Title

Increased survival after EMS witnessed cardiac arrest. Observations from the Resuscitation Outcomes Consortium (ROC) Epistry-Cardiac arrest.


Citation Hostler D, Thomas EG, Emerson SS, Christenson J, Stiell IG, Rittenberger JC, Gorman KR, Bigham BL, Callaway CW, Vilke GM, Beaudoin T, Cheskes S, Craig A, Davis DP, Reed A, Idris A, Nichol G, ROC Investigators. Increased survival after EMS witnessed cardiac arrest. Observations from the Resuscitation Outcomes Consortium (ROC) epistry-cardiac arrest. Resuscitation 2010; 81(7):826-830. PMCID: PMC2893256

Abstract BACKGROUND Out of hospital cardiac arrest (OHCA) is common and lethal. It has been suggested that OHCA witnessed by EMS providers is a predictor of survival because advanced help is immediately available. We examined EMS witnessed OHCA from the Resuscitation Outcomes Consortium (ROC) to determine the effect of EMS witnessed vs. bystander witnessed and unwitnessed OHCA.

METHODS Data were analyzed from a prospective, population-based cohort study in 10 U.S. and Canadian ROC sites. Individuals with non-traumatic OHCA treated 04/01/06-03/31/07 by EMS providers with defibrillation or chest compressions were included. Cases were grouped into EMS-witnessed, bystander witnessed, and unwitnessed and further stratified for bystander CPR. Multiple logistic regressions evaluated the odds ratio (OR) for survival to discharge relative to the EMS-witnessed group after adjusting for age, sex, public/private location of collapse, ROC site, and initial ECG rhythm. Of 9991 OHCA, 1022 (10.2%) of EMS-witnessed, 3369 (33.7%) bystander witnessed, and 5600 (56.1%) unwitnessed.

RESULTS The most common initial rhythm in the EMS-witnessed group was PEA which was higher than in the bystander- and unwitnessed groups (p<0.001). The adjusted OR (95% CI) of survival compared to the EMS-witnessed group was 0.41, (0.36, 0.46) in bystander witnessed with bystander CPR, 0.37 (0.33, 0.43) in bystander witnessed without bystander CPR, 0.17 (0.14, 0.20) in unwitnessed with bystander CPR and 0.21 (0.18, 0.24) in unwitnessed cases without bystander CPR.

CONCLUSIONS Immediate application of prehospital care for OHCA may improve survival. Efforts should be made to educate patients to access 9-1-1 for prodromal symptoms.


Title

Chest compression fraction: A time dependent variable of survival in shockable out-of-hospital cardiac arrest.


Citation Cheskes S, Schmicker RH, Rea T, Powell J, Drennan IR, Kudenchuk P, Vaillancourt C, Conway W, Stiell I, Stub D, Davis D, Alexander N, Christenson J, and the ROC Investigators. Chest compression fraction: A time dependent variable of survival in shockable out-of-hospital cardiac arrest. Resuscitation 2015; 97:129-135

Abstract INTRODUCTION The role of chest compression fraction (CCF) in resuscitation of shockable out-of-hospital cardiac arrest (OHCA) is uncertain. We evaluated the relationship between CCF and clinical outcomes in a secondary analysis of the Resuscitation Outcomes Consortium PRIMED trial.

METHODS We included patients presenting in a shockable rhythm who suffered OHCA prior to EMS arrival. Multivariable logistic regression was used to determine the relationship between CCF and survival to hospital discharge, return of spontaneous circulation (ROSC), and neurologically intact survival. We also performed a secondary analysis restricted to patients without ROSC in the first 10 min of EMS resuscitation.

RESULTS Among the 2011 patients, median (IQR) age was 65 (54, 75) years, 78.2% were male, and mean (SD) CCF was 0.71 (0.14). Compared to the reference group (CCF<0.60), the odds ratio (OR) for survival was 0.49 (95% CI: 0.36, 0.68) for CCF 0.60-0.79 and 0.30 (95% CI: 0.20, 0.44) for CCF≥0.80. Results were similar for outcomes of ROSC and neurologically intact survival. Conversely, when restricted to the cohort who did not achieve ROSC during the first 10 min (n=1633), compared to the reference group (CCF<0.60), the OR for survival was 0.79 (95% CI: 0.53, 1.18) for CCF 0.60-0.79 and OR 0.88 (95% CI: 0.56, 1.36) for CCF≥0.80.

CONCLUSIONS In this study of OHCA patients presenting in a shockable rhythm, CCF was paradoxically associated with lower odds of survival. CCF is a complex measure and taken by itself may not be a consistent predictor of good clinical outcomes.


Title

Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial.


Citation Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G, ROC Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ 2011; 342:d512. PMCID: PMC3033623

Abstract OBJECTIVE To investigate whether real-time audio and visual feedback during cardiopulmonary resuscitation outside hospital increases the proportion of subjects who achieved prehospital return of spontaneous circulation.

DESIGN A cluster-randomised trial.

SUBJECTS 1586 people having cardiac arrest outside hospital in whom resuscitation was attempted by emergency medical services (771 procedures without feedback, 815 with feedback).

SETTING Emergency medical services from three sites within the Resuscitation Outcomes Consortium in the United States and Canada.

INTERVENTION Real-time audio and visual feedback on cardiopulmonary resuscitation (CPR) provided by the monitor-defibrillator.

MAIN OUTCOME MEASURE Prehospital return of spontaneous circulation after CPR.

RESULTS Baseline patient and emergency medical service characteristics did not differ between groups. Emergency medical services muted the audible feedback in 14% of cases during the period with feedback. Compared with CPR clusters lacking feedback, clusters assigned to feedback were associated with increased proportion of time in which chest compressions were provided (64% v 66%, cluster-adjusted difference 1.9 (95% CI 0.4 to 3.4)), increased compression depth (38 v 40 mm, adjusted difference 1.6 (0.5 to 2.7)), and decreased proportion of compressions with incomplete release (15% v 10%, adjusted difference -3.4 (-5.2 to -1.5)). However, frequency of prehospital return of spontaneous circulation did not differ according to feedback status (45% v 44%, adjusted difference 0.1% (-4.4% to 4.6%)), nor did the presence of a pulse at hospital arrival (32% v 32%, adjusted difference -0.8 (-4.9 to 3.4)), survival to discharge (12% v 11%, adjusted difference -1.5 (-3.9 to 0.9)), or awake at hospital discharge (10% v 10%, adjusted difference -0.2 (-2.5 to 2.1)).

CONCLUSIONS Real-time visual and audible feedback during CPR altered performance to more closely conform with guidelines. However, these changes in CPR performance were not associated with improvements in return of spontaneous circulation or other clinical outcomes. Trial Registration Clinical Trials NCT00539539.


Title

The Resuscitation Outcomes Consortium Epistry-Trauma: design, development, and implementation of a North American epidemiologic prehospital trauma registry.


Citation Newgard CD, Sears GK, Rea TD, Davis DP, Pirrallo RG, Callaway CW, Atkins DL, Stiell IG, Christenson J, Minei JP, Williams CR, Morrison LJ, ROC Investigators. The Resuscitation Outcomes Consortium epistry-tauma: Design, development, and implementation of a North American Epidemiologic Prehospital Trauma Registry. Resuscitation 2008; 78:170-178. PMCID: PMC2562032

Abstract Injury is a major public health problem generating substantial morbidity, mortality, and economic burden on society. The majority of seriously injured persons are initially evaluated and cared for by prehospital providers, however the effect of emergency medical services (EMS) systems, EMS clinical care, and EMS interventions on trauma patient outcomes is largely unknown. Outcome-based information to guide future EMS care has been hampered by the lack of comprehensive, standardized, multi-center prehospital data resources that include meaningful patient outcomes. In this paper, we describe the background, design, development, implementation, content, and potential uses of the first North American comprehensive epidemiologic prehospital data registry for injured persons. This data registry samples patients from 264 EMS agencies transporting to 287 acute care hospitals in both the United States and Canada.


Title

A geospatial assessment of transport distance and survival to discharge in out of hospital cardiac arrest patients: Implications for resuscitation centers.


Citation Cudnik M, Schmicker R, Thomas L, Newgard C, Loew R, Christensen J, Davis D, Vaillancourt C, Cook A. A geospatial assessment of transport distance and survival to discharge in out of hospital cardiac arrest patients: Implications for resuscitation centers. Resuscitation 2010; 81(5):518-523. PMCID: PMC2856760

Abstract OBJECTIVES National leaders have suggested that patients with an out of hospital cardiac arrest (OOHCA) may benefit from transport to specialized hospitals. We sought to assess the survival of OOHCA patients by transport distance and hospital proximity.

METHODS Prospective, cohort study of OOHCA patients in 11 Resuscitation Outcomes Consortium (ROC) sites across North America. Transport distance and hospital proximity was calculated using weighted centroid of census tract location by Geographic Information Systems (GIS). Patients were stratified into quartiles based on transport distance to the receiving hospital calculated via GIS. Descriptive statistics were used to describe characteristics by transport distance and to compare proximity to other hospitals. Multivariate logistic regression was used to evaluate the impact of transport distance on survival.

RESULTS 26,628 patients were identified, 7540 (28%) were transported by EMS and included in the final analysis. The median transport time was 6.3 min (IQR 5.4); the median transport distance being 2.4 miles (3.9 km). Most patients were taken to the closest hospital (71.7%; N=5412). However, unadjusted survival to discharge was lower for those taken to the closest compared to further hospitals (12.1% vs. 16.5%) despite similar patient characteristics. Transport distance was not associated with survival on logistic analysis (OR 1.00; 95% CI 0.99-1.01).

CONCLUSIONS Survival to discharge was higher in OOHCA patients taken to hospitals located further than the closest hospital while transport distance was not associated with survival. This suggests that longer transport distance/time might not adversely affect outcome. Further studies are needed to inform policy decisions regarding best destination post-cardiac arrest.


Title

Out-of-hospital cardiac arrest frequency and survival: evidence for temporal variability.


Citation Brooks S, Schmicker R, Rea T, Aufderheide T, Davis D, Morrison L, Sahni R, Sears G, Griffiths D, Sopko G, Emerson S, Dorian P, ROC Investigators. Out-of-hospital cardiac arrest frequency and survival; evidence for temporal variability. Resuscitation 2010; 81(2):175-181. PMCID: PMC2815250

Abstract AIM Some cardiac phenomena demonstrate temporal variability. We evaluated temporal variability in out-of-hospital cardiac arrest (OHCA) frequency and outcome.

METHODS Prospective cohort study (the Resuscitation Outcomes Consortium) of all OHCA of presumed cardiac cause who were treated by emergency medical services within 9 US and Canadian sites between 12/1/2005 and 02/28/2007. In each site, Emergency Medical System records were collected and analyzed. Outcomes were individually verified by trained data abstractors.

RESULTS There were 9667 included patients. Median age was 68 (IQR 24) years, 66.7% were male and 8.3% survived to hospital discharge. The frequency of cardiac arrest varied significantly across time blocks (p<0.001). Compared to the 0001-0600 hourly time block, the odds ratios and 95% CIs for the occurrence of OHCA were 2.02 (1.90, 2.15) in the 0601-1200 block, 2.01 (1.89, 2.15) in the 1201-1800 block, and 1.73 (1.62, 1.85) in the 1801-2400 block. The frequency of all OHCA varied significantly by day of week (p=0.03) and month of year (p<0.001) with the highest frequencies on Saturday and during December. Survival to hospital discharge was lowest when the OHCA occurred during the 0001-0600 time block (7.3%) and highest during the 1201-1800 time block (9.6%). Survival was highest for OHCAs occurring on Mondays (10.0%) and lowest for those on Wednesdays (6.8%) (p=0.02).

CONCLUSION There is temporal variability in OHCA frequency and outcome. Underlying patient, EMS system and environmental factors need to be explored to offer further insight into these observed patterns.


Title

Early coronary angiography and induced hypothermia are associated with survival and functional recovery after out-of-hospital cardiac arrest.


Citation Callaway CW, Schmicker R, Brown SP, Albrich M, Andrusiek DL, Aufderheide TP, Christenson J, Daya MR, Falconer D, Husa R, Idris AH, Ornato JP, Rittenberger JC, Stiell IG, Rac VE, Rea TD, Sears G, and the ROC Investigators. Early coronary angiography and induced hypothermia are associated with survival and functional recovery after out-of-hospital cardiac arrest. Resuscitation 2014; 85(5): 657-63. PMCID: PMC4117649

Abstract BACKGROUND The rate and effect of coronary interventions and induced hypothermia after out-of-hospital cardiac arrest (OHCA) are unknown. We measured the association of early (≤24h after arrival) coronary angiography, reperfusion, and induced hypothermia with favorable outcome after OHCA.

METHODS We performed a secondary analysis of a multicenter clinical trial (NCT00394706) conducted between 2007 and 2009 in 10 North American regions. Subjects were adults (≥18 years) hospitalized after OHCA with pulses sustained ≥60min. We measured the association of early coronary catheterization, percutaneous coronary intervention, fibrinolysis, and induced hypothermia with survival to hospital discharge with favorable functional status (modified Rankin Score≤3).

