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 5.8% of all EV-positive cases which were voluntarily reported within the National Enterovirus surveillance (EVSurv, based on investigation of patients with suspected aseptic meningitis/encephalitis and/or acute flaccid paralysis) by physicians within this period of time. Among these 72 patients, 38 (52.8%) were enterovirus positive and typed as echovirus (18 pediatric and 20 adult cases, median age 18.5 years; echovirus 18 (1), echovirus 2 (1), echovirus 30 (31), echovirus 33 (1), echovirus 9 (4)). At the same time, 45 aseptic meningitis cases in our cohort were excluded to be due to enteroviral infection (EV-negative). Three EV-negative patients were tested positive for varicella zoster virus (VZV) and 1 EV-negative patient for herpes simplex virus 2. Hospitalization was significantly longer in EV-negative cases. Cerebrospinal fluid analysis did not reveal significant differences between the two groups. After discharge, EV-meningitis resulted in significant burden of sick leave in our pediatric cohort as parents had to care for the children at home. CONCLUSIONS: Voluntary syndromic surveillance, such as provided by the EVSurv in our study may be a valuable tool for epidemiological research. Our analyses suggest that EV-positive meningitis predominantly affects younger patients and may be associated with a rather benign clinical course, compared to EV-negative cases.

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). Subsequent PBLS demonstrations were video-documented and scored for adherence to guideline-based algorithm, temporal demands (such as correct pace of rescue breaths and chest compressions), and quality of procedural steps (e.g., correct head positioning), as well as overall competency by two group-blinded, independent pediatricians. RESULTS: Groups did not differ with regard to adherence to correct algorithm (88.7 ± 10.3, 93.3 ± 6.7 and 90.3 ± 10.5, respectively). Self-instruction with animated media - through videos or animation-enriched VP - resulted in a better adherence to temporal demands, as compared with training with static VP (64.5 ± 26.3 and 50.7 ± 25.7, respectively, vs. 23.8 ± 21.0). Procedural quality by the video group was slightly inferior compared with the animation-enriched VP group (79.5 ± 12.3 vs. 82.0 ± 11.9), and distinct inferior in overall 'competent' ratings (43.2% vs. 65.7%). The static VP group performed considerably most poorly of all three groups (temporal adherence 73.2 ± 11.9 and 19.4% 'competent' ratings). CONCLUSIONS: VP can feasibly enhance PBLS skill acquisition. Thoughtful design of animations and interactivity of the VP further improves such skill acquisition, both in quality of performance and in adherence to temporal demands.

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. Age group 2 received 100 minitablets, 400 minitablets, and 10 mL syrup. RESULTS: Superiority was demonstrated in age group 1 for acceptability (25 minitablets, P < .017; 100 minitablets, P < .0001) and swallowability (25 minitablets and 100 minitablets, both P < .0001) compared with syrup. In age group 2, noninferiority of acceptability was found only for 400 minitablets (P < .0003), not for 100 minitablets. Subgroup analysis revealed a strong sequential effect. For swallowability, noninferiority could be demonstrated for 100 minitablets (P < .01) but not for 400 minitablets. CONCLUSIONS: Administration of ≥25 minitablets is well-tolerated, feasible, and safe in children aged from 6 months, and was superior to the equivalent dose of syrup. Children aged >1 year accept ≤400 minitablets even better than the equivalent dose of syrup. Minitablets open the perspective for introducing small-sized solid drug formulations for all children, thus, further shifting the paradigm from liquid toward small-sized solid drug formulations. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00008843.

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. Each KFP consisted of a case vignette and three key features using a "long-menu" question format. We explored students' perceptions of the KFPs and crSBAs in eight focus groups and analyzed statistical data of 11 exams. RESULTS: Compared to crSBAs, KFPs were perceived as more realistic and difficult, providing a greater stimulus for the intense study of clinical reasoning, and were generally well accepted. The statistical analysis revealed no difference in difficulty, but KFPs resulted more reliable and efficient than crSBAs. The correlation between the two formats was high, while KFPs correlated more closely with the OSCE score. CONCLUSIONS: KFPs with long-menu exams seem to bring about a positive educational effect without psychometric drawbacks.

