Evaluate the benefit of obstetrical interventions on neonatal survival in twin pregnancies at the threshold of viability. This is a retrospective multi-center study of twin gestations delivered between 22 0/7 and 24 6/7 weeks gestation from January 2010 to July 2020 across 16 geographically distinct and diverse institutions. The primary objective was to assess the impact of obstetrical interventions on neonatal survival from delivery room. Secondary outcomes included assessing maternal demographic characteristics and mode of delivery on survival. Statistical analysis employed independent t-tests for continuous variables, chi square for categorical variables and generalized linear models to explore intervention differences. 377 mothers met the inclusion criteria. Overall survival was 91.7% and was not impacted by maternal characteristics (age, parity, race/ethnicity, or insurance). Neonates who survived had a higher birth weight than those that died (595g ± 120 vs. 466g ± 113, p< 0.01). Obstetrics inventions including: antenatal corticosteroids (96% vs 83.2%, p< 0.01), magnesium sulfate (97.7% vs 83.6%, p< 0.01), tocolytic therapy (97.4% vs 88.8%, p< 0.01) and GBS prophylaxis (97.3% vs 88.2%, p< 0.01) demonstrated a significant increase in overall survival. Vaginal delivery was associated with increased survival compared to cesarean delivery (95.4% vs 88.7%, p=0.02). A stratified analysis of survival and obstetrical intervention by weeks of gestation is shown in Table 1. There was no difference in survival based on obstetrical intervention at 24wk. Antenatal corticosteroids were associated with increased survival at 22wk. Magnesium sulfate and tocolytic therapy were associated with increased survival at 23wk. Receipt of obstetrical interventions and vaginal delivery increased overall survival from delivery room for twin neonates born in the periviable period.
ObjectiveShared decision-making (SDM) between parents facing extremely preterm delivery and the medical team is recommended to develop the best course of action for neonatal care. We aimed to describe the creation and testing of a literature-based checklist to assess SDM practices for consultation with parents facing extremely preterm delivery.Study designThe checklist of SDM counseling behaviors was created after literature review and with expert consensus. Mock consultations with a standardized patient facing extremely preterm delivery were performed, video-recorded, and scored using the checklist. Intraclass correlation coefficients and Cronbach's alpha were calculated.ResultThe checklist was moderately reliable for all scorers in aggregate. Differences existed between subcategories within classes of scorer, and between scorer classes. Agreement was moderate between expert scorers, but poor between novice scorers. Internal consistency of the checklist was excellent (Cronbach's alpha = 0.93).ConclusionThis novel checklist for evaluating SDM shows promise for use in future research, training, and clinical settings.
ObjectiveTo compare estimated healthcare resources needed to care for 22 through 24 weeks’ gestation infants.Study designThis multicenter, retrospective cohort study included 1,505 live in-born and out-born infants 22 through 24 weeks’ gestational age at delivery from six pediatric tertiary care hospitals from 2011 through 2020. Median neonatal intensive care unit (NICU) length of stay (LOS) for each gestational age was used as a proxy for hospital resource utilization, and the number of comorbidities and medical technology use for each infant were used as estimates of future medical care needs. Data were analyzed using Kruskal-Wallis with Nemenyi’s post hoc test and Fisher’s exact test.ResultsOf the identified newborns, 22-week infants had shorter median LOS than their 23- and 24-week counterparts due to low survival rates. There was no significant difference in LOS for surviving 22-week infants compared with surviving 23-week infants. Surviving 22-week infants had similar proportions of comorbidities and medical technology use as 23-week infants.ConclusionsCompared with 23- and 24-week infants, 22-week infants did not use a disproportionate amount of hospital resources. 22-week infants should not be excluded from resuscitation based on concern for increased hospital care and medical technology requirements. As overall resuscitation efforts and survival rates increase for 22-week infants, future research will be needed to assess the evolution of these results.
Objective The aim of this study was to examine bereavement support for siblings of patients who die in the neonatal intensive care unit (NICU) given the adverse effects of unprocessed grief and the paucity of information on children whose newborn siblings die Study Design This was an anonymous online original survey assessing pre-COVID-19 pandemic bereavement services for NICU families, clinicians' attitudes toward support interventions, challenges, and center characteristics. In spring 2020, nurse managers at 81 U.S. centers with neonatology and maternal-fetal medicine fellowship programs were asked to identify the individual most knowledgeable in their NICU's bereavement support services; these individuals were invited by email to complete an original online survey. Chi testing and odds ratios (ORs) compared responses from centers reporting involvement of palliative care teams (PCT) in NICU sibling bereavement versus no PCT. Results Fifty-six percent (45 of 80) of invitees responded. Most (77%) NICUs permitted perimortem sibling visitation. Challenges included sparse community resources and limited direct sibling contact. Sixty-nine percent ( n = 31) of centers were grouped as PCT. PCT respondents reported eightfold higher chances of providing direct education to the sibling (OR, 7.7; 95% confidence interval, 1.7-34; p = 0.01). Views on appropriateness of sharing educational information with extended family, babysitters, and teachers did not differ. While notifying pediatricians of families experiencing NICU death was more common in PCT ( p = 0.02), most respondents reported having "no individual responsible for such communications" (52% PCT vs. 100%, p = 0.001). Conclusion Despite limited direct contact with siblings of NICU patients who die, efforts are made to involve them in bereavement activities. Opportunities to support these children were identified. Where available, palliative care teams can help provide bereaved siblings with direct education. We recommend formalizing communication mechanisms to ensure that if a NICU patient dies and has surviving siblings, the outpatient physicians caring for these siblings are informed.
