Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of (...) agreement among English-speaking patients at primary care clinics in Washington State and Idaho who had a personal or family history of cancer. In Round 1, respondents rated the importance of 17 items, identified in prior qualitative work, for feeling respected. In Round 2, respondents re-rated each item after reviewing overall group ratings. In Round 3, respondents ranked a subset of the 8 most highly rated items. We calculated each item’s mean and median rankings in Round 3 to identify which approaches were most important for feeling respected in research. Results Forty-one patients consented to the survey, 21 (51%) completed Round 1, and 18 (86% of Round 1) completed each of Rounds 2 and 3. Two sets of rankings were excluded from analysis as speed of response suggested they had not completed the Round 3 ranking task. Respondents prioritized provision of study information to support decision-making (mean ranking 2.6 out of 8; median ranking 1.5) and interactions with research staff characterized by kindness, patience, and a lack of judgment (mean ranking 2.8; median ranking 2) as the most important approaches for conveying respect. Conclusions Informed consent and interpersonal interactions are key ways that research participants experience respect. These can be supported by other approaches to respecting participants, especially when consent and/or direct interactions are infeasible. Future work should continue to engage with patients in community-based settings to identify best practices for research without consent and examine unique perspectives across clinical and demographic groups in different types of research. (shrink)

Background: Theoretically, the principle of justice is strong in healthcare priorities both nationally and internationally. Research, however, has indicated that questions can be raised as to how this principle is dealt with in clinical intensive care. Objective: The objective of this article is to examine how significant others may affect the principle of justice in the medical treatment and nursing care of intensive care patients. Method: Field observations and in-depth interviews with physicians and nurses in intensive care units (ICU). Emphasis (...) was placed on eliciting the underlying rationale for prioritisations in clinical intensive care with particular focus on clinicians’ considerations when limiting ICU treatment. Results: Significant others could induce an unintentional discrimination of ICU patients. Family members who were demanding received more time and attention for both the patient and themselves. Patients’ and families’ status and position and/or an interesting medical diagnosis seemed to govern the clinicians’ priorities of patients and families—consciously as well as unconsciously. The clinicians emphasised that patient information given through families was important. However, patients’ preferences and values conveyed to clinicians through their families were not always taken seriously. This even applied in cases with very serious prognoses and an explicit patient wish to forego life-prolonging treatment. Conclusion: The principle of justice was violated when qualified attention was given to significant others, and through this also to patients. Attention given to significant others was influenced by the healthcare workers’ professional and personal values, attitudes and interests. (shrink)

Many academic medical centers are seeking to attract patients from outside their historical catchment areas for economic and programmatic reasons, and patients are traveling for treatment that is unavailable, of poorer quality, or more expensive at home. Treatment of these patients raises a number of ethical issues including whether they may be given priority in scheduling outpatient follow-up appointments in order to reduce the period of time they are away from home. Granting them priority is potentially unjust because (...) medical treatment is generally allocated based on medical need and resource utilization, and then on a first-come, first-served basis. While it is difficult to compare the opportunity cost of waiting for an appointment to different patients, nonresident patients incur higher expenditures for travel, room, and board than resident patients. Giving them priority in scheduling to reduce these costs may be justifiable. Preferentially scheduling nonresident patients may also indirectly benefit resident patients consistent with Rawls’s difference principle. This potential justification, however, rests on several empirical claims that should be demonstrated. In addition to reducing resident patients’ waiting times, medical centers should not prioritize nonresident patients over resident patients with more urgent medical needs. There is, therefore, a limited and circumscribed justification for prioritizing nonresident patients in scheduling follow-up appointments. (shrink)

There is a growing body of literature which suggests that decisions about healthcare priority setting should take into account the extent to which patients are worse off. However, such decisions are often based on how badly off patients are with respect to the condition targeted by the treatment whose priority is under consideration (condition‐specific severity). In this paper I argue that giving priority to the worse off in terms of condition‐specific severity does not reflect the morally relevant (...) sense of being worse off. I conclude that an account of giving priority to the worse off relevant for healthcare priority setting should take into account how badly off patients are when all of their conditions are considered (holistic severity). (shrink)

The distribution of scarce healthcare resources is an increasingly important issue due to factors such as expensive ‘high tech’ medicine, longer life expectancies and the rising prevalence of chronic illness. Furthermore, in the current healthcare context lifestyle-related factors such as high blood pressure, tobacco use and obesity are believed to contribute significantly to the global burden of disease. As such, this paper focuses on an ongoing debate in the academic literature regarding the role of responsibility for illness in healthcare resource (...) allocation: should patients with self-caused illness receive lower priority in access to healthcare resources? This paper critically describes the lower priority debate's 12 key arguments and maps out their relationships. This analysis reveals that most arguments have been refuted and that the debate has stalled and remains unresolved. In conclusion, we suggest progression could be achieved by inviting multidisciplinary input from a range of stakeholders for the development of evidence-based critical evaluations of existing arguments and the development of novel arguments, including the outstanding rebuttals. (shrink)

