Excluding patients from transplant due to social support: Results from a national survey of transplant providers.

Social support is used to determine transplant eligibility despite lack of an evidence base and vague regulatory guidance. It is unknown how many patients are disqualified from transplantation due to inadequate support, and whether providers feel confident using these subjective criteria to determine eligibility. Transplant providers (n = 551) from 202 centers estimated that, on average, 9.6% (standard deviation = 9.4) of patients evaluated in the prior year were excluded due to inadequate support. This varied significantly by United Network for Organ Sharing region (7.6%-12.2%), and by center (21.7% among top quartile). Significantly more providers used social support in listing decisions than believed it ought to be used (86.3% vs 67.6%). Nearly 25% believed that using social support in listing determinations was unfair or were unsure; 67.3% felt it disproportionately impacted patients of low socioeconomic status. Overall, 42.4% were only somewhat or not at all confident using social support to determine transplant suitability. Compared to surgical/medical transplant providers, psychosocial providers had 2.13 greater odds of supporting the criteria (P = .03). Furthermore, 69.2% supported revised guidelines for use of social support in listing decisions. Social support criteria should be reconsidered in light of the limited evidence, potential for disparities, practice variation, low provider confidence, and desire for revised guidelines.

Should Lack of Social Support Prevent Access to Organ Transplantation?

Transplantation programs commonly rely on clinicians' judgments about patients' social support (care from friends or family) when deciding whether to list them for organ transplantation. We examine whether using social support to make listing decisions for adults seeking transplantation is morally legitimate, drawing on recent data about the evidence-base, implementation, and potential impacts of the criterion on underserved and diverse populations. We demonstrate that the rationale for the social support criterion, based in the principle of utility, is undermined by its reliance on tenuous evidence. Moreover, social support requirements may reinforce transplant inequities, interfere in patients' personal relationships, and contribute to biased and inconsistent listing procedures. As such, accommodating the needs of patients with limited social support would better balance ethical commitments to equity, utility, and respect for persons in transplantation. We suggest steps for researchers, transplantation programs, and policymakers to improve fair use of social support in transplantation.

Combining A4R and MCDA in priority setting for health.

Multiple criteria decision analysis (MCDA) has been proposed as a method for determining the criteria to be used in health technology assessment. A standard criticism of MCDA is that it lacks attention to securing legitimacy for its decisions. The relevance condition of A4R has been criticized for its vagueness because it lacks a focus on criteria selection. Combining the two methods addresses the central criticisms of each and provides a way of addressing the problem of priority setting for health.

How important is social support in determining patients' suitability for transplantation? Results from a National Survey of Transplant Clinicians.

BACKGROUND: National guidelines require programmes use subjective assessments of social support when determining transplant suitability, despite limited evidence linking it to outcomes. We examined how transplant providers weigh the importance of social support for kidney transplantation compared with other factors, and variation by clinical role and personal beliefs. METHODS: The National survey of the American Society of Transplant Surgeons and the Society of Transplant Social Work in 2016. Using a discrete choice approach, respondents compared two hypothetical patient profiles and selected one for transplantation. Conditional logistic regression estimated the relative importance of each factor; results were stratified by clinical role (psychosocial vs medical/surgical providers) and beliefs (outcomes vs equity). RESULTS: Five hundred and eighy-four transplant providers completed the survey. Social support was the second most influential factor among transplant providers. Providers were most likely to choose a candidate who had social support (OR=1.68, 95% CI 1.50 to 1.86), always adhered to a medical regimen (OR=1.64, 95% CI 1.46 to 1.88), and had a 15 years life expectancy with transplant (OR=1.61, 95% CI 1.42 to 1.85). Psychosocial providers were more influenced by adherence and quality of life compared with medical/surgical providers, who were more influenced by candidates' life expectancy with transplant (p<0.05). For providers concerned with avoiding organ waste, social support was the most influential factor, while it was the least influential for clinicians concerned with fairness (p<0.05). CONCLUSIONS: Social support is highly influential in listing decisions and may exacerbate transplant disparities. Providers' beliefs and reliance on social support in determining suitability vary considerably, raising concerns about transparency and justice.

HEALTH TECHNOLOGY ASSESSMENT, DELIBERATIVE PROCESS, AND ETHICALLY CONTESTED ISSUES.

