Deep Brain Stimulation for Pediatric Dystonia: Clinicians' Perspectives on the Most Pressing Ethical Challenges.

INTRODUCTION: Pediatric deep brain stimulation (pDBS) is commonly used to manage treatment-resistant primary dystonias with favorable results and more frequently used for secondary dystonia to improve quality of life. There has been little systematic empirical neuroethics research to identify ethical challenges and potential solutions to ensure responsible use of DBS in pediatric populations. METHODS: Clinicians (n = 29) who care for minors with treatment-resistant dystonia were interviewed for their perspectives on the most pressing ethical issues in pDBS. RESULTS: Using thematic content analysis to explore salient themes, clinicians identified four pressing concerns: (1) uncertainty about risks and benefits of pDBS (22/29; 72%) that poses a challenge to informed decision-making; (2) ethically navigating decision-making roles (15/29; 52%), including how best to integrate perspectives from diverse stakeholders (patient, caregiver, clinician) and how to manage surrogate decisions on behalf of pediatric patients with limited capacity to make autonomous decisions; (3) information scarcity effects on informed consent and decision quality (15/29; 52%) in the context of patient and caregivers' expectations for treatment; and (4) narrow regulatory status and access (7/29; 24%) such as the lack of FDA-approved indications that contribute to decision-making uncertainty and liability and potentially limit access to DBS among patients who may benefit from it. CONCLUSION: These results suggest that clinicians are primarily concerned about ethical limitations of making difficult decisions in the absence of informational, regulatory, and financial supports. We discuss two solutions already underway, including supported decision-making to address uncertainty and further data sharing to enhance clinical knowledge and discovery.

A Call for Behavioral Science in Embedded Bioethics.

Bioethicists today are taking a greater role in the design and implementation of emerging technologies by "embedding" within the development teams and providing their direct guidance and recommendations. Ideally, these collaborations allow ethical considerations to be addressed in an active, iterative, and ongoing process through regular exchanges between ethicists and members of the technological development team. This article discusses a challenge to this embedded ethics approach-namely, that bioethical guidance, even if embraced by the development team in theory, is not easily actionable in situ. Many of the ethical problems at issue in emerging technologies are associated with preexisting structural, socioeconomic, and political factors, making compliance with ethical recommendations sometimes less a matter of choice and more a matter of feasibility. Moreover, incentive structures within these systemic factors maintain them against reform efforts. The authors recommend that embedded bioethicists utilize principles from behavioral science (such as behavioral economics) to better understand and account for these incentive structures so as to encourage the ethically responsible uptake of technological innovations.

A principal components analysis of factors associated with successful implementation of an LVAD decision support tool.

BACKGROUND: A central goal among researchers and policy makers seeking to implement clinical interventions is to identify key facilitators and barriers that contribute to implementation success. Despite calls from a number of scholars, empirical insights into the complex structural and cultural predictors of why decision aids (DAs) become routinely embedded in health care settings remains limited and highly variable across implementation contexts. METHODS: We examined associations between "reach", a widely used indicator (from the RE-AIM model) of implementation success, and multi-level site characteristics of nine LVAD clinics engaged over 18 months in implementation and dissemination of a decision aid for left ventricular assist device (LVAD) treatment. Based on data collected from nurse coordinators, we explored factors at the level of the organization (e.g. patient volume), patient population (e.g. health literacy; average sickness level), clinician characteristics (e.g. attitudes towards decision aid; readiness for change) and process (how the aid was administered). We generated descriptive statistics for each site and calculated zero-order correlations (Pearson's r) between all multi-level site variables including cumulative reach at 12 months and 18 months for all sites. We used principal components analysis (PCA) to examine any latent factors governing relationships between and among all site characteristics, including reach. RESULTS: We observed strongest inclines in reach of our decision aid across the first year, with uptake fluctuating over the second year. Average reach across sites was 63% (s.d. = 19.56) at 12 months and 66% (s.d. = 19.39) at 18 months. Our PCA revealed that site characteristics positively associated with reach on two distinct dimensions, including a first dimension reflecting greater organizational infrastructure and standardization (characteristic of larger, more established clinics) and a second dimension reflecting positive attitudinal orientations, specifically, openness and capacity to give and receive decision support among coordinators and patients. CONCLUSIONS: Successful implementation plans should incorporate specific efforts to promote supportive and mutually informative interactions between clinical staff members and to institute systematic and standardized protocols to enhance the availability, convenience and salience of intervention tool in routine practice. Further research is needed to understand whether "core predictors" of success vary across different intervention types.