With healthcare systems under pressure from scarcity of resources and ever‐increasing demand for services, difficult priority setting choices need to be made. At the same time, increased attention to patient involvement in a wide range of settings has given rise to the idea that those who are eventually affected by priority setting decisions should have a say in those decisions. In this paper, we investigate arguments for the inclusion of patient representatives in priority setting bodies (...) at the policy level. We find that the standard justifications for patient representation, such as to achieve patient‐relevant decisions, empowerment of patients, securing legitimacy of decisions, and the analogy with democracy, all fall short of supporting patient representation in this context. We conclude by briefly outlining an alternative proposal for patient participation that involves patient consultants. (shrink)

The study examined the question of who should make decisions for a National Health Scheme about the allocation of health resources when the health states of beneficiaries could change because of adaptation. Eight semi-structured small group discussions were conducted. Following focus group theory, interviews commenced with general questions followed by transition questions and ended with a ‘focus’ or ‘key’ question. Participants were presented with several scenarios in which patients adapted to their health states. They were then asked their views about (...) the appropriate role of the public, patients and health professionals in making social judgements of quality of life. After discussion and debate, all groups were asked the key question: ‘In light of adaptation, who should evaluate quality of life for the purpose of setting priorities in the allocation of health care?’ In all groups participants presented strong arguments for and against decision making by patients, the public and health professionals. However, most groups thought a representative body which included a range of perspectives should make the relevant judgements. This is at odds with the recommendations in most national pharmaceutical guidelines. The main conclusion of the paper is that health economists and other researchers should explore the possibility of adopting a deliberative, consensus-based approach to evaluating health-related quality of life when such judgements are to be used to inform priority setting in a public system. (shrink)

Intensive care units 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. (shrink)

It is well documented that the higher the socioeconomic status (SES) of patients, the better their health and life expectancy. SES also influences the use of health services—the higher the patients' SES, the more time and specialised health services provided. This leads to the following question: should clinicians give priority to individual patients with low SES in order to enhance health equity? Some argue that equity is best preserved by physicians who remain loyal to ‘ordinary medical fairness’ in non-ideal (...) circumstances when health disparities persist; ie, doctors should allocate care according to needs only and treat everyone with equal regard by being neutral with respect to patients' SES. This paper furthers a discussion of this view by questioning how equitable needs relate to SES. To clarify, it distinguishes between four versions of ‘healthcare need’ and approaches an acceptable conceptualisation of the notion supported by Norman Daniels' theory on health equity. It concludes that doctors should remain neutral to patients' SES in cases in which several patients require the same health care. However, equitable health care requires considerations of the impact of socioeconomic factors (SEF) on patients' capacity to benefit from the care. Remaining neutral towards patients' SES in this respect does not promote equal regard. It follows that priority setting on the basis of SEF is required in fair clinical distribution of care, eg, through allocating more time to patients with low SES. In order to advance equity accurately, the concept of ordinary medical fairness should be amplified according to this clarification. (shrink)

This article provides a systematic analysis of the proposal to use Covid‐19 vaccination status as a criterion for admission of patients with Covid‐19 to intensive care units (ICUs) under conditions of resource scarcity. The general consensus is that it is inappropriate to use vaccination status as a criterion because doing so would be unjust; many health systems, including the UK National Health Service, are based on the principle of equality of access to care. However, the analysis reveals that there are (...) several unique features of Covid vaccination status in the context of a pandemic that make this issue disanalogous to cases (such as lung cancer caused by smoking) discussed previously. First, there is equality in access to care at the point of vaccination; the unvaccinated refuse the offer of preventive care when they decline vaccination, weakening their claim to ongoing care if they become ill (this is qualitatively different from ‘poor lifestyle choices’ such as smoking). Second, the decision of one person to refuse vaccination substantially increases the risk that they will become seriously ill and need ICU care; the person who chooses not to get vaccinated thus potentially increases the pressure on intensive care bed provision, as well as increasing the risk that he or she will infect others who in turn might end up needing ICU care. Third, justice cuts both ways, and giving unvaccinated patients equal priority may itself be unjust when other patients have reduced their risk of ending up on the ICU by getting vaccinated. (shrink)

Health care systems across the world are unable to afford the best treatment for all patients in all situations. Choices have to be made. One key ethical issue that arises for health authorities is whether the principle of the “rule of rescue” should be adopted or rejected. According to this principle more funding should be available in order to save lives of identifiable, compared with unidentifiable, individuals. Six reasons for giving such priority to identifiable individuals are considered. All are (...) rejected. It is concluded that the principle of the rule of rescue should not be used in determining the allocation of health resources. (shrink)

