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.

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.

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.

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.

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.

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.

Correction: Expanded HTA: Enhancing Fairness and Legitimacy.

The authors would like to correct the name of the third author in this paper to Julian Urrutia.

How providers influence the implementation of provider-initiated HIV testing and counseling in Botswana: a qualitative study.

BACKGROUND: Understanding the motivations and perspectives of providers in following guidance and evidence-based policies can contribute to the evidence on how to better implement and deliver care, particularly in resource-constrained settings. This study explored how providers' attitudes and behaviors influenced the implementation of an intervention, provider-initiated HIV testing and counseling, in primary health care settings in Botswana. METHODS: Using a grounded-theory approach, we purposively selected and interviewed 45 providers in 15 facilities in 3 districts and inductively analyzed data for themes and patterns. RESULTS: We found that nurses across facilities and districts were largely resistant to offering and delivering provider-initiated testing and counseling for HIV (PITC) for three reasons: (1) they felt they were overworked and had no time, (2) they felt it was not their job, and (3) they were afraid to counsel patients, particularly fearing a positive HIV test. These factors were largely related to health system constraints that affected the capacity of providers to do their job. An important underlying themes emerged: nurses and lay counselors were unsatisfied with pay and career prospects, which made them unmotivated to work in general. Variations were seen by urban and rural areas: nurses in urban areas felt generally overworked and PITC was seen as contributing to the workload. While nurses in rural areas did not feel overworked, they felt that PITC was not their job and they were unmotivated because of general unhappiness with their rural posts. CONCLUSIONS: The attitudes and behaviors of providers and barriers they faced played a critical role in whether and how PITC was being implemented in Botswana. Provider factors should be considered in the improvement of existing PITC programs and design of new ones. Addressing constraints faced by providers can do more to improve supply of human resources than merely recruiting more providers.

Expanded HTA: Enhancing Fairness and Legitimacy.

All societies face the need to make judgments about what interventions (both public health and personal medical) to provide to their populations under reasonable resource constraints. Their decisions should be informed by good evidence and arguments from health technology assessment (HTA). But if HTA restricts itself to evaluations of safety, efficacy, and cost-effectiveness, it risks being viewed as insufficient to guide health decision-makers; if it addresses other issues, such as budget impact, equity, and financial protection, it may be accused of overreaching. But the risk of overreaching can be reduced by embedding HTA in a fair, deliberative process that meets the conditions required by accountability for reasonableness.

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.

Role of the Courts in the Progressive Realization of the Right to Health: Between the Threat and the Promise of Judicialization in Mexico.

Abstract-A moral right to health or health care, given reasonable resource constraints, implies a reasonable array of services, as determined by a fair deliberative process. Such a right can be embodied in a constitution where it becomes a legal right with similar entitlements. What is the role of the courts in deciding what these entitlements are? The threat of "judicialization" is that the courts may overreach their ability if they attempt to carry out this task; the promise of judicialization is that the courts can do better than health systems have done at determining such entitlements. We propose a middle ground that requires the health system to develop a fair, deliberative process for determining how to achieve the progressive realization of the same right to health or health care and that also requires the courts to develop the capacity to assess whether the deliberative process in the health system is fair.

Points to consider for prioritizing clinical genetic testing services: a European consensus process oriented at accountability for reasonableness.

Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set of prioritization criteria would be desirable. A decision process following the accountability for reasonableness framework was undertaken, including a multidisciplinary EuroGentest/PPPC-ESHG workshop to develop shared prioritization criteria. Resources are currently too limited to fund all the beneficial genetic testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit of information for important life decisions, benefit for other people apart from the person tested and the patient-specific likelihood of being affected by the condition tested for. It may be subject to a finite time window. Health need includes the severity of the condition tested for and its progression at the time of testing. Further discussion and better evidence is needed before clearly defined recommendations can be made or a prioritization algorithm proposed. To our knowledge, this is the first time a clinical society has initiated a decision process about health-care prioritization on a European level, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.

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).

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.