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.

Death Notification in Italian Critical Care Unites and Emergency Services. A Qualitative Study with Physicians, Nurses and Relatives.

This qualitative study was conducted in critical care units and emergency services and was aimed at considering the death notification (DN) phenomenology among physicians (notifiers), patient relatives (receivers) and those who work between them (nurses). Through the qualitative method, a systemic perspective was adopted to recognise three different categories of representation: 23 clinicians, 13 nurses and 11 family members of COVID-19 victims were interviewed, totalling 47 people from all over Italy (25 females, mean age: 46,36; SD: 10,26). With respect to notifiers, the following themes emerged: the changes in the relational dimension, protective factors and difficulties related to DN. With respect to receivers, the hospital was perceived as a prison, bereavement between DN, lost rituals and continuing bonds. Among nurses, changes in the relational dimension, protective factors and the impact of the death. Some common issues between physicians and nurses were relational difficulties in managing distancing and empathy and the support of relatives and colleagues. The perspective of receivers showed suffering related to loss and health care professionals' inefficacy in communication. Specifically, everyone considered DNs mismanaged because of the COVID-19 emergency. Some considerations inherent in death education for DN management among health professionals were presented.

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.

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.

[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.

[Ethical use of antibiotics in the era of multiresistance: a common good for the individual or the society?]. / L'uso etico degli antibiotici nell'era delle multiresistenze: risorse per singoli pazienti o "beni comuni" a disposizione della collettività?

Common goods refer to goods that may be used by anyone belonging to the community that has use rights over a commons and are fundamental to people's lives. Appropriate measures for safeguarding common goods should be undertaken, also for the benefit of future generations. Drugs in general, and antibiotics in particular, should be considered a common good as well. However, antibiotic use confined to the individual health benefit not only leads to less favorable outcomes for the society but also results in the development of antimicrobial resistance in the individual patient. This phenomenon is termed "tragedy of the commons" and identifies the impossibility of achieving over time the optimal treatment for each individual subject/patient. As a consequence, pursuing individual interests may lead to societal detriment. Conversely, restricting antibiotic prescriptions (e.g., avoiding overuse or misuse of last-generation antibiotics for the treatment of an infection) is not harmful for the individual, would benefit society with increased efficacy, and does not favor the emergence of antibiotic resistance. In this editorial, several suggestions as to how antibiotics should be appropriately used are provided in accordance with distributive justice principles, where individual and social interests meet.

Ethical issues associated with in-hospital emergency from the Medical Emergency Team's perspective: a national survey.

BACKGROUND: Medical Emergency Teams (METs) are frequently involved in ethical issues associated to in-hospital emergencies, like decisions about end-of-life care and intensive care unit (ICU) admission. MET involvement offers both advantages and disadvantages, especially when an immediate decision must be made. We performed a survey among Italian intensivists/anesthesiologists evaluating MET's perspective on the most relevant ethical aspects faced in daily practice. METHODS: A questionnaire was developed on behalf of the Italian scientific society of anesthesia and intensive care (SIAARTI) and administered to its members. Decision making criteria applied by respondents when dealing with ethical aspects, the estimated incidence of conflicts due to ethical issues and the impact on the respondents' emotional and moral distress were explored. RESULTS: The questionnaire was completed by 327 intensivists/anesthesiologists. Patient life-expectancy, wishes, and the quality of life were the factors most considered for decisions. Conflicts with ward physicians were reported by most respondents; disagreement on appropriateness of ICU admission and family unpreparedness to the imminent patient death were the most frequent reasons. Half of respondents considered that in case of conflicts the final decision should be made by the MET. Conflicts were generally recognized as causing increased and moral distress within the MET members. Few respondents reported that dedicated protocols or training were locally available. CONCLUSION: Italian intensivists/anesthesiologists reported that ethical issues associated with in-hospital emergencies are occurring commonly and are having a significant negative impact on MET well-being. Conflicts with ward physicians happen frequently. They also conveyed that hospitals don't offer ethics training and have no protocols in place to address ethical issues.

Corneomandibular reflex: Anatomical basis.

Corneomandibular reflex is a pathological phenomenon evident in cases of severe brainstem damage. It is considered to be a pathological exteroceptive reflex, associated with precentro bulbar tract lesions. The sign is useful in distinguishing central neurological injuries to metabolic disorders in acutely comatose patients, localizing lesions to the upper brainstem area, determining the depth of coma and its evolution, providing evidence of uncal or transtentorial herniation in acute cerebral hemisphere lesions, and it is a marker of supraspinal level impairment in amyotrophic lateral sclerosis and multiple sclerosis. This sign was evident in a patient with severe brain damage. We discuss the literature findings and its relevance in prognosis establishment.