Growing data on the socioeconomic determinants of health pose a challenge to analysis and application of fairness in health. In Just health: meeting health needs fairly, Norman Daniels argues for a change in the population end of our thinking about just health. What about clinical care? Given our knowledge of the importance of wealth, education or social status to health, is fairness in medicine served better by continuing to avoid considering our patients’ social status in setting clinical priorities, or by (...) attempting to equalise existing health inequalities by giving priority to the socioeconomically disadvantaged at the point of care? In this article, I argue that doctors should not attempt the latter. Granted, giving priority to low status would go some way towards compensating unjust health inequalities and the impression of being left aside in other social spaces. It would represent reverse discrimination, but could still be justified inasmuch as disadvantaged groups could be identifiable, and as long as the intent was compensation rather than retribution. However, under current circumstances such priority would risk being attributed arbitrarily, would represent a form of medical proselytising, risk leaving the worst-off with less by alienating the powerful, and require teaching doctors to act in strongly counter-cultural ways—possibly at great cost. Crucially, however, we protect both equal health and equal regard by treating all alike: priority to low status would promote the first somewhat, but at the expense of sacrificing the second. (shrink)

Some philosophers and segments of the public think age is relevant to healthcare priority-setting. One argument for this is based in equity: “Old” patients have had either more of a relevant good than “young” patients or enough of that good and so have weaker claims to treatment. This article first notes that some discussions of age-based priority that focus in this way on old and young patients exhibit an ambiguity between two claims: that patients classified as old should (...) have a low priority, and that patients classified as young should have high priority. The author next argues, drawing on a problem raised by Christine Overall, that equity cannot justify giving “old” patients low priority, since there is wide variety in the total lifetime experiences of older people, partly influenced by gender, race, class, and disability injustice. Finally, the author suggests that there might be a limited role for age-based prioritization in the context of infant and childhood death, since those who die in childhood are always and uncontroversially among the worst-off. (shrink)

There has been much discussion about how to obtain legitimacy at macro-level priority setting in health care by use of fair procedures, but how should we consider priority setting by individual clinicians or health workers at the micro-level? Despite the fact that just health care totally hinges upon their decisions, surprisingly little attention seems being paid to the legitimacy of these decisions. This paper addresses the following question: what are the conditions that have to be met in order (...) to ensure that individual claims on health care are well aligned with an overall concept of just health care? Drawing upon a distinction between individual and aggregated needs, I argue that even though we assume the legitimacy of macro-level guidelines, this legitimacy is not directly transferable to decisions at micro-level simply by adherence to the guidelines’ recommendation. Further, I argue that individual claims are subject to the formal principle of equality and the demands of vertical and horizontal equity in a way that gives context- and patient-related equity concerns precedence over equity concerns captured at the macro-level. I conclude that if we aim to achieve just health care, we need to develop a complementary framework for legitimising individual judgment of patients’ claims on health care resources. Moreover, I suggest the basic structure of such a framework. (shrink)

Medical decision making often utilizes subjective observations to arrive at concrete judgments. The decisions frequently affect who receives scarce medical treatments and, thus, who lives or dies. In this paper, a model health status index is described. It is specific for the problem of choosing patients for hemodialysis or transplantation. Such a health status index may be designed for any medical decision involving such issues as drug treatment priorities, identification of salvageable patients, and selection of patients for scarce medical treatment. (...) This index (1) incorporates a physician''s own medical criteria and values, (2) can be modified as the data base improves, (3) assures consistency from decision to decision, and (4) can be developed and used without the help of a mathematician or computer. (shrink)

Background:The global COVID-19 pandemic has imposed challenges on healthcare systems and professionals worldwide and introduced a ´maelstrom´ of ethical dilemmas. How ethically demanding situations are handled affects employees’ moral stress and job satisfaction.Aim:Describe priority-setting dilemmas, moral distress and support experienced by nurses and physicians across medical specialties in the early phase of the COVID-19 pandemic in Western Norway.Research design:A cross-sectional hospital-based survey was conducted from 23 April to 11 May 2020.Ethical considerations:Ethical approval granted by the Regional Research Ethics Committee (...) in Western Norway (131421).Findings:Among the 1606 respondents, 67% had experienced priority-setting dilemmas the previous two weeks. Healthcare workers who were directly involved in COVID-19 care, were redeployed or worked in psychiatry/addiction medicine experienced it more often. Although 59% of the respondents had seen adverse consequences due to resource scarcity, severe consequences were rare. Moral distress levels were generally low (2.9 on a 0–10 scale), but higher in selected groups (redeployed, managers and working in psychiatry/addiction medicine). Backing from existing collegial and managerial structures and routines, such as discussions with colleagues and receiving updates and information from managers that listened and acted upon feedback, were found more helpful than external support mechanisms. Priority-setting guidelines were also helpful.Discussion:By including all medical specialties, nurses and physicians, and various institutions, the study provides information on how the COVID-19 mitigation also influenced those not directly involved in the COVID-19 treatment of patients. In the next stages of the pandemic response, support for healthcare professionals directly involved in outbreak-affected patients, those redeployed or those most impacted by mitigation strategies must be a priority.Conclusion:Empirical research of healthcare workers experiences under a pandemic are important to identify groups at risks and useful support mechanisms. (shrink)

