PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.

BACKGROUND/AIMS: Despite evidence that preferential use of balanced/buffered fluids may improve outcomes compared with chloride-rich 0.9% saline, saline remains the most commonly used fluid for children with septic shock. We aim to determine if resuscitation with balanced/buffered fluids as part of usual care will improve outcomes, in part through reduced kidney injury and without an increase in adverse effects, compared to 0.9% saline for children with septic shock. METHODS: The Pragmatic Pediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) study is an international, open-label pragmatic interventional trial being conducted at > 40 sites in the USA, Canada, and Australia/New Zealand starting on August 25, 2020, and continuing for 5 years. Children > 6 months to < 18 years treated for suspected septic shock with abnormal perfusion in an emergency department will be randomized to receive either balanced/buffered crystalloids (intervention) or 0.9% saline (control) for initial resuscitation and maintenance fluids for up to 48 h. Eligible patients are enrolled and randomized using serially numbered, opaque envelopes concurrent with clinical care. Given the life-threatening nature of septic shock and narrow therapeutic window to start fluid resuscitation, patients may be enrolled under "exception from informed consent" in the USA or "deferred consent" in Canada and Australia/New Zealand. Other than fluid type, all decisions about timing, volume, and rate of fluid administration remain at the discretion of the treating clinicians. For pragmatic reasons, clinicians will not be blinded to study fluid type. Anticipated enrollment is 8800 patients. The primary outcome will be major adverse kidney events within 30 days (MAKE30), a composite of death, renal replacement therapy, and persistent kidney dysfunction. Additional effectiveness, safety, and biologic outcomes will also be analyzed. DISCUSSION: PRoMPT BOLUS will provide high-quality evidence for the comparative effectiveness of buffered/balanced crystalloids versus 0.9% saline for the initial fluid management of children with suspected septic shock in emergency settings. TRIAL REGISTRATION: PRoMPT BOLUS was first registered at ClinicalTrials.gov ( NCT04102371 ) on September 25, 2019. Enrollment started on August 25, 2020.

Trends in Emergent Head Computed Tomography Utilization for Minor Head Trauma After Implementation of a Clinical Pathway.

OBJECTIVE: The aims of this study were to evaluate trends over time in computed tomography (CT) scan utilization after implementation of a clinical pathway in a tertiary care children's hospital emergency department (ED), to determine how ED throughput differs by CT utilization, and to determine provider reasoning for obtaining head CT in low-risk patients. METHODS: This was a retrospective cohort study of patients 21 years or younger discharged from our ED with head trauma (Glasgow Coma Scale score ≥13 and a head trauma International Classification of Diseases code) over a 5-year period, starting 1 year after pathway implementation (January 2012 to December 2016). A manual chart review of 10% of patients who received a CT was performed to determine reasoning for CT utilization and guideline compliance. RESULTS: In total, 6.3% (95% confidence interval [CI], 5.9%-6.6%) of 21,129 discharged patients received a head CT, decreasing annually by an average of 0.9%. Pediatricians were more likely to obtain a CT than pediatric emergency medicine physicians after adjusting for acuity (odds ratio, 1.37; 95% CI, 1.02-1.82). Those who received a CT stayed 90 minutes longer (95% CI, 79-101 minutes) than those who did not after propensity score matching. Thirty percent of patients who received a CT in our manual chart review met low-risk Pediatric Emergency Care Applied Research Network criteria. CONCLUSIONS: Head CT rates in patients with minor head trauma consistently decreased each year after guideline implementation. Children who received head CT did not have prolonged lengths of stay compared with those who did not. A minority of patients who received a CT and were discharged met low-risk criteria by standardized guidelines.

Effects, uptake, and translocation of aluminum oxide nanoparticles in lettuce: A comparison study to phytotoxic aluminum ions.

