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Hypothesis:Emergency Medical Services (EMS) systems have developed protocols for prehospital activation of the cardiac catheterization laboratory for patients with suspected ST-elevation myocardial infarction (STEMI) to decrease first-medical-contact-to-balloon time (FMC2B). The rate of “false positive” prehospital activations is high. In order to decrease this rate and expedite care for patients with true STEMI, the American Heart Association (AHA; Dallas, Texas USA) developed the Mission Lifeline PreAct STEMI algorithm, which was implemented in Los Angeles County (LAC; California USA) in 2015. The hypothesis of this study was that implementation of the PreAct algorithm would increase the positive predictive value (PPV) of prehospital activation.Methods:This is an observational pre-/post-study of the effect of the implementation of the PreAct algorithm for patients with suspected STEMI transported to one of five STEMI Receiving Centers (SRCs) within the LAC Regional System. The primary outcome was the PPV of cardiac catheterization laboratory activation for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). The secondary outcome was FMC2B.Results:A total of 1,877 patients were analyzed for the primary outcome in the pre-intervention period and 405 patients in the post-intervention period. There was an overall decrease in cardiac catheterization laboratory activations, from 67% in the pre-intervention period to 49% in the post-intervention period (95% CI for the difference, -14% to -22%). The overall rate of cardiac catheterization declined in post-intervention period as compared the pre-intervention period, from 34% to 30% (95% CI, for the difference -7.6% to 0.4%), but actually increased for subjects who had activation (48% versus 58%; 95% CI, 4.6%-15.0%). Implementation of the PreAct algorithm was associated with an increase in the PPV of activation for PCI or CABG from 37.9% to 48.6%. The overall odds ratio (OR) associated with the intervention was 1.4 (95% CI, 1.1-1.8). The effect of the intervention was to decrease variability between medical centers. There was no associated change in average FMC2B.Conclusions:The implementation of the PreAct algorithm in the LAC EMS system was associated with an overall increase in the PPV of cardiac catheterization laboratory activation.

Objective:Low rates of bystander cardiopulmonary resuscitation (CPR) were identified as a shortcoming in the “chain of survival” for out-of-hospital cardiac arrest (OHCA) care in the Korean city of Ansan. This study sought to evaluate the effect of an initiative to increase bystander CPR and quality of out-of-hospital resuscitation on outcome from OHCA. The post-intervention data were used to determine the next quality improvement (QI) target as part of the “Plan-Do-Study-Act” (PDSA) model for QI.Hypothesis:The study hypothesis was that bystander CPR, return of spontaneous circulation (ROSC), and survival to discharge after OHCA would increase in the post-intervention period.Methods:This was a retrospective pre/post study. The data from the pre-intervention period were abstracted from 2008–2011 and the post-intervention period from 2012–2013. The effect of the intervention on the odds of ROSC and survival to hospital discharge was determined using a generalized estimating equation to account for confounders and the effect of clustering within medical centers. The analysis was then used to identify other factors associated with outcomes to determine the next targets for intervention in the chain of survival for cardiac arrest in this community.Results:Rates of documented bystander CPR increased from 13% in the pre-intervention period to 37% in the post-intervention period. The overall rate of ROSC decreased from 18.4% to 14.3% (risk difference −4.1%; 95% CI, −7.1%–1.0%), whereas survival to hospital discharge increased from 3.9% to 5.0% (risk difference 1.1%; 95% CI, −1.8%–3.8%), and survival with good neurologic outcome increased from 0.8% to 1.6% (risk difference 0.8%; 95% CI, −0.8%–2.4%). In multivariable analyses, there was no association between the intervention and the rate of ROSC or survival to hospital discharge. The designated level of the treating hospital was a significant predictor of both survival and ROSC.Conclusion:In this case study, there were no observed improvements in outcomes from OHCA after the targeted intervention to improve out-of-hospital CPR. However, utilizing the PDSA model for QI, the designated level of the treating hospital was found to be a significant predictor of survival in the post-period, identifying the next target for intervention.

Author(s): Pedigo, Ryan; Tolles, Juliana; Watcha, Daena; Kaji, Amy H.; Lewis, Roger J.; Stark, Elena; Jordan, Jaime | Abstract: Introduction: The optimal method to train novice learners to perform endotracheal intubation (ETI)is unknown. The study objective was to compare two models: unembalmed cadaver vs simulationmanikin.Methods: Fourth-year medical students, stratified by baseline ETI experience, were randomized 1:1to train on a cadaver or simulation manikin. Students were tested and video recorded on a separatecadaver; two reviewers, blinded to the intervention, assessed the videos. Primary outcome wastime to successful ETI, analyzed with a Cox proportional hazards model. Authors also comparedpercentage of glottic opening (POGO), number of ETI attempts, learner confidence, and satisfaction.Results: Of 97 students randomized, 78 were included in the final analysis. Median time to ETI didnot differ significantly (hazard ratio [HR] 1.1; 95% CI [confidence interval], 0.7-1.8): cadaver group =34.5 seconds (interquartile ratio [IQR]: 23.3-55.8) vs manikin group = 35.5 seconds (IQR: 23.8-80.5),with no difference in first-pass success (odds ratio [OR] = 1; 95% CI, 0.1-7.5) or median POGO: 80%cadaver vs 90% manikin (95% CI, -14-34%). Satisfaction was higher for cadavers (median difference= 0.5; p = 0.002; 95% CI, 0-1) as was change in student confidence (median difference = 0.5; p= 0.03; 95% CI, 0-1). Students rating their confidence a 5 (“extremely confident”) demonstrateddecreased time to ETI (HR = 4.2; 95% CI, 1.0-17.2).Conclusion: Manikin and cadaver training models for ETI produced similar time to ETI, POGO,and first-pass success. Cadaver training was associated with increased student satisfaction andconfidence; subjects with the highest confidence level demonstrated decreased time to ETI.

Importance Sepsis is a common syndrome with substantial morbidity and mortality. A combination of vitamin C, thiamine, and corticosteroids has been proposed as a potential treatment for patients with sepsis. Objective To determine whether a combination of vitamin C, thiamine, and hydrocortisone every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis. Design, setting, and participants Multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. Participants were enrolled in the emergency departments or intensive care units at 43 hospitals in the United States between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020. Interventions Participants were randomized to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 hours (n = 252) or matching placebo (n = 249) for 96 hours or until discharge from the intensive care unit or death. Participants could be treated with open-label corticosteroids by the clinical team, with study hydrocortisone or matching placebo withheld if the total daily dose was greater or equal to the equivalent of 200 mg of hydrocortisone. Main outcomes and measures The primary outcome was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following the day of randomization. The key secondary outcome was 30-day mortality. Results Among 501 participants randomized (median age, 62 [interquartile range {IQR}, 50-70] years; 46% female; 30% Black; median Acute Physiology and Chronic Health Evaluation II score, 27 [IQR, 20.8-33.0]; median Sequential Organ Failure Assessment score, 9 [IQR, 7-12]), all completed the trial. Open-label corticosteroids were prescribed to 33% and 32% of the intervention and control groups, respectively. Ventilator- and vasopressor-free days were a median of 25 days (IQR, 0-29 days) in the intervention group and 26 days (IQR, 0-28 days) in the placebo group, with a median difference of -1 day (95% CI, -4 to 2 days; P = .85). Thirty-day mortality was 22% in the intervention group and 24% in the placebo group. Conclusions and relevance Among critically ill patients with sepsis, treatment with vitamin C, thiamine, and hydrocortisone, compared with placebo, did not significantly increase ventilator- and vasopressor-free days within 30 days. However, the trial was terminated early for administrative reasons and may have been underpowered to detect a clinically important difference. Trial registration ClinicalTrials.gov Identifier: NCT03509350.

Background Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups. Methods We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921. Findings Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20–1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74–1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30–1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00–5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group. Interpretation Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2–3 days sooner. Funding European Commission's Seventh Framework Programme.

Septic shock carries substantial morbidity and mortality. The failure of many promising therapies during late-phase clinical trials prompted calls for alternative trial designs. We describe an innovative trial evaluating selepressin, a novel selective vasopressin V1a receptor agonist, for adults with septic shock. SEPSIS-ACT (Selepressin Evaluation Programme for Sepsis-induced Shock—Adaptive Clinical Trial) is a blinded, randomized, placebo-controlled, two-part, adaptive phase 2b/3 trial, evaluating up to four selepressin dosing strategies. The primary outcome is pressor- and ventilator-free days, with a value of zero assigned for death within 30 days. We calculate Bayesian probabilities of final trial success to guide interim decision-making. Part 1 (dose-finding) has an adaptive sample size based on response-adaptive randomization and prespecified rules to determine stopping for futility or selection of the best dosing regimen for Part 2. Part 2 (confirmation) randomizes a minimum of 1,000 patients equa...