Background:Since the adoption of the Universal Declaration of Human Rights by the United Nations in 1948, human rights as set out in government documents have gradually changed, with more and more power being transferred to individual.Objectives:The aim of this article is to analyze how the position of the patient in need of care is constructed in Norway’s renamed and revised Patients’ and Service Users’ Rights Act (originally Patients’ Rights Act, 1999) and published comments which accompanying this legislation from the (...) Norwegian Ministry of Health and Care Service.Research design:A constructivist design was used, and Fairclough’s critical discourse approach was adopted to analyze the text of the Patients’ and Service Users’ Rights Act and comments.Findings:The analysis identified three discourses: (a) political discourse, containing ethical discourses about priority and economy, in which patients are constructed as powerless individuals; (b) expert discourse, containing a theme about patients’ trust in the healthcare team and its knowledge, in which patients are constructed as helpless individuals lacking knowledge; and (c) patient participation and patient autonomy discourse, containing ethical discourses about decision-making, in which patients are constructed not only as individuals with needs and rights but also as “troublesome.”Conclusion:Dominant paternalistic discourses in the legal text validate the power of medicine, the healthcare system, and heath personnel over the needs, rights, participation, and autonomy of the patient. (shrink)

The purpose of this paper is to consider the role that values play in priority setting through the use of EBP. It is important to be clear about the role of values at all levels of the decision making process. At one level, society as a whole has to make decisions about the kind of health provision that it wants. As is generally accepted, these priority setting questions cannot be answered by medical science alone but involve important judgements (...) of value. However, as I hope to show values come into priority setting questions at another level, one not often explicitly recognised in much of the literature: that of the very definition of the effectiveness of treatments. This has important consequences for patient care. If we do not recognise that the effectiveness of a treatment involve subjective elements — a patient's own assessment of the value of the treatment — then this could lead to the belief that we can purchase one treatment that is the most effective for all patients. This might result in a detrimental reduction in the range of options that a patient is given with some patients not receiving the treatment that is most effective for them. (shrink)

Case studies raise questions about patients' rights, advanced lifeprolonging measures, human subjects in medical research, and the allocation of health care resources.

Rationale, aims and objectives Given the increasing prevalence of cataract and demand for cataract extraction surgery, patients must often wait to undergo this procedure. We validated a previously developed priority scoring system in terms of clinical variables, pre-intervention health status, appropriateness of surgery and gain in visual acuity (VA) and health-related quality of life (HRQoL).Methods Explicit prioritization criteria for cataract extraction created by a variation of the Research and Development (RAND) and University of California Los Angeles appropriateness methodology were (...) retrospectively applied to a prospective cohort of 5257 patients on waiting lists to undergo cataract by phacoemulsification at 17 hospitals in Spain. Demographic data, clinical data and data related to surgical technique were collected by trained ophthalmologists. Patients were evaluated by their ophthalmologist before the intervention and 6 weeks afterward. They also completed, by mail, the Visual Function Index (VF-14) before the intervention and 3 months afterward.Results High-priority patients experienced greater improvement in VA and HRQoL than those classified as intermediate or low-priority (P < 0.0001), even after adjusting by VA and the VF-14 score at baseline. The time to intervention was the same for high-priority patients as it was for intermediate and low-priority patients.Conclusions The priority score we developed identified patients most likely to experience the greatest improvements from cataract extraction. Use of this tool could provide a fairer and more rational way to prioritize patients for cataract extraction. (shrink)

BackgroundThe idea that individuals are responsible for their health has been the focus of debate in the theoretical literature and in its concrete application to healthcare policy in many countries. Controversies persist regarding the form, substance and fairness of allocating health responsibility to the individual, particularly in universal, need-based healthcare systems.ObjectiveTo examine how personal health responsibility has been framed and rationalised in Norwegian key policy documents on priority setting.MethodsDocuments issued or published by the Ministry of Health and Care Services (...) between 1987 and 2018 were thematically analysed. We developed a predefined conceptual framework that guided the analysis. The framework included: the subject and object of responsibility, the level of conceptual abstraction, temporality, normative justificatory arguments and objections to the application of personal health responsibility.ResultsAs an additional criterion, personal health responsibility has been interpreted as relevant if: the patient’s harmful behaviour is repeated after receiving treatment, and if the success of the treatment is conditional on the patient’s behavioural change. When discussed as a retrospective criterion, considerations of reciprocal fairness have been dominant. When discussed as a prospective criterion, the expected benefit of treatment justified its relevance.ConclusionPersonal health responsibility appears to challenge core values of equality, inclusion and solidarity in the Norwegian context and has been repeatedly rejected as a necessary criterion for priority setting. However, the responsibility criterion seems to have some relevance in particular priority setting decisions. (shrink)

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA’s provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions. First, I argue that the ACA (...) is neither uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality. Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the health care system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy). Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry. (shrink)

