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 .).

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.

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.

A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis.

BACKGROUND: Compare the efficacy and safety of Plasma-Lyte A (PLA) versus 0.9 % sodium chloride (NaCl) intravenous (IV) fluid replacement in children with moderate to severe dehydration secondary to acute gastroenteritis (AGE). METHODS: Prospective, randomized, double-blind study conducted at eight pediatric emergency departments (EDs) in the US and Canada (NCT#01234883). The primary outcome measure was serum bicarbonate level at 4 h. Secondary outcomes included safety and tolerability. The hypothesis was that PLA would be superior to 0.9 % NaCl in improvement of 4-h bicarbonate. Patients (n = 100) aged ≥6 months to <11 years with AGE-induced moderate-to-severe dehydration were enrolled. Patients with a baseline bicarbonate level ≤22 mEq/L formed the modified intent to treat (mITT) group. RESULTS: At baseline, the treatment groups were comparable except that the PLA group was older. At hour 4, the PLA group had greater increases in serum bicarbonate from baseline than did the 0.9 % NaCl group (mean ± SD at 4 h: 18 ± 3.74 vs 18.0 ± 3.67; change from baseline of 1.6 and 0.0, respectively; P = .004). Both treatment groups received similar fluid volumes. The PLA group had less abdominal pain and better dehydration scores at hour 2 (both P = .03) but not at hour 4 (P = 0.15 and 0.08, respectively). No patient experienced clinically relevant worsening of laboratory findings or physical examination, and hospital admission rates were similar. One patient in each treatment group developed hyponatremia. Four patients developed hyperkalemia (PLA:1, 0.9 % NaCl:3). CONCLUSION: In comparison with 0.9 % NaCl, PLA for rehydration in children with AGE was well tolerated and led to more rapid improvement in serum bicarbonate and dehydration score. TRIAL REGISTRATION: NCT#01234883 (Registration Date: November 3, 2010).

Acute Disseminated Encephalomyelitis.

Acute disseminated encephalomyelitis is a primarily pediatric, immune-mediated disease characterized by demyelination and polyfocal neurologic symptoms that typically occur after a preceding viral infection or recent immunization. This article presents the pathophysiology, diagnostic criteria, and magnetic resonance imaging characteristics of acute disseminated encephalomyelitis. We also present evaluation and management strategies.

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.

Validation of the modified Vesikari score in children with gastroenteritis in 5 US emergency departments.

OBJECTIVES: The burden of acute gastroenteritis (AGE) in US children is substantial. Research into outpatient treatment strategies has been hampered by the lack of easily used and validated gastroenteritis severity scales relevant to the populations studied. We sought to evaluate, in a US cohort, the reliability, construct validity, and generalizability of a gastroenteritis severity scale previously derived in a Canadian population, the modified Vesikari score (MVS). METHODS: We conducted a prospective, cohort, clinical observational study of children 3 to 48 months of age with acute gastroenteritis presenting to 5 US emergency departments. A baseline MVS score was determined in the emergency department, and telephone follow-up 14 days after presentation was used to assign the follow-up MVS. We determined reliability using inter-item correlations; construct validity via principal component factor analysis; cross-sectional construct validity via correlations with the presence of dehydration, hospitalization, and day care and parental work absenteeism; and generalizability via score distribution among sites. RESULTS: Two hundred eighteen of 274 patients (80%) were successfully contacted for follow-up. Cronbach α was 0.63, indicating expectedly low internal reliability because of the multidimensional properties of the MVS. Factor analysis supported the appropriateness of retaining all variables in the score. Disease severity correlated with dehydration (P < 0.001), hospitalization (P < 0.001), and subsequent day care (P = 0.01) and work (P < 0.001) absenteeism. The MVS was normally distributed, and scores did not differ among sites. CONCLUSIONS: The MVS effectively measures global severity of disease and performs similarly in varying populations within the US health care system. Its characteristics support its use in multisite outpatient clinical trials.

