Craig D. Newgard

Rationale, Development and Implementation of the Resuscitation Outcomes Consortium Epistry–Cardiac Arrest

OBJECTIVE To describe the development, design and consequent scientific implications of the Resuscitation Outcomes Consortium (ROC) population-based registry; ROC Epistry-Cardiac Arrest. METHODS The ROC Epistry--Cardiac Arrest is designed as a prospective population-based registry of all Emergency Medical Services (EMSs)-attended 9-1-1 calls for patients with out-of-hospital cardiac arrest occurring in the geographical area described by the eight US and three Canadian regions. The dataset was derived by an North American interdisciplinary steering committee. Enrolled cases include individuals of all ages who experience cardiac arrest outside the hospital, with evaluation by organized EMS personnel and: (a) attempts at external defibrillation (by lay responders or emergency personnel), or chest compressions by organized EMS personnel; (b) were pulseless but did not receive attempts to defibrillate or CPR by EMS personnel. Selected data items are categorized as mandatory or optional and undergo revisions approximately every 12 months. Where possible all definitions are referenced to existing literature. Where a common definition did not exist one was developed. Optional items include standardized CPR process data elements. It is anticipated the ROC Epistry--Cardiac Arrest will enroll between approximately 9000 and 13,500 treated all rhythm arrests and 4000 and 5000 ventricular fibrillation arrests annually and approximately 8000 EMS-attended but untreated arrests. CONCLUSION We describe the rationale, development, design and future implications of the ROC Epistry--Cardiac Arrest. This paper will serve as the reference for subsequent ROC manuscripts and for the common data elements captured in both ROC Epistry--Cardiac Arrest and the ROC trials.

Out-of-Hospital Hypertonic Resuscitation Following Severe Traumatic Brain Injury: A Randomized Controlled Trial

CONTEXT Hypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury (TBI). OBJECTIVE To determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, randomized, placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium, conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock. Planned enrollment was 2122 patients. INTERVENTION A single 250-mL bolus of 7.5% saline/6% dextran 70 (hypertonic saline/dextran), 7.5% saline (hypertonic saline), or 0.9% saline (normal saline) initiated in the out-of-hospital setting. MAIN OUTCOME MEASURE Six-month neurologic outcome based on the Extended Glasgow Outcome Scale (GOSE) (dichotomized as >4 or ≤4). RESULTS The study was terminated by the data and safety monitoring board after randomization of 1331 patients, having met prespecified futility criteria. Among the 1282 patients enrolled, 6-month outcomes data were available for 1087 (85%). Baseline characteristics of the groups were equivalent. There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ≤4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, -4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, -4.0% to 9.7%]; P = .67). There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group. Survival at 28 days was 74.3% with hypertonic saline/dextran, 75.7% with hypertonic saline, and 75.1% with normal saline (P = .88). CONCLUSION Among patients with severe TBI not in hypovolemic shock, initial resuscitation with either hypertonic saline or hypertonic saline/dextran, compared with normal saline, did not result in superior 6-month neurologic outcome or survival. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00316004.

Mortality Benefit of Transfer to Level I versus Level II Trauma Centers for Head-Injured Patients

OBJECTIVE To determine whether head-injured patients transferred to level I trauma centers have reduced mortality relative to transfers to level II trauma centers. DATA SOURCE/STUDY SETTING Retrospective cohort study of 542 patients with head injury who initially presented to 1 of 31 rural trauma centers in Oregon and Washington, and were transferred from the emergency department to 1 of 15 level I or level II trauma centers, between 1991 and 1994. STUDY DESIGN A bivariate probit, instrumental variables model was used to estimate the effect of transfer to level I versus level II trauma centers on 30-day postdischarge mortality. Independent variables included age, gender, Injury Severity Scale (ISS), other indicators of injury severity, and a dichotomous variable indicating transfer to a level I trauma center. The differential distance between the nearest level I and level II trauma centers was used as an instrument. PRINCIPAL FINDINGS Patients transferred to level I trauma centers differ in unmeasured ways from patients transferred to level II trauma centers, biasing estimates based on standard statistical methods. Transfer to a level I trauma center reduced absolute mortality risk by 10.1% (95% confidence interval 0.3%, 22.2%) compared with transfer to level II trauma centers. CONCLUSIONS Patients with severe head injuries transferred from rural trauma centers to level I centers are likely to have improved survival relative to transfer to level II centers.

