Perspectives of Caregivers on Children Boarding With Mental Health Conditions.

OBJECTIVE: Addressing the acute mental healthcare needs of children is a national crisis. Despite the ongoing crisis, there are limited prior studies that capture caregiver perspectives on acute pediatric mental healthcare, notably in a general emergency department (ED) in a rural state. Based on these knowledge gaps, our objective was to assess caregiver opinions and perspectives of acute management for children boarding with mental health conditions. METHODS: Semistructured interviews were conducted with caregivers of patients (under 18 years old) with a primary mental health condition boarding in a general ED (length of stay ≥24 hours) within a qualitative grounded theory approach. An interview guide was developed a priori and reviewed among key stakeholders. A trained study team performed the interviews. A coding tree was developed through an iterative process that included double-coding transcripts and monitoring of interrater reliability to perform thematic analysis. RESULTS: Fourteen interviews were conducted to reach thematic saturation. Key themes elicited from caregivers included mental healthcare delivery, access to mental healthcare services, care setting, and level of support for families and caregivers. Most caregivers focused on the following challenges and suggestions: access to appropriate, evidence-based mental healthcare, improved communication between all stakeholders involved, and staff education on mental healthcare for children. CONCLUSIONS: Caregivers face considerable challenges in attaining timely and appropriate acute mental health care for their children. Immediate and innovative resource allocation is needed across the healthcare continuum to bolster the acute mental healthcare services currently offered to children and families, especially in the general ED setting.

Emergency department visits for mild traumatic brain injury in early childhood.

BACKGROUND: Brain injury during early childhood may disrupt key periods of neurodevelopment. Most research regarding mild traumatic brain injury (mTBI) has focused on school-age children. We sought to characterize the incidence and healthcare utilization for mTBI in young children presenting to U.S. emergency departments (ED). METHODS: The Nationwide Emergency Department Sample was queried for children age 0-6 years with mTBI from 2016 to 2019. Patients were excluded for focal or diffuse TBI, drowning or abuse mechanism, death in the ED or hospital, Injury Severity Score > 15, neurosurgical intervention, intubation, or blood product transfusion. RESULTS: National estimates included 1,372,291 patient visits: 63.5% were two years or younger, 57.5% were male, and 69.4% were injured in falls. The most common head injury diagnosis was "unspecified injury of head" (83%); this diagnosis decreased in frequency as age increased, in favor of a concussion diagnosis. Most patients were seen at low pediatric volume EDs (64.5%) and non-children's hospital EDs (86.2%), and 64.9% were seen at a non-teaching hospital. Over 98% were treated in the ED and discharged home. Computed tomography of the head and cervical spine were performed in 18.7% and 1.6% of patients, respectively, less often at children's hospitals (OR = 0.55, 95%CI = 0.41-0.76 for head and OR = 0.19, 95%CI = 0.11-0.34 for cervical spine). ED charges resulted in $540-681 million annually, and more than half of patients utilized Medicaid. CONCLUSIONS: Early childhood mTBI is prevalent and results in high financial burden in the U.S. There is wide variation in diagnostic coding and computed tomography scanning amongst EDs. More focused research is needed to identify optimal diagnostic tools and management strategies.

Assessment of primary outcome measures for a clinical trial of pediatric hemorrhagic injuries.