RESULTS From 16,875 OHCA subjects, 3981 (23.6%) arrived at 151 hospitals with sustained pulses. 1317 (33.1%) survived to hospital discharge, with 1006 (25.3%) favorable outcomes. Rates of early coronary catheterization (19.2%), coronary reperfusion (17.7%) or induced hypothermia (39.3%) varied among hospitals, and were higher in hospitals treating more subjects per year. Odds of survival and favorable outcome increased with hospital volume (per 5 subjects/year OR 1.06; 95%CI: 1.04-1.08 and OR 1.06; 95%CI: 1.04, 1.08, respectively). Survival and favorable outcome were independently associated with early coronary angiography (OR 1.69; 95%CI 1.06-2.70 and OR 1.87; 95%CI 1.15-3.04), coronary reperfusion (OR 1.94; 95%CI 1.34-2.82 and OR 2.14; 95%CI 1.46-3.14), and induced hypothermia (OR 1.36; 95%CI 1.01-1.83 and OR 1.42; 95%CI 1.04-1.94).

INTERPRETATION Early coronary intervention and induced hypothermia are associated with favorable outcome and are more frequent in hospitals that treat higher numbers of OHCA subjects per year.


Title

A descriptive analysis of Emergency Medical Service Systems participating in the Resuscitation Outcomes Consortium (ROC) network.


Citation Davis D, Garberson L, Andrusiek D, Hostler D, Daya M, Pirrallo R, Craig C, Stephens S, Larsen J, Drum A, Fowler R, ROC Investigators. A descriptive analysis of emergency medical service systems participating in the Resusciation Outcomes Consortium (ROC) network. Prehospital Emergency Care 2007; 11(4):369-382.

Abstract BACKGROUND The optimal Emergency Medical Services (EMS) system characteristics have not been defined, resulting in substantial variability across systems. The Resuscitation Outcomes Consortium (ROC) is a United States-Canada research network that organized EMS agencies from 11 different systems to perform controlled trials in cardiac arrest and life-threatening trauma resuscitation.

OBJECTIVES To describe EMS systems participating in ROC using a novel framework.

METHODS Standardized surveys were created by ROC investigators and distributed to each site for completion. These included separate questions for individual hospitals, EMS agencies, and dispatch centers. Results were collated and analyzed by using descriptive statistics.

RESULTS A total of 264 EMS agencies, 287 hospitals, and 154 dispatch centers were included. Agencies were described with respect to the type (fire-based, non-fire governmental, private), transport status (transport/non-transport), and training level (BLS/ALS). Hospitals were described with regard to their trauma designation and the presence of electrophysiology and cardiac catheterization laboratories. Dispatch center characteristics, including primary versus secondary public safety answering point (PSAP) status and the use of prearrival instructions, were also described. Differences in EMS system characteristics between ROC sites were observed with multiple intriguing patterns. Rural areas and fire-based agencies had more EMS units and providers per capita. This may reflect longer response and transport distances in rural areas and the additional duties of most fire-based providers. In addition, hospitals in the United States typically had catheterization laboratories, whereas Canadian hospitals generally did not. The vast majority of both primary and secondary PSAPs use computer-aided dispatch.

CONCLUSIONS Similarities and differences among EMS systems participating in the ROC network were described. The framework used in this analysis may serve as a template for future EMS research.


Title

Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART).


Citation Wang HE, Prince DK, Stephens SW, Herren H, Daya M, Richmond N, Carlson J, Warden C, Colella MR, Brienza A, Aufderheide TP, Idris AH, Schmicker R, May S, Nichol G. Design and implementation of the Resuscitation Outcomes Consortium Pragmatic Airway Resuscitation Trial (PART). Resuscitation 2016; 101:57-64. PMCID: PMC4792760

Abstract Airway management is an important component of resuscitation from out-of-hospital cardiac arrest (OHCA). The optimal approach to advanced airway management is unknown. The Pragmatic Airway Resuscitation Trial (PART) will compare the effectiveness of endotracheal intubation (ETI) and Laryngeal Tube (LT) insertion upon 72-h survival in adult OHCA. Encompassing United States Emergency Medical Services agencies affiliated with the Resuscitation Outcomes Consortium (ROC), PART will use a cluster-crossover randomized design. Participating subjects will include adult, non-traumatic OHCA requiring bag-valve-mask ventilation. Trial interventions will include (1) initial airway management with ETI and (2) initial airway management with LT. The primary and secondary trial outcomes are 72-h survival and return of spontaneous circulation. Additional clinical outcomes will include airway management process and adverse events. The trial will enroll a total of 3000 subjects. Results of PART may guide the selection of advanced airway management strategies in OHCA.


Title

Association between hospital post-resuscitative performance and clinical outcomes after out-of-hospital cardiac arrest.


Citation Stub D, Schmicker RH, Anderson ML, Callaway CW, Daya MR, Sayre MR, Elmer J, Grunau BE, Aufderheide TP, Lin S, Buick JE, Zive D, Peterson ED, Nichol G, and the ROC Investigators. Association between hospital post-resuscitative performance and clinical outcomes after out-of-hospital cardiac arrest. Resuscitation 2015; 19(4):475-481

Abstract BACKGROUND Survival varies among those resuscitated from out-of-hospital cardiac arrest (OHCA). Evidence-based performance measures have been used to describe hospital quality of care in conditions such as acute coronary syndrome and major trauma. It remains unclear if adherence to performance measures is associated with better outcome in patients hospitalized after OHCA.

OBJECTIVES To assess whether a composite performance score based on evidence-based guidelines for care of patients resuscitated from OHCA was independently associated with clinical outcomes.

METHODS Included were 3252 patients with OHCA who received care at 111 U.S. and Canadian hospitals participating in the Resuscitation Outcomes Consortium (ROC-PRIMED) study between June 2007 and October 2009. We calculated composite performance scores for all patients, aggregated these at the hospital level, then associated them with patient mortality and favorable neurological status at discharge.

RESULTS Composite performance scores varied widely (median [IQR] scores from lowest to highest hospital quartiles, 21% [20%, 25%] vs. 59% [55%, 64%]. Adjusted survival to discharge increased with each quartile of performance score (from lowest to highest: 16.2%, 20.8%, 28.5%, 34.8%, P<0.01), with similar findings for adjusted rates of good neurologic status. Hospital score was significantly associated with outcome after risk adjustment for established baseline factors (highest vs. lowest adherence quartile: adjusted OR of survival 1.64; 95% CI 1.13, 2.38).

CONCLUSIONS Greater survival and favorable neurologic status at discharge were associated with greater adherence to recommended hospital based post-resuscitative care guidelines. Consideration should be given to measuring, reporting and improving hospital adherence to guideline-based performance measures, which could improve outcomes following OHCA.


Title

Early prediction of outcome after severe traumatic brain injury: a simple and practical model.


Citation Rizoli S, Petersen A, Bulger E, Coimbra R, Kerby JD, Minei J, Morrison L, Nathens A, Schreiber M, de Oliveira Manoel AL; ROC Investigators. Early prediction of outcome after severe traumatic brain injury: a simple and practical model. BMC Emerg Med 2016. 16(1):32. PMCID: PMC4995825

Abstract BACKGROUND Traumatic brain injury (TBI) is a heterogeneous syndrome with a broad range of outcome. We developed a simple model for long-term outcome prognostication after severe TBI.

METHODS Secondary data analysis of a large multicenter randomized trial. Patients were grouped according to 6-month extended Glasgow outcome scale (eGOS): poor-outcome (eGOS ≤ 4; severe disability or death) and acceptable outcome (eGOS > 4; no or moderate disability). A prediction decision tree was built using binary recursive partitioning to predict poor or acceptable 6-month outcome. Comparison to two previously published and validated models was made.

RESULTS The decision tree included the predictors of head Abbreviated Injury Scale (AIS) severity, the Marshall computed tomography score, and pupillary reactivity. All patients with a head AIS severity of 5 were predicted to have a poor outcome. In patients with head AIS severity < 5, the model predicted an acceptable outcome for (1) those with Marshall score of 1, and (2) those with Marshall score above 1 but with reactive pupils at admission. The decision tree had a sensitivity of 72.3 % (95 % CI: 66.4-77.6 %) and specificity of 62.5 % (95 % CI: 54.9-69.6 %). The proportion correctly classified for the comparison models was similar to our model. Our model was more apt at correctly classifying those with poor outcome but more likely to misclassify those with acceptable outcome than the comparison models.

CONCLUSION Predicting long-term outcome early after TBI remains challenging and inexact. This model could be useful for research and quality improvement studies to provide an early assessment of injury severity, but is not sufficiently accurate to guide decision-making in the clinical setting.


Title

Volume versus outcome: More emergency medical services personnel on-scene and increased survival after out-of-hospital cardiac arrest.


Citation Warren SA, Prince DK, Huszti E, Rea TD, Fitzpatrick AL, Andrusiek DL, Darling S, Morrison LJ, Vilke GM, Nichol G, and the ROC Investigators. Volume versus outcome: More emergency medical services personnel on-scene and increased survival after out-of-hospital cardiac arrest. Resuscitation 2015; 94:40-48

Abstract BACKGROUND AND AIM The large regional variation in survival after treatment of out-of-hospital cardiac arrest (OHCA) is incompletely explained. Communities respond to OHCA with differing number of emergency medical services (EMS) personnel who respond to the scene. The effect of different numbers of EMS personnel on-scene upon outcomes is unclear. We sought to evaluate the association between number of EMS personnel on-scene and survival after OHCA.

METHODS We performed a retrospective review of prospectively collected data on 16,122 EMS-treated OHCA events from December 1, 2005 to May 31, 2007 from a combined population over 21 million people residing in an area of over 33,000 square miles in Canada and the United States. Number of EMS personnel on-scene was defined as the number of EMS personnel who responded to the scene of OHCA within 15 min after 9-1-1 call receipt and prior to patient death or transport away from the scene. Associations with survival to hospital discharge were assessed by using generalized estimating equations to construct multivariable logistic regression models.

RESULTS Compared to a reference number of EMS personnel on-scene of 5 or 6, 7 or 8 EMS personnel on-scene was associated with a higher rate of survival to hospital discharge, adjusted odds ratio [OR], 1.35 (95% CI: 1.05, 1.73). There was no significant difference in survival between 5 or 6 personnel on-scene versus fewer.

CONCLUSION More EMS personnel on-scene within 15 min of 9-1-1 call was associated with improved survival of out-of-hospital cardiac arrest. It is unlikely that this finding was mediated solely by earlier CPR or earlier defibrillation.


Title

Perishock pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest.


Citation Cheskes S, Schmicker RH, Christenson J, Salcido DD, Rea T, Powell J, Edelson DP, Sell R, May S, Menegazzi JJ, Van Ottingham L, Olsufka M, Pennington S, Simonini J, Berg RA, Stiell I, Idris A, Bigham B, Morrison L, on behalf of the Resuscitation Outcomes Consortium (ROC) Investigators. Perishock Pause: an independent predictor of survival from out-of-hospital shockable cardiac arrest. Circulation 2011; 124:158-166. PMCID: PMC3138806

Abstract BACKGROUND Perishock pauses are pauses in chest compressions before and after defibrillatory shock. We examined the relationship between perishock pauses and survival to hospital discharge.

METHODS AND RESULTS We included out-of-hospital cardiac arrest patients in the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest who suffered arrest between December 2005 and June 2007, presented with a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia), and had cardiopulmonary resuscitation process data for at least 1 shock (n=815). We used multivariable logistic regression to determine the association between survival and perishock pauses. In an analysis adjusted for Utstein predictors of survival, the odds of survival were significantly lower for patients with preshock pause ≥20 seconds (odds ratio, 0.47; 95% confidence interval, 0.27 to 0.82) and perishock pause ≥40 seconds (odds ratio, 0.54; 95% confidence interval, 0.31 to 0.97) compared with patients with preshock pause <10 seconds and perishock pause <20 seconds. Postshock pause was not independently associated with a significant change in the odds of survival. Log-linear modeling depicted a decrease in survival to hospital discharge of 18% and 14% for every 5-second increase in both preshock and perishock pause interval (up to 40 and 50 seconds, respectively), with no significant association noted with changes in the postshock pause interval.

CONCLUSIONS In patients with cardiac arrest presenting in a shockable rhythm, longer perishock and preshock pauses were independently associated with a decrease in survival to hospital discharge. The impact of preshock pause on survival suggests that refinement of automatic defibrillator software and paramedic education to minimize preshock pause delays may have a significant impact on survival.


Title

Trial of Continuous or Interrupted Chest Compressions during CPR.


Citation Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP, and the ROC Investigators. Trial of continuous or interrupted chest compressions during CPR. New England Journal of Medicine 2015; 373(23):2203-2214

Abstract BACKGROUND During cardiopulmonary resuscitation (CPR) in patients with out-of-hospital cardiac arrest, the interruption of manual chest compressions for rescue breathing reduces blood flow and possibly survival. We assessed whether outcomes after continuous compressions with positive-pressure ventilation differed from those after compressions that were interrupted for ventilations at a ratio of 30 compressions to two ventilations.

METHODS This cluster-randomized trial with crossover included 114 emergency medical service (EMS) agencies. Adults with non-trauma-related cardiac arrest who were treated by EMS providers received continuous chest compressions (intervention group) or interrupted chest compressions (control group). The primary outcome was the rate of survival to hospital discharge. Secondary outcomes included the modified Rankin scale score (on a scale from 0 to 6, with a score of ≤3 indicating favorable neurologic function). CPR process was measured to assess compliance.