The widespread use of aluminum oxide nanoparticles (Al2O3 NPs) unavoidably causes the release of NPs into the environment, potentially having unforeseen consequences for biological processes. Due to the well-known issue of Al phytoxicity, plant interactions with Al2O3 NPs are cause for concern, but these interactions remain poorly understood. This study investigated the effects of Al2O3 NPs on lettuce (Lactuca sativa L.) to elucidate the similarities and differences in plant growth responses when compared to those of Al ions. Seed germination, root length, biomass production, and uptake of Al and nutrients were measured from hydroponically-grown lettuce with varying concentrations of Al2O3 NPs (0, 0.4, 1, and 2 mg/mL) or AlCl3 (0, 0.04, 0.4, and 1 mg/mL). The Al2O3 NPs treatments had a positive influence on root elongation, whereas AlCl3 significantly reduced emerging root lengths. While 0.4 mg/mL Al2O3 NPs promoted biomass, 1 and 2 mg/mL showed a 10.4% and 17.9% decrease in biomass, respectively, when compared to the control. Similarly, 0.4 and 1 mg/mL AlCl3 reduced biomass to 22.3% and 9.96%, respectively. Both treatments increased Al uptake by roots linearly; however, translocation of Al2O3 NPs into shoots was limited, whereas translocation of AlCl3 increased with increasing treatment concentration. Further, Al2O3 NPs adsorbed on the roots serve as adsorbents for macronutrients, promoting their absorption and uptake in plants, but not micronutrients. Calcium uptake was the most inhibited by AlCl3. A new in vivo imaging technique, with elemental analysis, confirmed that Al2O3 NPs were assimilated as particles, not ions, suggesting that the observed phytotoxicity is not due to Al ions being released from the NPs. Thus, it is concluded that Al2O3 NPs pose less phytoxicity than AlCl3, primarily due to NPs role on stimulated root growth, significant adsorption/aggregation on roots, limited lateral translocation to shoots, and increased uptake of macronutrients.

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.

Sensitivity and Specificity of Empiric Treatment for Sexually Transmitted Infections in a Pediatric Emergency Department.

OBJECTIVE: To determine test characteristics of provider judgment for empiric antibiotic provision to patients undergoing testing for a sexually transmitted infection. STUDY DESIGN: We conducted a retrospective cross-sectional electronic health record review of all patients aged 13-19 years who had Neisseria gonorrhoeae (GC) and Chlamydia trachomatis (CT) testing sent from an urban, academic pediatric emergency department in 2012. We abstracted data, including patient demographics, chief complaint, sexually transmitted infection test results, and treatment. We calculated test characteristics comparing clinician judgment for presumptive treatment for a sexually transmitted infection with the reference standard of the actual results of testing for a sexually transmitted infection. RESULTS: Of 1223 patient visits meeting inclusion criteria, 284 (23.2%) had a positive GC and/or CT test result. Empiric treatment was provided in 615 encounters (50.3%). Provider judgment for presumptive treatment had an overall sensitivity of 67.6% (95% CI, 61.8-73.0) and a specificity of 55% (95% CI, 51.7-58.2) for accurate GC and/or CT detection. CONCLUSIONS: Many adolescents tested for GC and CT receive empiric treatment at the initial emergency department visit. Provider judgment may lack sufficient sensitivity and specificity for identifying infected patients, resulting in the potential for undertreatment of true disease, overtreatment of uninfected patients, or both.

Development of a Sexual Health Screening Tool for Adolescent Emergency Department Patients.

OBJECTIVE: The objective was to develop a content-valid audio computer-assisted self-interview (ACASI) sexual health survey (SHS) that is understandable and acceptable to adolescents and can be feasibly implemented in a pediatric emergency department (ED) for sexually transmitted infection (STI) risk assessment. METHODS: Multistep iterative qualitative study utilizing a Delphi panel of key informants for survey development and content validity, cognitive interviews with end-users to evaluate understanding, and pilot testing with end-users to evaluate acceptability and feasibility. RESULTS: We developed a 20-item questionnaire through an iterative modified Delphi process with experts in adolescent and pediatric emergency medicine. All items were assessed as understandable by >90% of adolescents during the cognitive interviews. All respondents found the SHS easy to use. A total of 76.5% preferred answering questions related to sexual health through the SHS compared to face-to-face interviews. Mean (±SD) length of survey completion was 17.5 (±6.7) minutes and 88.6% of participants found survey length to be "just right." With respect to feasibility testing, there was no statistically significant difference in median ED LOS between those who piloted the SHS and those who did not (230.0 minutes vs. 219.0 minutes; p = 0.7). CONCLUSIONS: We developed a content-valid ACASI for the identification of adolescents at risk for STIs that was understandable, acceptable, and easy to use by adolescent patients and feasible for implementation in the pediatric ED. Future planned steps include the evaluation of the SHS in providing clinical decision support for targeted STI screening in the ED.