Aim: This study explores priority dilemmas in dialysis treatment and care offered elderly patients within the Norwegian public healthcare system.Background: Inadequate healthcare due to advanced age is frequently reported in Norway. The Norwegian guidelines for healthcare priorities state that age alone is not a relevant criterion. However, chronological age, if it affects the risk or effect of medical treatment, can be a legitimate criterion.Method: A qualitative approach is used. Data were collected through semistructured interviews and analysed through hermeneutical content (...) analysis. The informants were five physicians and four nurses from dialysis wards.Findings: Pressing priority dilemmas centre around decision-making concerning withholding and withdrawal of dialysis treatment. Advanced age is rarely an absolute or sole priority criterion. It seems, however, that advanced age appears to be a more subtle criterion in relation with, for example, comorbidity, functional status and cognitive impairment. Nurses primarily prioritise specialised dialysis care and not comprehensive nursing care. The complex needs of elderly patients are therefore often not always met.Conclusions: Clinical priorities should be made more transparent in order to secure legitimate and fair resource allocation in dialysis treatment and care. Difficult decisions concerning withholding or withdrawal of dialysis ought to be openly discussed within the healthcare team as well as with patients and significant others. The biomedical focus and limitations on comprehensive care during dialysis should be debated. (shrink)

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws (...) of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

The authors report and comment on student reactions to a clinical example of moral choice in the microallocation of scarce resources. Four patients require dialysis simultaneously, but only one kidney machine is available. What moral, as opposed to clinical, criteria are available to determine who should have priority?

Next SectionBackground International and national agencies play a major role in setting HIV care-and-treatment priorities in low-income-countries. Little is known about priority setting at lower health-system levels. The objective of this article is to explore experiences of HIV priority decisions, at what levels these decisions are made and how they might influence the distribution of health benefits in a high-endemic region in Tanzania. Methods This is a qualitative study using observations, key documents and semistructured focus-group and individual interviews (...) (43) with health workers, patients and administrators at one regional and one district hospital. The analysis was based on an editing analysis style. Results Health workers did not perceive themselves as bedside rationing agents and they reported following national recommendations and felt they have little impact on important priority decisions. Health benefit distributions were largely determined by priority decisions made at a national level. External factors, such as eligibility criteria, inadequate funding and barriers to access seemed to play a major role in the actual distribution of health services and benefits in the region. Patient groups who were actually given high priority were the sickest patients, those living near a facility and those who could afford long journeys and frequent visits. Low-priority groups were those experiencing other co-morbidities or treatment failure, children, asymptomatic patients and the poorest. Conclusions/significance The interaction of priority setting across health-system levels and their impact on distribution of health outcomes in the population has been underestimated. The distributional pattern of health outcomes calls for further normative assessment. (shrink)

Individuals care about and guard their privacy intensely in many areas. With respect to patient medical records, people are exceedingly concerned about privacy protection, because they recognize that health care generates the most sensitive sorts of personal information. In an age of advancing technology, with the switch from paper medical files to massive computer databases, privacy protection for medical information poses a dramatic challenge. Given high-speed computers and Internet capabilities, as well as other advanced communications technologies, the potential for (...) abuse is much greater than ever before. At every stage in the process of collection and storage, dangers can arise, including entry errors, improper access, exploitation, and unauthorized disclosure. Secondary use and aggregation of data are all far easier, faster, and less expensive, and thus pose additional threats to an individual's control over the disposition of medical information. (shrink)

The Israeli health care system is looked upon by some people as one of the most advanced health care systems in the world in terms of access, quality, costs and coverage. The Israel health care system has four key components: (1) universal coverage; (2) ‘cradle to grave’ coverage; (3) coverage of both basic services and catastrophic care; and (4) coverage of medications. Patients pay a (relatively) small copayment to see specialists and to purchase medication; and, primary care is free. However, (...) during 2011 the Israeli Medical Association (IMA) spent 5 months on a strike, justifying it as trying to ‘save’ the Israeli public health. This paper describes some aspects of the Israeli Health Care System, the criteria for setting priorities for the expenditures on health care and values underlying these criteria. The paper observes that the new agreement between the IMA and the government has given timely priority to problematic areas of specialization (in which there is an acute shortage of physicians) and to hospitals in the periphery of the country. Yet weak points in the health system in Israel remain. Particularly, the extent to which national health care expenditures are being financed privately—which is rising—and the parallel decline in the role of government financing. (shrink)

BackgroundNusinersen is one of an increasing number of new, expensive orphan drugs to receive authorization. These drugs strain public healthcare budgets and challenge principles for resource allocation. Nusinersen was introduced in the Norwegian public healthcare system in 2018. A national expert group consisting of physicians was formed to oversee the introduction and continuation of treatment in light of specific start and stop criteria.MethodsWe have studied experiences within the expert group with a special emphasis on their application of the start and (...) stop criteria, rationing of treatment, and experienced moral dilemmas. A research interview with six members of the national expert group was performed, then analysed with manifest content analysis. The analysis was supplemented with publically available sources on priority setting and the process leading up to the introduction of nusinersen and the establishment of the expert group.ResultsSixty-six patients have received treatment within the first 25 months since the national expert group’s establishment. Treatment has not been discontinued for any patient. No patients under 18 years of age have been denied treatment, as those who were referred at this age were all deemed to fulfill the start criteria. The expert group has, however, increased geographical treatment equity and facilitated important cooperation at the national level. Furthermore, it has enhanced open and critical discussions of both medical issues and new ethical dilemmas.ConclusionAlthough facilitating equal access to treatment for SMA patients, the national expert group has not discontinued treatment for any patient. It is suggested that in order for clinicians to be able to ration care for individual patients, they require both adequate support and sufficient formal authority. Start and stop criteria need to be re-evaluated as more knowledge and experience are gained regarding the treatment. (shrink)

