[Time-limited trials (TLT) in the intensive care unit : Recommendations from the ethics section of the DIVI and the ethics section of the DGIIN]. / Zeitlich begrenzter Therapieversuch ("time-limited trial", TLT) auf der Intensivstation : Handlungsempfehlung der Sektion Ethik der DIVI und der Sektion Ethik der DGIIN.

The rise in intensive care treatment procedures is accompanied by an increase in the complexity of decisions regarding the selection, administration and duration of treatment measures. Whether a treatment goal is desirable in an individual case and the treatment plan required to achieve it is acceptable for the patient depends on the patient's preferences, values and life plans. There is often uncertainty as to whether a patient-centered treatment goal can be achieved. The use of a time-limited treatment trial (TLT) as a binding agreement between the intensive care unit (ICU) team and the patient or their legal representative on a treatment concept over a defined period of time in the ICU can be helpful to reduce uncertainties and to ensure the continuation of intensive care measures in the patients' best interest.

[Withholding or withdrawing life-sustaining treatments in acute oncology situations: History and regulatory aspects in France]. / La « Limitation et/ou arrêt des thérapeutiques ¼ (LAT) en oncologie face à une situation aigüe : historique et aspects réglementaires en France.

The management of oncology patients, especially hospitalized patients, can lead to almost daily discussions regarding therapeutic limitations. Here, we review the history and propose a summary of the texts framing the notion of "withholding and withdrawing life-sustaining treatment" in oncology practice in France. This decision is regulated by the Claeys-Léonetti Law of February 2, 2016 recommending a collegial discussion and its documentation in the medical record. The decision to withhold or withdraw life-sustaining treatments is the subject of discussion between the patient, his physicians and his family and may take place at any time during his management. The work of intensive-care physicians provides many useful recommendations for acute oncology situations, however articles specific for oncology practice are scarce; this is a topic that oncologists must take up.

The Discourse of Dignity in the Charlie Gard, Alfie Evans and Isaiah Haastrup Cases.

There are competing accounts of dignity and no agreement about how to adjudicate between them, but this does not prevent dignity from playing an important role in the law. In fact, this very multiplicity enables dignity to perform a range of functions, both explicit and implicit, intended and unintended. Its 'open character' allows dignity to serve as a locus of agreement, but it can also silence debate and limit speaker control of how their statements are received and interpreted. This paper considers dignity's roles in recent English court judgments relating to withdrawal of ventilation and associated care from three unresponsive, paralysed infants: Charlie Gard, Alfie Evans, and Isaiah Haastrup. It presents a critical discourse analysis focusing on the judgments of first instance in relation to these infants. It argues that a range of conceptions of dignity are operationalised, serving four functions: to express esteem; to establish a hierarchy of credibility; to justify a best interests judgment, and to socialise that judgment. The overall effect is that dignity serves to compel acceptance of, rather than providing reasons to support, a best interests judgment. While recognising the value of unspecified invocations of dignity, we voice a warning about its potential to stifle debate and legitimise and enforce existing power relations.

The Charlie Gard Case, and the Ethics of Obstructing International Transfer of Seriously Ill Children.

In 2017, the court case over medical treatment of UK infant, Charlie Gard, reached global attention. In this article, I will analyze one of the more distinctive elements of the case. The UK courts concluded that treatment of Charlie Gard was not in his best interests and that it would be permissible to withdraw life-sustaining treatment. However, in addition, the court ruled that Charlie should not be transferred overseas for the treatment that his parents sought, even though specialists in Italy and the US were willing to provide that treatment. Is it ethical to prevent parents from pursuing life-prolonging treatment overseas for their children? If so, when is it ethical to do this? I will outline arguments in defense of obstructing transfer in some situations. I will argue, however, that this is only justified if there is good reason to think that the proposed treatment would cause harm.

Getting the Balance Right: Medical Futility, Scientific Advancement, and the Role of Law.

