Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.

BACKGROUND: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics. METHODS: We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns. RESULTS: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias. CONCLUSIONS: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.

Health Care Provider Bias in Estimating the Health Literacy of Caregivers in a Pediatric Emergency Department.

BACKGROUND: Health literacy is a growing concern because of its effects on communication and health outcomes. One aspect of this communication is the ability of the health care provider to estimate the health literacy of a patient or their caregiver. The objectives of this study are to quantify misestimation of caregiver health literacy by providers and identify potential descriptive or demographic factors that might be related to those misestimations. METHODS: Providers were asked to perceive descriptive factors and estimate the health literacy of caregivers in a pediatric Emergency Department. Then, the health literacy of the caregiver was tested using the Short Assessment of Health Literacy, and cross-tabulated with provider estimates. RESULTS: Providers correctly estimated the health literacy of the caregivers 60% of the time, and misestimates were often underestimates (27.7%) rather than overestimates (12.3%). Providers overestimated the health literacy of 24.1% of fathers and only 9.8% of mothers (P = 0.012). They correctly estimated the health literacy of 63.9% of English-speaking caregivers compared with 30.6% of Spanish-speaking caregivers, and underestimated the health literacy of 50% of Spanish-speaking caregivers and 24.8% of English-speaking caregivers (P < 0.001). Providers correctly estimated the health literacy of 34.4% of racially and ethnically diverse caregivers compared with 71.5% of White/non-Hispanic caregivers. They underestimated the health literacy of 52.1% of these racially and ethnically diverse caregivers and 16.8% of White/non-Hispanic caregivers (P < 0.001). CONCLUSIONS: Providers often overestimate and underestimate the health literacy of parents in the pediatric emergency department. Misestimates are related to race, caregiver role, and language spoken by the caregiver. When providers misestimate health literacy, they may use words or phrases that are above or below the health literacy level of the caregiver. These results suggest a need for further health literacy research and interventions in provider education and clinical practice.

Developing a clinical research infrastructure embedded in an academic medicine center that equitably supports future clinician scientists.

Clinical research in academic medical centers can be difficult to conduct and meet enrollment goals. Students under-represented in medicine (URiM) are also under-represented in academic leadership positions and as physician-scientists but are critical to help solve health disparities. Barriers in pursuing medicine as a career may be high for URiM students, therefore it is important to create pre-medicine opportunities accessible to all students interested in healthcare careers. We describe an undergraduate clinical research platform, the Academic Associate (AcA) program, embedded in the medical system that supports clinical research for academic physician scientists and provides students equitable access to experiences and mentoring opportunities. Students have the opportunity of completing a Pediatric Clinical Research Minor (PCRM) degree. This program satisfies many pre-medicine opportunities for undergraduate students, including those URiM, and allows access to physician mentors and unique educational experiences for graduate school or employment. Since 2009, 820 students participated in the AcA program (17.5% URiM) and 235 students (18% URiM) completed the PCRM. Of the 820 students, 126 (10% URiM) students matriculated to medical school, 128 (11%URiM) to graduate school, and 85 (16.5% URiM) gained employment in biomedical research fields. Students in our program supported 57 publications and were top-enrollers for several multicentered studies. The AcA program is cost-effective and achieves a high level of success enrolling patients into clinical research. Additionally, the AcA program provides equitable access for students URiM to physician mentorship, pre-medical experiences, and an avenue to early immersion in academic medicine.

Communication Gaps Between Providers and Caregivers of Patients in a Pediatric Emergency Department.

Communication gaps between the healthcare team and caregivers of pediatric patients can result in negative consequences. This study aims to identify specific words and phrases used in a pediatric emergency department (ED) that are unclear or confusing to caregivers. Research assistants at the Primary Children's Hospital recorded caregivers' responses to the question, "What words or phrases have been used during this visit that are unclear or don't make sense to you?" Across all steps in the care process, 62 of 220 participants (28.2%) reported unclear words and phrases used by the healthcare team. Responses recorded after the discharge step had the highest proportion of communication problems, followed by the initial evaluation and then the update step (χ2 [2, N = 220] = 6.30, P = .043). Themes among responses included ED logistics, signs/symptoms, the diagnostic process, treatment/procedures, general confusion, and language barriers. These results provide feedback to pediatric emergency medicine providers about potential communication gaps and point to a need for further efforts to train providers in the practice of high-quality communication.