OBJECTIVES:Assess temporal changes, intercenter variability, and birthing person (BP) factors relating to interventions for extremely early deliveries. METHODS:Retrospective study of BPs and newborns delivered from 22-24 completed weeks at 13 US centers from 2011-2020. Rates of neonatology consultation, antenatal corticosteroids, cesarean delivery, live birth, attempted resuscitation (AR), and survival were assessed by epoch, center, and gestational age. RESULTS:2028 BPs delivering 2327 newborns were included. Rates increased in epoch 2-at 22 weeks: neonatology consultation (37.6 vs 64.3%, P < .001), corticosteroids (11.4 vs 29.5%, P < .001), live birth (66.2 vs 78.6%, P < .001), AR (20.1 vs 36.9%, P < .001), overall survival (3.0 vs 8.9%, P = .005); and at 23 weeks: neonatology consultation (73.0 vs 80.5%, P = .02), corticosteroids (63.7 vs 83.7%, P < .001), cesarean delivery (28.0 vs 44.7%, P < .001), live birth (88.1 vs 95.1%, P < .001), AR (67.7 vs 85.2%, P < .001), survival (28.8 vs 41.6%, P < .001). Over time, intercenter variability increased at 22 weeks for corticosteroids (interquartile range 18.0 vs 42.0, P = .014) and decreased at 23 for neonatology consultation (interquartile range 23.0 vs 5.2, P = .045). In BP-level multivariate analysis, AR was associated with increasing gestational age and birth weight, Black BP race, previous premature delivery, and delivery center. CONCLUSIONS:Intervention rates for extremely early newborns increased and intercenter variability changed over time. In BP-level analysis, factors significantly associated with AR included Black BP race, previous premature delivery, and center.
Abstract Objective The study aimed to explore physician views on whether extremely early newborns will have an acceptable quality of life (QOL), and if these views are associated with physician resuscitation preferences. Study Design We performed a cross-sectional survey of neonatologists and maternal fetal medicine (MFM) attendings, fellows, and residents at four U.S. medical centers exploring physician views on future QOL of extremely early newborns and physician resuscitation preferences. Mixed-effects logistic regression models examined association of perceived QOL and resuscitation preferences when adjusting for specialty, level of training, gender, and experience with ex-premature infants. Results A total of 254 of 544 (47%) physicians were responded. A minority of physicians had interacted with surviving extremely early newborns when they were ≥3 years old (23% of physicians in pediatrics/neonatology and 6% in obstetrics/MFM). The majority of physicians did not believe an extremely early newborn would have an acceptable QOL at the earliest gestational ages (11% at 22 and 23% at 23 weeks). The majority of physicians (73%) believed that having an extremely preterm infant would have negative effects on the family's QOL. Mixed-effects logistic regression models (odds ratio [OR], 95% confidence interval [CI]) revealed that physicians who believed infants would have an acceptable QOL were less likely to offer comfort care only at 22 (OR: 0.19, 95% CI: 0.05–0.65, p < 0.01) and 23 weeks (OR: 0.24, 95% CI: 0.07–0.78, p < 0.02). They were also more likely to offer active treatment only at 24 weeks (OR: 9.66, 95% CI: 2.56–38.87, p < 0.01) and 25 weeks (OR: 19.51, 95% CI: 3.33–126.72, p < 0.01). Conclusion Physician views of extremely early newborns' future QOL correlated with self-reported resuscitation preferences. Residents and obstetric physicians reported more pessimistic views on QOL. Key Points Views of QOL varied by specialty and level of training. Contact with former extremely early newborns was limited. QOL views were associated with preferred resuscitation practices.
To understand the future of neonatology, it is important to reflect upon the past and the factors that lead to significant advances in the field. In this article, we explore the evolving landscape of neonatology and the shifting practices in the resuscitation of extremely premature infants, with a particular focus on societal influences that have driven these changes. Using the political policy concept of an Overton Window, we explore how breakthroughs move from unthinkable to acceptable practice and how the increasing involvement of parents and their advocacy efforts have played a pivotal role in that progress. In the era of expanded shared decision making, it is crucial that we apply that same approach to setting priorities in our field, acknowledging the crucial perspectives of both parents and former premature infants in shaping the future of neonatology.
Abstract Objective The study aimed to better understand how neonatology and maternal fetal medicine (MFM) physicians convey information during antenatal counseling that requires facilitating shared decision-making with parents facing options of resuscitation versus comfort care after extremely early delivery Study Design Attending physicians at US centers with both Neo and MFM fellowships were invited to answer an original online survey about antenatal counseling for extremely early newborns. The survey assessed information conveyed, processes for facilitating shared decision-making (reported separately), and clinical experiences. Neonatology and MFM responses were compared. Multivariable logistic regression analyzed topics often and seldom discussed by specialty groups with respect to respondents' clinical experience and resuscitation option preferences at different gestational weeks. Results In total, 74 MFM and 167 neonatologists representing 94% of the 81 centers surveyed responded. Grouped by specialty, respondents were similar in counseling experience and distribution of allowing choices between resuscitation and no resuscitation for delivery at specific weeks of gestational ages. MFM versus neonatology reported similar rates of discussing long-term health and developmental concerns and differed in all other categories of topics. Neonatologists were less likely than MFM to discuss caregiver impacts (odds ratio [OR]: 0.14, 95% confidence interval [CI]: 0.11–0.18, p < 0.001) and comfort care details (OR: 0.19, 95% CI: 0.15–0.25, p < 0.001). Conversely, neonatology versus MFM respondents more frequently reported “usually” discussing topics pertaining to parenting in the NICU (OR: 1.5, 95% CI: 1.2–1.8, p < 0.001) and those regarding stabilizing interventions in the delivery room (OR: 1.8, 95% CI: 1.4–2.2, p < 0.001). Compared with less-experienced respondents, those with 17 years’ or more of clinical experience had greater likelihood in both specialties to say they “usually” discussed otherwise infrequently reported topics pertaining to caregiver impacts. Conclusion Parents require information to make difficult decisions for their extremely early newborns. Our findings endorse the value of co-consultation by MFM and neonatology clinicians and of trainee education on antenatal consultation education to support these families. Key Points Neonatology versus MFM counselors provide complementary information. More experience was linked to discussing some topics. Co-consultation and trainee education is supported. What information parents value requires study.
