Systematic online academic resource (SOAR) review: Pediatric respiratory infectious disease.

Background: Free open access medical education (FOAM) resources have become increasingly popular in graduate medical education. Despite their accessibility, the assessment of FOAM resources' quality is challenging due to their decentralized nature and the diverse qualifications of their authors and distribution platforms. In this first pediatric systematic online academic resource (SOAR) review, we utilized a systematic methodology to aggregate and assess the quality of FOAM resources on pediatric respiratory infectious disease topics. Methods: We searched 177 keywords using FOAMSearch, the top 50 FOAM websites on the Social Media Index, and seven additional pediatric emergency medicine-focused blogs. Following a basic initial screen, resources then underwent full-text quality assessment utilizing the revised Medical Education Translational Resources: Impact and Quality (rMETRIQ) tool. Results: The search yielded 44,897 resources. After 44,456 were excluded, 441 underwent quality assessment. A total of 36/441 posts (8% of posts) reached the high-quality threshold score (rMETRIQ ≥ 16). The most frequent topics overall were pneumonia and bronchiolitis. A total of 67/441 posts (15% of posts) were found to have a rMETRIQ score of less than or equal to 7, which may indicate poor quality. Conclusions: We systematically identified, described, and performed quality assessment on FOAM resources pertaining to the topic of pediatric respiratory infectious disease. We found that there is a paucity of high-quality posts on this topic. Despite this, the curated list of high-quality resources can help guide trainees and educators toward relevant educational information and suggest unmet needs for future FOAM resources.

Medical Knowledge Acquisition during a Pandemic: Pediatric Subspecialty in-Training Examination and Board Certification Exam Passing Rate.

OBJECTIVE: The COVID-19 pandemic resulted in training programs restructuring their curricula. Fellowship programs are required to monitor each fellow's training progress through a combination of formal evaluations, competency tracking, and measures of knowledge acquisition. The American Board of Pediatrics administers subspecialty in-training examinations (SITE) to pediatric fellowship trainees annually and board certification exams at the completion of the fellowship. The objective of this study was to compare SITE scores and certification exam passing rates before and during the pandemic. METHODS: In this retrospective observational study, we collected summative data on SITE scores and certification exam passing rates for all pediatric subspecialties from 2018 to 2022. Trends over time were assessed using analysis of variance (ANOVA) analysis to test for trends across years within one group and t-test analysis to compare groups before and during the pandemic. RESULTS: Data were obtained from 14 pediatric subspecialties. Comparing prepandemic to pandemic scores, Infectious Diseases, Cardiology, and Critical Care Medicine saw statistically significant decreases in SITE scores. Conversely, Child Abuse and Emergency Medicine saw increases in SITE scores. Emergency Medicine saw a statistically significant increase in certification exam passing rates, while Gastroenterology and Pulmonology saw decreases in exam passing rates. CONCLUSIONS: The COVID-19 pandemic resulted in restructuring didactics and clinical care based on the needs of the hospital. There were also societal changes affecting patients and trainees. Subspecialty programs with declining scores and certification exam passing rates may need to assess their educational and clinical programs and adapt to the needs of trainees' learning edges.

Guiding Fellows to Independent Practice: Current Trends in Pediatric Emergency Medicine Fellow Supervision.