New biomedical devices that use near-infrared technology to assist with phlebotomy and vascular access.

Obtaining intravenous access in children is often challenging. Devices using the novel technology of near-infrared imaging have been developed and marketed to facilitate intravenous catheter placement and phlebotomy. We review the technology of near-infrared imaging and the evidence for its use in the pediatric emergency population.

Lachnospiraceae and Bacteroidales alternative fecal indicators reveal chronic human sewage contamination in an urban harbor.

The complexity of fecal microbial communities and overlap among human and other animal sources have made it difficult to identify source-specific fecal indicator bacteria. However, the advent of next-generation sequencing technologies now provides increased sequencing power to resolve microbial community composition within and among environments. These data can be mined for information on source-specific phylotypes and/or assemblages of phylotypes (i.e., microbial signatures). We report the development of a new genetic marker for human fecal contamination identified through microbial pyrotag sequence analysis of the V6 region of the 16S rRNA gene. Sequence analysis of 37 sewage samples and comparison with database sequences revealed a human-associated phylotype within the Lachnospiraceae family, which was closely related to the genus Blautia. This phylotype, termed Lachno2, was on average the second most abundant fecal bacterial phylotype in sewage influent samples from Milwaukee, WI. We developed a quantitative PCR (qPCR) assay for Lachno2 and used it along with the qPCR-based assays for human Bacteroidales (based on the HF183 genetic marker), total Bacteroidales spp., and enterococci and the conventional Escherichia coli and enterococci plate count assays to examine the prevalence of fecal and human fecal pollution in Milwaukee's harbor. Both the conventional fecal indicators and the human-associated indicators revealed chronic fecal pollution in the harbor, with significant increases following heavy rain events and combined sewer overflows. The two human-associated genetic marker abundances were tightly correlated in the harbor, a strong indication they target the same source (i.e., human sewage). Human adenoviruses were routinely detected under all conditions in the harbor, and the probability of their occurrence increased by 154% for every 10-fold increase in the human indicator concentration. Both Lachno2 and human Bacteroidales increased specificity to detect sewage compared to general indicators, and the relationship to a human pathogen group suggests that the use of these alternative indicators will improve assessments for human health risks in urban waters.

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.

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.

Validation of two child passenger safety questionnaires.

OBJECTIVE: To measure the validity of a booster seat questionnaire and a car seat questionnaire so that they can be reliably used in future trials. DESIGN: The two child passenger safety questionnaires were created. Each underwent expert review to ensure face and content validity. Two reliability studies were conducted independently of each other. Care givers for children who were cared for in a paediatric emergency department were enrolled. Criterion validity was tested by direct observation, and inter-rater reliability was measured. Test-retest reliability and internal consistency were also measured on the booster seat questionnaire. RESULTS: Booster seat questionnaire: test-retest agreement was good, with 16 of the 18 questions having agreement of at least 80%. Agreement was acceptable (>70%) in all other questions in which agreement was expected when the answers of two different care givers were compared. All care givers were able to report booster seat use as it was found on direct observation, yielding a κ value of 1. Car seat questionnaire: the respondents showed 95% agreement between their reported type of child safety restraint and what was found on direct observation. Inter-rater agreement for the type of safety restraint was 77% or a κ value of 0.7. CONCLUSION: Both the booster seat questionnaire and the car seat questionnaire are valid and can be reliably used in future studies. The findings of this study need to be verified with larger studies and different populations.

Current therapies in bronchiolitis.

Viral bronchiolitis is the most common cause of hospitalization among infants. Despite its prevalence, no consistently effective therapy has been found to date, providing the driving force behind much of the ongoing research into this illness. In this review, we present a summary of the most recent published trials of interventions for bronchiolitis. Included are studies evaluating bronchodilators, corticosteroids, positive pressure ventilation, as well as 3 newer therapies for bronchiolitis: heliox, mucolytics, and leukotriene receptor antagonists.

Time motion study in a pediatric emergency department before and after computer physician order entry.