Rationale Efficacy of mechanical thrombectomy for acute stroke due to large vessel occlusion initiated beyond 6 h of time last seen well has not been demonstrated in randomized trials. Aim To establish whether subjects considered to have substantial areas of salvageable brain based on age-adjusted clinical core mismatch who can undergo endovascular treatment within 6–24 h from time last seen well (TLSW) have better outcomes at three months compared to subjects treated with standard medical therapy alone. Age-adjusted clinical core mismatch is defined by age (≤80 or >80 years), baseline National Institutes of Health Stroke Scale (NIHSS) (10–20 or ≥21), and core size (0–20 cm3 in subjects older than 80 and, in subjects younger than 80, 0–30 cm3 with NIHSS 10–20 and 31–50 cm3 with NIHSS ≥21). Design Prospective, randomized, multicenter, Bayesian adaptive-enrichment, open label trial with blinded endpoint assessment. For the purpose of enrolment, ischemic core size will be evaluated by CT perfusion or magnetic resonance imaging-diffusion-weighted imaging measured by automated software (RAPID). Procedures Subjects with acute ischemic stroke due to computed tomography angiography- or magnetic resonance angiogram-proven arterial occlusion of the intracranial internal carotid and/or proximal middle cerebral artery (M1) with age-adjusted clinical core mismatch in whom treatment can be initiated between 6 and 24 h from TSLW are randomized in a 1:1 ratio to receive mechanical embolectomy with the Trevo device or medical management alone. Sequential interim analyses allowing adaptation of enrolment criteria or stopping new enrolment for futility or predicted success will occur in every 50 randomized patients starting at 150 to a maximum of 500 patients. Study outcomes The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is stroke-related mortality at 90 days. Analysis The primary endpoint, expressed as a utility-weighted modified Rankin Scale score is analyzed using a Bayesian posterior probability with adjustment for ischemic core size. For regulatory reasons, a nested co-primary endpoint analysis was added consisting of the proportion of subjects with modified Rankin Scale 0–2 between the active and control groups also analyzed using a Bayesian model.

Delayed graft function (DGF) in kidney transplant significantly increases inpatient and outpatient cost. Targeted, mild hypothermia in organ donors after neurologic determination of death significantly reduced the rate of DGF in a recent randomized controlled clinical trial. To assess the potential economic benefit of national implementation of donor hypothermia, rates of reduction DGF were combined with estimates of the impact of DGF on hospital cost and total health expenditure for standard and extended criteria donor organs (SCD and ECD). DGF increases the cost of the transplant episode by $9487 for ECD transplant and $10 342 for SCD transplant. Medicare recipients with DGF incur an additional $18 513 spending for ECD and $14 948 in SCD transplants over the first year. An absolute reduction in DGF rate after kidney transplantation consistent with trial results (ECD 25%, SCD 7%) has the potential to lower annual hospital cost for kidney transplant by $13 178 746 and annual Medicare spending by $20 970 706 compared to standard donor management practice using static cold storage. Targeted mild hypothermia improves care of renal transplant patients by safely reducing DGF rates in both ECD and SCD transplant. Broader application of this safe, effective, and low-cost intervention could reduce healthcare expenditures for providers and insurers.

Objective: We evaluated the performance of individual trauma triage criteria using data from a regional trauma registry. Methods: Los Angeles County (LAC) paramedics use triage criteria adapted fro...

To provide an evaluation of the Pediatric Assessment Triangle (PAT) as an assessment tool for use by paramedic providers in the prehospital care of pediatric patients.Paramedics from Los Angeles Fire Department (LAFD) received training in the Pediatric Education for Prehospital Professionals (PEPP) course, PAT study procedures, and completed training in applying the PAT to assess children 0-14 years of age. A convenience sample of LAFD paramedic assessments of the pediatric patients transported to 29 participating institutions, over an 18-month period ending July 2010, were eligible for inclusion. Patients who were not transported were excluded from the study, as were the assessments of children with special health-care needs (CSHCN). PAT Study Forms, emergency medical services (EMS) report forms, and emergency department (ED) and hospital charts were entered into a secure database. Two study investigators, blinded to paramedic PAT assessment, reviewed hospital charts and determined the category of illness or injury.A total of 1,552 PAT Study Forms were collected. Overall, 1,168 of the patient (75%) assessments met inclusion criteria, were transported, and had all three data points (PAT Study Form, paramedic EMS report form, and ED/hospital chart) available for analysis. When paramedics used the PAT to identify abnormalities in the three arms of the triangle (PAT Paramedic Pattern) and applied that pattern to form a general impression (PAT Paramedic Impression), the agreement resulted in a κ coefficient of 0.93 [95% CI: 0.91-0.95]. The PAT paramedic impression was congruent with field management, as the majority of patients received consistent interventions with local EMS protocols. The PAT Paramedic Impression for instability demonstrated a sensitivity of 77.4% [95% CI: 72.6-81.5%], a specificity of 90.0% [95% CI: 87.1-91.5%] with a positive likelihood ratio (LR+) of 7.7 [95% CI: 5.9-9.1] and a negative likelihood ratio (LR-) of 0.3 [95% CI: 0.2-0.3].The PAT is a rapid assessment tool that can be readily and reliably used by paramedics in the prehospital setting. The PAT should be used in conjunction with other assessments but can safely drive initial field management.

Introduction The Pediatric Assessment Triangle (PAT) is a rapid evaluation tool that establishes a child's clinical status and his or her category of illness to direct initial management priorities. Recently the PAT has been incorporated widely into the pediatric resuscitation curriculum. Although intuitive, its performance characteristics have yet to be quantified. The purpose of this research is to determine quantitatively its accuracy, reliability, and validity as applied by nurses at triage. Methods In this prospective observational study, triage nurses performed the PAT on all patients presenting to the pediatric emergency department of an urban teaching hospital. Researchers performed blinded chart review using the physician's initial assessment and final diagnosis as the criterion standard for comparison. Results A total of 528 children were included in the analysis. Likelihood ratios (LRs) were found for instability and category of pathophysiology using the PAT. Children deemed stable by initial PAT were almost 10 times more likely to be stable on further assessment (LR 0.12, 95% confidence interval [CI] 0.06-0.25). The PAT further specified categories of pathophysiology: respiratory distress (LR+ 4, 95% CI 3.1-4.8), respiratory failure (LR+ 12, 95% CI 4.0-37), shock (LR+ 4.2, 95% CI 3.1-5.6), central nervous system/metabolic disorder (LR+ 7, 95% CI 4.3-11), and cardiopulmonary failure (LR+ 49, 95% CI 20-120). Discussion The structured assessment of the initial PAT, as performed by nurses in triage, readily and reliably identifies high-acuity pediatric patients and their category of pathophysiology. The PAT is highly predictive of the child's clinical status on further evaluation.

Background. The significance of hepatitis B core antibody (anti-HBc) without hepatitis B surface antigen (HBsAg) or hepatitis B surface antibody (anti-HBs) is unclear. Methods. This cohort study included men enrolled in the Multicenter AIDS Cohort to determine clinical and laboratory predictors of isolated anti-HBc. Results. A total of 2286 subjects (51% human immunodeficiency virus [HIV]–infected) were followed over 3.9 years. Overall, 16.9% (387) had at least 1 visit with isolated anti-HBc. The isolated anti-HBc pattern was stable 84% of the time, and transitioned to or from a pattern of past infection (anti-HBc and anti-HBs). Isolated anti-HBc was associated with HIV infection (odds ratio [OR], 2.19; 95% confidence interval [CI], 1.73–2.79) and hepatitis C virus (HCV; OR, 4.21; 95% CI; 2.99–5.91). The HCV association was stronger for chronic HCV infection (OR, 6.76; 95% CI, 5.08–8.99) than for cleared HCV (OR, 3.03; 95% CI, 1.83–5.03). HIV infection, chronic HCV, and cleared HCV infection all remained associated with isolated anti-HBc in multivariable models (OR, 1.74; 95% CI, 1.33–2.29; OR, 6.24; 95% CI, 4.62–8.42; and OR, 2.77; 95% CI, 1.65–4.66, respectively). Among HIV-infected subjects, highly active antiretroviral therapy was negatively associated (OR, 0.79; 95% CI, .66–.95) with isolated anti-HBc. Conclusions. Isolated anti-HBc is associated with HIV and HCV coinfection, especially active HCV replication, and most commonly occurs as a transition to or from the pattern of natural immunity (anti-HBc and anti-HBs). The isolated anti-HBc pattern likely represents resolved HBV infection with low or undetected anti-HBs.