Practice Pattern Variation in the Care of Children With Acute Asthma.

OBJECTIVES: Pediatric asthma is a highly prevalent disease, affecting over 7 million U.S. children and accounting for 750,000 annual emergency department (ED) visits. Guidelines from the National Asthma Education and Prevention Program recommend limited use of chest radiography (CXR), complete blood counts (CBCs), and antibiotics when managing acute exacerbations of asthma. However, studies suggest frequent overutilization of these resources. The objective was to evaluate differences between pediatric and general EDs in rates of CXRs, CBCs, and use of antibiotics for pediatric asthma exacerbations. METHODS: This was a repeated cross-sectional analysis of data from the National Hospital Ambulatory Medical Care Survey from 2000 through 2010 of CXR, CBCs, and antibiotics during ED visits for pediatric acute asthma exacerbations. Multivariable logistic regression was performed to identify differences in asthma management by ED type (pediatric vs. general) after adjusting for demographic covariates. RESULTS: There were 3,313 observations, representing an estimated 10.9 million (95% confidence interval [CI] = 9.7 to 12.1 million) ED visits for acute asthma without bacterial coinfection. Of these, 17.4% occurred in pediatric EDs. Multivariable logistic regression revealed that visits to pediatric EDs were less likely to include CXRs (adjusted odds ratio [AOR] = 0.39; 95% CI = 0.25 to 0.60), CBCs (AOR = 0.42; 95% CI = 0.22 to 0.80), and antibiotics (AOR = 0.50; 95% CI = 0.31 to 0.82) after adjustment for race/ethnicity, triage level, academic ED, metropolitan statistical area, and geographic region. CONCLUSIONS: There are substantial differences in diagnostic testing and antibiotic usage for management of acute exacerbations of asthma by ED type, suggesting potential resource overuse in general EDs. Future studies should focus on evaluating the effect of quality improvement efforts for ED asthma management.

Accuracy of diagnosis codes to identify febrile young infants using administrative data.

BACKGROUND: Administrative data can be used to determine optimal management of febrile infants and aid clinical practice guideline development. OBJECTIVE: Determine the most accurate International Classification of Diseases, Ninth Revision (ICD-9) diagnosis coding strategies for identification of febrile infants. DESIGN: Retrospective cross-sectional study. SETTING: Eight emergency departments in the Pediatric Health Information System. PATIENTS: Infants aged <90 days evaluated between July 1, 2012 and June 30, 2013 were randomly selected for medical record review from 1 of 4 ICD-9 diagnosis code groups: (1) discharge diagnosis of fever, (2) admission diagnosis of fever without discharge diagnosis of fever, (3) discharge diagnosis of serious infection without diagnosis of fever, and (4) no diagnosis of fever or serious infection. EXPOSURE: The ICD-9 diagnosis code groups were compared in 4 case-identification algorithms to a reference standard of fever ≥100.4°F documented in the medical record. MEASUREMENTS: Algorithm predictive accuracy was measured using sensitivity, specificity, and negative and positive predictive values. RESULTS: Among 1790 medical records reviewed, 766 (42.8%) infants had fever. Discharge diagnosis of fever demonstrated high specificity (98.2%, 95% confidence interval [CI]: 97.8-98.6) but low sensitivity (53.2%, 95% CI: 50.0-56.4). A case-identification algorithm of admission or discharge diagnosis of fever exhibited higher sensitivity (71.1%, 95% CI: 68.2-74.0), similar specificity (97.7%, 95% CI: 97.3-98.1), and the highest positive predictive value (86.9%, 95% CI: 84.5-89.3). CONCLUSIONS: A case-identification strategy that includes admission or discharge diagnosis of fever should be considered for febrile infant studies using administrative data, though underclassification of patients is a potential limitation.

