A pilot recruitment strategy to enhance ethical and equitable access to Covid-19 pediatric vaccine trials.

BACKGROUND/AIMS: The SARS-CoV-2 pandemic disproportionately impacted communities with lower access to health care in the United States, particularly before vaccines were widely available. These same communities are often underrepresented in clinical trials. Efforts to ensure equitable enrollment of participants in trials related to treatment and prevention of Covid-19 can raise concerns about exploitation if communities with lower access to health care are targeted for recruitment. METHODS: To enhance equity while avoiding exploitation, our site developed and implemented a three-part recruitment strategy for pediatric Covid-19 vaccine studies. First, we publicized a registry for potentially interested participants. Next, we applied public health community and social vulnerability indices to categorize the residence of families who had signed up for the registry into three levels to reflect the relative impact of the pandemic on their community: high, medium, and low. Finally, we preferentially offered study participation to interested families living in areas categorized by these indices as having high impact of the Covid-19 pandemic on their community. RESULTS: This approach allowed us to meet goals for study recruitment based on public health metrics related to disease burden, which contributed to a racially diverse study population that mirrored the surrounding community demographics. While this three-part recruitment strategy improved representation of minoritized groups from areas heavily impacted by the Covid-19 pandemic, important limitations were identified that would benefit from further study. CONCLUSION: Future use of this approach to enhance equitable access to research while avoiding exploitation should test different methods to build trust and communicate with underserved communities more effectively.

Pediatric Decision-Making for Children in State Custody.

In summer 2022, six points of consensus emerged from a symposium addressing the question, "In the context of U.S. pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" (Salter et al. 2023). The authors of this statement wrote, however, that the points of consensus may require modification or may not apply in their entirety to children in state custody. This article addresses the consensus recommendations in the context of the thousands of children removed annually from the custody of their parents. While the consensus statements developed at the symposium provide a good starting point for decision-making in the context of these children, some alterations and nuance must be applied to attend to the specific needs of this population. The article works through what special considerations and changes ought to be made to expand the reach of the original points of consensus without neglecting the particular conditions of children in state custody, as well as their parents and caregivers.

Barriers to enrollment in a pediatric critical care biorepository.

BACKGROUND: Individuals of minority race/ethnicity have lower rates of participation in genomic research. This study evaluated sociodemographic characteristics associated with decisions to enroll in a pediatric critical care biorepository. METHODS: Parents of children admitted to the PICU between November 2014 and May 2017 were offered to enroll their child in a biorepository using a single-page opt-in consent. Missed enrollment was assessed by failure to complete the form or declining consent on the form. We conducted a retrospective chart review for sociodemographic and clinical information. Bivariate and multivariable regression analyses were performed. RESULTS: In 4055 encounters, representing 2910 patients with complete data, 1480 (50%) completed the consent form and 1223 (83%) enrolled. We found higher odds of incomplete consent for non-English-speaking parents (OR = 2.1, p < 0.0001) and parents of children of all races except non-Hispanic white (OR = 1.27-1.99, p < 0.0001). We found higher odds of declined consent in patients with Medicaid (OR = 1.67, p = 0.003) and parents of children of all races except non-Hispanic white (OR = 1.32-2.9, p < 0.0001). CONCLUSION: Inability to enroll patients in a critical care biorepository may be associated with several sociodemographic factors at various points in recruitment/enrollment. IMPACT: Individuals of minority race/ethnicity are less likely to enroll in genomic research and in critical care research. This study evaluated sociodemographic characteristics associated with decisions to enroll a child in a pediatric critical care biorepository. Sociodemographic factors including race/ethnicity, primary language, and insurance status and patient clinical characteristics are associated with differential enrollment into a pediatric critical care biorepository. More research is needed to understand how study team-participant interactions may play a role in differential enrollment. Barriers to enrollment occur both at the time of approaching and consenting for enrollment.

Refusals of the Determination of Death by Neurologic Criteria: A Mixed Methods Study of Physician Perspectives on Refusals Cases.