RESULTS Of 23,711 patients included in the primary analysis, 12,653 were assigned to the intervention group and 11,058 to the control group. A total of 1129 of 12,613 patients with available data (9.0%) in the intervention group and 1072 of 11,035 with available data (9.7%) in the control group survived until discharge (difference, -0.7 percentage points; 95% confidence interval [CI], -1.5 to 0.1; P=0.07); 7.0% of the patients in the intervention group and 7.7% of those in the control group survived with favorable neurologic function at discharge (difference, -0.6 percentage points; 95% CI, -1.4 to 0.1, P=0.09). Hospital-free survival was significantly shorter in the intervention group than in the control group (mean difference, -0.2 days; 95% CI, -0.3 to -0.1; P=0.004).

CONCLUSIONS In patients with out-of-hospital cardiac arrest, continuous chest compressions during CPR performed by EMS providers did not result in significantly higher rates of survival or favorable neurologic function than did interrupted chest compressions. (Funded by the National Heart, Lung, and Blood Institute and others; ROC CCC ClinicalTrials.gov number, NCT01372748.).


Title

Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial.


Citation Kudenchuk PJ, Brown SP, Daya M, Morrison LJ, Grunau BE, Rea T, Aufderheide T, Powell J, Leroux B, Vaillancourt C, Larsen J, Wittwer L, Colella MR, Stephens SW, Gamber M, Egan D, Dorian P, and the ROC Investigators. Resuscitation Outcomes Consortium-Amiodarone, Lidocaine or Placebo Study (ROC-ALPS): Rationale and methodology behind an out-of-hospital cardiac arrest antiarrhythmic drug trial. American Heart Journal 2014; 167(5):653-59. PMCID: PMC4014351

Abstract BACKGROUND Despite their wide use, whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest (OHCA) is not known. The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia (VF/VT).

METHODS ALPS will randomize 3,000 adults across North America with nontraumatic OHCA, persistent or recurring VF/VT after ≥1 shock, and established vascular access to receive up to 450 mg amiodarone, 180 mg lidocaine, or placebo in the field using a double-blind protocol, along with standard resuscitation measures. The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT. A safety analysis includes all randomized patients regardless of their eligibility, initial arrhythmia, or actual receipt of ALPS drug. The primary outcome of ALPS is survival to hospital discharge; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score ≤3.

RESULTS The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine. Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge. Each aim also represents a clinically relevant comparison between treatments that is worth investigating.

CONCLUSIONS Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice.


Title

A Comparison of Invasive Airway Management and Rates of Pneumonia in Prehospital and Hospital Settings.


Citation Andrusiek DL, Szydlo D, May S, Brasel KJ, Minei J, van Heest R, MacDonald R, Schreiber M, and the ROC Investigators. A comparison of invasive airway management and rates of pneumonia in prehospital and hospital settings. Prehospital Emergency Care 2015; 19(4):475-481

Abstract INTRODUCTION Infection is a major cause of morbidity and mortality in trauma. Infection in trauma is poorly understood. The impact of prehospital invasive airway management (IAM) on the incidence of pneumonia and health services utilization is unknown. We hypothesized that trauma patients exposed to prehospital IAM will suffer higher rates of pneumonia compared to no IAM or exposure to IAM performed in the hospital. We hypothesized that patients who develop pneumonia subsequent to prehospital IAM will have longer intensive care unit (ICU) and hospital length of stay (LOS) compared to patients who acquired pneumonia after IAM performed in the hospital.

METHODS This is an observational cohort study of data previously collected for the Resuscitation Outcomes Consortium hypertonic resuscitation randomized trial. Patients were included if traumatic injury resulted in shock, traumatic brain injury, or both. Patients were excluded if they died 24 hours after injury, or pneumonia data were missing. Adjusted and unadjusted logistic regression was used to calculate the odds ratio of pneumonia if exposed in the prehospital setting compared to no exposure or exposure in the hospital.

RESULTS Of 2,222 patients enrolled in the hypertonic resuscitation trial, 1,676 patients met enrollment criteria for this study. Four and a half percent of patients suffered pneumonia. IAM in the prehospital setting resulted in 6.8-fold increase (C.I. 2.0, 23.0, p = 0.003) in the adjusted odds of developing pneumonia compared to not being intubated, while in-hospital intubation resulted in 4.8-fold increase (C.I. 1.4, 16.6, p = 0.01), which was not statistically significantly different to the odds ratio of prehospital IAM. There were no statistically significant increases in health services utilization resulting from pneumonia incurred after IAM.

CONCLUSION Exposure to IAM in prehospital and hospital settings results in an increase in pneumonia, but there does not appear to be a link between the source of pneumonia and an increase in ICU or hospital LOS.


Title

Regulatory challenges for the resuscitation outcomes consortium.


Citation Tisherman SA, Powell J, Schmidt TA, Aufderheide TP, Kudenchuk PJ, Spence J, Climer D, Kelly D, Marcantonio A, Brown T, Sopko G, Kerber R, Sugarman J, Hoyt D. Regulatory challenges for the Resuscitation Outcomes Consortium. Circulation 2008; 118:1585-1592. PMCID: PMC2757627

Abstract

Title

Epidemiology and outcomes from out-of-hospital cardiac arrest in children: the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest.


Citation Atkins D, Everson-Stewart S, Sears G, Daya M, Osmond M, Warden C, Berg R. Epidemiology and outcomes from out-of-hospital cardiac arrest in children: The ROC epistry-cardiac arrest. Circulation 2009; 119(11):1484-1491. PMCID: PMC2679169

Abstract BACKGROUND Population-based data for pediatric cardiac arrest are scant and largely from urban areas. The Resuscitation Outcomes Consortium (ROC) Epistry-Cardiac Arrest is a population-based emergency medical services registry of out-of-hospital nontraumatic cardiac arrest (OHCA). This study examined age-stratified incidence and outcomes of pediatric OHCA. We hypothesized that survival to hospital discharge is less frequent from pediatric OHCA than adult OHCA.

METHODS AND RESULTS This prospective population-based cohort study in 11 US and Canadian ROC sites included persons <20 years of age who received cardiopulmonary resuscitation or defibrillation by emergency medical service providers and/or received bystander automatic external defibrillator shock or who were pulseless but received no resuscitation by emergency medical services between December 2005 and March 2007. Patients were stratified a priori into 3 age groups: <1 year (infants; n=277), 1 to 11 years (children; n=154), and 12 to 19 years (adolescents; n=193). The incidence of pediatric OHCA was 8.04 per 100 000 person-years (72.71 in infants, 3.73 in children, and 6.37 in adolescents) versus 126.52 per 100,000 person-years for adults. Survival for all pediatric OHCA was 6.4% (3.3% for infants, 9.1% for children, and 8.9% for adolescents) versus 4.5% for adults (P=0.03). Unadjusted odds ratio for pediatric survival to discharge compared with adults was 0.71 (95% confidence interval, 0.37 to 1.39) for infants, 2.11 (95% confidence interval, 1.21 to 3.66) for children, and 2.04 (95% confidence interval, 1.24 to 3.38) for adolescents.

CONCLUSIONS This study demonstrates that the incidence of OHCA in infants approaches that observed in adults but is lower among children and adolescents. Survival to discharge was more common among children and adolescents than infants or adults.


Title

Effect of gender on outcome of out of hospital cardiac arrest in the Resuscitation Outcomes Consortium.


Citation Morrison LJ1, Schmicker RH2, Weisfeldt ML3, Bigham BL4, Berg RA5, Topjian AA5, Abramson BL6, Atkins DL7, Egan D8, Sopko G8, Rac VE9; Resuscitation Outcomes Consortium Investigators. Effect of gender on outcome of out of hospital cardiac arrest in the Resuscitation Outcomes Consortium. Resuscitation 2016. 100:76-81. PMCID: PMC4761304

Abstract INTRODUCTION This study examined the relationship between gender and outcomes of non-traumatic out-of-hospital cardiac arrest (OHCA).

METHODS All eligible, consecutive, non-traumatic Emergency Medical Services (EMS) treated OHCA patients in the Resuscitation Outcomes Consortium between December 2005 and May 2007. Patient age was analyzed as a continuous variable and stratified in two age cohorts: 15-45 and >55 years of age (yoa). Unadjusted and adjusted (based on Utstein characteristics) chi square tests and logistic regression models were employed to examine the relationship between gender, age, and survival outcomes.

RESULTS This study enrolled 14,690 patients: of which 36.4% were women with a mean age of 68.3 and 63.6% of them men with a mean age of 64.2. Women survived to hospital discharge less often than men (6.4% vs. 9.1%, p<0.001); the unadjusted OR was 0.69, 95%CI: 0.60, 0.77 whereas when adjusted for all Utstein predictors the difference was not significant (OR: 1.16, 95%CI: 0.98, 1.36, p=0.07). The adjusted survival rate for younger women (15-45 yoa) was 11.1% vs. 9.8% for younger men (OR: 1.66, 95%CI: 1.04, 2.64, p=0.03) but no difference in discharge rates was observed in the >55 cohort (OR: 0.94, 95%CI: 0.78, 1.15, p=0.57).

CONCLUSIONS Women who suffer OHCAs have lower rates of survival and have unfavourable Utstein predictors. When survival is adjusted for these predictors survival is similar between men and women except in younger women suggesting that age modifies the association of gender and survival from OHCA; a result that supports a protective hormonal effect among premenopausal women.


Title

Revisiting the "Golden Hour": An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury.


Citation Newgard C, Meier E, Bulger EM, Buick J, Sheehan K, Lin S, Minei JP, Barnes-Mackey R, Brasel KJ, and the ROC Investigators. Revisiting the Golden Hour: An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury. Annals of Emergency Medicine 2015; 66(1):30-41. PMCID: PMC4478150

Abstract STUDY OBJECTIVE We evaluate patients with shock and traumatic brain injury who were previously enrolled in an out-of-hospital clinical trial to test the association between out-of-hospital time and outcome.

METHODS This was a secondary analysis of patients with shock and traumatic brain injury who were aged 15 years or older and enrolled in a Resuscitation Outcomes Consortium out-of-hospital clinical trial by 81 emergency medical services agencies transporting to 46 Level I and II trauma centers in 11 sites (May 2006 through May 2009). Inclusion criteria were systolic blood pressure less than or equal to 70 mm Hg or systolic blood pressure 71 to 90 mm Hg with pulse rate greater than or equal to 108 beats/min (shock cohort) and Glasgow Coma Scale score less than or equal to 8 (traumatic brain injury cohort); patients meeting both criteria were placed in the shock cohort. Primary outcomes were 28-day mortality (shock cohort) and 6-month Glasgow Outcome Scale-Extended score less than or equal to 4 (traumatic brain injury cohort).

RESULTS There were 778 patients in the shock cohort (26% 28-day mortality) and 1,239 patients in the traumatic brain injury cohort (53% 6-month Glasgow Outcome Scale-Extended score ≤4). Out-of-hospital time greater than 60 minutes was not associated with worse outcomes after accounting for important confounders in the shock cohort (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.77 to 2.62) or traumatic brain injury cohort (aOR 0.77; 95% CI 0.51 to 1.15). However, shock patients requiring early critical hospital resources and arriving after 60 minutes had higher 28-day mortality (aOR 2.37; 95% CI 1.05 to 5.37); this finding was not observed among a similar traumatic brain injury subgroup.

CONCLUSION Among out-of-hospital trauma patients meeting physiologic criteria for shock and traumatic brain injury, there was no association between time and outcome. However, the subgroup of shock patients requiring early critical resources and arriving after 60 minutes had higher mortality.


Title

Relationship between chest compression rates and outcomes from cardiac arrest.


Citation Idris AH, Guffey D, Aufderheide TP, Brown S, Morrison LJ, Nichols P, Powell J, Daya M, Bigham BL, Atkins DL, Berg R, Davis D, Stiell I, Sopko G, Nichol, G The relationship between chest compression rates and outcomes from cardiac arrest. Circulation 2012; 125(24):3004-12. PMCID: PMC3388797

Abstract BACKGROUND Guidelines for cardiopulmonary resuscitation recommend a chest compression rate of at least 100 compressions per minute. Animal and human studies have reported that blood flow is greatest with chest compression rates near 120/min, but few have reported rates used during out-of-hospital (OOH) cardiopulmonary resuscitation or the relationship between rate and outcome. The purpose of this study was to describe chest compression rates used by emergency medical services providers to resuscitate patients with OOH cardiac arrest and to determine the relationship between chest compression rate and outcome.

METHODS AND RESULTS Included were patients aged ≥ 20 years with OOH cardiac arrest treated by emergency medical services providers participating in the Resuscitation Outcomes Consortium. Data were abstracted from monitor-defibrillator recordings during cardiopulmonary resuscitation. Multiple logistic regression analysis assessed the association between chest compression rate and outcome. From December 2005 to May 2007, 3098 patients with OOH cardiac arrest were included in this study. Mean age was 67 ± 16 years, and 8.6% survived to hospital discharge. Mean compression rate was 112 ± 19/min. A curvilinear association between chest compression rate and return of spontaneous circulation was found in cubic spline models after multivariable adjustment (P=0.012). Return of spontaneous circulation rates peaked at a compression rate of ≈ 125/min and then declined. Chest compression rate was not significantly associated with survival to hospital discharge in multivariable categorical or cubic spline models.

CONCLUSIONS Chest compression rate was associated with return of spontaneous circulation but not with survival to hospital discharge in OOH cardiac arrest.