The concept of medical futility as an applied ethical framework has seen a rise and fall in its popularity over the last 30 years. It is a term used in relation to the assessment of a patient's health condition that is deemed untreatable, irreversible, and unresolvable. In four recent cases, Gard, Evans, Haastrup, and Raqeeb, the concept has been brought to the fore once again. These cases highlight a mounting tension between clinicians and families. Parental desires to see their child's treatment continued, while understandable, should not dominate treatment planning. This article analyses judicial interpretation of the factors which determine an assessment of futility and in doing so, argues that the role of medical futility in judicial decisions of this kind is gaining prominence and will continue to do so as scientific advancement blurs the limits of medicine even further.

An alternative approach to developing guidelines for the management of an anticipated extremely preterm infant.

Objectives To identify the probability of survival and severe neurodevelopmental impairment (sNDI) at which perinatal physicians would or would not offer or recommend resuscitation at birth for extremely preterm infants. Methods A Delphi process consisting of five rounds was implemented to seek consensus (>80% agreement) amongst British Columbia perinatal physicians. The first-round consisted of neonatal and maternal-fetal-medicine Focus Groups. Rounds two to five surveyed perinatal physicians, building upon previous rounds. Draft guidelines were developed and agreement sought. Results Based on 401 responses across all rounds, consensus was obtained that resuscitation should not be offered if survival probability <5%, not recommended if survival probability 5 to <10%, resuscitation recommended if survival without sNDI probability >70 to 90% and resuscitation standard care if survival without sNDI >90%. Conclusions This physician consensus-based, objective framework for the management of an anticipated extremely preterm infant is a transparent alternative to existing guidelines, minimizing gestational-ageism and allowing for individualized management utilizing up-to-date data. Further input from other key stakeholders will be required prior to guideline implementation.

O feto e o recém-nascido com condições genéticas e congênitas graves: aspectos bioéticos e jurídicos no Brasil / El feto y el recién nacido con condiciones genéticas y congénitas graves: aspectos bioéticos y jurídicos en Brasil / Fetus and newborn with genetic and congenital severe conditions: bioethical and legal aspects in Brazil / El fetus I el nadó amb condicions genètiques I congènites greus: aspectes bioètics I jurídics a Brasil

O diagnóstico seguro de malformações congênitas possibilitado pelo avanço tecnológico da propedêutica fetal possibilita o exercício da autonomia reprodutiva da gestante, embora suscite dilemas éticos e jurídicos de difícil solução, como a opção pelo aborto e a tomada de decisões em neonatos com escassas possibilidades de sobrevivência. As decisões em fim de vida e o abandono de técnicas terapêuticas fúteis que não alteram o curso natural da doença despertam conflitos éticos entre a equipe de saúde e os familiares. Nesse cenário, importa analisar o âmbito de proteção aos direitos das pessoas com deficiência no Brasil e sua aplicação aos neonatos com graves malformações congênitas, visando contribuir ao debate sobre a morte digna no período neonatal

El diagnóstico efectivo de malformaciones congénitas que resulta del avance tecnológico de la propedéutica fetal posibilita el ejercicio de la autonomía reproductiva de la mujer embarazada, aunque presente dilemas éticos y jurídicos de solución difícil, como la opción por el aborto y la toma de decisiones en casos de recién nacidos con baja posibilidad de sobrevivir. Decisiones de fin de la vida y el abandono de técnicas terapéuticas fútiles que no cambian la evolución natural de la enfermedad producen conflictos éticos entre el equipo de salud y la familia. En ese escenario, es importante analizar el ámbito de protección a los derechos de las personas con deficiencia en Brasil y su aplicación a los recién nacidos con malformaciones congénitas graves, con el objetivo de contribuir al debate sobre la muerte digna en el periodo neonatal

The diagnostic certainty of congenital malformations, made possible by the technological advances in fetal propaedeutics, enables the exercise of reproductive autonomy by the pregnant woman, although it results in ethical and legal dilemmas that are difficult to solve, such as the option for abortion, and decision-making regarding newborns with meager survival possibility. End-of-life decisions and the abandonment of futile therapeutic techniques that do not alter the natural course of the illness give rise to ethical conflicts between the health team and family members. In this setting, it is important to analyze the scope of protection of the rights of handicapped persons in Brazil, and how it applies to the newborn with severe congenital malformations, with the goal of contributing to dignified death in the neonatal period