Background Adaptive designs have been increasingly used in the pharmaceutical and device industries, but adoption within the academic setting has been less widespread — particularly for confirmatory phase trials. We sought to understand perceptions about understanding, acceptability, and scientific validity of adaptive clinical trials (ACTs). Methods We used a convergent mixed methods design using survey and mini-focus group data collection procedures to elucidate attitudes and opinions among “trial community” stakeholders regarding understanding, acceptability, efficiency, scientific validity, and speed of discovery with adaptive designs. Data were collected about various aspects of ACTs using self-administered surveys (paper or Web-based) with visual analog scales (VASs) with free text responses and with mini-focus groups of key stakeholders. Participants were recruited as part of an ongoing NIH/FDA-funded research project exploring the incorporation of ACTs into an existing NIH network that focuses on confirmatory phase clinical trials in neurological emergencies. “Trial community” representatives, namely, clinical investigators, biostatisticians, NIH officials, and FDA scientists involved in the planning of four clinical trials, were eligible to participate. In addition, recent and current members of a clinical trial-oriented NIH study section were also eligible. Results A total of 76 stakeholders completed the survey (out of 91 who were offered it, response rate 84 %). While the VAS attitudinal data showed substantial variability across respondents about acceptability and understanding of ACTs by various constituencies, respondents perceived clinicians to be less likely to understand ACTs and that ACTs probably would increase the efficiency of discovery. Textual and focus group responses emerged into several themes that enhanced understanding of VAS attitudinal data including the following: acceptability of adaptive designs depends on constituency and situation; there is variable understanding of ACTs (limited among clinicians, perceived to be higher at FDA); views about the potential for efficiency depend on the situation and implementation. Participants also frequently mentioned a need for greater education within the academic community. Finally, the empiric, non-quantitative selection of treatments for phase III trials based on limited phase II trials was highlighted as an opportunity for improvement and a potential explanation for the high number of neutral confirmatory trials. Conclusions These data show considerable variations in attitudes and beliefs about ACTs among trial community representatives. For adaptive trials to be fully considered when appropriate and for the research enterprise to realize the full potential of adaptive designs will likely require extensive experience and trust building within the trial community. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1493-z) contains supplementary material, which is available to authorized users.

To determine the percentage of cases of epididymitis in pediatric patients that is of bacterial cause and to identify factors that predict a positive urine culture.We conducted a retrospective chart review of patients diagnosed with acute epididymitis or epididymo-orchitis in 1 pediatric emergency department for 11 years. Charts were reviewed for historical, physical, laboratory, and radiologic data. A positive urine culture was used to identify patients with a bacterial cause of epididymitis.A total of 160 patient records were initially identified as having a diagnosis of epididymitis; of these, 20 met exclusion criteria or did not have records available for review and 140 cases of epididymitis were reviewed. Patients' age ranged from 2 months to 17 years, with a median age of 11 years. Of these patients, 91% received empiric antibiotic therapy. Also, of these patients, 97 (69%) had a urine culture sent, of whom 4 (4.1%; 95% confidence interval, 1.1%-10.2%) were positive. Of the 4 positive urine cultures, 3 had organisms not sensitive to usual empiric therapy for urinary tract infections. The boys with positive urine cultures were not significantly different from the other patients in age, maximum temperature, or number of white blood cells on urinalysis.Given the low incidence of urinary tract infections in boys with epididymitis, in prepubertal patients, antibiotic therapy can be reserved for young infants and those with pyuria or positive urine cultures. Because it is difficult to predict which patients will have a positive urine culture, urine cultures should be sent on all pediatric patients with epididymitis.

Increased levels of cytokines have been reported after resuscitation from cardiac arrest. We hypothesized that proinflammatory cytokines, released in response to ischemia/reperfusion, increase following resuscitation and play a role in post-cardiac arrest myocardial dysfunction. Ventricular fibrillation (VF) was induced by coronary occlusion in 20 swine. After 7 min of VF, resuscitation was performed as per guidelines. Plasma levels of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1beta, and IL-6 were measured 15 min after the start of resuscitation in all animals and at intervals of 6 h in resuscitated animals. Intravascular pressures and cardiac output (CO) were also recorded. TNF-alpha abruptly increased after resuscitation, peaking at 15 min following return of spontaneous circulation, and declined to baseline levels after 3 h. IL-1beta increased more slowly, reaching a maximum 2 h after reperfusion. IL-6 concentrations were not significantly different from control values at any time point. Males demonstrated greater elevations of TNF-alpha and IL-1beta than females. Stroke work was significantly depressed at all time points with a nadir at 15-30 min after reperfusion, corresponding to the peak TNF-alpha values. The anti-TNF-alpha antibody infliximab attenuated the decrease in myocardial function observed 30 min after reperfusion. TNF-alpha increases during recovery from cardiac arrest are associated with depression of left ventricle (LV) function. The effect of TNF-alpha can be attenuated by anti-TNF-alpha antibodies.

Background: Diabetes is often not diagnosed until complications appear, and one-third of those with diabetes may be undiagnosed. Prediabetes and diabetes are conditions in which early detection would be appropriate, because the duration of hyperglycemia is a predictor of adverse outcomes, and there are effective interventions to prevent disease progression and to reduce complications. Objectives: The objectives were to determine the prevalence of diabetes mellitus and prediabetes in emergency department (ED) patients with an elevated random glucose or risk factors for diabetes but without previously diagnosed diabetes and to identify which at-risk ED patients should be considered for referral for confirmatory diagnostic testing. Methods: This two-part study was composed of a prospective 2-year cohort study, and a 1-week crosssectional survey substudy, set in an urban ED in Los Angeles County, California. A convenience sample was enrolled of 528 ED patients without previously diagnosed diabetes with either 1) a random serum glucose ‡ 140 mg ⁄dL regardless of the time of last food intake or a random serum glucose ‡ 126 mg ⁄dL if more than 2 hours since last food intake or 2) at least two predefined diabetes risk factors. Measurements included presence of diabetes risk factors, ED glucose, cortisol, insulin and glycosylated hemoglobin (HbA1c), and 2-hour oral glucose tolerance test results, administered at 6-week follow-up. Results: Glycemic status was confirmed at follow-up in 256 (48%) of the 528 patients. Twenty-seven (11%) were found to have diabetes, 141 (55%) had prediabetes, and 88 (34%) had normal results. Age, ED glucose, HbA1c, cortisol, and random serum glucose ‡ 140 mg ⁄dL were associated with both diabetes and prediabetes on univariate analysis. A random serum glucose ‡ 126 mg ⁄dL after 2 hours of fasting was associated with diabetes but not prediabetes; ED cortisol, insulin, age ‡ 45 years, race, and calculated body mass index (BMI) were associated with prediabetes but not diabetes. In multivariable models, among factors measurable in the ED, the only independent predictor of diabetes was ED glucose, while ED glucose, age ‡ 45 years, and symptoms of polyuria and polydipsia were independent predictors of prediabetes. All at-risk subjects with a random ED blood glucose > 155 mg ⁄dL had either prediabetes or diabetes on follow-up testing. Conclusions: A substantial fraction of this urban ED study population was at risk for undiagnosed diabetes and prediabetes, and among the at-risk patients referred for follow-up, the majority demonstrated diabetes or prediabetes. Notably, all patients with two risk factors and a random serum glucose > 155 mg ⁄dL were later diagnosed with prediabetes or diabetes. Consideration should be given to referring ED patients with risk factors and a random glucose > 155 mg ⁄dL for follow-up testing. ACADEMIC EMERGENCY MEDICINE 2009; 16:394‐402 a 2009 by the Society for Academic Emergency Medicine

Objectives: The objectives were to determine the effect of pediatric airway management training on paramedic self-efficacy and skill performance and to determine which of several retraining methods is superior. Methods: A total of 2,520 paramedics were trained to proficiency in pediatric bag-mask ventilation (BMV) and endotracheal intubation (ETI) on mannequins. Subjects were a convenience sample of 245 (10% of original cohort) presenting for voluntary retraining. A total of 212 of 245 (87%) completed skills testing. Self-efficacy was measured prior to and following initial training and retraining events. Paramedics were assigned to control (no retraining), videotape presentation, self-directed learning, or instructor-facilitated lecture and demonstration retraining. Following retraining, BMV and ETI skills were tested. Results: Paramedics from low-call-volume areas reported lower baseline self-efficacy and derived larger increases with training, but also experienced the most decline between training events. Pass rates for BMV and ETI were 66% (139 ⁄211) and 42% (88 ⁄212), respectively. However, overall cohort self-efficacy was maintained over the study period. In ordinal regression modeling, only the lecture and demonstration method was superior to control, with an odds ratio (OR) of achieving higher scores of 2.5 (95% confidence interval [CI] = 1.2 to 5.2) for BMV and 5.2 (95% CI = 2.4 to 11.2) for ETI. Poor performance with ETI but not BMV was associated with time elapsed since training (p = 0.01). Self-efficacy ratings were not predictive of skill performance. Conclusions: Training provides increases in self-efficacy, particularly among paramedics from low-callvolume areas. A gap exists between self-efficacy and skill performance, in that self-efficacy may be maintained even when skill performance declines. Pediatric airway skills decay quickly, ETI skills drop off more significantly than BMV skills, and a lecture and demonstration format seems superior to other retraining methods investigated. ACADEMIC EMERGENCY MEDICINE 2008; 15:1295‐1303 a 2008 by the Society for Academic Emergency Medicine

Sexually transmitted infections (STIs) have increased among men who have sex with men (MSM) and are associated with unsafe sex practices, intrinsic morbidity, and enhanced genital shedding and transmission of HIV. Screening for asymptomatic STIs is recommended as part of the HIV prevention efforts, however, optimal screening strategies among HIV-infected MSM have not been well defined. In this study, conducted from April 2004 to September 2006, 212 HIV-infected MSM from two urban HIV clinics were screened for asymptomatic STIs. Testing for Neisseria gonorrhea and Chlamydia trachomatis from pharynx, rectum, and urine, as well as serologic testing for syphilis were performed initially, and then after 6 and 12 months. A self-administered questionnaire was used to assess possible predictors of incident asymptomatic STIs. A cost analysis was performed to assess different screening strategies for detecting incident STIs. The baseline prevalence of STIs was 14% (n = 29; 95% confidence interval [CI] 9%–19%) and the incidence of new infections was 20.8 cases per 100 person years (95% CI 14.8–28.4 cases per 100 person years). Younger age, higher CD4 cell count, and marijuana use were associated with increased risk of acquiring an asymptomatic STI. The laboratory cost to detect one positive STI did not significantly differ between once- and twice-yearly screening. However, almost half of all incident STIs were detected at the 6-month screening visit, potentially resulting in an increased duration of infectivity if these cases remained undiagnosed. In conclusion, prevalent and incident asymptomatic STIs are common among HIV-infected MSM. Our data support current Center for Disease Control and Prevention STI guidelines that recommend routine screening at increased frequency for HIV-infected MSM.