Title

Collider bias in trauma comparative effectiveness research: the stratification blues for systematic reviews.


Citation del Junco DJ, Bulger EM, Fox EE, Holcomb JB, Brasel KJ, Hoyt DB, Grady JJ, Duran S, Klotz P, Dubick MA, Wade CE, and the ROC Investigators. Collider bias in trauma comparative effectiveness research: the stratification blues for systematic reviews. Injury 2015; 46(50):775-780. PMCID: PMC4402274

Abstract BACKGROUND Collider bias, or stratifying data by a covariate consequence rather than cause (confounder) of treatment and outcome, plagues randomised and observational trauma research. Of the seven trials of prehospital hypertonic saline in dextran (HSD) that have been evaluated in systematic reviews, none found an overall between-group difference in survival, but four reported significant subgroup effects. We hypothesised that an avoidable type of collider bias often introduced inadvertently into trauma comparative effectiveness research could explain the incongruous findings.

METHODS The two most recent HSD trials, a single-site pilot and a multi-site pivotal study, provided data for a secondary analysis to more closely examine the potential for collider bias. The two trials had followed the a priori statistical analysis plan to subgroup patients by a post-randomisation covariate and well-established surrogate for bleeding severity, massive transfusion (MT), ≥ 10 unit of red blood cells within 24h of admission. Despite favourable HSD effects in the MT subgroup, opposite effects in the non-transfused subgroup halted the pivotal trial early. In addition to analyzing the data from the two trials, we constructed causal diagrams and performed a meta-analysis of the results from all seven trials to assess the extent to which collider bias could explain null overall effects with subgroup heterogeneity.

RESULTS As in previous trials, HSD induced significantly greater increases in systolic blood pressure (SBP) from prehospital to admission than control crystalloid (p=0.003). Proportionately more HSD than control decedents accrued in the non-transfused subgroup, but with paradoxically longer survival. Despite different study populations and a span of over 20 years across the seven trials, the reported mortality effects were consistently null, summary RR=0.99 (p=0.864, homogeneity p=0.709).

CONCLUSIONS HSD delayed blood transfusion by modifying standard triggers like SBP with no detectable effect on survival. The reported heterogeneous HSD effects in subgroups can be explained by collider bias that trauma researchers can avoid by improved covariate selection and data capture strategies.


Title

Understanding traumatic shock: out-of-hospital hypotension with and without other physiologic compromise.


Citation Newgard C, Meier E, McKnight B, Drennan I, Richardson D, Brasel KJ, Schreiber M, Kerby JD, Kannas D, Austin M, Bulger EM, and the ROC Investigators. Understanding traumatic shock: Out-of-hospital hypotension with and without other physiologic compromise. Journal of Trauma and Acute Care Surgery 2015; 78(2):342-351. PMCID: PMC4355920

Abstract BACKGROUND Among trauma patients with out-of-hospital hypotension, we evaluated the predictive value of systolic blood pressure (SBP) with and without other physiologic compromise for identifying trauma patients requiring early critical resources.

METHODS This was a secondary analysis of a prospective cohort of injured patients 13 years or older with out-of-hospital hypotension (SBP ≤ 90 mm Hg) who were transported by 114 emergency medical service agencies to 56 Level I and II trauma centers in 11 regions of the United States and Canada from January 1, 2010, through June 30, 2011. The primary outcome was early critical resource use, defined as blood transfusion of 6 U or greater, major nonorthopedic surgery, interventional radiology, or death within 24 hours.

RESULTS Of 3,337 injured patients with out-of-hospital hypotension, 1,094 (33%) required early critical resources and 1,334 (40%) had serious injury (Injury Severity Score [ISS] ≥ 16). Patients with isolated hypotension required less early critical resources (14% vs. 52%), had less serious injury (20% vs. 61%), and had lower mortality (24 hours, 1% vs. 26%; in-hospital, 3% vs. 34%). The standardized probability of requiring early critical resources was lowest among patients with blunt injury and isolated moderate hypotension (0.12; 95% confidence interval, 0.09-0.15) and steadily increased with additional physiologic compromise, more severe hypotension, and penetrating injury (0.94; 95% confidence interval, 0.90-0.98).

CONCLUSION A minority of trauma patients with isolated out-of-hospital hypotension require early critical resuscitation resources. However, hypotension accompanied by additional physiologic compromise or penetrating injury markedly increases the probability of requiring time-sensitive interventions.

LEVEL OF EVIDENCE Prognostic study, level II.


Title

Regional variation in out-of-hospital cardiac arrest incidence and outcome.


Citation Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell IG. Regional variation in out-of-hospital cardiac arrest incidence and outcome. Journal of the American Medical Association 2008; 300:1423-1431. PMCID: PMC3187919

Abstract CONTEXT The health and policy implications of regional variation in incidence and outcome of out-of-hospital cardiac arrest remain to be determined.

OBJECTIVE To evaluate whether cardiac arrest incidence and outcome differ across geographic regions.

DESIGN, SETTING, AND PATIENTS Prospective observational study (the Resuscitation Outcomes Consortium) of all out-of-hospital cardiac arrests in 10 North American sites (8 US and 2 Canadian) from May 1, 2006, to April 30, 2007, followed up to hospital discharge, and including data available as of June 28, 2008. Cases (aged 0-108 years) were assessed by organized emergency medical services (EMS) personnel, did not have traumatic injury, and received attempts at external defibrillation or chest compressions or resuscitation was not attempted. Census data were used to determine rates adjusted for age and sex.

MAIN OUTCOME MEASURES Incidence rate, mortality rate, case-fatality rate, and survival to discharge for patients assessed or treated by EMS personnel or with an initial rhythm of ventricular fibrillation.

RESULTS Among the 10 sites, the total catchment population was 21.4 million, and there were 20,520 cardiac arrests. A total of 11,898 (58.0%) had resuscitation attempted; 2729 (22.9% of treated) had initial rhythm of ventricular fibrillation or ventricular tachycardia or rhythms that were shockable by an automated external defibrillator; and 954 (4.6% of total) were discharged alive. The median incidence of EMS-treated cardiac arrest across sites was 52.1 (interquartile range [IQR], 48.0-70.1) per 100,000 population; survival ranged from 3.0% to 16.3%, with a median of 8.4% (IQR, 5.4%-10.4%). Median ventricular fibrillation incidence was 12.6 (IQR, 10.6-5.2) per 100,000 population; survival ranged from 7.7% to 39.9%, with a median of 22.0% (IQR, 15.0%-24.4%), with significant differences across sites for incidence and survival (P<.001).

CONCLUSION In this study involving 10 geographic regions in North America, there were significant and important regional differences in out-of-hospital cardiac arrest incidence and outcome.


Title

Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable?


Citation Sugarman J, Sitlani C, Andrusiek D, Aufderheide T, Bulger E, Davis D, Hoyt D, Idris A, Kerby J, Powell J, Schmidt T, Slutsky A, Sopko G, Stephens S, Williams C, Nichol G. Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable? Resuscitation 2009; 80(6):644-649. PMCID: PMC2692408

Abstract BACKGROUND Concerns have been raised about the enrollment of racial and ethnic minorities in research in the emergency setting when it is not possible to obtain informed consent. However, there is a paucity of data related to the validity of such claims.

METHODS Retrospective comparison of registry enrollment (4/1/2006-3/31/2007) and trial enrollment (4/1/2007-3/31/2008) from three sites in the Resuscitation Outcomes Consortium. Subjects compared met the following criteria: (1) shock, defined by blunt or penetrating force to the body with either systolic blood pressure (SBP) < or =70 mmHg or SBP 71-90 mmHg and heart rate > or =108 beats/min and/or (2) traumatic brain injury (TBI), defined by blunt force to the head with out-of-hospital Glasgow Coma Score < or =8.

RESULTS Overall, compared to a registry there were no differences in the percent of racial or ethnic groups enrolled in the clinical trial [odds ratio (OR) for Blacks versus Whites: 0.87, 95% confidence interval (CI) 0.65-1.16, p=.34; OR for Hispanics versus Whites 1.04; 95% CI 0.72-1.49, p=.85]. However, Blacks were less likely than Whites to be enrolled in the TBI cohort [OR 0.58 (0.34-0.97), p=.04].

CONCLUSIONS Despite some discordance in subgroups, there was no overall difference in the racial and ethnic distribution of subjects enrolled in a multi-center clinical trial of severe trauma compared to a registry accounting for study entry criteria. These findings help address justice concerns about enrollment of racial and ethnic minorities in trauma research performed using an exception from informed consent under emergency circumstances.


Title

Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation.


Citation Baraniuk S, Tilley BC, del Junco DJ, Fox EE, van Belle G, Wade CE, Podbielski JM, Beeler AM, Hess JR, Bulger EM, Schreiber MA, Inaba K, Fabian TC, Kerby JD, Cohen MJ, Miller CN, Rizoli S, Scalea TM, OKeeffe T, Brasel KJ, Cotton BA, Muskat P, Holcomb JB and the PROPPR Study Group. Pragmatic randomized optimal platelet and plasma ratios (PROPPR) trial: design, rationale and implementation. Injury 2014; 45(9):1287-1295. PMCID: PMC4137482

Abstract BACKGROUND Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR.

STUDY DESIGN PROPPR was designed as a randomized, two-group, Phase III trial conducted in subjects with the highest level of trauma activation and predicted to have a massive transfusion. Subjects at 12 North American level 1 trauma centres were randomized into one of two standard transfusion ratio interventions: 1:1:1 or 1:1:2, (plasma, platelets, and red blood cells). Clinical data and serial blood samples were collected under Exception from Informed Consent (EFIC) regulations. Co-primary mortality endpoints of 24h and 30 days were evaluated.

RESULTS Between August 2012 and December 2013, 680 patients were randomized. The overall median time from admission to randomization was 26min. PROPPR enrolled at higher than expected rates with fewer than expected protocol deviations.

CONCLUSION PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.


Title

Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation.


Citation Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway C, Bishop D, Vaillancourt C, Davis D, Aufderheide T, Idris A, Stouffer J, Stiell I, Berg R, ROC Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation 2009; 120(13):1241-1247. PMCID: PMC2795631

Abstract BACKGROUND Quality cardiopulmonary resuscitation contributes to cardiac arrest survival. The proportion of time in which chest compressions are performed in each minute of cardiopulmonary resuscitation is an important modifiable aspect of quality cardiopulmonary resuscitation. We sought to estimate the effect of an increasing proportion of time spent performing chest compressions during cardiac arrest on survival to hospital discharge in patients with out-of-hospital ventricular fibrillation or pulseless ventricular tachycardia.

METHODS AND RESULTS This is a prospective observational cohort study of adult patients from the Resuscitation Outcomes Consortium Cardiac Arrest Epistry with confirmed ventricular fibrillation or ventricular tachycardia, no defibrillation before emergency medical services arrival, electronically recorded cardiopulmonary resuscitation before the first shock, and a confirmed outcome. Patients were followed up to discharge from the hospital or death. Of the 506 cases, the mean age was 64 years, 80% were male, 71% were witnessed by a bystander, 51% received bystander cardiopulmonary resuscitation, 34% occurred in a public location, and 23% survived. After adjustment for age, gender, location, bystander cardiopulmonary resuscitation, bystander witness status, and response time, the odds ratios of surviving to hospital discharge in the 2 highest categories of chest compression fraction compared with the reference category were 3.01 (95% confidence interval 1.37 to 6.58) and 2.33 (95% confidence interval 0.96 to 5.63). The estimated adjusted linear effect on odds ratio of survival for a 10% change in chest compression fraction was 1.11 (95% confidence interval 1.01 to 1.21).

CONCLUSIONS An increased chest compression fraction is independently predictive of better survival in patients who experience a prehospital ventricular fibrillation/tachycardia cardiac arrest.


Title

Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial.


Citation Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB, ROC Investigators. Out-of-hospital hypertonic resuscitation following traumatic hypovolemic shock: a randomized, placebo controlled trial. Annals of Surgery 2011; 253(3):431-441. PMCID: PMC3015143

Abstract OBJECTIVE To determine whether out-of-hospital administration of hypertonic fluids would improve survival after severe injury with hemorrhagic shock.

BACKGROUND Hypertonic fluids have potential benefit in the resuscitation of severely injured patients because of rapid restoration of tissue perfusion, with a smaller volume, and modulation of the inflammatory response, to reduce subsequent organ injury.

METHODS Multicenter, randomized, blinded clinical trial, May 2006 to August 2008, 114 emergency medical services agencies in North America within the Resuscitation Outcomes Consortium.

INCLUSION CRITERIA injured patients, age ≥ 15 years with hypovolemic shock (systolic blood pressure ≤ 70 mm Hg or systolic blood pressure 71-90 mm Hg with heart rate ≥ 108 beats per minute). Initial resuscitation fluid, 250 mL of either 7.5% saline per 6% dextran 70 (hypertonic saline/dextran, HSD), 7.5% saline (hypertonic saline, HS), or 0.9% saline (normal saline, NS) administered by out-of-hospital providers. Primary outcome was 28-day survival. On the recommendation of the data and safety monitoring board, the study was stopped early (23% of proposed sample size) for futility and potential safety concern.

