Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study.

Objective: This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments.

Methods: In this open-label study acceptability of oral formulations was tested in three age groups (1-<6 months, 6-<12 years, and 12-<18 years) with a 2-way cross-over design in children aged 1-<6 months (syrup and mini-tablets), and with an incomplete block design of four sequences with three out of four formulations (syrup, mini-tablets, oblong tablet, and round tablet) each in children aged 6-<18 years. The primary endpoint was acceptability derived from the composite acceptability endpoint.

[Retrospective analysis of the resuscitation room management of nontraumatic critically ill children in a university emergency department (OBSERvE-DUS-PED study)].

Background: The establishment of a resuscitation room management for nontraumatic critically ill children appears to make sense. This study collected data of pediatric patients suffering from nontraumatic critically ill conditions treated in a resuscitation room.

Methods: The retrospective OBSERvE-DUS-PED study (November 2019-October 2022) recorded pediatric patients (age < 18 years) who were admitted to the emergency department (ED) for resuscitation room care.

Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital.

Although drug acceptability can have a significant impact on patient adherence in pediatric therapy, data are limited, even for common therapeutic areas. We present the second part of an acceptability study conducted at the University Children's Hospital Düsseldorf, Germany. The study investigated the acceptability of most commonly used antibiotics in a pediatric hospital setting.

Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study.

Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month-6 years (stratified: 4-6 years, 2-<4 years, 1-<2 years, 6-<12 months, and 1-<6 months), and their preference for swallowing either a high quantity of 2.0 mm or a low quantity of 2.

Preference matters: New aspects on how foreign bodies should and could be removed from a child's airway.

Background: Foreign body aspiration in children is a potentially life-threatening event that can be diagnosed and treated by airway endoscopy. We aimed to analyze the influence of the examiner's experience and preference on the choice of the technique and the resulting complication rate.

Methods: In this international study, experts in the field documented their preferred and applied technique as well as the outcome of each case of foreign body removal.

Acceptability of multiple coated mini-tablets in comparison to syrup in infants and toddlers: a randomised controlled study.

Objectives: Drug treatment of children is often limited to liquid formulations or manipulation of adult solid oral dosage forms because of the lack of age-appropriate formulations, concerns around particle aspiration and paediatric acceptability. Recent research revealed that the administration of mini-tablets has substantial advantages in improving dose accuracy and avoiding issues related to drug stability, storage conditions, potentially toxic excipients and taste masking (especially effective when the mini-tablets are coated). Most trials were performed with single and multiple mini-tablets.

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2-<7 Years: Results of an Open-Label Randomised Study.

This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2-<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administration of 16 (group A) or 32 (group B) mini-tablets with soft food or 16 (group C) or 32 (group D) mini-tablets with water. Children in each group were stratified by age group (2-<3 years; 3-<4 years; 4-<5 years; 5-<6 years; and 6-<7 years).

Quantitative analysis of different respiratory specimens on two automated test systems for detection of SARS-CoV-2 RNA.

Molecular testing of SARS-CoV-2 RNA is essential during the pandemic. Here, we compared the results of different respiratory specimens including anterior nasal swabs, pharyngeal swabs, saliva swabs, and gargle lavage samples to nasopharyngeal swabs on two automated SARS-CoV-2 test systems. Samples were collected and tested simultaneously from a total of 36 hospitalized symptomatic COVID-19 patients.

Dosage Forms Suitability in Pediatrics: Acceptability of Analgesics and Antipyretics in a German Hospital.

Although medicine acceptability is likely to have a significant impact on the patient's adherence in pediatrics and therefore on therapy success, there is still little data even for common therapeutic areas. For analgesics/antipyretics, healthcare professionals face a wide variety of products and need knowledge to select the best adapted product for each patient. We investigated acceptability of those products most used at the University Children's Hospital Düsseldorf, Germany.

Pooled RT-qPCR testing for SARS-CoV-2 surveillance in schools - a cluster randomised trial.

Background: The extent to which children and adolescents contribute to SARS-CoV-2 transmission remains not fully understood. Novel high-capacity testing methods may provide real-time epidemiological data in educational settings helping to establish a rational approach to prevent and minimize SARS-CoV-2 transmission. We investigated whether pooling of samples for SARS-CoV-2 detection by RT-qPCR is a sensitive and feasible high-capacity diagnostic strategy for surveillance of SARS-CoV-2 infections in schools.

The Use of Entrustable Professional Activities in Pediatric Postgraduate Medical Education: A Systematic Review.

Background: Entrustable Professional Activities (EPAs) provide a framework to make judgments of trainees' abilities in several settings including postgraduate medical education. No systematic review of the role of EPAs in pediatrics has yet been performed.

Objectives: In our systematic review, we sought to determine the use of EPAs in pediatrics to identify research gaps, summarize and discuss evidence relating to the development, implementation, and assessment.

Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A randomized controlled trial.

Objective: There is limited evidence for the acceptability of various drug formulations holding the potential to improve medicines administration to children. Suitable formulations need to meet the requirements of pediatric patients. Previous studies have demonstrated the acceptance of mini-tablets.

Undergraduate medical education amid COVID-19: a qualitative analysis of enablers and barriers to acquiring competencies in distant learning using focus groups.

Due to comprehensive social distancing measures related to the COVID-19 pandemic, medical faculties worldwide have made a virtue of necessity in resorting to online teaching. Medical faculties grapple with how to convey clinical competencies to students in this context. There is a need for research not only to map but also to explain the effect of these secondary measures on students' learning and mental wellbeing.

