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This report is informed by the themes of the session Trisomy 13/18, Exploring the Changing Landscape of Interventions at NeoHeart 2020—The Fifth International Conference of the Neonatal Heart Society. The faculty reviewed the present evidence in the management of patients and the support of families in the setting of trisomy 13 and trisomy 18 with congenital heart disease. Until recently medical professionals were taught that T13 and 18 were “lethal conditions” that were “incompatible with life” for which measures to prolong life are therefore ethically questionable and likely futile. While the medical literature painted one picture, family support groups shared stories of the long-term survival of children who displayed happiness and brought joy along with challenges to families. Data generated from such care shows that surgery can, in some cases, prolong survival and increase the likelihood of time at home. The authors caution against a change from never performing heart surgery to always—we suggest that the pendulum of intervention find a balanced position where all therapies including comfort care and surgery can be reviewed. Families and clinicians should typically be supported and empowered to define the best care for their children and patients. Key concepts in communication and case vignettes are reviewed including the importance of supportive relationships and the fact that palliative care may serve as an additional layer of support for decision-making and quality of life interventions. While cardiac surgery may be beneficial in some cases, surgery should not be the primary focus of initial family education and support.

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

Rapid whole genome sequencing (WGS) and whole exome sequencing (WES), sometimes referred to as "next generation sequencing" (NGS) are now recommended by some experts as a first-line diagnostic test to diagnose infants with suspected monogenic conditions. Estimates of how often NGS leads to diagnoses or changes in management vary widely depending on the population being studied and the indications for testing. Finding a genetic variant that is classified as pathogenic may not necessarily equate with being able to predict the resultant phenotype or to give a reliable prognosis. Molecular diagnoses do not usually lead to changes in clinical management but they often end a family's diagnostic Odyssey and allow informed decisions about future reproductive choices. The likelihood that NGS will be beneficial for patients and families in the NICU remains uncertain. The goal of this paper is to highlight the implications of these ambiguities in interpreting the results of NGS. To do that, we will first review the types of cases that are admitted to NICUs and show why, at least in theory, NGS is unlikely to be useful for most NICU patients and families and may even be harmful for some, although it can help families in some cases. We then present a number of real cases in which NGS results were obtained and show that they often lead to unforeseen and unpredictable consequences. Finally, we will suggest ways to communicate with families about NGS testing and results in order to help them understand the meaning of NGS results and the uncertainty that surrounds them.

Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures. The broad expertise and perspectives of this group were invaluable in developing recommendations addressing: (1) use of neonate-specific adaptive trial designs, (2) inclusion/exclusion criteria, (3) stratification and randomization, (4) statistical analysis, (5) safety monitoring, and (6) definitions of important outcomes. The guidelines are based on available literature and expert consensus, pharmacokinetic analyses, ethical considerations, and parental concerns. These recommendations will ultimately facilitate development of a Master Protocol and design of efficient and successful drug trials to improve the treatment and outcome for this highly vulnerable population.

This paper reviews the development of the concept of medical futility, particularly as it applies to pediatrics. It discusses the difference between technical considerations and value considerations in futility determinations, and then breaks down the concept of futility into four components - power, money, trust and hope.

This study tests the feasibility of a partnership between an academic medical center and community health workers to perform mutually beneficial research investigating asthma in an urban Latino neighborhood. Community heath workers participated in the study design, instrument development, implementation, and analysis. The 103 participants recruited by the community health workers were primarily Mexican with very low education and acculturation levels. After the 1-year enrollment period, the community health workers described the challenges of data collection and gave explanations for the access to care outcomes. This academic-community partnership showed that community health workers can be effective research partners.

Evidence suggests that parental leave (PL) benefits child health and infant-parent attachment, yet little is known about how pediatricians view and discuss PL with parents.To determine pediatricians' attitudes, practices, and their own use of PL, and how these may vary by gender.Random mail surveys to 750 male and 750 female pediatricians focusing on attitudes about PL and the discussion of PL. Respondents with children were asked about their own PL use. After stratifying by gender, questions were compared using the chi-square, linear trend, and t test. Logistic regression was used to predict the likelihood of discussing PL.Forty-four percent of men and 92% of women took time off after the arrival of a new child--a median of 14 days and 67 days, respectively. The majority (55%) believe it is important to discuss PL; however, 8% of men and 24% of women do so (P.01). Men who took PL were 3.6 times more likely to discuss PL (P=.04) than men who did not. For women, each month increase in length of leave was associated with 2.2 times greater likelihood of discussing PL (P.01). Women in smaller practices were 2.1 times more likely to discuss PL (P=.01) than women in larger practices.Many pediatricians take PL and believe it is an important topic for discussion. Few pediatricians, however, incorporate discussion into their practices. In an era when most children grow up in households where both parents work outside the home, pediatricians should consider discussing with parents this important element of child health.

It has become increasingly difficult to place a value on the work that doctors do. Yet fiscal pressures have lead to economic incentives for performing certain kinds work instead of others. So the question arises: what are the ethics and consequences of trying to objectively compare the many services physicians offer?

When parents voice their dissatisfaction with the neonatal intensive care unit (NICU), it is often not because they think their baby has not received good medical care. Instead, it is often because their needs have not been addressed. Policy statements and pedagogy alike urge professionals to be empathetic, compassionate, honest, and caring. However, these theoretical concepts are generally endorsed without practical suggestions on how to achieve these goals. Negative encounters for parents are generally not about the caregivers' technical expertise or knowledge and often reflect a failure in a different domain. Simple rules of etiquette are not always applied in a busy NICU or in the hospital at large. The investigators of the POST (Parents from the Other Side of Treatment) group are health care professionals who regularly communicate with parents of sick children and who were also "NICU parents." We have developed an etiquette-based systematic approach to communication with families in the NICU. These specific and practical recommendations may help parents feel well treated and respected as they go through a challenging NICU stay.