The aims of this study were to determine whether National Kidney Foundation (NKF) guidelines for native arteriovenous fistula (AVF) creation (at least 50% of all new end-stage renal disease [ESRD] patients and 40% of prevalent hemodialysis patients) could be met in an underserved population who presented in late stages of ESRD. We also sought to determine 1-year AVF patency rates and factors associated with early thrombosis. One hundred seventy-six patients underwent hemodialysis access surgery during the period 2003-2005 with a mean age of 51 years. Sixty-two percent were male, and 48% had diabetes mellitus. Ultrasound vein mapping was performed in only 37%. Temporary central venous access was necessary in 109 patients (62%) due to late presentation. Of the 160 patients who were first-time access, 137 (86%) received a native AVF and 23 (14%) had an arteriovenous graft. There was a higher rate of AVF creation in males (91% vs. 75% for females, p = 0.005). The 1-year primary patency was 90%. There were no differences in early thrombosis or 1-year patency rates with respect to gender, age, ethnicity, insurance status, presence of temporary access, or use of preoperative vein mapping. In an underserved population, NKF guidelines for native AVF for first-time access can be superseded with an excellent 1-year patency, despite late presentation.

We conducted a study to evaluate the efficacy of an introductory ultrasound (US) curriculum for medical students rotating through our emergency department.Third- and 4th-year medical students indicated their previous US experience and were given a pretest consisting of static US images to assess baseline interpretation skills. They participated in a 45-min interactive didactic session followed by a 45-min session of hands-on experience practicing real-time US image acquisition on a normal model. After this session, we tested the timing and quality of their image acquisition skills on a separate normal model. Quality of images was based on a point value from 0 to 2 per image. This was followed by a posttest of static US images, which was graded in the same manner as the pretest.Thirty-one students participated in the study. Median time to acquire 2 images was 112.5 sec (range = 15420 sec). Acquisition time was unaffected by previous experience (p = .97). The mean score on the quality of 2 images (maximum score = 4) was 3.84; median was 4 (range = 14). Image quality was significantly better in participants with previous US experience (p = .014). Scores on interpretation of static images improved significantly from pretest to posttest by a median of 8.25 points (p = .0001).Our introductory US course is effective at significantly improving medical students' interpretation of static US images. The majority of students were able to acquire high quality images in a short period of time after this session.

Objectives The Broselow tape is a length-based tool used for the rapid estimation of pediatric weight and was developed to reduce dosage-related errors during emergencies. This study seeks to assess the accuracy of the Broselow tape and age-based formulas in predicting weights of South Sudanese children of varying nutritional status. Methods This was a retrospective, cross-sectional study using data from existing acute malnutrition screening programs for children less than 5 years of age in South Sudan. Using anthropometric measurements, actual weights were compared with estimated weights from the Broselow tape and three age-based formulas. Mid-upper arm circumference was used to determine if each child was malnourished. Broselow accuracy was assessed by the percentage of measured weights falling into the same color zone as the predicted weight. For each method, accuracy was assessed by mean percentage error and percentage of predicted weights falling within 10% of actual weight. All data were analyzed by nutritional status subgroup. Results Only 10.7% of malnourished and 26.6% of nonmalnourished children had their actual weight fall within the Broselow color zone corresponding to their length. The Broselow method overestimated weight by a mean of 26.6% in malnourished children and 16.6% in nonmalnourished children (p

Objectives: To prospectively validate a previously published out-of-hospital clinical decision rule to identify seriously injured children involved in motor vehicle crashes (MVCs). Methods: The authors selected 20 Los Angeles County Fire Department fire stations, based on pediatric MVC call volume and geographic diversity, and 21 associated hospitals for participation in the study. Immediately following an MVC call involving a pediatric patient aged 0‐14 years, each engine/paramedic squad completed a data form (15 variables, including vital signs, Glasgow Coma Scale score, and vehicular and crash characteristics). This study was conducted over a 24-month period. Outcomes included: 1) ‘‘serious injury’’ as defined by an Injury Severity Score (ISS) $ 16 (primary outcome), and 2) need for specialized trauma care (emergent intubation, major nonorthopedic operative intervention or death in the first 24 hours, or pediatric intensive care unit stay longer than 48 hours), as assessed by retrospective chart review. Accuracy measures and binominal confidence intervals (CIs) were calculated for the decision rule validation. Results: One hundred seventy-five children were prospectively enrolled in the study; 36 children were excluded due to lack of hospital participation or missing hospital charts. There were four children with ISS $ 16 (3%) and six children requiring specialized trauma care (4%). The sensitivities and specificities of the rule were: 100% (95% CI = 40% to 100%) and 73% (95% CI = 65% to 81%) for serious injury, and 83% (95% CI = 36% to 100%) and 74% (95% CI = 65% to 81%) for specialized trauma care, respectively. Conclusions: Although definitive conclusions are limited by the sample size, the decision rule identified all seriously injured children involved in MVCs and had moderate specificity. The decision rule was less sensitive for identifying children requiring specialized trauma care. Larger validation studies are needed to adequately assess the utility of this rule before implementation. Key words: clinical decision rule; pediatrics; motor vehicle collisions; trauma; prediction. ACADEMIC EMERGENCY MEDICINE 2005; 12:679‐687.

OBJECTIVE Left ventricular dysfunction after successful cardiopulmonary resuscitation contributes to early death following resuscitation. The stress-induced proinflammatory cytokines, particularly tumor necrosis factor-alpha and interleukin-1beta, are known to depress myocardial function. We hypothesized that tumor necrosis factor-alpha and interleukin-1beta, synthesized and released in response to the stress of global ischemia accompanying cardiac arrest, play a role in development of postresuscitation left ventricular dysfunction. METHODS Hemodynamic variables, tumor necrosis factor-alpha , interleukin-1beta, interleukin-6 (enzyme-linked immunosorbent assay method), and ionized calcium were measured in ten anesthetized swine before and after 7 mins of cardiac arrest and during the early postresuscitation period (60-90 mins). RESULTS Tumor necrosis factor-alpha increased three-fold within 15 mins of restoration of circulation and remained elevated throughout the observation period. A significant negative correlation was observed between tumor necrosis factor-alpha and left ventricular systolic change in pressure over time (r = -.54, p

Study objective We determine the efficacy of prophylactic phenytoin in preventing early posttraumatic seizures in children with moderate to severe blunt head injury. Methods Children younger than 16 years and experiencing moderate to severe blunt head injury were randomized to receive phenytoin or placebo within 60 minutes of presentation at 3 pediatric trauma centers. The primary endpoint was posttraumatic seizures within 48 hours; secondary endpoints were survival and neurologic outcome 30 days after injury. A Bayesian decision-theoretic clinical trial design was used to determine the probability of remaining posttraumatic seizure free for each treatment group. Results One hundred two patients were enrolled, with a median age of 6.1 years. Sixty-eight percent were boys. The 2 treatment groups were well matched. During the 48-hour observation period, 3 (7%) of 46 patients given phenytoin and 3 (5%) of 56 patients given placebo experienced a posttraumatic seizure. There were no significant differences between the treatment groups in survival or neurologic outcome after 30 days. According to these results, the probability that phenytoin has the originally hypothesized effect of reducing the rate of early posttraumatic seizures by 12.5% is 0.0053. The probability that phenytoin has any prophylactic efficacy is 0.383. The median effect size in this trial was −0.015 (seizure rate increased by 1.5% in the phenytoin group), 95% probability interval −0.127 to 0.091 (12.7% higher rate of posttraumatic seizures to a 9.1% lower rate of posttraumatic seizures with phenytoin). Conclusion The rate of early posttraumatic seizures in children may be much lower than previously reported. Phenytoin did not substantially reduce that rate.

