Leah Tzimenatos

Informing the design of clinical decision support services for evaluation of children with minor blunt head trauma in the emergency department

Integration of clinical decision support services (CDSS) into electronic health records (EHRs) may be integral to widespread dissemination and use of clinical prediction rules in the emergency department (ED). However, the best way to design such services to maximize their usefulness in such a complex setting is poorly understood. We conducted a multi-site cross-sectional qualitative study whose aim was to describe the sociotechnical environment in the ED to inform the design of a CDSS intervention to implement the Pediatric Emergency Care Applied Research Network (PECARN) clinical prediction rules for children with minor blunt head trauma. Informed by a sociotechnical model consisting of eight dimensions, we conducted focus groups, individual interviews and workflow observations in 11 EDs, of which 5 were located in academic medical centers and 6 were in community hospitals. A total of 126 ED clinicians, information technology specialists, and administrators participated. We clustered data into 19 categories of sociotechnical factors through a process of thematic analysis and subsequently organized the categories into a sociotechnical matrix consisting of three high-level sociotechnical dimensions (workflow and communication, organizational factors, human factors) and three themes (interdisciplinary assessment processes, clinical practices related to prediction rules, EHR as a decision support tool). Design challenges that emerged from the analysis included the need to use structured data fields to support data capture and re-use while maintaining efficient care processes, supporting interdisciplinary communication, and facilitating family-clinician interaction for decision-making.

RNA transcriptional biosignature analysis for identifying febrile infants with serious bacterial infections in the emergency department: a feasibility study.

Objectives To develop the infrastructure and demonstrate the feasibility of conducting microarray-based RNA transcriptional profile analyses for the diagnosis of serious bacterial infections in febrile infants 60 days and younger in a multicenter pediatric emergency research network. Methods We designed a prospective multicenter cohort study with the aim of enrolling more than 4000 febrile infants 60 days and younger. To ensure success of conducting complex genomic studies in emergency department (ED) settings, we established an infrastructure within the Pediatric Emergency Care Applied Research Network, including 21 sites, to evaluate RNA transcriptional profiles in young febrile infants. We developed a comprehensive manual of operations and trained site investigators to obtain and process blood samples for RNA extraction and genomic analyses. We created standard operating procedures for blood sample collection, processing, storage, shipping, and analyses. We planned to prospectively identify, enroll, and collect 1 mL blood samples for genomic analyses from eligible patients to identify logistical issues with study procedures. Finally, we planned to batch blood samples and determined RNA quantity and quality at the central microarray laboratory and organized data analysis with the Pediatric Emergency Care Applied Research Network data coordinating center. Below we report on establishment of the infrastructure and the feasibility success in the first year based on the enrollment of a limited number of patients. Results We successfully established the infrastructure at 21 EDs. Over the first 5 months we enrolled 79% (74 of 94) of eligible febrile infants. We were able to obtain and ship 1 mL of blood from 74% (55 of 74) of enrolled participants, with at least 1 sample per participating ED. The 55 samples were shipped and evaluated at the microarray laboratory, and 95% (52 of 55) of blood samples were of adequate quality and contained sufficient RNA for expression analysis. Conclusions It is possible to create a robust infrastructure to conduct genomic studies in young febrile infants in the context of a multicenter pediatric ED research setting. The sufficient quantity and high quality of RNA obtained suggests that whole blood transcriptional profile analysis for the diagnostic evaluation of young febrile infants can be successfully performed in this setting.

The Pediatric Emergency Care Applied Research Network: a history of multicenter collaboration in the United States.

In this article, we review the history and progress of a large multicenter research network pertaining to emergency medical services for children. We describe the history, organization, infrastructure, and research agenda of the Pediatric Emergency Care Applied Research Network and highlight some of the important accomplishments since its inception. We also describe the networks strategy to grow its research portfolio, train new investigators, and study how to translate new evidence into practice. This strategy ensures not only the sustainability of the network in the future but the growth of research in emergency medical services for children in general.

Use of Traumatic Brain Injury Prediction Rules With Clinical Decision Support

The investigators provide data from a multicenter trial regarding whether implementation of prediction rules safely decreases computed tomography use in children with minor head trauma. OBJECTIVES: We determined whether implementing the Pediatric Emergency Care Applied Research Network (PECARN) traumatic brain injury (TBI) prediction rules and providing risks of clinically important TBIs (ciTBIs) with computerized clinical decision support (CDS) reduces computed tomography (CT) use for children with minor head trauma. METHODS: Nonrandomized trial with concurrent controls at 5 pediatric emergency departments (PEDs) and 8 general EDs (GEDs) between November 2011 and June 2014. Patients were <18 years old with minor blunt head trauma. Intervention sites received CDS with CT recommendations and risks of ciTBI, both for patients at very low risk of ciTBI (no Pediatric Emergency Care Applied Research Network rule factors) and those not at very low risk. The primary outcome was the rate of CT, analyzed by site, controlling for time trend. RESULTS: We analyzed 16 635 intervention and 2394 control patients. Adjusted for time trends, CT rates decreased significantly (P < .05) but modestly (2.3%–3.7%) at 2 of 4 intervention PEDs for children at very low risk. The other 2 PEDs had small (0.8%–1.5%) nonsignificant decreases. CT rates did not decrease consistently at the intervention GEDs, with low baseline CT rates (2.1%–4.0%) in those at very low risk. The control PED had little change in CT use in similar children (from 1.6% to 2.9%); the control GED showed a decrease in the CT rate (from 7.1% to 2.6%). For all children with minor head trauma, intervention sites had small decreases in CT rates (1.7%–6.2%). CONCLUSIONS: The implementation of TBI prediction rules and provision of risks of ciTBIs by using CDS was associated with modest, safe, but variable decreases in CT use. However, some secular trends were also noted.