OBJECTIVE: We evaluated the acceptability of the Pediatric Quality of Life Inventory (PedsQL) and other outcomes as the primary outcomes for a pediatric hemorrhagic trauma trial (TIC-TOC) among clinicians. METHODS: We conducted a mixed-methods study that included an electronic questionnaire followed by teleconference discussions. Participants confirmed or rejected the PedsQL as the primary outcome for the TIC-TOC trial and evaluated and proposed alternative primary outcomes. Responses were compiled and a list of themes and representative quotes was generated. RESULTS: 73 of 91 (80%) participants completed the questionnaire. 61 (84%) participants agreed that the PedsQL is an appropriate primary outcome for children with hemorrhagic brain injuries. 32 (44%) participants agreed that the PedsQL is an acceptable primary outcome for children with hemorrhagic torso injuries, 27 (38%) participants were neutral, and 13 (18%) participants disagreed. Several themes were identified from responses, including that the PedsQL is an important and patient-centered outcome but may be affected by other factors, and that intracranial hemorrhage progression assessed by brain imaging (among patients with brain injuries) or blood product transfusion requirements (among patients with torso injuries) may be more objective outcomes than the PedsQL. CONCLUSIONS: The PedsQL was a well-accepted proposed primary outcome for children with hemorrhagic brain injuries. Traumatic intracranial hemorrhage progression was favored by a subset of clinicians. A plurality of participants also considered the PedsQL an acceptable outcome for children with hemorrhagic torso injuries. Blood product transfusion requirement was favored by fewer participants.

Occult head injury is common in children with concern for physical abuse.

BACKGROUND: Studies evaluating small patient cohorts have found a high, but variable, rate of occult head injury in children <2 years old with concern for physical abuse. The American College of Radiology (ACR) recommends clinicians have a low threshold to obtain neuroimaging in these patients. OBJECTIVES: Our aim was to determine the prevalence of occult head injury in a large patient cohort with suspected physical abuse using similar selection criteria from previous studies. Additionally, we evaluated proposed risk factors for associations with occult head injury. MATERIALS AND METHODS: This was a retrospective, secondary analysis of data collected by an observational study of 20 U.S. child abuse teams that evaluated children who underwent subspecialty evaluation for concern of abuse. We evaluated children <2 years old and excluded those with abnormal mental status, bulging fontanelle, seizure, respiratory arrest, underlying neurological condition, focal neurological deficit or scalp injury. RESULTS: One thousand one hundred forty-three subjects met inclusion criteria and 62.5% (714) underwent neuroimaging with either head computed tomography or magnetic resonance imaging. We found an occult head injury prevalence of 19.7% (141). Subjects with emesis (odds ratio [OR] 3.5, 95% confidence interval [CI] 1.8-6.8), macrocephaly (OR 8.5, 95% CI 3.7-20.2), and loss of consciousness (OR 5.1, 95% CI 1.2-22.9) had higher odds of occult head injury. CONCLUSION: Our results show a high prevalence of occult head injury in patients <2 years old with suspected physical abuse. Our data support the ACR recommendation that clinicians should have a low threshold to perform neuroimaging in patients <2 years of age.

Emergency Care for Children in the United States: Epidemiology and Trends Over Time.

BACKGROUND: The emergency care system for children in the United States is fragmented. A description of epidemiological trends based on emergency department (ED) volume over time could help focus efforts to improve emergency care for children. OBJECTIVES: To describe the trends of emergency care for children in the United States from 2006-2014 in EDs across different pediatric volumes. METHODS: We analyzed pediatric visits to EDs using the Health Care Utilization Project Nationwide Emergency Department Sample in a representative sample of 1,000 EDs annually from 2006-2014. We report trends in disease severity, mortality, and transfers based on strata by pediatric volume and other hospital characteristics. RESULTS: From 2006-2014, there were 318,114,990 pediatric ED visits. Pediatric visits remained steady but declined as a percentage of total visits (-3.91%, p = 0.0007). The majority (92.7%) of children were cared for in lower-volume EDs (<50,000 pediatric visits/year), where mortality was higher vs. the highest-volume EDs. Mortality decreased over time (0.34/1,000 to 0.27, p = 0.0099), whereas interhospital transfers increased (p = 0.0020). ED visits increased for children with Medicaid insurance (40.7% to 56.7%, p < 0.0001), whereas rates of self-pay insurance decreased (13.6% to 9.45%, p = 0.0006). The most common reasons for pediatric ED visits were trauma (25.6%); ear, nose, and throat; dental/mouth disorders (21.8%); gastrointestinal diseases (17.0%); and respiratory diseases (15.6%). CONCLUSIONS: Overall, pediatric ED visits have remained stable, with lower mortality rates, whereas Medicaid-funded pediatric visits have increased over time. Most children still seek care in lower-volume EDs. Efforts to improve pediatric care could be best focused on lower-volume EDs and interhospital transfers.