Madam: The two articles on "Experts in Ethics" (HCR, November-December 1998) present an interesting view on the nature of expertise in the field of clinical ethics. The first article (David J. Casarett, Frona Daskal, and John Lantos, "The Authority of the Clinical Ethicist") stresses the importance of communication and consensus. The second (Scot D. Yoder, "The Nature of Ethical Expertise") defines expertise in terms of reasoning and providing justifications. As such, they make explicit some central aspects of clinical ethics work. Both articles try to give a foundation for clinical ethics by referring, respectively, to Habermas and Aristotle. Although the two contributions are certainly relevant, they also tend to be onesided, both in their view of clinical ethics practice and in their interpretation of philosophical theory. They tend to underestimate the fact that clinical ethics is highly contextual, and that its most important feature is the ethical assessment of concrete situations-an issue that makes the ethical theories of Habermas and Aristotle relevant for clinical ethics in ways the authors seem to overlook. According to Aristotle ethics is always about concrete situations. Clinical ethics is a splendid example of practical philosophy in the Aristotelian sense-that is, of a discipline that requires knowledge about particulars as well as knowledge about general rules and principles. The essence of expertise in this field is to apply general rules to the concrete situation, to see how general principles fit to specific circumstances. This means that an expert in clinical ethics is not only able to establish relevant general rules, but also to see to it that they are applied in the right manner. This expertise can be called hermeneutic competence. The Aristotelian perspective presupposes that ethics deals with truth. In this respect it is at odds with Yoder's suggestion that it is sufficient to provide a coherent justification for one's judgment. For Aristotle, coherence is not good enough; a recommendation is valid only if it is the best policy, given the concrete situation. It is, however, not easy to establish this. People need experience to apply rules and principles. Even experienced persons will have to know a lot about the details of the situation before they can give a sound judgment. This may explain the divergence in outcome when ethics consultants are asked to respond to hypothetical cases: such cases are probably too abstract and too thin for concrete recommendations. Habermas shares with Aristotle the presupposition that ethics is about truth. He claims that moral judgments can be right or wrong. He also agrees with Aristotle that ethics deals both with principles and with their application to concrete circumstances. Habermas gives ethics an intersubjective twist, however. Both the validity of general principles and the adequacy of their application to specific situations are not to be established through individual reasoning, but through dialogue and discussion. Habermas distinguishes between two kinds of institutionalized discussions regarding ethical issues: practical discourse and application discourse. Practical discourse is about the general validity of norms and principles; application discourse is about their application to a specific situation. Practical discourse aims at universalization, whereas application discourse aims at contextualization. In his theory of discourse ethics, Habermas puts most emphasis on the concept of practical discourse. This has given rise to the criticism that he tends to overlook the im

Randomized controlled trials raise a number of ethical issues. Physicians who participate in such trials must be in a state of "equipoise," or genuine uncertainty about the relative merits of the two arms of the trial. Otherwise, they would be ethically compelled to recommend the treatment they preferred. However, an agreement to participate in a masked trial is an agreement to deny oneself access to the knowledge that might allow one to judge which therapy is better. Physicians may dodge this dilemma in a number of ways. First, they may refuse to participate in randomized control trials. However, this does not allow assumptions about treatment to be tested. Second, they may judge participation ethically acceptable if other clinicians believe that an alternative treatment is better. By this formulation, individuals do not need to be in a state of equipoise, as long as the expert medical community is. Finally, they may use alternative methodologies, such as retrospective studies; crossover studies; or nonmasked, nonrandomized selection of alternative treatments with careful risk stratification and data collection. All of these solutions may be valid ways of dealing with the ethical dilemmas associated with randomized controlled trials.

Two misconceptions about informed consent concern the difference between the legal and moral justification for it, and the rationale for more rigorous consent for research than for "standard" therapy. Legally, informed consent for therapy is a risk-management tool that functions essentially as a release of liability. If the patient is informed of all expected or potential side-effects or toxicities of a treatment, he cannot sue because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability, but to help the patient make the best decision. These two goals are not necessarily incompatible, but they often lead to different attitudes toward informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management, then informed consent forms should be encyclopedic, providing the "whole truth" to patients. This would, however, not meet the moral goals of shared decision-making, because few patients could make sense of such data. Informed consent for research often leads to a different paradox. If a new therapy becomes available and a physician thinks it may benefit a patient, the physician may use it in an uncontrolled manner. This does not require the approval of an institutional review board and does not need the more rigorous approach to informed consent generally associated with research. In contrast, if the physician wants to evaluate the effectiveness of the same therapy carefully and intends to gather data to do so, he will need to describe his protocol, defend it before an institutional review board, and provide a more carefully written and closely scrutinized informed consent form. The paradox derives from the fact that the patient in the first, uncontrolled situation is inevitably at higher risk of harm than the patient in the second situation. The distinction between informed consent for treatment and informed consent for research is based on a distinction that is growing ever more cloudy and ever less relevant to the moral goals that informed consent seeks to achieve. Current standards for informed consent for research are, in many ways, counterintuitive and probably counter-productive.

To the Editor.— At a recent meeting of the Society for Pediatric Research, Tyson et al presented an algorithm that correctly predicted outcome or could correctly predict outcome for 78% to 85% of infants.1 A subset of infants could be correctly assigned a mortality rate of >90%. I asked a number of neonatologists who read the poster about the implications. For most, a prediction of >90% mortality rate would not justify a decision to withhold or withdraw treatment.