Living Donor Kidney Transplantation in Older Individuals: An Ethical Legal and Psychological Aspects of Transplantation (ELPAT) View.

Living donor transplantation is the optimal treatment for suitable patients with end-stage kidney disease. There are particular advantages for older individuals in terms of elective surgery, timely transplantation, and early graft function. Yet, despite the superiority of living donor transplantation especially for this cohort, older patients are significantly less likely to access this treatment modality than younger age groups. However, given the changing population demographic in recent decades, there are increasing numbers of older but otherwise healthy individuals with kidney disease who could benefit from living donor transplantation. The complex reasons for this inequity of access are explored, including conscious and unconscious age-related bias by healthcare professionals, concerns relating to older living donors, ethical anxieties related to younger adults donating to aging patients, unwillingness of potential older recipients to consider living donation, and the relevant legislation. There is a legal and moral duty to consider the inequity of access to living donor transplantation, recognising both the potential disparity between chronological and physiological age in older patients, and benefits of this treatment for individuals as well as society.

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.

The Reality of Inadequate Patient Care and the Need for a Global Action Framework in Organ Donation and Transplantation.

BACKGROUND: Transplant therapy is considered the best and often the only available treatment for thousands of patients with organ failure that results from communicable and noncommunicable diseases. The number of annual organ transplants is insufficient for the worldwide need. METHODS: We elaborate the proceedings of the workshop entitled "The Role of Science in the Development of International Standards of Organ Donation and Transplantation," organized by the Pontifical Academy of Sciences and cosponsored by the World Health Organization in June 2021. RESULTS: We detail the urgency and importance of achieving national self-sufficiency in organ transplantation as a public health priority and an important contributor to reaching relevant targets of the United Nations Agenda for Sustainable Development. It details the elements of a global action framework intended for countries at every level of economic development to facilitate either the establishment or enhancement of transplant activity. It sets forth a proposed plan, by addressing the technical considerations for developing and optimizing organ transplantation from both deceased and living organ donors and the regulatory oversight of practices. CONCLUSIONS: This document can be used in governmental and policy circles as a call to action and as a checklist for actions needed to enable organ transplantation as treatment for organ failure.

Improving control over euthanasia of persons with psychiatric illness: Lessons from the first Belgian criminal court case concerning euthanasia.

Background: Belgium is one of very few countries that legally allow euthanasia for suffering caused by psychiatric illness. In the first criminal trial in Belgium of physicians involved in euthanasia, three physicians recently faced the accusation of "murder by poisoning," for allegedly having failed to comply with several requirements of the Belgian Euthanasia Law in granting the euthanasia request a woman suffering from psychiatric illness. Although all three physicians were acquitted, the case generated much debate among policy makers, medical professionals, and the general public. Method: We use this trial as the starting point for a critical analysis of the adequacy of the three-level control system established in the Euthanasia Law, as it is applied in the evaluation of euthanasia requests from persons who suffer unbearably from a psychiatric illness. This analysis is based on information presented during the criminal trial as well as information on the euthanasia that was published in the press. Results: Our analysis highlights substantial problems in the assessment and granting of the euthanasia request. The patient was euthanized without it having been substantiated that her psychiatric illness had no prospect of improvement and that her suffering could not be alleviated. The three-step control system enshrined in the Law and promoted by the Federal Control and Evaluation Commission for Euthanasia appears to have failed at each level. Conclusion: To evaluate requests for euthanasia for mental suffering caused by psychiatric illness, the requirements of the Belgian Euthanasia Law should be complemented by mandating the advice of two psychiatrists, and face-to-face discussions between all physicians involved. In parallel with the process of evaluating the euthanasia request, a treatment track should be guaranteed where reasonable evidence-based treatments and recovery-oriented options are tried.

Inequitable Access to Transplants: Adults With Impaired Decision-Making Capacity.

Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The "Ethical and Legal Issues" working group of the European Society of Transplantation undertook an expert consensus process. Literature relating to transplantation in patients with IDC was examined and collated to investigate whether IDC is associated with inferior transplant outcomes and the legitimacy of this healthcare inequality was examined. Even though the available evidence of inferior transplant outcomes in these patients is limited, the working group concluded that access to transplantation in patients with IDC may be inequitable. Consequently, we argue that IDC should not in and of itself be considered as a barrier to either registration on the transplant waiting list or allocation of an organ. Strategies for non-discrimination should focus on ensuring eligibility is based upon sound evidence and outcomes without reference to non-medical criteria. Recommendations to support policy makers and healthcare providers to reduce unintended inequity and inadvertent discrimination are set out. We call upon transplant centres and national bodies to include data on decision-making capacity in routine reporting schedules in order to improve the evidence base upon which organ policy decisions are made going forward.

Donor Autonomy and Self-Sacrifice in Living Organ Donation: An Ethical Legal and Psychological Aspects of Transplantation (ELPAT) View.

Clinical teams understandably wish to minimise risks to living kidney donors undergoing surgery, but are often faced with uncertainty about the extent of risk, or donors who wish to proceed despite those risks. Here we explore how these difficult decisions may be approached and consider the conflicts between autonomy and paternalism, the place of self-sacrifice and consideration of risks and benefits. Donor autonomy should be considered as in the context of the depth and strength of feeling, understanding risk and competing influences. Discussion of risks could be improved by using absolute risk, supra-regional MDMs and including the risks to the clinical team as well as the donor. The psychological effects on the donor of poor outcomes for the untransplanted recipient should also be taken into account. There is a lack of detailed data on the risks to the donor who has significant co-morbidities.

Pre-emptive live donor kidney transplantation-moving barriers to opportunities: An ethical, legal and psychological aspects of organ transplantation view.

Live donor kidney transplantation (LDKT) is the optimal treatment modality for end stage renal disease (ESRD), enhancing patient and graft survival. Pre-emptive LDKT, prior to requirement for renal replacement therapy (RRT), provides further advantages, due to uraemia and dialysis avoidance. There are a number of potential barriers and opportunities to promoting pre-emptive LDKT. Significant infrastructure is needed to deliver robust programmes, which varies based on socio-economic standards. National frameworks can impact on national prioritisation of pre-emptive LDKT and supporting education programmes. Focus on other programme's components, including deceased kidney transplantation and RRT, can also hamper uptake. LDKT programmes are designed to provide maximal benefit to the recipient, which is specifically true for pre-emptive transplantation. Health care providers need to be educated to maximize early LDKT referral. Equitable access for varying population groups, without socio-economic bias, also requires prioritisation. Cultural barriers, including religious influence, also need consideration in developing successful outcomes. In addition, the benefit of pre-emptive LDKT needs to be emphasised, and opportunities provided to potential donors, to ensure timely and safe work-up processes. Recipient education and preparation for pre-emptive LDKT needs to ensure increased uptake. Awareness of the benefits of pre-emptive transplantation require prioritisation for this population group. We recommend an approach where patients approaching ESRD are referred early to pre-transplant clinics facilitating early discussion regarding pre-emptive LDKT and potential donors for LDKT are prioritized for work-up to ensure success. Education regarding pre-emptive LDKT should be the norm for patients approaching ESRD, appropriate for the patient's cultural needs and physical status. Pre-emptive transplantation maximize benefit to potential recipients, with the potential to occur within successful service delivery. To fully embrace preemptive transplantation as the norm, investment in infrastructure, increased awareness, and donor and recipient support is required.

COVID-19 vaccination for people with severe mental illness: why, what, and how?

Psychiatric disorders, and especially severe mental illness, are associated with an increased risk of severe acute respiratory syndrome coronavirus 2 infection and COVID-19-related morbidity and mortality. People with severe mental illness should therefore be prioritised in vaccine allocation strategies. Here, we discuss the risk for worse COVID-19 outcomes in this vulnerable group, the effect of severe mental illness and psychotropic medications on vaccination response, the attitudes of people with severe mental illness towards vaccination, and, the potential barriers to, and possible solutions for, an efficient vaccination programme in this population.

COVID-19-Related Mortality Risk in People With Severe Mental Illness: A Systematic and Critical Review.