Epidemiology of blunt head trauma in children in U.S. emergency departments.

Among more than 43,000 children treated in 25 emergency departments for blunt head trauma, traumatic brain injury was identified on CT scan in 7% of the patients. Falls were the most frequent injury mechanism for children under the age of 12 years.

Pediatric Concussion Management in the Emergency Department: A National Survey of Parents.

OBJECTIVE: To examine parental expectations and beliefs about diagnosis and management of pediatric concussion. STUDY DESIGN: We conducted a cross-sectional web-based survey of a nationally representative panel of US parents in March 2014. Parents of 10- to 17-year-old children responded to questions about their expectations and beliefs about diagnosis and management of pediatric concussion in the emergency department (ED). Weighted percentages for descriptive statistics were calculated, and χ2 statistics were used for bivariate analysis. RESULTS: Survey participation was 53%, and of 912 parent respondents with a child 10-17 years of age who were presented with a scenario of their child having mild symptoms of concussion, 42% would seek immediate ED care. Parents who would seek immediate ED care for this scenario were more likely than parents who would consult their child's usual provider or wait at home to "definitely expect" imaging (65% vs 21%), definitive diagnosis of concussion (77% vs 61%), a timeline for return to activity (80% vs 60%), and a signed return to play form (55% vs 41%). CONCLUSIONS: Many parents who bring children to the ED following a possible concussion are likely to expect comprehensive and definitive care, including imaging, a definitive diagnosis, a timeline for return to activity, and a signed return to play form. To manage these expectations, healthcare providers should continue to educate parents about the evaluation and management of concussion.

Patient- and Community-Level Sociodemographic Characteristics Associated with Emergency Department Visits for Childhood Injury.

OBJECTIVE: To examine pediatric emergency department (ED) visits over 5 years, trends in injury severity, and associations between injury-related ED visit outcome and patient and community-level sociodemographic characteristics. STUDY DESIGN: Retrospective analysis of administrative data provided to the Pediatric Emergency Care Applied Research Network Core Data Project, 2004-2008. Home addresses were geocoded to determine census block group and associated sociodemographic characteristics. Maximum Abbreviated Injury Scale severity and Severity Classification System scores were calculated. Generalized estimating equations were used to test for associations between sociodemographic characteristics and admission or transfer among injury-related ED visits. RESULTS: Overall ED visits and injury-related visits increased from 2004 to 2008 at study sites. Of 2,833676 successfully geocoded visits, 700,821 (24.7%) were injury-related. The proportion of higher severity injury-related visits remained consistent. Nearly 10% of injury-related visits resulted in admission or transfer each year. After adjusting for age, sex, payer, and injury severity, odds of admission or transfer were lower among minority children and children from areas with moderate and high prevalence of poverty. CONCLUSIONS: Pediatric injury-related ED visits to included sites increased over the study period while injury severity, anticipated resource utilization, and visit outcomes remained stable, with low rates of admission or transfer. Sociodemographic differences in injury-related visits and ED disposition were apparent. ED-based injury surveillance is essential to understand disparities, inform targets for prevention programs, and reduce the overall burden of childhood injuries.

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.

Progesterone for neuroprotection in pediatric traumatic brain injury.