Social Needs Screening During Pediatric Emergency Department Visits: Disparities in Unmet Social Needs.

OBJECTIVE: To determine the prevalence of unmet social needs (USN) in a pediatric emergency department (PED) patient population and examine disparities in USN by self-selected language and patient demographics. METHODS: We surveyed a convenience sample of English- and Spanish-speaking caregivers of patients <18-years-old presenting to a free-standing children's hospital in Salt Lake City, Utah. In the caregiver's self-selected language, the pediatric version of the Screener for Intensifying Community Referrals for Health (p-SINCERE) assessed patient demographics and 10 areas of social needs. The primary outcome was presence of USN. Descriptive statistics compared 1) self-selected languages and 2) absence versus presence of USN. Patient and caregiver-level risk factors associated with USN were identified using multivariable logistic regression. RESULTS: Of the 10,156 patients seen in our PED from 04/01/2021 to 08/03/2021, there were 9922 eligible, 5357 approached, and 3987 enrolled caregivers. Of the 3987 caregivers enrolled, self-selected language was English for 3662 (91.8%) and Spanish for 325 (8.2%). There were 1680 enrolled caregivers with ≥1 USN, representing 39.7% of English-speaking and 70.2% of Spanish-speaking caregivers (P < .001). The odds of having ≥1 USN was more than 2 times higher in Spanish-speakers than in English-speakers after adjustment. CONCLUSIONS: USN are common for families presenting for care to a PED, especially among Spanish-speaking caregivers. Furthermore, this study demonstrates disparities in limited English proficiency, race and ethnicity, and child insurance status. These findings support the practicality of utilizing the PED as an access point to initiate social need screening and referrals to address social determinants of health and health disparities.

Cultural identity central to Native American persistence in science.

Native Americans are the least represented population in science fields. In recent years, undergraduate and graduate level summer research programs that aimed to increase the number of Native Americans in science have made some progress. As new programs are designed, key characteristics that address science self-efficacy and science identity and provide supports for Native American students' commitment to a scientific career should be considered. In this study, we used sequential mixed methods to investigate the potential of culturally tailored internship programs on Native American persistence in science. We analyzed surveys (n = 47) and interviews (n = 4) with Native American students to understand their perceptions of themselves in relation to science research and how summer research experiences might develop science identities. Based on regression modeling, science identity, but not science self-efficacy, predicted intent to persist in science. In turn, science self-efficacy and Native American identity predicted science identity, and this suggests cultural identity is central to Native American persistence in science. In interviews, students' comments reinforced these findings and shed light on students' reasoning about the kinds of science experiences they sought; specifically, they chose to participate in culturally tailored internships because these programs provided a sense of belonging to the scientific community that did not conflict with their cultural identities. Based on our analysis, we propose an Indigenous science internship model and recommend that agencies target funding for culturally tailored programs from high school through early-investigator levels as well as provide inclusive programmatic and mentoring guidelines.

Early Neurologic Recovery, Practice Pattern Variation, and the Risk of Endotracheal Intubation Following Established Status Epilepticus.

OBJECTIVE: To quantify the association between early neurologic recovery, practice pattern variation, and endotracheal intubation during established status epilepticus, we performed a secondary analysis within the cohort of patients enrolled in the Established Status Epilepticus Treatment Trial (ESETT). METHODS: We evaluated factors associated with the endpoint of endotracheal intubation occurring within 120 minutes of ESETT study drug initiation. We defined a blocked, stepwise multivariate regression, examining 4 phases during status epilepticus management: (1) baseline characteristics, (2) acute treatment, (3) 20-minute neurologic recovery, and (4) 60-minute recovery, including seizure cessation and improving responsiveness. RESULTS: Of 478 patients, 117 (24.5%) were intubated within 120 minutes. Among high-enrolling sites, intubation rates ranged from 4% to 32% at pediatric sites and 19% to 39% at adult sites. Baseline characteristics, including seizure precipitant, benzodiazepine dosing, and admission vital signs, provided limited discrimination for predicting intubation (area under the curve [AUC] 0.63). However, treatment at sites with an intubation rate in the highest (vs lowest) quartile strongly predicted endotracheal intubation independently of other treatment variables (adjusted odds ratio [aOR] 8.12, 95% confidence interval [CI] 3.08-21.4, model AUC 0.70). Site-specific variation was the factor most strongly associated with endotracheal intubation after adjustment for 20-minute (aOR 23.4, 95% CI 6.99-78.3, model AUC 0.88) and 60-minute (aOR 14.7, 95% CI 3.20-67.5, model AUC 0.98) neurologic recovery. CONCLUSIONS: Endotracheal intubation after established status epilepticus is strongly associated with site-specific practice pattern variation, independently of baseline characteristics, and early neurologic recovery and should not alone serve as a clinical trial endpoint in established status epilepticus. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT01960075.

