Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines).

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.

Real-world ethics in palliative care: A systematic review of the ethical challenges reported by specialist palliative care practitioners in their clinical practice.

BACKGROUND: Ethical issues arise daily in the delivery of palliative care. Despite much (largely theoretical) literature, evidence from specialist palliative care practitioners about day-to-day ethical challenges has not previously been synthesised. This evidence is crucial to inform education and adequately support staff. AIM: To synthesise the evidence regarding the ethical challenges which specialist palliative care practitioners encounter during clinical practice. DESIGN: Systematic review with narrative synthesis (PROSPERO registration CRD42018105365). Quality was dual-assessed using the Mixed-Methods Appraisal Tool. Tabulation, textural description, concept mapping and thematic synthesis were used to develop and present the narrative. DATA SOURCES: Seven databases (MEDLINE, Philosopher's Index, EMBASE, PsycINFO, LILACS, Web of Science and CINAHL) were searched from inception to December 2019 without language limits. Eligible papers reported original research using inductive methods to describe practitioner-reported ethical challenges. RESULTS: A total of 8074 records were screened. Thirteen studies from nine countries were included. Challenges were organised into six themes: application of ethical principles; delivering clinical care; working with families; engaging with institutional structures and values; navigating societal values and expectations; philosophy of palliative care. Challenges related to specific scenarios/contexts rather than the application of general ethical principles, and occurred at all levels (bedside, institution, society, policy). CONCLUSION: Palliative care practitioners encounter a broad range of contextual ethical challenges, many of which are not represented in palliative care ethics training resources, for example, navigating institutional policies, resource allocation and inter-professional conflict. Findings have implications for supporting ethical practice and training practitioners. The lack of low- and middle- income country data needs addressing.

Defining ethical challenge(s) in healthcare research: a rapid review.

BACKGROUND: Despite its ubiquity in academic research, the phrase 'ethical challenge(s)' appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of 'ethical challenge(s)' and closely related terms as used in current healthcare research literature. METHODS: Rapid review to identify peer-reviewed reports examining 'ethical challenge(s)' in any context, extracting data on definitions of 'ethical challenge(s)' in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher's Index, EMBASE, CINAHL) were searched from April 2016 to April 2021. RESULTS: 393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of 'ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to 'ethical challenge(s)' within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study. CONCLUSIONS: Only 12/72 studies contained an explicit definition of 'ethical challenge(s)', with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

Principles for pandemics: COVID-19 and professional ethical guidance in England and Wales.

BACKGROUND: During the arrival of the COVID-19 pandemic, various professional ethical guidance was issued to (and for) health and social care professionals in England and Wales. Guidance can help to inform and support such professionals and their patients, clients and service users, but a plethora of guidance risked information overload, confusion, and inconsistency. METHODS: During the early months of the pandemic, we undertook a rapid review, asking: what are the principles adopted by professional ethical guidance in England and Wales for dealing with COVID-19? We undertook thematic content analysis of the 29 documents that met our inclusion criteria. RESULTS: The 29 documents captured 13 overlapping principles: respect, fairness, minimising harm, reciprocity, proportionality, flexibility, working together, inclusiveness, communication, transparency, reasonableness, responsibility, and accountability. CONCLUSIONS: We intend this attempt to collate and outline the prominent principles to be helpful, particularly, for healthcare practice during the COVID-19 pandemic and, hopefully, for future pandemic planning. We also offer some reflections on the guidance and the principles therein. After describing the principles, we reflect on some of the similarities and differences in the guidance, and the challenges associated not only with the specific guidance reviewed, but also with the nature and import of "professional ethical guidance".

Bin it or pin it? Which professional ethical guidance on managing COVID-19 should I follow?