BACKGROUND: Recent studies highlight the importance of physician readiness to practice beyond graduate training. The Accreditation Council for Graduate Medical Education mandates that pediatric emergency medicine (PEM) fellows be prepared for independent practice by allowing "progressive responsibility for patient care." Prior unpublished surveys of program directors (PDs) indicate variability in approaches to provide opportunities for more independent practice during fellowship training. OBJECTIVES: The aims of the study were to describe practices within PEM fellowship programs allowing fellows to work without direct supervision and to identify any barriers to independent practice in training. DESIGN/METHODS: An anonymous electronic survey of PEM fellowship PDs was performed. Survey items were developed using an iterative modified Delphi process and pilot tested. Close-ended survey responses and demographic variables were summarized with descriptive statistics. Responses to open-ended survey items were reviewed and categorized by theme. RESULTS: Seventy two of 84 PDs (88%) responded to the survey; however, not all surveys were completed. Of the 68 responses to whether fellows could work without direct supervision (as defined by the Accreditation Council for Graduate Medical Education) during some part of their training, 31 (45.6%) reported that fellows did have this opportunity. In most programs, clinical independence was conditional on specific measures including the number of clinical hours completed, milestone achievement, and approval by the clinical competency committee. Reported barriers to fellow practice without direct oversight included both regulatory and economic constraints. CONCLUSIONS: Current training practices that provide PEM fellows with conditional clinical independence are variable. Future work should aim to determine best practices of entrustment, identify ideal transition points, and mitigate barriers to graduated responsibility.

Derivation of the Pediatric Acute Gastroenteritis Risk Score to Predict Moderate-to-Severe Acute Gastroenteritis.

OBJECTIVES: Although most acute gastroenteritis (AGE) episodes in children rapidly self-resolve, some children go on to experience more significant and prolonged illness. We sought to develop a prognostic score to identify children at risk of experiencing moderate-to-severe disease after an index emergency department (ED) visit. METHODS: Data were collected from a cohort of children 3 to 48 months of age diagnosed with AGE in 16 North American pediatric EDs. Moderate-to-severe AGE was defined as a Modified Vesikari Scale (MVS) score ≥9 during the 14-day post-ED visit. A clinical prognostic model was derived using multivariable logistic regression and converted into a simple risk score. The model's accuracy was assessed for moderate-to-severe AGE and several secondary outcomes. RESULTS: After their index ED visit, 19% (336/1770) of participants developed moderate-to-severe AGE. Patient age, number of vomiting episodes, dehydration status, prior ED visits, and intravenous rehydration were associated with MVS ≥9 in multivariable regression. Calibration of the prognostic model was strong with a P value of 0.77 by the Hosmer-Lemenshow goodness-of-fit test, and discrimination was moderate with an area under the receiver operator characteristic curve of 0.68 (95% confidence interval [CI] 0.65-0.72). Similarly, the model was shown to have good calibration when fit to the secondary outcomes of subsequent ED revisit, intravenous rehydration, or hospitalization within 72 hours after the index visit. CONCLUSIONS: After external validation, this new risk score may provide clinicians with accurate prognostic insight into the likely disease course of children with AGE, informing disposition decisions, anticipatory guidance, and follow-up care.

Oral Ondansetron Administration in Children Seeking Emergency Department Care for Acute Gastroenteritis: A Patient-Level Propensity-Matched Analysis.

STUDY OBJECTIVE: This study aimed to explore oral ondansetron usage and impact on outcomes in clinical practice. METHODS: This observational study was a planned secondary analysis of 2 trials conducted in 10 US and 6 Canadian institutions between 2014 and 2017. Children 3 to 48 months old with gastroenteritis and ≥3 episodes of vomiting in the 24 hours preceding emergency department (ED) presentation were included. Oral ondansetron was administered at the discretion of the provider. The principal outcomes were intravenous fluid administration and hospitalization at the index visit and during the subsequent 72 hours and diarrhea and vomiting frequency during the 24 hours following the ED visit. RESULTS: In total, 794 children were included. The median age was 16.0 months (interquartile range 10.0 to 26.0), and 50.1% (398/794) received oral ondansetron. In propensity-adjusted analysis (n=528), children administered oral ondansetron were less likely to receive intravenous fluids at the index visit (adjusted odds ratio [aOR] 0.50; 95% confidence interval [CI] 0.29 to 0.88). There were no differences in the frequencies of intravenous fluid administration within the first 72 hours (aOR 0.65; 95% CI 0.39 to 1.10) or hospitalization at the index visit (aOR 0.31; 95% CI 0.09 to 1.10) or the subsequent 72 hours (aOR 0.52; 95% CI 0.21 to 1.28). Episodes of vomiting (aRR 0.86; 95% CI 0.63 to 1.19) and diarrhea (aRR 1.11; 95% CI 0.93 to 1.32) during the 24 hours following ED discharge also did not differ. CONCLUSION: Among preschool-aged children with gastroenteritis seeking ED care, oral ondansetron administration was associated with a reduction in index ED visit intravenous fluid administration; it was not associated with intravenous fluids administered within 72 hours, hospitalization, or vomiting and diarrhea in the 24 hours following discharge.