RESULTS  : A total of 853 treated patients were enrolled, among whom 62% were with blunt trauma, 38% with penetrating. There was no difference in 28-day survival-HSD: 74.5% (0.1; 95% confidence interval [CI], -7.5 to 7.8); HS: 73.0% (-1.4; 95% CI, -8.7-6.0); and NS: 74.4%, P = 0.91. There was a higher mortality for the postrandomization subgroup of patients who did not receive blood transfusions in the first 24 hours, who received hypertonic fluids compared to NS [28-day mortality-HSD: 10% (5.2; 95% CI, 0.4-10.1); HS: 12.2% (7.4; 95% CI, 2.5-12.2); and NS: 4.8%, P < 0.01].

CONCLUSION Among injured patients with hypovolemic shock, initial resuscitation fluid treatment with either HS or HSD compared with NS, did not result in superior 28-day survival. However, interpretation of these findings is limited by the early stopping of the trial.

CLINICAL TRIAL REGISTRATION Clinical Trials.gov, NCT00316017.


Title

The availability and use of out-of-hospital physiologic information to identify high-risk injured children in a multisite, population-based cohort.


Citation Newgard C, Rudser K, Atkins D, Berg R, Osmond M, Bulger E, Davis D, Schreiber M, Warden C, Rea T, Emerson S, ROC Investigators. The availability and use of out-of-hospital physiologic information to identify high-risk injured children in a multisite, population-based cohort. Prehospital Emergency Care 2009; 13(4):420-431. PMCID: 3008574

Abstract OBJECTIVE The validity of using adult physiologic criteria to triage injured children in the out-of-hospital setting remains unproven. Among children meeting adult field physiologic criteria, we assessed the availability of physiologic information, the incidence of death or prolonged hospitalization, and whether age-specific criteria would improve the specificity of the physiologic triage step.

METHODS We analyzed a prospective, out-of-hospital cohort of injured children aged < or =14 years collected from December 2005 through February 2007 by 237 emergency medical services (EMS) agencies transporting to 207 acute care hospitals (trauma and nontrauma centers) in 11 sites across the United States and Canada. Inclusion criteria were standard adult physiologic values: systolic blood pressure (SBP) < or =90 mmHg, respiratory rate < 10 or > 29 breaths/min, Glasgow Coma Scale (GCS) score < or =12, and field intubation attempt. Seven physiologic variables (including age-specific values) and three demographic and mechanism variables were included in the analysis. "High-risk" children included those who died (field or in-hospital) or were hospitalized > 2 days. The decision tree was derived and validated using binary recursive partitioning.

RESULTS Nine hundred fifty-five children were included in the analysis, of whom 62 (6.5%) died and 117 (12.3%) were hospitalized > 2 days. Missing values were common, ranging from 6% (respiratory rate) to 53% (pulse oximetry), and were associated with younger age and high-risk outcome. The final decision rule included four variables (assisted ventilation, GCS score < 11, pulse oximetry < 95%, and SBP > 96 mmHg), which demonstrated improved specificity (71.7% [95% confidence interval (CI) 66.7-76.6%]) at the expense of missing high-risk children (sensitivity 76.5% [95% CI 66.4-86.6%]).

CONCLUSIONS The incidence of high-risk injured children meeting adult physiologic criteria is relatively low and the findings from this sample do not support using age-specific values to better identify such children. However, the amount and pattern of missing data may compromise the value and practical use of field physiologic information in pediatric triage.


Title

The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent.


Citation Bulger E, Schmidt T, Cook A, Brasel K, Griffiths D, Kudenchuk P, Davis D, Bardarson B, Idris A, Aufderheide T, ROC Investigators. The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent. Annals of Emergency Medicine 2009; 53(3):351-353. PMCID: 3005614

Abstract STUDY OBJECTIVE In 1996, the Food and Drug Administration and the Department of Health and Human Services enacted rules allowing a narrow exception from informed consent for critically ill patients enrolled in emergency research. These include requirements for community consultation prior to trial implementation. Previous studies have noted difficulty in engaging the community. We seek to describe the experience with random dialing surveys as a tool for community consultation across 5 metropolitan regions in the United States.

METHODS Random dialing surveys were used as part of the community consultation for an out-of-hospital clinical trial sponsored by the Resuscitation Outcomes Consortium. The survey method was designed to obtain a representative sample of the community according to population demographics and geography. Logistics of survey administration, role of the survey in community consultation, and survey results by population demographics are discussed.

RESULTS Random dialing surveys were conducted in 5 of 8 US Resuscitation Outcomes Consortium sites. Overall, 70% to 79% of respondents indicated they would be willing to be enrolled in this study. Support for the inclusion of children (aged 15 to 18 years) ranged from 52% to 71%. Respondents aged 18 to 34 years were more willing to participate in the trial than older age groups. Women and racial minorities were less likely to favor the inclusion of minors.

CONCLUSION Random dialing surveys provide an additional tool to engage the community and obtain a sample of the opinion of the population about research conducted under the emergency exception from informed consent regulations. Similar results were obtained across 5 diverse communities in the United States.


Title

Association of early withdrawal of life-sustaining therapy for perceived neurological prognosis with mortality after cardiac arrest.


Citation Elmer J, Torres C, Aufderheide TP, Austin MA, Callaway CW, Golan E, Herren H, Jasti J, Kudenchuk PJ, Scales DC, Stub D, Richardson DK, Zive DM, and the ROC Investigators. Association of early withdrawal of life-sustaining therapy for perceived neurological prognosis with mortality after cardiac arrest. Resuscitation 2016; 102:127-135. PMCID: PMC4834233

Abstract BACKGROUND Withdrawing life-sustaining therapy because of perceived poor neurological prognosis (WLST-N) is a common cause of hospital death after out-of-hospital cardiac arrest (OHCA). Although current guidelines recommend against WLST-N before 72h (WLST-N<72), this practice is common and may increase mortality. We sought to quantify these effects.

METHODS In a secondary analysis of a multicenter OHCA trial, we evaluated survival to hospital discharge and survival with favorable functional status (modified Rankin Score ≤3) in adults alive >1h after hospital admission. Propensity score modeling the probability of exposure to WLST-N<72 based on pre-exposure covariates was used to match unexposed subjects with those exposed to WLST-N<72. We determined the probability of survival and functionally favorable survival in the unexposed matched cohort, fit adjusted logistic regression models to predict outcomes in this group, and then used these models to predict outcomes in the exposed cohort. Combining these findings with current epidemiologic statistics we estimated mortality nationally that is associated with WLST-N<72.

RESULTS Of 16,875 OHCA subjects, 4265 (25%) met inclusion criteria. WLST-N<72 occurred in one-third of subjects who died in-hospital. Adjusted analyses predicted that exposed subjects would have 26% survival and 16% functionally favorable survival if WLST-N<72 did not occur. Extrapolated nationally, WLST-N<72 may be associated with mortality in approximately 2300 Americans each year of whom nearly 1500 (64%) might have had functional recovery.

CONCLUSIONS After OHCA, death following WLST-N<72 may be common and is potentially avoidable. Reducing WLST-N<72 has national public health implications and may afford an opportunity to decrease mortality after OHCA.


Title

Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.


Citation Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P, and the ROC Investigators. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. New England Journal of Medicine 2016; 374:1711-1722

Abstract BACKGROUND Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit.

METHODS In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock.

RESULTS In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P=0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P=0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P=0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P=0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo.

CONCLUSIONS Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT01401647.).


Title

Trauma in the neighborhood: a geospatial analysis and assessment of social determinants of major injury in North America.


Citation Newgard CD, Schmicker RH, Sopko G, Andrusiek D, Bialkowski W, Minei JP, Brasel K, Bulger E, Fleischman RJ, Kerby JD, Bigham BL, Warden CR, ROC Investigators. Trauma in the neighborhood: A geospatial analysis and assessment of social determinants of major injury in North America. American Journal of Public Health 2011; 101(4):669-677. PMCID: PMC3052353

Abstract OBJECTIVES We sought to identify and characterize areas with high rates of major trauma events in 9 diverse cities and counties in the United States and Canada.

METHODS We analyzed a prospective, population-based cohort of injured individuals evaluated by 163 emergency medical service agencies transporting patients to 177 hospitals across the study sites between December 2005 and April 2007. Locations of injuries were geocoded, aggregated by census tract, assessed for geospatial clustering, and matched to sociodemographic measures. Negative binomial models were used to evaluate population measures.

RESULTS Emergency personnel evaluated 8786 major trauma patients, and data on 7326 of these patients were available for analysis. We identified 529 (13.7%) census tracts with a higher than expected incidence of major trauma events. In multivariable models, trauma events were associated with higher unemployment rates, larger percentages of non-White residents, smaller percentages of foreign-born residents, lower educational levels, smaller household sizes, younger age, and lower income levels.

CONCLUSIONS Major trauma events tend to cluster in census tracts with distinct population characteristics, suggesting that social and contextual factors may play a role in the occurrence of significant injury events.


Title

Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models.


Citation Zelnick L, Morrison L, Devlin S, Bulger E, Brasel K, Sheehan K, Minei J, Kerby J, Tisherman S, Rizoli S, Karmy-Jones R, van Heest R, Newgard C, and the ROC Investigators. Addressing the challenges of obtaining functional outcomes in traumatic brain injury research: missing data patterns, timing of follow-up, and three prognostic models. Journal of Neurotrauma 2014; 31(11):1029-38. PMCID: PMC4043258

Abstract Traumatic brain injury (TBI) is common and debilitating. Randomized trials of interventions for TBI ideally assess effectiveness by using long-term functional neurological outcomes, but such outcomes are difficult to obtain and costly. If there is little change between functional status at hospital discharge versus 6 months, then shorter-term outcomes may be adequate for use in future clinical trials. Using data from a previously published multi-center, randomized, placebo-controlled TBI clinical trial, we evaluated patterns of missing outcome data, changes in functional status between hospital discharge and 6 months, and three prognostic models to predict long-term functional outcome from covariates available at hospital discharge (functional measures, demographics, and injury characteristics). The Resuscitation Outcomes Consortium Hypertonic Saline trial enrolled 1282 TBI patients, obtaining the primary outcome of 6-month Glasgow Outcome Score Extended (GOSE) for 85% of patients, but missing the primary outcome for the remaining 15%. Patients with missing outcomes had less-severe injuries, higher neurological function at discharge (GOSE), and shorter hospital stays than patients whose GOSE was obtained. Of 1066 (83%) patients whose GOSE was obtained both at hospital discharge and at 6-months, 71% of patients had the same dichotomized functional status (severe disability/death vs. moderate/no disability) after 6 months as at discharge, 28% had an improved functional status, and 1% had worsened. Performance was excellent (C-statistic between 0.88 and 0.91) for all three prognostic models and calibration adequate for two models (p values, 0.22 and 0.85). Our results suggest that multiple imputation of the standard 6-month GOSE may be reasonable in TBI research when the primary outcome cannot be obtained through other means.


Title

A comparison of the universal TOR Guideline to the absence of prehospital ROSC and duration of resuscitation in predicting futility from out-of-hospital cardiac arrest.


Citation Drennan IR, Case E, Verbeek PR, Reynolds JC, Goldberger ZD, Jasti J, Charleston M, Herren H, Idris AH, Leslie PR, Austin MA, Xiong Y, Schmicker RH, Morrison LJ; Resuscitation Outcomes Consortium Investigators. A comparison of the universal TOR Guideline to the absence of prehospital ROSC and duration of resuscitation in predicting futility from out-of-hospital cardiac arrest. Resuscitation 2017. 111:96-102. PMCID: PMC5272920

Abstract INTRODUCTION The Universal Termination of Resuscitation (TOR) Guideline accurately identifies potential out-of-hospital cardiac arrest (OHCA) survivors. However, implementation is inconsistent with some Emergency Medical Service (EMS) agencies using absence of return of spontaneous circulation (ROSC) as sole criterion for termination.

OBJECTIVE To compare the performance of the Universal TOR Guideline with the single criterion of no prehospital ROSC. Second, to determine factors associated with survival for patients transported without a ROSC. Lastly, to compare the impact of time to ROSC as a marker of futility to the Universal TOR Guideline.

DESIGN Retrospective, observational cohort study.

PARTICIPANTS Non-traumatic, adult (≥18 years) OHCA patients of presumed cardiac etiology treated by EMS providers.

SETTING ROC-PRIMED and ROC-Epistry post ROC-PRIMED databases between 2007 and 2011.

OUTCOMES Primary outcome was survival to hospital discharge and the secondary outcome was functional survival. We used multivariable regression to evaluate factors associated with survival in patients transported without a ROSC.

RESULTS 36,543 treated OHCAs occurred of which 9467 (26%) were transported to hospital without a ROSC. Patients transported without a ROSC who met the Universal TOR Guideline for transport had a survival of 3.0% (95% CI 2.5-3.4%) compared to 0.7% (95% CI 0.4-0.9%) in patients who met the Universal TOR Guideline for termination. The Universal TOR Guideline identified 99% of survivors requiring continued resuscitation and transportation to hospital including early identification of survivors who sustained a ROSC after extended durations of CPR.

CONCLUSION Using absence of ROSC as a sole predictor of futility misses potential survivors. The Universal TOR Guideline remains a strong predictor of survival.


Title

Emergency medical services intervals and survival in trauma: assessment of the "golden hour" in a North American prospective cohort.


