Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries.

BACKGROUND: There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. DISCUSSION: A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants. CONCLUSION: Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits.

The Dilemma of Daily Physical Examination in the NICU.

Babies in the NICU should be managed in a neurodevelopment-friendly environment. Frequent handling by multiple examiners potentially increases the risk of cross infection. Interruption in kangaroo care is not advisable unless urgent. A minimum of three-point exam should be done (chest, heart, and abdomen) using a stethoscope and gentle palpation. However, the infant should not be wakened from sleep and all handling should be synchronized with the touch time.

Decision-making at the limit of viability: differing perceptions and opinions between neonatal physicians and nurses.

BACKGROUND: In the last 20 years, the chances for intact survival for extremely preterm infants have increased in high income countries. Decisions about withholding or withdrawing intensive care remain a major challenge in infants born at the limits of viability. Shared decision-making regarding these fragile infants between health care professionals and parents has become the preferred model today. However, there is an ongoing ethical debate on how decisions regarding life-sustaining treatment should be reached and who should have the final word when health care professionals and parents do not agree. We designed a survey among neonatologists and neonatal nurses to analyze practices, difficulties and parental involvement in end-of-life decisions for extremely preterm infants. METHODS: All 552 physicians and nurses with at least 12 months work experience in level III neonatal intensive care units (NICU) in Switzerland were invited to participate in an online survey with 50 questions. Differences between neonatologists and NICU nurses and between language regions were explored. RESULTS: Ninety six of 121 (79%) physicians and 302 of 431(70%) nurses completed the online questionnaire. The following difficulties with end-of-life decision-making were reported more frequently by nurses than physicians: insufficient time for decision-making, legal constraints and lack of consistent unit policies. Nurses also mentioned a lack of solidarity in our society and shortage of services for disabled more often than physicians. In the context of limiting intensive care in selected circumstances, nurses considered withholding tube feedings and respiratory support less acceptable than physicians. Nurses were more reluctant to give parents full authority to decide on the course of action for their infant. In contrast to professional category (nurse or physician), language region, professional experience and religion had little influence if any on the answers given. CONCLUSIONS: Physicians and nurses differ in many aspects of how and by whom end-of-life decisions should be made in extremely preterm infants. The divergencies between nurses and physicians may be due to differences in ethics education, varying focus in patient care and direct exposure to the patients. Acknowledging these differences is important to avoid potential conflicts within the neonatal team but also with parents in the process of end-of-life decision-making in preterm infants born at the limits of viability.

Moral Distress in PICU and Neonatal ICU Practitioners: A Cross-Sectional Evaluation.

OBJECTIVES: To measure the level of moral distress in PICU and neonatal ICU health practitioners, and to describe the relationship of moral distress with demographic factors, burnout, and uncertainty. DESIGN: Cross-sectional survey. SETTING: A large pediatric tertiary care center. SUBJECTS: Neonatal ICU and PICU health practitioners with at least 3 months of ICU experience. INTERVENTIONS: A 41-item questionnaire examining moral distress, burnout, and uncertainty. MEASUREMENTS AND MAIN RESULTS: The main outcome was moral distress measured with the Revised Moral Distress Scale. Secondary outcomes were frequency and intensity Revised Moral Distress Scale subscores, burnout measured with the Maslach Burnout Inventory depersonalization subscale, and uncertainty measured with questions adapted from Mishel's Parent Perception of Uncertainty Scale. Linear regression models were used to examine associations between participant characteristics and the measures of moral distress, burnout, and uncertainty. Two-hundred six analyzable surveys were returned. The median Revised Moral Distress Scale score was 96.5 (interquartile range, 69-133), and 58% of respondents reported significant work-related moral distress. Revised Moral Distress Scale items involving end-of-life care and communication scored highest. Moral distress was positively associated with burnout (r = 0.27; p < 0.001) and uncertainty (r = 0.04; p = 0.008) and inversely associated with perceived hospital supportiveness (r = 0.18; p < 0.001). Nurses reported higher moral distress intensity than physicians (Revised Moral Distress Scale intensity subscores: 57.3 vs 44.7; p = 0.002). In nurses only, moral distress was positively associated with increasing years of ICU experience (p = 0.02) and uncertainty about whether their care was of benefit (r = 0.11; p < 0.001) and inversely associated with uncertainty about a child's prognosis (r = 0.03; p = 0.03). CONCLUSIONS: In this single-center, cross-sectional study, we found that moral distress is present in PICU and neonatal ICU health practitioners and is correlated with burnout, uncertainty, and feeling unsupported.