Having a premature or critically ill infant in a neonatal intensive care unit (NICU) is a traumatic experience for parents that can alter their lives. Parents navigate complex emotions of fear, uncertainty, and guilt as they attempt to adapt their vision of parenthood to the realities of intensive care (Haward, Lantos, and Janvier 2020). With little to no preparation, parents of critically ill patients may be faced with making complicated decisions that alter the care their infant receives. The “Trauma Informed Ethics Consultation” (TIEC) framework proposed by Lanphier and Anani highlights the need to more mindfully address the intersectionality of trauma that parents may be facing prior to engaging them in ethically complex scenarios in patient care (Lanphier and Anani 2022). In their proposal, they rightfully state that “we are not gatekeepers of what counts as trauma” and they urge ethics consultants to shift from asking “what’s wrong?” to asking “what happened?” to the stakeholders involved. Inherent in the TIEC approach is the need to understand the ways in which diverse groups experience trauma to steer systemic changes that can lead to more inclusive caregiving environments. Lanphier and Anani use an example from a neonatal intensive care unit to highlight the use of TIEC in a complex caregiving environment. NICUs contribute to significant amounts of stress on parents of hospitalized infants. As described in their example, Sarah is the mother of a critically ill infant in the NICU whose care team is concerned about her absence from the bedside and emotional withdrawal. These concerns prompted the question of whether an ethics consultation would be beneficial in engaging her in discussion to elucidate her values. The paper describes implementing the TIEC model in four steps: Realizing that trauma is pervasive, Recognizing signs of trauma, Responding to trauma through Trauma Informed Care (TIC) practices, and Resisting retraumatization by weaving TIC into the ethics consultation process. The successful implementation of TIEC results in nurturing a “morally habitable space [that is] sensitive to context, and particularly bias, stereotype, and cultural differences” (Lanphier and Anani 2022). In order to best support different kinds of parents, it is imperative to understand the stress experiences among parents of diverse racial groups in a variety of clinical environments. Analysis of the lived experiences of Black NICU mothers has identified “community” as a unique domain of stress that had not been previously reported in mothers of other racial groups (Witt et al. 2022). Additionally, studies examining pregnant women who faced a threat of periviable delivery show differences in the way women of different races perceive disability, suffering, and coping. These studies suggest that understanding cultural differences when counseling may be beneficial for patients and families from marginalized or minoritized groups (Tucker Edmonds et al. 2021). Decisionmaking for critically ill newborns is inherently difficult for parents without the added potential stressors of poorly understood cultural differences between patients and NICU care teams. We agree with Lanphier and Anani that “past histories of trauma, both among families, and within care teams, may influence the options each are willing to put on the
BACKGROUND: Clinicians caring for neonates with congenital heart disease encounter challenges with ethical implications in daily practice and must have some basic fluency in ethical principles and practical applications. METHODS: Good ethical practice begins with a thorough understanding of the details and narrative of each individual case, examination via classic principles of bioethics, and further framing of that translation into practice. RESULTS: We explore some of these issues and expand awareness through the lens of a case presentation beginning with fetal considerations through end-of-life discussions. CONCLUSIONS: We include specific sections that bring attention to shared decision-making, research ethics, and outcomes reporting. We review empirical evidence and highlight recommendations.
97–102 e3. Syltern, J., L. Ursin, B. Solberg, and R. Stoen. 2022. Postponed withholding: Balanced decision-making at the margins of viability. The American Journal of Bioethics 22 (11):15–26. doi:10.1080/15265161.2021.1925777. Turner, S., and A. Alborz. 2003. Academic attainments of children with down’s syndrome: A longitudinal study. The British Journal of Educational Psychology 73 (Pt 4): 563–83. doi:10.1348/000709903322591244. Verhagen, A. A., A. Janvier, S. R. Leuthner, B. Andrews, J. Lagatta, A. F. Bos, and W. Meadow. 2010. Categorizing neonatal deaths: A cross-cultural study in the United States, Canada, and the Netherlands. The Journal of Pediatrics 156 (1):33–7. doi:10.1016/j.jpeds.2009.07.019.
Objective To synthesize and describe important elements of decision-making during antenatal consultation for threatened preterm delivery at the margin of gestational viability. Study design Data sources including PubMed, EMBASE, Web of Science, and CINAHL Plus were searched. We included all qualitative literature published on decision-making from 1990 to July 2021. Two authors independently screened and evaluated each study using the Critical Appraisal Skills Programme checklist; studies reaching moderate and high quality were included. We developed an extraction tool to collect and categorize data from each qualitative article, then used thematic analysis to analyze and describe the findings. Results Twenty-five articles incorporating the views of 504 providers and 352 parents were included for final review. Thematic analysis revealed 4 main themes describing the experience of health care providers and parents participating in decision-making: factors that influence decision-making, information sharing, building a partnership, and making the decision. Parents and providers were not always in agreement upon which elements were most essential to the process of decision-making. Articles published in languages other than English were excluded. Conclusions Qualitative literature highlighting key factors which are important during antenatal counseling can inform and guide providers through the process of shared decision-making. Communicating clear, honest, and balanced information; avoiding artificially dichotomized options; and focusing on partnership building with families will help providers use the antenatal consultation to reach personalized decisions for each infant. (J Pediatr 2022;251:6-16).
This chapter examines treatment decisions for two high-risk newborns who, forty years ago, would have died in hospice: one born with hypoplastic left heart syndrome; the other prenatally diagnosed with trisomy 18 and ventricular septal defect. It reviews evolution of management, empirical studies of parents' and professionals' attitudes, ethical debates surrounding these changes, and necessary elements of informed consent when counseling parents. It argues that when a clear "best-interests" choice for medical management does not exist, physicians must assist parents in making fully-informed decisions, ensuring all ethically acceptable options and their accurate outcomes are considered.