BACKGROUND: As the COVID-19 (coronavirus) pandemic develops, healthcare professionals are looking for support with, and guidance to inform, the difficult decisions they face. In the (current) absence of an authoritative national steer in England, professional bodies and local organisations have been developing and disseminating their own ethical guidance. Questions inevitably arise, some of which are particularly pressing during the pandemic, as events are unfolding quickly and the field is becoming crowded. My central question here is: which professional ethical guidance should the professional follow? MAIN BODY: Adopting a working definition of "professional ethical guidance", I offer three domains for a healthcare professional to consider, and some associated questions to ask, when determining whether - in relation to any guidance document - they should "bin it or pin it". First, the professional should consider the source of the guidance: is the issuing body authoritative or, if not, at least sufficiently influential that its guidance should be followed? Second, the professional should consider the applicability of the guidance, ascertaining whether the guidance is available and, if so, whether it is pertinent. Pertinence has various dimensions, including whether the guidance applies to this professional, this patient and/or this setting, whether it is up-to-date, and whether the guidance addresses the situation the professional is facing. Third, the professional should consider the methodology and methods by which the guidance was produced. Although the substantive quality of the guidance is important, so too are the methods by which it was produced. Here, the professional should ask whether the guidance is sufficiently inclusive - in terms of who has prepared it and who contributed to its development - and whether it was rigorously developed, and thus utilised appropriate processes, principles and evidence. CONCLUSION: Asking and answering such questions may be challenging, particularly during a pandemic. Furthermore, guidance will not do all the work: professionals will still need to exercise their judgment in deciding what is best in the individual case, whether or not this concerns COVID-19. But such judgments can and should be informed (and constrained) by guidance, and hopefully these preliminary observations will provide some useful pointers for time-pressed professionals.

Forgoing life-sustaining treatment - a comparative analysis of regulations in Japan, Korea, Taiwan, and England.

BACKGROUND: Regulations on forgoing life-sustaining treatment (LST) have developed in Asian countries including Japan, Korea and Taiwan. However, other countries are relatively unaware of these due to the language barrier. This article aims to describe and compare the relevant regulatory frameworks, using the (more familiar) situation in England as a point of reference. We undertook literature reviews to ascertain the legal and regulatory positions on forgoing LST in Japan, Korea, Taiwan, and England. MAIN TEXT: Findings from a literature review are first presented to describe the development of the regulatory frameworks surrounding the option of forgoing LST in each country. Based on the findings from the four countries, we suggest five ethically important points, reflection on which should help to inform the further development of regulatory frameworks concerning end-of-life care in these countries and beyond. There should be reflection on: (1) the definition of - and reasons for defining - the 'terminal stage' and associated criteria for making such judgements; Korea and Taiwan limit forgoing LST to patients in this stage, but there are risks associated with defining this too narrowly or broadly; (2) foregoing LST for patients who are not in this stage, as is allowed in Japan and England, because here too there are areas of controversy, including (in England) whether the law in this area does enough to respect the autonomy of (now) incapacitated patients; (3) whether 'foregoing' LST should encompass withholding and withdrawing treatment; this is also an ethically disputed area, particularly in the Asian countries we examine; (4) the family's role in end-of-life decision-making, particularly as, compared with England, the three Asian countries traditionally place a greater emphasis on families and communities than on individuals; and (5) decision-making with and for those incapacitated patients who lack families, surrogate decision-makers or ADs. CONCLUSION: Comparison of, and reflection on, the different legal positions that obtain in Japan, Korea, Taiwan, and England should prove informative and we particularly invite reflection on five areas, in the hope the ensuing discussions will help to establish better end-of-life regulatory frameworks in these countries and elsewhere.

Conceptualising Surgical Innovation: An Eliminativist Proposal.

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.

Dying too soon or living too long? Withdrawing treatment from patients with prolonged disorders of consciousness after Re Y.

BACKGROUND: In the ruling in Y [2018], the UK Supreme Court has confirmed that there is no general requirement for the courts in England and Wales to authorise the withdrawal of clinically assisted nutrition and hydration from patients with prolonged disorders of consciousness. The perceived requirement, which originated in a court ruling in 1993, encompassed those in the vegetative state and those in the minimally conscious state. The ruling in Y confirms that the court may still be approached to decide difficult or contested cases, but there is otherwise no routine requirement that the judges be approached. MAIN BODY: There is much to welcome in this ruling, particularly as it means that these decisions for these patients are no longer (unusually) singled out for a judicial decision, with all the financial and emotional costs that court proceedings can entail. However, there is also a risk that the ruling might have unwelcome consequences. First, there is the possibility that patients might die too soon, particularly if doctors should now adopt the courts' previous reasoning, which has suggested that patients in the vegetative state lack interests, so treatment may - perhaps must - be withdrawn. Secondly, there is the converse possibility that patients might live too long, since empirical research suggests that - whether intentionally or not - patients' families, clinicians, and the health system appear to promote treatment-by-default. CONCLUSION: Rather than adopt general positions, which may be contestable and potentially risky, this article argues, on a pluralistic basis, that the individual patient should be the focus of any decision made in his or her 'best interests'. The existing legal framework in England and Wales, which is provided by the Mental Capacity Act 2005, already points in this direction, although more efforts may be needed to ensure that those involved in making these decisions are suitably educated and supported. Fortunately, new guidance from the British Medical Association could help clinicians and families to make decisions in the future, which are appropriate for the incapacitated individual patient in question.

