Conceptualization of utility in translational clinical genomics research.

Prior to integration into clinical care, a novel medical innovation is typically assessed in terms of its balance of benefits and risks, often referred to as utility. Members of multidisciplinary research teams may conceptualize and assess utility in different ways, which has implications within the translational genomics community and for the evidence base upon which clinical guidelines groups and healthcare payers make decisions. Ambiguity in the conceptualization of utility in translational genomics research can lead to communication challenges within research teams and to study designs that do not meet stakeholder needs. We seek to address the ambiguity challenge by describing the conceptual understanding of utility and use of the term by scholars in the fields of philosophy, medicine, and the social sciences of decision psychology and health economics. We illustrate applications of each field's orientation to translational genomics research by using examples from the Clinical Sequencing Evidence-Generating Research (CSER) consortium, and we provide recommendations for increasing clarity and cohesion in future research. Given that different understandings of utility will align to a greater or lesser degree with important stakeholders' views, more precise use of the term can help researchers to better integrate multidisciplinary investigations and communicate with stakeholders.

Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for pediatric diagnostic testing.

PURPOSE: Measuring the effects of genomic sequencing (GS) on patients and families is critical for translational research. We aimed to develop and validate an instrument to assess parents' perceived utility of pediatric diagnostic GS. METHODS: Informed by a 5-domain conceptual model, the study comprised 5 steps: (1) item writing, (2) cognitive testing, (3) pilot testing and item reduction, (4) psychometric testing, and (5) evaluation of construct validity. Parents of pediatric patients who had received results of clinically indicated GS participated in structured cognitive interviews and 2 rounds of surveys. After eliminating items based on theory and quantitative performance, we conducted an exploratory factor analysis and calculated Pearson correlations with related instruments. RESULTS: We derived the 21-item Pediatric Diagnostic version of the GENEtic Utility (GENE-U) scale, which has a 2-factor structure that includes an Informational Utility subscale (16 items, α = 0.91) and an Emotional Utility subscale (5 items, α = 0.71). Scores can be summed to calculate a Total scale score (α = 0.87). The Informational Utility subscale was strongly associated with empowerment and personal utility of GS, and the Emotional Utility subscale was moderately associated with psychosocial impact and depression and anxiety. CONCLUSION: The pediatric diagnostic GENE-U scale demonstrated good psychometric performance in this initial evaluation and could be a useful tool for translational genomics researchers, warranting additional validation.

Genomic sequencing research in pediatric cancer care: Decision making, attitudes, and perceived utility among adolescents and young adults and their parents.

PURPOSE: Professional guidelines recommend engaging adolescents and young adults (AYAs) in medical decision making (DM), including whether to undergo genomic sequencing (GS). We explored DM around GS and attitudes after return of GS results among a diverse group of AYAs with cancer and their parents. METHODS: We surveyed AYAs with cancer (n = 75) and their parents (n = 52) 6 months after receiving GS results through the Texas KidsCanSeq study. We analyzed AYAs' DM role in GS research enrollment and their satisfaction with that role. We compared AYAs' and parents' self-reported understanding of, attitudes toward, and perceived utility of the AYA's GS results. RESULTS: Most AYAs reported equally sharing DM with their parents (55%) or leading DM (36%) about GS research. Compared with their cancer care DM role, 56% of AYAs reported the same level of involvement in GS research DM, whereas 32% were more involved, and 13% were less involved (P = .011). AYAs were satisfied (99%) with their DM role regarding GS study participation. AYAs and parents had similar self-reported understanding of, attitudes toward, and perceived utility of the GS results. CONCLUSION: Our results support engaging AYAs in DM about GS research and provide insights into AYAs' DM preferences and positive attitudes toward GS.

From Bridge to Destination? Ethical Considerations Related to Withdrawal of ECMO Support over the Objections of Capacitated Patients.

Extracorporeal membrane oxygenation (ECMO) is typically viewed as a time-limited intervention-a bridge to recovery or transplant-not a destination therapy. However, some patients with decision-making capacity request continued ECMO support despite a poor prognosis for recovery and lack of viability as a transplant candidate. In response, critical care teams have asked for guidance regarding the ethical permissibility of unilateral withdrawal over the objections of a capacitated patient. In this article, we evaluate several ethical arguments that have been made in favor of withdrawal, including distributive justice, quality of life, patients' rights, professional integrity, and the Equivalence Thesis. We find that existing justifications for unilateral withdrawal of ECMO support in capacitated patients are problematic, which leads us to conclude that either: (1) additional ethical arguments are necessary to defend this approach or (2) the claim that it is not appropriate to use ECMO as a destination therapy should be questioned.

Uninformed Origins: Should We Be Advising Parents on the Source of Medicines and Therapies?