Citation Newgard C, Schmicker R, Hedges J, Trickett J, Davis D, Bulger E, Aufderheide T, Minei J, Hata S, Gubler D, Brown T, Yelle J, Bardarson B, Nichol G, ROC Investigators. Out-of-hospital time and survival: Assessment of the "Golden Hour" in a North American prospective trauma cohort. Annals of Emergency Medicine 2010; 55(3):235-264.e4. PMCID: 3008652

Abstract STUDY OBJECTIVE The first hour after the onset of out-of-hospital traumatic injury is referred to as the "golden hour," yet the relationship between time and outcome remains unclear. We evaluate the association between emergency medical services (EMS) intervals and mortality among trauma patients with field-based physiologic abnormality.

METHODS This was a secondary analysis of an out-of-hospital, prospective cohort registry of adult (aged > or =15 years) trauma patients transported by 146 EMS agencies to 51 Level I and II trauma hospitals in 10 sites across North America from December 1, 2005, through March 31, 2007. Inclusion criteria were systolic blood pressure less than or equal to 90 mm Hg, respiratory rate less than 10 or greater than 29 breaths/min, Glasgow Coma Scale score less than or equal to 12, or advanced airway intervention. The outcome was in-hospital mortality. We evaluated EMS intervals (activation, response, on-scene, transport, and total time) with logistic regression and 2-step instrumental variable models, adjusted for field-based confounders.

RESULTS There were 3,656 trauma patients available for analysis, of whom 806 (22.0%) died. In multivariable analyses, there was no significant association between time and mortality for any EMS interval: activation (odds ratio [OR] 1.00; 95% confidence interval [CI] 0.95 to 1.05), response (OR 1.00; 95% CI 9.97 to 1.04), on-scene (OR 1.00; 95% CI 0.99 to 1.01), transport (OR 1.00; 95% CI 0.98 to 1.01), or total EMS time (OR 1.00; 95% CI 0.99 to 1.01). Subgroup and instrumental variable analyses did not qualitatively change these findings.

CONCLUSION In this North American sample, there was no association between EMS intervals and mortality among injured patients with physiologic abnormality in the field.


Title

Regional incidence and outcome of out-of-hospital cardiac arrest associated with overdose.


Citation Salcido DD, Torres C, Koller AC, Orkin AM, Schmicker RH, Morrison LJ, Nichol G, Stephens S, Menegazzi JJ, and the ROC Investigators. Regional incidence and outcome of out-of-hospital cardiac arrest associated with overdose. Resuscitation 2016; 99:13-19

Abstract BACKGROUND The frequency of lethal overdose due to prescription and non-prescription drugs is increasing in North America. The aim of this study was to estimate overall and regional variation in incidence and outcomes of out-of-hospital cardiac arrest due to overdose across North America.

METHODS We conducted a retrospective cohort study using case data for the period 2006-2010 from the Resuscitation Outcomes Consortium, a clinical research network with 10 regional clinical centers in United States and Canada. Cases of out-of-hospital cardiac arrest due to drug overdose were identified through review of data derived from prehospital clinical records. We calculated incidence of out-of-hospital cardiac arrest due to overdose per 100,000 person-years and proportion of the same among all out-of-hospital cardiac arrests. We analyzed the association between overdose cardiac arrest etiology and resuscitation outcomes.

RESULTS Included were 56,272 cases, of which 1351 were due to overdose. Regional incidence of out-of-hospital cardiac arrest due to overdose varied between 0.5 and 2.7 per 100,000 person years (p<0.001), and proportion of the same among all treated out-of-hospital cardiac arrests ranged from 0.8% to 4.0%. Overdose cases were younger, less likely to be witnessed, and less likely to present with a shockable rhythm. Compared to non-overdose, overdose was directly associated with return of spontaneous circulation (OR: 1.55; 95% CI: 1.35-1.78) and survival (OR: 2.14; 95% CI: 1.72-2.65).

CONCLUSIONS Overdose made up 2.4% of all out-of-hospital cardiac arrest, although incidence varied up to 5-fold across regions. Overdose cases were more likely to survive than non-overdose cases.


Title

Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium.


Citation Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Annals of Surgery 2015; 261(3):586-90. PMCID: PMC4309746

Abstract OBJECTIVE To identify causes and timing of mortality in trauma patients to determine targets for future studies.

BACKGROUND In trials conducted by the Resuscitation Outcomes Consortium in patients with traumatic hypovolemic shock (shock) or traumatic brain injury (TBI), hypertonic saline failed to improve survival. Selecting appropriate candidates is challenging.

METHODS Retrospective review of patients enrolled in multicenter, randomized trials performed from 2006 to 2009. Inclusion criteria were as follows: injured patients, age 15 years or more with hypovolemic shock [systolic blood pressure (SBP) ≤ 70 mm Hg or SBP 71-90 mm Hg with heart rate ≥ 108) or severe TBI [Glasgow Coma Score (GCS) ≤ 8]. Initial fluid administered was 250 mL of either 7.5% saline with 6% dextran 70, 7.5% saline or 0.9% saline.

RESULTS A total of 2061 subjects were enrolled (809 shock, 1252 TBI) and 571 (27.7%) died. Survivors were younger than nonsurvivors [30 (interquartile range 23) vs 42 (34)] and had a higher GCS, though similar hemodynamics. Most deaths occurred despite ongoing resuscitation. Forty-six percent of deaths in the TBI cohort were within 24 hours, compared with 82% in the shock cohort and 72% in the cohort with both shock and TBI. Median time to death was 29 hours in the TBI cohort, 2 hours in the shock cohort, and 4 hours in patients with both. Sepsis and multiple organ dysfunction accounted for 2% of deaths.

CONCLUSIONS Most deaths from trauma with shock or TBI occur within 24 hours from hypovolemic shock or TBI. Novel resuscitation strategies should focus on early deaths, though prevention may have a greater impact.


Title

Survival increases with CPR by Emergency Medical Services before defibrillation of out-of-hospital ventricular fibrillation or ventricular tachycardia: observations from the Resuscitation Outcomes Consortium.


Citation Bradley S, Gabriel E, Aufderheide T, Barnes R, Christenson J, Davis D, Stiell I, Nichol G, ROC Investigators. Survival increases with CPR by emergency medical services before defibrillation of out-of-hospital ventricular fibrillation or ventricular tachycardia: Observations from the Resuscitation Outcomes Consortium. Resuscitation 2010; 81(2):155-162. PMCID: PMC2814939

Abstract BACKGROUND Immediate defibrillation is the traditional approach to resuscitation of cardiac arrest due to ventricular fibrillation or tachycardia (VF/VT). Delaying defibrillation to provide chest compressions may improve survival. We examined the effect of the duration of Emergency Medical Services (EMS) cardiopulmonary resuscitation (CPR) prior to first defibrillation on survival in patients with out-of-hospital VF/VT.

MATERIALS AND METHODS From a prospective multi-center observational registry of EMS-treated out-of-hospital cardiac arrest, we identified 1638 EMS-treated cardiac arrests with first recorded rhythm VF/VT or "shockable" and complete data for analysis. Survival to hospital discharge was determined as a function of EMS CPR duration prior to first shock.

RESULTS Compared to the reference group of first EMS CPR duration < or =45 s, the odds of survival was greater among patients who received between 46 and 195 s of EMS CPR before first shock (46-75 s odds ratio [OR] 1.15, 95% confidence interval [CI] 0.71-1.87; 76-105 s, OR 1.37, 95% CI 0.80-2.35; 106-135 s, OR 1.53, 95% CI 0.96-2.45; 136-165 s, OR 1.24, 95% CI 0.71-2.15; 166-195 s, OR 1.47, 95% CI 0.85-2.52). The benefit of EMS CPR before defibrillation was reduced when the duration of CPR exceeded 195 s (196-225 s, OR 0.95, 95% CI 0.47-1.81; 226-255 s, OR 0.91, 95% CI 0.46-1.79; 256-285 s, OR 0.46, 95% CI 0.17-1.29; 286-315 s, OR 1.29, 95% CI 0.59-2.85). An optimal EMS CPR duration was not identified and no duration achieved statistical significance.

CONCLUSION In this observational analysis of VF/VT arrest, between 46 and 195 s of EMS CPR prior to defibrillation was weakly associated with improved survival compared to < or =45 s. Randomized trials are needed to confirm the optimal duration of EMS CPR prior to defibrillation and to assess the impact of first CPR duration on all initial rhythms.


Title

Cardiac arrest survival did not increase in the Resuscitation Outcomes Consortium after implementation of the 2005 AHA CPR and ECC guidelines.


Citation Bigham BL, Koprowicz K, Rea T, Dorian P, Aufderheide TP, Davis DP, Powell J, Morrison LJ, ROC Investigators. Cardiac arrest survival did not increase in the Resuscitation Outcomes Consortium after implementation of the 2005 AHA CPR and ECC guidelines. Resuscitation 2011; 82:979-983. PMCID: PMC3744665

Abstract INTRODUCTION We examined the effect of the 2005 American Heart Association guidelines on survival in the Resuscitation Outcomes Consortium (ROC) Cardiac Arrest Epistry.

METHODS We surveyed 174 EMS agencies from 8 of 10 ROC sites to determine 2005 AHA guideline implementation, or crossover, date. Two sites with 2005 compatible treatment algorithms prior to guideline release, and agencies that did not adopt the new guidelines during the study period were excluded. Non-traumatic adult cardiac arrests that were not witnessed by EMS, and did not have do not resuscitate orders were included. A linear mixed effects model was applied for survival controlling for time and agency. The "crossover" date was added to the model to determine the effect of the 2005 guidelines.

RESULTS Of 174 agencies, 85 contributed cases to both cohorts during the 18 month period between 2005/12/01 and 2007/05/31. Of 7779 cases, 5054 occurred during the 13 month (median) interval before crossover and 2725 occurred in the five month (median) interval after crossover. The overall survival rate was 6.1%; 5.8% in the old cohort vs. 6.5%, p=0.23. For VF/VT patients, survival was 14.6% vs. 18.0%, p=0.063. Our model estimated no increase in survival over time (monthly OR 1.014, 95% CI 0.988, 1.041, p=0.28).

CONCLUSION This study found no significant change in survival rate over time in the early months after implementation. Further longitudinal study is needed to determine the full impact of the guidelines on survival and methods to translate knowledge quickly and effectively in EMS.


Title

Association of advanced airway device with chest compression fraction during out-of-hospital cardiopulmonary arrest.


Citation Kurz MC, Prince D, Christenson J, Carlson J, May S, Stub D, Cheskes S, Lin S, Aziz M, Austin M, Vaillancourt C, Colvin J, Wang HE, and the ROC Investigators. Association of advanced airway device with chest compression fraction during out-of-hospital cardiopulmonary arrest. Resuscitation 2016; 98:35-40

Abstract BACKGROUND Select Emergency Medical Services (EMS) practitioners substitute endotracheal intubation (ETI) with supraglottic airway (SGA) insertion to minimize CPR chest compression interruptions, but the resulting effects upon chest compression fraction (CCF) are unknown. We sought to determine the differences in CCF between adult out-of-hospital cardiac arrest (OHCA) receiving ETI and those receiving SGA.

METHODS We studied adult, non-traumatic OHCA patients enrolled in the Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation using an Impedance valve and an Early vs. Delayed analysis (PRIMED) trial. Chest compressions were measured using compression or thoracic impedance sensors. We limited the analysis to those receiving ETI or SGA (Combitube, King Laryngeal Tube, or Laryngeal Mask Airway) and >2min of chest compression data before and after airway insertion. We compared CCF between ETI and SGA before and after airway insertion, adjusting for age, sex, witnessed arrest, bystander CPR, shockable initial rhythm, public location, PRIMED trial arm, and regional ROC center. We also compared the change in CCF for each airway technique.

RESULTS Of 14,955 patients enrolled in the ROC PRIMED trial, we analyzed 2767 cases, including 2051 ETI, 671 SGA, and 45 both. Among subjects in this investigation the mean age was 66.4 years with a male predominace, 46% with witnessed event, 37% receiving bystander CPR, and 22% presenting with an initially shockable rhythm. Pre- and post-airway CCF was higher for SGA than ETI (SGA pre-airway CCF 73.2% [95%CI: 71.6-74.7%] vs. ETI 70.6% [95%CI: 69.7-71.5%]; post-airway 76.7% [95%CI: 75.2-78.1%] vs. 72.4% [95%CI: 71.5-73.3%]). After adjusting for potential confounders, these significant changes persisted (pre-airway difference 2.2% favoring SGA, p-value=0.046; post-airway 3.4% favoring SGA, p=0.001).

CONCLUSION In patients with OHCA, we detected a slightly higher rate of CCF in patients for whom a SGA was inserted, both before and after insertion. However, the actual differences were so small, that in the context of this observational, secondary analysis, it is unclear if this represents a clinically significant difference.


Title

Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest.


Citation Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya M, Wang HE, Morrison L, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M, and the ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. New England Journal of Medicine 2011; 365(9):787-797. PMCID: PMC3181067

Abstract BACKGROUND In a departure from the previous strategy of immediate defibrillation, the 2005 resuscitation guidelines from the American Heart Association-International Liaison Committee on Resuscitation suggested that emergency medical service (EMS) personnel could provide 2 minutes of cardiopulmonary resuscitation (CPR) before the first analysis of cardiac rhythm. We compared the strategy of a brief period of CPR with early analysis of rhythm with the strategy of a longer period of CPR with delayed analysis of rhythm.