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 .5 mL syrup. RESULTS: All neonates (N = 151) accepted the uncoated mini-tablet as well as the syrup (both formulations 100%; 95% CI 97.6%-100.0%; primary objective). The level of swallowability of uncoated mini-tablets was not inferior (P < .0001), in fact even higher (difference in proportions 10.0%; 95% CI 1.37%-19.34%; P = .0315) compared with syrup. Both pharmaceutical formulations were well tolerated, and in none of the 151 neonates, serious adverse events occurred; particularly none of the neonates inhaled or coughed in either of the formulations. CONCLUSIONS: The administration of uncoated mini-tablets proved to be a valuable alternative to syrup for term neonates. Our data on neonates close the age gap of prior findings in toddlers and infants: uncoated mini-tablets offer the potential of a single formulation for all age groups. These findings further shift the paradigm from liquid toward small-sized solid drug formulations for children of all age groups, as the World Health Organization proposes. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien [DRKS; germanctr.de]): DRKS00005609.

Improving Pediatric Basic Life Support Performance Through Blended Learning With Web-Based Virtual Patients: Randomized Controlled Trial.

BACKGROUND: E-learning and blended learning approaches gain more and more popularity in emergency medicine curricula. So far, little data is available on the impact of such approaches on procedural learning and skill acquisition and their comparison with traditional approaches. OBJECTIVE: This study investigated the impact of a blended learning approach, including Web-based virtual patients (VPs) and standard pediatric basic life support (PBLS) training, on procedural knowledge, objective performance, and self-assessment. METHODS: A total of 57 medical students were randomly assigned to an intervention group (n=30) and a control group (n=27). Both groups received paper handouts in preparation of simulation-based PBLS training. The intervention group additionally completed two Web-based VPs with embedded video clips. Measurements were taken at randomization (t0), after the preparation period (t1), and after hands-on training (t2). Clinical decision-making skills and procedural knowledge were assessed at t0 and t1. PBLS performance was scored regarding adherence to the correct algorithm, conformance to temporal demands, and the quality of procedural steps at t1 and t2. Participants' self-assessments were recorded in all three measurements. RESULTS: Procedural knowledge of the intervention group was significantly superior to that of the control group at t1. At t2, the intervention group showed significantly better adherence to the algorithm and temporal demands, and better procedural quality of PBLS in objective measures than did the control group. These aspects differed between the groups even at t1 (after VPs, prior to practical training). Self-assessments differed significantly only at t1 in favor of the intervention group. CONCLUSIONS: Training with VPs combined with hands-on training improves PBLS performance as judged by objective measures.

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). In an OSCE with standardized patients using the Calgary-Cambridge Referenced Observation Guide both groups achieved comparable high scores (results published). In this study, corresponding costs were assessed as man-hours resulting from hours of work of SP and tutors. A cost-effectiveness analysis was performed. RESULTS: Cost-effectiveness analysis revealed a major advantage for RP as compared to SP (112 vs. 172 man hours; cost effectiveness ratio .74 vs. .45) at comparable performance levels after training with both methods. CONCLUSIONS: While both peer role play and training with standardized patients have their value in medical curricula, RP has a major advantage in terms of cost-effectiveness. This could be taken into account in future decisions.

The benefit of repetitive skills training and frequency of expert feedback in the early acquisition of procedural skills.

BACKGROUND: Redundant training and feedback are crucial for successful acquisition of skills in simulation trainings. It is still unclear how or how much feedback should best be delivered to maximize its effect, and how learners' activity and feedback are optimally blended. To determine the influence of high- versus low-frequency expert feedback on the learning curve of students' clinical procedural skill acquisition in a prospective randomized study. METHODS: N = 47 medical students were trained to insert a nasogastric tube in a mannequin, including structured feedback in the initial instruction phase at the beginning of the training (T1), and either additional repetitive feedback after each of their five subsequent repetitions (high-frequency feedback group, HFF group; N = 23) or additional feedback on just one occasion, after the fifth repetition only (low-frequency feedback group, LFF group; N = 24). We assessed a) task-specific clinical skill performance and b) global procedural performance (five items of the Integrated Procedural Performance Instrument (IPPI); on the basis of expert-rated videotapes at the beginning of the training (T1) and during the final, sixth trial (T2). RESULTS: The two study groups did not differ regarding their baseline data. The calculated ANOVA for task-specific clinical skill performance with the between-subject factor 'Group' (HFF vs. LFF) and within-subject factors 'Time' (T1 vs. T2) turned out not to be significant (p < .147). An exploratory post-hoc analyses revealed a trend towards a superior performance of HFF compared to LFF after the training (T2; p < .093), whereas both groups did not differ at the beginning (T1; p < .851). The smoothness of the procedure assessed as global procedural performance, was superior in HFF compared to LFF after the training (T2; p < .004), whereas groups did not differ at the beginning (T1; p < .941). CONCLUSION: Deliberate practice with both high- and low-frequency intermittent feedback results in a strong improvement of students' early procedural skill acquisition. High-frequency intermittent feedback, however, results in even better and smoother performance. We discuss the potential role of the cognitive workload on the results. We advocate a thoughtful allocation of tutor resources to future skills training.

Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children.

OBJECTIVE: To evaluate acceptability of 2 mm solid dosage forms (mini-tablets) as an alternative administration modality in young children in comparison with syrup. STUDY DESIGN: Three hundred six pediatric in- and outpatients aged 6 months-5 years (51 in each of 6 age groups) were recruited. An open, randomized cross-over study was conducted to compare acceptability and capability to swallow 2 mm uncoated or coated mini-tablets vs 3 mL syrup. RESULTS: In the overall patient population of 306 children, the acceptability of uncoated mini-tablets was superior to syrup (difference in proportions 14.8%, 95% CI 10.2-19.4; P < .0001). In line with this finding, the level of capability to swallow was higher for uncoated mini-tablets compared with syrup as well (difference in proportions 12.3%, 95% CI 5.4-19.3; P = .0008). All 3 pharmaceutical formulations were well tolerated, and none of the 306 children inhaled or coughed because of the syrup or the uncoated mini-tablet; only 2 of the 306 children (both in age group 0.5-1 year) coughed because of the coated mini-tablet, in both cases without clinical relevance. CONCLUSIONS: Mini-tablets are a valuable alternative to syrup for children 6 months-6 years of age and are more acceptable compared with liquid formulation. Regulatory bodies such as Food and Drug Administration and European Medicine Agency are encouraged to take our data into account for guideline updates and future drug approval processes.

An innovative blended learning approach using virtual patients as preparation for skills laboratory training: perceptions of students and tutors.

BACKGROUND: Currently only a few reports exist on how to prepare medical students for skills laboratory training. We investigated how students and tutors perceive a blended learning approach using virtual patients (VPs) as preparation for skills training. METHODS: Fifth-year medical students (N=617) were invited to voluntarily participate in a paediatric skills laboratory with four specially designed VPs as preparation. The cases focused on procedures in the laboratory using interactive questions, static and interactive images, and video clips. All students were asked to assess the VP design. After participating in the skills laboratory 310 of the 617 students were additionally asked to assess the blended learning approach through established questionnaires. Tutors' perceptions (N=9) were assessed by semi-structured interviews. RESULTS: From the 617 students 1,459 VP design questionnaires were returned (59.1%). Of the 310 students 213 chose to participate in the skills laboratory; 179 blended learning questionnaires were returned (84.0%). Students provided high overall acceptance ratings of the VP design and blended learning approach. By using VPs as preparation, skills laboratory time was felt to be used more effectively. Tutors perceived students as being well prepared for the skills laboratory with efficient uses of time. CONCLUSION: The overall acceptance of the blended learning approach was high among students and tutors. VPs proved to be a convenient cognitive preparation tool for skills training.

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). Groups C and D were pooled for statistical analyses. The rates of acceptability (swallowed ≥80% of the mini-tablets with or without chewing), swallowability (swallowed all mini-tablets without chewing or any leftover), and palatability (positive/neutral responses) were ≥80.0%, ≥42.0%, and ≥82.0%, respectively, across the study groups. No marked differences were observed between groups or across age groups. No adverse events or issues of clinical relevance with deglutition were reported. Mini-tablets taken with soft food or water provide a suitable method for administering medicines to children aged ≥2-<7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617).