Respecting patient autonomy through the process of soliciting informed consent is a cornerstone of clinical ethics. In pediatrics, until a child becomes an adult or legally emancipated, that ethical tenet takes the form of respect for parental decision-making authority. In instances of respecting religious beliefs, doing so is not always apparent and sometimes the challenge lies not only in the healthcare provider's familiarity of religious restrictions but also their knowledge of medical interventions themselves which might conflict with those restrictions. We examine a case of a newborn receiving animal-derived surfactant, a common scenario in neonatology, and present considerations for providers to weigh when confronting when such an intervention might conflict with parent's religious beliefs. We end with strategizing ways to address this issue as a medical community.

Building Effective Mentoring Relationships During Clinical Ethics Fellowships: Pedagogy, Programs, and People.

How should clinical ethicists be trained? Scholars have stated that clinical ethics fellowships create well-trained, competent ethicists. While this appears intuitive, few features of fellowship programs have been publicly discussed, let alone debated. In this paper, we examine how fellowships can foster effective mentoring relationships. These relationships provide the foundation for the fellow's transition from novice to competent professional. In this essay, we begin by discussing our pedagogical commitments. Next, we describe the structures our program has created to assist our fellows in becoming competent ethicists. We then outline the kinds of knowledge, skills, and professional attributes mentors should possess. Following this, we focus on the knowledge, skills, and professional attributes that fellows develop as they co-create effective mentoring relationships. We will not prescribe a single approach to fellowship training; instead, our perspective will, we hope, become a catalyst for further conversation on training and mentoring clinical ethics fellows.

"You can't make me!" Managing adolescent dissent to anesthesia.

When adolescents require health care, the need to obtain consent from the parent/legal guardian and assent from the patient can create the potential for an ethical dilemma when these two parties are not in agreement. Here, we describe a representative and common case scenario in which both parent and adolescent patient gave consent and assent, respectively, with a full understanding of the risks and benefits of the procedure and anesthetic. At the time of anesthetic induction, however, the patient expresses that she no longer wishes to have the procedure. We identify a number of considerations that inform the ethical analysis of such cases and offer recommendations about the most appropriate path forward for a practitioner faced with a difficult decision about how to respond.

What the HEC-C? An Analysis of the Healthcare Ethics Consultant-Certified Program: One Year in.

Efforts to professionalize the field of bioethics have led to the development of the Healthcare Ethics Consultant-Certified (HEC-C) Program intended to credential practicing healthcare ethics consultants (HCECs). Our team of professional ethicists participated in the inaugural process to support the professionalization efforts and inform our views on the value of this credential from the perspective of ethics consultants. In this paper, we explore the history that has led to this certification process, and evaluate the ability of the HEC-C Program to meet the goals it has set forth for HCECs. We describe the benefits and weaknesses of the program and offer constructive feedback on how the process might be strengthened, as well as share our team's experience in preparing for the exam.

The Top 10 Questions Facing the Field of Clinical Ethics in 2020: Reflections on the Evolving Clinical Ethics UnConference.

Evolving Clinical Ethics: A Working UnConference, held 5 through 7 February 2020 in Houston, Texas, brought together 91 participants from a variety of institutions, many of whom are engaged in clinical ethics work. The event followed the success of the first Clinical Ethics UnConference hosted by the Cleveland Clinic Center for Bioethics in 2018, and offered an opportunity for ethicists to share both their challenges and their solutions to clinical ethics issues. In this article we explore the emerging themes of the second UnConference and identify the top 10 questions currently faced by the field. We address both unresolved issues and areas of agreement and highlight new collaborations that have been developed to work toward greater standardization in our field.

Responsibility, culpability, and parental views on genomic testing for seriously ill children.

PURPOSE: We describe parental perceptions of and experiences with genomic sequencing (GS) in the care of seriously ill children. Understanding parents' perspectives is vital for clinicians caring for children, given the uptake of genomic technologies into clinical practice. METHODS: Longitudinal, semistructured interviews were conducted with parents of pediatric cancer patients who underwent exome sequencing (ES) as a part of the BASIC3 study. Interviews were conducted at baseline, one to eight months after results disclosure, and approximately one year after disclosure. Using thematic qualitative analysis, parent interviews were coded with both inductive and deductive approaches. RESULTS: Before receiving genomic information, parents indicated that they saw ES as something responsible parents would agree to if their child had cancer. Some parents talked about the possibility of sequencing affecting feelings of culpability for their child's cancer, worrying that they passed on a cancer-causing gene or made parenting decisions that caused the disease. However, after receiving their child's ES results many reported feeling relieved of guilt and worry, and felt they had fulfilled parental duties by agreeing to ES for their child. CONCLUSION: These results reveal a layer of meaning that parents associate with GS that may inform clinicians' approach to care.

Comprehensive Quality Assessment in Clinical Ethics.

Scholars and professional organizations in bioethics describe various approaches to "quality assessment" in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes "quality" in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, iin this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction.

The Appropriate Role of a Clinical Ethics Consultant's Religious Worldview in Consultative Work: Nearly None.