Intranasal ketorolac versus intravenous ketorolac for treatment of migraine headaches in children: A randomized clinical trial.

BACKGROUND: Intravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time-consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle-free and easier to administer. We aimed to determine whether intranasal ketorolac is non-inferior to intravenous ketorolac for reducing pain in children with migraine headaches. METHODS: We conducted a randomized double-blind non-inferiority clinical trial. Children aged 8-17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 min after administration measured using the Faces Pain Scale-Revised (scored 0-10). Non-inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain; ancillary emergency department outcomes (e.g. receipt of rescue medications, headache relief, headache freedom, percentage improvement); 24-h follow-up outcomes; functional disability; and adverse events. RESULTS: Fifty-nine children were enrolled. We analyzed 27 children who received intranasal ketorolac and 29 who received intravenous ketorolac. The difference in mean pain reduction at 60 min between groups was 0.2 (95% CI -0.9, 1.3), with the upper limit of the 95% CI being less than the non-inferiority margin. There were no statistical differences between groups for secondary outcomes. CONCLUSIONS: Intranasal ketorolac was non-inferior to intravenous ketorolac for reducing migraine headache pain in the emergency department.

Pediatric emergency medicine fellows' milestone evaluations: Do they all meet the targets for graduation?

BACKGROUND: The ACGME Milestone Project created a competency-based trainee assessment tool. Subcompetencies (SCs) are scored on a 5-point scale; level 4 is recommended for graduation. The 2018 Milestones Report found that across subspecialties, not all graduates attain level 4 for every SC. OBJECTIVE: The objective was to describe the number of pediatric emergency medicine (PEM) fellows who achieve ≥ level 4 in all 23 SCs at graduation and identify SCs where level 4 is not achieved and factors predictive of not achieving a level 4. METHODS: This is a multicenter, retrospective cohort study of PEM fellows from 2014 to 2018. Program directors provided milestone reports. Descriptive analysis of SC scores was performed. Subanalyses assessed differences in residency graduation scores, first-year fellowship scores, and the rate of milestone attainment between fellows who did and did not attain ≥ level 4 at graduation. RESULTS: Data from 392 fellows were obtained. There were no SCs in which all fellows attained ≥ level 4 at graduation; the range of fellows scoring < level 4 per SC was 7% to 39%. A total of 67% of fellows did not attain ≥ level 4 on one or more SC. While some fellows failed to attain ≥ level 4 on up to all 23 SCs, 26% failed to meet level 4 on only one or two. In 19 SCs, residency graduation and/or first year fellow scores were lower for fellows who did not attain ≥ level 4 at graduation compared to those who did (mean difference = 0.74 points). Among 10 SCs, fellows who did not attain ≥ level 4 at graduation had a faster rate of improvement compared to those who did attain ≥ level 4. CONCLUSION: In our sample, 67% of PEM fellows did not attain level 4 for one or more of the SCs at graduation. Low scores during residency or early in fellowship may predict difficulty in meeting level 4 by fellowship completion.

Association Between Diarrhea Duration and Severity and Probiotic Efficacy in Children With Acute Gastroenteritis.