OBJECTIVE: To provide an overview of the preclinical literature on progesterone for neuroprotection after traumatic brain injury and to describe unique features of developmental brain injury that should be considered when evaluating the therapeutic potential for progesterone treatment after pediatric traumatic brain injury. DATA SOURCES: National Library of Medicine PubMed literature review. STUDY SELECTION: The mechanisms of neuroprotection by progesterone are reviewed, and the preclinical literature using progesterone treatment in adult animal models of traumatic brain injury is summarized. Unique features of the developing brain that could either enhance or limit the efficacy of neuroprotection by progesterone are discussed, and the limited preclinical literature using progesterone after acute injury to the developing brain is described. Finally, the current status of clinical trials of progesterone for adult traumatic brain injury is reviewed. DATA EXTRACTION AND DATA SYNTHESIS: Progesterone is a pleiotropic agent with beneficial effects on secondary injury cascades that occur after traumatic brain injury, including cerebral edema, neuroinflammation, oxidative stress, and excitotoxicity. More than 40 studies have used progesterone for treatment after traumatic brain injury in adult animal models, with results summarized in tabular form. However, very few studies have evaluated progesterone in pediatric animal models of brain injury. To date, two human phase II trials of progesterone for adult traumatic brain injury have been published, and two multicenter phase III trials are underway. CONCLUSIONS: The unique features of the developing brain from that of a mature adult brain make it necessary to independently study progesterone in clinically relevant, immature animal models of traumatic brain injury. Additional preclinical studies could lead to the development of a novel neuroprotective therapy that could reduce the long-term disability in head-injured children and could potentially provide benefit in other forms of pediatric brain injury (global ischemia, stroke, and statue epilepticus).

Emergency department practice variation in computed tomography use for children with minor blunt head trauma.

OBJECTIVE: To describe factors associated with computed tomography (CT) use for children with minor blunt head trauma that are evaluated in emergency departments. STUDY DESIGN: Planned secondary analysis of a prospective observational study of children <18 years with minor blunt head trauma between 2004 and 2006 at 25 emergency departments. CT scans were obtained at the discretion of treating clinicians. We risk-adjusted patients for clinically important traumatic brain injuries and performed multivariable regression analyses. Outcome measures were rates of CT use by hospital and by clinician training type. RESULTS: CT rates varied between 19.2% and 69.2% across hospitals. Risk adjustment had little effect on the differential rate of CT use. In low- and middle-risk patients, clinicians obtained CTs more frequently at suburban and nonfreestanding children's hospitals. Physicians with emergency medicine (EM) residency training obtained CTs at greater rates than physicians with pediatric residency or pediatric EM training. In multivariable analyses, compared with pediatric EM-trained physicians, the OR for CT use among EM-trained physicians in children <2 years was 1.24 (95% CI 1.04-1.46), and for children >2 years was 1.68 (95% CI 1.50-1.89). Physicians of all training backgrounds, however, overused CT scans in low-risk children. CONCLUSIONS: Substantial variation exists in the use of CT for children with minor blunt head trauma not explained by patient severity or rates of positive CT scans or clinically important traumatic brain injuries.

Postconcussive Symptoms After Early Childhood Concussion.

