Deferred consent for delivery room studies: the providers' perspective.

OBJECTIVE: To gain insight into neonatal care providers' perceptions of deferred consent for delivery room (DR) studies in actual scenarios. METHODS: We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0. RESULTS: Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent. CONCLUSION: Insight into providers' perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.

Benefits of recording and reviewing neonatal resuscitation: the providers' perspective.

OBJECTIVE: To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. DESIGN: A qualitative study using semistructured interviews questioning neonatal care providers about their experiences with recording and reviewing neonatal resuscitation. Data were analysed using the qualitative data analysis software Atlas.ti V.7.0. SETTING: Neonatal care providers working at neonatal intensive care units (NICUs) of the Leiden University Medical Center, the Netherlands, and the University of Pennsylvania School of Medicine, USA, participated in this study. RESULTS: In total, 48 NICU staff members were interviewed. Reported experiences and attitudes are broadly similar for both NICUs. All interviewed providers reported positive experiences and benefits, with special emphasis on educational benefits. Recording and reviewing neonatal resuscitation is used for various learning activities, such as plenary review meetings and as tool for objective feedback. Providers reported to learn from reviewing their own performance during resuscitation, as well as from reviewing performances of others. Improved time perception, reflection on guideline compliance and acting less invasively during resuscitations were often mentioned as learning outcomes. All providers would recommend other NICUs to implement recording and reviewing neonatal resuscitation, as it is a powerful tool for learning and improving. However, they emphasised preconditions for successful implementation, such as providing information, not being punitive and focusing on the benefits for learning and improving. CONCLUSION: Recording and reviewing neonatal resuscitation is considered highly beneficial for learning and improving resuscitation skills and is recommended by providers participating in it.

Ethical dilemmas of recording and reviewing neonatal resuscitation.

Neonatal resuscitation is provided to approximately 3% of neonates. Adequate ventilation is often the key to successful resuscitation, but this can be difficult to provide. There is increasing evidence that inappropriate respiratory support can have severe consequences. Several neonatal intensive care units have recorded and reviewed neonatal resuscitation procedures for quality assessment, education and research; however, ethical dilemmas sometimes make it difficult to implement this review process. We reviewed the literature on the development of recording and reviewing neonatal resuscitation and have summarised the ethical concerns involved. Recording and reviewing vital physiological parameters and video imaging of neonatal resuscitation in the delivery room is a valuable tool for quality assurance, education and research. Furthermore, it can improve the quality of neonatal resuscitation provided. We observed that ethical dilemmas arise as the review process is operating in several domains of healthcare that all have their specific moral framework with requirements and conditions on issues such as consent, privacy and data storage. These moral requirements and conditions vary due to local circumstances. Further research on the ethical aspects of recording and reviewing is desirable before wider implementation of this technique can be recommended.

Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences.

BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. METHODOLOGY: An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. RESULTS: Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. CONCLUSION: Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes.

[Pregnancy and coma: more than one dilemma]. / Zwangerschap en coma: meer dan één dilemma.

A previously healthy 33-year-old woman presented at 13 weeks gestation in a comatose state after a new onset of seizures. Evaluation revealed an intraventricular haemorrhage from an arterioventricular malformation. Coma in pregnancy is a rare event. The moral, legal and medical aspects of prolongation of pregnancy, termination, withdrawal of medical treatment and organ donation are discussed.

Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation.

BACKGROUND: Various regulations and guidelines stipulate the importance of involving adolescents in decision-making concerning research participation. Several studies have shown that in the context of pediatric oncology this involvement is difficult to achieve due to emotional stress, the complexity of research protocols and limited time. Still, up to 80% of adolescents with cancer enter onto a trial during their illness. The aim of this study was to determine clinicians' views and attitudes towards enrolling adolescents in research, considering the difficulties surrounding their involvement in decision-making. METHODS: A qualitative multicenter study was performed, using in-depth semi-structured interviews on the informed consent process with 15 pediatric hemato-oncologists. RESULTS: Four central themes emerged that characterize clinicians' attitudes towards involving adolescents in the decision-making process: (1) clinicians regard most adolescents as not capable of participating meaningfully in discussions regarding research; (2) clinicians do not always provide adolescents with all information; (3) proxy consent from parents is obtained and is deemed sufficient; (4) clinician-investigator integrity: clinicians judge research protocols as not being harmful and even in the best interest of the adolescent. CONCLUSIONS: Clinicians justify not involving adolescents in research discussions by referring to best interest arguments (adolescents' incompetence, proxy consent, and investigator integrity), although this is not in line with legal regulations and ethical guidelines.

Attitudes of physicians and parents towards discussing infertility risks and semen cryopreservation with male adolescents diagnosed with cancer.

BACKGROUND: In paediatric oncology, the risk of infertility due to treatment constitutes an important problem. For sexually mature male adolescents, sperm cryopreservation is an option, but discussing the topic is complex because of the sensitive nature and the limited time frame. In this article, we determined attitudes and preferred roles of physicians and parents towards discussing sperm banking with male adolescents. METHODS: Qualitative multi-centre study, using in-depth semi-structured interviews with 14 physicians and 15 parents of male adolescents undergoing cancer treatment. RESULTS: Although physicians and parents agreed that infertility would have a major impact on the future quality of life, they sometimes disagreed on whether the topic should be discussed with adolescents. Physicians always wanted a separate discussion with adolescents because of the sensitive nature and the experience that parents sometimes misjudged the stage of maturity of their son. Parents, however, wanted control over whether physicians discussed the topic with their child and what was said. Physicians did not accept this control and, when necessary, were willing to bypass the parents and discuss the topic with the adolescent even when parents refused consent. CONCLUSIONS: Physicians face the difficult task of balancing between their ideas of what is in the (future) interest of the adolescent and accommodating parental wishes. We argue that, because of the private character of sexuality and the potentially inadequate maturity assessment by parents, semen cryopreservation should be discussed separately with adolescent and parents. In addition, there should be an open communication with parents to address potential discomforts.