Clinician adherence to recommendations for screening of adolescents for sexual activity and sexually transmitted infection/human immunodeficiency virus.

OBJECTIVES: To evaluate clinician adherence to guidelines for documentation of sexual history and screening for sexually transmitted infection (STI)/HIV infection during routine adolescent well visits. Secondary objectives were to determine patient and clinician factors associated with sexual history documentation and STI/HIV testing. STUDY DESIGN: Retrospective, cross-sectional study of 1000 randomly selected 13- to 19-year-old routine well visits at all 29 pediatric primary care practices affiliated with a children's hospital. We evaluated frequency of documentation of sexual history and testing for gonorrhea (GC)/chlamydia (CT) and HIV testing. Multivariable logistic regression was performed to identify factors associated with documentation and testing. RESULTS: Of the 1000 patient visits reviewed, 212 (21.2%; 95% CI, 18.7-23.7) had a documented sexual history, of which 45 adolescents' (21.2%; 95% CI, 15.7-26.8) encounters were documented as being sexually active. Overall, 26 (2.6%; 95% CI, 1.6-3.6) patients were tested for GC/CT and 16 (1.6%; 95% CI, 0.8-2.4) were tested for HIV infection. In multivariable analyses, factors associated with sexual history documentation included older patient age, non-Hispanic black race/ethnicity, nonprivate insurance status, and care by female clinician. Factors associated with GC/CT testing included male gender, non-Hispanic black race/ethnicity, and nonprivate insurance. HIV testing was more likely to be performed on older adolescents, those of non-Hispanic black race/ethnicity, and those with nonprivate insurance. CONCLUSIONS: Pediatric primary care clinicians infrequently document sexual histories and perform STI and HIV testing on adolescent patients. Future studies should investigate provider beliefs, clinical decision-making principles, and perceived barriers to improve the sexual health care of adolescents and evaluate interventions to increase rates of adolescent sexual health screening.

Developing emergency department-based education about emergency contraception: adolescent preferences.

OBJECTIVES: The objective was to identify adolescent preferences for emergency department (ED)-based education about emergency contraception. METHODS: This was a cross-sectional computerized survey, using adaptive conjoint analysis (ACA). Patients were eligible if they were females ages 14 through 19 years old and were seeking care in one of two urban EDs. Patients were excluded if they were too ill to participate in the survey or if they were non-English speaking. Participants completed a computerized survey that used ACA, a technique that can be used to assess patients' relative preferences for services. ACA uses the individual's answers to update and refine questions through trade-off comparisons, so that each respondent answers a customized set of questions. The survey assessed preferences for the following attributes of emergency contraception education: who should deliver the education, if anyone (e.g., nurse, doctor); how the education should be delivered (e.g., by a person or via video); how often the education should be offered if patients were to frequent the ED (e.g., every time or only when asking for it); length (e.g., 5 minutes, 10 minutes); and chief complaint that would trigger the education (e.g., headache or stomach pain). RESULTS: A total of 223 patients were enrolled (37.2% at Hospital 1 and 62.8% at Hospital 2). The mean (±SD) age of the participants was 16.1 (±1.3) years. Just over half (55%) reported a history of sexual activity; 8% reported a history of pregnancy. Overall, the participants preferred education that was delivered by a person, specifically a doctor or nurse. They preferred a slightly longer education session and preferred education directed at patients seeking care in the ED for complaints potentially related to sexual activity. CONCLUSIONS: Adolescents have specific preferences for how education about emergency contraception would best serve their needs. This information can inform clinicians as they work to improve adolescents' knowledge about pregnancy prevention and emergency contraception in particular.