Paediatric primary care in Germany during the early COVID-19 pandemic: the calm before the storm.

Objectives: Globally, the COVID-19 pandemic has a major impact on healthcare provision. The effects in primary care are understudied. This study aimed to explore changes in consultation numbers and patient management during the COVID-19 pandemic, and to identify challenges for patient care.

[Alice in the digital wonderland-pediatric teaching during the COVID-19 pandemic].

The COVID-19 pandemic led to a rapid switch from undergraduate classroom teaching to online-teaching; a challenging process for teachers and students. Based on a recent online survey among German pediatric university hospitals the "AG Lehre der DGKJ" (teaching working group of the German Society of Pediatrics and Adolescent Medicine) summarizes latest experiences with e‑learning during the summer term of 2020. The survey participants from 17 pediatric university hospitals report that the large spectrum of e‑learning formats could sufficiently replace classical lectures and seminars but could not fully replace teaching involving direct contact to patients.

Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial.

Objectives: Reliable pediatric pharmacotherapy in all age groups requires the availability of age-appropriate drug administration. Orodispersible films (ODF) are a promising pediatric oral dosage form. ODFs would meet relevant targets: one dosage form matching the full range of pediatric patients, a minimum of non-toxic excipients, a stable drug formulation easily to be produced.

Meningitis gone viral: description of the echovirus wave 2013 in Germany.

Background: Aseptic meningitis epidemics may pose various health care challenges.

Methods: We describe the German enterovirus meningitis epidemics in the university hospital centers of Düsseldorf, Cologne and Berlin between January 1st and December 31st, 2013 in order to scrutinize clinical differences from other aseptic meningitis cases.

Results: A total of 72 enterovirus (EV-positive) meningitis cases were detected in our multicenter cohort, corresponding to 5.

Animation and interactivity facilitate acquisition of pediatric life support skills: a randomized controlled trial using virtual patients versus video instruction.

Background: Several promising studies suggest a positive impact of interactive and media-enriched e-learning resources such as virtual patients (VP) on skill acquisition in pediatric basic life support (PBLS). This study investigates which immanent VP components account for this effect.

Methods: N = 103 medical students in their 5th year were assigned to one of three groups: a video group prepared with self-instructional videos on PBLS (N = 37); an animation-enriched VP group with VP containing interactive questions (N = 35), static and animated media, and a static VP group with VP containing interactive questions and only static media (N = 31).

Acceptability of Multiple Uncoated Minitablets in Infants and Toddlers: A Randomized Controlled Trial.

Objectives: To assess the acceptability and swallowability of several minitablets when administered as a unit dose compared with an equivalent dose of syrup in children aged 6 months to 5 years.

Study Design: The acceptability and swallowability of multiple drug-free minitablets in comparison with glucose syrup was assessed in 372 children of 2 age groups (186 in age group 1 [6-23 months of age] and 186 in age group 2 [2-5 years of age]) in a randomized, 3-way, single administration cross-over study. Age group 1 received 25 minitablets, 100 minitablets, and 5 mL syrup.

Electronic assessment of clinical reasoning in clerkships: A mixed-methods comparison of long-menu key-feature problems with context-rich single best answer questions.

Background: It remains unclear which item format would best suit the assessment of clinical reasoning: context-rich single best answer questions (crSBAs) or key-feature problems (KFPs). This study compared KFPs and crSBAs with respect to students' acceptance, their educational impact, and psychometric characteristics when used in a summative end-of-clinical-clerkship pediatric exam.

Methods: Fifth-year medical students (n = 377) took a computer-based exam that included 6-9 KFPs and 9-20 crSBAs which assessed their clinical reasoning skills, in addition to an objective structured clinical exam (OSCE) that assessed their clinical skills.

Student perceptions of a video-based blended learning approach for improving pediatric physical examination skills.

Aim: Physical examination skills are crucial for a medical doctor. The physical examination of children differs significantly from that of adults. Students often have only limited contact with pediatric patients to practice these skills.

Cost-effectiveness of peer role play and standardized patients in undergraduate communication training.

Background: The few studies directly comparing the methodological approach of peer role play (RP) and standardized patients (SP) for the delivery of communication skills all suggest that both methods are effective. In this study we calculated the costs of both methods (given comparable outcomes) and are the first to generate a differential cost-effectiveness analysis of both methods.

Methods: Medical students in their prefinal year were randomly assigned to one of two groups receiving communication training in Pediatrics either with RP (N = 34) or 19 individually trained SP (N = 35).

Acceptance and effectiveness for learning of a simulation manikin for suprapubic aspiration in toddlers constructed with simple means.

Background: Skills trainings are increasing in popularity in undergraduate medical education enhancing clinical competencies and motivation for clinical practice. A suprapubic aspiration (SPA) is the gold standard to obtain urine from toddlers and young infants with fever and unclear focus to prove an urinary tract infection.

Methods: In a blended-learning scenario with virtual patients and skills lab training students were trained for a SPA.

Acceptability of Uncoated Mini-Tablets in Neonates--A Randomized Controlled Trial.

Objective: To evaluate the suitability of drug-free solid dosage forms (2 mm mini-tablets) as an alternative administration modality in neonates in comparison with syrup.

Study Design: A total of 151 neonates (inpatients; aged 2-28 days; median 4 days) were recruited. An open, randomized, prospective cross-over study was conducted to compare the acceptability and swallowability of 2 mm uncoated mini-tablets compared with .