Lessons From the First Decade of the Native American Summer Research Internship at the University of Utah.

PROBLEM: American Indian/Alaska Native (AI/AN) populations are facing multiple health crises, including limited access to care, high rates of chronic disease, and early mortality that is far worse than other underrepresented minorities in the United States. According to the Association of American Indian Physicians, AI/AN people represent 2.0% of the U.S. population but only 0.2% of medical students and 0.1% of full-time faculty at MD-granting institutions. Increasing the number of AI/AN clinicians and scientists is one strategy to improve health outcomes in the AI/AN population and address these crises. APPROACH: In 2010, the University of Utah partnered with research, cultural, and professional mentors to create a 10-week summer Native American Research Internship (NARI) program for AI/AN college students across the United States who are interested in pursuing biomedical careers. NARI attracts and supports AI/AN students by offering mentored summer research internships in an innovative, culturally aware framework that adapts to observed challenges to optimize educational experiences and support biomedical career aspirations. OUTCOMES: During the first decade of the NARI program, 128 students from 22 U.S. states, representing 46 tribal nations and 57 colleges and universities, participated. Of those 128 students, 113 (88%) have completed a bachelor's degree and the remaining 15 (12%) are currently working toward a bachelor's degree. No NARI student has dropped out of college. Twenty-six (20%) NARI alumni have matriculated to medical school and 30 (23%) to graduate school. Eight (6%) participants have completed medical school, and 3 (2%) are pursuing a PhD in science. An additional 36 (28%) have gained employment in biomedical research fields. NEXT STEPS: The NARI program has increased the participation of AI/AN students in medicine and the biomedical sciences. The innovative, culturally aware, and adaptive framework is a model for other programs for AI/AN students and students in other underrepresented communities.

Efficacy of levetiracetam, fosphenytoin, and valproate for established status epilepticus by age group (ESETT): a double-blind, responsive-adaptive, randomised controlled trial.

BACKGROUND: Benzodiazepine-refractory, or established, status epilepticus is thought to be of similar pathophysiology in children and adults, but differences in underlying aetiology and pharmacodynamics might differentially affect response to therapy. In the Established Status Epilepticus Treatment Trial (ESETT) we compared the efficacy and safety of levetiracetam, fosphenytoin, and valproate in established status epilepticus, and here we describe our results after extending enrolment in children to compare outcomes in three age groups. METHODS: In this multicentre, double-blind, response-adaptive, randomised controlled trial, we recruited patients from 58 hospital emergency departments across the USA. Patients were eligible for inclusion if they were aged 2 years or older, had been treated for a generalised convulsive seizure of longer than 5 min duration with adequate doses of benzodiazepines, and continued to have persistent or recurrent convulsions in the emergency department for at least 5 min and no more than 30 min after the last dose of benzodiazepine. Patients were randomly assigned in a response-adaptive manner, using Bayesian methods and stratified by age group (<18 years, 18-65 years, and >65 years), to levetiracetam, fosphenytoin, or valproate. All patients, investigators, study staff, and pharmacists were masked to treatment allocation. The primary outcome was absence of clinically apparent seizures with improved consciousness and without additional antiseizure medication at 1 h from start of drug infusion. The primary safety outcome was life-threatening hypotension or cardiac arrhythmia. The efficacy and safety outcomes were analysed by intention to treat. This study is registered in ClinicalTrials.gov, NCT01960075. FINDINGS: Between Nov 3, 2015, and Dec 29, 2018, we enrolled 478 patients and 462 unique patients were included: 225 children (aged <18 years), 186 adults (18-65 years), and 51 older adults (>65 years). 175 (38%) patients were randomly assigned to levetiracetam, 142 (31%) to fosphenyltoin, and 145 (31%) were to valproate. Baseline characteristics were balanced across treatments within age groups. The primary efficacy outcome was met in those treated with levetiracetam for 52% (95% credible interval 41-62) of children, 44% (33-55) of adults, and 37% (19-59) of older adults; with fosphenytoin in 49% (38-61) of children, 46% (34-59) of adults, and 35% (17-59) of older adults; and with valproate in 52% (41-63) of children, 46% (34-58) of adults, and 47% (25-70) of older adults. No differences were detected in efficacy or primary safety outcome by drug within each age group. With the exception of endotracheal intubation in children, secondary safety outcomes did not significantly differ by drug within each age group. INTERPRETATION: Children, adults, and older adults with established status epilepticus respond similarly to levetiracetam, fosphenytoin, and valproate, with treatment success in approximately half of patients. Any of the three drugs can be considered as a potential first-choice, second-line drug for benzodiazepine-refractory status epilepticus. FUNDING: National Institute of Neurological Disorders and Stroke, National Institutes of Health.