Mapping, framing, shaping: a framework for empirical bioethics research projects.

BACKGROUND: There is growing interest in the use and incorporation of empirical data in bioethics research. Much of the recent focus has been on specific "empirical bioethics" methodologies, which attempt to integrate the empirical and the normative. Researchers in the field are, however, beginning to explore broader questions, including around acceptable standards of practice for undertaking such research. The framework: In this article, we further widen the focus to consider the overall shape of an empirical bioethics research project. We outline a framework that identifies three key phases of such research, which are conveyed via a landscaping metaphor of Mapping-Framing-Shaping. First, the researcher maps the field of study, typically by undertaking literature reviews. Second, the researcher frames particular areas of the field of study, exploring these in depth, usually via qualitative research. Finally, the researcher seeks to (re-)shape the terrain by issuing recommendations that draw on the findings from the preceding phases. To qualify as empirical bioethics research, the researcher will utilise a methodology that seeks to bridge these different elements in order to arrive at normative recommendations. We illustrate the framework by citing examples of diverse projects which broadly adopt the three-phase framework. Amongst the strengths of the framework are its flexibility, since (as the examples indicate) it does not prescribe any specific methods or particular bridging methodology. However, the framework might also have its limitations, not least because it appears particularly to capture projects that involve qualitative - as opposed to quantitative - research. CONCLUSIONS: Despite its possible limitations, we offer the Mapping-Framing-Shaping framework in the hope that this will prove useful to those who are seeking to plan and undertake empirical bioethics research projects.

Clinic, courtroom or (specialist) committee: in the best interests of the critically Ill child?

Law's processes are likely always to be needed when particularly intractable conflicts arise in relation to the care of a critically ill child like Charlie Gard. Recourse to law has its merits, but it also imposes costs, and the courts' decisions about the best interests of such children appear to suffer from uncertainty, unpredictability and insufficiency. The insufficiency arises from the courts' apparent reluctance to enter into the ethical dimensions of such cases. Presuming that such reflection is warranted, this article explores alternatives to the courts, and in particular the merits of specialist ethics support services, which appear to be on the rise in the UK. Such specialist services show promise, as they are less formal and adversarial than the courts and they appear capable of offering expert ethical advice. However, further research is needed into such services - and into generalist ethics support services - in order to gauge whether this is indeed a promising development.

Institute of Medical Ethics Guidelines for confirmation of appointment, promotion and recognition of UK bioethics and medical ethics researchers.

This document is designed to give guidance on assessing researchers in bioethics/medical ethics. It is intended to assist members of selection, confirmation and promotion committees, who are required to assess those conducting bioethics research when they are not from a similar disciplinary background. It does not attempt to give guidance on the quality of bioethics research, as this is a matter for peer assessment. Rather it aims to give an indication of the type, scope and amount of research that is the expected in this field. It does not cover the assessment of other activities such as teaching, policy work, clinical ethics consultation and so on, but these will be mentioned for additional context. Although it mentions the UK's Research Excellence Framework (REF), it is not intended to be a detailed analysis of the place of bioethics in the REF.

Standards of practice in empirical bioethics research: towards a consensus.

BACKGROUND: This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds. METHODS: The consensus process used a modified Delphi approach. RESULTS: Consensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise). CONCLUSIONS: Through articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of practice of empirical bioethics research can develop and evolve further.

Cryonics in the Courtroom: Which Interests? Whose Interests?

In an apparent international first, the High Court has allowed a terminally ill 14-year-old to be cryopreserved after her death. The patient, JS, requested this, as she hoped one day to be reanimated and cured. Jackson J focused on the welfare (or best interests) of JS as she approached the end of her life and particularly on her (apparently) competent wish to be cryopreserved. I consider the interests involved in a decision to undergo cryonics, specifically exploring which interests and whose interests are engaged. Starting with autonomy interests, the judgment implicitly supported a relational account of autonomy, but was dominated by a subjective interpretation of autonomy, which prioritized JS's wishes. Questions nevertheless arise about whether the dying person is entitled to legislate for the reanimated person he or she might become. Temporal concerns also feature when we interpret welfare in terms of happiness, because the dying person and the (potential) future reanimated person might have different interests at different times. Finally, I widen the analysis to accommodate the interests of others, by exploring whether cryonics is in, or contrary to, the public interest. Utilizing different accounts of the public interest, I argue that the case for cryonics is not entirely made out. These observations on autonomy, happiness and the public interest combine to suggest that, although there may not be a decisive case for denying a wish like JS's, there is a case for caution, at least while we seek to clarify and resolve the different interests in issue.

