Accelerated Predictive Stability Study of a Pediatric Drug Product for a Supplemental New Drug Application.

In this paper, we report two Accelerated Stability Assessment Program (ASAP) studies for a pediatric drug product. Whereas the first study using a generic design failed to establish a predictive model, the second one was successful after troubleshooting the first study and customizing the study conditions. This work highlighted important lessons learned from designing an ASAP study for formulations containing excipients that could undergo phase change at high humidity levels. The stability predictions by the second ASAP model were consistent with available long-term stability data of the drug product under various storage conditions in two different packaging configurations. The ASAP model was part of the justifications accepted by the health authority to submit a stability package with reduced long-term stability data from the primary stability batches for a Supplemental New Drug Application (sNDA).

Pediatric Decision-Making: ethical aspects specific to neonates.

Recently published consensus recommendations on pediatric decision-making by Salter and colleagues (2023) did not address neonatal decision-making, due to the unique complexities of neonatal care. This essay explores three areas that impact neonatal decision-making: legal and policy considerations, rapid technological advancement, and the unique emotional burdens faced by parents and clinicians during the medical care of neonates. The authors evaluate the six consensus recommendations related to these considerations and conclude that the consensus recommendations apply to neonates.

How We Found Consensus on Pediatric Decision-Making and Why It Matters.

This article describes the process engaged by 17 expert scholars in the development of a set of six consensus recommendations about the normative foundations of pediatric decision-making. The process began with a robust pre-reading assignment, followed by three days of in-person symposium discussions that resulted in a publication in Pediatrics entitled "Pediatric Decision-Making: Consensus Recommendations" (Salter et al. 2023). This article next compares the six recommendations to existing statements about pediatric decision-making (specifically those developed by the American Academy of Pediatrics), highlighting similarities and differences. Finally, the article discusses the value of finding consensus in the field of pediatric bioethics.

Limits on Parental Discretion in Medical Decision-Making: pediatric intervention principles converge.

Pediatric intervention principles help clinicians and health-care institutions determine appropriate responses when parents' medical decisions place children at risk. Several intervention principles have been proposed and defended in the pediatric ethics literature. These principles may appear to provide conflicting guidance, but much of that conflict is superficial. First, seemingly different pediatric intervention principles sometimes converge on the same guidance. Second, these principles often aim to solve different problems in pediatrics or to operate in different background conditions. The potential for convergence between intervention principles-or at least an absence of conflict between them-matters for both the theory and practice of pediatric ethics. This article builds on the recent work of a diverse group of pediatric ethicists tasked with identifying consensus guidelines for pediatric decision-making.

Pediatric Decision-Making for Children in State Custody.

In summer 2022, six points of consensus emerged from a symposium addressing the question, "In the context of U.S. pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" (Salter et al. 2023). The authors of this statement wrote, however, that the points of consensus may require modification or may not apply in their entirety to children in state custody. This article addresses the consensus recommendations in the context of the thousands of children removed annually from the custody of their parents. While the consensus statements developed at the symposium provide a good starting point for decision-making in the context of these children, some alterations and nuance must be applied to attend to the specific needs of this population. The article works through what special considerations and changes ought to be made to expand the reach of the original points of consensus without neglecting the particular conditions of children in state custody, as well as their parents and caregivers.

Probiotic use in pediatric kidney transplant recipients: What are current practices, and are they evidence-based? A pediatric nephrology research consortium study.

BACKGROUND: Probiotics are living microorganisms that may confer health benefits to their host if administered in sufficient quantities. However, data on the use of probiotics in transplant recipients are scarce. METHOD: This multi-center survey of pediatric nephrologists aimed to examine variations in practice regarding the use of probiotics in pediatric kidney transplant recipients. The survey was conducted via a 10-item questionnaire (developed in Survey Monkey) administered to pediatric nephrologists participating in the Pediatric Nephrology Research Consortium meeting in April 2023. RESULTS: Sixty-four pediatric nephrologists completed the survey. Twenty-seven (42.2%) respondents reported having prescribed probiotics to pediatric kidney transplant recipients. The primary reason for probiotic use was the treatment of antibiotic-associated diarrhea (n = 20), with other reasons including recurrent Clostridium difficile infection (n = 15), general gut health promotion (n = 12), recurrent urinary tract infections (n = 8), and parental request (n = 1). Of those who prescribed probiotics, 48.1% held them during periods of neutropenia and 14.8% during central venous line use. Of the 64 respondents, 20 reported the lack of safety data as a concern for using probiotics in kidney transplant recipients. CONCLUSION: Pediatric nephrologists are increasingly prescribing probiotics to pediatric kidney transplant recipients; nevertheless, substantial practice variations exist. The paucity of safety data is a significant deterrent to probiotic use in this population.

Simulation-based team training for healthcare professionals in pediatric departments: study protocol for a nonrandomized controlled trial.