METHODS We conducted a cluster-randomized trial involving adults with out-of-hospital cardiac arrest at 10 Resuscitation Outcomes Consortium sites in the United States and Canada. Patients in the early-analysis group were assigned to receive 30 to 60 seconds of EMS-administered CPR and those in the later-analysis group were assigned to receive 180 seconds of CPR, before the initial electrocardiographic analysis. The primary outcome was survival to hospital discharge with satisfactory functional status (a modified Rankin scale score of ≤3, on a scale of 0 to 6, with higher scores indicating greater disability).

RESULTS We included 9933 patients, of whom 5290 were assigned to early analysis of cardiac rhythm and 4643 to later analysis. A total of 273 patients (5.9%) in the later-analysis group and 310 patients (5.9%) in the early-analysis group met the criteria for the primary outcome, with a cluster-adjusted difference of -0.2 percentage points (95% confidence interval, -1.1 to 0.7; P=0.59). Analyses of the data with adjustment for confounding factors, as well as subgroup analyses, also showed no survival benefit for either study group.

CONCLUSIONS Among patients who had an out-of-hospital cardiac arrest, we found no difference in the outcomes with a brief period, as compared with a longer period, of EMS-administered CPR before the first analysis of cardiac rhythm. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.).


Title

Rationale, development and implementation of the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest.


Citation Morrison LJ, Nichol G, Rea TD, Christenson J, Callaway CW, Stephens S, Pirrallo RG, Atkins DL, Davis DP, Idris AH, Newgard CD. Rationale, development and implementation of the Resuscitation Outcomes Consortium epistry-cardiac arrest. Resuscitation 2008; 78:161-169. PMCID: PMC4159466

Abstract 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.


Title

Prehospital traumatic cardiac arrest: Management and outcomes from the resuscitation outcomes consortium epistry-trauma and PROPHET registries.


Citation Evans CCD, Petersen A, Meier EN, Buick JE, Schreiber M, Kannas D, Austin M, and the ROC Investigators. Prehospital traumatic cardiac arrest: Management and outcomes from the resuscitation outcomes consortium epistry-trauma and PROPHET registries. Journal of Trauma and Acute Care Surgery 2016; 81(2):285-293

Abstract BACKGROUND Traumatic arrests have historically had poor survival rates. Identifying salvageable patients and ideal management is challenging. We aimed to (1) describe the management and outcomes of prehospital traumatic arrests; (2) determine regional variation in survival; and (3) identify Advanced Life Support (ALS) procedures associated with survival.

METHODS This was a secondary analysis of cases from the Resuscitation Outcomes Consortium Epistry-Trauma and Prospective Observational Prehospital and Hospital Registry for Trauma (PROPHET) registries. Patients were included if they had a blunt or penetrating injury and received cardiopulmonary resuscitation. Logistic regression analyses were used to determine the association between ALS procedures and survival.

RESULTS We included 2,300 patients who were predominately young (Epistry mean [SD], 39 [20] years; PROPHET mean [SD], 40 [19] years), males (79%), injured by blunt trauma (Epistry, 68%; PROPHET, 67%), and treated by ALS paramedics (Epistry, 93%; PROPHET, 98%). A total of 145 patients (6.3%) survived to hospital discharge. More patients with blunt (Epistry, 8.3%; PROPHET, 6.5%) vs. penetrating injuries (Epistry, 4.6%; PROPHET, 2.7%) survived. Most survivors (81%) had vitals on emergency medical services arrival. Rates of survival varied significantly between the 12 study sites (p = 0.048) in the Epistry but not PROPHET (p = 0.14) registries.Patients in the PROPHET registry who received a supraglottic airway insertion or intubation experienced decreased odds of survival (adjusted OR, 0.27; 95% confidence interval, 0.08-0.93; and 0.37; 95% confidence interval, 0.17-0.78, respectively) compared to those receiving bag-mask ventilation. No other procedures were associated with survival.

CONCLUSIONS Survival from traumatic arrest may be higher than expected, particularly in blunt trauma and patients with vitals on emergency medical services arrival. Although limited by confounding and statistical power, no ALS procedures were associated with increased odds of survival.

LEVEL OF EVIDENCE Prognostic study, level IV.


Title

Predicting survival after out-of-hospital cardiac arrest: role of the Utstein data elements.


Citation Rea T, Cook A, Stiell I, Powell J, Bigham B, Callaway C, Chugh S, Aufderheide T, Morrison L, Terndrup T, Beaudoin T, Wittwer L, Davis D, Idris A, Nichol G, ROC Investigators. Predicting survival following out-of-hospital cardiac arrest: Role of the Utstein data elements. Annals of Emergency Medicine 2010; 55(3):249-257. NIHMSID: NIHMS257398. PMC: In Process

Abstract STUDY OBJECTIVE Survival after out-of-hospital cardiac arrest depends on the links in the chain of survival. The Utstein elements are designed to assess these links and provide the basis for comparing outcomes within and across communities. We assess whether these measures sufficiently predict survival and explain outcome differences.

METHODS We used an observational, prospective data collection, case-series of adult persons with nontraumatic out-of-hospital cardiac arrest from December 1, 2005, through March 1, 2007, from the multisite, population-based Resuscitation Outcomes Consortium Epistry-Cardiac Arrest. We used logistic regression, receiver operating curves, and measures of variance to estimate the extent to which the Utstein elements predicted survival to hospital discharge and explained outcome variability overall and between 7 Resuscitation Outcomes Consortium sites. Analyses were conducted for all emergency medical services-treated cardiac arrests and for the subset of bystander-witnessed patient arrests because of presumed cardiac cause presenting with ventricular fibrillation or ventricular tachycardia.

RESULTS Survival was 7.8% overall (n=833/10,681) and varied from 4.6% to 14.7% across Resuscitation Outcomes Consortium sites. Among bystander-witnessed ventricular fibrillation or ventricular tachycardia, survival was 22.1% overall (n=323/1459) and varied from 12.5% to 41.0% across sites. The Utstein elements collectively predicted 72% of survival variability among all arrests and 40% of survival variability among bystander-witnessed ventricular fibrillation. The Utstein elements accounted for 43.6% of the between-site survival difference among all arrests and 22.3% of the between-site difference among the bystander-witnessed ventricular fibrillation subset.

CONCLUSION The Utstein elements predict survival but account for only a modest portion of outcome variability overall and between Resuscitation Outcomes Consortium sites. The results underscore the need for ongoing investigation to better understand characteristics that influence cardiac arrest survival.


Title

Variation in the type, rate, and selection of patients for out-of-hospital airway procedures among injured children and adults.


Citation Newgard C, Koprowicz K, Wang H, Monnig A, Kerby J, Sears G, Davis D, Bulger E, Stephens S, Daya M, ROC Investigators. Variation in the type, rate, and selection of patients for out-of-hospital airway procedures among injured children and adults. Academic Emergency Medicine 2009; 16(23):1269-1276. PMC: PMC3954116

Abstract OBJECTIVES The objective was to compare the type, rate, and selection of injured patients for out-of-hospital airway procedures among emergency medical services (EMS) agencies in 10 sites across North America.

METHODS The authors analyzed a consecutive patient, prospective cohort registry of injured adults and children with an out-of-hospital advanced airway attempt, collected from December 1, 2005, through February 28, 2007, by 181 EMS agencies in 10 sites across the United States and Canada. Advanced airway procedures were defined as orotracheal intubation, nasotracheal intubation, supraglottic airway, or cricothyrotomy. Airway procedure rates were calculated based on age-specific population values for the 10 sites and the number of injured patients with field physiologic abnormality (systolic blood pressure of < or = 90 mm Hg, respiratory rate of <10 or >29 breaths/min, Glasgow Coma Scale [GCS] score of < or = 12). Descriptive measures were used to compare patients between sites.

RESULTS A total 1,738 patients had at least one advanced airway attempt and were included in the analysis. There was wide variation between sites in the types of airway procedures performed, including orotracheal intubation (63% to 99%), supraglottic airways (0 to 27%), nasotracheal intubation (0 to 21%), and cricothyrotomy (0 to 2%). Use of rapid sequence intubation (RSI) varied from 0% to 65%. The population-adjusted rates of field airway intervention (by site) ranged from 1.2 to 22.8 per 100,000 adults and 0.2 to 4.0 per 100,000 children. Among trauma patients with physiologic abnormality, some sites performed airway procedures in almost 50% of patients, while other sites used these procedures in fewer than 10%. There was also large variation in demographic characteristics, physiologic measures, mechanism of injury, mode of transport, field cardiopulmonary resuscitation, and unadjusted mortality among airway patients.

CONCLUSIONS Among 10 sites across North America, there was wide variation in the types of out-of-hospital airway procedures performed, population-based rates of airway intervention, and the selection of injured patients for such procedures.


Title

A trial of an impedance threshold device in out-of-hospital cardiac arrest.


Citation Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G, ROC Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. New England Journal of Medicine 2011; 365:798-806. PMCID: PMC3204381

Abstract BACKGROUND The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.

METHODS We compared the use of an active ITD with that of a sham ITD in patients with out-of-hospital cardiac arrest who underwent standard CPR at 10 sites in the United States and Canada. Patients, investigators, study coordinators, and all care providers were unaware of the treatment assignments. The primary outcome was survival to hospital discharge with satisfactory function (i.e., a score of ≤3 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating greater disability).

RESULTS Of 8718 patients included in the analysis, 4345 were randomly assigned to treatment with a sham ITD and 4373 to treatment with an active device. A total of 260 patients (6.0%) in the sham-ITD group and 254 patients (5.8%) in the active-ITD group met the primary outcome (risk difference adjusted for sequential monitoring, -0.1 percentage points; 95% confidence interval, -1.1 to 0.8; P=0.71). There were also no significant differences in the secondary outcomes, including rates of return of spontaneous circulation on arrival at the emergency department, survival to hospital admission, and survival to hospital discharge.

CONCLUSIONS Use of the ITD did not significantly improve survival with satisfactory function among patients with out-of-hospital cardiac arrest receiving standard CPR. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.).


Title

A Geospatial Analysis of Severe Firearm Injuries Compared to Other Injury Mechanisms: Event Characteristics, Location, Timing, and Outcomes.


Citation Newgard CD, Sanchez BJ, Bulger EM, Brasel KJ, Byers A, Buick JE, Sheehan KL, Guyette FX, King RV, Mena-Munoz J, Minei JP, Schmicker RH; ROC Investigators. A geospatial analysis of severe firearm injuries compared to other injury mechanisms: event characteristics, location, timing, and outcomes. Acad Emerg Med 2016. 23(5):554-565.

Abstract OBJECTIVES Relatively little is known about the context and location of firearm injury events. Using a prospective cohort of trauma patients, we describe and compare severe firearm injury events to other violent and nonviolent injury mechanisms regarding incident location, proximity to home, time of day, spatial clustering, and outcomes.

METHODS This was a secondary analysis of a prospective cohort of injured children and adults with hypotension or Glasgow Coma Scale score ≤ 8, injured by one of four primary injury mechanisms (firearm, stabbing, assault, and motor vehicle collision [MVC]) who were transported by emergency medical services to a Level I or II trauma center in 10 regions of the United States and Canada from January 1, 2010, through June 30, 2011. We used descriptive statistics and geospatial analyses to compare the injury groups, distance from home, outcomes, and spatial clustering.

RESULTS There were 2,079 persons available for analysis, including 506 (24.3%) firearm injuries, 297 (14.3%) stabbings, 339 (16.3%) assaults, and 950 (45.7%) MVCs. Firearm injuries resulted in the highest proportion of serious injuries (66.3%), early critical resources (75.3%), and in-hospital mortality (53.5%). Injury events occurring within 1 mile of a patient's home included 53.9% of stabbings, 49.2% of firearm events, 41.3% of assaults, and 20.0% of MVCs; the non-MVC events frequently occurred at home. While there was geospatial clustering, 94.4% of firearm events occurred outside of geographic clusters.

CONCLUSIONS Severe firearm events tend to occur within a patient's own neighborhood, often at home, and generally outside of geospatial clusters. Public health efforts should focus on the home in all types of neighborhoods to reduce firearm violence.


Title

Unchanged pediatric out-of-hospital cardiac arrest incidence and survival rates with regional variation in North America.


Citation Fink EL, Prince DK, Kaltman JR, Atkins DL, Austin M, Warden C, Hutchison J, Daya M, Goldberg S, Herren H, Tijssen JA, Christenson J, Vaillancourt C, Miller R, Schmicker RH, Callaway CW, Resuscitation Outcomes Consortium. Unchanged pediatric out-of-hospital cardiac arrest incidence and survival rates with regional variation in North America. Resuscitation 2016. 107:121-128. PMCID: PMC5037038

Abstract AIM Outcomes for pediatric out-of-hospital cardiac arrest (OHCA) are poor. Our objective was to determine temporal trends in incidence and mortality for pediatric OHCA.

METHODS Adjusted incidence and hospital mortality rates of pediatric non-traumatic OHCA patients from 2007-2012 were analyzed using the 9 region Resuscitation Outcomes Consortium-Epidemiological Registry (ROC-Epistry) database. Children were divided into 4 age groups: perinatal (<3 days), infants (3days-1year), children (1-11 years), and adolescents (12-19 years). ROC regions were analyzed post-hoc.