Healthcare technology assessment (HTA) aims to support decisions as to which technologies should be used in which situations to optimize value. Because such decisions will create winners and losers, they are bound to be controversial. HTA, then, faces a dilemma: should it stay away from such controversies, remaining a source of incomplete advice and risking an important kind of marginalization, or should it enter the controversy? The question is a challenging one, because we lack agreement on principles that are fine grained enough to tell us what choices we should make. In this study, we will argue that HTA should take a stand on ethical issues raised by the technology that is being investigated. To do so, we propose adding a form of procedural justice to HTA to arrive at decisions that the public can regard as legitimate and fair. A fair process involves deliberation about the reasons, evidence, and rationales that are considered relevant to meeting population-health needs fairly. One important way to make sure that there is real deliberation about relevant reasons is to include a range of stakeholders in the deliberative process. To illustrate how such deliberation might work, we use the case of cochlear implants for deaf children.

A Progressively Realizable Right to Health and Global Governance.

A moral right to health or health care is a special instance of a right to fair equality of opportunity. Nation-states generally have the capabilities to specify the entitlements of such a right and to raise the resources needed to satisfy those entitlements. Can these functions be replicated globally, as a global right to health or health care requires? The suggestion that "better global governance" is needed if such a global right is to be claimed requires that these two central capabilities be present. It is unlikely that nation-states would concede these two functions to a form of global governance, for doing so would seriously compromise the authority that is generally included in sovereignty. This claim is a specification of what is often recognized as the "sovereignty problem." The argument of this paper is not an "impossibility" claim, but a best guess about whether the necessary conditions for better global governance that supports a global right to health or health care can be achieved.

Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis.

This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria. THE GUIDANCE WAS DEVELOP THROUGH A SERIES OF EXPERT CONSULTATION MEETINGS AND INVOLVED THREE STEPS: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders. The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

Decision maker priorities for providing antiretroviral therapy in HIV-infected South Africans: a qualitative assessment.

In resource-limited settings, successful HIV treatment scale-up has been tempered by reports of funding shortfalls. We aimed to determine the priorities, including ethical considerations, of decision makers for HIV antiretroviral programs. We conducted qualitative interviews with 12 decision makers, identified using purposive sampling. Respondents engaged in one-on-one, semi-structured interviews. We developed an interview guide to direct questions about key priorities and motivations for decision making about HIV antiretroviral programs. We evaluated textual data from the interviews to identify themes. Among 12 respondents, 10 (83%) lived and worked in South Africa. Respondents came from Western Cape, Gauteng, and KwaZulu-Natal provinces and worked primarily in urban settings. The respondents supported prioritizing individual patients based on treatment adherence, pregnancy status to prevent maternal-to-child HIV transmission and/or orphans, and severity of illness. However, priorities based on severity of illness varied, with first-come/first-serve, prioritization of the most severely ill, and prioritization of the least severely ill discussed. Respondents opposed prioritizing based on patient socioeconomic characteristics. Other priorities included the number of persons receiving treatment; how treated patients are distributed in the population (e.g., urban/rural); and treatment policy (e.g., number of antiretroviral regimens). Motivations included humanitarian concerns; personal responsibility for individual patients; and clinical outcomes (e.g., patient-level morbidity/mortality, saving lives) and/or social outcomes (e.g., restoring patients as functional family members). Decision makers have a wide range of priorities for antiretroviral provision in South Africa, and the motivations underlying these priorities suggest at times conflicting ethical considerations for providing HIV treatment when resources are limited.

Patient- and population-level health consequences of discontinuing antiretroviral therapy in settings with inadequate HIV treatment availability.

BACKGROUND: In resource-limited settings, HIV budgets are flattening or decreasing. A policy of discontinuing antiretroviral therapy (ART) after HIV treatment failure was modeled to highlight trade-offs among competing policy goals of optimizing individual and population health outcomes. METHODS: In settings with two available ART regimens, we assessed two strategies: (1) continue ART after second-line failure (Status Quo) and (2) discontinue ART after second-line failure (Alternative). A computer model simulated outcomes for a single cohort of newly detected, HIV-infected individuals. Projections were fed into a population-level model allowing multiple cohorts to compete for ART with constraints on treatment capacity. In the Alternative strategy, discontinuation of second-line ART occurred upon detection of antiretroviral failure, specified by WHO guidelines. Those discontinuing failed ART experienced an increased risk of AIDS-related mortality compared to those continuing ART. RESULTS: At the population level, the Alternative strategy increased the mean number initiating ART annually by 1,100 individuals (+18.7%) to 6,980 compared to the Status Quo. More individuals initiating ART under the Alternative strategy increased total life-years by 15,000 (+2.8%) to 555,000, compared to the Status Quo. Although more individuals received treatment under the Alternative strategy, life expectancy for those treated decreased by 0.7 years (-8.0%) to 8.1 years compared to the Status Quo. In a cohort of treated patients only, 600 more individuals (+27.1%) died by 5 years under the Alternative strategy compared to the Status Quo. Results were sensitive to the timing of detection of ART failure, number of ART regimens, and treatment capacity. Although we believe the results robust in the short-term, this analysis reflects settings where HIV case detection occurs late in the disease course and treatment capacity and the incidence of newly detected patients are stable. CONCLUSIONS: In settings with inadequate HIV treatment availability, trade-offs emerge between maximizing outcomes for individual patients already on treatment and ensuring access to treatment for all people who may benefit. While individuals may derive some benefit from ART even after virologic failure, the aggregate public health benefit is maximized by providing effective therapy to the greatest number of people. These trade-offs should be explicit and transparent in antiretroviral policy decisions.