["Dignity" at the end of life: ethical and deontologic reflections]. / Quale dignità al termine della vita? Considerazioni etico-deontologiche.

Bioethical reflection is often raised to qualify medical treatment in relation to the concept of "dignity" of the human being. In philosophy, the concept of human dignity is used to refer to the intrinsic value of every human being but it has been framed in many different ways depending on the theoretical matrix we refer to. According to Christian principles, the dignity of human beings resides on their being created in the image and likeness of God: hence, the holiness of life for the believer and the condemnation of all means of action intended to anticipate death from suicide to euthanasia. On the contrary, according to the liberal tradition, human dignity is especially expressed in the autonomy of every human being. The Italian and the German Constitutions recall the value of human dignity. In the article 32 of the Italian Constitution, the concept of dignity is taken into account when stating the autonomy of the individual decision-making about health treatment. This is confirmed by the Code of Medical Ethics (2014): the right to self-determination and the right of patients to decide for themselves in accordance with their own life plans, are at the core of the concept of "human dignity". For this reason, doctors should support and encourage the full right of every patient to be considered as an autonomous person until the end of life, affirming his dignity. The acronym ABCD (airway, breathing, circulation, drugs) synthetises the essentials of intensive care procedures in life-threatening events. The same acronym should guide our behavior in promoting dignity in clinical settings. Attitude: moving away from our certainties, to better understand the real nature of the sick person we are approaching. Behavior: always be inspired by kindness and respect. Compassion, that is, deep awareness of the suffering, coupled with the desire to bring relief. Dialogue, being open to know the human being "behind" disease. This approach, developed by Chochinov and called "Dignity in Care", promotes the expression of the dignity of people and allows them to operate, together with the healthcare team, the choices consistent with their own life plans to the end of life.

End-of-life decision-making and quality of ICU performance: an observational study in 84 Italian units.

PURPOSE: To appraise the end-of-life decision-making in several intensive care units (ICUs) and to evaluate the association between the average inclination to limit treatment and overall survival at ICU level. DESIGN: Prospective, multicenter, observational study, lasting 12 months. SETTING: Eighty-four Italian, adult ICUs. PATIENTS: Consecutive patients (3,793) who died in ICU or were discharged in terminal condition, in 2005. MEASUREMENTS: Data collection included patient description, treatment limitation and decision-makers, involvement of patients and relatives in the decision, and organ donation. A logistic regression model was used to identify predictors of treatment limitation and develop a measure of the inclination to limit treatment for each ICU. This was compared with the standardized mortality ratio, an index of the overall performance of the unit. RESULTS: Treatment limitation preceded 62% of deaths. In 25% of cases, nurses were involved in the decision. Half the limitations were do-not-resuscitate orders, with the remaining half almost equally split between withholding and withdrawing treatment. Units less inclined to limit treatments (odds ratio <0.77) showed higher overall standardized mortality ratio (1.08; 95% confidence interval: 1.04-1.12). LIMITATIONS: The voluntary nature of participation, with self-selected ICUs from a self-selected independent network. CONCLUSIONS: Treatment limitation is common in ICU and still principally a physician's responsibility. Units with below-average inclination to limit treatments have worse performance in terms of overall mortality, showing that limitation is not against the patient's interests. On the contrary, the inclination to limit treatments at the end of life can be taken as an indication of quality in the unit.

Old patients in intensive care unit (ICU): what decisions to make?

This report is aimed at identifying and suggesting a decision-making approach to handle old patients in ICUs in the light of current epidemiological findings and literature. We reviewed the data provided by the GIVITI network on 107,459 patients admitted to 150 Italian ICUs between 2000 and 2005; patients were divided into age groups (18-65 years: group I; 66-75 years: group II; 76-85 years: group III; > or =85 years: group IV). Comorbidities were recorded on admission in all groups [I (62.2%), II (92.2%), III (94.9%) and IV (94.5%), respectively]. Therapeutic means were virtually applied in the same way to all groups under examination [I (82.1%), II (83.9%), III (85.9%) and IV (83.5%), respectively]. Mortality in ICU was higher in group IV (27.2%), followed by groups III (24.3%), II (19.1%) and I (13.2%). The multivariate logistic regression analysis of GIVITI and some reviewed studies suggest that age is an independent mortality factor; however, current literature is controversial. The choice of admitting and treating old patients in ICUs should result from a balance between clinical and ethical factors.