Background— Left ventricular (LV) dysfunction with a low cardiac index after successful CPR contributes to early death attributable to multiorgan failure, and an effective treatment has not been identified. The purpose of this study was to investigate the use of milrinone, a selective phosphodiesterase III inhibitor, as treatment for LV dysfunction after resuscitation. Methods and Results— Ventricular fibrillation (VF) was induced electrically in 32 swine. After 5 minutes of VF, CPR was initiated and animals were randomized to receive either saline (control group, n=16) as a bolus and infusion or milrinone 50 μg/kg as a bolus and then 0.5 μg/kg per min for 60 minutes (treatment group, n=16). After 2 minutes of CPR (total VF time, 7 minutes), countershocks were given. Coronary perfusion pressures during CPR were similar for the groups (24±2 versus 21±4 mm Hg). All animals were defibrillated; 6 of 16 control animals developed refractory postcountershock pulseless electrical activity compared with 0 of 16 treated animals ( P =0.018). At 30 minutes after restoration of spontaneous circulation, stroke volume (16±3 versus 26±7 mL, P P Conclusions— Milrinone facilitates resuscitation from prolonged VF and attenuates LV dysfunction after resuscitation without worsening major determinants of myocardial oxygen demand.

The ACLS (advanced cardiac life support) Score was previously developed to predict survival from out-ofhospital cardiac arrest. Whether the arrest was witnessed, initial cardiac rhythm, performance of bystander cardiopulmonary resuscitation (CPR), and the response time of the paramedic unit were determined to be predictive of survival. However, the ACLS Score has not been validated in other emergency medical services systems. Objectives: The purpose of this study was to externally validate the ACLS Score in one patient population. Methods: This was a retrospective cohort study performed at an urban county teaching hospital. The study population consisted of consecutive adult patients treated for out-of-hospital, nontraumatic cardiac arrest, and transported to the authors’ institution between November 1, 1994, and September 30, 2001. Patient records for all cardiac arrests during the study period were reviewed. Study variables included witnessed arrest, initial arrest rhythm, bystander CPR, paramedic response time, and survival to hospital discharge. Predicted probability of survival to hospital discharge was calculated for each patient using the ACLS Score. The overall predicted and observed survival rates were compared using Flora’s Z score. The Hosmer-Lemeshow test was used to evaluate the model’s goodness-of-fit over a range of survival probabilities. Results: Of 754 cardiac arrest patients enrolled in the study period, 575 (76%) patients had documentation that allowed scoring using the ACLS Score. Twenty-five (4%) patients survived to hospital discharge. The predicted number of survivors based on the ACLS Score was 104 (18%), yielding a Flora’s Z statistic of � 4.46 (p \ 0.0001). After categorizing predicted survival probabilities into four categories, the resulting Hosmer-Lemeshow statistic was 210 (p � 10 � 6 ). Both goodness-of-fit statistics demonstrated extremely poor fit of the model. A receiver operating characteristic (ROC) curve was created, yielding an area under the ROC curve of 0.33 (95% CI ¼ 0.19 to 0.47), signifying extremely poor discrimination. Conclusions: The previously published ACLS Score was not valid when applied to an external cohort of out-of-hospital cardiac arrest patients. An externally valid model is needed to predict survival to hospital discharge following out-ofhospital cardiac arrest. Key words: ACLS Score; survival; prediction; cardiac arrest; out-of-hospital cardiac arrest. ACADEMIC EMERGENCY MEDICINE 2003; 10:621–626.

Background: Drugs administered endotracheally are effectively absorbed during normal spontaneous cardiac activity. However, animal cardiac arrest studies and limited clinical investigations do not support either the use of endotracheal (ET) drugs in doses currently recommended for adults or the method of direct endotracheal instillation. The purpose of this study was to compare the effect of intravenous (IV) and ET drug therapy on outcome from out-of-hospital cardiac arrest secondary to all cardiac arrest rhythms. Design: Five and one-half year retrospective cohort study. Setting: Municipal, university affiliated hospital. Patients: Consecutive patients >18 years of age in nontraumatic out-of-hospital cardiac arrest who received advanced cardiac life support (ACLS) medications by only the ET or IV route were included. Interventions: None. Results: Five hundred and ninety-six patients met inclusion criteria (IV drugs=495, ET drugs=101). There was no difference between groups in the rate of witnessed arrest and the frequency of bystander cardiopulmonary resuscitation (CPR). In the ET drug group, a significantly greater number of patients had an initial documented arrest rhythm of asystole compared to the IV drug group (56 vs 37%, P =0.01). The rate of return of spontaneous circulation (27 vs 15%, P =0.01) and survival to hospital admission rate (20 vs 9%, P =0.01) were significantly greater in the IV drug group. No patient who received ET drugs survived to hospital discharge compared to 5% of those receiving IV drugs ( P =0.01). Conclusion: For our out-of-hospital advanced rescuer system, ET drugs at recommended doses (twice the IV dose) injected into an ET tube during cardiac arrest and CPR were of no benefit.

Objective: In the prehospital setting, countershock terminates ventricular fibrillation (VF) in about 80% of cases. However, countershock is most commonly followed by asystole or pulseless electrical activity (PEA). The consequences of such a countershock outcome have not been well studied. The purpose of this investigation was to compare the outcome of prehospital VF victims shocked into asystole or PEA with that of patients whose first documented rhythm was asystole or PEA (primary asystole or PEA). Design: Observational, retrospective study conducted over 5 yrs (1995-1999). Setting: A municipal hospital with a catchment area of >200,000. Patients: Consecutive adult patients with out-of-hospital non-traumatic cardiopulmonary arrest of cardiac origin. Patients found in VF who developed asystole or PEA after countershocks (group 1) and patients found in asystole or PEA (primary asystole or PEA) (group 2) were included if the reported downtime was

In 1996, the US Food and Drug Administration (FDA) enacted Rule 21 CFR section 50.24, which allows a narrow exception to the requirement for prospective informed consent from human research subjects in clinical trials investigating potentially beneficial therapies for acute, life-threatening conditions. The first clinical trial to be conducted under this rule was sponsored by Baxter Healthcare Corporation and approved by the FDA on November 21, 1996. This large, multicenter, randomized clinical trial was designed to compare the addition of diaspirin cross-linked hemoglobin (DCLHb) with standard care in the initial resuscitation of adults experiencing severe, uncompensated, traumatic hemorrhagic shock. Before the first planned interim analysis of the data, review of fatal adverse events revealed an imbalance in mortality between the 2 treatment groups. The Data Monitoring Committee (DMC) recommended suspension of patient enrollment 24 days later. Additional data collection and analyses confirmed the excess number of deaths in patients treated with DCLHb but failed to reveal the cause of these deaths. The trial was formally terminated after only 112 of the planned 850 patients had been enrolled. We review the events leading up to and the rationale behind the DMC recommendations for suspension of patient enrollment and trial termination. Although the DCLHb trial was unsuccessful in achieving its goals, the monitoring process worked well. Emergency research was facilitated by DMC oversight, and the interests of research subjects were protected by the actions of the DMC.

Objective: Biphasic waveforms for transthoracic defibrillation (DF) have been tested extensively after brief (15 s) episodes of VF in animal models and in patients undergoing electrophysiologic testing. The purpose of this study was to compare the effects mono- and biphasic waveforms for DF on postdefibrillation ST segments and left ventricular pressure, markers of myocardial injury, after more extended periods of VF (30 and 90 s). Methods: 21 anesthetized and instrumented swine were randomized to truncated exponential monophasic or biphasic waveform DF. VF was induced electrically and 30 s later, DF with the designated waveform was attempted with a shock dose of 200 J. If unsuccessful, 300 J and then 360 J were administered if necessary. Following return to control hemodynamic values and normalization of the surface ECG, VF was again induced and, after 90 s, DF was attempted as in the 30 s VF period. CPR was not performed during VF and each animal was countershocked with only one waveform for both VF episodes. Waveforms were compared for frequency of first shock defibrillation success, surface ECG indicators of myocardial injury (ST segment changes at 10, 20, and 30 s after countershock) and time to return to pre-VF hemodynamics after successful DF, an indicator of postshock ventricular function. Results: Successful first shock conversion rates at 30 and 90 s were 60 and 63% for monophasic and 64 and 82% for biphasic (NS). Biphasic DF after 30 s produced ST segment changes (measured 10 s after DF) in 1/10 animals while six of eight animals in the monophasic group showed ST segment changes ( P =0.013). After 90 s of VF, ST segment changes were observed in 6/8 in the monophasic group and 2/10 in the biphasic group ( P =0.054). Differences in the time to hemodynamic recovery (return to control peak left ventricular pressure) were not observed between biphasic and monophasic waveforms after 30 or 90 s of VF. Conclusions: Monophasic and biphasic transthoracic defibrillation are equally effective in terminating VF of 30 and 90 s duration and restoring a perfusing rhythm. The biphasic waveform produced less ECG evidence of transient myocardial injury. However, there was no difference in the rate of return to control hemodynamics. ST segment changes following countershock of VF of brief duration are transient and of questionable significance.