Pretest probability assessment derived from attribute matching

BackgroundPretest probability (PTP) assessment plays a central role in diagnosis. This report compares a novel attribute-matching method to generate a PTP for acute coronary syndrome (ACS). We compare the new method with a validated logistic regression equation (LRE).MethodsEight clinical variables (attributes) were chosen by classification and regression tree analysis of a prospectively collected reference database of 14,796 emergency department (ED) patients evaluated for possible ACS. For attribute matching, a computer program identifies patients within the database who have the exact profile defined by clinician input of the eight attributes. The novel method was compared with the LRE for ability to produce PTP estimation <2% in a validation set of 8,120 patients evaluated for possible ACS and did not have ST segment elevation on ECG. 1,061 patients were excluded prior to validation analysis because of ST-segment elevation (713), missing data (77) or being lost to follow-up (271).ResultsIn the validation set, attribute matching produced 267 unique PTP estimates [median PTP value 6%, 1st–3rd quartile 1–10%] compared with the LRE, which produced 96 unique PTP estimates [median 24%, 1st–3rd quartile 10–30%]. The areas under the receiver operating characteristic curves were 0.74 (95% CI 0.65 to 0.82) for the attribute matching curve and 0.68 (95% CI 0.62 to 0.77) for LRE.The attribute matching system categorized 1,670 (24%, 95% CI = 23–25%) patients as having a PTP < 2.0%; 28 developed ACS (1.7% 95% CI = 1.1–2.4%). The LRE categorized 244 (4%, 95% CI = 3–4%) with PTP < 2.0%; four developed ACS (1.6%, 95% CI = 0.4–4.1%).ConclusionAttribute matching estimated a very low PTP for ACS in a significantly larger proportion of ED patients compared with a validated LRE.

Hypertonic Resuscitation: Design and Implementation of a Prehospital Intervention Trial

BACKGROUND Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonic saline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients. STUDY DESIGN Two multicenter, randomized, clinical trials were designed to compare hypertonic saline resuscitation with or without dextran with conventional isotonic resuscitation in patients with hypovolemic shock or traumatic brain injury. During a 3-year period, 5,848 patients will be randomized, with a primary end point of 28-day survival in the hypovolemic shock cohort and 6-month neurologic outcomes in the traumatic brain injury cohort. RESULTS This is a report of the study design and implementation of 2 large-scale prehospital intervention trials from the Resuscitation Outcomes Consortium that qualify for exception from informed consent required for emergency research outlined in FDA regulation 21CFR50.24 and the Canadian Tri-Council Agreement for research in emergency health situations (Article 2.8). CONCLUSIONS We have successfully designed and implemented two prehospital intervention trials. The proc-ess has helped define the numerous challenges that must be overcome to pursue exception from informed consent resuscitation research in the prehospital setting. The results of these studies will hopefully advance and improve the early care of the severely injured patient.

The Cost Of Overtriage: More Than One-Third Of Low-Risk Injured Patients Were Taken To Major Trauma Centers

Regionalized trauma care has been widely implemented in the United States, with field triage by emergency medical services (EMS) playing an important role in identifying seriously injured patients for transport to major trauma centers. In this study we estimated hospital-level differences in the adjusted cost of acute care for injured patients transported by 94 EMS agencies to 122 hospitals in 7 regions, overall and by injury severity. Among 301,214 patients, the average adjusted per episode cost of care was

Racial disparities in mortality among adults hospitalized after injury.

5,590 higher in a level 1 trauma center than in a nontrauma hospital. We found hospital-level differences in cost among patients with minor, moderate, and serious injuries. Of the 248,342 low-risk patients-those who did not meet field triage guidelines for transport to trauma centers-85,155 (34.3 percent) were still transported to major trauma centers, accounting for up to 40 percent of acute injury costs. Adhering to field triage guidelines that minimize the overtriage of low-risk injured patients to major trauma centers could save up to

A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

136.7 million annually in the seven regions we studied.

Use of pulse oximetry to predict in-hospital complications in normotensive patients with pulmonary embolism

Background:Injury is a major cause of death in adults. Although racial disparities in healthcare access and health outcomes are well documented for medical conditions, the influence of race on access to emergent care after injury has received little scrutiny. Objectives:We sought to determine whether race was associated with risk of in-hospital death after injury. Research Design:Data from the Healthcare Cost and Utilization Project (1998–2002) were used to estimate multivariate models of in-hospital mortality, controlling for age, race, gender, comorbid conditions, injury severity, primary payer, median income of zip code of residence, and hospital type. Additional multivariate models were estimated among stratified subsets of patients, including injury severity and hospital type. Subjects:Patients age 18–64 with a primary diagnosis of injury. Results:Relative to injured white patients, black and Asian patients had a higher risk of death [1.5% vs. 2.1% and 2.0%, multivariate odds ratios (OR) = 1.14 and 1.39]. Other racial/ethnic groups showed no significant mortality difference from white patients. In stratified analyses, we found large black-white mortality disparities among mild to moderately injured patients (OR = 1.40, 95% confidence interval: 1.18–1.66), whereas Asian-white disparities were concentrated among more severely injured patients (OR = 1.37, 95% confidence interval: 1.03–1.80). Conclusions:Black and Asian patients have a higher risk of death after injury than white patients. These data raise important questions about access to quality trauma care for racial minority patients.

Methodology and analytic rationale for the American College of Surgeons Trauma Quality Improvement Program.

BACKGROUND Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) of 90 mm Hg or lower. CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater. The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival. RESULTS A total of 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. The mean (SD) crystalloid volume administered during the study period was 1.0 L (1.5) in the CR group and 2.0 L (1.4) in the SR group, a difference of 1.0 L (95% confidence interval [CI], 0.6–1.4). Intensive care unit–free days, ventilator-free days, renal injury, and renal failure did not differ between the groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio, 0.39; 95% CI, 0.12–1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03–0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19–19.17). CONCLUSION CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted. LEVEL OF EVIDENCE Therapeutic study, level I.