BACKGROUND: Healthcare systems worldwide face challenges related to patient safety, quality of care, and interprofessional collaboration. Simulation-based team training has emerged as a promising approach to address some of these challenges by providing healthcare professionals with a controlled and safe environment to enhance their teamwork and communication skills. The purpose of this study protocol is to describe an intervention using simulation-based team training in pediatric departments. METHODS: Using a parallel-group, non-randomized controlled trial design, a simulation-based team training intervention will be implemented across four pediatric departments in Denmark. Another four pediatric departments will serve as controls. The intervention implies that healthcare professionals engage in simulation-based team training at a higher quantity and frequency than they did previously. Development of the intervention occurred from April 2022 to April 2023. Implementation of the intervention occurs from April 2023 to April 2024. Evaluation of the intervention is planned from April 2024 to April 2025. All simulation activity both before and during the intervention will be registered, making it possible to compare outcomes across time periods (before versus after) and across groups (intervention versus control). To evaluate the effects of the intervention, we will conduct four analyses. Analysis 1 investigates if simulation-based team training is related to sick leave among healthcare professionals. Analysis 2 explores if the simulation intervention has an impact on patient safety culture. Analysis 3 examines if simulation-based team training is associated with the treatment of critically ill newborns. Finally, Analysis 4 conducts a cost-benefit analysis, highlighting the potential return on investment. DISCUSSION: The implemented simulation-based team training intervention can be defined as a complex intervention. Following the Medical Research Council framework and guidelines, the intervention in this project encompasses feasibility assessment, planning of intervention, implementation of intervention, and rigorous data analysis. Furthermore, the project emphasizes practical considerations such as stakeholder collaboration, facilitator training, and equipment management. TRIAL REGISTRATION: Registered as a clinical trial on clinicaltrials.gov, with the identifier NCT06064045.

An evaluation of a Transition to Foundations curriculum for first year pediatric residents in Competency Based Medical Education.

A Transition to Foundations (TTF) curriculum that includes didactic and simulation components prepares first-year pediatric residents for increased roles and responsibilities in the Foundations of Discipline stage of Competency Based Medical Education, including junior night float rotations. Simulations of acute presentations improve resident comfort before overnight on-call experiences.

Un programme de transition vers les fondements de la discipline (TTF) comportant des volets didactique et de simulation prépare les résidents de première année en pédiatrie à des rôles et des responsabilités accrus à l'étape des fondements de la discipline dans le cadre d'une approche par compétences, notamment aux stages de nuit des résidents juniors. Les simulations de présentations aiguës améliorent le confort des résidents avant les gardes de nuit.

Study protocol OKRA: orientation compass for the preparing, delivering and following up on breaking bad news conversations in paediatric oncology.

INTRODUCTION: In paediatric oncology, 'breaking bad news'-BBN-like cancer diagnosis is perceived as particularly challenging. Enabling a trialogue between children with their relatives and health professionals requires profound communication skills. Lacking the skills, experience or adequate support tools might result in negative consequences for both paediatric oncologists as BBN transmitters and BBN receivers as children with cancer and their relatives.In contrast to oncology for adults, multiperspective studies that explore BBN experience and specific support needs are rare, especially in Germany. Systematically developed and practically piloted support instruments, which address the specific needs of paediatric oncology, are missing. OBJECTIVE: To systematically design and mature in practice an orientation compass for preparing, delivering and following up on BBN conversations in paediatric oncology-so-called Orientierungskompass zur Übermittlung schwerwiegender Nachrichten in der Kinderonkologie (OKRA). METHODS AND ANALYSIS: OKRA is based on a QUAL-quant mixed study design, comprising two phases. Four groups will contribute (1) experts through personal experience (representatives for children receiving BBN and their parents), (2) medical care providers and representatives of national medical societies, (3) ambulant psychosocial/psychological support providers and (4) researchers. In phase 1, multiperspective knowledge is generated through a participatory group Delphi that involves in-depth interviews, focus group discussions and questionnaires. This process culminates in formulating theses for a high-quality BBN process (output phase 1). In phase 2, based on the theses, a pilot orientation compass is designed. Through iterative cycles with the participatory action research method, this instrument will be piloted in three paediatric oncological settings and consequently optimised. ETHICS AND DISSEMINATION: OKRA was approved on 19 September 2023 by the ethics committee of the Medical Faculty of the University of Cologne (No. 23-1187). After project completion, the OKRA compass will be distributed to multidisciplinary paediatric oncology teams throughout Germany. TRIAL REGISTRATION NUMBER: DRKS00031691.

Exploring dental and oral hygiene students' interprofessional readiness: a cross-sectional study in joint paediatric outreach training.