The Intensive Care Lifeboat: a survey of lay attitudes to rationing dilemmas in neonatal intensive care.

BACKGROUND: Resuscitation and treatment of critically ill newborn infants is associated with relatively high mortality, morbidity and cost. Guidelines relating to resuscitation have traditionally focused on the best interests of infants. There are, however, limited resources available in the neonatal intensive care unit (NICU), meaning that difficult decisions sometimes need to be made. This study explores the intuitions of lay people (non-health professionals) regarding resource allocation decisions in the NICU. METHODS: The study design was a cross-sectional quantitative survey, consisting of 20 hypothetical rationing scenarios. There were 119 respondents who entered the questionnaire, and 109 who completed it. The respondents were adult US and Indian participants of the online crowdsourcing platform Mechanical Turk. Respondents were asked to decide which of two infants to treat in a situation of scarce resources. Demographic characteristics, personality traits and political views were recorded. Respondents were also asked to respond to a widely cited thought experiment involving rationing. RESULTS: The majority of respondents, in all except one scenario, chose the utilitarian option of directing treatment to the infant with the higher chance of survival, higher life expectancy, less severe disability, and less expensive treatment. As discrepancy between outcomes decreased, however, there was a statistically significant increase in egalitarian responses and decrease in utilitarian responses in scenarios involving chance of survival (P = 0.001), life expectancy (P = 0.0001), and cost of treatment (P = 0.01). In the classic 'lifeboat' scenario, all but two respondents were utilitarian. CONCLUSIONS: This survey suggests that in situations of scarcity and equal clinical need, non-health professionals support rationing of life-saving treatment based on probability of survival, duration of survival, cost of treatment or quality of life. However, where the difference in prognosis or cost is very small, non-health professionals preferred to give infants an equal chance of receiving treatment.

Care of the Family of an Infant With a Congenital Heart Defect During the NICU Hospitalization.

The family of an infant born with a congenital heart defect is challenged by both the short- and long-term implications of the diagnosis and the neonatal intensive care unit (NICU) hospitalization. Nurses are in a key position to support these families as they deal with the psychological, emotional, and financial impact of the NICU experience. Understanding how families perceive the NICU environment and their grief in losing the desired healthy baby provides the NICU nurse with the knowledge to engage in self-reflection on her or his interpersonal style and caregiving attitudes. Utilizing the concepts and principles of family-centered care and relationship-based practice, nurses can work together with the families to determine how to best meet the families' needs and to find the resources to support them. Families and colleagues appreciate nurses who demonstrate expertise in this approach to family-centered care. This appreciation leads to greater job satisfaction and decreased job-related stress.

Ethical Dilemmas in Postnatal Treatment of Severe Congenital Hydrocephalus.

Severe congenital hydrocephalus manifests as accumulation of a large amount of excess fluid in the brain. It is a paradigmatic example of a condition in which diagnosis is relatively straightforward and long-term survival is usually associated with severe disability. It might be thought that, should parents agree, palliative care and limitation of treatment would be clearly permissible on the basis of the best interests of the infant. However, severe congenital hydrocephalus illustrates some of the neuroethical challenges in pediatrics. The permissibility of withholding or withdrawing treatment is limited by uncertainty in prognosis and the possibility of "palliative harm." Conversely, although there are some situations in which treatment is contrary to the interests of the child, or unreasonable on the grounds of limited resources, acute surgical treatment of hydrocephalus rarely falls into that category.

Ethical Considerations for Perinatal Toxicology Screening.

