Mapping trust relationships in organ donation and transplantation: a conceptual model.

The organ donation and transplantation (ODT) system heavily relies on the willingness of individuals to donate their organs. While it is widely believed that public trust plays a crucial role in shaping donation rates, the empirical support for this assumption remains limited. In order to bridge this knowledge gap, this article takes a foundational approach by elucidating the concept of trust within the context of ODT. By examining the stakeholders involved, identifying influential factors, and mapping the intricate trust relationships among trustors, trustees, and objects of trust, we aim to provide a comprehensive understanding of trust dynamics in ODT. We employ maps and graphs to illustrate the functioning of these trust relationships, enabling a visual representation of the complex interactions within the ODT system. Through this conceptual groundwork, we pave the way for future empirical research to investigate the link between trust and organ donation rates, informed by a clarified understanding of trust in ODT. This study can also provide valuable insights to inform interventions and policies aimed at enhancing organ donation rates.

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries.

BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. OBJECTIVE: This study investigated public preferences for digital health data sharing. METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; being informed and asked to consent; and a review process for data transfer and use, or transfer only. On the other hand, collection of their data by a technological company and data use for commercial communication were the least acceptable. There was preference heterogeneity across Europe and within European regions. CONCLUSIONS: This study showed the importance of transparency in data use and oversight of health-related data sharing for European respondents. Regional and intraregional preference heterogeneity for "data collector," "data user," "reason," "type of consent," and "review" calls for governance solutions that would grant data subjects the ability to control their digital health data being shared within different contexts. These results suggest that the use of data without consent will demand weighty and exceptional reasons. An interactive and dynamic informed consent model combined with oversight mechanisms may be a solution for policy initiatives aiming to harmonize health data use across Europe.

Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey.

BACKGROUND: European countries are increasingly harmonising their organ donation and transplantation policies. Although a growing number of nations are moving to presumed consent to deceased organ donation, no attempts have been made to harmonise policies on individual consent and the role of the family in the decision-making process. Little is known about public awareness of and attitudes towards the role of the family in their own country and European harmonisation on these health policy dimensions. To improve understanding of these issues, we examined what university students think about the role of the family in decision-making in deceased organ donation and about harmonising consent policies within Europe. METHODS: Using LimeSurvey© software, we conducted a comparative cross-sectional international survey of 2193 university students of health sciences and humanities/social sciences from Austria (339), Belgium (439), Denmark (230), Germany (424), Greece (159), Romania (190), Slovenia (190), and Spain (222). RESULTS: Participants from opt-in countries may have a better awareness of the family's legal role than those from opt-out countries. Most respondents opposed the family veto, but they were more ambivalent towards the role of the family as a surrogate decision-maker. The majority of participants were satisfied with the family's legal role. However, those who were unsatisfied preferred to limit family involvement. Overall, participants were opposed to the idea of national sovereignty over consent policies. They favoured an opt-out policy harmonisation and were divided over opt-in. Their views on harmonisation of family involvement were consistent with their personal preferences. CONCLUSIONS: There is overall division on whether families should have a surrogate role, and substantial opposition to granting them sole authority over decision-making. If European countries were to harmonise their policies on consent for organ donation, an opt-out system that grants families a surrogate decision-making role may enjoy the widest public support.

How do people use 'killing', 'letting die' and related bioethical concepts? Contrasting descriptive and normative hypotheses.

Bioethicists involved in end-of-life debates routinely distinguish between 'killing' and 'letting die'. Meanwhile, previous work in cognitive science has revealed that when people characterize behaviour as either actively 'doing' or passively 'allowing', they do so not purely on descriptive grounds, but also as a function of the behaviour's perceived morality. In the present report, we extend this line of research by examining how medical students and professionals (N = 184) and laypeople (N = 122) describe physicians' behaviour in end-of-life scenarios. We show that the distinction between 'ending' a patient's life and 'allowing' it to end arises from morally motivated causal selection. That is, when a patient wishes to die, her illness is treated as the cause of death and the doctor is seen as merely allowing her life to end. In contrast, when a patient does not wish to die, the doctor's behaviour is treated as the cause of death and, consequently, the doctor is described as ending the patient's life. This effect emerged regardless of whether the doctor's behaviour was omissive (as in withholding treatment) or commissive (as in applying a lethal injection). In other words, patient consent shapes causal selection in end-of-life situations, and in turn determines whether physicians are seen as 'killing' patients, or merely as 'enabling' their death.