Enhancing the emergency department approach to pediatric sexual assault care: implementation of a pediatric sexual assault response team program.

OBJECTIVES: The objectives of this study were to describe the experience of a novel pediatric sexual assault response team (SART) program in the first 3 years of implementation and compare patient characteristics, evaluation, and treatment among subpopulations of patients. METHODS: This was a retrospective chart review of a consecutive sample of patients evaluated at a pediatric emergency department (ED) who met institutional criteria for a SART evaluation. Associations of evaluation and treatment with sex, menarchal status, and presence of injuries were measured using logistic regression. RESULTS: One hundred eighty-four patients met criteria for SART evaluation, of whom 87.5% were female; mean age was 10.1 (SD, 4.6) years. The majority of patients underwent forensic evidence collection (89.1%), which varied by menarchal status among girls (P < 0.01), but not by sex. Evidence of acute anogenital injury on physical examination was found in 20.6% of patients. As per the Centers for Disease Control and Prevention guidelines for acute sexual assault evaluations in pediatric patients, menarchal girls were more likely to undergo testing for sexually transmitted infections and pregnancy (P < 0.01) and to be offered pregnancy, sexually transmitted infection, and HIV prophylaxis (P < 0.01). CONCLUSIONS: In an effort to improve quality and consistency of acute sexual assault examinations in a pediatric ED, development of a SART program supported the majority of eligible patients undergoing forensic evidence collection. Furthermore, a substantial number of patients had evidence of injury on examination. These findings underscore the importance of having properly trained personnel to support ED care for pediatric victims of acute sexual assault.

Knowledge, attitudes, and beliefs about emergency contraception: a survey of female adolescents seeking care in the emergency department.

OBJECTIVES: This study aimed to assess urban adolescents' knowledge of and attitudes about emergency contraception (EC) and to assess the intention to use EC in particular hypothetical situations. We hypothesized that knowledge about EC would be limited, but that adolescents would support using EC in certain situations. METHODS: A cross-sectional survey of English-speaking, 14- to 19-year-old adolescent girls presenting for care at 2 urban pediatric emergency departments. The survey was based on previous research with this target population and the constructs of the theory of planned behavior. RESULTS: We enrolled 223 adolescents; 56% reported a history of sexual activity. Sixty-four percent stated that they had heard of EC. Participants with a history of sexual activity were more likely to have heard of EC compared with those without (odds ratio, 2.6; 95% confidence interval, 1.4-4.7), as were those 17 years and older (odds ratio, 2.3; 95% confidence interval, 1.2-4.3). The majority of participants were concerned about potential short-term and long-term adverse effects (86% and 78%, respectively); many participants were concerned about the cost of EC (45%) and about being able to get to a doctor for a prescription (45%). Participants supported using EC in the following situations: rape (88%), the condom breaks (82%), or no birth control was used (76%). Fewer supported using EC in the following situations: missed 1 oral contraceptive pill (51%) or first sexual experience (57%). CONCLUSIONS: Participants indicated that although they would support EC use in several situations, they have concerns about EC use and access. Awareness of these factors and potential influences of EC use can guide providers toward effective counseling and interventions aimed to increase adolescents' use of EC in appropriate settings.

Racial disparities in testing for sexually transmitted infections in the emergency department.

OBJECTIVES: The objective of this study was to determine predictors of sexually transmitted infection (STI) testing among adolescent females presenting to an urban pediatric emergency department (ED) with symptoms potentially suggestive of an STI. METHODS: This was a secondary analysis of data collected in a prospective prevalence study of STIs among a consecutive sample of symptomatic females aged 14 to 19 years presenting to a pediatric ED with lower abdominal or genitourinary complaints. The outcome of interest was performance of an STI test. Correlates of interest included patient age, race, insurance status, chief complaint, presence of comorbid conditions, and treating physician sex. RESULTS: Of the 328 adolescent females who presented to the ED with STI-related complaints and met inclusion criteria, 15.6% did not undergo STI testing. Univariable analysis revealed that black or African American race (odds ratio [OR] = 4.98, 95% confidence interval [CI] = 2.67 to 9.30) and nonprivate insurance (OR = 3.47; 95% CI = 1.83 to 6.58) were significantly associated with the performance of STI testing. In a multivariable model, only black or African American race (OR = 3.94; 95% CI = 1.96 to 7.91) remained significantly associated with the performance of STI testing. CONCLUSIONS: A substantial number of adolescent females who presented with complaints suggestive of an STI did not undergo STI testing, and a racial disparity in STI testing was noted. The racial disparity in rates of STI testing among symptomatic adolescent girls presenting to the ED warrants further study to confirm validity, to determine if disparity reflects physicians' biases, and to inform strategies for controlling the present epidemic of STIs in adolescents.