Impact of an Offline Pain Management Protocol on Prehospital Provider Self-Efficacy: A Randomized Trial.

BACKGROUND: Pain in children is inadequately treated in the prehospital setting despite the reported recognition by prehospital providers (PHPs) of pain treatment as an important part of patient care. The impact of pediatric pain management protocol (PPP) implementation on PHP self-efficacy (SE), a measure congruent with performance, is unknown. OBJECTIVE: The aim of this study was to evaluate the impact of PPP implementation and pain management education on PHP SE. METHODS: This was a prospective study evaluating the change in PHP SE after a PPP was implemented. Prehospital providers were randomized to 3 groups: protocol introduction alone, protocol introduction with education, and protocol introduction with education and a 3-month interim review. Prehospital provider SE was assessed for pain management given 3 age-based scenarios. Self-efficacy was measured with a tool that uses a ranked ordinal scale ranging from "certain I cannot do it" (0) to "completely certain I can do it" (100) for 10 pain management actions: pain assessment (3), medication administration (4), dosing (1), and reassessment (2). An averaged composite score (0-100) was calculated for each of the 3 age groups (adult, child, toddler). Paired-sample t tests compared post-PPP and 13-month scores to pre-PPP scores. RESULTS: Of 264 PHPs who completed initial surveys, 142 PHPs completed 13-month surveys. Ninety-three (65%) received education with protocol review, and 49 (35%) had protocol review only. Self-efficacy scores increased over the study period, most notably for pain assessment. This increase persisted at 13 months for child (6.6 [95% confidence interval {CI}, 1.4-11.8]) and toddler pain assessment (22.3 [95% CI, 16.4-28.3]). Composite SE scores increased immediately for all age groups (adult, 3.1 [95% CI, 1.3-4.9]; child, 6.1 [95% CI, 3.8-8.5]; toddler, 12.0 [95% CI, 9.5-14.5]) and persisted at 13 months for the toddler group alone (7.0 [95% CI, 4.3-9.7]). There was no difference between groups who received protocol review alone compared with those with education or education plus a 3-month interim review. CONCLUSIONS: After a pain management protocol was introduced, SE scores among PHPs increased immediately and remained elevated for some individual actions involved in pain management, most notably pain assessment. Prehospital provider pain assessment SE scores declined 13 months after protocol introduction for adults, but remained elevated compared with baseline for the pediatric age groups.

Seizure Treatment in Children Transported to Tertiary Care: Recommendation Adherence and Outcomes.

BACKGROUND AND OBJECTIVES: Convulsive seizures account for 15% of pediatric air transports. We evaluated seizure treatment received in community hospital emergency departments among transported patients for adherence to recommended management. METHODS: This study was a retrospective cohort study of children transported for an acute seizure to a tertiary pediatric hospital from 2010 to 2013. Seizure treatment was evaluated for adherence to recommended management. The primary outcome was intubation. RESULTS: Among 126 events, 61% did not receive recommended acute treatment. The most common deviation from recommended care was administration of >2 benzodiazepine doses. Lack of adherence to recommended care was associated with a greater than twofold increased risk of intubation (relative risk 2.4; 95% confidence interval, 1.4-4.13) and 1.5-fold increased risk of admission to the ICU (relative risk 1.65; 95% confidence interval, 1.24-2.16). Duration of ventilation was commonly <24 hours (87%) for patients who did or did not receive recommended acute seizure care. Among events treated initially with a benzodiazepine, only 32% received a recommended weight-based dosage, and underdosing was most common. CONCLUSIONS: Adherence to evidence-based recommended acute seizure treatment during initial care of pediatric patients using medical air transportation was poor. Intubation was more common when patients did not receive recommended acute seizure care. Educational efforts with a sustained quality focus should be directed to increase adherence to appropriate pediatric seizure treatment of children in community emergency departments.

Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

BACKGROUND: The US federal regulation "Exception from Informed Consent for Emergency Research," 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation. AIM: To describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial. METHODS: Community consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. RESULTS: Every Institutional Review Board, among the 15 participating sites, had a varied interpretation of Exception from Informed Consent regulations for community consultation and public disclosure activities. Institutional Review Boards required various combinations of focus groups, interviews, surveys, and meetings for community consultation, and news releases, mailings, and public service announcements for public disclosure. At least 4335 patients received information about the study from these efforts. In all, 158 chose to be included in the "Opt Out" list. Of the 304 participants who were enrolled under Exception from Informed Consent, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families. CONCLUSION: There is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.

Impact of newly adopted guidelines for management of children with isolated skull fracture.

PURPOSE: In an effort to standardize practices and reduce unnecessary hospital resource utilization, we implemented guidelines for management of patients with isolated skull fractures (ISF). We sought to examine the impact of these guidelines. METHODS: Patients with nondisplaced/depressed fracture of the skull vault without intracranial hemorrhage were prospectively enrolled from February 2010 to February 2014. RESULTS: Eighty-eight patients (median age=10months) were enrolled. Fall was the most common mechanism of injury (87%). The overall admission rate was 57%, representing an 18% decrease from that reported prior to guideline implementation (2003-2008; p=0.001). Guideline criteria for admission included vomiting, abnormal neurologic exam, concern for abuse, and others. Forty-two percent of patients were admitted outside of the guideline, primarily because of young age (20%). Patients transferred from another hospital (36%) were more likely to be admitted, though the majority (63%) did not meet admission criteria. No ED-discharged patient returned for neurologic symptoms, and none reported significant ongoing symptoms on follow-up phone call. CONCLUSIONS: Implementation of a new guideline for management of ISF resulted in a reduction of admissions without compromising patient safety. Young age remains a common concern for practitioners despite not being a criterion for admission. Interhospital transfer may be unnecessary in many cases.

Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial.

IMPORTANCE: Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication. OBJECTIVE: To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus. DESIGN, SETTING, AND PARTICIPANTS: This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam. INTERVENTIONS: Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration. RESULTS: Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%). CONCLUSIONS AND RELEVANCE: Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00621478.

Cervical spine computed tomography utilization in pediatric trauma patients.

BACKGROUND: Guidelines for evaluating the cervical spine in pediatric trauma patients recommend cervical spine CT (CSCT) when plain radiographs suggest an injury. Our objective was to compare usage of CSCT between a pediatric trauma center (PTC) and referral general emergency departments (GEDs). METHODS: Patient data from a pediatric trauma registry from 2002 to 2011 were analyzed. Rates of CSI and CSCT of patients presenting to the PTC and GED were compared. Factors associated with use of CSCT were assessed using multivariate logistic regression. RESULTS: 5148 patients were evaluated, 2142 (41.6%) at the PTC and 3006 (58.4%) at the GED. Groups were similar with regard to age, gender, GCS, and triage category. GED patients had a higher median ISS (14 vs. 9, p<0.05) and more frequent ICU admissions (44.3% vs. 26.1% p<0.05). CSI rate was 2.1% (107/5148) and remained stable. CSCT use increased from 3.5% to 16.1% over time at the PTC (mean 9.6% 95% CI=8.3, 10.9) and increased from 6.8% to 42.0% (mean 26.9%, CI=25.4, 28.4) at the GED. Initial care at a GED remained strongly associated with CSCT. CONCLUSIONS: Despite a stable rate of CSI, rate of CSCT increased significantly over time, especially among patients initially evaluated at a GED.

Developing future clinician scientists while supporting a research infrastructure.

BACKGROUND: Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research. OBJECTIVE: Describe an innovative undergraduate course that supports clinical research in an AMC. METHODS: The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students. RESULTS: Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support. CONCLUSIONS: The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research.

Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy.