Neonatal nurses frequently care for babies who have been exposed in utero to potentially harmful substances, both licit and illicit. The risks to the fetus from nicotine, marijuana, alcohol, and opiates are significant. Adverse effects from environmental factors may confound pharmacologic effects of substances. Nurses are called to shift the perception of substance use disorder from that of willful harm to the fetus to that of an opportunity to provide treatment assistance that can positively affect child health and development. Concerns for unethical practices in the toxicology screening of pregnant women and their babies by risk factors that are unproven or disproven are discussed, and three goals of toxicology screening based on the ethical principles of justice and beneficence are proposed. This article will help equip neonatal nurses to fulfill their professional responsibility to advocate for just screening and referral practices in their institutions and communities.

Trisomy 13: Changing Perspectives.

The diagnosis of trisomy 13 has been considered incompatible with life. Trisomy 13 is associated with a pattern of congenital anomalies and mental disabilities that make caring for these infants a challenge for both the family and health care professionals. The clinical management of trisomy 13 varies based on the organ systems involved. The current standard of care has been withholding intensive support and providing comfort care. Recent literature suggests there are improved outcomes in infants who receive intensive care at birth. In addition, case reports evaluating older children with trisomy 13 report that, although there are significant intellectual and psychomotor disabilities, these children do meet developmental milestones such as smiling in response to parents, sitting unassisted, and walking with a walker. This case review will include a discussion of the clinical course of an infant born with mosaic trisomy 13 where the parents requested intensive care.

Were There "Additional Foreseeable Risks" in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.

Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.

SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies.

The design of SUPPORT has been widely misunderstood. This confusion has driven much of the debate about the trial - and threatens the whole enterpise of comparative effectiveness research.

The ethics of an ordinary medical technology.

Some routinely applied hospital technologies may have unintended consequences for patients and their families. The neonatal cardiorespiratory monitor, a computer-like display used to show an infant's vital functions, is one such technology that may become part of a parent's day-to-day being with his or her hospitalized child. In this phenomenological study, I explored how the monitor may mediate parental sensibilities, reshaping the contact of parent and child. This exploration speaks to understanding the relational ethics of even the seemingly most ordinary of medical technologies in clinical contexts.

How to Help Parents, Couples, and Clinicians When an Extremely Premature Infant Is Born.

Parents may experience profound stress when their infant is extremely premature or has exceptionally low birth weight. This article presents several approaches that clinicians and ethics consultants can use to reduce this stress when a parent is single and alone, as well as when both parents are present. Offering parents additional options, taking preventative measures, and using approaches based on recent innovations in psychotherapies are emphasized. Since the clinicians who care for these neonates may find it exceptionally stressful and may experience "burn out," especially over time, this article also addresses what may work best for them. Finally it will discuss clinicians, who, despite their best efforts, find that caring for these infants is simply too painful to bear.

Prenatal Consultation for Extremely Preterm Neonates: Ethical Pitfalls and Proposed Solutions.

In current practice, decisions regarding whether or not to resuscitate infants born at the limits of viability are generally made with expectant parents during a prenatal consultation with a neonatologist. This article reviews the current practice of prenatal consultation and describes three areas in which current practice is ethically problematic: (1) risks to competence, (2) risks to information, and (3) risks to trust. It then reviews solutions that have been suggested in the literature, and the drawbacks to each. Finally, it suggests that the model of prenatal consultation be altered in three ways: (1) that the prenatal consultation be viewed as a process over time, rather than a onetime event; (2) that decision making in the prenatal consultation be framed as a choice between nonresuscitation and a trial of neonatal intensive care, rather than a choice between "doing nothing" and "doing everything"; and (3) that the prenatal consultation process devote serious attention to both the transfer of information and the non-informational needs of families, rather than focus on the transfer of information alone.

A quality of life quandary: a framework for navigating parental refusal of treatment for co-morbidities in infants with underlying medical conditions.

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents' perceptions of their child's projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider the appropriateness of parental refusal based upon an infant's projected quality of life.