El diagnòstic efectiu de malformacions congènites que resulta de l'avanç tecnològic de la propedèutica fetal possibilita l'exercici de l'autonomia reproductiva de la dona embarassada, encara que presenta dilemes ètics I jurídics de solució difícil, com l'opció per l'avortament I la presa de decisions en casos de nounats amb baixa possibilitat de sobreviure. Les decisions de final de la vida I l'abandonament de tècniques terapèutiques fútils que no canvien l'evolució natural de la malaltia donen lloc a conflictes ètics entre l'equip de salut I la família. En aquest escenari, és important analitzar l'àmbit de protecció dels drets de les persones amb deficiència a Brasil I la seva aplicació als nadons amb malformacions congènites greus, a fi de contribuir al debat sobre la mort digna en el període neonatal

Conceptions of dignity in the Charlie Gard, Alfie Evans and Isaiah Haastrup cases.

In 2017 and 2018, the English courts were asked to decide whether continued life-sustaining treatment was in the best interests of three infants: Charlie Gard, Alfie Evans and Isaiah Haastrup. Each infant had sustained catastrophic, irrecoverable brain damage. Dignity played an important role in the best interests assessments reached by the Family division of the High Court in each case. Multiple conceptions of dignity circulate, with potentially conflicting implications for infants such as Charlie, Alfie and Isaiah. The judgements do not explicate the conceptions of dignity upon which they rely. This article reconstructs the conceptions of dignity invoked in these judgements, finding that a broadly Kantian, agential conception dominates, under which human dignity requires the prospect of agency. This conception is situated within the broader body of thought on dignity, and the potentially adverse implications of applying the reconstructed conception in best interests assessments for infants with severely restricted consciousness are discussed.

[Susceptibility genetics of common conditions in clinical practice]. / Des tests génétiques pour prédire des maladies communes.

The genetic tests for "non-rare thrombophilias" (TNR) were introduced into clinical setting immediately after the identification of genetic variants in the mid-90s to predict and prevent venous thromboembolism (VTE). Although being a rare example of a genetic test of susceptibility for complex diseases that has been integrated in medical routine, it is the most widespread post-natal genetics inquiry in France nowadays. Yet, determining whom to test and how to use the results is still controversial. This article outlines the trajectory of its clinical regulation and illustrates the importance of the context of use to understand its diffusion. This analysis is intended to feed a more general reflection on the issues raised by the clinical integration of genetic surveys for common diseases, particularly with regard to the clinical utility of a test (statistical vs. biological), the subjects to be tested (the case index and/or her/his relatives), and the criteria underlying access to these tests (modalities of medico-economic assessment).

TITLE: Des tests génétiques pour prédire des maladies communes. ABSTRACT: Introduit au lendemain de l'identification des « thrombophilies non rares ¼ (TNR), au milieu des années 1990 afin de prédire et de prévenir la maladie thromboembolique veineuse (MTEV), le bilan génétique pour ces thrombophilies est un exemple assez rare de test génétique de susceptibilité pour une maladie complexe, à avoir franchi le pas d'un véritable usage de routine en clinique. Bien que ce test soit le plus répandu des tests de génétique post-natale en France, son usage (À qui proposer le test ? Que faire des résultats ?) fait encore l'objet de débats. Cet article analyse la trajectoire de régulation clinique de ce test et illustre l'importance du contexte spécifique d'usage pour comprendre sa diffusion. Cette analyse vise à nourrir une réflexion plus générale sur les enjeux que pose l'intégration clinique des tests génétiques pour les maladies communes, en considérant notamment les modalités de définition de l'utilité clinique d'un test (statistique versus biologique), des sujets du test (le cas index versus ses apparentés), et des critères en sous-tendant l'accès (modalités des calculs médico-économiques).