OBJECTIVE: To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy. DESIGN: Prospective randomized study. SETTING: Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states. PATIENTS: A total of 358 pediatric patients who visited a pediatric neurology clinic from July 2006 through September 2008 and were prescribed a home rescue medication for their next seizure. INTERVENTION: Caretakers were randomized to use either 0.2 mg/kg of IN-MMAD (maximum, 10 mg) or 0.3 to 0.5 mg/kg of RD (maximum, 20 mg) at home for their child's next seizure if it lasted more than 5 minutes. OUTCOME MEASURES: The primary outcome measure was total seizure time after medication administration. Our secondary outcome measures were total seizure time, time to medication administration, respiratory complications, emergency medical service support, emergency department visits, hospitalizations, and caretakers' ease of administration and satisfaction with the medication. RESULTS: A total of 92 caretakers gave the study medication during a child's seizure (50 IN-MMAD, 42 RD). The median time from medication administration to seizure cessation for IN-MMAD was 1.3 minutes less than for RD (95% confidence interval, 0.0-3.5 minutes; P=.09). The median time to medication administration was 5.0 minutes for each group. No differences in complications were found between treatment groups. Caretakers were more satisfied with IN-MMAD and report that it was easier to give than RD. CONCLUSIONS: There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD. Trial Registration clinicaltrials.gov Identifier: NCT00326612.

Magnetic attraction leading to a small bowel obstruction in a child.

Foreign body ingestion in small children is common yet only 1% of cases require operative management of associated complications (Arana et al. in Eur J Pediatr 160:468-472, 2001). A 6-year-old boy was referred to our institution with a 12 h history of abdominal pain. This pain was diffuse and crampy in nature and associated with multiple episodes of non-bilious, non-bloody emesis. On evaluation he was stable and his abdomen demonstrated slight distention and tenderness without peritoneal signs. Plain abdominal radiographs demonstrated some distended loops of small bowel and a radio-opaque foreign object within the mid-abdomen. A small bowel obstruction secondary to foreign body ingestion was diagnosed and an emergent laparotomy performed. Upon exploration, a transition zone was noted near the ileocecal valve. Further exploration revealed the obstruction to be caused secondary to the apposition of two small (8 mm) magnets, one in the proximal ileum and the other near the ileocecal valve, resulting in an internal hernia. The magnets were easily separated relieving the obstruction and both were removed via two small bowel enterotomies. After being presented with the magnets, his parents suspected that they came from the clothes of a Polly Pocket (Mattel, Inc., El Segundo, CA) doll. The patient had an uneventful post-operative course and was discharged to home on the second post-operative day. This case demonstrates the complications that may occur with multiple magnet ingestion. It highlights the need for close observation and early surgical intervention in children with a suspected history of foreign body ingestion, a clinical picture of gastrointestinal distress, and radiographic evidence of a radio-opaque foreign object.

Prehospital intranasal midazolam for the treatment of pediatric seizures.

BACKGROUND: The local emergency medical services (EMS) council implemented a new pediatric treatment protocol using a Mucosal Atomization Device (MAD) to deliver intranasal (IN) midazolam for seizure activity. METHODS: We sought to compare outcomes in seizing pediatric patients treated with IN midazolam using a MAD (IN-MAD midazolam) to those treated with rectal (PR) diazepam, 18 months before and after the implementation of the protocol. RESULTS: Of 857 seizure patients brought by EMS to our emergency department (ED), 124 patients (14%) had seizure activity in the presence of EMS and were eligible for inclusion in this study. Of the 124 patients eligible for this study, 67 patients (54%) received no medications in the prehospital setting, 39 patients (32%) were treated with IN-MAD midazolam, and 18 patients (15%) were treated with PR diazepam. Median seizure time noted by EMS was 19 minutes longer for PR diazepam (30 minutes) when compared with IN-MAD midazolam (11 minutes, P = 0.003). Patients treated with PR diazepam in the prehospital setting were significantly more likely to have a seizure in the ED (odds ratio [OR], 8.4; confidence interval [CI], 1.6-43.7), ED intubation (OR, 12.2; CI, 2.0-75.4), seizure medications in the ED to treat ongoing seizure activity (OR, 12.1; CI, 2.2-67.8), admission to the hospital (OR, 29.3; CI, 3.0-288.6), and admission to the pediatric intensive care unit (OR, 53.5; CI, 2.7-1046.8). CONCLUSIONS: The IN-MAD midazolam controlled seizures better than PR diazepam in the prehospital setting and resulted in fewer respiratory complications and fewer admissions.