OBJECTIVES: Refusals to allow examination for determination of death by neurologic criteria (DNC) challenge pediatric physicians and create distress for medical teams and families of patients suspected to meet criteria for DNC. The objective of this study was to inquire about and assess experiences with such refusals from the perspective of physicians. DESIGN: We conducted a mixed-methods survey and interview-based study to understand physicians' experiences with refusals. SETTING: An online survey was sent to pediatric intensivists and neurologists; phone interviews were conducted in a subset. PATIENTS/PARTICIPANTS: The study included 80 physician survey respondents and 12 interview physician respondents. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Refusals occur for many reasons regarding patients with both acute and progressive brain injury. The most common reasons were consistent in surveys and interviews and include "waiting on a miracle," not wanting to give up, religious objections and disbelief in brain death. Time was an important mediator in many cases. Physicians described several approaches to managing refusals, highlighting the impact on medical teams, distraction from other patients, and need for resources to support physicians. CONCLUSIONS: Refusals may have important sociodemographic associations that should be considered in managing complex cases. Physicians seek more guidance in law and policies to manage refusals.

Addressing Racism in the Healthcare Encounter: The Role of Clinical Ethics Consultants.

Clinical ethicists move in different environments and interface with a variety of stakeholders, and are therefore uniquely positioned to answer the call for equity and anti-racism. We describe why a clinical ethicist should contribute to anti-racism efforts and describe general approaches for addressing racism across institutional contexts, including: (1) addressing racism as bedside clinical ethics consultant, (2) addressing wider lens of anti-racism work across multiple ethics consults over time, and (3) addressing racism at the organizational level.

In the Wake of a Pandemic: Revisiting School Approaches to Nonmedical Exemptions to Mandatory Vaccination in the US.

Mandatory school vaccination policies with exclusion of unvaccinated students can be a powerful tool in ensuring high vaccination rates. Some parents may object to mandatory vaccination policies, claiming exemptions based on medical, religious, or philosophical reasons. Individual schools, school systems, or local or regional governments have different policies with respect to whether, and what kind of, exemptions may be allowed. In the setting of the current pandemic, questions regarding the acceptability of exemptions have resurfaced, as schools and local governments struggle with how to safely return children to school. Anticipating that school attendance will be facilitated by the development of a vaccine, school systems will face decisions about whether to mandate vaccination and whether to permit exemptions. The American Academy of Pediatrics promulgates policy favoring the elimination of nonmedical exemptions generally in schools. This discussion considers whether schools should eliminate nonmedical exemptions to vaccination as proposed in the American Academy of Pediatrics policy, ultimately concluding that broad elimination of exemptions is not justified and advocating a more nuanced approach that encourages school attendance while promoting vaccination and broader public health goals.

Pediatric Intensivist and Pediatric Neurologist Perspectives and Practices on Death by Neurologic Criteria.

Controversies surrounding the determination of death by neurologic criteria (DNC), also known as brain death, have become increasingly common over the last decade, occasionally leading to parental refusal of all or part of an evaluation or declaration of DNC. We performed a prospective, cross-sectional study of pediatric neurologists and intensivists who participate in professional listservs to ascertain perspectives and practices concerning the evaluation of DNC, specifically on obtaining permission for evaluations and managing refusals. Of the 334 respondents who had performed an evaluation for DNC, 35 percent reported they had experienced at least one parental refusal, and 64.4 percent reported that they did not seek permission to perform an evaluation. Pediatric neurologists, careproviders who had less experience doing evaluations, and careproviders who had experienced parental refusal of an evaluation were more likely to obtain permission from parents. Most (80.8 percent) of respondents reported that their institution had a DNC policy. We found variability in many aspects of DNC evaluations and declarations, as well as the handling of refusals. Lack of consistency may make it more difficult for careproviders and families. Greater understanding of parental refusal of DNC evaluation is essential to inform efforts to increase consistency.

Surrogate Decision Making for Children: Who Should Decide?

