Annette Rid

Systematic Review: The Effect on Surrogates of Making Treatment Decisions for Others

BACKGROUND Clinical practice relies on surrogates to make or help to make treatment decisions for incapacitated adults; however, the effect of this practice on surrogates has not been evaluated. PURPOSE To assess the effect on surrogates of making treatment decisions for adults who cannot make their own decisions. DATA SOURCES Empirical studies published in English and listed in MEDLINE, EMBASE, CINAHL, BIOETHICSLINE, PsycINFO, or Scopus before 1 July 2010. STUDY SELECTION Eligible studies provided quantitative or qualitative empirical data, by evaluating surrogates, regarding the effect on surrogates of making treatment decisions for an incapacitated adult. DATA EXTRACTION Information on study location, number and type of surrogates, timing of data collection, type of decisions, patient setting, methods, main findings, and limitations. DATA SYNTHESIS 40 studies, 29 using qualitative and 11 using quantitative methods, provided data on 2854 surrogates, more than one half of whom were family members of the patient. Most surrogates were surveyed several months to years after making treatment decisions, the majority of which were end-of-life decisions. The quantitative studies found that at least one third of surrogates experienced a negative emotional burden as the result of making treatment decisions. The qualitative studies reported that many or most surrogates experienced negative emotional burden. The negative effects on surrogates were often substantial and typically lasted months or, in some cases, years. The most common negative effects cited by surrogates were stress, guilt over the decisions they made, and doubt regarding whether they had made the right decisions. Nine of the 40 studies also reported beneficial effects on a few surrogates, the most common of which were supporting the patient and feeling a sense of satisfaction. Knowing which treatment is consistent with the patients preferences was frequently cited as reducing the negative effect on surrogates. LIMITATIONS Thirty-two of the 40 articles reported data collected in the United States. Because the study populations were relatively homogenous, it is unclear whether the findings apply to other groups. In some cases, the effect of making treatment decisions could not be isolated from that of other stressors, such as grief or prognostic uncertainty. Nine of the studies had a response rate less than 50%, and 9 did not report a response rate. Many of the studies had a substantial interval between the treatment decisions and data collection. CONCLUSION Making treatment decisions has a negative emotional effect on at least one third of surrogates, which is often substantial and typically lasts months (or sometimes years). Future research should evaluate ways to reduce this burden, including methods to identify which treatment options are consistent with the patients preferences. PRIMARY FUNDING SOURCE National Institutes of Health.

Ethical considerations of experimental interventions in the Ebola outbreak

2and is therefore extremely complex to address. Second, experimental interventions that are still in the preclinical trial phase—and hence untested in human beings—were fi rst given to health-care workers from high-income countries, focusing extensive attention and controversy on investigational treatments and vaccines for Ebola. 3–5

Evaluating the Risks of Clinical Research

The ethical appropriateness of clinical research depends on protecting participants from excessive risks. Yet no systematic framework has been developed to assess research risks, and as a result, investigators, funders, and review boards rely only on their intuitive judgments. Because intuitive judgments of risk are subject to well-documented cognitive biases, this approach raises concern that research participants are not being adequately protected. To address this situation, we delineate a method called the systematic evaluation of research risks (SERR), which evaluates the risks of research interventions by comparing these interventions with the risks of comparator activities that have been deemed acceptable. This method involves a 4-step process: (1) identify the potential harms posed by the proposed research intervention; (2) categorize the magnitude of the potential harms into 1 of 7 harm levels on a harm scale; (3) quantify or estimate the likelihood of each potential harm; and (4) compare the likelihood of each potential harm from the research intervention with the likelihood of harms of the same magnitude occurring as a result of an appropriate comparator activity. By explicitly delineating, quantifying, and comparing the risks of research interventions with the risks posed by appropriate comparator activities, SERR offers a way to minimize the influence of cognitive biases on the evaluation of research risks and thereby better protect research participants from excessive risks.

Disclosure of Incidental Findings From Next-Generation Sequencing in Pediatric Genomic Research

Next-generation sequencing technologies will likely be used with increasing frequency in pediatric research. One consequence will be the increased identification of individual genomic research findings that are incidental to the aims of the research. Although researchers and ethicists have raised theoretical concerns about incidental findings in the context of genetic research, next-generation sequencing will make this once largely hypothetical concern an increasing reality. Most commentators have begun to accept the notion that there is some duty to disclose individual genetic research results to research subjects; however, the scope of that duty remains unclear. These issues are especially complicated in the pediatric setting, where subjects cannot currently but typically will eventually be able to make their own medical decisions at the age of adulthood. This article discusses the management of incidental findings in the context of pediatric genomic research. We provide an overview of the current literature and propose a framework to manage incidental findings in this unique context, based on what we believe is a limited responsibility to disclose. We hope this will be a useful source of guidance for investigators, institutional review boards, and bioethicists that anticipates the complicated ethical issues raised by advances in genomic technology.

A Framework for Risk-Benefit Evaluations in Biomedical Research

Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.

Systematic Review: Individuals' Goals for Surrogate Decision‐Making

To determine to what extent current practice promotes the goals of individuals who did not designate a surrogate while competent with respect to decision‐making during periods of decisional incapacity.

Justice and procedure: how does “accountability for reasonableness” result in fair limit-setting decisions?

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as “accountability for reasonableness”. Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called “constrained pure procedural justice” best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions.

Can We Improve Treatment Decision‐Making for Incapacitated Patients?

When patients cannot make their own treatment decisions, surrogates typically step in to do it for them. Surrogate decision-making is far from ideal, of course, as the surrogate may not know what the patient prefers or what best promotes her interests. One way to improve it would be to arm surrogates with information about what patients in similar circumstances tend to prefer, allowing them to make empirically grounded predictions about what their patient would want.

Research led by participants: a new social contract for a new kind of research

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Why Should High-Income Countries Help Combat Ebola?

The outbreak of Ebola in West Africa is devastating to the affected countries. With no specific treatments or preventive measures available, Ebola has, to date, caused almost 2300 deaths,1 overwhelmed fragile health care systems and thereby led to inadequate care for other serious diseases, and slowed economic activity. Yet Ebola most likely will not become a global health threat.2 Ebola only spreads through direct contact with infected bodily fluids, and containment is readily achievable in high-income countries. This undermines the standard rationale for these countries to address infectious disease outbreaks in other regions—namely, to protect their own populations. For example, fear of global spread has been a key motivation for addressing influenza outbreaks in southeast Asia. Why, then, should high-income countries help the affected countries combat Ebola and strengthen their health systems and infrastructure in the longer term? Three independent reasons justify action.