Purpose: This study assessed in a prospective, blinded fashion whether a reversible defect on dipyridamole-thallium (DTHAL)/sestamibi (DMIBI) can predict adverse cardiac events after elective vascular surgery in patients with one or more clinical risk factors. Methods: Consecutive patients with one or more clinical risk factors underwent a preoperative blinded DTHAL/DMIBI. Patients with recent congestive heart failure (CHF) or myocardial infarction (MI) or severe or unstable angina were excluded. Results: Eighty patients (78% men; mean age, 65 years) completed the study. Diabetes mellitus was the most frequent clinical risk factor (73%), followed by age older than 70 years (41%), angina (29%), Q wave on electrocardiogram (26%), history of CHF (7%), and ventricular ectopy (3%). The results of DTHAL/DMIBI were normal in 36 patients (45%); a reversible plus or minus fixed defect was demonstrated in 28 patients (36%), and a fixed defect alone was demonstrated in 15 patients (19%). Nine adverse cardiac events (11%) occurred, including three cases of CHF, and one case each of unstable angina, Q wave MI, non-Q wave MI, and cardiac arrest (successfully resuscitated). Two cardiac deaths occurred (2% overall mortality), one after a Q wave MI and one after CHF and a non-Q wave MI. The cardiac event rate was 14% for reversible defect and 9.8% without reversible defect ( P =.71). The cardiac event rate was 12.5% (one of eight cases) for two or more reversible defects, versus 11.1% (eight of 72 cases) for fewer than two reversible defects ( P = 1.0). The sensitivity rate of two or more areas of redistribution was 11% (95% CI, 0.3%-48%), the specificity rate was 90%, and the positive and negative predictive values were 12.5% and 89%, respectively. Conclusion: Our study demonstrated no association between reversible defects on DTHAL/DMIBI and adverse cardiac events in moderate-risk patients undergoing elective vascular surgery. (J Vasc Surg 2000;32:77-89.)

Background: Initial nonoperative treatment for patients with periappendiceal mass has been shown to be safe and effective. Our goal was to evaluate the safety and efficacy of initial nonoperative management for perforated appendicitis not accompanied by a palpable mass. Methods: The study population consisted of 77 patients with appendicitis treated initially nonoperatively between 1992 and 1998. All had localized abdominal tenderness and computed tomography findings of abscess or phlegmon. None had a palpable abdominal mass. Outcome parameters evaluated were rate of failure, complication, and recurrence. Results: There were 49 males and 28 females with a mean age of 35 years (range 16 to 75). Initial nonoperative management was successful in 95% of patients. Complications occurred in 12% of patients. Recurrent appendicitis developed in 6.5% of patients after an average follow-up of 30 weeks. Conclusions: Perforated appendicitis patients with localized abdominal tenderness and abscess or phlegmon can safely and effectively be treated in an initial nonoperative fashion.

Objectives In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. Methods Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. Results Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. Conclusions Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.

Previous studies have suggested that the degree of difference between rectal temperature and peripheral skin temperature [rectal-skin temperature difference (RSTD)] is predictive of serious illness in young infants. The authors sought to determine the clinical utility of the RSTD in the outpatient evaluation of infants up to 2 months of age for serious infectious illness (SII).Simultaneous rectal and skin (anterior mid-lower leg) temperatures were recorded for all infantsor = 2 months of age seen in the ED over a one-year period. The physician's clinical assessment, rectal temperature, skin temperature, laboratory results, and final diagnoses were also recorded. The RSTD (rectal temperature - skin temperature) was calculated for each infant. Final diagnoses were recorded and classified as SII or nonserious illness (NSI). Mean RSTD for each group was calculated and data were analyzed by the Wilcoxon rank sum test and multivariate regression model.A total of 601 infants [mean age of 28 days (range 2-65 days)] were enrolled. Nine percent (57 of 601) of infants had SII. Forty percent (23 of 57) of infants with SII were febrile, and 60% (34 of 57) were afebrile. The mean RSTD of febrile infants with SII was 5.8 +/- 1.7 degrees C (range 3.2-9.7 degrees C) and 5.3 +/- 1.4 degrees C (range 3.0-7.6 degrees C) for febrile infants with NSI. The mean RSTD of afebrile infants with SII was 4.8 +/- 1.8 degrees C (range 2-12.5 degrees C) and 4.4 +/- 1.5 degrees C (range 0.04-10.9 degrees C) for afebrile infants with NSI. The RSTD was not associated with SII in either febrile or afebrile infants (p0.05, Wilcoxon rank sum test). A multivariate logistic regression model of age, rectal temperature, and RSTD suggested an independent association of rectal temperature with SII (p0.0001), but none between age or RSTD and SII (p0.05).Once the rectal temperature is known, the RSTD is not a clinically useful test in the evaluation of young infants for serious infectious illness.

The ability of the Eagle criteria (age70 years, angina, diabetes, Q wave on EKG, history of congestive heart failure) to predict adverse cardiac events following major vascular surgery has previously been demonstrated. However, the utility of these criteria for lower-extremity amputation is not well established. To determine the value of the Eagle criteria for predicting cardiac morbidity and operative mortality following major lower-extremity amputation, we reviewed 214 consecutive procedures performed at two institutions over a 3-year period. Mean age was 62.7 years and 85% of the patients were male. Diabetes was the most frequent Eagle criterion (74%). The mean number of Eagle criteria was 1.6. Fifty-six percent of the amputations were below the knee, 24% were above the knee, and 20% were guillotine. On multivariate regression analysis, the presence of two or more Eagle criteria (16% vs. 4%, p = 0.04) and decompensated heart failure (39% vs. 7%, p = 0.003) were predictive of adverse cardiac events. The only predictor of postoperative mortality was the presence of two or more Eagle criteria (15% vs. 4%, p = 0.004). Our evaluation of the results of this study led us to conclude that patients requiring major lower-extremity amputation for major vascular disease who have multiple Eagle criteria or decompensated congestive heart failure are at high risk for adverse cardiac events and postoperative death. These findings should be used to guide perioperative cardiac evaluation and therapy.

Eighty-nine male veterans presenting to a vascular surgery clinic with symptomatic lower extremity atherosclerosis were prospectively screened by duplex scan for asymptomatic carotid artery stenosis (CAS). Their chief complaint was: claudication (90%), rest pain (6%), and ischemic ulcer or gangrene (4%). The mean ankle-brachial index (ABI) was 0.77. Twenty-five CAS50% were detected in 18 (20%) patients. Twelve CAS75% were detected in 11 (12%) patients. There was no difference between patients with and without CAS50% with regards to mean ABI, history of angina, diabetes, hypertension, prior coronary artery bypass, or history of smoking. Carotid bruit was associated with ipsilateral CAS50% [p0.0001, sensitivity (52%), specificity (88%), positive predictive value (41%), negative predictive value (92%)]. As a result of the screening, eight elective carotid endarterectomies have been performed to date in six (7%) patients with one transient twelfth cranial nerve paresis as the only postoperative complication. We conclude that: (1) male patients presenting with symptomatic lower extremity atherosclerosis have a 20% prevalence of asymptomatic CAS50%, (2) there is no correlation between the degree of lower extremity ischemia and CAS50%, (3) carotid bruit is significantly associated with CAS50%, but has a low sensitivity, and (4) routine CAS screening should be considered for all male patients with symptomatic lower extremity atherosclerosis regardless of whether a bruit is present.

Objectives: The objective was to determine if use of ultrasound (US) by emergency physicians (EPs) to localize spinal landmarks improves the performance of lumbar puncture (LP). Methods: This was a prospective, randomized, controlled study conducted in a county teaching hospital. Subjects, adults 18 years of age or older who were to receive LPs for routine clinical care in the emergency department (ED), were randomized either to undergo US localization of the puncture site or to have the puncture site determined by palpation of spinal landmarks. Primary outcomes were the number of needle insertion attempts and success of the procedure. Secondary outcomes were pain associated with the procedure, time to perform the procedure, number of traumatic taps, and patient satisfaction with the procedure. Results: One-hundred patients were enrolled in the study, with 50 in each study group. There were no significant differences between the two groups in terms of age, sex, body mass index (BMI), indication for LP, or ease of palpation of landmarks. For both primary outcomes and secondary outcomes there were no significant differences between those undergoing US localization and those with palpation alone. Conclusions: These data do not suggest any advantage to the routine use of US localization for LP insertion, although further study may be warranted to look for benefit in the difficult to palpate or obese patient subgroups. ACADEMIC EMERGENCY MEDICINE 2014; 21:130–136 © 2014 by the Society for Academic Emergency Medicine

Dipyridamole-sestamibi (PMIBI) is recommended prior to vascular surgery in patients with > or = 1 Eagle criteria (Q waves, history of ventricular ectopy, diabetes, advanced age, and/or angina). To review our cardiac morbidity and mortality and the need for preoperative PMIBI, we reviewed 109 consecutive patients with a mean age of 59 years who underwent 145 elective major vascular procedures over a 1-year period. Seventy patients (with a mean of 0.8 Eagle criteria) underwent 92 vascular procedures without preoperative PMIBI and without coronary revascularization. Thirty-one patients (with a mean of 1.1 Eagle criteria) underwent 39 procedures without coronary revascularization following PMIBI, which showed reversible ischemia in seven and a fixed defect in 10; findings were normal in 14. Preoperative coronary bypass or angioplasty was limited to eight patients (14 procedures, mean of 1.6 Eagle criteria) who had unstable angina with (2 patients) or without (6 patients) acute myocardial infarction. There were four perioperative myocardial infarctions (2.8%), seven cardiac events overall (4.8%), and one cardiac death (0.7%). Three (43%) of the seven cardiac events occurred in patients with a normal scan or fixed defect on PMIBI imaging. In the absence of unstable angina, PMIBI had a sensitivity of only 25% and a specificity of 80% for cardiac events. We conclude that among patients without severe cardiac symptoms (1) PMIBI has a very limited ability to identify patients at risk for cardiac complications, and (2) preoperative PMIBI is neither necessary nor cost-effective.

