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... Show moreBackground: 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. Show less
Boer, M.C. den; Houtlosser, M.; Witlox, R.S.G.M.; Stap, R. van der; Vries, M.C. de; Lopriore, E.; Pas, A.B. te 2021
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... Show moreBackground 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. Show less
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,... Show moreMedical 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. Show less
Boer, M.C. den; Martherus, T.; Houtlosser, M.; Root, L.; Witlox, R.S.G.M.; Pas, A.B. te 2020
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... Show moreVideo 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. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Lopriore, E.; Vries, M.C. de; Engberts, D.P.; Pas, A.B. te 2020
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... Show moreObjective 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. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Tan, R.N.G.B.; Engberts, D.P.; Pas, A.B. te 2019
Objective To assess benefits of recording and reviewing neonatal resuscitation as experienced by neonatal care providers. Design A qualitative study using semistructured interviews questioning... Show moreObjective 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. Show less
Boer, M.C. den; Houtlosser, M.; Foglia, E.E.; Davis, P.G.; Kaam, A.H. van; Kamlin, C.O.F.; ... ; Pas, A.B. te 2019
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... Show moreBACKGROUND 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. Show less
Vries, M.C. de; Houtlosser, M.; Wit, J.M.; Engberts, D.P.; Bresters, D.; Kaspers, G.J.L.; Leeuwen, E. van 2011
In good hands. Nursing practice in a moral perspective. There is much debate about the moral aspects of nursing and the possibilities for moral professionalization. In this study we contribute to... Show moreIn good hands. Nursing practice in a moral perspective. There is much debate about the moral aspects of nursing and the possibilities for moral professionalization. In this study we contribute to the debate by describing the possibilities nurses see for themselves to handle moral problems in patient care. Regarding ethical issues, nurses consider a specific role for themselves as patients advocates, a specific standpoint being based on a nursing domain which they can contribute to multidisciplinary consultation and an ethic of their own, being ethics of care. Analyzing the application of these positions in three pediatric case-study__s reveals that each position offers nurses insufficient support. Advocacy proves to be at odds with team-nursing, the nursing system that is most common. Successful participation in treatment decision-making turns out not to be based on a nursing domain but on a mutual frame of reference with doctors. Although a care-ethical analysis helps to understand the problems that may arise during care and treatment, important problems can not be solved with the aid of care ethics. Elements of all positions are used to construct a new ethical framework that can serve as a fundament for the moral professional practice of nurses and offer assistance to nurses in handling moral problems in patient care. Show less