Development, Evaluation and Implementation of Chief Complaint Groupings to Activate Data Collection: A Multi-Center Study of Clinical Decision Support for Children with Head Trauma

BACKGROUND Overuse of cranial computed tomography scans in children with blunt head trauma unnecessarily exposes them to radiation. The Pediatric Emergency Care Applied Research Network (PECARN) blunt head trauma prediction rules identify children who do not require a computed tomography scan. Electronic health record (EHR) based clinical decision support (CDS) may effectively implement these rules but must only be provided for appropriate patients in order to minimize excessive alerts. OBJECTIVES To develop, implement and evaluate site-specific groupings of chief complaints (CC) that accurately identify children with head trauma, in order to activate data collection in an EHR. METHODS As part of a 13 site clinical trial comparing cranial computed tomography use before and after implementation of CDS, four PECARN sites centrally developed and locally implemented CC groupings to trigger a clinical trial alert (CTA) to facilitate the completion of an emergency department head trauma data collection template. We tested and chose CC groupings to attain high sensitivity while maintaining at least moderate specificity. RESULTS Due to variability in CCs available, identical groupings across sites were not possible. We noted substantial variability in the sensitivity and specificity of seemingly similar CC groupings between sites. The implemented CC groupings had sensitivities greater than 90% with specificities between 75-89%. During the trial, formal testing and provider feedback led to tailoring of the CC groupings at some sites. CONCLUSIONS CC groupings can be successfully developed and implemented across multiple sites to accurately identify patients who should have a CTA triggered to facilitate EHR data collection. However, CC groupings will necessarily vary in order to attain high sensitivity and moderate-to-high specificity. In future trials, the balance between sensitivity and specificity should be considered based on the nature of the clinical condition, including prevalence and morbidity, in addition to the goals of the intervention being considered.

The Yale Observation Scale Score and the Risk of Serious Bacterial Infections in Febrile Infants

In our large prospective cohort of febrile infants, neither the YOS score nor unstructured clinician suspicion reliably identified infants with serious bacterial infections. OBJECTIVES: To assess the performance of the Yale Observation Scale (YOS) score and unstructured clinician suspicion to identify febrile infants ≤60 days of age with and without serious bacterial infections (SBIs). METHODS: We performed a planned secondary analysis of a prospective cohort of non–critically ill, febrile, full-term infants ≤60 days of age presenting to 1 of 26 participating emergency departments in the Pediatric Emergency Care Applied Research Network. We defined SBIs as urinary tract infections, bacteremia, or bacterial meningitis, with the latter 2 considered invasive bacterial infections. Emergency department clinicians applied the YOS (range: 6–30; normal score: ≤10) and estimated the risk of SBI using unstructured clinician suspicion (<1%, 1%–5%, 6%–10%, 11%–50%, or >50%). RESULTS: Of the 4591 eligible infants, 444 (9.7%) had SBIs and 97 (2.1%) had invasive bacterial infections. Of the 4058 infants with YOS scores of ≤10, 388 (9.6%) had SBIs (sensitivity: 51/439 [11.6%]; 95% confidence interval [CI]: 8.8%–15.0%; negative predictive value: 3670/4058 [90.4%]; 95% CI: 89.5%–91.3%) and 72 (1.8%) had invasive bacterial infections (sensitivity 23/95 [24.2%], 95% CI: 16.0%–34.1%; negative predictive value: 3983/4055 [98.2%], 95% CI: 97.8%–98.6%). Of the infants with clinician suspicion of <1%, 106 had SBIs (6.4%) and 16 (1.0%) had invasive bacterial infections. CONCLUSIONS: In this large prospective cohort of febrile infants ≤60 days of age, neither the YOS score nor unstructured clinician suspicion reliably identified those with invasive bacterial infections. More accurate clinical and laboratory predictors are needed to risk stratify febrile infants.

