Position statement on ethics, equipoise and research on charged particle radiation therapy.

The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research.

Valuing hope.

This article argues that hope is of value in clinical ethics and that it can be important for clinicians to be sensitive to both the risks of false hope and the importance of retaining hope. However, this sensitivity requires an understanding of the complexity of hope and how it bears on different aspects of a well-functioning doctor-patient relationship. We discuss hopefulness and distinguish it, from three different kinds of hope, or 'hopes for', and then relate these distinctions back to differing accounts of autonomy. This analysis matters because it shows how an overly narrow view of the ethical obligations of a clinician to their patient, and autonomy, might lead to scenarios where patients regret the choices they make.

The ethics of attaching research conditions to access to new health technologies.

Decisions on which new health technologies to provide are controversial because of the scarcity of healthcare resources, the competing demands of payers, providers and patients and the uncertainty of the evidence base. Given this, additional information about new health technologies is often considered valuable. One response is to make access to a new health technology conditional on further research. Access can be restricted to patients who participate in a research study, such as a randomised controlled trial; alternatively, a new treatment can be made generally available, but only on condition that further evidence is collected (eg, on long-term outcomes and adverse events, in patient registries). The National Institute for Health and Clinical Excellence (NICE), which provides guidance on which new health technologies to make available under the UK's NHS, for example, has made some research conditional recommendations, and the current interest in such options suggests that they are likely to become more prevalent in the future. This paper identifies and discusses the main ethical issues created by this distinctive range of recommendations. We argue that decisions to put research conditions on access to new technologies are compatible with widely accepted values, principles and practices relevant to resource allocation. However, there are important features of these distinctive judgements that must be taken into account by resource allocation decision-making bodies and research ethics committees, and that require new sorts of empirical data.

Threats and offers in community mental healthcare.

Making threats and offers to patients is a strategy used in community mental healthcare to increase treatment adherence. In this paper, an ethical analysis of these types of proposal is presented. It is argued (1) that the primary ethical consideration is to identify the professional duties of care held by those working in community mental health because the nature of these duties will enable a threat to be differentiated from an offer, (2) that threatening to act in a way that would equate with a failure to uphold the requirements of these duties is wrong, irrespective of the benefit accrued through treatment adherence and (3) that making offers to patients raises a number of secondary ethical considerations that need to be judged on their own merit in the context of individual patient care. The paper concludes by considering the implications of these arguments, setting out a pathway designed to assist community mental healthcare practitioners to determine whether making a specific proposal to a patient is right or wrong.

Physicians' duties and the non-identity problem.

The non-identity problem arises when an intervention or behavior changes the identity of those affected. Delaying pregnancy is an example of such a behavior. The problem is whether and in what ways such changes in identity affect moral considerations. While a great deal has been written about the non-identity problem, relatively little has been written about the implications for physicians and how they should understand their duties. We argue that the non-identity problem can make a crucial moral difference in some circumstances, and that it has some interesting implications for when it is or is not right for a physician to refuse to accede to a patient's request. If a physician is asked to provide an intervention (identity preserving) that makes a person worse off, then such harm provides a good reason for the physician to refuse to provide the intervention. However, in cases where different (identity-altering) interventions result in different people having a better or worse life, physicians should normally respect patient choice.

Intensive care triage: priority should be independent of whether patients are already receiving intensive care.

Intensive care units (ICUs) are not always able to admit all patients who would benefit from intensive care. Pressure on ICU beds is likely to be particularly high during times of epidemics such as might arise in the case of swine influenza. In making choices as to which patients to admit, the key US guidelines state that significant priority should be given to the interests of patients who are already in the ICU over the interests of patients who would benefit from intensive care but who have not been admitted. We examine four reasons that in principle might justify such a prioritization rule and conclude that none is convincing. We argue that the current location of patients should not, in principle, affect their priority for intensive care. We show, however, that under some but not all circumstances, maximizing lives saved by intensive care might require continuing to treat in the ICU a patient already admitted rather than transferring that patient out of the unit in order to admit a sicker patient who would also benefit more from intensive care. We conclude that further modelling is required in order to clarify what practical policies would maximize lives saved by intensive care.