No method currently exists to predict which patients with acute AIDS-associated cryptococcal meningitis can be effectively treated with fluconazole. The objective of this study was to determine the relationship of cryptococcal susceptibility to fluconazole, along with clinical variables, to the risk of treatment failure for patients with acute AIDS-associated cryptococcal meningitis. Results of in vitro fluconazole susceptibility testing of cryptococcal isolates and data from two clinical trials were analyzed. Susceptibility to fluconazole was determined by means of both microtiter and macrobroth (M27-P) dilution methods. Treatment was defined as successful if the patient was alive at 10 weeks and if a cerebrospinal fluid culture was sterile at that time. Seventy-six patients receiving fluconazole:±: flucytosine were included; therapy failed for 19. Patients whose therapy failed were more likely to have a positive blood and urine culture and a higher titer in serum and cerebrospinal fluid of cryptococcal antigen, and the MIC of fluconazole against their isolates (as determined by the microtiter method) was more likely to be higher; they were less likely to have received flucytosine. Logistic regression modeling revealed that a negative blood culture, a low MIC of fluconazole (per the microtiter method), and treatment with flucytosine were factors independently associated with successful treatment. Cryptococcal meningitis is the most common life-threatening fungal infection in patients with AIDS, occurring in up to 10% of patients with AIDS in the United States [1-3]. Standard therapy for acute cryptococcal meningitis consists of adminis­ tration of amphotericin B alone or in combination with flucy­ tosine; this regimen is curative for 75%-85% of patients who

Study objective We identify differences in the process of care for admitted patients who board in the emergency department (ED) compared with admitted patients who are transferred to an inpatient care area. Methods This is a retrospective study of a random sample of adult patients admitted through the ED at one urban teaching hospital. Patients who boarded in the ED for at least 6 hours after the decision to admit were matched to similar control patients. Data were collected by 2 trained medical students using a standardized data abstraction tool. All physician orders placed in the first 24 hours after admission orders were signed were identified. The medical record was searched for documentation of order completion. Each order was classified as being executed on time, delayed, or missed. Results Of 848 patients screened for inclusion in the study, a total of 145 matched case-control pairs were included, making a total of 290 patients. A total of 9,260 distinct orders were identified. Use of a generalized estimating equation that controlled for correlation within subjects showed that orders were less likely to be completed on time for boarders than for controls (odds ratio [OR] 0.46; 95% confidence interval [CI] 0.38 to 0.55). Among boarders, orders were more likely to be either delayed (OR 1.84; 95% CI 1.46 to 2.30) or missed entirely (OR 2.58; 95% CI 1.94 to 3.42). Boarders missed a median of 11 orders during their first 24 hours of admission compared with 6 orders for control patients. Conclusion This study detected an important process difference between boarded patients compared with control patients, which could explain previously suggested outcome differences between these 2 groups. This provides additional support for efforts to move patients to inpatient care areas in a timely fashion rather than board in the ED.

Study objectives: To determine whether admission to an acute care hospital is medically justified for all patients with acute stroke or transient ischemic attack (TIA) and whether those patients for whom admission is justified can be identified in the emergency department. Design: Retrospective descriptive study. Setting: Urban county teaching hospital. Participants: Consecutive adult patients seen in an ED with nonhemorrhagic stroke, TIA, or hemorrhagic stroke. Methods: Admission to an acute care hospital was deemed medically justified when the patient had any of the following criteria: another diagnosis that warranted admission, an inadequate home situation, altered mental status, or an adverse event during hospitalization or if they underwent hospital-based treatment that could not be provided on an outpatient basis. Results: One hundred sixty-eight patients were seen during a 1-year period: 120 had an ED diagnosis of nonhemorrhagic stroke, 22 had a diagnosis of TIA, and 26 had a diagnosis of hemorrhagic stroke. One hundred sixty-one patients (96%) were admitted to our hospital. Sixty-three of the 161 admissions (39%) were retrospectively categorized as medically justified. Seventeen of the 63 patients (27%) whose admissions were medically justified developed the criteria justifying their admission after leaving the ED. Conclusion: The practice of admitting all patients with nonhemorrhagic stroke, TIA, or hemorrhagic stroke to an acute care hospital is medically justified because the ED evaluation cannot reliably identify patients whose condition will worsen. [Henneman PL, Lewis RJ: Is admission medically justified for all patients with acute stroke or transient ischemic attack? Ann Emerg Med April 1995;25:458-463.]

In Reply Dr Stevens and colleagues highlight the KNN method and further the discussion about moving away from overly simplistic, biased methods for handling missing values. Our review of missing data methods was not exhaustive. For simplicity and clarity, we focused on methods that are more common in practice and readily available in statistical software packages. As a result, we omitted certain viable techniques for handling missing values (eg, KNN, hot-deck imputation, and maximum likelihood estimation).

Over the past decade, clinicians have become increasingly reliant on computed tomography (CT) for the evaluation of patients with suspected acute appendicitis. To limit the radiation risks and costs of CT, investigators have searched for biomarkers to aid in diagnostic decision-making. We evaluated one such biomarker, calprotectin or S100A8/A9, and determined the diagnostic performance characteristics of a developmental biomarker assay in a multicenter investigation of patients presenting with acute right lower quadrant abdominal pain.This was a prospective, double-blinded, single-arm, multicenter investigation performed in 13 emergency departments (EDs) from August 2009 to April 2010 of patients presenting with acute right lower quadrant abdominal pain. Plasma samples were tested using the investigational S100A8/A9 assay. The primary outcome of acute appendicitis was determined by histopathology for patients undergoing appendectomy or 2-week telephone follow-up for patients discharged without surgery. The sensitivity, specificity, negative likelihood ratio (LR-), and positive likelihood ratio (LR+) of the biomarker assay were calculated using the prespecified cutoff value of 14 units. A post hoc stability study was performed to investigate the potential effect of time and courier transport on the measured value of the S100A8/A9 assay test results.Of 1,052 enrolled patients, 848 met criteria for analysis. The median age was 24.5 years (interquartile range [IQR] = 16-38 years), 57% were female, and 50% were white. There was a 27.5% prevalence of acute appendicitis. The sensitivity and specificity for the investigational S100A8/A9 assay in diagnosing acute appendicitis were estimated to be 96% (95% confidence interval [CI] = 93% to 98%) and 16% (95% CI = 13% to 19%), respectively. The LR- ratio was 0.24 (95% CI = 0.12 to 0.47), and the LR+ was 1.14 (95% CI = 1.10 to 1.19). The post hoc stability study demonstrated that in the samples that were shipped, the estimated time coefficient was 7.6 × 10(-3) ± 2.0 × 10(-3) log units/hour, representing an average increase of 43% in the measured value over 48 hours; in the samples that were not shipped, the estimated time coefficient was 2.5 × 10(-3) ± 0.4 × 10(-3) log units/hour, representing a 13% increase on average in the measured value over 48 hours, which was the maximum delay allowed by the study protocol. Thus, adjusting the cutoff value of 14 units by the magnitude of systematic inflation observed in the stability study at 48 hours would result in a new cutoff value of 20 units and a "corrected" sensitivity and specificity of 91 and 28%, respectively.In patients presenting with acute right lower quadrant abdominal pain, we found the investigational enzyme-linked immunosorbent assay (ELISA) test for S100A8/A9 to perform with high sensitivity but very limited specificity. We found that shipping effect and delay in analysis resulted in a subsequent rise in test values, thereby increasing the sensitivity and decreasing the specificity of the test. Further investigation with hospital-based laboratory analyzers is the next critical step for determining the ultimate clinical utility of the ELISA test for S100A8/A9 in ED patients presenting with acute right lower quadrant abdominal pain.

Study objectives: To determine which adult patients with new-onset seizures require admission and whether those who require admission can be identified in the emergency department. Design: Retrospective chart review of patients seen during a 5-yearperiod. Setting: Urban county teaching hospital in southern California. Participants: Three hundred thirty-three adult patients with new-onset seizures. Patients were excluded if they had acute head trauma, hypoglycemia from diabetic therapy, or alcohol- or recreational drug-related seizures. Interventions: Standardized medical evaluation including physical examination, CBC, SMA-7 (electrolytes, blood urea nitrogen, creatinine, glucose), calcium, cranial computed tomography (CT), lumbar puncture if indicated, and admission to the hospital. Results: Forty-six percent of patients (136 of 294) admitted toour hospital required admission as judged by a retrospective evaluation of the ED and hospital course. The numbers of patients who had a clinically significant result with each part of the evaluation were: physical examination, 75 of 333 (23%); CBC, 25 of 319 (8%); SMA-7, 21 of 329 (6%); calcium, 2 of 208 (1%); CT, 134 of 325 (41%); and lumbar puncture, 19 of 227 (8%). Ninety-five percent of patients requiring admission (129 of 136) were detected by the standardized medical evaluation. Conclusion: One half of patients with new-onset seizures require admission. Patients with new-onset seizures who require admission can usually be detected by a standardized medical evaluation in the ED.