This article is referred to by:Health Disparities, Systemic Racism, and Failures of Cultural Competence: Authors' Response to Commentaries
Abstract Objective This study aimed to compare attitudes of providers regarding perinatal management and outcomes for periviable newborns of caregivers at centers with higher resuscitation (HR) and lower resuscitation (LR) rates in the delivery room. Study Design All obstetric and neonatal clinical providers at six U.S. sites were invited to complete an anonymous online survey. Survey responses were compared with clinical data collected from a previous retrospective study comparing centers' rates of planned resuscitation. Responses were analyzed by multivariable logistic and linear regression to assess how HR versus LR center respondents differed in management preferences and outcome predictions. Results Paradoxically, HR versus LR respondents, when adjusting for other variables, were less likely to respond that interventions such as antenatal steroids (odds ratio: 0.61, 95% confidence interval [CI]: 0.42–0.88, p < 0.009) and resuscitation (OR: 0.59, 95% CI: 0.44–0.78, p < 0.001) should be given at 22 weeks. HR versus LR respondents also reported lower likelihood of survival and acceptable quality of life (OR: 0.7, 95% CI: 0.53–0.93, p = 0.012) at 23 weeks. Conclusion Despite higher rates of planned resuscitation at 22 and 23 weeks, steroid usage and survival rates did not differ between HR and LR sites. In this subsequent survey, respondents from HR centers had a less favorable outlook on interventions for these newborns than those at LR centers, suggesting that instead of driving practices, attitudes may be more closely associated with experiences of clinical outcomes.
As COVID-19 related hospitalizations surged in other countries and began to rise sharply in the United States, hospitals, healthcare systems, and states began to grapple with the terrifying questio...
Pediatricians often serve as interpreters and mediators of health guidelines when discussing vaccines, health screening, and lifestyle choices with parents of our patients. Outside of public health emergencies, these discussions nearly exclusively focus on optimizing the health of the individual child and a focus on family preferences. However, in the current pandemic, nearly everyone has experienced limitations of personal activities for the population health goal of curbing the spread of the novel coronavirus disease-2019 (COVID-19). New information continues to become available about infrequent but serious COVID-19 complications in children, including neurologic and inflammatory sequalae from illness, as well as the role children play in the spread of the virus.1Abdel-Mannan O. Eyre M. Löbel U. Bamford A. Eltze C. Hameed B. et al.Neurologic and radiographic findings associated with COVID-19 infection in children.JAMA Neurol. 2020; 77: 1-6Crossref Scopus (281) Google Scholar, 2Feldstein L.R. Rose E.B. Horwitz S.M. Collins J.P. Newhams M.M. Son M.F. et al.Multisystem inflammatory syndrome in U.S. children and adolescents.N Engl J Med. 2020; 383: 334-346Crossref PubMed Scopus (1716) Google Scholar, 3Wald E.R. Schmit K.M. Gusland D.Y. A pediatric infectious disease perspective on COVID-19.Clin Infect Dis. 2020; ([Epub ahead of print])Crossref Scopus (20) Google Scholar Moreover, children of color experience a greater proportion of severe COVID-19-related disease, including higher rates of hospitalization and death.4Rabin R.C. Why the Coronavirus more often strikes children of color.www.nytimes.com/2020/09/01/health/coronavirus-children-minorities.htmlDate accessed: November 20, 2020Google Scholar We also know that the measures helping to control COVID-19 infection rates have negatively impacted the health of children through delays in routine vaccination and well-child care, the mental health consequences of school closures, and heightened concerns about the risk of child abuse in socially isolated children.5United Nations Sustainable Development GroupThe impact of COVID-19 on children.https://unsdg.un.org/resources/policy-brief-impact-covid-19-childrenDate accessed: November 20, 2020Google Scholar, 6Feltman D.M. Moore G.P. Beck A.F. Sifferman E. Bellieni C. Lantos J. Seeking normalcy as the curve flattens: ethical considerations for pediatricians managing collateral damage of COVID-19.J Pediatr. 2020; 225: 233-238Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar, 7Rosenthal C.M. Thompson L.A. Child Abuse Awareness Month during the coronavirus disease 2019 pandemic.JAMA Pediatr. 2020; 174: 812Crossref PubMed Scopus (44) Google Scholar These unintended consequences are presumed to be acceptable harms to protect the public health. As children return to medical care and some return to in-person schooling, pediatricians are now tasked with navigating concepts in public health ethics when helping parents make decisions affecting their children and the larger community. The American Academy of Pediatrics (AAP) has released guidance on face coverings, testing protocols, and the use of personal protective equipment in the context of communities and schools trying to reopen even as rates of new COVID-19 infections increase.8American Academy of PediatricsCloth face coverings.https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/cloth-face-coverings/Date accessed: November 20, 2020Google Scholar Nonetheless, questions for pediatricians remain problematic. How can pediatricians balance the needs of their patients with those of the population at large during the COVID-19 public health crisis? How should pediatricians respond when parents' preferences do not align with public health strategies? What adjustments must be made to the typical model of pediatric shared decision-making (SDM) when guiding parents through clinical decisions that benefit the population as a whole, but lead to limiting choices of the individual patient? In this commentary, we examine how values typically prioritized in public health ethics such as solidarity and justice can be integrated into SDM, where the individual child's best interest and caregiver preferences are often paramount. Additionally, we suggest a framework to integrate public health ethics into the traditional SDM continuum using 4 scenarios that we examine for risks, benefits, settings, and appropriate levels of directiveness. Although maintaining an awareness of the evolving epidemiology of COVID-19, and in particular, its impact on vulnerable groups, pediatricians must have a solid working knowledge of public health ethics and law to allow them to navigate these conversations effectively. When multiple ethically reasonable approaches to care exist, parents or legal guardians (caregivers) and pediatricians typically engage in SDM, grounded in principles of caregiver authority (respect for autonomy) and the child's best interests (beneficence).9Kon A.A. The shared decision-making continuum.JAMA. 2010; 304: 903-904Crossref PubMed Scopus (329) Google Scholar Both parties bring knowledge, values, and preferences to the discussion and work collaboratively, negotiating the contributions of each party to the decision making process and facilitating information exchange to decide what is best for the child, within the context of family goals. The process is highly value sensitive and, importantly, relies on the provider encouraging a bidirectional exchange of information to elicit patient and caregiver preferences.10Global Seminar Salzburg Salzburg statement on shared decision making.BMJ. 2011; 342: d1745Crossref PubMed Scopus (163) Google Scholar SDM generally defers the decision to caregiver views of what is "best" provided they are reasonable and do not lead to harm for the child.11Katz A.L. Webb S.A. American Academy of Pediatrics Committee on BioethicsInformed consent in decision-making in pediatric practice.Pediatrics. 