Smart homes, private homes? An empirical study of technology researchers' perceptions of ethical issues in developing smart-home health technologies.

BACKGROUND: Smart-home technologies, comprising environmental sensors, wearables and video are attracting interest in home healthcare delivery. Development of such technology is usually justified on the basis of the technology's potential to increase the autonomy of people living with long-term conditions. Studies of the ethics of smart-homes raise concerns about privacy, consent, social isolation and equity of access. Few studies have investigated the ethical perspectives of smart-home engineers themselves. By exploring the views of engineering researchers in a large smart-home project, we sought to contribute to dialogue between ethics and the engineering community. METHODS: Either face-to-face or using Skype, we conducted in-depth qualitative interviews with 20 early- and mid-career smart-home researchers from a multi-centre smart-home project, who were asked to describe their own experience and to reflect more broadly about ethical considerations that relate to smart-home design. With participants' consent, interviews were audio-recorded, transcribed and analysed using a thematic approach. RESULTS: Two overarching themes emerged: in 'Privacy', researchers indicated that they paid close attention to negative consequences of potential unauthorised information sharing in their current work. However, when discussing broader issues in smart-home design beyond the confines of their immediate project, researchers considered physical privacy to a lesser extent, even though physical privacy may manifest in emotive concerns about being watched or monitored. In 'Choice', researchers indicated they often saw provision of choice to end-users as a solution to ethical dilemmas. While researchers indicated that choices of end-users may need to be restricted for technological reasons, ethical standpoints that restrict choice were usually assumed and embedded in design. CONCLUSIONS: The tractability of informational privacy may explain the greater attention that is paid to it. However, concerns about physical privacy may reduce acceptability of smart-home technologies to future end-users. While attention to choice suggests links with privacy, this may misidentify the sources of privacy and risk unjustly burdening end-users with problems that they cannot resolve. Separating considerations of choice and privacy may result in more satisfactory treatment of both. Finally, through our engagement with researchers as participants this study demonstrates the relevance of (bio)ethics as a critical partner to smart-home engineering.

Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

BACKGROUND: Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe 'core information sets' which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. MAIN BODY: The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this 'core information'. We propose that such information addresses the 'reasonable patient' standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. CONCLUSION: The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice.

Seeking Certainty? Judicial Approaches to the (Non-)Treatment of Minimally Conscious Patients.

A modest, but growing, body of case law is developing around the (non-)treatment of patients in the minimally conscious state. We sought to explore the approaches that the courts take to these decisions. Using the results of a qualitative analysis, we identify five key features of the rulings to date. First, the judges appear keen to frame the cases in such a way that these are rightly matters for judicial determination. Secondly, the judges appraise the types and forms of expertise that enter the courtroom, seeming to prefer the 'objective' and 'scientific', and particularly the views of the doctors. Thirdly, the judges appear alert to the reasonableness of the evidence (and, indeed, the parties) and will look favourably on parties who are willing to co-operate. But the judges will not simply endorse any consensus reached by the parties; rather, the judges will reach their own decisions. Those decisions must be taken in the best interests of the patient. Fourthly, the judges approach this assessment in different ways. A balancing exercise is not consistently undertaken and, even in those cases in which it is, the weight accorded to particular factors varies. As we discuss, the consistency and predictability of the law in this area is open to question. Finally, however, we cautiously suggest that some consistent messages do begin to emerge: the courts' apparent preference for certainty in diagnosis and prognosis provide pointers for how cases might be decided.

Core Outcomes for Colorectal Cancer Surgery: A Consensus Study.