Background: Increasing clinical evidence suggests that people with severe mental illness (SMI), including schizophrenia spectrum disorders, bipolar disorder (BD), and major depressive disorder (MDD), are at higher risk of dying from COVID-19. Several systematic reviews examining the association between psychiatric disorders and COVID-19-related mortality have recently been published. Although these reviews have been conducted thoroughly, certain methodological limitations may hinder the accuracy of their research findings. Methods: A systematic literature search, using the PubMed, Embase, Web of Science, and Scopus databases (from inception to July 23, 2021), was conducted for observational studies assessing the risk of death associated with COVID-19 infection in adult patients with pre-existing schizophrenia spectrum disorders, BD, or MDD. Methodological quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS). Results: Of 1,446 records screened, 13 articles investigating the rates of death in patients with pre-existing SMI were included in this systematic review. Quality assessment scores of the included studies ranged from moderate to high. Most results seem to indicate that patients with SMI, particularly patients with schizophrenia spectrum disorders, are at significantly higher risk of COVID-19-related mortality, as compared to patients without SMI. However, the extent of the variation in COVID-19-related mortality rates between studies including people with schizophrenia spectrum disorders was large because of a low level of precision of the estimated mortality outcome(s) in certain studies. Most studies on MDD and BD did not include specific information on the mood state or disease severity of patients. Due to a lack of data, it remains unknown to what extent patients with BD are at increased risk of COVID-19-related mortality. A variety of factors are likely to contribute to the increased mortality risk of COVID-19 in these patients. These include male sex, older age, somatic comorbidities (particularly cardiovascular diseases), as well as disease-specific characteristics. Conclusion: Methodological limitations hamper the accuracy of COVID-19-related mortality estimates for the main categories of SMIs. Nevertheless, evidence suggests that SMI is associated with excess COVID-19 mortality. Policy makers therefore must consider these vulnerable individuals as a high-risk group that should be given particular attention. This means that targeted interventions to maximize vaccination uptake among these patients are required to address the higher burden of COVID-19 infection in this already disadvantaged group.

Raising awareness of unspecified living kidney donation: an ELPAT view.

BACKGROUND: Living donor kidney transplantation (LDKT) is the preferred treatment for patients with end-stage renal disease and unspecified living kidney donation is morally justified. Despite the excellent outcomes of LDKT, unspecified kidney donation (UKD) is limited to a minority of European countries due to legal constraints and moral objections. Consequently, there are significant variations in practice and approach between countries and the contribution of UKD is undervalued. Where UKD is accepted as routine, an increasing number of patients in the kidney exchange programme are successfully transplanted when a 'chain' of transplants is triggered by a single unspecified donor. By expanding the shared living donor pool, the benefit of LDKT is extended to patients who do not have their own living donor because a recipient on the national transplant list always completes the chain. Is there a moral imperative to increase the scope of UKD and how could this be achieved? METHODS: An examination of the literature and individual country practices was performed to identify the limitations on UKD in Europe and recommend strategies to increase transplant opportunities. RESULTS: Primary limitations to UKD, key players and their roles and responsibilities were identified. CONCLUSIONS: Raising awareness to encourage the public to volunteer to donate is appropriate and desirable to increase UKD. Recommendations are made to provide a framework for increasing awareness and engagement in UKD. The public, healthcare professionals, policy makers and society and religious leaders have a role to play in creating an environment for change.

Characteristics of Women Who Present for Abortion Beyond the Legal Limit in Flanders, Belgium.

CONTEXT: Women who seek abortion care beyond the first trimester of gestation are often in a vulnerable socioeconomic position with limited social support, and in Belgium, the details of their circumstances are insufficiently understood. A better understanding of this group is essential to a critical evaluation of Belgian abortion policy, which restricts abortions on request after the first trimester. METHODS: Anonymized patient records were collected between 2013 and 2016 from LUNA centers, which are non-hospital-based abortion clinics in Flanders. Logistic regression analyses were used to identify associations between women's characteristics and whether they presented within or beyond the legal limit, which was 13 weeks and 1 day at the time of the study. RESULTS: A total of 28,741 women requested an abortion, and 972 individuals (3.4%) presented beyond the legal limit; 29% of these latter women were unable to receive abortion care as a result of the mandatory six-day waiting period. Characteristics positively associated with presenting beyond the limit, instead of beforehand, were being younger than 20, as opposed to 20-24 (odds ratio, 1.7); receiving a primary, lower secondary, upper secondary or special-needs education, rather than a higher education (1.8-3.1); being unemployed, rather than employed (1.3); and holding Belgian rather than a foreign nationality (0.8). Being accompanied by someone to the LUNA center (0.8), having irregularly (0.6) or regularly used contraceptives (0.7), and having ever had an abortion (0.8) were negatively associated with presenting beyond, rather than before, the limit. CONCLUSIONS: A fuller consideration of patients' characteristics when evaluating Belgian abortion policy is needed to ensure that the needs and rights of socioeconomically vulnerable women are addressed.