As one of the most compelling technologies for imaging the brain, functional MRI (fMRI) produces measurements and persuasive pictures of research subjects making cognitive judgments and even reasoning through difficult moral decisions. Even after centuries of studying the link between brain and behavior, this capability presents a number of novel significant questions. For example, what are the implications of biologizing human experience? How might neuroimaging disrupt the mysteries of human nature, spirituality, and personal identity? Rather than waiting for an ethical (...) agenda to emerge from some unpredictable combination of the concerns of ethicists and researchers, the attention of journalists, or after controversy is sparked by research that cannot be retracted, we queried key figures in bioethics and the humanities, neuroscience, media, industry, and patient advocacy in focus groups and interviews. We identified specific ethical, legal and social issues (ELSI) that highlight researcher obligations and the nonclinical impact of the technology at this new frontier. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how (...) should they be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)

In their essay, ‘When Clinical Trials Compete: Prioritizing Study Recruitment’, Gelinas et al describe a collective action problem that can arise if multiple trials at a single institution are all trying to recruit participants from the same patient population. Each trial may be addressing an important question, and each will need a certain number of participants to provide an informative answer. But because these trials are all recruiting from the same population, it is possible that there will not be (...) enough participants to go around. It may turn out, then, that none successfully achieves its target sample size and all end up being uninformative or less informative than hoped. As Gelinas et al observe, these kinds of uninformative or less-informative trials are ethically problematic, since they fail to fully redeem participant risks and burdens with adequate gains in generalisable knowledge. Such trials also represent wasteful or inefficient research activities, since each necessarily has a human and material cost, but then fails to offset these costs by providing a definitive answer to the research …. (shrink)

Research documents that many chronic non-malignant pain patients experience existential, spiritual and religious needs; however, research knowledge is missing on if and how physicians approach these needs. We conducted a systematic review to explore the extent to which physicians address these needs in their communication with chronic non-malignant pain patients and to explore the facilitators and challenges of this communication. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, searching Embase, Medline, Scopus and PsycINFO. The quality of (...) the included articles was assessed based on design-specific screening tools. We included four of 2337 screened articles and found the quality to be good. Physicians’ communication about existential, spiritual and religious needs was given low priority and depended on the patients’ own initiative, except when clinicians were interested in holistic care. Patient dissatisfaction with the physician’s attention to these needs was related to higher pain and depression. Physicians’ challenges for addressing these needs were their tendency to prioritize physiological aspects and close further elaboration of existential needs when addressed by the patients. The main facilitator was the individual physician’s willingness to listen with openness and empathy to the patients’ existential concerns. A tentative conclusion is that physicians rarely meet the existential, spiritual and religious needs of their chronic non-malignant pain patients. This might be due to higher priority of physical aspects, lack of time and a lack of knowledge about the importance of and training in the ability to address these needs. Further research is needed on physicians’ communication about existential, spiritual and religious needs and on their training in here. (shrink)

In medical practice, the doctrine of informed consent is generally understood to have priority over the medical practitioner’s duty of care to her patient. A common consequentialist argument for the prioritisation of informed consent above the duty of care involves the claim that respect for a patient’s free choice is the best way of protecting that patient’s best interests; since the patient has a special expertise over her values and preferences regarding non-medical goods she is (...) ideally placed to make a decision that will protect her interests. In this paper I argue against two consequentialist justifications for a blanket prioritisation of informed consent over the duty of care by considering cases in which patients have imperfect access to their overall best interests. Furthermore, I argue that there are cases where the mere presentation of choice under the doctrine of informed consent is detrimental to patient best interests. I end the paper by considering more nuanced approaches to resolving the conflict between informed consent and the duty of care and consider the option of permitting patients to waive informed consent. (shrink)

Background There is broad international agreement from clinicians and academics that healthcare rationing should be undertaken as explicitly as possible, and the BMA have publicly supported the call for more accountable priority setting for some time. However, studies in the UK and elsewhere suggest that clinicians experience a number of barriers to rationing openly, and the information needs of patients at the point of provision are largely unknown. Methodology In-depth interviews were undertaken with NHS professionals working at the community (...) level of provision, and with patients and professionals receiving or providing treatment for morbid obesity and breast cancer (n=52). Results Nearly all patients wanted to know about healthcare rationing and had high expectations of their clinical professionals to provide all relevant information about treatment options. However, professionals did not always understand these information requirements, and cases of implicit rationing were common. The existence of relevant national guidance was not always known about, meaning that patients were often reliant on other sources of information about treatment options, which included the popular media, the internet, patient advocacy groups and informal networks of support. Discussion Clinical professionals need to understand patients' need for detailed information when it comes to rationing, and to understand that they are the main gateway for this to be provided. However, disclosure could be distressing for both patients and professionals, and thus the most sensitive and acceptable ways to make this information available requires further investigation. (shrink)