INTRODUCTION: It is unclear whether the alleged efficacy of probiotics in childhood acute gastroenteritis depends on the duration and severity of symptoms before treatment. METHODS: Preplanned secondary analysis of 2 randomized placebo-controlled trials in children 3-48 months of age was conducted in 16 emergency departments in North America evaluating the efficacy of 2 probiotic products (Lactobacillus rhamnosus GG and a combination probiotic: L. rhamnosus and L. helveticus). Participants were categorized in severity groups according to the duration (<24, 24-<72, and ≥72 hours) and the frequency of diarrhea episodes in the 24 hours (≤3, 4-5, and ≥6) before presentation. We used regression models to assess the interaction between pretreatment diarrhea severity groups and treatment arm (probiotic or placebo) in the presence of moderate-to-severe gastroenteritis (Modified Vesikari Scale score ≥9). Secondary outcomes included diarrhea frequency and duration, unscheduled healthcare provider visits, and hospitalization. RESULTS: A total of 1,770 children were included, and 882 (50%) received a probiotic. The development of moderate-to-severe gastroenteritis symptoms after the initiation of treatment did not differ between groups (probiotic-18.4% [162/882] vs placebo-18.3% [162/888]; risk ratio 1.00; 95% confidence interval 0.87, 1.16; P = 0.95). There was no evidence of interaction between baseline severity and treatment (P = 0.61) for the primary or any of the secondary outcomes: diarrhea duration (P = 0.88), maximum diarrheal episodes in a 24-hour period (P = 0.87), unscheduled healthcare visits (P = 0.21), and hospitalization (P = 0.87). DISCUSSION: In children 3-48 months with acute gastroenteritis, the lack of effect of probiotics is not explained by the duration of symptoms or frequency of diarrheal episodes before presentation.

Milestone achievements in a national sample of pediatric emergency medicine fellows: impact of primary residency training.

BACKGROUND: Pediatric emergency medicine (PEM) fellowships recruit trainees from both pediatric and emergency medicine (EM) residencies. The Accreditation Council for Graduate Medical Education (ACGME) defines separate training pathways for each. The 2015 PEM milestones reflect a combination of subcompetencies from the two residencies. This project aims to compare the milestone achievement of PEM fellows based on their primary residency training. We hypothesize that fellows trained in pediatrics achieve PEM milestones at different rates than EM-trained fellows in the ACGME domains of patient care, medical knowledge, systems-based practice, practice-based learning, professionalism, and interpersonal and communication skills. METHODS: This is a multicenter, retrospective cohort study of fellows from a national sample of U.S. PEM fellowship programs. Basic demographic information and deidentified, biannual milestone scores for 23 competencies were collected for fellows training between 2015 and 2018. Subcompetencies are scored on a 5-point milestone scale. Descriptive and multivariable analyses for longitudinal data were performed to compare milestone assessments by primary residency training. RESULTS: Complete data were obtained for 600 fellows; 95% (570) and 5% (30) completed pediatric and EM residency, respectively. In both year 1 and year 2 of fellowship, the mean milestone scores of EM-trained fellows were statistically higher than pediatrics-trained fellows across the majority of subcompetencies. By the final year of training, there were no statistically significant differences in milestone scores for any of the subcompetencies. CONCLUSIONS: Fellow milestone achievement between groups was not significantly different by graduation. However, fellows entering PEM training from an EM background attained higher scores on the milestones than fellows from a pediatric background in the first year of fellowship.

Milestones comparisons from residency to pediatric emergency medicine fellowship: Resetting expectations.