BACKGROUND: Interprofessional education is vital in oral healthcare education and should be integrated into both theoretical and work-based education. Little research addresses interprofessional education in dental hands-on training in authentic oral healthcare settings. The aim of the study was to examine the readiness and attitudes of dental and oral hygiene students towards interprofessional education during joint paediatric outreach training. METHODS: In the spring of 2022, a cross-sectional study was done involving dental and oral hygiene students using the Readiness for Interprofessional Learning Scale (RIPLS) during joint paediatric outreach training. The 19-item tool was answered on a five-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree). Means, standard deviations, minimums, maximums, and medians were calculated for each subscale and overall score. Students grouped according to their categorical variables were compared for statistically significant differences. The Mann-Whitney U-test was used for groups of two and the Kruskal-Wallis one-way analysis for groups of three or more. The internal consistency of the scale was measured with Cronbach's alpha. Statistical level was set at 0.05. RESULTS: The survey included 111 participants, consisting of 51 oral hygiene students and 60 dental students, with a response rate of 93%. The questionnaire yielded a high overall mean score of 4.2. Both oral hygiene (4.3) and dental students (4.2) displayed strong readiness for interprofessional education measured by the RIPLS. The subscale of teamwork and collaboration achieved the highest score of 4.5. Students lacking prior healthcare education or work experience obtained higher RIPLS scores. Oral hygiene students rated overall items (p = 0.019) and the subscales of positive professional identity (p = < 0.001) and roles and responsibilities (p = 0.038) higher than dental students. The Cronbach's alpha represented high internal consistency for overall RIPLS scores on the scale (0.812). CONCLUSIONS: Both oral hygiene and dental students perceived shared learning as beneficial and showcased high readiness for interprofessional education, as evident in their RIPLS scores. Integrating interprofessional learning into oral hygiene and dental curricula is important. Studying together can form a good basis for future working life collaboration.

Improving Access to Autism Evaluation: A Coordinated Developmental-Behavioral Pediatrics and Pediatric Neurology Diagnostic Pathway.

A shortage of board-certified developmental-behavioral pediatricians generates a bottleneck for children and families who seek autism diagnostic services. Wait time for autism evaluation commonly exceeds a year. To improve access, clinicians developed a coordinated Developmental-Behavioral Pediatrics and Pediatric Neurology autism diagnostic pathway. For a subset of children referred to neurology clinic, pediatric neurologists completed the medical part of an autism evaluation and Knights of Columbus Developmental Center psychologists or speech-language pathologists completed developmental assessments. Forty-four autism diagnostic evaluations completed through this coordinated pathway over the course of six months had shortened wait time [mean=50.89 days; range 3 to 184 days; median= 48.50 day]. Parents reported satisfaction with the autism evaluation and resources navigation process. Sustainability and scalability efforts are discussed.

Diabetes and Dyslipidemia Screening in Pediatric Practice.

The incidence of diabetes and hyperlipidemia are increasing at rapid rates in children. These conditions are associated with increased risk of macrovascular and microvascular complications causing major morbidity and mortality later in life. Early diagnosis and treatment can reduce the lifelong risk of complications from these diseases, exemplifying the importance of screening in the pediatric population. The following article presents a summary of the current guidelines for diabetes and hyperlipidemia screening in pediatric patients.

Developing and transferring a children's surgical training program from India to Africa a south-to-south global initiative.

PURPOSE: The availability of children's surgical care in lower middle-income countries is lacking. The authors describe a hub and spoke global training initiative in children's surgery for adult teams from district hospitals (spokes) comprising general and orthopaedic surgeons, anaesthetists, and nurses and specialist children's surgical trainers from tertiary centres (hubs) in delivering the course. METHODS: The training course developed in Vellore, trained several sets of district hospital adult teams and trainer teams in India. Six specialist children's surgical trainer teams were invited from African countries to the course delivered in Vellore, India. The aim was to train them to deliver the course in their countries. RESULTS: Participants underwent a precourse 'train the trainer' program, observed and assessed the suitability of the district hospital training course. The program received positive feedback, government supported planning of similar courses in some of the countries and discussions in others. CONCLUSION: The availability of children's surgical care is similarly limited in the Asian and African continent, and the regions have shared challenges of disease burden, lack of access, poverty, deficient infrastructure, and trained human resources. They would benefit from this 'South to South' collaboration to impart training skills and modules to the children's surgical trainers.

Pediatric rheumatology education: the virtual frontier a review.

BACKGROUND: Many children with rheumatic and musculoskeletal diseases are unrecognized. Identifying these children requires health care provider awareness, knowledge, and skills to recognize disease features and how (and when) to refer to specialist care. The aim of this paper is to highlight the need for better access to health care, review the essential role that education and virtual care play to address unmet need in low resource areas and especially to expand workforce capacity. Using collaborative partnerships, virtual platforms, and innovative assessment methods, musculoskeletal care and education can be delivered to reach a greater audience than ever before. Increased awareness through multiple initiatives and readily available resources are imperative to improve global rheumatology care. CONCLUSION: The needs of children with rheumatic diseases and musculoskeletal conditions are vastly underserved around the world resulting in preventable morbidity and mortality. Expanded implementation of virtual education and e-health care platforms provides an opportunity to increase access to care for children globally.