This article examines the consequences of the politicization of health care in the United Kingdom following the creation of the National Health Service (NHS) in 1948. The NHS is founded on the principle of universal access to health care free at the point of use but in reality charges exist for some services and other services are rationed. Not to charge and/or ration would create a common-pool resource with no means of conserving scarce resources. Taking rationing decisions in the political (...) realm means that the values and priorities of individual patients are marginalized and the preferences of powerful organized groups able to capture the political process dominate. The key lesson for international health care reform is that the politicization of health care via the NHS has not led to the realization of egalitarian ends but rather has empowered vested and organized interests at the expense of individual patients. (shrink)

The way Cambodian patients and health professionals judge the priority of HIV-infected patients in relation to the allocation of antiretroviral drugs was examined. Participants were either HIV-infected patients attending the HIV/AIDS Care and Support Centre for People Living with HIV/AIDS in Phnom Penh (29 females and 21 males) or members of the staff (9 physicians, 6 pharmacists and 15 health counsellors and health educators). They were presented with stories of a few lines depicting a patient's situation and were (...) instructed to judge the extent to which the patient should be given priority for HIV drugs. The stories were composed according to a four within-subject factor design: (a) the patient's family responsibilities, (b) the severity of infection, (c) the time elapsed since the first consultation, and (d) the financial difficulties of the family. Most patients expressed the view that the drugs should be used for the patients who are most important from a familial point of view, namely, when the family contains small children and/or is already in a precarious financial condition. (shrink)

We have studied ethical considerations of care among health professionals when treating and setting priorities for elderly patients in Norway. The views of medical doctors and nurses were analysed using qualitative methods. We conducted 21 in depth interviews and 3 focus group interviews in hospitals and general practices. Both doctors and nurses said they treated elderly patients different from younger patients, and often they were given lower priorities. Too little or too much treatment, in the sense of too many interventions (...) and too much drugs, combined with too little care and comfort, was admitted as a relatively frequent yet unwanted consequence of the way clinical priorities were set for elderly patients. This was explained in terms of elderly patients not tolerating the same treatment as younger patients, and questions were raised about the quality of life of many elderly patients after treatment. These explanations were frequently referred to as medically sound decision making. Other explanations had little to do with medically sound decisions. These often included deep frustration with executive guidelines and budget constraints. (shrink)

There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient’s rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare professionals, (...) regulators and policy makers. We used a qualitative design to examine Swiss healthcare stakeholders’ experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries’ patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients’ rights and citizens’ involvement on the other. The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

New technologies such as smart sensors improve rehabilitation processes and thereby increase older adults’ capabilities to participate in social life, leading to direct physical and mental health benefits. Wearable smart sensors for home use have the additional advantage of monitoring day-to-day activities and thereby identifying rehabilitation progress and needs. However, identifying and selecting rehabilitation priorities is ethically challenging because physicians, therapists, and caregivers may impose their own personal values leading to paternalism. Therefore, we develop a discussion template consisting of a (...) series of adaptable questions for the patient–physician encounter based on the capability approach. The goal is to improve geriatric rehabilitation and thereby increase participation in social life and well-being. To achieve this goal, we first analyzed what is considered important for participation on basis of the capability approach, human rights, and ethics of care. Second, we conducted an ethical analysis of each of the four identified dimensions of participation: political, economic, socio-cultural, and care. To improve compliance with rehabilitation measures, health professionals must align rehabilitation measures in an open dialogue with the patient’s aspiration for participation in each dimension. A discussion template based on the capability approach allows for a proactive approach in patient information and stimulates a critical assessment of treatment alternatives while reducing the risk of imposing personal values. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Patient Self-Determination ActElizabeth Leibold McCloskey (bio)What are the ethics of extending the length of life? We know that we cannot artificially end life (Thou Shalt not Kill), but how about artificially extending life? Is that always good, sometimes good?... In ethics, is keeping people alive the highest good? Should our priority be to keep people breathing?... What does basic religious ethics say about this?(John C. Danforth, (...) letter to the author, 19 August 1989)The Patient Self-Determination Act, signed into law as part of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) last November, marks the first time that Congress has passed legislation concerning the ethics of life-sustaining medical treatment. The bill was spearheaded by Senator John C. Danforth (RMO), who has a special interest in this area. An Episcopal priest, Danforth was formerly an assistant chaplain at New York's Memorial Sloan-Kettering Cancer Center and now sits as a senior member of the Senate Finance Committee, which oversees Medicare and Medicaid. Although Senator Danforth's legislative initiative was not a result of the Cruzan case, it was in his state of Missouri that the U.S. Supreme Court case involving removal of Nancy Cruzan's feeding tube arose (Cruzan v. Director of Missouri Department of Health, U.S. Supreme Court, 58 LW 4916, 26 June 1990). From his unique vantage point, he felt it was time to craft a legislative response to some of the difficult issues surrounding prolongation of life.The short answer to Senator Danforth's questions about when to artificially extend life is simple enough: people must be free to determine that for themselves. Common law and common sense dictate such a conclusion; living will and health care proxy statutes, enacted in almost every state, codify that right. The Catholic moral tradition teaches that one is not morally obligated to use extraordinary means to prolong life, a tradition shared both by the mainline Protestant and the reform and conservative Jewish community. Yet most people are unaware of their fundamental legal right to make such decisions, and as court cases from Quinlan (In re Quinlin, 137 N.J. Super. 227, 1975) to Cruzan demonstrate, few know [End Page 163] how to make arrangements for this right to be exercised if they become incapacitated.Meanwhile, health care practices are often driven by a denial of death. When Senator Danforth and Senator Daniel Patrick Moynihan (D-NY) introduced the bill on October 17, 1989, Senator Danforth said:More and more it is arguable that we play God by subjecting people to unwanted and sometimes unnecessary treatment, treatment that unnaturally prolongs the dying process. Our health care system has become obsessed with extending life, at times neglecting the caring component of medicine and trampling on the rights of patients.(Congressional Record 1989, 135:5.13566)The American Hospital Association estimates that 70 percent of deaths now occur after a determination to withhold or withdraw medical treatment. Many of those decisions are made without the benefit of an incapacitated patient's views, yet a Harvard study revealed that 95 percent of the population would like to prepare in advance for such decisions. Only 4 percent of hospitals have a systematic method of asking patients if they have an advance directive. Family members confront painful choices in the face of uncertainty about their loved one's wishes and it can be even more painful when a family knows the patient's desires but providers and the courts act otherwise because clear evidence is lacking.The Patient Self-Determination Act is rooted in the belief that people should be given information that enables them to specify the extent of medical treatment they wish to receive should they become incapacitated. The public should be educated about applicable state laws that protect the individual's right to make such choices through the use of an advance directive.The Act moves toward that goal by promoting knowledge of state laws. It requires every hospital, nursing home, home health agency, hospice, and health maintenance organization that participates in Medicaid or Medicare to routinely give all adult patients information about advance directives. Patients will also be given information on the... (shrink)