2016; 138: e20161485Crossref PubMed Scopus (202) Google Scholar In public health emergencies, the principles of beneficence (maximizing benefit), and nonmaleficence (avoiding harm) that commonly guide individual decisions in health care are viewed instead through the lens of impact at the population level. Values of justice (the fair distribution of societal burdens and benefits) and solidarity increase in importance. Solidarity is characterized as affirming the moral standing of others and their membership in a community of equal dignity and respect. As Jennings summarizes, solidarity emphasizes an "attention to the moral (and mortal) being of others and their needs, suffering, and vulnerability."12Jennings B. Relational ethics for public health: interpreting solidarity and care.Health Care Anal. 2019; 27: 4-12Crossref PubMed Scopus (15) Google Scholar Solidarity can also be understood as a call to stand with or assist community members for overall community good and a method to combat structural and systemic injustices.13Gould C. Solidarity and the problem of structural injustice in healthcare.Bioethics. 2018; 32: 541-552Crossref PubMed Scopus (29) Google Scholar Applying these values may at times conflict with principles guiding individual health decisions, such as autonomy.14Gostin L.O. Jacobson V. Massachusetts at 100 years: police power and civil liberties in tension.Am J Public Health. 2005; 95: 576-581Crossref PubMed Scopus (57) Google Scholar The state's police powers to safeguard its people permit paternalistic restrictions on individual liberties when the population-level benefits of the interventions outweigh the harms of individual restrictions. Protection is sometimes achieved through restrictions to individual liberties to actively prevent 1 person from making choices that increase the risk of harm to others. When public health authorities legally mandate a public health practice, the intervention must prevent an avoidable harm, have a "real or substantial relation" to protecting public health, ensure that burdens are not disproportionate to expected benefits, and not pose undue risks.15Harlan, John Marshall, Supreme Court of the United StatesU.S. Reports: Jacobson v. Massachusetts, 197 U.S. 11.www.loc.gov/item/usrep197011/Date: 1904Date accessed: November 20, 2020Google Scholar Interventions are also justified under frameworks of public health ethics when the intervention is effective, offers significant public health benefit, confers minimal individual burden and risk, and distributes burdens and benefits fairly.16Kass N.E. An ethics framework for public health.Am J Public Health. 2001; 91: 1776-1782Crossref PubMed Scopus (631) Google Scholar When such conditions are met, pediatricians (within their practices) and public health officials may have more authority to impose such interventions. However, these interventions may run counter to caregiver preferences under traditional SDM. As described elsewhere in the Commentary, the traditional SDM framework is guided by caregiver and patient goals and values. The public health framework requires serious attention to population-level goals and, therefore, heavily relies on the consideration of risks or burdens and benefits at the population level, even if these measures require subsuming some individual interests to meet the goals of justice and solidarity. Pediatricians accustomed to the traditional SDM framework need to navigate these discussions of risk, burden, and benefit at both the individual and population levels when guiding parents through individual health decisions and considerations of various public health interventions. Contributions to SDM may shift from the traditional model, as demonstrated in the Figure. Under traditional SDM, pediatricians defer to caregiver choices, offering more directive recommendations as interventions present children lower risks and higher benefits. Contributions to decision making will be most equally distributed between physician and caregiver when neither benefits nor risks to the child predominate, with differential ratios of risks and benefits shifting contributions to decision making more toward physician or caregiver. Public health decision making prioritizes solidarity, justice, and law, resulting in more physician directiveness when interventions present high population benefits, fairly distributed burdens proportionate to benefits, and low risks or harms to child. To this end, pediatricians will need become facile in discussing justice considerations with families and older children and explain how following public health guidelines benefits communities as a whole and those that might be at greater risk. We discuss 4 applications of the combined SDM and public health frameworks relevant to COVID-19. These examples, although not exhaustive, were chosen to illustrate varying risk-benefit profiles to the individual and population. Under this framework, information exchange that occurs in SDM will need to include a discussion of the risks and benefits to public health when appropriate. Contributions to SDM will differ depending on the population-level benefits of particular interventions and the risks and benefits to the child. Such conversations should nonetheless incorporate patient and caregiver preferences to the greatest extent possible, respecting traditional principles of SDM. Because people may be asymptomatic carriers of COVID-19, masks are recommended to prevent transmission when social distancing is not possible, except in very young children or those with medical conditions precluding their use.17Chu D.K. Akl E.A. Duda S. Solo K. Yaacoub S. Schunemann H.J. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis.Lancet. 2020; 395: 1973-1987Abstract Full Text Full Text PDF PubMed Scopus (2660) Google Scholar However, there is no national masking policy and recommendations remain variable across different regions.18Miller H. Coronavirus mask mandates differ across the country as hot spots multiply and states play politics.www.cnbc.com/2020/06/26/coronavirus-mask-mandates-differ-across-the-country-as-hot-spots-multiply.htmlDate accessed: November 20, 2020Google Scholar Pediatricians may encounter decisions about mask wearing both within the context of policies and practices within their own clinical environment and in helping families navigate the potential need for mask wearing in other settings. Public health ethics principles described above would support pediatricians who mandate mask wearing in clinical settings given the minimal burden to wearers and collective benefits for other patients and staff. Masking can be thought of as a universal precaution similar to immunizations; both are intended to afford the individual protection, but also to diminish disease transmission to others. Similar to the case of vaccinations, pediatricians may be asked by some caregivers to allow exceptions to rules for mask wearing. Permissible exceptions will require strong medical justification, such