OBJECTIVE: To identify caregivers' views on preferred surrogate decision makers for their children. STUDY DESIGN: A respondent-anonymous survey was distributed to a convenience sample of adults who accompanied a child to general and subspecialty pediatric care at 2 different institutions or were at the bedside of a child in the pediatric intensive care unit at a third institution in Chicago. RESULTS: We collected 462 valid surveys. The average age of the legal guardian and accompanying child was 36.8 years and 6.6 years, respectively. Most legal guardians designated "other parent with legal authority" as their first choice surrogate decision maker (70%). Respondent's sex, respondent's age, child's age, and child's ethnicity had no effect on first choice surrogate decision maker. "Other parent with legal authority" was less likely to be first choice surrogate if respondents had Medicaid insurance, less than a college degree, or lived in a non-nuclear household (P<.01 for all factors). The surrogacy ladder selected by 31% of legal guardians was "other parent with legal authority," "child's grandparent(s)," and "child's aunt(s) or uncle(s)." No other sequence received more than 10% designation. Study site had no effect on surrogate preference (P = .30). CONCLUSIONS: A surrogacy priority ladder for minors needs to include relatives who are often not included in state surrogacy statutes (eg, grandparents, aunts and uncles). The most popular surrogacy ladder will not be ideal for many families. Parents need to be informed and empowered to choose alternate surrogates, and documented preferences must be easily and widely accessible.

Ethical and legal considerations related to disorders of consciousness.

PURPOSE OF REVIEW: The purpose of this review is to describe ethical and legal issues that arise in the management of patients with disorders of consciousness ranging from the minimally conscious state to the coma state, as well as brain death. RECENT FINDINGS: The recent literature highlights dilemmas created by diagnostic and prognostic uncertainties in patients with disorders of consciousness. The discussion also reveals the challenges experienced by the disability community, which includes individuals with severe brain injury who are classified as having a disorder of consciousness. We review current guidelines for management of patients with disorders of consciousness including discussions around diagnosis, prognosis, consideration of neuropalliation, and decisions around life sustaining medical treatment. SUMMARY: In the setting of uncertainty, this review describes the utility of applying a disability rights perspective and shared decision-making process to approach medical decision-making for patients with disorders of consciousness. We outline approaches to identifying surrogate decision makers, standards for decision-making and decision-making processes, specifically addressing the concept of futility as a less useful framework for making decisions. We also highlight special considerations for research, innovative and controversial care, brain death, organ donation, and child abuse and neglect.

Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics.

Whether there is an upper limit of net risk that volunteers can consent to in research, and what that limit happens to be, has been the subject of persistent controversy in research ethics. This article defends the concept of an upper limit of risk in research against recent critics and supports the most promising approach for identifying this limit, that of finding comparator activities that are generally accepted in society and pose high levels of risk. However, high-risk activities that have been proposed as relevant comparators involve more certain benefits and confer considerable social esteem to those who take on the risks. This suggests that developing a robust approach to identifying social value, whether by developing a procedural safeguard or a systematic framework, could more effectively identify research with sufficient social value to justify high net risk. Additionally, the social status of research participants should be elevated to be more on par with others who laudably take on high risk for the benefit of others. By attending to the benefits necessary for the justification of high-risk research, the level of allowable risk will no longer be so controversial.

Post-operative discharge education for parent caregivers of children with congenital heart disease: a needs assessment.