Determination of Death: A Discussion on Responsible Scholarship, Clinical Practices, and Public Engagement.

The concept and determination of death by neurological or cardio-circulatory criteria play a crucial role for medical practice, society, and the law. Academic debates on death determination have regained momentum, and recent cases involving the neurological determination of death ("brain death") in the United States have sparked sustained public debate. The determination of death by neurological criterion (irreversible cessation of the whole brain or of the brain stem) is medically practiced in at least 80 countries. However, academic debates persist about the conceptual and scientific validity of death determined by neurological criterion. The cardio-circulatory criterion, which permits organ donation following cardio-circulatory arrest, has also recently been challenged. Given the presence of academic debates, several questions ensue about the responsible conduct of clinicians and scholars involved in clinical practices and academic research. This article identifies tension points for responsible practices in the domains of scholarship, clinical practice, and public discourse and formulates suggestions to stimulate further dialogue on responsible practices and to identify questions in need of further research.

Dying and multiplying life.

It was only after James P. Lovette's death, in 2006, that I discovered that the twenty-four-year-old colleague and friend with whom I had spent so many afternoons debating issues in organ transplantation had been the first successful child heart transplantee in the world and one of the longest-living survivors of a second transplant. During the years we met, he never even hinted at the fact that three different hearts had beaten in his chest. The revelation that his life had been an almost uninterrupted chain of medical challenges suddenly made me appreciate his quirkiness in a whole new light. Organ transplantation crudely exemplifies a traditional moral dilemma between means and ends: in order to save a life, someone else has to die. Bioethicists involved in this field have the role of identifying the ethical issues surrounding organ donation and helping others to argue in an intelligible and convincing way. In my view, bioethicists have the obligation to foster a discussion as open and transparent as possible on these matters. Still, I sometimes fear that I may be helping to cause unnecessary harms to potential recipients who are desperately waiting for a vital organ. Scholars would be chillingly cold if their quest for truth systematically came at the cost of lives lost. Every life can be meaningful and provide meaning to many others. This is true even with organ recipients, who often have short lives full of considerable suffering.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

Death pluralism: a proposal.

The debate over the determination of death has been raging for more than fifty years. Since then, objections against the diagnosis of brain death from family members of those diagnosed as dead-have been increasing and are causing some countries to take novel steps to accommodate people's beliefs and preferences in the determination of death. This, coupled with criticism by some academics of the brain death criterion, raises some questions about the issues surrounding the determination of death. In this paper, we discuss some of the main approaches to death determination that have been theoretically proposed or currently put into practice and propose a new approach to death determination called "weak pluralism" as a reasonable ethical and political alternative to respect diversity in death determination.

Family bereavement and organ donation in Spain: a mixed method, prospective cohort study protocol.

INTRODUCTION: There is a discrepancy in the literature as to whether authorising or refusing the recovery of organs for transplantation is of direct benefit to families in their subsequent grieving process. This study aims to explore the impact of the family interview to pose the option of posthumous donation and the decision to authorise or refuse organ recovery on the grieving process of potential donors' relatives. METHODS AND ANALYSIS: A protocol for mixed methods, prospective cohort longitudinal study is proposed. Researchers do not randomly assign participants to groups. Instead, participants are considered to belong to one of three groups based on factors related to their experiences at the hospital. In this regard, families in G1, G2 and G3 would be those who authorised organ donation, declined organ donation or were not asked about organ donation, respectively. Their grieving process is monitored at three points in time: 1 month after the patient's death, when a semistructured interview focused on the lived experience during the donation process is carried out, 3 months and 9 months after the death. At the second and third time points, relatives' grieving process is assessed using six psychometric tests: State-Trait Anxiety Inventory, Beck Depression Inventory-II, Inventory of Complicated Grief, The Impact of Event Scale: Revised, Posttraumatic Growth Inventory and Connor-Davidson Resilience Scale. Descriptive statistics (means, SDs and frequencies) are computed for each group and time point. Through a series of regression models, differences between groups in the evolution of bereavement are estimated. Additionally, qualitative analyses of the semistructured interviews are conducted using the ATLAS.ti software. ETHICS AND DISSEMINATION: This study involves human participants and was approved by Comité Coordinador de Ética de la Investigación Biomédica de Andalucía (CCEIBA) ID:1052-N-21. The results will be disseminated at congresses and ordinary academic forums. Participants gave informed consent to participate in the study before taking part.

A multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and torque teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation: TTVguideIT.

BACKGROUND: Immunosuppression after kidney transplantation is mainly guided via plasma tacrolimus trough level, which cannot sufficiently predict allograft rejection and infection. The plasma load of the non-pathogenic and highly prevalent torque teno virus (TTV) is associated with the immunosuppression of its host. Non-interventional studies suggest the use of TTV load to predict allograft rejection and infection. The primary objective of the current trial is to demonstrate the safety, tolerability and preliminary efficacy of TTV-guided immunosuppression. METHODS: For this purpose, a randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, investigator-driven phase II trial was designed. A total of 260 stable, low-immunological-risk adult recipients of a kidney graft with tacrolimus-based immunosuppression and TTV infection after month 3 post-transplantation will be recruited in 13 academic centres in six European countries. Subjects will be randomised in a 1:1 ratio (allocation concealment) to receive tacrolimus either guided by TTV load or according to the local centre standard for 9 months. The primary composite endpoint includes the occurrence of infections, biopsy-proven allograft rejection, graft loss, or death. The main secondary endpoints include estimated glomerular filtration rate, graft rejection detected by protocol biopsy at month 12 post-transplantation (including molecular microscopy), development of de novo donor-specific antibodies, health-related quality of life, and drug adherence. In parallel, a comprehensive biobank will be established including plasma, serum, urine and whole blood. The date of the first enrolment was August 2022 and the planned end is April 2025. DISCUSSION: The assessment of individual kidney transplant recipient immune function might enable clinicians to personalise immunosuppression, thereby reducing infection and rejection. Moreover, the trial might act as a proof of principle for TTV-guided immunosuppression and thus pave the way for broader clinical applications, including as guidance for immune modulators or disease-modifying agents. TRIAL REGISTRATION: EU CT-Number: 2022-500024-30-00.

[The ethics of health nudges: a discussion about their acceptability in public health.] / La ética de los nudges sanitarios: una discusión sobre su aceptabilidad en salud pública.

In behavioral science, the term nudge refers to any aspect of decision architecture that predictably alters people's behavior to improve the chooser's own welfare without forbidding or significantly restricting their choices. Its promoters invoke libertarian paternalism, which means, on the one hand, that the behavior of the individual is guided without counting on his autonomy, but, on the other hand, that this form of influence does not reach the point of restricting freedom of choice when it is manifest. This paper analyzes the role of nudges in the field of health policies. A cognitive analysis of these nudges is carried out and are distinguished the clinical nudges (those that take place within the healthcare professional and patient relationship) from the public health nudges (specific to public health policies). The ethical aspects of both categories of nudge will be analyzed to point out some of their virtues and the ethical challenges they face. This study focuses in particular on public health nudges, to consider whether it is reasonable, and with what limits, their implementation in health crises (for example, pandemics). Analyzing that public policies face the dilemma between preserving freedom at the expense of health or, on the contrary, prioritize health to the point of limiting freedom. It is raised whether in this context greater restrictions on individual freedoms should be allowed (for example, through mandatory lockdowns and quarantines, imposed vaccinations, forced tests) or whether to use nudges as an intermediate solution and less harmful to individual rights to promote health measures.