as medical conditions in which the mask would make breathing difficult or if an individual lacks the capacity to remove the mask, such as children younger than 2 years of age or those with severe neurodevelopmental impairments. One might also consider allowing exceptions for a child with strong behavioral challenges that practically make wearing a mask very difficult—if the struggle to continue the mask wearing could actually increase transmission of viral particles, clearly the benefit of the mask would be lost. In such circumstances, alternatives to masks such as face shields or alternatives to visits in the clinical setting, such as a telehealth appointment, should be considered when feasible. Negotiating such conversations requires balancing the public health benefits of mask wearing with the potential individual risks and benefits associated with the practice. Only when there are compelling risks to the patient or loss of benefit to the public would it be ethically acceptable for pediatricians to accommodate requests to exempt patients from mask wearing requirements or to recommend against mask wearing generally.17Chu D.K. Akl E.A. Duda S. Solo K. Yaacoub S. Schunemann H.J. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis.Lancet. 2020; 395: 1973-1987Abstract Full Text Full Text PDF PubMed Scopus (2660) Google Scholar Community rates of disease and acceptance of masking varies across regions and at different points in time. Compliance becomes more critical as rates of infection increase. Exceptions to masking, therefore, may vary in impact based on the local disease burden at the time in question. However, the best practice remains to counsel universal masking, regardless of rates of COVID-19, so that when exceptions are necessary, those surrounding the child are in compliance and making the situation as safe as possible. Conversely, pediatricians may need to support patients seeking to protect themselves and others but who are struggling with family or community members who do not comply with public health recommendations. Pediatricians can equip families with evidence, information, and tools to help facilitate conversations with family members or community members (eg, how to get a child to become comfortable with mask wearing, why masking protects others, airborne transmission in indoor gathering vs outdoor gatherings, etc).19American Academy of PediatricsCOVID 19.www.healthychildren.org/English/health-issues/conditions/COVID-19/Pages/default.aspxDate accessed: November 20, 2020Google Scholar Many hospitals require COVID-19 testing of asymptomatic children before certain invasive procedures and hospital admissions. Although some patients may individually benefit from knowing test results, the primary benefit of testing is not to the individual, but to facilitate appropriate levels of infection control, including proper room assignment, judicious use of personal protective equipment, and optimizing hospital operations.20Centers for Disease Control and PreventionGuidance for healthcare professionals who have the potential for direct or indirect exposure to patients or infectious materials.www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.htmlDate accessed: November 20, 2020Google Scholar Some parents may prefer to forego testing to avoid the perceived burden of discomfort to the child. Although this is a small but real burden to the child, the benefits of protecting health care resources and other patients make mandating COVID-19 testing ethically permissible. However, accommodations may need to be considered as burdens and risks to patient increase (eg, for children who may have such significant aversions that they would require sedation to tolerate testing). As testing methods become less invasive, more rapid and reliable, and available in greater volumes, risks and benefits will continue to evolve. The AAP has recently advocated for continued asymptomatic testing after contact exposure because of the high rates of many (but not all) asymptomatic children.21Goza S. AAP statement on CDC recommendations against COVID-19 testing for asymptomatic individuals.https://services.aap.org/en/news-room/news-releases/aap/2020/aap-statement-on-cdc-recommendation-against-covid-19-testing-for-asymptomatic-individuals/Date accessed: November 20, 2020Google Scholar Mandating repeated testing protocols such as those proposed to allow for safer activities (eg, testing every few days of on-campus college students) should improve the calculus of the benefits over risks, although even despite such a program, for example, at the University of Illinois at Urbana-Champaign, surges have forced temporary in-person instruction closures.22Nadworny E. Despite mass testing, University of Illinois sees coronavirus cases rise. NPR.www.npr.org/sections/coronavirus-live-updates/2020/09/03/909137658/university-with-model-testing-regime-doubles-down-on-discipline-amid-case-spikeDate accessed: November 20, 2020Google Scholar When a vaccine is available, supplies will likely be limited, requiring consideration of whom should be prioritized for vaccination. Children will be an important population to vaccinate, given potential for spreading through asymptomatic carrier children, particularly as schools and daycares reopen. Pediatricians will need to engage families in SDM and directive counseling to the weigh benefits of viral protection for the child and others against possible unknown risks. There also exists a need from professional societies and the public health infrastructure to provide clear guidance and messaging on the importance of vaccination specifically in the context of COVID-19.23Mello M.M. Silverman R.D. Omer S.B. Ensuring uptake of vaccines against SARS-CoV-2.N Engl J Med. 2020; 383: 1296-1299Crossref PubMed Scopus (66) Google Scholar Returning children to school safely is important for academics and the healthy development and well-being of children, and although this goal remains elusive for many reasons, mass vaccination of children may need to be an important consideration.24American Academy of PediatricsCOVID-19 planning considerations: guidance for school re-entry.https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/covid-19-planning-considerations-return-to-in-person-education-in-schools/Date accessed: November 20, 2020Google Scholar Nevertheless, mandating vaccination soon after release would be fraught with challenges given the accelerated vaccine development timeline, potential unknown risks and complications, and evolving understanding of COVID-19 epidemiology.25O'Callaghan K.P. Blatz A.M. Offit P.A. Developing a SARS-CoV-2 vaccine at warp speed.JAMA. 2020; 324: 437-438Crossref PubMed Scopus (55) Google Scholar,26Lurie N. Sharfstein J.M. Goodman J.L. The development of COVID-19 vaccines: safeguards needed.JAMA. 2020; 324: 439-440Crossref PubMed Scopus (48) Google Scholar The US Food and Drug Administration's options for approving a new vaccine (whether a vaccine works) will depend on its efficacy, its proportional uptake, and the rates of the virus in that community. Whether a vaccine is safe will be gauged by risks and degrees of harm agreed upon as acceptable.27Shah A. Marks P.W. Hahn S.M. Unwavering regulatory safeguards for COVID-19 vaccines.JAMA. 2020; 324: 931-932Crossref PubMed Scopus (44) Google Scholar Despite the anticipated public health benefits of achieving herd immunity and the possibility of returning to school faster, prematurely mandating COVID-19 vaccination could also aggravate hesitancy and refusals pediatricians already face with vaccines.28Gidengil C. Chen C. Parker A.M. Nowak S. Matthews L. Beliefs around childhood vaccines in the United States: a systematic review.Vaccine. 