Adolescent input for designing an emergency department-based intervention about emergency contraception: results from an in-depth interview study.

OBJECTIVE: To explore the attitudes of urban, minority adolescent girls about an emergency department (ED)-based intervention to address emergency contraceptive pill (ECP) use. METHODS: We conducted an in-depth, semistructured interview study of healthy, 15- to 19-year-old African-American girls seeking care in a children's hospital ED. Purposive sampling was used to recruit sexually and nonsexually active adolescents and those with or without a history of pregnancy. We collected demographic data and opinions about an ED-based intervention addressing ECP use. A modified grounded theory approach was used for analysis. RESULTS: Thirty interviews were completed. Mean participant age was 16.4 years; 53% reported sexual activity; and 17% reported a history of pregnancy. Most participants expressed that an intervention focused on ECP would be useful in the ED setting, but this varied depending upon the type of ED visit. For example, although most believed that patients with symptoms related to sexual activity should be offered an ECP intervention, fewer stated that this type of intervention would be appropriate for patients presenting with headache or an injury. Participants stated that the information could be delivered by a health care professional or a peer counselor, although no particular delivery modality was clearly favored. CONCLUSIONS: Urban, minority adolescent girls are generally supportive of learning about ECP during an ED visit. Preferences about the appropriateness of the intervention related to the type of patient complaint. Because multiple sources and delivery modalities were acceptable, future studies should determine whether tailoring the source and delivery modality to demographic characteristics enhances the uptake of the message.

Assessing attitudes about emergency contraception among urban, minority adolescent girls: an in-depth interview study.

OBJECTIVE: The purpose of this work was to explore the knowledge, attitudes, and beliefs of urban, minority adolescent girls about intention to use emergency contraception pills and to identify barriers to emergency contraception pill use. PATIENTS AND METHODS: We conducted an in-depth, semistructured interview study of healthy, urban-dwelling, English-speaking 15- to 19-year-old black adolescents seeking care in a children's hospital emergency department. Purposive sampling was used to recruit sexually active and nonsexually active adolescents and those with and without a history of pregnancy. Enrollment continued until saturation of key themes was achieved. Participants returned after their emergency department visit for a 1-hour interview. The interview consisted of semistructured questions based on the theory of planned behavior constructs: attitudes (including knowledge), subjective norms, and perceived behavioral control, as well as demographic data collection. Interviews were recorded and transcribed. Transcripts were coded by 2 members of the study team by using a modified grounded-theory method. RESULTS: Thirty interviews were required for saturation. Mean participant age was 16.4 years; 53% reported being sexually active, and 17% reported a history of pregnancy. Specific knowledge gaps exist about emergency contraception pills, including misconceptions about the recommended time frame for taking the medication. Several major themes were noted for each of the constructs. Intention to use emergency contraception pills is affected by the conflicting attitudes that the emergency contraception pill works faster than birth control pills and that those who use emergency contraception pills are irresponsible; family and friends are important influences and have uninformed but generally supportive opinions; and adolescents have a perception of limited behavioral control because of their young age and concerns about confidentiality. CONCLUSIONS: Urban, minority adolescent girls have misconceptions about emergency contraception pills, are affected by the opinions of those close to them, and express concern about specific barriers. These findings can inform specific interventions aimed at addressing the barriers to emergency contraception pill use that are of most importance to this population of young women.