Accuracy of the Urinalysis for Urinary Tract Infections in Febrile Infants 60 Days and Younger

This prospective study reveals the accuracy of the urinalysis for diagnosing UTIs in febrile infants 60 days and younger with and without bacteremia. OBJECTIVES: Reports of the test accuracy of the urinalysis for diagnosing urinary tract infections (UTIs) in young febrile infants have been variable. We evaluated the test characteristics of the urinalysis for diagnosing UTIs, with and without associated bacteremia, in young febrile infants. METHODS: We performed a planned secondary analysis of data from a prospective study of febrile infants ≤60 days old at 26 emergency departments in the Pediatric Emergency Care Applied Research Network. We evaluated the test characteristics of the urinalysis for diagnosing UTIs, with and without associated bacteremia, by using 2 definitions of UTI: growth of ≥50 000 or ≥10 000 colony-forming units (CFUs) per mL of a uropathogen. We defined a positive urinalysis by the presence of any leukocyte esterase, nitrite, or pyuria (>5 white blood cells per high-power field). RESULTS: Of 4147 infants analyzed, 289 (7.0%) had UTIs with colony counts ≥50 000 CFUs/mL, including 27 (9.3%) with bacteremia. For these UTIs, a positive urinalysis exhibited sensitivities of 0.94 (95% confidence interval [CI]: 0.91–0.97), regardless of bacteremia; 1.00 (95% CI: 0.87–1.00) with bacteremia; and 0.94 (95% CI: 0.90–0.96) without bacteremia. Specificity was 0.91 (95% CI: 0.90–0.91) in all groups. For UTIs with colony counts ≥10 000 CFUs/mL, the sensitivity of the urinalysis was 0.87 (95% CI: 0.83–0.90), and specificity was 0.91 (95% CI: 0.90–0.92). CONCLUSIONS: The urinalysis is highly sensitive and specific for diagnosing UTIs, especially with ≥50 000 CFUs/mL, in febrile infants ≤60 days old, and particularly for UTIs with associated bacteremia.

Risk of Bacterial Coinfections in Febrile Infants 60 Days Old and Younger with Documented Viral Infections

Objective To determine the risk of serious bacterial infections (SBIs) in young febrile infants with and without viral infections. Study design Planned secondary analyses of a prospective observational study of febrile infants 60 days of age or younger evaluated at 1 of 26 emergency departments who did not have clinical sepsis or an identifiable site of bacterial infection. We compared patient demographics, clinical, and laboratory findings, and prevalence of SBIs between virus‐positive and virus‐negative infants. Results Of the 4778 enrolled infants, 2945 (61.6%) had viral testing performed, of whom 1200 (48.1%) were virus positive; 44 of the 1200 had SBIs (3.7%; 95% CI, 2.7%‐4.9%). Of the 1745 virus‐negative infants, 222 had SBIs (12.7%; 95% CI, 11.2%‐14.4%). Rates of specific SBIs in the virus‐positive group vs the virus‐negative group were: UTIs (33 of 1200 [2.8%; 95% CI, 1.9%‐3.8%] vs 186 of 1745 [10.7%; 95% CI, 9.2%‐12.2%]) and bacteremia (9 of 1199 [0.8%; 95% CI, 0.3%‐1.4%] vs 50 of 1743 [2.9%; 95% CI, 2.1%‐3.8%]). The rate of bacterial meningitis tended to be lower in the virus‐positive group (0.4%) than in the viral‐negative group (0.8%); the difference was not statistically significant. Negative viral status (aOR, 3.2; 95% CI, 2.3‐4.6), was significantly associated with SBI in multivariable analysis. Conclusions Febrile infants ≤60 days of age with viral infections are at significantly lower, but non‐negligible risk for SBIs, including bacteremia and bacterial meningitis.

Applying the RE-AIM Framework for the Evaluation of a Clinical Decision Support Tool for Pediatric Head Trauma: A Mixed-Methods Study

Background  The overuse of cranial computed tomography (CT) to diagnose potential traumatic brain injuries (TBIs) exposes children with minor blunt head trauma to unnecessary ionizing radiation. The Pediatric Emergency Care Applied Research Network and the Clinical Research on Emergency Services and Treatments Network implemented TBI prediction rules via electronic health record (EHR) clinical decision support (CDS) to decrease use of CTs in children with minor blunt head trauma. Objective  This article aims to facilitate implementation and dissemination of a CDS alert into emergency departments around the country. Methods  We evaluated the EHR CT CDS tool through a mixed-methods analysis of 38 audio-recorded interviews with health care stakeholders and quantitative data sources, using the Reach, Efficacy, Adoption, Implementation, and Maintenance framework. Results   Reach — The demographics of participants enrolled in the clinical trial were consistent with national estimates of TBI prevalence. Efficacy —There was a variable and modest reduction in CT rates for the 8,067 children with minor head trauma whose clinicians received CDS. Adoption — The EHR CT CDS tool was well matched with the organizational mission, values, and priorities of the implementation sites. Implementation — The most important predisposing factors for successful implementation were the presence of an approachable clinical champion at each site and belief that the tool was a relevant, reusable knowledge asset. Enabling factors included an effective integration within the clinical workflow, organizational investment in user training, and ease of use. Maintenance — Reinforcing factors for the EHR CT CDS tool included a close fit with the institutional culture, belief that it was useful for providers and families, and a good educational and informational tool. As such, the EHR CT CDS tool was maintained in clinical practice long after study completion. Conclusion  Data from this mixed-methods study complement findings from the efficacy trial and provide critical components for consideration prior to integration and subsequent dissemination of the EHR CT CDS tool. Trial Registration  NCT01453621, Registered September 27, 2011