Limits on Parental Discretion in Medical Decision-Making: pediatric intervention principles converge.

Pediatric intervention principles help clinicians and health-care institutions determine appropriate responses when parents' medical decisions place children at risk. Several intervention principles have been proposed and defended in the pediatric ethics literature. These principles may appear to provide conflicting guidance, but much of that conflict is superficial. First, seemingly different pediatric intervention principles sometimes converge on the same guidance. Second, these principles often aim to solve different problems in pediatrics or to operate in different background conditions. The potential for convergence between intervention principles-or at least an absence of conflict between them-matters for both the theory and practice of pediatric ethics. This article builds on the recent work of a diverse group of pediatric ethicists tasked with identifying consensus guidelines for pediatric decision-making.

Pediatric Decision Making: Consensus Recommendations.

Despite apparent disagreement in the scholarly literature on standards of pediatric decision making, a recognition that similar norms underpin many of the dominant frameworks motivated a June 2022 symposium "Best Interests and Beyond: Standards of Decision Making in Pediatrics" in St Louis, MO. Over the course of this 3-day symposium, 17 expert scholars (see author list) deliberated on the question "In the context of US pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" The symposium and subsequent discussion generated 6 consensus recommendations for pediatric decision making, constructed with the primary goals of accessibility, teachability, and feasibility for practicing clinicians, parents, and legal guardians. In this article, we summarize these recommendations, including their justification, limitations, and remaining concerns.

An ethical analysis of obesity as a contraindication to pediatric liver transplant candidacy.

Childhood obesity is becoming more prevalent in the United States (US) and worldwide, including among children in need of a liver transplant. Unlike with heart and kidney failure, end-stage liver disease (ESLD) is unique in that no widely available medical technology can re-create the life-sustaining function of a failing liver. Therefore, delaying a life-saving liver transplant for weight loss, for example, is much harder, if not impossible for many pediatric patients, especially those with acute liver failure. For adults in the United States, guidelines consider obesity a contraindication to liver transplant. Although formal guidelines are lacking in children, many pediatric transplant centers also consider obesity a contraindication to a pediatric liver transplant. Variations in practice among pediatric institutions may result in biased and ad hoc decisions that worsen healthcare inequities. In this article, we define and report the prevalence of childhood obesity among children with ESLD, review existing guidelines for liver transplant in adults with obesity, examine pediatric liver transplant outcomes, and discuss the ethical considerations of using obesity as a contraindication to pediatric liver transplant informed by the principles of utility, justice, and respect for persons.

An ethical analysis of obesity as a contraindication of pediatric kidney transplant candidacy.

The inclusion of body mass index (BMI) as a criterion for determining kidney transplant candidacy in children raises clinical and ethical challenges. Childhood obesity is on the rise and common among children with kidney failure. In addition, obesity is reported as an independent risk factor for the development of CKD and kidney failure. Resultantly, more children with obesity are anticipated to need kidney transplants. Most transplant centers around the world use high BMI as a relative or absolute contraindication for kidney transplant. However, use of obesity as a relative or absolute contraindication for pediatric kidney transplant is controversial. Empirical data demonstrating poorer outcomes following kidney transplant in obese pediatric patients are limited. In addition, pediatric obesity is distributed inequitably among groups. Unlike adults, most children lack independent agency to choose their food sources and exercise opportunities; they are dependent on their families for these choices. In this paper, we define childhood obesity and review (1) the association and impact of obesity on kidney disease and kidney transplant, (2) existing adult guidelines and rationale for using high BMI as a criterion for kidney transplant, (3) the prevalence of childhood obesity among children with kidney failure, and (4) the existing literature on obesity and pediatric kidney transplant outcomes. We then discuss ethical considerations related to the use of obesity as a criterion for kidney transplant.

Parental Refusals of Blood Transfusions from COVID-19 Vaccinated Donors for Children Needing Cardiac Surgery.

There is a growing trend of refusal of blood transfusions from COVID-19 vaccinated donors. We highlight three cases where parents have refused blood transfusions from COVID-19 vaccinated donors on behalf of their children in the setting of congenital cardiac surgery. These families have also requested accommodations such as explicit identification of blood from COVID-19 vaccinated donors, directed donation from a COVID-19 unvaccinated family member, or use of a non-standard blood supplier. We address the ethical challenges posed by these issues. We describe the current screening and safety processes for standard blood donation and explore the importance of donor anonymity and challenges with directed donation and non-standard blood suppliers. We present an ethical framework using the Best Interest Standard, the Zone of Parental Discretion, and the Harm Principle when considering these refusals. Finally, we provide recommendations for how to approach these requests as they potentially become more commonplace in pediatrics.

Health Care Clinicians and Product Promotion by Industry.

Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care providers and industry is necessary in the design, testing, and manufacture of these medical products. However, health care providers must recognize that their duties and the interests of industry may, at times, diverge. Relationships with industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care providers as a target of their efforts, and some of the interactions that occur between industry and health care providers have the potential to alter decision making in ways that may not necessarily benefit patients. Health care providers have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. Health care providers should be aware of the techniques used to attempt to alter their behavior and guard against them.

Health Care Clinicians and Product Promotion by Industry.

Medical pharmaceutical and device manufacturers are essential in making products that benefit patients, and collaboration between health care clinicians and the industry is necessary for the design and manufacture of these medical products. However, health care clinicians must recognize that their duties and the interests of the industry may at times diverge. Relationships with the industry, even seemingly minor ones, have the potential to shape the decisions made on behalf of patients. The marketing divisions of pharmaceutical and medical device firms view health care clinicians as targets of their efforts, and some of the interactions that occur between the industry and health care clinicians have the potential to alter decision making in ways that may not necessarily benefit patients. Health care clinicians have an ethical duty to recognize situations and marketing strategies that are designed to influence their choice of diagnostic and therapeutic options for their patients. At a minimum, health care clinicians should be aware of the techniques used to attempt to alter their behavior and guard against them.

Staffing crisis capacity: a different approach to healthcare resource allocation for a different type of scarce resource.

Severe staffing shortages have emerged as a prominent threat to maintaining usual standards of care during the COVID-2019 pandemic. In dire settings of crisis capacity, healthcare systems assume the ethical duty to maximise aggregate population-level benefit of existing resources. To this end, existing plans for rationing mechanical ventilators and intensive care unit beds in crisis capacity focus on selecting individual patients who are most likely to survive and prioritising these patients to receive scarce resources. However, staffing capacity is conceptually different from availability of these types of discrete resources, and the existing strategy of identifying and prioritising patients with the best prognosis cannot be readily adapted to fit this real-world scenario. We propose that two alternative approaches to staffing resource allocation offer a better conceptual fit: (1) prioritise the worst off: restrict access to acute care services and hospital admission for patients at relatively low clinical risk and (2) prioritise staff interventions with high near-term value: universally restrict selected interventions and treatments that require substantial staff time and/or energy but offer minimal near-term patient benefit. These strategies-while potentially resulting in care that deviates from usual standards-support the goal of maximising the aggregate benefit of scarce resources in crisis capacity settings triggered by staffing shortages. This ethical framework offers a foundation to support institutional leaders in developing operationalisable crisis capacity policies that promote fairness and support healthcare workers.

Caregiver COVID-19 vaccination for solid organ transplant candidates.

An increasing proportion of transplant centers have implemented a mandate for vaccination against COVID-19 for solid organ transplant candidates. There has been comparatively little exploration of the ethical considerations of mandating vaccination of a candidate's primary caregiver, despite a high risk of transmission given the close nature of contact between the candidate and caregiver. We examine how a caregiver mandate can improve overall utility in organ allocation, particularly in circumstances where vaccine effectiveness at preventing transmission and serious disease is low among recipients but high in caregivers. Our analysis reveals how sensitive such mandates must be to the evolving circumstances of disease severity, transmissibility, and vaccine effectiveness: as the facts change, the degree of benefit gained and therefore the degree of infringement on access to transplant and caregiver choice that is tolerated will likewise change.

Perspectives of Triage Team Members Participating in Statewide Triage Simulations for Scarce Resource Allocation During the COVID-19 Pandemic in Washington State.

Importance: The COVID-19 pandemic prompted health care institutions worldwide to develop plans for allocation of scarce resources in crisis capacity settings. These plans frequently rely on rapid deployment of institutional triage teams that would be responsible for prioritizing patients to receive scarce resources; however, little is known about how these teams function or how to support team members participating in this unique task. Objective: To identify themes illuminating triage team members' perspectives and experiences pertaining to the triage process. Design, Setting, and Participants: This qualitative study was conducted using inductive thematic analysis of observations of Washington state triage team simulations and semistructured interviews with participants during the COVID-19 pandemic from December 2020 to February 2021. Participants included clinician and ethicist triage team members. Data were analyzed from December 2020 through November 2021. Main Outcomes and Measures: Emergent themes describing the triage process and experience of triage team members. Results: Among 41 triage team members (mean [SD] age, 50.3 [11.4] years; 21 [51.2%] women) who participated in 12 simulations and 21 follow-up interviews, there were 5 Asian individuals (12.2%) and 35 White individuals (85.4%); most participants worked in urban hospital settings (32 individuals [78.0%]). Three interrelated themes emerged from qualitative analysis: (1) understanding the broader approach to resource allocation: participants strove to understand operational and ethical foundations of the triage process, which was necessary to appreciate their team's specific role; (2) contending with uncertainty: team members could find it difficult or feel irresponsible making consequential decisions based on limited clinical and contextual patient information, and they grappled with ethically ambiguous features of individual cases and of the triage process as a whole; and (3) transforming mindset: participants struggled to disentangle narrow determinations about patients' likelihood of survival to discharge from implicit biases and other ethically relevant factors, such as quality of life. They cited the team's open deliberative process, as well as practice and personal experience with triage as important in helping to reshape their usual cognitive approach to align with this unique task. Conclusions and Relevance: This study found that there were challenges in adapting clinical intuition and training to a distinctive role in the process of scarce resource allocation. These findings suggest that clinical experience, education in ethical and operational foundations of triage, and experiential training, such as triage simulations, may help prepare clinicians for this difficult role.