BACKGROUND: Pediatric emergency medicine (PEM) fellowships accept trainees who have completed a residency in either emergency medicine (EM) or pediatrics and have adopted 17 subcompetencies with accompanying set of milestones from these two residency programs. This study aims to examine the changes in milestone scores among common subcompetencies from the end of EM or pediatrics residency to early PEM fellowship and evaluates time to reattainment of scores for subcompetencies in which a decline was noted. METHODS: This is a national, retrospective cohort study of trainees enrolled in PEM fellowship programs from July 2014 to June 2018. PEM fellowship program directors voluntarily submitted deidentified milestone reports within the study time frame, including end-of-residency reports. Descriptive analyses of milestone scores between end of residency and PEM fellowship were performed. RESULTS: Forty-eight U.S. PEM fellowship programs (65%) provided fellowship milestone data on 638 fellows, 218 (34%) of whom also had end-of-residency milestone scores submitted. Of 218 fellows eligible for analysis, 210 (96%) had completed a pediatrics residency and eight (4%) had completed an EM residency. Pediatric-trained fellows had statistically significant decreases in mean milestone scores in all 10 shared subcompetencies. Reattainment of milestone scores across all common subcompetencies for both EM and pediatric-trained PEM fellows occurred by the end of fellowship. CONCLUSIONS: This study demonstrated declines in milestone scores from the end of primary residency training in pediatrics to early PEM fellowship in shared subcompetencies, which may suggest that performance expectations are reset at the beginning of PEM fellowship. Changes in subcompetency milestone anchors to provide subspecialty-specific context may be needed to more accurately define skills acquisition in the residency-to-fellowship transition.

Gender Differences Among Milestone Assessments in a National Sample of Pediatric Emergency Medicine Fellowship Programs.

BACKGROUND: Understanding gender gaps in trainee evaluations is critical because these may ultimately determine the duration of training. Currently, no studies describe the influence of gender on the evaluation of pediatric emergency medicine (PEM) fellows. OBJECTIVE: The objective of our study was to compare milestone scores of female versus male PEM fellows. METHODS: This is a multicenter retrospective cohort study of a national sample of PEM fellows from July 2014 to June 2018. Accreditation Council for Medical Education (ACGME) subcompetencies are scored on a 5-point scale and span six domains: patient care (PC), medical knowledge, systems-based practice, practice-based learning and improvement, professionalism, and interpersonal and communication skills (ICS). Summative assessments of the 23 PEM subcompetencies are assigned by each program's clinical competency committee and submitted semiannually for each fellow. Program directors voluntarily provided deidentified ACGME milestone reports. Demographics including sex, program region, and type of residency were collected. Descriptive analysis of milestones was performed for each year of fellowship. Multivariate analyses evaluated the difference in scores by sex for each of the subcompetencies. RESULTS: Forty-eight geographically diverse programs participated, yielding data for 639 fellows (66% of all PEM fellows nationally); sex was recorded for 604 fellows, of whom 67% were female. When comparing the mean milestone scores in each of the six domains, there were no differences by sex in any year of training. When comparing scores within each of the 23 subcompetencies and correcting the significance level for comparison of multiple milestones, the scores for PC3 and ICS2 were significantly, albeit not meaningfully, higher for females. CONCLUSION: In a national sample of PEM fellows, we found no major differences in milestone scores between females and males.

Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States.

BACKGROUND: Between-country variation in health care resource use and its impact on outcomes in acute care settings have been challenging to disentangle from illness severity by using administrative data. METHODS: We conducted a preplanned analysis employing patient-level emergency department (ED) data from children enrolled in 2 previously conducted clinical trials. Participants aged 3 to <48 months with <72 hours of gastroenteritis were recruited in pediatric EDs in the United States (N = 10 sites; 588 participants) and Canada (N = 6 sites; 827 participants). The primary outcome was an unscheduled health care provider visit within 7 days; the secondary outcomes were intravenous fluid administration and hospitalization at or within 7 days of the index visit. RESULTS: In adjusted analysis, unscheduled revisits within 7 days did not differ (adjusted odds ratio [aOR]: 0.72; 95% confidence interval (CI): 0.50 to 1.02). At the index ED visit, although participants in Canada were assessed as being more dehydrated, intravenous fluids were administered more frequently in the United States (aOR: 4.6; 95% CI: 2.9 to 7.1). Intravenous fluid administration rates did not differ after enrollment (aOR: 1.4; 95% CI: 0.7 to 2.8; US cohort with Canadian as referent). Overall, intravenous rehydration was higher in the United States (aOR: 3.8; 95% CI: 2.5 to 5.7). Although hospitalization rates during the 7 days after enrollment (aOR: 1.1; 95% CI: 0.4 to 2.6) did not differ, hospitalization at the index visit was more common in the United States (3.9% vs 2.3%; aOR: 3.2; 95% CI: 1.6 to 6.8). CONCLUSIONS: Among children with gastroenteritis and similar disease severity, revisit rates were similar in our 2 study cohorts, despite lower rates of intravenous rehydration and hospitalization in Canadian-based EDs.

Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials.

Importance: Despite guidelines endorsing oral rehydration therapy, intravenous fluids are commonly administered to children with acute gastroenteritis in high-income countries. Objective: To identify factors associated with intravenous fluid administration and hospitalization in children with acute gastroenteritis. Design, Setting, and Participants: This study is a planned secondary analysis of the Pediatric Emergency Research Canada (PERC) and Pediatric Emergency Care Applied Research Network (PECARN) probiotic trials. Participants include children aged 3 to 48 months with 3 or more watery stools in 24 hours between November 5, 2013, and April 7, 2017, for the PERC study and July 8, 2014, and June 23, 2017, for the PECARN Study. Children were from 16 pediatric emergency departments throughout Canada (6) and the US (10). Data were analyzed from November 2, 2018, to March 16, 2021. Exposures: Sex, age, preceding health care visit, distance between home and hospital, country (US vs Canada), frequency and duration of vomiting and diarrhea, presence of fever, Clinical Dehydration Scale score, oral ondansetron followed by oral rehydration therapy, and infectious agent. Main Outcomes and Measures: Intravenous fluid administration and hospitalization. Results: This secondary analysis of 2 randomized clinical trials included 1846 children (mean [SD] age, 19.1 [11.4] months; 1007 boys [54.6%]), of whom 534 of 1846 (28.9%) received oral ondansetron, 240 of 1846 (13.0%) received intravenous rehydration, and 67 of 1846 (3.6%) were hospitalized. The following were independently associated with intravenous rehydration: higher Clinical Dehydration Scale score (mild to moderate vs none, odds ratio [OR], 8.73; 95% CI, 5.81-13.13; and severe vs none, OR, 34.15; 95% CI, 13.45-86.73); country (US vs Canada, OR, 6.76; 95% CI, 3.15-14.49); prior health care visit with intravenous fluids (OR, 4.55; 95% CI, 1.32-15.72); and frequency of vomiting (per 5 episodes, OR, 1.66; 95% CI, 1.39-1.99). The following were independently associated with hospitalization: higher Clinical Dehydration Scale score (mild to moderate vs none, OR, 11.10; 95% CI, 5.05-24.38; and severe vs none, OR, 23.55; 95% CI, 7.09-78.25) and country (US vs Canada, OR, 3.37; 95% CI, 1.36-8.40). Oral ondansetron was associated with reduced odds of intravenous rehydration (OR, 0.21; 95% CI, 0.13-0.32) and hospitalization (OR, 0.44; 95% CI, 0.21-0.89). Conclusions and Relevance: Intravenous rehydration and hospitalization were associated with clinical evidence of dehydration and lack of an oral ondansetron-supported oral rehydration period. Strategies focusing on oral ondansetron administration followed by oral rehydration therapy in children with dehydration may reduce the reliance on intravenous rehydration and hospitalization. Trial Registration: ClinicalTrials.gov Identifiers: NCT01853124 (PERC) and NCT01773967 (PECARN).

Factors Associated With Nonadherence in an Emergency Department-based Multicenter Randomized Clinical Trial of a Probiotic in Children With Acute Gastroenteritis.