Can a Parent Refuse the Brain Death Examination?

The American Academy of Neurology believes that doctors have the right to do tests to evaluate whether a patient is brain dead even if the family does not consent. They argue that physicians have "both the moral authority and professional responsibility" to do such evaluations, just as they have the authority and responsibility to declare someone dead by circulatory criteria. Not everyone agrees. Truog and Tasker argue that apnea testing to confirm brain death has risks and that, for some families, those risks may outweigh the benefits. So, what should doctors do when caring for a patient whom they believe to be brain dead but whose parents refuse to allow testing to confirm that the patient meets neurologic criteria for death? In this article, we analyze the issues that arise when parents refuse such testing.

An Analysis of Charlie's Law and Alfie's Law.

The Charlie Gard and Alfie Evans cases were high-profile cases involving disagreements between the parents of young infants and medical practitioners, which have given impetus to pre-existing calls for law reform that have been rebranded as 'Charlie's Law' and 'Alfie's Law'. I argue against the proposal to replace the best interest test, which is currently determinative in such contentious cases, with a significant harm test, as it would render UK law divergent from international law. I also employ critical theory to rebut the notion that parents are the best decision makers and refute criticisms of clinicians (who reflexively acknowledged the limits of medicine). I utilise theories of distributive justice to demonstrate that legal reform may exacerbate unfairness, and case law to show that it may be unworkable. Nonetheless, I apply critical and Foucauldian theory to critique the lack of patient and public empowerment within the NHS and I endorse the proposal to ensure that mediation is offered in contentious cases, as this may empower patients and their carers. I also aver that the best interests test should be informed by clearer criteria regarding the allocation of finite resources, which the public should influence via the democratisation of the NHS.

Would it be ethical or legal for doctors in South Africa to administer testosterone-reducing drugs to Caster Semenya?

The Court of Arbitration for Sport recently confirmed that the decision by the International Association of Athletics Federations to require hyperandrogenic female athletes such as Caster Semenya to reduce their testosterone levels to compete in certain races has been widely condemned. The World Medical Association has warned doctors not to assist in implementing the decision, as it would be unethical. The same would apply in terms of the Health Professions Council of South Africa's rules of professional conduct. Such treatment is 'futile' in medical terms, and does not serve the purpose of providing healthcare. Therefore, doctors may lawfully refuse to prescribe it. The decision is a violation of Semenya's constitutional rights and would be regarded as unethical should doctors comply with it. However, the prescription of such drugs would not be unlawful if Semenya gave informed consent to taking them. Such consent would not be a defence to a disciplinary hearing on unprofessional conduct, but would be a good defence to any legal action arising from unpleasant side-effects - provided they were explained to her.

Neonatal organ donation: Ethical insights and policy implications.

In the realm of clinical ethics as well as in health policy and organizational ethics, the onus of our work as ethicists is to optimize the medical care and experience of the patient to better target ethical dilemmas that develop in the course of care delivery. The role of ethics is critical in all aspects of medicine, but particularly so in the difficult and often challenging cases that arise in the care of pregnant women and newborns. One exemplary situation is that when a pregnant woman and her partner consider neonatal organ donation after receiving news of a terminal diagnosis and expected death of the newborn. While a newer, less practiced form of organ donation, this approach is gaining greater visibility as an option for parents facing this terminal outcome. The aim of our paper is to highlight some of the key ethical issues associated with neonatal organ donation and identify clinical and logistical aspects of implementing such an approach to facilitate organ donation.

Consultation before 'do not attempt resuscitation' orders.

Richard Griffith, Senior Lecturer in Health Law at Swansea University, set out the steps nurses must take to ensure that a DNACPR notice is lawful.

Doctor's Criminal Liability and Medically Assisted Death - The Portuguese Case.