2019; 37: 6793-6802Crossref PubMed Scopus (54) Google Scholar These considerations are likely to be more salient in communities of color, who have already suffered a disproportionate burden of disease. For COVID-19, involvement in vaccine trials has also been lower for Black participants, which may also contribute to increasing vaccine hesitancy in the future.29Farmer B. As Covid-19 vaccine trials move at warp speed, recruiting black volunteers takes time.www.npr.org/sections/health-shots/2020/09/11/911885577/as-covid-19-vaccine-trials-move-at-warp-speed-recruiting-black-volunteers-takesDate accessed: November 20, 2020Google Scholar Therefore, parents should be allowed to refuse any potential COVID-19 vaccine until the risks and efficacy are well-established in children. When a COVID-19 vaccine is deemed to be safe and available for distribution to children, pediatricians will be asked to help interpret for families the guidance from federal agencies and professional societies such as the AAP to make thoughtful decisions for their children. Pediatricians who have already established trusting relationships with their patients will be the best ambassadors for vaccine-related questions. Families who display vaccine hesitancy for existing immunizations will benefit from pediatricians who strengthen families' health literacy and who use proven methods to ensure understanding of information, including information technology.30Marti M. de Cola M. MacDonald N.E. Dumolard L. Duclos P. Assessments of global drivers of vaccine hesitancy in 2014-Looking beyond safety concerns.PLoS One. 2017; 12: e0172310Crossref PubMed Scopus (122) Google Scholar, 31Gianfredi V. Moretti M. Lopalco P.L. Countering vaccine hesitancy through immunization information systems, a narrative review.Hum Vaccin Immunother. 2019; 15: 2508-2526Crossref PubMed Scopus (42) Google Scholar, 32Goodman J.L. Grabenstein J.D. Braun M.M. Answering key questions about COVID-19 vaccines.JAMA. 2020; ([Epub ahead of print])Crossref PubMed Scopus (25) Google Scholar Therapeutics for COVID-19 remain under investigation, and some children suffer serious postinfectious complications.2Feldstein L.R. Rose E.B. Horwitz S.M. Collins J.P. Newhams M.M. Son M.F. et al.Multisystem inflammatory syndrome in U.S. children and adolescents.N Engl J Med. 2020; 383: 334-346Crossref PubMed Scopus (1716) Google Scholar Pediatricians should anticipate counseling families about current knowledge on alternative treatments and assist them in understanding the risks and benefits of enrolling infected children in pediatric studies. Participation of children in COVID-19 research studies remains important so that children have appropriate and early access to future medical treatments and support for psychological sequelae; such sequelae have been reported during and after natural disasters. For observational studies (eg, tracking outcomes for children with multisystem inflammatory syndrome in children) that pose minimal risk to the child, pediatricians may be more directive in recommending participation while being mindful that children may have special vulnerabilities after a traumatic event like this pandemic.33Ferreira R.J. Buttell F. Cannon C. Ethical issues in conducting research with children and families affected by disasters.Curr Psychiatry Rep. 2018; 20: 42Crossref PubMed Scopus (6) Google Scholar In contrast, investigational treatments with higher potential harms but possible benefits such as an unproven medication to prevent multisystem inflammatory syndrome in children in a child infected with COVID-19 or a vaccine trial will likely pose greater risks to the child and require careful exploration by pediatrician and caregiver with more deference to caregiver preferences. Specifically, the AAP has advocated for the inclusion of children in research on potential COVID-19 vaccine and said:[I]t is counter to the ethical principle of distributive justice to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine, or to delay that benefit for an extended period of time, because they have not been included in vaccine trials. Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.34American Academy of PediatricsLetter to HHS and FDA-Children in COVID 19 Vaccine Trials.https://downloads.aap.org/DOFA/AAPLettertoHHSandFDAChildreninCOVID19VaccineTrials.pdfDate accessed: November 20, 2020Google Scholar Recently, children older than age 12 years are eligible to participate in COVID-19 vaccine clinical trials.35Aubrey A. Will kids get a COVID-19 vaccine? Pfizer to expand trial to ages 12 and up.www.npr.org/sections/health-shots/2020/10/13/923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-to-ages-12-and-upDate accessed: November 20, 2020Google Scholar Families considering participating will need to weigh risk to their child as well as the potential public health benefit; pediatricians can support caregivers' decision making by helping the family to understand the potential overall benefit to the adolescent and ensure there is assent from the adolescent. Ultimately, deference should be given to caregiver choices. Adolescents have developing autonomy and some may have decision making capacity similar to that of an adult and should participate in SDM as it pertains to their own health care. When adolescent values differ from that of their family and impact health care choices, pediatricians need to share information, practice good communication, ensure transparency, and sometimes engage in conflict resolution. If there is a disagreement related to COVID-19 where a family endorses masking, social distancing, and testing, but the adolescent does not, the pediatrician may need to explore personal and community barriers and provide best practice guidance through evidence-based current public health recommendations. Although state laws differ in adolescents' ability to give sole consent for immunizations, the pediatrician can strive to help parents and the patient arrive at a shared decision by providing a space for clarifying concerns, medical facts, and goals in a way that respects both stakeholders. Finally, the pediatrician may need to help support decision making that allows the adolescent to feel safe, such as if the patient attends school in a region where there is no masking requirement. In each scenario, the pediatrician will need to assess the adolescent's level of evolving decision-making capacity to help titrate information delivery, the deliberation over risks and benefits, and the degree of adolescent participation in decision making. Minority groups have experienced higher rates of illness and mortality from COVID-19. Higher rates of infection and mortality are due, in large part, to systemic biases and structural inequities that create baseline disparate health care access, quality, and outcomes for certain groups of people.36Abedi V. Olulana O. Avula V. Chaudhary D. Khan A. Shahjouei S. et al.Racial, economic and health inequality and COVID-19 infection in the United States.J Racial Ethn Health Disparities. 