A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial).

BACKGROUND: Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy. METHODS: After an extensive user-centered design process, we conducted a multisite randomized trial of the DA compared with standard education (SE) among inpatients considering LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1 week and 1 month after administration of the DA versus the SE, according to a validated scale. Secondary measures included prespecified quality decision making measures recommended by the International Patient Decision Aid Standards collaboration. RESULTS: Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high in acceptability and usability. CONCLUSIONS: The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during the peak period of decision making. The DA does not encourage decision direction and reflects patient, caregiver, and physician preferences for content and format. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02248974. The trial is registered with clinicaltrials.gov (NCT02248974).

In Defense of "Denial": Difficulty Knowing When Beliefs Are Unrealistic and Whether Unrealistic Beliefs Are Bad.

Bioethicists often draw sharp distinctions between hope and states like denial, self-deception, and unrealistic optimism. But what, exactly, is the difference between hope and its more suspect cousins? One common way of drawing the distinction focuses on accuracy of belief about the desired outcome: Hope, though perhaps sometimes misplaced, does not involve inaccuracy in the way that these other states do. Because inaccurate beliefs are thought to compromise informed decision making, bioethicists have considered these states to be ones where intervention is needed either to correct the person's mental state or to persuade the person to behave differently, or even to deny the person certain options (e.g., another round of chemotherapy). In this article, we argue that it is difficult to determine whether a patient is really in denial, self-deceived, or unrealistically optimistic. Moreover, even when we are confident that beliefs are unrealistic, they are not always as harmful as critics contend. As a result, we need to be more permissive in our approach to patients who we believe are unrealistically optimistic, in denial, or self-deceived-that is, unless patients significantly misunderstand their situation and thus make decisions that are clearly bad for them (especially in light of their own values and goals), we should not intervene by trying to change their mental states or persuade them to behave differently, or by paternalistically denying them certain options (e.g., a risky procedure).

Biases and Heuristics in Decision Making and Their Impact on Autonomy.

Cognitive scientists have identified a wide range of biases and heuristics in human decision making over the past few decades. Only recently have bioethicists begun to think seriously about the implications of these findings for topics such as agency, autonomy, and consent. This article aims to provide an overview of biases and heuristics that have been identified and a framework in which to think comprehensively about the impact of them on the exercise of autonomous decision making. I analyze the impact that these biases and heuristics have on the following dimensions of autonomy: understanding, intentionality, absence of alienating or controlling influence, and match between formally autonomous preferences or decisions and actual choices or actions.

Psychiatry's new manual (DSM-5): ethical and conceptual dimensions.

The introduction of the Diagnostic and statistical manual of mental disorders (DSM-5) in May 2013 is being hailed as the biggest event in psychiatry in the last 10 years. In this paper I examine three important issues that arise from the new manual:(1) Expanding nosology: Psychiatry has again broadened its nosology to include human experiences not previously under its purview (eg, binge eating disorder, internet gaming disorder, caffeine use disorder, hoarding disorder, premenstrual dysphoric disorder). Consequence-based ethical concerns about this expansion are addressed, along with conceptual concerns about a confusion of "construct validity" and "conceptual validity" and a failure to distinguish between "disorder" and "non disordered conditions for which we help people."(2) The role of claims about societal impact in changes in nosology: Several changes in the DSM-5 involved claims about societal impact in their rationales. This is due in part to a new online open comment period during DSM development. Examples include advancement of science, greater access to treatment, greater public awareness of condition, loss of identify or harm to those with removed disorders, stigmatization, offensiveness, etc. I identify and evaluate four importantly distinct ways in which claims about societal impact might operate in DSM development. (3) Categorisation nosology to spectrum nosology: The move to "degrees of severity" of mental disorders, a major change for DSM-5, raises concerns about conceptual clarity and uniformity concerning what it means to have a severe form of a disorder, and ethical concerns about communication.

Patients' and physicians' beliefs and attitudes towards integrating personalized risk estimates into patient education about left ventricular assist device therapy.