The ethics of the affordability of health insurance.

In this essay we argue that the concept of affordable health insurance is rooted in a social obligation to protect fair equality of opportunity. Specifically, health insurance plays a limited but significant role in protecting opportunity in two ways: it helps keep people functioning normally and it protects their financial security. Together these benefits enable household members to exercise reasonable choices about their plans of life. To achieve truly affordable coverage, society must be able to contain the overall cost of health care, and health insurance must be progressively financed, meaning that those who are best able to pay for coverage should pay the largest share. While the recently passed Patient Protection and Affordable Care Act (ACA) falls short on both of these counts, we argue that it makes important contributions toward household affordability through the use of subsidies and regulations. The main shortcoming of the ACA is an insufficient protection against burdensome cost sharing, which we illustrate using several hypothetical scenarios. We conclude with recommendations about how to make opportunity-enhancing expansions to the current coverage subsidies.

A Mixed-Methods Approach to Understanding Variation in Social Support Requirements and Implications for Access to Transplantation in the United States.

Social support is a key component of transplantation evaluation in the United States. Social support definitions and evaluation procedures require examination to achieve clear, consistent implementation. We surveyed psychosocial clinicians from the Society for Transplant Social Workers and American Society of Transplant Surgeons about their definitions and evaluation procedures for using social support to determine transplant eligibility. Bivariate statistical analysis was used for quantitative data and content analysis for qualitative data. Among 276 psychosocial clinicians (50.2% response rate), 92% had ruled out patients from transplantation due to inadequate support. Social support definitions varied significantly: 10% of respondents indicated their center lacked a definition. Key domains of social support included informational, emotional, instrumental, motivational, paid support, and the patient's importance to others. Almost half of clinicians (47%) rarely or never requested second opinions when excluding patients due to social support. Confidence and perceived clarity and consistency in center guidelines were significantly associated with informing patients when support contributed to negative wait-listing decisions (P = .001). Clinicians who excluded fewer patients because of social support offered significantly more supportive health care (P = .02). Clearer definitions and more supportive care may reduce the number of patients excluded from transplant candidacy due to inadequate social support.

Process is the point: justice and human rights: priority setting and fair deliberative process.

Most people responsible for setting priorities in health have considerable expertise relevant to deciding how to use resources effectively and the kinds of improvements that should be emphasized. Most are also concerned with distributing improvements equitably. Accordingly, they often invoke human rights or principles of distributive justice to legitimize choices that create winners and losers. We propose an approach that draws on the strengths of both perspectives as a way to add legitimacy to efforts to set priorities in health. Our proposal provides a process for setting priorities but is not a formula or an algorithm for generating particular priorities. We propose an approach that would do away with the process through which priorities are set and decisions made, and suggest the value of a focus on the process of legitimizing these decisions.

Seeking Legitimacy for DSM-5: The Bereavement Exception as an Example of Failed Process.

In 2013 the American Psychiatric Association (APA) published the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Even before publication, DSM-5 received a torrent of criticism, most prominently over removal of the "bereavement exclusion" for the diagnosis of major depression. We argue that while the APA can claim legitimate authority for deciding scientific questions, it does not have legitimacy for resolving what is ultimately a question of ethics and public policy. We show how the "accountability for reasonableness" framework for seeking legitimacy in health policy could have been used to achieve a better resolution of the conflict than actually occurred.

Equity and population health: toward a broader bioethics agenda.

Bioethics' traditional focus on clinical relationships and exotic technologies has led the field away from population health, health disparities, and issues of justice. The result: a myopic view that misses the institutional context in which clinical relationships operate and can overlook factors that affect health more broadly than do exotic technologies. A broader bioethics agenda would take up unresolved questions about the distribution of health and the development of fair policies that affect health distribution.