Frailty is a state of increased vulnerability to poor resolution of homeostasis after a stressor event. Frailty is most frequently assessed in the old using the Clinical Frailty Scale (CSF) which ranks frailty from 1 to 9. This assessment typically takes less than one minute and is not validated in patients with learning difficulties or those under 65 years old. The National Institute for Health and Care Excellence (NICE) developed guidelines that use “frailty” as one of the priority-setting criteria (...) for how scarce, but potentially lifesaving, health care resources should be allocated during the COVID-19 pandemic. Similar guidelines have been developed elsewhere. This paper discusses the ethical implications of such rationing and argues that this is an unproven and ethically problematic form of health care rationing. It specifically discusses: (1) how the frailty ascription becomes a self-fulfilling prophecy, (2) the problematic use of “frailty” in COVID-19 “triage,” (3) the circularity of the link between age and frailty, (4) indirect discrimination because of the use of a seemingly neutral criterion in health care rationing, and (5) the difficult link between comorbidities and frailty. It is found that there was no research into the use of global frailty scores as a criterion for access to acute treatment before January 2020 and so it is concerning how readily frailty scoring has been adopted to ration access to potentially lifesaving treatments. Existing gerontological frailty scoring systems have not been developed for this purpose, and repurposing them creates significant ethical issues. (shrink)

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient data, i.e. healthcare (...) professionals, regulators and policy makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

Priority for solid organ transplant generally does not consider the underlying cause of the need for transplantation. This paper argues that a distinctive set of factors justify assigning lower priority to willfully unvaccinated individuals who require transplant as a result of suffering from COVID‐19. These factors include the personal responsibility of the patients for their own condition and the public outrage likely to ensue if willfully unvaccinated patients receive organs at the expense of vaccinated ones. The paper then (...) proposes a three‐prong test for similar deviations from the current allocation standard that incorporates patient responsibility, foreseeability and avoidability, and the frequency of the occurrence. (shrink)

Summary Background The principle of maximization, which roughly means that we should save more lives and more years of life, is usually taken for granted by the health community. This principle is even more forceful in crises like the COVID-19 pandemic, where we have scarce resources which can be allocated only to some patients. However, the standard consequentialist version of this principle can be challenging particularly when we have to reallocate a resource that has already been given to a (...) class='Hi'>patient. -/- Methodology Engaging in thought experiments, conceptual analysis, providing counterexamples, and appealing to moral intuitions, we challenge the standard consequentialist version of the maximization principle and make a case for adopting an alternative deontological version. -/- Discussion In certain cases, the standard consequentialist version of the maximization principle is shown to yield intuitively immoral results. The deontological version of this principle is preferable because it can retain the merits of the standard consequentialist version without falling prey to its problems. -/- Conclusion Compared to the standard consequentialist version, the deontological version of the maximization principle can better guide the ethical decisions of the health community, even in cases where we face a scarcity of resources. (shrink)