En ciencias del comportamiento, la expresión nudge (del inglés, empujón, codazo) se refiere a cualquier aspecto de la arquitectura de la decisión que altera predeciblemente la conducta de las personas en su propio beneficio sin prohibir o restringir de forma significativa sus opciones. Sus promotores invocan el paternalismo libertario para justificarlo, lo que significa que se promueve el beneficio del individuo sin contar con su autonomía, pero sin llegar al punto de coartar la libertad de elección cuando ésta es manifiesta. En este trabajo se analiza el papel de los nudges en el ámbito de las políticas de salud. Se lleva a cabo un análisis cognitivo de ellos y se distinguen los nudges clínicos (aquellos que tienen lugar en el seno de la relación sanitario-paciente) de los nudges salubristas (específicos de políticas de salud pública). Se analizan los aspectos éticos de ambas categorías para señalar algunas de sus virtudes y los retos éticos que plantean. El estudio se centra, de manera particular, en los nudges salubristas, para considerar si es razonable, y con qué límites, su implementación en crisis sanitarias (por ejemplo, pandemias), donde las políticas públicas se enfrentan al dilema entre preservar la libertad a costa de la salud pública o, por el contrario, priorizar ésta hasta el punto de limitar aquélla. Se plantea si en este contexto se deberían permitir mayores restricciones de las libertades individuales (por ejemplo, mediante confinamientos y cuarentenas obligatorias, vacunación impuesta, etc.) o bien utilizar nudges como una salida intermedia y menos lesiva de derechos individuales para promover medidas sanitarias.

Differential impact of opt-in, opt-out policies on deceased organ donation rates: a mixed conceptual and empirical study.

OBJECTIVES: To increase postmortem organ donation rates, several countries are adopting an opt-out (presumed consent) policy, meaning that individuals are deemed donors unless they expressly refused so. Although opt-out countries tend to have higher donation rates, there is no conclusive evidence that this is caused by the policy itself. The main objective of this study is to better assess the direct impact of consent policy defaults per se on deceased organ recovery rates when considering the role of the family in the decision-making process. This study does not take into account any indirect effects of defaults, such as potential psychological and behavioural effects on individuals and their relatives. DESIGN: Based on previous work regarding consent policies, we created a conceptual model of the decision-making process for deceased organ recovery that included any scenario that could be directly influenced by opt-in or opt-out policies. We then applied this model to internationally published data of the consent process to determine how frequently policy defaults could apply. MAIN OUTCOME MEASURES: We measure the direct impact that opt-in and opt-out policies have per se on deceased organ recovery. RESULTS: Our analysis shows that opt-in and opt-out have strictly identical outcomes in eight out of nine situations. They only differ when neither the deceased nor the family have expressed a preference and defaults therefore apply. The direct impact of consent policy defaults is typically circumscribed to a range of 0%-5% of all opportunities for organ recovery. Our study also shows that the intervention of the family improves organ retrieval under opt-in but hinders it under opt-out. CONCLUSIONS: This study may warn policy makers that, by emphasising the need to introduce presumed consent to increase organ recovery rates, they might be overestimating the influence of the default and underestimating the power granted to families.

"Just" accuracy? Procedural fairness demands explainability in AI-based medical resource allocations.

The increasing application of artificial intelligence (AI) to healthcare raises both hope and ethical concerns. Some advanced machine learning methods provide accurate clinical predictions at the expense of a significant lack of explainability. Alex John London has defended that accuracy is a more important value than explainability in AI medicine. In this article, we locate the trade-off between accurate performance and explainable algorithms in the context of distributive justice. We acknowledge that accuracy is cardinal from outcome-oriented justice because it helps to maximize patients' benefits and optimizes limited resources. However, we claim that the opaqueness of the algorithmic black box and its absence of explainability threatens core commitments of procedural fairness such as accountability, avoidance of bias, and transparency. To illustrate this, we discuss liver transplantation as a case of critical medical resources in which the lack of explainability in AI-based allocation algorithms is procedurally unfair. Finally, we provide a number of ethical recommendations for when considering the use of unexplainable algorithms in the distribution of health-related resources.