STUDY OBJECTIVE: To determine the effect of computer physician order entry on pediatric emergency department (ED) care providers allocation of time. We seek to determine whether the increase in time by ED care providers on the computer will decrease time spent with patients. METHODS: This was a before-and-after observational time-and-motion study conducted at an urban pediatric ED. Observers recorded how caregivers allocated their time during 180-minute observation periods at 30-second increments the summers before after computer physician order entry introduction. Time on the computer was recorded in seconds. Observations were placed into 3 categories (direct patient care, indirect patient care, other), each with its own subcategories. RESULTS: For attending physicians, median computer time increased from 5.0 minutes before computer physician order entry to 9.5 minutes after computer physician order entry (P=.01). For resident physicians, median computer time increased from 5.5 minutes before computer physician order entry to 14.3 minutes after computer physician order entry (P=.001). For nurses, time on the computer was not significantly different before and after computer physician order entry (P=.15), although it appears there was still some change in time allocation. After computer physician order entry, nurses' talking with staff about patient care decreased from 24.5 minutes to 13.3 minutes (P=.01). Computer physician order entry did not decrease time with patients for any of the caregiver types. CONCLUSION: The addition of computer physician order entry to a pediatric ED increases time spent on the computer by both attending and resident physicians but not for emergency nurses. This additional time on the computer is allocated from nonpatient care activities. The addition of computer physician order entry decreases nurses' time talking with other staff for patient care.

A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain.

STUDY OBJECTIVE: We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component). METHODS: This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed. RESULTS: Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures. CONCLUSION: Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.

Health-related quality of life for pediatric emergency department febrile illnesses: an evaluation of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales.

OBJECTIVE: We sought to assess the validity and short-term responsiveness of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL) for febrile illnesses evaluated in the pediatric emergency department (ED). DESIGN: Prospective cohort study of children 2-18 years discharged after ED evaluation for fever (>or= 38 degrees C). Self-administered, parent-report of health-related quality of life (HRQOL) was assessed using the PedsQL Acute Version, a validated HRQOL instrument. HRQOL was measured on ED presentation and at 7-10 day follow-up. At follow-up, duration of fever, child functional impairment, missed daycare/school, and disrupted family unit functioning, were assessed. RESULTS: Of 160 subjects enrolled, 97 (61%) completed the study; mean follow-up was 8.7 days. Mean total HRQOL score on ED presentation was 76.4; mean follow-up score was 86.3. Compared to subjects that returned to baseline, statistically significant differences in HRQOL were noted for those with prolonged fever, child functional impairment, and relapse. Significant correlation was observed between HRQOL at follow-up and days of daycare/school missed (r = -0.35, p = .003) and days of family disruption (r = -0.43, p < .001). Mean change in HRQOL within subjects, from ED visit to follow-up, was +9.8 (95% CI: 5.6-14.6). Effect size was 0.53, indicating moderate responsiveness. CONCLUSION: The PedsQL appears to be a valid and responsive indicator of HRQOL for short-term febrile illnesses evaluated in the ED.

Interobserver agreement in assessment of clinical variables in children with blunt head trauma.

