[Conscientious objection to assisted suicide. Switching the rule.] / Obiezione di coscienza nel suicidio assistito. E se invertissimo il paradigma?

In the last years the legal weight of the sick person's autonomy has been increasingly promoted, and many countries have today legislations allowing euthanasia and/or assisted suicide within the law. Even though assisted suicide could cause discomfort to the sick person, it has been often preferred, in order to balance the right of doctors to have respected their ethical and deontological principles with that of sick people to put an end to their suffering. In line with the need to keep in balance the deontological rules of medicine and the rights of sick people, it would be appropriate to shift from the current legal framework considering physician assisted suicide as an obligation for the doctor, having the conscientious objection as an exception, to another that does not envisage physician assisted suicide as an obligation of the doctor considering a "conscientious willingness" as an exception.

The Italian document: decisions for intensive care when there is an imbalance between care needs and resources during the COVID-19 pandemic.

BACKGROUND: In early 2020, the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) published clinical ethics recommendations for the allocation of intensive care during COVID-19 pandemic emergency. Later the Italian National Institute of Health (ISS) invited SIAARTI and the Italian Society of Legal and Insurance Medicine to prepare a draft document for the definition of triage criteria for intensive care during the emergency, to be implemented in case of complete saturation of care resources. METHODS: Following formal methods, including two Delphi rounds, a multidisciplinary group with expertise in intensive care, legal medicine and law developed 12 statements addressing: (1) principles and responsibilities; (2) triage; (3) previously expressed wishes; (4) reassessment and shifting to palliative care; (5) collegiality and transparency of decisions. The draft of the statements, with their explanatory comments, underwent a public consultation opened to Italian scientific or technical-professional societies and other stakeholders (i.e., associations of citizens, patients and caregivers; religious communities; industry; public institutions; universities and research institutes). Individual healthcare providers, lay people, or other associations could address their comments by e-mail. RESULTS: Eight stakeholders (including scientific societies, ethics organizations, and a religious community), and 8 individuals (including medical experts, ethicists and an association) participated to the public consultation. The stakeholders' agreement with statements was on average very high (ranging from 4.1 to 4.9, on a scale from 1-full disagreement to 5-full agreement). The 4 statements concerning triage stated that in case of saturation of care resources, the intensive care triage had to be oriented to ensuring life-sustaining treatments to as many patients as possible who could benefit from them. The decision should follow full assessment of each patient, taking into account comorbidities, previous functional status and frailty, current clinical condition, likely impact of intensive treatment, and the patient's wishes. Age should be considered as part of the global assessment of the patient. CONCLUSIONS: Lacking national guidelines, the document is the reference standard for healthcare professionals in case of imbalance between care needs and available resources during a COVID-19 pandemic in Italy, and a point of reference for the medico-legal assessment in cases of dispute.

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.

[Perioperative strategies: taking care of the elderly patient with severe advanced comorbidities needing acute surgery.] / Strategie perioperatorie: presa in carico dell'anziano con gravi comorbilità e fase avanzata di malattia con patologia chirurgica acuta.

In the common clinical practice the perioperative risk assessment of an acute surgical patient with advanced chronic comorbidities is carried out independently by surgeon and anesthesiologist, usually in two different steps. While the surgeon evaluates the risk mainly in relation to the surgical outcome, the perioperative risk assessment regarding the weight of the coexisting medical condition on the quality of recovery in the short- mid- and long-term is all about the anesthesiologist evaluation. When frailty and/or comorbidities are so serious that will make surgery seem futile, the patient's assessment on one hand, and the decisions regarding the further clinical waypoint on the other, have to be discussed firstly between surgeons and anesthesiologists before being shared with the patients and their relatives. This is mostly true in the event of an emergency surgical procedure. In regard, a consensus conference attended by a panel of experts respectively from the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) and the Italian Society of Surgery (SIC) was called for developing a shared clinical pathway aimed to select the best care option - operative vs palliative - in the best interest of the surgical patient with advanced chronic comorbidities, in emergency or elective condition. After two years, the panel of experts developed a position paper recommending, in case of potentially futile surgery, to assess the patient verifying two coexisting conditions ("Two Steps method"): Palliative Performance Scale <50%, and at least one of the following general clinical criteria: 1) more than one hospital admission within the last 12 months; 2) hospital admission from or awaiting admission to long-term care facilities, home care service, hospice; 3) chronic renal failure requiring weekly dialysis sessions; 4) home oxygen use and/or non-invasive ventilation. Under these conditions, the surgeon together with the anesthesiologist can share with the patient and/or his relatives the decision between palliative surgery or palliative care taking into account his wishes and preferences.

[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.

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.

[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.

[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.

"Why can't I give you my organs after my heart has stopped beating?" An overview of the main clinical, organisational, ethical and legal issues concerning organ donation after circulatory death in Italy.

Donation after circulatory death (DCD) is a valuable option for the procurement of functioning organs for transplantation. Clinical results are promising and public acceptance is quite good in most western countries. Yet, although DCD is widespread in Europe, several problems still persist in Italy as well as in some other countries. This paper aims to describe the main clinical, organisational, ethical and legal issues at stake, bearing in mind the particular situation created by Italian legislation. Currently, as regards DCD, Italy is somewhat different from other countries. Therefore, every effort should be made for the safe and effective implementation of DCD programs: uncontrolled DCD programs should be promoted and encouraged, within the framework of shared and authoritative rules. At the same time, we need to tackle the question of controlled DCD, promoting debate among all involved subjects regarding the fundamental issues of end-of-life care within protocols that best integrate the highest standard of care for the dying and the legitimate interests of those awaiting a life-saving organ.

[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.

Systematic review of the literature and evidence-based recommendations for antibiotic prophylaxis in trauma: results from an Italian consensus of experts.

BACKGROUND: Antibiotic prophylaxis is frequently administered in severe trauma. However, the risk of selecting resistant bacteria, a major issue especially in critical care environments, has not been sufficiently investigated. The aim of the present study was to provide guidelines for antibiotic prophylaxis for four different trauma-related clinical conditions, taking into account the risks of antibiotic-resistant bacteria selection, thus innovating previous guidelines in the field. METHODS: The MEDLINE database was searched for studies comparing antibiotic prophylaxis to controls (placebo or no antibiotic administration) in four clinical traumatic conditions that were selected on the basis of the traumatic event frequency and/or infection severity. The selected studies focused on the prevention of early ventilator associated pneumonia (VAP) in comatose patients with traumatic brain injury, of meningitis in severe basilar skull fractures, of wound infections in long-bone open fractures. Since no placebo-controlled study was available for deep surgical site-infections prevention in abdominal trauma with enteric contamination, we compared 24-hour and 5-day antibiotic prophylaxis policies. A separate specific research focused on the question of antibiotic-resistant bacteria selection caused by antibiotic prophylaxis, an issue not adequately investigated by the selected studies. Randomised trials, reviews, meta-analyses, observational studies were included. Data extraction was carried out by one author according to a predefined protocol, using an electronic form. The strength of evidence was stratified and recommendations were given according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. RESULTS: Uncertain evidence deserving further studies was found for two-dose antibiotic prophylaxis for early VAP prevention in comatose patients. In the other cases the risk of resistant-bacteria selection caused by antibiotic administration for 48 hours or more, outweighed potential benefits. CONCLUSIONS: When accounting for antibiotic-resistant bacteria selection we found no evidence in favour of antibiotic prophylaxis lasting two or more days in the studied clinical conditions.

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.