, and, on the other, to the renewal of the concept of health from the mere psycho-physical aspect to that connected to social risks in a society in which health inequalities continuously increase, affecting the most vulnerable groups. After providing a definition and clarifying the different implementation methods of TS, the article analyzes the key factors supporting its adoption and those that hinder it. Then, an assumption is put forward that TS could be part of a renewal process of both the public health care systems and the different health care professionals functions.

[Abortion: memories and thoughts of a physician.] / Aborto: ricordi e riflessioni di un medico.

In light of the recent ruling of the US Supreme Court overturning abortion rights, and drawing inspiration from a case came to his observation of hemorrhagic shock complicating an illegal abortion, the author briefly comments on the health, ethical, political and economic aspects that the denial of the right to terminate pregnancy entails for women, health care professionals and for the society as a whole.

[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 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.

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.

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.

[The handover in clinical practice of anesthesiologists and intensivists.] / Il passaggio delle consegne nella pratica clinica degli anestesisti rianimatori.

The handover among healthcare professionals has been a topic of increasing interest over recent years. Many studies have shown that ineffective communication during handover can be critical, particularly for anaesthesiologists and intensivists because of the highly complex needs of patients under their care. Numerous studies have identified the information transfer process as the greatest risk of errors and adverse events (AEs), which results in harm to patients, increases legal issues and damages relations between health professionals. The adoption of effective communication methods determines a significant improvement of the handover and a reduction in the frequency of errors and AEs. The purpose of this document is to focus attention on the problem in order to promote heightened safety procedures within health facilities. Among the numerous methods validated in clinical practice, the authors have chosen the I-PASS method (Illness, Patient, Action, Situation, Synthesis) for its effectiveness on a clinical level, to prevent AEs, and because it is easily tailored to the various work environments in which Italian Anaesthesiologists and Intensivists operate.

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.

[Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances.] / 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 February 21st, 2020 the first case of severe acute respiratory syndrome due to the coronavirus 2 (SARS-CoV-2) causing the CoViD-19 disease, was identified in Italy. In the following days, despite the restrictive public health measures aimed to avoid the infection's spread, the number of cases increased. As of March 8th, 2020, Italy is the 2nd most affected country in the world. As of March 6th, 2020, the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) published operational recommendations and ethical considerations to support the clinicians involved in the care of critically-ill CoViD-19 patients, in regard a probable scenario where an imbalance between supply and demand of ICU beds, is put in place by a steadily rising number of these patients.

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.

[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.