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Beta-lactam allergy is reported in 5–10% of children in North America, but up to 94–97% of patients are deemed not allergic after allergist assessment. The utility of standardized skin testing for penicillin allergy in the pediatric population has been recently questioned. Oral drug challenges when appropriate, are preferred over skin testing, and can definitively rule out immediate, IgE-mediated drug allergy. To our knowledge, this is the only pediatric study to assess the reliability of a penicillin allergy stratification tool using a paper and electronic clinical algorithm. By using an electronic algorithm, we identified 61 patients (of 95 deemed not allergic by gold standard allergist decision) as low risk for penicillin allergy, with no false negatives and without the need for allergist assessment or skin testing. In this study, we demonstrate that an electronic algorithm can be used by various pediatric clinicians when evaluating possible penicillin allergy to reliably identify low risk patients. We identified the electronic algorithm was superior to the paper version, capturing an even higher percentage of low risk patients than the paper version. By developing an electronic algorithm to accurately assess penicillin allergy risk based on appropriate history, without the need for diagnostic testing or allergist assessment, we can empower non-allergist health care professionals to safely de-label low risk pediatric patients and assist in alleviating subspecialty wait times for penicillin allergy assessment. [ABSTRACT FROM AUTHOR]

Background: Pediatric traumatic brain injury (TBI) affects about 475,000 children in the United States annually. Studies from the 1990s showed worse mortality in pediatric TBI patients not transferred to a pediatric trauma center (PTC), but did not examine mild pediatric TBI. Evidence-based guidelines used to identify children with clinically insignificant TBI who do not require head CT were developed by the Pediatric Emergency Care Applied Research Network (PECARN). However, which patients can be safely observed at a non-PTC is not directly addressed.Methods: A systematic review of the literature was conducted, focusing on management of pediatric TBI and transfer decisions from 1990 to 2020.Results: Pediatric TBI patients make up a great majority of preventable transfers and admissions, and comprise a significant portion of avoidable costs to the health care system. Majority of mild TBI patients admitted to a PTC following transfer do not require ICU care, surgical intervention, or additional imaging. Studies have shown that as high as 83% of mild pediatric TBI patients are discharged within 24 hrs.Conclusions: An evidence-based clinical practice algorithm was derived through synthesis of the data reviewed to guide transfer decision. The papers discussed in our systematic review largely concluded that transfer and admission was unnecessary and costly in pediatric patients with mild TBI who met the following criteria: blunt, no concern for NAT, low risk on PECARN assessment, or intermediate risk on PECARN with negative imaging or imaging with either isolated, nondisplaced skull fractures without ICH and/or EDH, or SDH <0.3 cm with no midline shift. [ABSTRACT FROM AUTHOR]

Background: Few papers discuss the pragmatics of conducting large, cluster randomized clinical trials. Here we describe the sequential steps taken to develop methods to implement the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) trial that tested the effect of a nurse-implemented, goal-directed, comfort algorithm on clinical outcomes in pediatric patients with acute respiratory failure.Methods: After development in a single institution, the RESTORE intervention was pilot-tested in two pediatric intensive care units (PICUs) to evaluate safety and feasibility. After the pilot, the RESTORE intervention was simplified to enhance reproducibility across multiple PICUs. The final RESTORE trial was developed as a cluster randomized clinical trial where the unit of randomization was the PICU, stratified by PICU size, and the unit of inference was the patient. Study execution was revised based on our Data and Safety Monitoring Board's recommendation to consult with the Department of Health and Human Services' Office of Human Research Protection (OHRP) on how best to consent eligible subjects. OHRP deemed that the RESTORE intervention posed greater than minimal risk and that all enrolled subjects provide consent reflecting their level of participation.Results: Thirty-one PICUs of varying size, organization and academic affiliation participated and over 2800 critically ill infants and children supported on mechanical ventilation for acute pulmonary disease were enrolled. The primary outcome for the trial was the duration of mechanical ventilation; secondary outcomes included time awake and comfortable, total sedative exposure and iatrogenic withdrawal symptoms. Throughout the clinical trial the investigative team worked to maintain treatment fidelity, enrollment milestones and co-investigator enthusiasm. We considered the potential impact of competing clinical trials through a decision-making framework.Conclusions: The RESTORE clinical trial was a large and complex multicenter study that has provided the necessary evidence to guide sedation practices in the field of pediatric critical care. Specific issues that were unique to this trial included level of consent, adding clinical sites to augment enrollment and evaluating the potential impact of competing clinical trials.Trial Registration: ClinicalTrials.gov , Identifiers: Pilot trial: NCT00142766 ; Retrospectively registerd on 2 September 2005. Cluster randomized trial: NCT00814099 . Registered on 23 December 2008. [ABSTRACT FROM AUTHOR]