Rhetoric, Persuasion, Compulsion, and the Stubborn Problem of Vaccine Hesitancy.

Despite the impact of vaccination on the control and prevention of many infectious diseases, vaccine opposition and hesitancy remain significant barriers to fully protecting individuals and communities against serious disease. The primary response to the problem of vaccine hesitancy includes persuasion and some degree of compulsion, usually in the form of vaccine mandates. Persuasion, if it can be successfully leveraged to provide sufficient control of disease spread, is the ethically preferred approach. Yet persuasion has proven less than adequate, leading to increasing calls for vaccination mandates and the elimination of nonmedical exemptions to those mandates. Four scholars have recently examined the underlying causes of vaccine hesitancy in the interest of improving rhetoric surrounding vaccination. This article reviews those books and offers suggestions for optimizing the strategy of persuasion in the interest of reducing the need for compulsion.

Patient Information Items Needed to Guide the Allocation of Scarce Life-Sustaining Resources: A Delphi Study of Multidisciplinary Experts.

OBJECTIVE: Plans for allocation of scarce life-sustaining resources during the coronavirus disease 2019 (COVID-19) pandemic often include triage teams, but operational details are lacking, including what patient information is needed to make triage decisions. METHODS: A Delphi study among Washington state disaster preparedness experts was performed to develop a list of patient information items needed for triage team decision-making during the COVID-19 pandemic. Experts proposed and rated their agreement with candidate information items during asynchronous Delphi rounds. Consensus was defined as ≥80% agreement. Qualitative analysis was used to describe considerations arising in this deliberation. A timed simulation was performed to evaluate feasibility of data collection from the electronic health record. RESULTS: Over 3 asynchronous Delphi rounds, 50 experts reached consensus on 24 patient information items, including patients' age, severe or end-stage comorbidities, the reason for and timing of admission, measures of acute respiratory failure, and clinical trajectory. Experts weighed complex considerations around how information items could support effective prognostication, consistency, accuracy, minimizing bias, and operationalizability of the triage process. Data collection took a median of 227 seconds (interquartile range = 205, 298) per patient. CONCLUSIONS: Experts achieved consensus on patient information items that were necessary and appropriate for informing triage teams during the COVID-19 pandemic.

Functionality of Scarce Healthcare Resource Triage Teams During the COVID-19 Pandemic: A Multi-Institutional Simulation Study.

Plans for allocating scarce healthcare resources during the COVID-19 pandemic commonly involve the activation of institutional triage teams. These teams would be responsible for selecting patients who are most likely to survive to be prioritized to receive scarce resources. However, there is little empirical support for this approach. DESIGN: High-fidelity triage-team simulation study. SETTING: Healthcare institutions in Washington state. SUBJECTS: Triage teams, consisting of at least two senior clinicians and a bioethicist. INTERVENTIONS: Participants reviewed a limited amount of deidentified information for a diverse sample of critically ill patients. Teams then assigned each patient to one of five prioritization categories defined by likelihood of survival to hospital discharge. The process was refined based on observation and participant feedback after which a second phase of simulations was conducted. MEASUREMENTS AND MAIN RESULTS: Feasibility was assessed by the time required for teams to perform their task. Prognostic accuracy was assessed by comparing teams' prediction about likelihood of survival to hospital discharge with real-world discharge outcomes. Agreement between the teams on prognostic categorization was evaluated using kappa statistics. Eleven triage team simulations (eight in phase 1 and three in phase 2) were conducted from December 2020 to February 2021. Overall, teams reviewed a median of 23 patient cases in each session (interquartile range [IQR], 17-29) and spent a median of 102 seconds (IQR, 50-268) per case. The concordance between expected survival and real-world survival to discharge was 71% (IQR, 64-76%). The overall agreement between teams for placement of patients into prognostic categories was moderate (weighted kappa = 0.53). CONCLUSIONS: These findings support the potential feasibility, accuracy, and effectiveness of institutional triage teams informed by a limited set of patient information items as part of a strategy for allocating scarce resources in healthcare emergencies. Additional work is needed to refine the process and adapt it to local contexts.