OBJECTIVE: Children with congenital heart disease (CHD) have complex unique post-operative care needs. Limited data assess parents' hospital discharge preparedness and education quality following cardiac surgery. The goals were to identify knowledge gaps in discharge preparedness after congenital heart surgery and to assess the acceptability of an educational mobile application to improve discharge preparedness. METHODS: Telephonic interviews with parents of children with two-ventricle physiology who underwent cardiac surgery 5-7 days post-discharge and in-person interviews with clinicians were conducted. We collected parent and clinician demographics, parent health literacy information and patient clinical data. We analysed interview transcripts using summative content analysis. RESULTS: We interviewed 26 parents and 6 clinicians. Twenty-two of the 26 (85%) parents felt ready for discharge; 4 of the 6 (67%) clinicians did not feel most parents were ready for discharge. Fifteen of the 26 parents (58%) reported receiving the majority of discharge teaching on the day of discharge. Eight parents did not feel like all of their questions were answered. Most parents (14/26, 54%) preferred visual educational learning aids and could accurately describe important aspects of care. Most parents (23/26, 88%) and all 6 clinicians felt a mobile application for post-operative care education would be helpful. CONCLUSIONS: Most parents received education on the day of discharge and could describe the information they received prior to discharge, although there were some preparedness gaps identified after discharge. Clinicians and parents varied in their perceptions of the readiness for discharge. Most responses suggest that a mobile application for discharge education may be helpful for transition to home.

Abusive Head Trauma and Parental Participation in Pediatric Decision Making.

Decision making for children who suffer abusive head trauma invokes multiple ethical considerations. The degree to which parents are permitted to participate in decision making after the injury has occurred is controversial. In particular, in this issue of The Journal of Clinical Ethics, Grigorian and colleagues raise concerns about the potential for conflict of interest in end-of-life decision making if the parents are facing criminal charges that could be escalated if the child dies. There are additional concerns about the parents' capacity to make decisions that are best for the child, given that the injury occurred. We argue that there are important reasons not to exclude parents from the decision-making process and that, with appropriate safeguards in place, parents are integral to determining what is best for the child.

The Multidimensional Illness Severity Questionnaire: Preliminary evaluation of a brief parent-reported measure of illness severity.

AIM: This study describes the reliability and concurrent validity of the Multidimensional Illness Severity Questionnaire (MISQ), a five-item measure for capturing parents' reports of their child's illness severity. METHODS: We conducted a cross-sectional survey of parents of children participating in a paediatric research study (n = 20). We assessed parents' perceptions of illness severity using five measures: (i) the MISQ, (ii) the Lansky Play Performance scale, (iii) the Severity of Illness Scale, (iv) subscales of the Parent Experience of Child Illness and (v) general health. We calculated the internal reliability of the MISQ using Cronbach's alpha and assessed concurrent validity through correlations between scores on the MISQ and other measures. RESULTS: MISQ scores ranged from 6/21 to 17/21 (mean = 11.5). The MISQ had adequate internal consistency (Cronbach's α = 0.76) and correlated strongly with other measures. CONCLUSION: Preliminary evaluation suggests that the MISQ is an easy-to-administer and internally consistent multidimensional assessment of parent-reported illness severity.

Constrained Parental Autonomy and the Interests of Children in Non-Intimate Families.

Children's age and developmental capacity leave them incapable of making medical decisions for themselves. Decisions for children are traditionally made under the best interest standard. Ross calls into question whether the best interest standard can function as both a guidance and intervention principle, able to be applied across the spectrum of pediatric decision making. Ross describes constrained parental autonomy as an alternative model, arguing that it affords parents the ability to make decisions within the context of their family while upholding a child's current and future interests. Although the model provides a robust framework for intrafamilial decision making, I question whether it can be broadly applied to children living in non-intimate families.

Involving Minors in Medical Decision Making: Understanding Ethical Issues in Assent and Refusal of Care by Minors.

When caring for minors, the clinician-patient relationship becomes more ethically complex by the inclusion of parents in the clinician-parent-patient triad. As they age, children become more capable of participating in the decision-making process. This involvement may lead them to either accept or refuse proposed care, both of which are ethically acceptable positions when the minor's capacity to participate in decision making is carefully considered in the context of their age, development, and overall health. Certain conditions may be more likely to impact their capacity for participation, but it is important for clinicians to avoid categorical presumption that minors of a certain age or with certain conditions are incapable of participating in decisions regarding their care. Understanding the ethical bases for decision making in pediatric patients and considerations for the involvement of minors who both assent to and refuse proposed treatment will equip clinicians to respect the growing autonomy of minor patients.