BACKGROUND: Personalized risk (PR) estimates may enhance clinical decision making and risk communication by providing individualized estimates of patient outcomes. We explored stakeholder attitudes toward the utility, acceptability, usefulness and best-practices for integrating PR estimates into patient education and decision making about Left Ventricular Assist Device (LVAD). METHODS AND RESULTS: As part of a 5-year multi-institutional AHRQ project, we conducted 40 interviews with stakeholders (physicians, nurse coordinators, patients, and caregivers), analyzed using Thematic Content Analysis. All stakeholder groups voiced positive views towards integrating PR in decision making. Patients, caregivers and coordinators emphasized that PR can help to better understand a patient's condition and risks, prepare mentally and logistically for likely outcomes, and meaningfully engage in decision making. Physicians felt it can improve their decision making by enhancing insight into outcomes, enhance tailored pre-emptive care, increase confidence in decisions, and reduce bias and subjectivity. All stakeholder groups also raised concerns about accuracy, representativeness and relevance of algorithms; predictive uncertainty; utility in relation to physician's expertise; potential negative reactions among patients; and overreliance. CONCLUSION: Stakeholders are optimistic about integrating PR into clinical decision making, but acceptability depends on prospectively demonstrating accuracy, relevance and evidence that benefits of PR outweigh potential negative impacts on decision making quality.

"Choosing wisely" to reduce low-value care: a conceptual and ethical analysis.

The American Board of Internal Medicine (ABIM) Foundation has recently initiated a campaign called "Choosing Wisely," which is aimed at reducing "low-value" care services. Lists of low-value care services are being developed and the ABIM Foundation is urging the American Medical Association and other organizations to get behind the lists, disseminate them, and implement them. Yet, there are many ethical questions that remain about the development, dissemination, and implementation of these low-value care lists. In this paper I argue for conceptual clarity with respect to the label "low-value care." Thus far it has not been precisely defined, and I argue that there are actually 10 distinct categories of low-value care. I discuss the ethical challenges and considerations associated with each category. I also provide arguments that can be used to justify the reduction of some of these categories of low-value care. These arguments rely on Rawlsian and Hegelian notions of justice, as well as on concepts about the fiduciary obligations of physicians. Finally, I outline the various mechanisms that could be utilized for the reduction of low-value care (i.e., incentives, punishments, nonrational influences such as appeals to social norms, emotions, or ego, and creation of conditions that make avoidance easy such as defaults and reminders). I provide normative guidelines for the use of each.

Seeking better health care outcomes: the ethics of using the "nudge".

Policymakers, employers, insurance companies, researchers, and health care providers have developed an increasing interest in using principles from behavioral economics and psychology to persuade people to change their health-related behaviors, lifestyles, and habits. In this article, we examine how principles from behavioral economics and psychology are being used to nudge people (the public, patients, or health care providers) toward particular decisions or behaviors related to health or health care, and we identify the ethically relevant dimensions that should be considered for the utilization of each principle.

Between reason and coercion: ethically permissible influence in health care and health policy contexts.

In bioethics, the predominant categorization of various types of influence has been a tripartite classification of rational persuasion (meaning influence by reason and argument), coercion (meaning influence by irresistible threats-or on a few accounts, offers), and manipulation (meaning everything in between). The standard ethical analysis in bioethics has been that rational persuasion is always permissible, and coercion is almost always impermissible save a few cases such as imminent threat to self or others. However, many forms of influence fall into the broad middle terrain-and this terrain is in desperate need of conceptual refining and ethical analysis in light of recent interest in using principles from behavioral science to influence health decisions and behaviors. This paper aims to address the neglected space between rational persuasion and coercion in bioethics. First, I argue for conceptual revisions that include removing the "manipulation" label and relabeling this space "nonargumentative influence," with two subtypes: "reason-bypassing" and "reason-countering." Second, I argue that bioethicists have made the mistake of relying heavily on the conceptual categories themselves for normative work and instead should assess the ethical permissibility of a particular instance of influence by asking several key ethical questions, which I elucidate, that relate to (1) the impact of the form of influence on autonomy and (2) the relationship between the influencer and the influenced. Finally, I apply my analysis to two examples of nonargumentative influence in health care and health policy: (1) governmental agencies such as the Food and Drug Administration (FDA) trying to influence the public to be healthier using nonargumentative measures such as vivid images on cigarette packages to make more salient the negative effects of smoking, and (2) a physician framing a surgery in terms of survival rates instead of mortality rates to influence her patient to consent to the surgery.

Mitigating Racial Bias in Machine Learning.

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.