Consent for Delivery Room Studies: What Can Be Learned from Perceptions of Parents.

BACKGROUND: Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight into parental experiences with and perceptions of consent for DR studies. METHODS: Semistructured interviews were conducted with parents of very and extreme preterm infants. Interviews were audio-recorded, transcribed, and analyzed using the qualitative data analysis software Atlas. ti V.8.4. RESULTS: Twenty-five parents were interviewed. Despite being in an emotional and stressful situation, most parents considered being approached for DR studies as valuable. According to parents, this was mostly due to appropriate timing and communication, compassion, and investigators not being obtrusive. Interviewed parents generally decided to accept or decline study participation based on perceived risk. Parents differed widely in how risk of specific study interventions was perceived, but agreed on the fact that parental consent is needed for DR studies that involve risk. There was no consensus among parents on deferred consent for DR studies running at our NICU. However, parents considered deferred consent appropriate for observational studies. Furthermore, it became clear that parental misunderstanding of various aspects of DR studies, including aims, the concept of randomization, and risk associated with specific interventions, was common. CONCLUSIONS: Insight into parental perceptions of consent for DR studies allowed us to determine areas where the validity of parental consent can be improved. Further research on parental perspectives for consent for DR studies will allow us to establish consent procedures that are considered both valid and valuable.

Twelve tips for fostering the next generation of medical teachers.

Medical professionals with a special interest in and focus on education are essential to provide good quality education. Despite high numbers of students expressing an interest in teaching, concerns are rising regarding the supply of medical teachers, with few junior educators on the career ladder. To date, only some medical schools offer in-depth courses to students wanting to explore or aspire a career as a specialised medical teacher. We propose twelve tips for an elective course to foster the next generation of medical teachers. This course aims to enhance theoretical foundations and educational practices to cultivate the next generation of medical teachers.

Reviewing recordings of neonatal resuscitation with parents.

BACKGROUND: Recording of neonatal resuscitation, including video and respiratory parameters, was implemented for research and quality purposes at the neonatal intensive care unit (NICU) of the Leiden University Medical Center, and parents were offered to review the recording of their infant together with a neonatal care provider. We aimed to provide insight in parental experiences with reviewing the recording of the neonatal resuscitation of their premature infant. METHODS: This study combined participant observations during parental review of recordings with retrospective qualitative interviews with parents. RESULTS: Parental review of recordings of neonatal resuscitation was observed on 20 occasions, reviewing recordings of 31 children (12 singletons, 8 twins and 1 triplet), of whom 4 died during admission. Median (range) gestational age at birth was 27+5 (24+5-30+3) weeks. Subsequently, 25 parents (13 mothers and 12 fathers) were interviewed.Parents reported many positive experiences, with special emphasis on the value for getting hold of the start of their infant's life and coping with the trauma of neonatal resuscitation. Reviewing recordings of neonatal resuscitation frequently resulted in appreciation for the child, the father and the medical team. Timing and set-up of the review contributed to positive experiences. Parents considered screenshots/copies of the recording of the resuscitation of their infant as valuable keepsakes of their NICU story and reported that having the screenshots/video comforted them, especially when their child died during admission. CONCLUSION: Parents consider reviewing recordings of neonatal resuscitation as valuable. These positive parental experiences could allay concerns about sharing recordings of neonatal resuscitation with parents.

Improving the Quality of Provided Care: Lessons Learned From Auditing Neonatal Stabilization.

Video and physiological parameter recording of neonatal stabilization was implemented at the Neonatal Intensive Care Unit (NICU) of the Leiden University Medical Center. In order to improve documentation and the quality of care provided during neonatal transition, we implemented weekly plenary audits reviewing recordings of neonatal stabilization in 2014. In audits, provided care is reviewed, discussing, among others, mask technique, compliance to the prevailing local guideline, and clinical decision making and alternative treatment options. In this perspective, we argue that auditing neonatal stabilization is a valuable tool to improve patient safety and the quality of care provided during neonatal stabilization. We, therefore, report lessons learned and areas for improvement that could be identified and addressed during audits conducted at our NICU. Important areas for improvement were guideline compliance, documentation, the usage of medical devices, the conduct of delivery room studies, and clinical decision making. By reporting our experiences, we hope to encourage other NICUs to also implement regular audit meetings, fitting to their improvement needs.

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.

A practical framework for remediating unprofessional behavior and for developing professionalism competencies and a professional identity.

The relatively new term "Professional Identity Formation" (PIF) complements behavior-based and attitude-based perspectives on professionalism. Unprofessional behavior and its remediation should also be addressed from this perspective. However, a framework is needed to guide discussion and remediation of unprofessional behavior, which can encompass behavior-based, attitude-based, and identity-based perspectives on professionalism. To this end, the authors propose a multi-level professionalism framework which describes, apart from professional behavior, more levels which influence professional performance: environment, competencies, beliefs, values, identity, and mission. The different levels can provide tools for educators to address and discuss unprofessional behavior with their students in a comprehensive way. By reflecting on all the different levels of the framework, educators guard themselves against narrowing the discussion to either professional behavior or professional identity. The multi-level professionalism framework can help educators and students to gain a better understanding of the root of unprofessional behavior, and of remediation strategies that would be appropriate. For despite the recent emphasis on PIF, unprofessional behavior and its remediation will remain important issues in medical education.

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.