Anorexia nervosa and the language of authenticity.

People with anorexia nervosa struggle with questions of authenticity. They thought about whether they were being their authentic selves, and which of their desires, emotions, and choices were authentic. More attention should be paid this important concept and its role and status--both how patients think about it, and how clinicians should think about it.

An inquiry into the principles of needs-based allocation of health care.

The concept of need is often proposed as providing an additional or alternative criterion to cost-effectiveness in making allocation decisions in health care. If it is to be of practical value it must be sufficiently precisely characterized to be useful to decision makers. This will require both an account of how degree of need for an intervention is to be determined and a prioritization rule that clarifies how degree of need and the cost of the intervention interact in determining the relative priority of the intervention. Three common features of health care interventions must be accommodated in a comprehensive theory of need: the probabilistic nature of prognosis (with and without the intervention); the time course of effects; and the fact that the most effective treatments often combine more than one intervention. These common features are problematic for the concept of need. We outline various approaches to prioritization on the basis of need and argue that some approaches are more promising than others.

Ethical dilemmas in the care of people with dementia.

Following a two-year inquiry, the Nuffield Council on Bioethics published a report in October 2009 on the ethical dilemmas raised by dementia. Community nurses play an important role in supporting carers of people with dementia, but face ethical dilemmas of their own, for example, balancing the needs of the person with dementia and those of the carers, and deciding when to share confidential information with others. The report sets out an ethical approach to care, as well as recommendations on specific ethical dilemmas. A key conclusion is that all professionals involved in the care of people with dementia should have access to ongoing education and support to equip them to respond appropriately to ethical questions that arise.

Health care need: three interpretations.

The argument that scarce health care resources should be distributed so that patients in 'need' are given priority for treatment is rarely contested. In this paper, we argue that if need is to play a significant role in distributive decisions it is crucial that what is meant by need can be precisely articulated. Following a discussion of the general features of health care need, we propose three principal interpretations of need, each of which focuses on separate intuitions. Although this account may not be a completely exhaustive reflection of what people mean when they refer to need, the three interpretations provide a starting-point for further debate of what the concept means in its specific application. We discuss combined interpretations, the meaning of grading needs, and compare needs-based priority setting to social welfare maximisation.

Helping patients to reach decisions regarding their treatment: Do 'non-directive' approaches cause systematic bias?

OBJECTIVES: Many patients want help in considering medical information relevant to treatment decisions they have to make or agree to. The present research investigated whether focussing on particular issues relevant to a medical treatment decision (using an apparently non-directive procedure) could systematically bias a treatment decision. DESIGN AND METHODS: In a randomized design, participants (community volunteers, n = 146) were given standard information about treatment of cardiac risk factors by medication (statins). There were four experimental interventions in which the participants focussed on the likely personal relevance of subsets of the information previously given (positive, negative, or mixed aspects) or on irrelevant information. Participants were asked to rate their anticipated likelihood of accepting treatment before and after the experimental intervention. RESULTS: The rating of acceptance of treatment was significantly increased by positive focussing; negative focussing did not significantly alter the decision rating. CONCLUSIONS: The results partially replicate similar studies in health screening decisions. Reasons for the differences in results from those obtained in screening studies are considered. It is suggested that negative focussing may have less effect in decisions in which there are few risks. Statement of contribution What is already known on this subject? Decision-making in the context of health behaviour change has been widely described, but there are few experimental studies testing hypothesised strategies. 'Non-directiveness' is often regarded as desirable because it supposedly allows exploration of the decision without influencing it. Previous studies on health screening (but not treatment) have shown that health decision outcomes can be systematically influenced by the way in which a 'non-directive' intervention is implemented. This can be accounted for by a modified subjective expected utility theory previously applied to both health screening and child vaccination decisions. What does this study add? The hypothetical decision about whether or not, in future, to take statins for elevated cholesterol levels was influenced by positive but not by negative focussing. Results were consistent with the theoretical framework. This study extends previous work on influences on the decision to undertake health screening and vaccination to treatment offered as secondary prevention. 'Non-directive' approaches to helping facilitate decisions can modify those decisions, and as such cannot be regarded as non-directive.