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. Personal data of the bronchoscopists and their medical center were collected via an online questionnaire separately from the case specifics. RESULTS: A total of 399 foreign body removals were performed by 64 examiners. A total of 279 removals were performed using rigid endoscopy, and 120 procedures were performed by flexible. When a difficulty was expected, flexible endoscopy was used significantly more often (χ2 (1) = 11.06, p < 0.001). Complications occurred significantly less often when the bronchoscopist used their preferred technique (χ2 (1) = 6.41, p = 0.011), had more than 5 years of experience (χ2 (1) = 5.13, p = 0.023) or performed more than 100 removals (χ2 (2) = 11.51, p = 0.003). In medical centers, complication rates significantly decreased if more than 200 bronchoscopies were performed in children, compared to the centers that perform 50-200 bronchoscopies per year (χ2 (1) = 24.56, p < 0.001). CONCLUSION: Preference and experience of a bronchoscopist and his/her medical center with flexible or rigid foreign body removal distinctively affect the outcome of the procedure and cannot be neglected in the discourse on the appropriate technique. This link also emphasizes the importance of a structured training program.

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 uncoated mini-tablets. This study here aimed to investigate young children's acceptability and swallowability of multiple coated placebo mini-tablets compared with glucose syrup. DESIGN: This clinical trial was conducted as a single-centre randomised cross-over study. SETTING: Prospective cross-over study performed at the Children's University Hospital Düsseldorf. PATIENTS: This study was conducted on 50 children in five age groups from 1 to <6 years. INTERVENTIONS: An age-adapted amount of 16-28 mini-tablets and 3-6 mL syrup was administered in randomised order. MAIN OUTCOME MEASURES: Acceptability and swallowability of multiple coated mini-tablets and syrup. RESULTS: In all age groups, administration of multiple coated mini-tablets and syrup showed good acceptability (mini-tablets 80%-100%, syrup 90%-100%) and swallowability (mini-tablets 30%-70%, syrup 20%-80%) without any clinically meaningful difference. This is consistent with results from large studies with uncoated mini-tablets. CONCLUSION: Multiple coated mini-tablets are a suitable age-appropriate alternative to liquid formulations in the paediatric population. No safety concerns with the use of coated mini-tablets were observed in the study. TRIAL REGISTRATION NUMBER: DRKS00010395.

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. The researchers used the acceptability reference framework to score the acceptability of five antibiotics based on 150 real-life observer reports of medicine intake. Four antibiotics assessed in this study were formulated as preparations for injection (ampicillin, ampicillin/sulbactam, ceftriaxone, and gentamicin) and one as a powder for oral liquid suspension (co-amoxiclav). All the antibiotics formulated as preparations for injection were rated negatively due to high rates of negative reactions (80%), the use of restraint (51%), the use of extra devices (99%), and long preparation and administration times (100%). The antibiotic formulated as a powder was significantly more well accepted. The study concluded that there is a lack of appropriate formulations for antibiotics for use in children. These findings are important in improving knowledge on acceptability drivers and might help in formulating and prescribing better medicines for children. The study highlights the need for healthcare professionals to have knowledge about the acceptability of different products to select the best-adapted product for each patient.

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. Detection and quantification of SARS-CoV-2 was performed on cobas®6800 (Roche) and NeuMoDx™ (Qiagen) systems. Both assays showed reliable detection and quantification of SARS-CoV-2 RNA, with nasopharyngeal swabs showing the highest sensitivity. SARS-CoV-2 RNA concentrations in other respiratory specimens were lower (mean 2.5 log10 copies/ml) or even undetectable in up to 20%. These data clearly indicate that not all respiratory materials are equally suitable for the management of hospitalized patients, especially, in the late phase of COVID-19, when the viral phase subsides and inflammation becomes the predominant factor, making detection of even lower viral loads increasingly important.

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 2.5 mm diameter mini-tablets. The primary endpoint was acceptability derived from swallowability. The secondary endpoints were investigator-observed palatability, acceptability as a composite endpoint derived from both swallowability and palatability, and safety. Of 320 children randomized, 319 completed the study. Across all tablet sizes, quantities and age groups, acceptability rates based on swallowability were high (at least 87%). Palatability was rated as "pleasant/neutral" in 96.6% of children. The acceptability rates as per the composite endpoint were at least 77% and 86% for the 2.0 mm and 2.5 mm film-coated mini-tablets, respectively. No adverse events or deaths were reported. Recruitment in the 1-<6-months group was stopped early due to coughing-evaluated as "choked on" in three children. Both 2.0 mm and 2.5 mm film-coated mini-tablets are suitable formulations for young children.