Psychiatric patients requesting euthanasia: Guidelines for sound clinical and ethical decision making.

BACKGROUND: Since Belgium legalised euthanasia, the number of performed euthanasia cases for psychological suffering in psychiatric patients has significantly increased, as well as the number of media reports on controversial cases. This has prompted several healthcare organisations and committees to develop policies on the management of these requests. METHOD: Five recent initiatives that offer guidance on euthanasia requests by psychiatric patients in Flanders were analysed: the protocol of Ghent University Hospital and advisory texts of the Flemish Federation of Psychiatry, the Brothers of Charity, the Belgian Advisory Committee on Bioethics, and Zorgnet-Icuro. These were examined via critical point-by-point reflection, focusing on all legal due care criteria in order to identify: 1) proposed measures to operationalise the evaluation of the legal criteria; 2) suggestions of additional safeguards going beyond these criteria; and 3) remaining fields of tension. RESULTS: The initiatives are well in keeping with the legal requirements but are often more stringent. Additional safeguards that are formulated include the need for at least two positive advices from at least two psychiatrists; an a priori evaluation system; and a two-track approach, focusing simultaneously on the assessment of the patient's euthanasia request and on that person's continuing treatment. Although the initiatives are similar in intent, some differences in approach were found, reflecting different ethical stances towards euthanasia and an emphasis on practical clinical assessment versus broad ethical reflection. CONCLUSIONS: All initiatives offer useful guidance for the management of euthanasia requests by psychiatric patients. By providing information on, and proper operationalisations of, the legal due care criteria, these initiatives are important instruments to prevent potential abuses. Apart from the additional safeguards suggested, the importance of a decision-making policy that includes many actors (e.g. the patient's relatives and other care providers) and of good aftercare for the bereaved are rightly stressed. Shortcomings of the initiatives relate to the aftercare of patients whose euthanasia request is rejected, and to uncertainty regarding the way in which attending physicians should manage negative or conflicting advices, or patients' suicide threats in case of refusal. Given the scarcity of data on how thoroughly and uniformly requests are handled in practice, it is unclear to what extent the recommendations made in these guidelines are currently being implemented.

Strengthening Global Efforts to Combat Organ Trafficking and Transplant Tourism: Implications of the 2018 Edition of the Declaration of Istanbul.

The 2018 Edition of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (DoI) provides an updated set of principles and definitions to guide policymakers and health professionals working in organ donation and transplantation. A draft of the new edition was circulated to the public and transplant professionals through an online consultation process, which also sought feedback on a draft explanatory article that explained the principles and discussed some of their practical implications. Both drafts were revised in response to feedback from participants in the consultation. We present here the discussion article, which is intended to assist stakeholders in applying the principles of the DoI by providing more detailed information about the meaning and potential implications of implementing the DoI in various contexts.

'Capacity for Discernment' and Euthanasia on Minors in Belgium.

In 2014, the Belgian Euthanasia Law was amended so as to extend the possibility of obtaining euthanasia to minors who have the capacity for discernment. The amendment led to considerable debate among Belgian legal experts, health care professionals and ethicists, in large part due to concerns about the scope and assessment of the minor's 'capacity for discernment', a concept first introduced in Belgian medical law by the amendment. This article offers a critical legal analysis of the concept of 'capacity for discernment' and its implications for euthanasia practice in Belgium. We do so by focusing on a ruling of the Belgian Constitutional Court of 29 October 2015, where the concept figured prominently in the examination of the constitutionality of the amendment. This approach also allows us to shed light on the interpretation of several core aspects of the original 2002 Euthanasia Law and its 2014 amendment.