Importance: Research on postconcussive symptoms (PCS) following early childhood concussion has been hindered by a lack of measures suitable for this age group, resulting in a limited understanding of their evolution in young children. Objective: To document PCS in the first 3 months after early childhood concussion using a developmentally appropriate measure. Design, Setting, and Participants: This cohort study used data collected at 3 Canadian and 1 US urban pediatric emergency departments (EDs) and 8 Canadian daycares from December 2018 to December 2022 as part of the Kids' Outcomes and Long-Term Abilities (KOALA) project, a prospective, multicenter, longitudinal cohort study. Participants included children aged 6 to 72 months with early childhood concussion or orthopedic injury (OI) or uninjured children from the community to serve as controls. Data were analyzed from March 2023 to January 2024. Exposure: Concussion sustained between ages 6 and 72 months. Main Outcomes and Measures: Primary outcomes were cognitive, physical, behavioral and total PCS assessed prior to injury (retrospectively), acutely (within 48 hours), and at 10 days, 1 month, and 3 months after injury or recruitment through caregiver observations using the Report of Early Childhood Traumatic Injury Observations & Symptoms inventory. Group comparisons were analyzed using ordinal regression models. Results: The study included 303 children (mean [SD] age, 35.8 [20.2] months; 152 [50.2%] male). Of these, 174 children had a concussion (mean [SD] age, 33.3 [19.9] months), 60 children had an OI (mean [SD] age, 38.4 [19.8] months) and 69 children were uninjured controls (mean [SD] age, 39.7 [20.8] months). No meaningful differences were found between the concussion and comparison groups in retrospective preinjury PCS. Significant group differences were found for total PCS at the initial ED visit (concussion vs OI: odds ratio [OR], 4.33 [95% CI, 2.44-7.69]; concussion vs control: OR, 7.28 [95% CI, 3.80-13.93]), 10 days (concussion vs OI: OR, 4.44 [95% CI, 2.17-9.06]; concussion vs control: OR, 5.94 [95% CI, 3.22-10.94]), 1 month (concussion vs OI: OR, 2.70 [95% CI, 1.56-4.68]; concussion vs control: OR, 4.32 [95% CI, 2.36-7.92]), and 3 months (concussion vs OI: OR, 2.61 [95% CI, 1.30-5.25]; concussion vs control: OR, 2.40 [95% CI, 1.36-4.24]). Significant group differences were also found for domain-level scores (cognitive, physical, behavioral) at various time points. Conclusions and Relevance: In this early childhood cohort study, concussion was associated with more PCS than OIs or typical development up to 3 months after injury. Given the limited verbal and cognitive abilities typical of early childhood, using developmentally appropriate manifestations and behaviors is a valuable way of tracking PCS and could aid in concussion diagnosis in young children.

Pharmacokinetics of intravenous lorazepam in pediatric patients with and without status epilepticus.

OBJECTIVE: To evaluate the single dose pharmacokinetics of an intravenous dose of lorazepam in pediatric patients treated for status epilepticus (SE) or with a history of SE. STUDY DESIGN: Ten hospitals in the Pediatric Emergency Care Applied Research Network enlisted patients 3 months to 17 years with convulsive SE (status cohort) or for a traditional pharmacokinetics study (elective cohort). Sparse sampling was used for the status cohort, and intensive sampling was used for the elective cohort. Non-compartmental analyses were performed on the elective cohort, and served to nest compartmental population pharmacokinetics analysis for both cohorts. RESULTS: A total of 48 patients in the status cohort and 15 patients in the elective cohort were enrolled. Median age was 7 years, 2 months. The population pharmacokinetics parameters were: clearance, 1.2 mL/min/kg; half-life, 16.8 hours; and volume of distribution, 1.5 L/kg. On the basis of the pharmacokinetics model, a 0.1 mg/kg dose is expected to achieve concentrations of approximately 100 ng/mL and maintain concentrations >30 to 50 ng/mL for 6 to 12 hours. A second dose of 0.05 mg/kg would achieve desired therapeutic serum levels for approximately 12 hours without excessive sedation. Age-dependent dosing is not necessary beyond using a maximum initial dose of 4 mg. CONCLUSIONS: Lorazepam pharmacokinetics in convulsive SE is similar to earlier pharmacokinetics measured in pediatric patients with cancer, except for longer half-life, and similar to adult pharmacokinetics parameters except for increased clearance.

Intracranial hemorrhage after blunt head trauma in children with bleeding disorders.

OBJECTIVE: To determine computerized tomography (CT) use and prevalence of traumatic intracranial hemorrhage (ICH) in children with and without congenital and acquired bleeding disorders. STUDY DESIGN: We compared CT use and ICH prevalence in children with and without bleeding disorders in a multicenter cohort study of 43 904 children <18 years old with blunt head trauma evaluated in 25 emergency departments. RESULTS: A total of 230 children had bleeding disorders; all had Glasgow Coma Scale (GCS) scores of 14 to 15. These children had higher CT rates than children without bleeding disorders and GCS scores of 14 to 15 (risk ratio, 2.29; 95% CI, 2.15 to 2.44). Of the children who underwent imaging with CT, 2 of 186 children with bleeding disorders had ICH (1.1%; 95% CI, 0.1 to 3.8) , compared with 655 of 14 969 children without bleeding disorders (4.4%; 95% CI, 4.1-4.7; rate ratio, 0.25; 95% CI, 0.06 to 0.98). Both children with bleeding disorders and ICHs had symptoms; none of the children required neurosurgery. CONCLUSION: In children with head trauma, CTs are obtained twice as often in children with bleeding disorders, although ICHs occurred in only 1.1%, and these patients had symptoms. Routine CT imaging after head trauma may not be required in children without symptoms who have congenital and acquired bleeding disorders.

Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study.

OBJECTIVE: The objective of the study was to compare change in asthma knowledge among parents with low or adequate health literacy after video or written asthma education delivered during their child's asthma-related emergency department (ED) visit. METHODS: We recruited a convenience sample of parents presenting to the ED with their asthmatic child 2 to 14 years old. Parents were randomized to receive video (intervention) or written (active-control) asthma education materials. Health literacy levels were determined using the Rapid Estimate of Adult Literacy in Medicine tool. Asthma knowledge was evaluated at enrollment and 6-week telephone follow-up. Differences in knowledge scores were analyzed using Wilcoxon signed rank tests; χ² tests were used for comparisons of categorical variables. RESULTS: Of 150 eligible parents, 129 participated (86%), and 117 were eligible for follow-up. Telephone follow-up was completed with 86 parents (74%). Health literacy levels were low in 31% of the parents. High asthma knowledge scores at enrollment were achieved by 33% of low-literacy and 59% of adequate-health-literacy parents (P = 0.025). Improvement in knowledge was realized for low-literacy parents regardless of the type of education (P < 0.001). Parents with adequate health literacy showed increased knowledge scores only after viewing the video. CONCLUSIONS: Asthma education materials distributed at the time of an ED visit increase parental knowledge about the disease. Video-based asthma education appears promising as a tool for increasing asthma knowledge in both low- and adequate-health-literacy parents.

A survey of emergency physicians' fear of malpractice and its association with the decision to order computed tomography scans for children with minor head trauma.

OBJECTIVE: The objective of the study was to determine whether fear of malpractice is associated with emergency physicians' decision to order head computed tomography (CT) in 3 age-specific scenarios of pediatric minor head trauma. We hypothesized that physicians with higher fear of malpractice scores will be more likely to order head CT scans. METHODS: Board-eligible/board-certified members of the Michigan College of Emergency Physicians were sent a 2-part survey consisting of case scenarios and demographic questions. Effect of fear of malpractice on the decision to order a CT scan was evaluated using a cumulative logit model. RESULTS: Two hundred forty-six members (36.5%) completed the surveys. In scenario 1 (infant), being a male and working in a university setting were associated with reduced odds of ordering a CT scan (odds ratio [OR], 0.40; 95% confidence interval [CI], 0.18-0.88; and OR, 0.35; 95% CI, 0.13-0.96, respectively). In scenario 2 (toddler), working for 15 years or more, at multiple hospitals, and for a private group were associated with reduced odds of ordering a CT scan (OR, 0.46; 95% CI, 0.26-0.79; OR, 0.36; 95% CI, 0.16-0.80; and OR, 0.51; 95% CI, 0.27-0.94, respectively). No demographic variables were significantly associated with ordering a CT scan in scenario 3 (teen). Overall, the fear of malpractice was not significantly associated with ordering a CT scan (OR, 1.28; 95% CI, 0.73-2.26; and OR, 1.70; 95% CI, 0.97-3.0). Only in scenario 2 was high fear significantly associated with increased odds of ordering a CT scan (OR, 2.09; 95% CI, 1.08-4.05). CONCLUSIONS: Members of Michigan College of Emergency Physicians with a higher fear of malpractice score tended to order more head CT scans in pediatric minor head trauma. However, this trend was shown to be statistically significant only in 1 case and not overall.

Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.

BACKGROUND: Federal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries. METHODS: We conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC. RESULTS: We enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months. CONCLUSIONS: In a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study.

BACKGROUND: CT imaging of head-injured children has risks of radiation-induced malignancy. Our aim was to identify children at very low risk of clinically-important traumatic brain injuries (ciTBI) for whom CT might be unnecessary. METHODS: We enrolled patients younger than 18 years presenting within 24 h of head trauma with Glasgow Coma Scale scores of 14-15 in 25 North American emergency departments. We derived and validated age-specific prediction rules for ciTBI (death from traumatic brain injury, neurosurgery, intubation >24 h, or hospital admission >or=2 nights). FINDINGS: We enrolled and analysed 42 412 children (derivation and validation populations: 8502 and 2216 younger than 2 years, and 25 283 and 6411 aged 2 years and older). We obtained CT scans on 14 969 (35.3%); ciTBIs occurred in 376 (0.9%), and 60 (0.1%) underwent neurosurgery. In the validation population, the prediction rule for children younger than 2 years (normal mental status, no scalp haematoma except frontal, no loss of consciousness or loss of consciousness for less than 5 s, non-severe injury mechanism, no palpable skull fracture, and acting normally according to the parents) had a negative predictive value for ciTBI of 1176/1176 (100.0%, 95% CI 99.7-100 0) and sensitivity of 25/25 (100%, 86.3-100.0). 167 (24.1%) of 694 CT-imaged patients younger than 2 years were in this low-risk group. The prediction rule for children aged 2 years and older (normal mental status, no loss of consciousness, no vomiting, non-severe injury mechanism, no signs of basilar skull fracture, and no severe headache) had a negative predictive value of 3798/3800 (99.95%, 99.81-99.99) and sensitivity of 61/63 (96.8%, 89.0-99.6). 446 (20.1%) of 2223 CT-imaged patients aged 2 years and older were in this low-risk group. Neither rule missed neurosurgery in validation populations. INTERPRETATION: These validated prediction rules identified children at very low risk of ciTBIs for whom CT can routinely be obviated. FUNDING: The Emergency Medical Services for Children Programme of the Maternal and Child Health Bureau, and the Maternal and Child Health Bureau Research Programme, Health Resources and Services Administration, US Department of Health and Human Services.

High turnover stays for pediatric asthma in the United States: analysis of the 2006 Kids' Inpatient Database.

BACKGROUND: Pediatric observation units provide an alternative to traditional hospitalization. The extent to which observation units could replace inpatient care for asthmatic children is unknown. OBJECTIVE: To describe brief inpatient ("high-turnover," HTO) stays for US children hospitalized with a principal discharge diagnosis of asthma, to characterize cases that may be appropriate for observation. DESIGN: We analyzed the 2006 Kids' Inpatient Database, a nationally representative sample of hospital discharges. HTO stays were defined as hospitalizations of 0 or 1 night in duration. We conducted descriptive statistics and case-mix adjusted, sample-weighted regression analysis of HTO stays, and associated hospital charges. SUBJECTS: Discharges among children aged 2 to 20 years with a principal discharge diagnosis of asthma. MEASURES: HTO stays and total charges. RESULTS: Overall, 34,592 (34%) pediatric asthma hospitalizations were HTO, accounting for 66,278 hospital days in 2006. HTO stays were associated with younger age, uncomplicated asthma, and private insurance. Freestanding children's hospitals had the highest proportion of HTO stays, 38% (95% CI: 34%-42%) compared with 32% (95% CI: 28%-36%) for children's units and 33% (95% CI: 31%-34%) for general hospitals. In multivariate regression analyses, charges were significantly higher across hospital types when HTO stays begin in the emergency department. CONCLUSIONS: The presence of a large number of HTO stays for children hospitalized for asthma suggests the need to explore opportunities to restructure care for this condition, perhaps through the development of physically or operationally distinct observation units.