Experiences of US Clinicians Contending With Health Care Resource Scarcity During the COVID-19 Pandemic, December 2020 to December 2021.

Importance: The second year of the COVID-19 pandemic saw periods of dire health care resource limitations in the US, sometimes prompting official declarations of crisis, but little is known about how these conditions were experienced by frontline clinicians. Objective: To describe the experiences of US clinicians practicing under conditions of extreme resource limitation during the second year of the pandemic. Design, Setting, and Participants: This qualitative inductive thematic analysis was based on interviews with physicians and nurses providing direct patient care at US health care institutions during the COVID-19 pandemic. Interviews were conducted between December 28, 2020, and December 9, 2021. Exposure: Crisis conditions as reflected by official state declarations and/or media reports. Main Outcomes and Measures: Clinicians' experiences as obtained through interviews. Results: Interviews with 23 clinicians (21 physicians and 2 nurses) who were practicing in California, Idaho, Minnesota, or Texas were included. Of the 23 total participants, 21 responded to a background survey to assess participant demographics; among these individuals, the mean (SD) age was 49 (7.3) years, 12 (57.1%) were men, and 18 (85.7%) self-identified as White. Three themes emerged in qualitative analysis. The first theme describes isolation. Clinicians had a limited view on what was happening outside their immediate practice setting and perceived a disconnect between official messaging about crisis conditions and their own experience. In the absence of overarching system-level support, responsibility for making challenging decisions about how to adapt practices and allocate resources often fell to frontline clinicians. The second theme describes in-the-moment decision-making. Formal crisis declarations did little to guide how resources were allocated in clinical practice. Clinicians adapted practice by drawing on their clinical judgment but described feeling ill equipped to handle some of the operationally and ethically complex situations that fell to them. The third theme describes waning motivation. As the pandemic persisted, the strong sense of mission, duty, and purpose that had fueled extraordinary efforts earlier in the pandemic was eroded by unsatisfying clinical roles, misalignment between clinicians' own values and institutional goals, more distant relationships with patients, and moral distress. Conclusions and Relevance: The findings of this qualitative study suggest that institutional plans to protect frontline clinicians from the responsibility for allocating scarce resources may be unworkable, especially in a state of chronic crisis. Efforts are needed to directly integrate frontline clinicians into institutional emergency responses and support them in ways that reflect the complex and dynamic realities of health care resource limitation.

Beyond Autonomy: Ethics of Decision Making About Treatments for Kidney Failure at the Extremes of Age.

Decisions around initiating and forgoing treatments for kidney failure are complex, and contemporary approaches to medical decision making are designed to uphold patients' own preferences and values when there are multiple clinically reasonable treatment options. When patients do not have cognitive capacity to make their own decisions, these models can be adapted to support the previously expressed preferences of older adults and to promote open futures as autonomous persons for young children. Nonetheless, an autonomy-focused approach to decision making may not align with other overlapping values and needs of these groups. Dialysis profoundly shapes life experience. Values framing decisions about this treatment extend beyond independence and self-determination and vary between life stages. Patients at the extremes of age may place a strong emphasis on dignity, caring, nurturing, and joy. Models of decision making tailored to support an autonomous individual may also discount the role of family as not only surrogate decision makers but stakeholders whose lives and experience are interwoven with a patient's and will be shaped by their treatment decisions. These considerations underline a need to more flexibly incorporate a diversity of ethical frameworks to support medical decisions, especially for the very young and old, when facing complex medical decisions such as initiating or forgoing treatments for kidney failure.

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.

Psychiatric Diagnoses in Children With CKD Compared to the General Population.

Rationale & Objective: Children with chronic kidney disease (CKD) are subject to physical and psychosocial challenges, which may confer greater risk of developing psychiatric disorders. We sought to examine key psychiatric diagnoses in children with CKD compared with those in the general pediatric population and assess the correlation between parent-reported diagnosis and self-reported symptoms of depression. Study Design: Cross-sectional. Setting & Participants: Children ages 2-17 years receiving current medical care who participated in the Chronic Kidney Disease in Children Study (CKiD) or the National Survey of Children's Health. Exposure: CKD. Outcomes: Parent-reported diagnoses of depression, anxiety, or attention-deficit and hyperactivity disorder (ADHD). Analytical Approach: Using Poisson regression, we determined the age, sex, and race-adjusted prevalence ratio comparing diagnoses between children with CKD and those in the general population overall and within subgroups of sex, race, maternal education status, and CKD stage. Secondarily, we examined the correlation between depression status using standardized self-reported screening instrument scores and parent-reported diagnosis. Results: Eight hundred seventy-five children with CKD and 72,699 children in the general population were included. Those with CKD had an adjusted prevalence ratio of 1.32 (95% CI, 1.01-1.73) for depression, 0.72 (95% CI, 0.52-0.99) for anxiety, and 1.03 (95% CI, 0.86-1.25) for ADHD. The results were similar across subgroups of CKD stage, sex, race, or maternal education. The correlation between parent-reported diagnosis and instrument-detected depression was weak, r = 0.13 (95% CI, 0.03-0.23). Limitations: Retrospective parent- or self-reported data were used. Conclusions: Children with CKD had a higher prevalence of parent-reported depression, equivalent prevalence of attention-deficit and hyperactivity disorder, and lower prevalence of anxiety diagnoses compared to other children. These findings are inconsistent with results of prior studies and suggest that baseline assessments used in CKiD may have limited utility in describing psychiatric disorders among children with CKD. Improved mental health assessment approaches in pediatric nephrology are needed.