Should Health Care Institutions Mandate SARS-CoV-2 Vaccination for Staff?

Health care workers have been prioritized for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, but vaccine hesitancy among workers may limit uptake. Institutions may wish to consider SARS-CoV-2 vaccine mandates for health care workers, but such proposals raise important ethical questions. Arguments supporting mandates emphasize the proposed favorable balance of harms and benefits for both individuals and communities, as well as moral duties of health care workers and organizations. Arguments in opposition seek to challenge some claims about utility and raise additional concerns about infringement on autonomy, damage to organizational relationships, and injustice. While available SARS-CoV-2 vaccines remain under an experimental designation, mandates may be excessively problematic, but following approval by the Food and Drug Administration mandates may be reconsidered. The authors summarize ethical arguments and practical considerations, concluding that mandates may be ethically permissible in select circumstances.

Competencies and Milestones for Bioethics Trainees: Beyond ASBH's Healthcare Ethics Certification and Core Competencies.

Clinical ethics training programs are responsible for preparing their trainees to be competent ethics consultants worthy of the trust of patients, families, surrogates, and healthcare professionals. While the American Society for Bioethics and Humanities (ASBH) offers a certification examination for healthcare ethics consultants, no tools exist for the formal evaluation of ethics trainees to assess their progress toward competency. Medical specialties accredited by the Accreditation Council for Graduate Medical Education (ACGME) use milestones to report trainees' progress along a continuum of professional development as a means of "operationalizing and implementing" medical competencies. Utilizing the Core Competencies for Healthcare Ethics Consultation and the ACGME and American Board of Pediatrics' (ABP) Pediatric Milestones Project, we developed milestones for 17 subcompetencies in clinical ethics consultation and academic bioethics. As the field of clinical ethics becomes more standardized, such tools will be needed to promote the development of robust training programs and to certify that their graduates are competent practitioners.

Pandemics and Beyond: Considerations When Personal Risk and Professional Obligations Converge.

With each novel infectious disease outbreak, there is scholarly attention to healthcare providers' obligation to assume personal risk while they care for infected patients. While most agree that healthcare providers have a duty to assume some degree of risk, the extent of this obligation remains uncertain. Furthermore, these analyses rarely examine healthcare institutions' obligations during these outbreaks. As a result, there is little practical guidance for healthcare institutions that are forced to weigh whether or when to exclude healthcare providers from providing care or allow them to opt out from providing care to protect themselves. This article uses the COVID-19 pandemic to examine the concept of risk and the professional duties of both healthcare providers and healthcare institutions, and proposes a framework that can be used to make concrete institutional policy choices. This framework should be a useful tool for any hospital, clinic, or health agency that must make these choices during the current pandemic and beyond.

Vaccine ethics: an ethical framework for global distribution of COVID-19 vaccines.

This paper addresses the just distribution of vaccines against the SARS-CoV-2 virus and sets forth an ethical framework that prioritises frontline and essential workers, people at high risk of severe disease or death, and people at high risk of infection. Section I makes the case that vaccine distribution should occur at a global level in order to accelerate development and fair, efficient vaccine allocation. Section II puts forth ethical values to guide vaccine distribution including helping people with the greatest need, reducing health disparity, saving the most lives and promoting narrow social utility. It also responds to objections which claim that earlier years have more value than later years. Section III puts forth a practical ethical framework to aid decision-makers and compares it with alternatives.

The limits of refusal: An ethical review of solid organ transplantation and vaccine hesitancy.

Patients pursuing solid organ transplantation are encouraged to receive many vaccines on an accelerated timeline. Vaccination prior to transplantation offers the best chance of developing immunity and may expand the pool of donor organs that candidates can accept without needing posttransplant therapy. Furthermore, transplant recipients are at greater risk for acquiring vaccine-preventable illnesses or succumbing to severe sequelae of such illnesses. However, a rising rate of vaccine refusal has challenged transplant centers to address the phenomenon of vaccine hesitancy. Transplant centers may need to consider adopting a policy of denial of solid organ transplantation on the basis of vaccine refusal for non-medical reasons (i.e., philosophical or religious objections or personal beliefs that vaccines are unnecessary or unsafe). Arguments supporting such a policy are motivated by utility, stewardship, and beneficence. Arguments opposing such a policy emphasize justice and respect for persons, and seek to avoid worsening inequities or medical coercion. This paper examines these arguments and situates them within the special cases of pediatric transplantation, emergent transplantation, and living donation. Ultimately, a uniform national policy addressing vaccine refusal among transplant candidates is needed to resolve this ethical dilemma and establish a consistent, fair, and standard approach to vaccine refusal in transplantation.