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.

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.

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.

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).

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.

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.

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.

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. METHODS: In this study, students and school staff of 14 educational facilities in Germany were tested sequentially between November 9 and December 23, 2020, two or three times per week for at least three consecutive weeks. Participants were randomized for evaluation of two different age adjusted swab sampling methods (oropharyngeal swabs or buccal swabs compared to saliva swabs using a 'lolli method'). Swabs were collected and pooled for SARS-CoV-2 RT-qPCR. Individuals of positive pooled tests were retested by RT-qPCR the same or the following day. Positive individuals were quarantined while the SARS-CoV-2 negative individuals remained in class with continued pooled RT-qPCR surveillance. The study is registered with the German Clinical Trials register (registration number: DRKS00023911). FINDINGS: 5,537 individuals were eligible and 3970 participants were enroled and included in the analysis. In students, a total of 21,978 swabs were taken and combined in 2218 pooled RT-qPCR tests. We detected 41 positive pooled tests (1·8%) leading to 36 SARS-CoV-2 cases among students which could be identified by individual re-testing. The cumulative 3-week incidence for primary schools was 564/100,000 (6/1064, additionally 1 infection detected in week 4) and 1249/100,000 (29/2322) for secondary schools. In secondary schools, there was no difference in the number of SARS-CoV-2 positive students identified from pooled oropharyngeal swabs compared to those identified from pooled saliva samples (lolli method) (14 vs. 15 cases; 1·3% vs. 1·3%; OR 1.1; 95%-CI 0·5-2·5). A single secondary school accounted for 17 of 36 cases (47%) indicating a high burden of asymptomatic prevalent SARS-CoV-2 cases in the respective school and community. INTERPRETATION: In educational settings, SARS-CoV-2 screening by RT-qPCR-based pooled testing with easily obtainable saliva samples is a feasible method to detect incident cases and observe transmission dynamics. FUNDING: Federal Ministry of education and research (BMBF; Project B-FAST in "NaFoUniMedCovid19"; registration number: 01KX2021).

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.

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. DESIGN: Survey of paediatric primary care practices on consultation numbers and patient management changes, and semistructured interviews to identify challenges for patient care. Surveys and interviews were partially linked in an explanatory sequential design to identify patient groups perceived to be at higher risk for worse care during the pandemic. SETTING: In and around Düsseldorf, a densely populated area in Western Germany. The primary care facilities are spread over an area with approximately 2 million inhabitants. PARTICIPANTS: Primary care in Germany is provided through practices run by self-employed specialist physicians that are contracted to offer services to patients under public health insurance which is compulsory to the majority of the population. The sample contained 44 paediatric primary care practices in the area, the response rate was 50%. RESULTS: Numbers of consultations for scheduled developmental examinations remained unchanged compared with the previous year while emergency visits were strongly reduced (mean 87.3 less/week in March-May 2020 compared with 2019, median reduction 55.0%). Children dependent on developmental therapy and with chronic health conditions were identified as patient groups receiving deteriorated care. High patient numbers, including of mildly symptomatic children presenting for health certificates, in combination with increased organisational demands and expected staff outages are priority concerns for the winter. CONCLUSIONS: Primary care paediatricians offered stable service through the early pandemic but expected strained resources for the upcoming winter. Unambiguous guidance on which children should present to primary care and who should be tested would help to allocate resources appropriately, and this guidance needs to consider age group specific issues including high prevalence of respiratory symptoms, dependency on carers and high contact rates.

[Alice in the digital wonderland-pediatric teaching during the COVID-19 pandemic]. / Alice im digitalen Wunderland: pädiatrische Lehre in der COVID-19-Pandemie: Eine Umfrage und Stellungnahme der AG Lehre der Deutschen Gesellschaft für Kinder- und Jugendmedizin (DGKJ).

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 e­learning during the summer term of 2020. The survey participants from 17 pediatric university hospitals report that the large spectrum of e­learning formats could sufficiently replace classical lectures and seminars but could not fully replace teaching involving direct contact to patients. The introduction of new digital teaching formats is time-consuming, needs high-quality IT infrastructure, should be embedded in a continuous curriculum and provide the possibility of regular exchange between students and teachers. Teachers should be provided with the opportunity for training in didactic methods and IT skills. These results correspond to the literature on e­learning in general and undergraduate medical education during the COVID-19 pandemic in particular. The experiences summarized here should not only facilitate the development of e­learning tools during the ongoing pandemic but also stimulate to establish e­learning as a valuable component of future pediatric medical education. New digital substitutes for teaching involving pediatric patients need to be developed.The statement was drafted by consensus by the German Society of Pediatrics and Adolescent Medicine Working Group on Teaching and approved by the DGKJ board.

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. However, there is a lack of reliable data on ODFs' acceptability, swallowability and palatability, especially in young children. The primary objective was to demonstrate non-inferiority in acceptability of a drug-free ODF in comparison to glucose syrup in children aged below one year. Secondary objectives were swallowability and palatability of the two formulations. STUDY DESIGN: The study was performed in an open, randomized, two-way cross-over design with three age groups: 2-28 days, 29 days-5 months, 6-12 months. 150 children (N = 50 per age group) were randomized to the order of receiving the ODF (2 × 3 cm) and age-adapted amounts of glucose syrup (0.5-3 mL). Deglutition and swallowing were assessed according to predefined evaluation criteria. The application of the formulations was documented by video to evaluate the palatability. RESULTS: The primary objective was confirmed: Non-inferiority of the acceptability of an ODF compared to syrup was demonstrated, even superiority of the ODF was shown (p < 0.0001). The secondary endpoints demonstrated positive results including the superior swallowability of the ODF in comparison to syrup (p < 0.0001). The palatability assessments were in favor of the ODF. CONCLUSION: ODFs are a promising and safe alternative to liquid formulations, even for children of very young ages.

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.

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. In order to improve the acquisition of pediatric physical examination skills during bedside teaching, we have developed a combined video-based training concept, subsequently evaluating its use and perception. METHODS: Fifteen videos were compiled, demonstrating defined physical examination sequences in children of different ages. Students were encouraged to use these videos as preparation for bedside teaching during their pediatric clerkship. After bedside teaching, acceptance of this approach was evaluated using a 10-item survey, asking for the frequency of video use and the benefits to learning, self-confidence, and preparation of bedside teaching as well as the concluding OSCE. RESULTS: N=175 out of 299 students returned survey forms (58.5%). Students most frequently used videos, either illustrating complete examination sequences or corresponding focus examinations frequently assessed in the OSCE. Students perceived the videos as a helpful method of conveying the practical process and preparation for bedside teaching as well as the OSCE, and altogether considered them a worthwhile learning experience. Self-confidence at bedside teaching was enhanced by preparation with the videos. The demonstration of a defined standardized procedural sequence, explanatory comments, and demonstration of infrequent procedures and findings were perceived as particularly supportive. Long video segments, poor alignment with other curricular learning activities, and technical problems were perceived as less helpful. Students prefer an optional individual use of the videos, with easy technical access, thoughtful combination with the bedside teaching, and consecutive standardized practice of demonstrated procedures. CONCLUSIONS: Preparation with instructional videos combined with bedside teaching, were perceived to improve the acquisition of pediatric physical examination 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). 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.