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. DATA SOURCES: Medline, Scopus, PsycINFO, MedEdPortal, and Web of Science. STUDY ELIGIBILITY CRITERIA: Two independent reviewers used a structured screening protocol in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and Association for Medical Education in Europe's guide for systematic reviews to include all articles reporting on EPAs in postgraduate medical education and pediatrics in particular. There were no restrictions due to language, study design, or participants. STUDY APPRAISAL AND SYNTHESIS METHODS: Data on development, implementation, feasibility, acceptance, and assessment of EPAs were extracted and analyzed by the 2 independent researchers. RESULTS: Twenty-eight articles published between 2014 and 2020 were included in the review. We found an increase in publications and a notable shift from descriptions of development processes toward aspects beyond development, ie, implementation, feasibility, acceptance/perception, and assessment. LIMITATIONS: Studies from non-English-speaking countries are scarce which might lead to an inaccurate representation of actual international practice. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: We provide a comprehensive overview of EPAs in pediatrics to guide future curriculum developers in collaborative development, implementation and assessment of EPAs in pediatric postgraduate medical education.

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. Based on 180 real-life observer reports of medicine intake, we used the acceptability reference framework to score acceptability of six distinct medicines. Both ibuprofen and paracetamol tablets, mainly used in adolescents, were positively accepted. This was not the case for the solution for injection of metamizole sodium. Regarding syrups, mainly used in children under 6 years of age, ibuprofen flavored with strawberry and provided with an oral syringe was positively accepted, while paracetamol flavored with orange and provided with a measuring cup was not. Suppository appeared to be an alternative to oral liquids in infants and toddlers with palatability and administration issues. Differences appeared to be driven by dosage forms and formulations. These findings improve knowledge on acceptability drivers and might help formulating and prescribing better medicines for children.

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. During a period of ongoing comprehensive social distancing measures in Germany, we translated a competency-based curriculum including obstetrics, paediatrics, and human genetics to an e-learning course based on online patient and teacher encounters. In our qualitative study on students' and teachers' views, we identify potential enablers and drivers as well as barriers and challenges to undergraduate medical education under lockdown. In summer 2020, we conducted six focus group interviews to investigate medical students' and teachers' perspectives, experiences and attitudes. All focus groups were videotaped, transcribed verbatim and coded. To guide our deductive and inductive analysis, we applied the theoretical framework of Regmi and Jones. Content analysis was performed in a multi-perspective group. We identified five major themes contributing to a successful use of clinical competency-based e-learning under lockdown: Communication (with teachers, students, and patients), Mental wellbeing, Structure and self-organization, Technical issues, and Learning and commitment. We discuss enablers and potential barriers within all themes and their overlap and link them in an explanatory model. In our setting, students and teachers find e-learning holds strong potential and especially in times of COVID-19 it is greatly appreciated. We broaden the understanding of the impact of distant learning on acquiring competencies, on attitudes, and on mental wellbeing. Our model may serve for a thoughtful, necessary transition to future e-learning and hybrid programs for a competency-based medical education with ongoing social distancing measures.

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. Oblong tablets may carry more active ingredient content per unit than mini-tablets and could be an important alternative when the drug substance requires administration of higher doses. The primary objective was to demonstrate non-inferiority of acceptability of oblong tablets in comparison to 3 ml glucose syrup in children aged 1 to 5 years. Secondary objectives were investigation of acceptability, swallowability and palatability of mini-tablets, oblong tablets and glucose syrup in children between 1 and 5 years. METHODS: An open, randomized, single dose two-way cross-over design in two parallel study arms was applied. 280 children were stratified to one of five age groups and randomized to receiving one oblong tablet (2.5 × 6 mm) in comparison either to 3 ml glucose syrup or to three mini-tablets (2 × 2 mm). Acceptability and swallowability were assessed according to pre-defined evaluation criteria. The application of the formulations was video documented to evaluate the palatability. RESULTS: As primary objective, non-inferiority was observed regarding acceptability of the oblong tablet compared to syrup in all age groups (84.4% vs 80.1%, difference 4,29% points with 95% CI of -3.00%,11.57%). For swallowability, superiority of the oblong tablet compared to syrup could be shown (74.5% vs. 53.2%, difference 21.26% points, 95% CI of 11.29%, 31.23%). Regarding palatability, <10% of children demonstrated unpleasant reaction after intake of the oblong tablet or mini-tablets as graded by both raters, however, in contrast up to 40% of children after intake of syrup. CONCLUSION: Oblong tablets are a promising, safe alternative to liquid drug formulations and administration of multiple mini-tablets in children.