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OBJECTIVES: To describe study design considerations and to simulate a trial of biomarker-guided sepsis management aimed to reduce acute kidney injury (acute kidney injury). Tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7, urinary biomarkers of cell-cycle arrest, and indicators of kidney stress can detect acute kidney injury before clinical manifestations. We sought to determine the event rates for acute kidney injury as a function of serial measurements of urinary (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) in patients at risk of sepsis-associated acute kidney injury, so that an escalating series of kidney-sparing sepsis bundles based on international guidelines could be applied. DESIGN: We described the study protocol of "Limiting acute kidney injury Progression In Sepsis," a phase 4, multicenter, adaptive, randomized controlled trial. We performed simulations to estimate the rates for the trial's primary endpoint using patient-level data from two previous studies (Sapphire and Protocolized Care for Early Septic Shock). SETTING: Academic and community ICUs. PATIENTS: Critically ill patients with sepsis or septic shock, without evidence of stage 2/3 acute kidney injury at enrollment. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Our primary endpoint is progression of two or more stages of acute kidney injury, death, or dialysis within 72 hours after enrollment. In the Sapphire simulation, 45 of 203 patients (22%) with sepsis met the endpoint. In Protocolized Care for Early Septic Shock, 144 of 607 patients (24%) with septic shock met the endpoint. In both simulations, (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) patterns, suggested by Limiting acute kidney injury Progression In Sepsis protocol, stratified the risk for the endpoint from 6% (three negative tests) to 41% (for patients eligible for the highest level of kidney-sparing sepsis bundle) in Sapphire, and 14% (two negative tests) to 46% (for the highest level of kidney-sparing sepsis bundle) in Protocolized Care for Early Septic Shock. CONCLUSIONS: Findings of our Limiting acute kidney injury Progression In Sepsis trial simulation confirmed that (tissue inhibitor of metalloproteinases-2)•(insulin-like growth factor-binding protein 7) could identify patients with different rates of progression to moderate/severe acute kidney injury, death, or dialysis in 72 hours. The Limiting acute kidney injury Progression In Sepsis protocol algorithm is therefore feasible in terms of identifying suitably high-risk individuals for kidney-sparing sepsis bundle.

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OBJECTIVES: The objectives were to evaluate general emergency department (ED) variation in head computed tomography (CT) use for pediatric head trauma, hospital factors associated with CT use, and recent secular trends in CT utilization for pediatric head trauma. METHODS: This was a cross-sectional study of a sample of general EDs in the Nationwide Emergency Department Sample (NEDS; 2006-2010). The authors included visits by patients <19 years of age with International Classification of Diseases, 9th Revision, Clinical Modification, diagnosis codes for head trauma and determined head CT use via Current Procedural Terminology (CPT), Fourth Edition, codes. Crude and risk-adjusted proportions of visits with CT for each hospital were calculated using multilevel mixed effects logistic regression. The association between hospital-level characteristics and head CT were evaluated by constructing multivariable negative binomial regression models. RESULTS: There were 324,435 pediatric head trauma visits to 848 EDs in the sample. Median patient age was 8 years (interquartile range [IQR] = 2 to 15 years) and 62% of visits were by males. A minority of patients (0.7%) were severely injured, and only 4.2% were admitted to the hospital. Most EDs (79%) were nonteaching institutions, and 84% were nontrauma centers. Risk-adjusted median CT use was 56.0% (IQR = 46.4% to 64.7%). In multivariate analysis, nontrauma centers were 9% (95% confidence interval [CI] = 4% to 15%) less likely to use head CT for pediatric head trauma patients and among discharged patients, EDs within nonteaching hospitals were 8% more likely to perform CT imaging (95% CI = 2% to 14%). There was no change in CT use from 2006 through 2010 (p = 0.31). CONCLUSIONS: There is significant variability among general EDs in CT use for pediatric head trauma, indicating the need for strategies to reduce variation and improve ED imaging practices for this population.

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OBJECTIVES: Emergency medical services (EMS) providers deliver the initial care for millions of people in the United States each year. The Institute of Medicine noted a deficit in research necessary to improve prehospital care, created by the existence of data silos, absence of long-term outcomes, and limited stakeholder engagement in research. This article describes a regional effort to create a high-performing infrastructure in southwestern Pennsylvania addressing these fundamental barriers. METHODS: Regional EMS records from 33 agencies in January 2011 were linked to hospital-based electronic health records (EHRs) in a single nine-hospital system, with manual review of matches for accuracy. The use of community stakeholder engagement was included to guide scientific inquiry, as well as 2-year follow up for patient-centered outcomes. RESULTS: Local EMS medicine stakeholders emphasized the limits of single-agency EMS research and suggested that studies focus on improving cross-cutting, long-term outcomes. Guided by this input, more than 95% of EMS records (2,675 of 2,800) were linked to hospital-based EHRs. More than 80% of records were linked to 2-year mortality, with more deaths among EMS patients with prehospital hypotension (30.5%) or respiratory distress (19.5%) than chest pain (5.4%) or nonspecific complaints (9.4%). CONCLUSIONS: A prehospital comparative effectiveness research infrastructure composed of patient-level EMS data, EHRs at multiple hospitals, long-term outcomes, and community stakeholder perspectives is feasible and may be scalable to larger regions and networks. The lessons learned and barriers identified offer a roadmap to answering community and policy-relevant research questions in prehospital care.

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OBJECTIVES: Despite the existence of various clinical prediction rules, no data exist defining what frequency of death or serious nonfatal outcomes comprises a realistic "low-risk" group for clinicians. This exploratory study sought to identify emergency physicians' (EPs) definition of low-risk acute decompensated heart failure (ADHF) emergency department (ED) patients. METHODS: Surveys were mailed to full-time physicians (n = 88) in a multihospital EP group in southwestern Pennsylvania between December 2004 and February 2005. Participation was voluntary, and each EP was asked to define low risk (low risk of all-cause 30-day death and low risk of either hospital death or other serious medical complications) and choose a risk threshold at which they might consider outpatient management for those with ADHF. A range of choices was offered (<0.5, <1, <2, <3, <4, and <5%), and demographic data were collected. RESULTS: The response rate was 80%. Physicians defined low risk both for all-cause 30-day death and for hospital death or other serious complications, at <1% (38.8 and 40.3%, respectively). The decision threshold to consider outpatient therapy was <0.5% risk both for all-cause 30-day death (44.6%) and for hospital death or serious medical complications (44.4%). CONCLUSIONS: Emergency physicians in this exploratory study define low-risk ADHF patients as having less than a 1% risk of 30-day death or inpatient death or complications. They state a desire to have and use an ADHF clinical prediction rule that can identify low-risk ADHF patients who have less than a 0.5% risk of 30-day death or inpatient death or complications.

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