ABSTRACT: Nonadherence in clinical trials affects safety and efficacy determinations. Predictors of nonadherence in pediatric acute illness trials are unknown. We sought to examine predictors of nonadherence in a multicenter randomized trial of 971 children with acute gastroenteritis receiving a 5-day oral course of Lactobacillus rhamnosus GG or placebo. Adherence, defined as consuming all doses of the product, was reported by the parents and recorded during daily follow-up contacts. Of 943 patients with follow-up data, 766 (81.2%) were adherent. On multivariate analysis, older age (OR 1.19; 95% CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42), and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21--14.30) were factors associated with nonadherence; however, those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95). These data may inform strategies and specific targets to maximize adherence in future pediatric trials.

Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis.

BACKGROUND: Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes. OBJECTIVES: We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered. METHODS: This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3-48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received. RESULTS: A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05). CONCLUSIONS: LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE.This trial was registered at clinicaltrials.gov as NCT01773967.

Building an adaptable resident curriculum for acute pediatric sexual abuse evaluations: A qualitative needs assessment.

BACKGROUND: Residents are undertrained to perform acute pediatric sexual abuse evaluations. The American Academy of Pediatrics has proposed development of an adaptable child abuse curriculum, though no such curriculum exists. OBJECTIVES: Our goal was to perform a needs assessment for pediatric residents performing acute sexual abuse evaluations in an emergency department setting, thus laying groundwork for an adaptable curriculum. The objective was to explore pediatric resident training, knowledge, confidence, expectations, learning needs, and educational goals. PARTICIPANTS AND SETTING: We conducted a qualitative exploratory study of pediatric residents, faculty, and program directors at two academic health centers in New York City. METHODS: Using purposive and convenience sampling, we conducted focus groups and semi-structured interviews until saturation of ideas was achieved. Through an iterative process using constructivist grounded theory, themes were organized into a curricular model. RESULTS: We conducted 3 resident focus groups (n = 21) and 7 interviews with emergency medicine, pediatric, and child abuse faculty. Themes emerged in three categories: barriers (e.g., knowledge deficits), facilitators (e.g., pre-learning), and educational goals. Despite recognizing the importance and increased availability of subspecialists, participants supported gradual autonomy for pediatric residents in the evaluation of suspected sexual abuse, with a goal of independent competency in history and examination skills, and supervised competency of forensic evidence collection. CONCLUSIONS: Our data support a multimodal, blended curriculum for the acute sexual abuse evaluation, including: (1) asynchronous pre-learning; (2) live workshops; (3) reference tools; and (4) modeled clinical experiences. Our proposed curricular model may be utilized by a variety of frontline clinicians.

Discrete event simulation modelling to evaluate the impact of a quality improvement initiative on patient flow in a paediatric emergency department.

OBJECTIVE: We developed a discrete event simulation model to evaluate the impact on system flow of a quality improvement (QI) initiative that included a time-specific protocol to decrease the time to antibiotic delivery for children with cancer and central venous catheters who present to a paediatric ED with fever. METHODS: The model was based on prospective observations and retrospective review of ED processes during the maintenance phase of the QI initiative between January 2016 and June 2017 in a large, urban, academic children's hospital in New York City, USA. We compared waiting time for full evaluation (WT) and length of stay (LOS) between a model with and a model without the protocol. We then gradually increased the proportion of patients receiving the protocol in the model and recorded changes in WT and LOS. RESULTS: We validated model outputs against administrative data from 2016, with no statistically significant differences in average WT or LOS for any emergency severity index (ESI). There were no statistically significant differences in these flow metrics between the model with and the model without the protocol. By increasing the proportion of total patients receiving this protocol, from 0.2% to 1.3%, the WT increased by 2.8 min (95% CI: 0.6 to 5.0) and 7.6 min (95% CI: 2.0 to 13.2) for ESI 2 and ESI 3 patients, respectively. This represents a 14.0% increase in WT for ESI 3 patients. CONCLUSIONS: Simulation modelling facilitated the testing of system effects for a time-specific protocol implemented in a large, urban, academic paediatric ED, showing no significant impact on patient flow. The model suggests system resilience, demonstrating no detrimental effect on WT until there is a 7-fold increase in the proportion of patients receiving the protocol.

Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children.

BACKGROUND: Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited. METHODS: We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×1010 colony-forming units twice daily or matching placebo. Follow-up surveys were conducted daily for 5 days and again 14 days after enrollment and 1 month after enrollment. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease), within 14 days after enrollment. Secondary outcomes included the duration and frequency of diarrhea and vomiting, the duration of day-care absenteeism, and the rate of household transmission (defined as the development of symptoms of gastroenteritis in previously asymptomatic household contacts). RESULTS: Among the 971 participants, 943 (97.1%) completed the trial. The median age was 1.4 years (interquartile range, 0.9 to 2.3), and 513 participants (52.9%) were male. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P=0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16). CONCLUSIONS: Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT01773967 .).

The Development and Validation of a Concise Instrument for Formative Assessment of Team Leader Performance During Simulated Pediatric Resuscitations.

AIM: The aim of this study was to assess the validity of a formative feedback instrument for leaders of simulated resuscitations. METHODS: This is a prospective validation study with a fully crossed (person × scenario × rater) study design. The Concise Assessment of Leader Management (CALM) instrument was designed by pediatric emergency medicine and graduate medical education experts to be used off the shelf to evaluate and provide formative feedback to resuscitation leaders. Four experts reviewed 16 videos of in situ simulated pediatric resuscitations and scored resuscitation leader performance using the CALM instrument. The videos consisted of 4 pediatric emergency department resuscitation teams each performing in 4 pediatric resuscitation scenarios (cardiac arrest, respiratory arrest, seizure, and sepsis). We report on content and internal structure (reliability) validity of the CALM instrument. RESULTS: Content validity was supported by the instrument development process that involved professional experience, expert consensus, focused literature review, and pilot testing. Internal structure validity (reliability) was supported by the generalizability analysis. The main component that contributed to score variability was the person (33%), meaning that individual leaders performed differently. The rater component had almost zero (0%) contribution to variance, which implies that raters were in agreement and argues for high interrater reliability. CONCLUSIONS: These results provide initial evidence to support the validity of the CALM instrument as a reliable assessment instrument that can facilitate formative feedback to leaders of pediatric simulated resuscitations.

Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol.

INTRODUCTION: Acute gastroenteritis (AGE) is a common and burdensome condition that affects millions of children worldwide each year. Currently available strategies are limited to symptomatic management, treatment and prevention of dehydration and infection control; no disease-modifying interventions exist. Probiotics, defined as live microorganisms beneficial to the host, have shown promise in improving AGE outcomes, but existing studies have sufficient limitations such that the use of probiotics cannot currently be recommended with confidence. Here we present the methods of a large, rigorous, randomised, double-blind placebo-controlled study to assess the effectiveness and side effect profile of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) in children with AGE. METHODS AND ANALYSIS: The study is being conducted in 10 US paediatric emergency departments (EDs) within the federally funded Pediatric Emergency Care Applied Research Network, in accordance with current SPIRIT and CONSORT statement recommendations. We will randomise 970 children presenting to participating EDs with AGE to either 5 days of treatment with LGG (1010colony-forming unit twice a day) or placebo between July 2014 to December 2017. The main outcome is the occurrence of moderate-to-severe disease over time, as defined by the Modified Vesikari Scale. We also record adverse events and side effects related to the intervention. We will conduct intention-to-treat analyses and use an enrichment design to restore the statistical power in case the presence of a subpopulation with a substantially low treatment effect is identified. ETHICS AND DISSEMINATION: Institutional review board approval has been obtained at all sites, and data and material use agreements have been established between the participating sites. The results of the trial will be published in peer-reviewed journals. A deidentified public data set will be made available after the completion of all study procedures. TRIAL REGISTRATION NUMBER: NCT01773967.