Study objective: To determine the efficacy and feasibility of adenosine for the treatment of paroxysmal supraventricular tachycardia (PSVT) in the prehospital setting. Design: Prospective case series. Setting: Large, urban, advanced life support emergency medical services system. Participants: One hundred twenty-nine adult patients with PSVT, as identified by paramedic personnel. Pregnant patients and those taking carbamazepine or dipyridamole were excluded. Interventions: Dose of 12 mg adenosine by rapid IV push followed by a 5-mL saline flush and a repeat dose of 12 mg adenosine IV push if the patient's rhythm remained unchanged. Measurements and main results: Six-second lead II rhythm strips and vital signs were documented before and 2 minutes after the administration of adenosine. Demographic information, past medical history, medications, number of adenosine doses given, and complications were recorded by the paramedic on a case-report form. One hundred six of 129 (82%) of the case-report forms included the rhythm strips from before and after adenosine administration. Actual initial rhythms were determined by a consensus panel. The initial rhythms were PSVT in 79% (84 of 106) of patients, atrial fibrillation in 12% (13 of 106), sinus tachycardia in 5% (five of 106), atrial flutter in 2% (two of 106), and ventricular tachycardia in 2% (two of 106). Eighty-five percent (71 of 84) of patients in PSVT were successfully converted to sinus rhythms; four (5.6%) of these patients required a second 12-mg dose. One patient in atrial fibrillation spontaneously converted to normal sinus rhythm and one patient in ventricular tachycardia converted after adenosine. All other patients not initially in PSVT remained in their initial rhythm. Complications occurred in 12 of 129 patients and included chest pain (five), flushing (three), shortness of breath (two), nausea (one), anxiety (one), dizziness (one), headache (one), and seizure (one). All complications were transient and required no treatment. Prior history of PSVT was the only variable associated with a higher rate of conversion ( P =.029). Conclusion: Paramedics are able to accurately identify PSVT using a single lead. Adenosine is safe and effective treatment for PSVT in the prehospital setting. This series is the largest prehospital study of adenosine use to date. [Gausche M, Persse DE, Sugarman T, Shea SR, Palmer GL, Lewis RJ, Brueske PJ, Mahadevan S, Melio FR, Kuwata JH, Niemann JT: Adenosine for the prehospital treatment of paroxysmal supraventricular tachycardia. Ann Emerg Med August 1994;24:183-189.]

To determine the clinical characteristics associated with early post-traumatic seizures in children with head trauma. DESIGN, SETTING, AND TYPE OF PARTICIPANTS: Retrospective chart review; urban trauma center/pediatric emergency department. Trauma patients aged 3 months to 15 years given discharge diagnosis ICD-9-CM codes indicating head trauma and seen from 1988 to 1990 were eligible for the study.None.Of 194 patients, 96% suffered blunt trauma and 53% had a loss of consciousness. Fifty-one percent of 141 computed tomography (CT) scans of the head were abnormal, most frequently demonstrating skull fractures (34%), subdural hematomas (15%), and cerebral contusions (14%). Eighteen patients (9.3%) suffered post-traumatic seizures. A loss of consciousness, a low Glasgow Coma Scale (GCS) score (3 to 8), and an abnormal CT scan were associated with post-traumatic seizures (P.02, .001, and .02, respectively). However, only a low GCS score was predictive of post-traumatic seizures when these factors were considered simultaneously (P.001), with 38.7% of patients with low GCS scores suffering post-traumatic seizures and 3.8% of patients with high GCS scores suffering post-traumatic seizures. In children with low GCS scores, treatment with phenytoin was associated with a decrease in post-traumatic seizures.In the pediatric head trauma patient, a GCS score of 3 to 8 appears to be predictive of post-traumatic seizures. The data from this retrospective study are consistent with the hypothesis that prophylactic phenytoin reduces post-traumatic seizures in the pediatric head trauma patient with a low GCS score.

BACKGROUND Early countershock of ventricular fibrillation has been shown to improve immediate and long-term outcome of cardiac arrest. However, a number of investigations in the laboratory and in the clinical population indicate that immediate countershock of prolonged ventricular fibrillation most commonly is followed by asystole or a nonperfusing spontaneous cardiac rhythm, neither of which rarely respond to current therapy. The use of epinephrine in doses greater than those currently recommended has recently been shown to improve both cerebral and myocardial perfusion during cardiopulmonary resuscitation (CPR). The purpose of this study was to compare cardiac resuscitation outcome between immediate countershock of prolonged ventricular fibrillation with high-dose epinephrine therapy and conventional CPR before countershock of prolonged ventricular fibrillation in a canine model. METHODS AND RESULTS After sedation, intubation, induction of anesthesia, and instrumentation, ventricular fibrillation was electrically induced in 28 dogs. After 7.5 minutes of ventricular fibrillation, animals were randomly allocated to two treatment groups: group 1, immediate countershock followed by recommended advanced cardiac life support (ACLS) interventions, or group 2, 0.08 mg/kg epinephrine and manual closed-chest CPR before countershock and ACLS. In both groups, ACLS was continued until a spontaneous perfusing rhythm was restored or for 20 minutes (total arrest time, 27.5 minutes). A spontaneous perfusing rhythm was restored in three of 14 group 1 animals and in nine of 14 group 2 animals (p = 0.014 by sequential analysis method of Whitehead). Coronary perfusion pressure (aortic minus right atrial pressure during CPR diastole) before countershock was significantly greater in group 2 (21 +/- 7 mm Hg) when compared with mean circulatory pressure in group 1 (9 +/- 8, p less than 0.01). CONCLUSIONS The findings of this study suggest that a brief period of myocardial perfusion before countershock improves cardiac resuscitation outcome from prolonged ventricular fibrillation.

Accepted guidelines for preoperative endoscopic retrograde cholangiopancreatography (ERCP) in gallstone pancreatitis are lacking. Our previous investigations suggested that serum total bilirubin on hospital Day 2 best predicts persisting common bile duct (CBD) stones. We aim to identify an optimal total bilirubin threshold on hospital Day 2 that would predict persisting CBD stones and guide obtaining preoperative ERCP. Prospective and retrospective data were available from 200 consecutive patients with gallstone pancreatitis at a public teaching hospital from 2003 through 2007. Charts were examined for persisting CBD stones on ERCP and/or intraoperative cholangiography during laparoscopic cholecystectomy. Patients with cholangitis (n = 18) were excluded. Nineteen of the remaining 182 (10%) patients had CBD stones. Mean hospital Day 2 bilirubin was 3.7 mg/dL for patients with CBD stones versus 1.4 mg/dL for those without (P < 0.0001). Seventeen patients (9%) had total bilirubin 4 or greater on hospital Day 2. Of these, eight (4%) had CBD stones (specificity 94%). Of the 165 patients with total bilirubin less than 4, 11 (7%) had CBD stones (P < 0.0001). In gallstone pancreatitis, a serum total bilirubin level 4 mg/dL or greater on hospital Day 2 predicts persisting CBD stones with enough specificity to serve as a practical guideline for ERCP while minimizing unnecessary procedures.

BACKGROUND Considerable concern has been raised about the effects of restricted duty hours on surgical training. However, to our knowledge, the effect of the 80-hour resident workweek on operative outcomes after laparoscopic cholecystectomy has not been well studied. OBJECTIVE To compare the rates of bile duct injury and overall complications after laparoscopic cholecystectomy before and after the institution of the duty-hour restriction. DESIGN Retrospective review of patient medical records to determine morbidity and mortality before (January 1, 2000, to June 30, 2003; period 1) and after (July 1, 2003, to June 30, 2006; period 2) implementation of duty hour limitations. SETTING Major public teaching hospital. PATIENTS A total of 2470 patients who had undergone laparoscopic cholecystectomy. MAIN OUTCOME MEASURES Bile duct injury and overall complication rates as determined using multivariate analysis. RESULTS Overall, 2470 laparoscopic cholecystectomy procedures were performed, including 1353 in period 1 and 1117 in period 2. In period 2, more patients had acute cholecystitis as the indication for surgery (49% vs 35% in period 1, P < .001), and a higher percentage of patients were male (22% vs 18%, P = .01). The incidence of bile duct injury and total complications decreased in period 2 from 1% to 0.4%(P = .04) and from 5% to 2% (P < .001), respectively. Mortality was unchanged. Multivariate analysis revealed that period 2 was protective for bile duct injury (odds ratio, 0.31; 95% confidence interval, 0.1-0.96; P = .04). For complications, both female sex (odds ratio, 0.62; 95% confidence interval, 0.38-0.9) and surgery during period 2 (odds ratio, 0.46; 95% confidence interval, 0.28-0.75) were protective, whereas older age (odds ratio, 1.03; 95% confidence interval, 1.02-1.05) was associated with complications. CONCLUSION At a major public teaching hospital, the bile duct injury rate and the overall complication rate decreased after implementation of the 80-hour workweek.