BACKGROUND: Colorectal cancer (CRC) is a major cause of worldwide morbidity and mortality. Surgical treatment is common, and there is a great need to improve the delivery of such care. The gold standard for evaluating surgery is within well-designed randomized controlled trials (RCTs); however, the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting. A solution to these issues is to develop an agreed standard "core" set of outcomes to be measured in all trials to facilitate cross-study comparisons, meta-analysis, and minimize outcome reporting bias. This study defines a core outcome set for CRC surgery. METHODS AND FINDINGS: The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer. Excluded were nonsurgical oncological interventions. Potential outcomes of importance to patients and professionals were identified through systematic literature reviews and patient interviews. All outcomes were transcribed verbatim and categorized into domains by two independent researchers. This informed a questionnaire survey that asked stakeholders (patients and professionals) from United Kingdom CRC centers to rate the importance of each domain. Respondents were resurveyed following group feedback (Delphi methods). Outcomes rated as less important were discarded after each survey round according to predefined criteria, and remaining outcomes were considered at three consensus meetings; two involving international professionals and a separate one with patients. A modified nominal group technique was used to gain the final consensus. Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain questionnaire. First round questionnaires were returned from 63 out of 81 (78%) centers, including 90 professionals, and 97 out of 267 (35%) patients. Second round response rates were high for all stakeholders (>80%). Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys, respectively. Consensus meetings generated agreement on a 12 domain COS. This constituted five perioperative outcome domains (including anastomotic leak), four quality of life outcome domains (including fecal urgency and incontinence), and three oncological outcome domains (including long-term survival). CONCLUSION: This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials. It is now necessary to validate the use of this set in research practice.

When Opportunity Knocks Twice: Dual Living Kidney Donation, Autonomy and the Public Interest.

Living kidney transplantation offers the best treatment in terms of life-expectancy and quality of life for those with end-stage renal disease. The long-term risks of living donor nephrectomy, although real, are very small, with evidence of good medium-term outcomes. Who should be entitled to donate, and in which circumstances, is nevertheless a live question. We explore the ethical dimensions of a request by an individual to donate both of their kidneys during life: 'dual living kidney donation'. Our ethical analysis is tethered to a hypothetical case study in which a father asks to donate a kidney to each of his twin boys. We explore the autonomy of the protagonists, alongside different dimensions of the public interest, such as the need to protect not only the recipients, but also the donor and even the wider community. Whilst acknowledging objections to 'dual-donation', not least by reference to the harms that the donor might be expected to endure, we suggest there is a prima facie case for permitting this, provided that both donor and recipients are willing and that due attention is paid to such considerations as the autonomy and welfare of all parties, as well as to the wider ramifications of acting on such a request. We argue for broader interpretations of the concepts of autonomy and welfare, recognizing the importance of relationships and the relevance of more than merely physical well-being. Equipped with such a holistic assessment, we suggest there is a prima facie case for allowing 'dual living kidney donation'.

Dying well with reduced agency: a scoping review and thematic synthesis of the decision-making process in dementia, traumatic brain injury and frailty.

BACKGROUND: In most Anglophone nations, policy and law increasingly foster an autonomy-based model, raising issues for large numbers of people who fail to fit the paradigm, and indicating problems in translating practical and theoretical understandings of 'good death' to policy. Three exemplar populations are frail older people, people with dementia and people with severe traumatic brain injury. We hypothesise that these groups face some over-lapping challenges in securing good end-of-life care linked to their limited agency. To better understand these challenges, we conducted a scoping review and thematic synthesis. METHODS: To capture a range of literature, we followed established scoping review methods. We then used thematic synthesis to describe the broad themes emerging from this literature. RESULTS: Initial searches generated 22,375 references, and screening yielded 49, highly heterogeneous, studies that met inclusion criteria, encompassing 12 countries and a variety of settings. The thematic synthesis identified three themes: the first concerned the processes of end-of-life decision-making, highlighting the ambiguity of the dominant shared decision-making process, wherein decisions are determined by families or doctors, sometimes explicitly marginalising the antecedent decisions of patients. Despite this marginalisation, however, the patient does play a role both as a social presence and as an active agent, by whose actions the decisions of those with authority are influenced. The second theme examined the tension between predominant notions of a good death as 'natural' and the drive to medicalise death through the lens of the experiences and actions of those faced with the actuality of death. The final theme considered the concept of antecedent end-of-life decision-making (in all its forms), its influence on policy and decision-making, and some caveats that arise from the studies. CONCLUSIONS: Together these three themes indicate a number of directions for future research, which are likely to be applicable to other conditions that result in reduced agency. Above all, this review emphasises the need for new concepts and fresh approaches to end of life decision-making that address the needs of the growing population of frail older people, people with dementia and those with severe traumatic brain injury.