Recently, the Portuguese Parliament discussed four proposals aimed at allowing some forms of medically assisted death. However, all of them were rejected by the majority. Therefore, doctors who in some way accelerate a patient's death risk being convicted of the crime of homicide. Portuguese law provides some legal mechanisms that can exempt a doctor from criminal liability, such as causes excluding the conduct's wrongfulness, and causes excluding the doctor's culpability. Other elements to take into consideration are a proper interpretation of homicide crimes, thereby excluding conducts without the intent to kill; the relevance of patient consent; and the rejection of medical futility. This article explains how a doctor may not be held criminally accountable for medically assisted death, even in restrictive jurisdictions such as the Portuguese one.

Early Routine Upper Gastrointestinal Contrast Study Following Bariatric Surgery: an Indispensable Postoperative Care or a Medicolegal Heritage?

Concerns still exist regarding the role of early routine upper gastrointestinal contrast study (UGI) after bariatric procedures for detection of early complications. We reviewed our database to identify patients who underwent laparoscopic primary or redo surgery (previously placement of adjustable gastric banding), between January 2012 and December 2017. All the patients underwent UGI within 48 h after surgery. Among 1094 patients, early UGI was abnormal in 5 patients: in 4 cases a leak (one false positive) and in one case stenosis (one true positive) were suspected. In this clinical setting, five leaks were observed and required surgical re-exploration: 3 correctly identified and 2 not detected at UGI. Overall, 3 patients developed anastomotic stenosis. Our data suggest that early routine UGI after bariatric procedures has limited utility.

Debating Medical Utility, Not Futility: Ethical Dilemmas in Treating Critically Ill People Who Use Injection Drugs.

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal.

Tratamiento potencialmente inapropiado en oposición a futilidad y otras cuestiones éticas del caso de Charlie Gard / Potentially inappropriate treatment as opposed to futility and other ethical issues in the Charlie Gard case / Tractament potencialment inadequat en oposició a futilitat i altres qüestions ètiques del cas Charlie Gard

Durante los primeros 6 meses de 2017 se desarrolló un encendido debate sobre el caso de un niño inglés con una enfermedad rara y muy grave. Charlie Gard permaneció 9 meses en una unidad de cuidados intensivos paralizado, sometido a ventilación mecánica y con una función neurológica en constante deterioro. Mientras, en la prensa especializada y en los medios de comunicación general se desarrollaba un debate sobre quien tenía que tomar la decisión de retirar o continuar con los tratamientos de soporte vital y cuáles eran los criterios que había que utilizar para tomarla. En este artículo, analizamos estos y otros problemas éticos y sugerimos que, para tomar las mejores decisiones, se ha ido evolucionando de los intentos de definir la futilidad y determinar quién decide, hacia el concepto de tratamientos potencialmente inapropiados y el recurso a estrategias de toma de decisiones compartidas

In the first 6 months of 2017, there was a heated debate about the case of an English child with a rare and serious illness. Charlie Gard spent 9 months in an Intensive Care Unit paralyzed, undergoing mechanical ventilation and with a deteriorating neurological function. Meanwhile, a debate took place in the specialized press and general media about who had to make the decision to withdraw or continue with life support treatments, and on the criteria necessary to make that decision. In this article, we analyze these and other ethical problems, and suggest that in order to make the best decisions, attempts to define futility, and determine who decides has evolved into the concept of potentially inappropriate treatments and shared decision-making strategies

Durant els primers 6 mesos de 2017 es va desenvolupar un encès debat sobre el cas d'un nen anglès amb una malaltia rara i molt greu. Charlie Gard va romandre 9 mesos en una unitat de vigilància intensiva paralitzat, sotmès a ventilació mecànica i amb una funció neurològica en constant deterioració. Mentre, en la premsa especialitzada i en els mitjans de comunicació generals, tenia lloc un debat sobre qui havia de prendre la decisió de retirar o de continuar amb els tractaments de suport vital i quins eren els criteris que calia utilitzar per prendre-la. En aquest article analitzem aquests i altres problemes ètics i suggerim que, a fi de prendre les millors decisions, s'ha anat evolucionant dels intents de definir la futilitat, i determinar qui decideix, cap al concepte de tractaments potencialment inadequats i el recurs a estratègies de presa de decisions compartides