2020; : 1-11PubMed Google Scholar Of the nearly 800 reported cases of multisystem inflammatory syndrome in children, 70% occurred in Black and Hispanic/Latino children.37Center for Disease Control and PreventionHealth department-reported cases of multisystem inflammatory syndrome in children (MIS-C) in the United States.www.cdc.gov/mis-c/cases/ind37,ex.htmlDate accessed: November 20, 2020Google Scholar The very same groups that would most likely benefit from an effective vaccine or study of this disease have also shown greater rates of mistrust in the health system and in research attributable to historical experiences of unethical treatment.38Sullivan L.S. Trust, risk, and race in American medicine.Hastings Cent Rep. 2020; 50: 18-26Crossref PubMed Scopus (61) Google Scholar Given this delicate juxtaposition of need and trust, public health efforts that aim to address health equity have the best chances of restoring faith in general medical care. This dynamic generates additional considerations and challenges for pediatricians who counsel minority families in situations where public health goals may differ from individual preferences. Pediatricians need to use models that bridge the gaps between health care professionals and the families they serve, especially in the face of different cultural experiences.39Ellis W.R. Dietz W.H. A new framework for addressing adverse childhood and community experiences: the building community resilience model.Acad Pediatr. 2017; 17: S86-S93Abstract Full Text Full Text PDF PubMed Scopus (180) Google Scholar Preserving and respecting SDM requires that pediatricians engage in thoughtful and informed dialogue with special attention to reflective listening, incorporation of health-literate sensitive educational materials, acknowledgement of explicit and implicit biases, awareness and validation of current and past mistreatment, and with attention to the potential for institutional inequities to build trust and to avoid perpetuating existing disparities.40Derrington S.F. Paquette E. Johnson K.A. Cross-cultural interactions and shared decision-making.Pediatrics. 2018; 142: S187-S192Crossref PubMed Scopus (30) Google Scholar Any consideration of mandatory interventions in particular should include specific attention to measuring the impact on groups at risk for disparities and gauging whether changes in structural and systemic practices may have unintended consequences that worsen existing disparities and mistrust.41Trent M. Dooley D.G. Dougé J, Section on Adolescent Health, Council on Community Pediatrics, Committee on Adolescence. The impact of racism on child and adolescent health.Pediatrics. 2019; 144: e20191765Crossref PubMed Scopus (585) Google Scholar It is important to note that, in addition to considerations for their interpersonal interactions with caregivers and families, to further principles of public health ethics, pediatricians also have a special role in addressing these structural and systemic issues as advocates for children. It is especially important that existing disparities are not worsened when negotiating public health goals and SDM. Interventions offering high chances of benefit to the population and low risks to individuals may be ethically mandated by pediatricians and legally mandated by public health officials under ethical and legal public health frameworks. As risks to the individual patient increase in likelihood or in degree of harmfulness, a more traditional SDM model emphasizing individual goals may be most appropriate. By integrating public health law and ethics into traditional models of SDM, pediatricians can guide families through decisions affecting public health and their children.
BACKGROUND:Despite medical advances in the care of extremely preterm neonates and growing acceptance of resuscitation at 23 and even 22 weeks gestation, controversy remains concerning the use of antepartum obstetric intervention s that are intended to improve outcomes in the setting of anticipated extremely preterm birth. In the absence of demonstrated benefit at <23 weeks gestation and with uncertain benefit at 23 weeks gestation, previous obstetric committee opinions have advised against their use at these gestational ages.OBJECTIVE:The purpose of this study was to review the use of obstetric intervention s at the threshold of viability based on neonatal resuscitation plan and to review the odds of survival to neonatal intensive care unit discharge based on use of obstetric intervention s with adjustment for neonatal factors.STUDY DESIGN:This retrospective study of 6 study centers reviewed pregnant patients who were admitted between 22+0/7 and 24+6/7 weeks gestation facing delivery from 2011-2015. Patients with known anomalies or missing data were excluded. Records were reviewed for demographics, resuscitation plan, and obstetric intervention s. Mode of delivery, delivery room care, and final infant dispositions were recorded. Multiple gestations were included as 1 pregnancy in regard to the use of obstetric intervention s and were excluded from survival analysis.RESULTS:Four hundred seventy-eight mothers met the inclusion criteria. When resuscitation was planned, mothers were more likely to receive all conventional obstetric intervention s (antenatal steroids, magnesium sulfate for neuroprotection, tocolytics, and Group Beta Streptococcus prophylaxis), regardless of gestational age at admission, and were more likely to be delivered by cesarean section (P<.05). Analyzed as a group, when antenatal steroids, magnesium sulfate, tocolytics and Group Beta Streptococcus prophylaxis were administered, the odds of survival to neonatal intensive care unit discharge increased for newborn infants who were born at 22 (odds ratio, 11.33; 95% confidence interval, 1.405-91.4) and 23 weeks gestation (odds ratio, 15.5; 95% confidence interval, 3.747-64.11; P<.05). In singletons, the odds of survival to neonatal intensive care unit discharge was not improved by cesarean delivery vs vaginal delivery, even after adjustment for the use of additional interventions, weight, gender, and gestational age (odds ratio, 1.0; 95% confidence interval, 0.59-1.8; P=.912).CONCLUSION:In this study, when postnatal resuscitation was planned at 22 and 23 weeks gestation, women were more likely to receive antenatal steroids, magnesium sulfate, and antibiotics; provision of this bundle imparted survival benefit at 23 weeks gestation but could not be demonstrated at 22 weeks gestation because of the small sample size. These findings support of neonate-oriented obstetric interventions in the setting of delivery at 23 weeks gestation when resuscitation is planned and further exploration of optimal obstetric care when resuscitation of infants who were born at 22 weeks gestation is anticipated.
Fearful. Uncertain. Overwhelmed. Committed. Hopeful. Pediatricians around the world have cycled through these emotions when considering the health and safety of patients and families during this coronavirus disease 2019 (COVID-19) pandemic. We worry about the direct medical effects of COVID-19. We also worry about the ancillary effects of the lockdowns, stay-at-home orders, closed clinics, schools, and daycare centers, and newly unemployed parents on the well-being of children. We focus on those concerns. We believe that responding to these ancillary effects of COVID-19 will be a bigger challenge for pediatricians than the clinical care of children with COVID-19. These challenges will be with us for the foreseeable future.