Pediatric Death by Neurologic Criteria: The Ever-Changing Landscape and the Expanding Role of Palliative Care Professionals.

Pediatric palliative care providers are especially suited to support families and medical teams facing a potential diagnosis of brain death, or death by neurologic criteria (DNC), when a child suffers a devastating brain injury. To support pediatric palliative care providers' effectiveness in this role, this article elucidates the clinical determination of DNC and the evolution of the ethical and legal controversies surrounding DNC. Conceptual definitions of death used in the context of DNC have been and continue to be debated amongst academicians, and children's families often have their own concept of death. Increasingly, families have brought legal cases challenging the definition of death, arguing for a right to refuse examination to diagnose DNC, and/or voicing religious objections. We describe these conceptual definitions and legal challenges then explore some potential reasons why families may dispute a determination of DNC. We conclude that working with patients, families, and healthcare providers facing DNC carries inherent and unique challenges suited to intervention by interdisciplinary palliative care teams.

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.

US Clinicians' Experiences and Perspectives on Resource Limitation and Patient Care During the COVID-19 Pandemic.

Importance: Little is known about how US clinicians have responded to resource limitation during the coronavirus disease 2019 (COVID-19) pandemic. Objective: To describe the perspectives and experiences of clinicians involved in institutional planning for resource limitation and/or patient care during the pandemic. Design, Setting, and Participants: This qualitative study used inductive thematic analysis of semistructured interviews conducted in April and May 2020 with a national group of clinicians (eg, intensivists, nephrologists, nurses) involved in institutional planning and/or clinical care during the COVID-19 pandemic across the United States. Main Outcomes and Measures: Emergent themes describing clinicians' experience providing care in settings of resource limitation. Results: The 61 participants (mean [SD] age, 46 [11] years; 38 [63%] women) included in this study were practicing in 15 US states and were more heavily sampled from areas with the highest rates of COVID-19 infection at the time of interviews (ie, Seattle, New York City, New Orleans). Most participants were White individuals (39 [65%]), were attending physicians (45 [75%]), and were practicing in large academic centers (≥300 beds, 51 [85%]; academic centers, 46 [77%]). Three overlapping and interrelated themes emerged from qualitative analysis, as follows: (1) planning for crisis capacity, (2) adapting to resource limitation, and (3) multiple unprecedented barriers to care delivery. Clinician leaders worked within their institutions to plan a systematic approach for fair allocation of limited resources in crisis settings so that frontline clinicians would not have to make rationing decisions at the bedside. However, even before a declaration of crisis capacity, clinicians encountered varied and sometimes unanticipated forms of resource limitation that could compromise care, require that they make difficult allocation decisions, and contribute to moral distress. Furthermore, unprecedented challenges to caring for patients during the pandemic, including the need to limit in-person interactions, the rapid pace of change, and the dearth of scientific evidence, added to the challenges of caring for patients and communicating with families. Conclusions and Relevance: The findings of this qualitative study highlighted the complexity of providing high-quality care for patients during the COVID-19 pandemic. Expanding the scope of institutional planning to address resource limitation challenges that can arise long before declarations of crisis capacity may help to support frontline clinicians, promote equity, and optimize care as the pandemic evolves.

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility.

Our aims are to (1) set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; (2) defend this system by appealing to justice principles; and (3) illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies.

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Update on Ethical Issues in Pediatric Dialysis: Has Pediatric Dialysis Become Morally Obligatory?

Improvements in pediatric dialysis over the past 50 years have made the decision to proceed with dialysis straightforward for the majority of pediatric patients. For certain groups, however, such as children with multiple comorbid conditions, children and families with few social and economic resources, and neonates and infants, the decision of whether to proceed with dialysis remains much more controversial. In this review, we will examine the best available data regarding the outcomes of dialysis in these populations and analyze the important ethical considerations that should guide decisions regarding dialysis for these patients. We conclude that providers must continue to follow a nuanced and individualized approach in decision making for each child and to recognize that, regardless of the decision reached about dialysis, there is a continued duty to care for patients and families to maximize the remaining quality of their lives.

Pediatric nephrologists' beliefs regarding randomized controlled trials.

BACKGROUND: Pediatrics and pediatric nephrology lag behind adult medicine in producing randomized controlled trials (RCTs). Physician attitudes have been shown to play a significant role in RCT enrollment. METHODS: We surveyed members of the American Society of Pediatric Nephrology regarding beliefs about RCTs and factors influencing decisions to recommend RCT enrollment. Regression analyses were used to identify the effects of variables on an aggregate score summarizing attitudes toward RCTs. RESULTS: One hundred thirty replies were received. Sixty-six percent had enrolled patients in RCTs. Respondents in practice for more than 15 years were more likely to have recruited a patient to an RCT than those in practice for less than 5 years. Respondents were more willing to recommend RCT enrollment if the study was multicenter, patients were sicker or had a poorer prognosis, or if the parent or participant received a financial incentive versus the provider. In multiple regression analysis, history of enrolling patients in an RCT was the only significant predictor of higher aggregate RCT-friendly attitude. CONCLUSIONS: Many pediatric nephrologists have never enrolled a patient in an RCT, particularly those in practice for less than 5 years. Respondents who have not enrolled patients in RCTs have a less RCT-friendly attitude. Provision of improved training and resources might increase participation of junior providers in RCTs.