OBJECTIVES: To be useful in development of clinical decision rules, clinical variables must demonstrate acceptable agreement when assessed by different observers. The objective was to determine the interobserver agreement in the assessment of historical and physical examination findings of children undergoing emergency department (ED) evaluation for blunt head trauma. METHODS: This was a prospective cohort study of children younger than 18 years evaluated for blunt head trauma at one of 25 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). Patients were excluded if injury occurred more than 24 hours prior to evaluation, if neuroimaging was obtained at another hospital prior to evaluation, or if the patient had a clinically trivial mechanism of injury. Two clinicians independently completed a standardized clinical assessment on a templated data form. Assessments were performed within 60 minutes of each other and prior to clinician review of any neuroimaging (if obtained). Agreement between the two observers beyond that expected by chance was calculated for each clinical variable, using the kappa (kappa) statistic for categorical variables and weighted kappa for ordinal variables. Variables with a lower 95% confidence limit (LCL) of kappa > 0.4 were considered to have acceptable agreement, RESULTS: Fifteen-hundred pairs of observations were obtained. Acceptable agreement was achieved in 27 of the 32 variables studied (84%). Mechanism of injury (low, medium, or high risk) had kappa = 0.83. For subjective symptoms, kappa ranged from 0.47 (dizziness) to 0.93 (frequency of vomiting); all had 95% LCL > 0.4. Of the physical examination findings, kappa ranged from 0.22 (agitated) to 0.89 (Glasgow Coma Scale [GCS] score). The 95% LCL for kappa was < 0.4 for four individual signs of altered mental status and for quality (i.e., boggy or firm) of scalp hematoma if present. CONCLUSIONS: Both subjective and objective clinical variables in children with blunt head trauma can be assessed by different observers with acceptable agreement, making these variables suitable candidates for clinical decision rules.

Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access.

OBJECTIVE: To develop a clinical prediction rule that would be easy to apply and be useful for predicting success or failure of peripheral intravenous line insertion in children. METHODS: This was a prospective cohort study of children aged 0 to 21 years undergoing peripheral intravenous placement by staff nurses in a pediatric emergency department. Information on candidate predictor variables was obtained before attempting intravenous placement, and the outcome was successful on first attempt. Backward stepwise logistic regression was used to identify factors independently predictive of success. Those factors remaining in the model were used in a set of linear scores. Receiver operating characteristic curves were constructed for each model, and the areas under the curve were calculated. RESULTS: Six hundred fifteen subjects were enrolled. Success rate for intravenous insertion on first attempt was 75%. A 4-variable proportionally weighted rule (known as the difficult intravenous access [DIVA] score) was created (3 points for prematurity, 3 for younger than 1 year, 1 for 1-2 years of age, 2 for vein not palpable, and 2 for vein not visible). The area under the receiver operating characteristic curve was 0.67. Subjects with a DIVA score of 4 or more were more than 50% likely to have failed intravenous placement on first attempt. CONCLUSIONS: A clinical prediction rule that is easy to apply and is useful for predicting success or failure of peripheral intravenous insertion has been created. If externally validated, this DIVA score can be used to predict which children will have difficult intravenous access.

The Pediatric Emergency Care Applied Research Network Registry: A Multicenter Electronic Health Record Registry of Pediatric Emergency Care.

BACKGROUND: Electronic health record (EHR)-based registries allow for robust data to be derived directly from the patient clinical record and can provide important information about processes of care delivery and patient health outcomes. METHODS: A data dictionary, and subsequent data model, were developed describing EHR data sources to include all processes of care within the emergency department (ED). ED visit data were deidentified and XML files were created and submitted to a central data coordinating center for inclusion in the registry. Automated data quality control occurred prior to submission through an application created for this project. Data quality reports were created for manual data quality review. RESULTS: The Pediatric Emergency Care Applied Research Network (PECARN) Registry, representing four hospital systems and seven EDs, demonstrates that ED data from disparate health systems and EHR vendors can be harmonized for use in a single registry with a common data model. The current PECARN Registry represents data from 2,019,461 pediatric ED visits, 894,503 distinct patients, more than 12.5 million narrative reports, and 12,469,754 laboratory tests and continues to accrue data monthly. CONCLUSION: The Registry is a robust harmonized clinical registry that includes data from diverse patients, sites, and EHR vendors derived via data extraction, deidentification, and secure submission to a central data coordinating center. The data provided may be used for benchmarking, clinical quality improvement, and comparative effectiveness research.

Strategies to improve flow in the pediatric emergency department.

As emergency departments (EDs) experience overcrowding, there is ever-growing pressure to improve patient flow. We present a review of strategies to increase efficiency of patient inflow, throughput, and output in the ED, with an emphasis on approaches that are under greater control of the ED itself and therefore more amenable to implementation without major institutional changes.