Ethical reasoning is an integral part of the work of a clinical ethics consultant (CEC). Ethical reasoning has a close relationship with an individual's beliefs and values, which, for religious adherents, are likely to be tightly connected with their spiritual perspectives. As a result, for individuals who identify with a religious tradition, the process of thinking through ethical questions is likely to be influenced by their religious worldview. The connection between ethical reasoning and one's spiritual perspective raises questions about the role that CECs' personal religious worldviews should play in their professional lives and their consultative work. This paper offers numerous arguments critiquing the inclusion of a consultant's own spiritual perspective in her work and has identified only limited circumstances under which such inclusion might be permissible. In particular, these arguments lead to the conclusion that a CEC's personal beliefs should never influence her ethical analysis or development of a recommendation. Further, religious appeals should not be used in communication during decision-making conversations other than to describe the patient or surrogate's stated perspective. There may be limited cases in which a CEC may share her spiritual worldview with a patient with the intent of building a collaborative relationship, but such situations should be approached with extreme caution.

Why Families Get Angry: Practical Strategies for Clinical Ethics Consultants to Rebuild Trust Between Angry Families and Clinicians in the Critical Care Environment.

Developing a care plan in a critical care context can be challenging when the therapeutic alliance between clinicians and families is compromised by anger. When these cases occur, clinicians often turn to clinical ethics consultants to assist them with repairing this alliance before further damage can occur. This paper describes five different reasons family members may feel and express anger and offers concrete strategies for clinical ethics consultants to use when working with angry families acting as surrogate decision makers for critical care patients. We reviewed records of consults using thematic analysis between January 2015 and June 2016. Each case was coded to identify whether the case involved a negative encounter with an angry family. In our review, we selected 11 cases with at least one of the following concerns or reasons for anger: (1) perceived or actual medical error, (2) concerns about the medical team's competence, (3) miscommunication, (4) perceived conflict of interest or commitment, or (5) loss of control. To successfully implement these strategies, clinical ethics consultants, members of the medical team, and family members should share responsibility for creating a mutually respectful relationship.

Minimum Age of Sale for Tobacco Products and Electronic Cigarettes: Ethical Acceptability of US "Tobacco 21 Laws".

Several US jurisdictions have recently passed laws that raise the minimum age of sale for tobacco products and electronic cigarettes to 21 years (Tobacco 21 laws). Although these laws have been demonstrated to be an effective means to reduce youth smoking initiation, their passage and potential expansion have provoked controversy. Critics have objected to these laws, claiming that they unduly intrude on individual freedom and that they irrationally and paternalistically restrict the freedom of those aged 18 to 20 years, who were previously able to legally purchase tobacco products. We have examined the ethical acceptability of Tobacco 21 laws. First, we have described ethical support for such a restriction grounded in its public health benefit. We have then offered arguments that raise doubts about the soundness of critics' objections to these regulations and described an additional ethical justification arising from concern about preventing harm to others. On the basis of this analysis, we conclude that Tobacco 21 laws are ethically justifiable.

Should Providers Discuss Breastfeeding With Women Living With HIV in High-Income Countries? An Ethical Analysis.

As men and women with human immunodeficiency virus (HIV) are living longer, healthier lives and having children, many questions regarding reproduction in the context of HIV arise. One question is whether breastfeeding is an option for mothers living with HIV. The established recommendation is that women living with HIV in high-income countries avoid breastfeeding. However, some women may still choose to breastfeed for a variety of personal, social, or cultural reasons. Nonmaleficence ("do no harm") must be weighed against maternal autonomy. We propose that providers caring for women in this situation are ethically justified in discussing breastfeeding as a reasonable, though inferior, option. Providers should pursue a shared decision-making approach, engaging in open conversations to learn about the mother's preferences and values, providing education about risks and benefits of various feeding options, and together with the mother formulating a plan to ensure the best possible outcome for the mother and baby.

Cultivating Administrative Support for a Clinical Ethics Consultation Service.

Hospital administrators may lack familiarity with what clinical ethicists do (and do not do), and many clinical ethicists report receiving inadequate financial support for their clinical ethics consultation services (CECSs). Ethics consultation is distinct in that it is not reimbursable by third parties, and its financial benefit to the hospital may not be quantifiable. These peculiarities make it difficult for clinical ethicists to resort to tried-and-true outcome-centered evaluative strategies, like cost reduction or shortened length of stay for patients, to show a "need" for ethics consultation. Likewise, it can be difficult for clinical ethicists to "speak the same language" as healthcare administrators and managers, which, in turn, means that CECSs run the risk of being unable to demonstrate value to those who pay for the service. The purpose of this descriptive article is to provide practical guidance to clinical ethicists and program directors on how to cultivate administrative support for a CECS. Specifically, we discuss two elements that clinical ethics leaders must critically appraise and successfully argue to meet the expectations of administrators-the value of a CECS and its fit in clinical workflow.