RESULTS We studied 1738 children with OHCA. The age- and sex-adjusted incidence rate of OHCA was 8.3 per 100,000 person-years (75.3 for infants vs. 3.7 for children and 6.3 for adolescents, per 100,000 person-years, p<0.001). Incidence rates differed by year (p<0.001) without overall linear trend. Annual survival rates ranged from 6.7-10.2%. Survival was highest in the perinatal (25%) and adolescent (17.3%) groups. Stratified by age group, survival rates over time were unchanged (all p>0.05) but there was a non-significant linear trend (1.3% increase) in infants. In the multivariable logistic regression analysis, infants, unwitnessed event, initial rhythm of asystole, and region were associated with worse survival, all p<0.001. Survival by region ranged from 2.6-14.7%. Regions with the highest survival had more cases of EMS-witnessed OHCA, bystander CPR, and increased EMS-defibrillation (all p<0.05).

CONCLUSIONS Overall incidence and survival of children with OHCA in ROC regions did not significantly change over a recent 5year period. Regional variation represents an opportunity for further study to improve outcomes.


Title

Increased trauma center volume is associated with improved survival after severe injury: results of a Resuscitation Outcomes Consortium study.


Citation Minei JP, Fabian TC, Guffey DM, Newgard CD, Bulger EM, Brasel KJ, Sperry JL, MacDonald RD. Increased trauma center volume is associated with improved survival after severe injury: results of a resuscitation outcomes consortium study. Annals of Surgery 2014; 260(3):456-465. PMCID: PMC4153990

Abstract OBJECTIVE To investigate the relationship between trauma center volume and outcome.

BACKGROUND The Resuscitation Outcomes Consortium is a network of 11 centers and 60 hospitals conducting emergency care research. For many procedures, high-volume centers demonstrate superior outcomes versus low-volume centers. This remains controversial for trauma center outcomes.

METHODS This study was a secondary analysis of prospectively collected data from the Resuscitation Outcomes Consortium multicenter out-of-hospital Hypertonic Saline Trial in patients with Glasgow Coma Scale score of 8 or less (traumatic brain injury) or systolic blood pressure of 90 or less and pulse of 110 or more (shock). Regression analyses evaluated associations between trauma volume and the following outcomes: 24-hour mortality, 28-day mortality, ventilator-free days, Multiple Organ Dysfunction Scale incidence, worst Multiple Organ Dysfunction Scale score, and poor 6-month Glasgow Outcome Scale-Extended score.

RESULTS A total of 2070 patients were evaluated: 1251 in the traumatic brain injury cohort and 819 in the shock cohort. Overall, 24-hour and 28-day mortality was 16% and 25%, respectively. For every increase of 500 trauma center admissions, there was a 7% decreased odds of 24-hour and 28-day mortality for all patients. As trauma center volume increased, nonorgan dysfunction complications increased, ventilator-free days increased, and worst Multiple Organ Dysfunction Scale score decreased. The associations with higher trauma center volume were similar for the traumatic brain injury cohort, including better neurologic outcomes at 6 months, but not for the shock cohort.

CONCLUSIONS Increased trauma center volume was associated with increased survival, more ventilator-free days, and less severe organ failure. Trauma system planning and implementation should avoid unnecessary duplication of services.


Title

Apples to apples or apples to oranges? International variation in reporting of process and outcome of care for out-of-hospital cardiac arrest.


Citation Nishiyama C, Brown SP, May S, Iwami T, Koster RW, Beesems SG, Kuisma M, Salo A, Jacobs I, Finn J, Sterz F, Nurnberger A, Smith K, Morrison L, Olasveengen TM, Callaway CW, Do Shin , Grasner J-T, Daya M, Huei-Ming Ma M, Herlitz J, Stromsoe A, Aufderheide TP, Masterson S, Wang H, Christenson J, Stiell I, Davis D, Huszti E, Nichol G. Apples to apples or apples to oranges? International variation in reporting of process and outcome of care for out-of-hospital cardiac arrest. Resuscitation 2014; 85(11):1599-1609. PMCID: PMC4253685

Abstract OBJECTIVES Survival after out-of-hospital cardiac arrest (OHCA) varies between communities, due in part to variation in the methods of measurement. The Utstein template was disseminated to standardize comparisons of risk factors, quality of care, and outcomes in patients with OHCA. We sought to assess whether OHCA registries are able to collate common data using the Utstein template. A subsequent study will assess whether the Utstein factors explain differences in survival between emergency medical services (EMS) systems.

STUDY DESIGN Retrospective study.

SETTING This retrospective analysis of prospective cohorts included adults treated for OHCA, regardless of the etiology of arrest. Data describing the baseline characteristics of patients, and the process and outcome of their care were grouped by EMS system, de-identified, and then collated. Included were core Utstein variables and timed event data from each participating registry. This study was classified as exempt from human subjects' research by a research ethics committee.

MEASUREMENTS AND MAIN RESULTS Thirteen registries with 265 first-responding EMS agencies in 13 countries contributed data describing 125,840 cases of OHCA. Variation in inclusion criteria, definition, coding, and process of care variables were observed. Contributing registries collected 61.9% of recommended core variables and 42.9% of timed event variables. Among core variables, the proportion of missingness was mean 1.9±2.2%. The proportion of unknown was mean 4.8±6.4%. Among time variables, missingness was mean 9.0±6.3%.

CONCLUSIONS International differences in measurement of care after OHCA persist. Greater consistency would facilitate improved resuscitation care and comparison within and between communities.


Title

Out-of-hospital cardiac arrest survival improving over time: Results from the Resuscitation Outcomes Consortium (ROC).


Citation Daya MR, Schmicker RH, Zive DM, Rea TD, Nichol G, Buick JE, Brooks S, Christenson J, MacPhee R, Craig A, Rittenberger JC, Davis DP, May S, Wigginton J, Wang H, and the ROC Investigators. Out-of-hospital cardiac arrest survival improving over time: results from the Resuscitation Outcomes Consortium (ROC). Resuscitation 2015; 91:108-115. PMCID: PMC4433591

Abstract BACKGROUND Out-of-hospital cardiac arrest (OHCA) remains a leading cause of death and a 2010 meta-analysis concluded that outcomes have not improved over several decades. However, guidelines have changed to emphasize CPR quality, minimization of interruptions, and standardized post-resuscitation care. We sought to evaluate whether OHCA outcomes have improved over time among agencies participating in the Resuscitation Outcomes Consortium (ROC) cardiac arrest registry (Epistry) and randomized clinical trials (RCTs).

METHODS Observational cohort study of 47,148 EMS-treated OHCA cases in Epistry from 139 EMS agencies at 10 ROC sites that participated in at least one RCT between 1/1/2006 and 12/31/2010. We reviewed patient, scene, event characteristics, and outcomes of EMS-treated OHCA over time, including subgroups with initial rhythm of pulseless ventricular tachycardia or ventricular fibrillation (VT/VF).

RESULTS Mean response interval, median age and male proportion remained similar over time. Unadjusted survival to discharge increased between 2006 and 2010 for treated OHCA (from 8.2% to 10.4%), as well as for subgroups of VT/VF (21.4% to 29.3%) and bystander witnessed VT/VF (23.5% to 30.3%). Compared with 2006, adjusted survival to discharge was significantly higher in 2010 for treated cases (OR = 1.72; 95% CI 1.53, 1.94), VT/VF cases (OR = 1.69; 95% CI 1.45, 1.98) and bystander witnessed VT/VF cases (OR = 1.65; 95% CI 1.36, 2.00). Tests for trend in each subgroup were significant (p < 0.001).

CONCLUSIONS ROC-wide survival increased significantly between 2006 and 2010. Additional research efforts are warranted to identify specific factors associated with this improvement.


Title

The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation.


Citation Vaillancourt C, Everson-Stewart S, Christenson J, Andrusiek D, Powell J, Nichol G, Cheskes S, Aufderheide TP, Berg R, Stiell IG, and the ROC Investigators. The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation. Resuscitation 2011; 82(12):1501-7. PMCID: PMC3215827

Abstract OBJECTIVE Greater chest compression fraction (CCF, or proportion of CPR time spent providing compressions) is associated with better survival for out-of-hospital cardiac arrest (OOHCA) patients in ventricular fibrillation (VF). We evaluated the effect of CCF on return of spontaneous circulation (ROSC) in OOHCA patients with non-VF ECG rhythms in the Resuscitation Outcomes Consortium Epistry.

METHODS This prospective cohort study included OOHCA patients if: not witnessed by EMS, no automated external defibrillator (AED) shock prior to EMS arrival, received >1 min of CPR with CPR process measures available, and initial non-VF rhythm. We reviewed the first 5 min of electronic CPR records following defibrillator application, measuring the proportion of compressions/min during the resuscitation.

RESULTS Demographics of 2103 adult patients from 10 U.S. and Canadian centers were: mean age 67.8; male 61.2%; public location 10.6%; bystander witnessed 32.9%; bystander CPR 35.4%; median interval from 911 to defibrillator turned on 8 min:27 s; initial rhythm asystole 64.0%, PEA 28.0%, other non-shockable 8.0%; median compression rate 110/min; median CCF 71%; ROSC 24.2%; survival to hospital discharge 2.0%. The estimated linear effect on adjusted odds ratio with 95% confidence interval (OR; 95%CI) of ROSC for each 10% increase in CCF was (1.05; 0.99, 1.12). Adjusted (OR; 95%CI) of ROSC for each CCF category were: 0-40% (reference group); 41-60% (1.14; 0.72, 1.81); 61-80% (1.42; 0.92, 2.20); and 81-100% (1.48; 0.94, 2.32).

CONCLUSIONS This is the first study to demonstrate that increased CCF among non-VF OOHCA patients is associated with a trend toward increased likelihood of ROSC.


Title

Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest.


Citation Wang HE, Szydlo D, Sotouffer JA, Lin S, Carlson JN, Vaillancourt C, Sears G, Verbeek RP, Fowler R, Idris AH, Koenig K, Christenson J, Minokadeh A, Brandt J, Rea T, ROC Investigators. Endotracheal intubation versus supraglottic airway insertion in out-of-hospital cardiac arrest. Resuscitation 2012; 83(9):1061-1066. PMCID: PMC3733371

Abstract OBJECTIVE To simplify airway management and minimize cardiopulmonary resuscitation (CPR) chest compression interruptions, some emergency medical services (EMS) practitioners utilize supraglottic airway (SGA) devices instead of endotracheal intubation (ETI) as the primary airway adjunct in out-of-hospital cardiac arrest (OHCA). We compared the outcomes of patients receiving ETI with those receiving SGA following OHCA.

METHODS We performed a secondary analysis of data from the multicenter Resuscitation Outcomes Consortium (ROC) PRIMED trial. We studied adult non-traumatic OHCA receiving successful SGA insertion (King Laryngeal Tube, Combitube, and Laryngeal Mask Airway) or successful ETI. The primary outcome was survival to hospital discharge with satisfactory functional status (Modified Rankin Scale ≤3). Secondary outcomes included return of spontaneous circulation (ROSC), 24-h survival, major airway or pulmonary complications (pulmonary edema, internal thoracic or abdominal injuries, acute lung injury, sepsis, and pneumonia). Using multivariable logistic regression, we studied the association between out-of-hospital airway management method (ETI vs. SGA) and OHCA outcomes, adjusting for confounders.

RESULTS Of 10,455 adult OHCA, 8487 (81.2%) received ETI and 1968 (18.8%) received SGA. Survival to hospital discharge with satisfactory functional status was: ETI 4.7%, SGA 3.9%. Compared with successful SGA, successful ETI was associated with increased survival to hospital discharge (adjusted OR 1.40; 95% CI: 1.04, 1.89), ROSC (adjusted OR 1.78; 95% CI: 1.54, 2.04) and 24-h survival (adjusted OR 1.74; 95% CI: 1.49, 2.04). ETI was not associated with secondary airway or pulmonary complications (adjusted OR 0.84; 95% CI: 0.61, 1.16).

CONCLUSIONS In this secondary analysis of data from the multicenter ROC PRIMED trial, ETI was associated with improved outcomes over SGA insertion after OHCA.


Title

Compression-to-ventilation ratio and incidence of rearrest-A secondary analysis of the ROC CCC trial.


Citation Salcido DD, Schmicker RH, Buick JE, Cheskes S, Grunau B, Kudenchuk P, Leroux B, Zellner S, Zive D, Aufderheide TP, Koller AC, Herren H, Nuttall J, Sundermann ML, Menegazzi JJ; Resuscitation Outcomes Consortium Investigators. Compression-to-ventilation ratio and incidence of rearrest-A secondary analysis of the ROC CCC trial. Resuscitation 2017. 115:68-74

Abstract BACKGROUND Previous work has demonstrated that when out-of-hospital cardiac arrest (OHCA) patients achieve return of spontaneous circulation (ROSC), but subsequently have another cardiac arrest prior to hospital arrival (rearrest), the probability of survival to hospital discharge is significantly decreased. Additionally, few modifiable factors for rearrest are known. We sought to examine the association between rearrest and compression-to-ventilation ratio during cardiopulmonary resuscitation (CPR) and to confirm the association between rearrest and outcomes.

HYPOTHESIS Rearrest incidence would be similar between cases treated with 30:2 or continuous chest compression (CCC) CPR, but inversely related to survival and good neurological outcome.

METHODS We conducted a secondary analysis of a large randomized-controlled trial of CCC versus 30:2 CPR for the treatment of OHCA between 2011 and 2015 among 8 sites of the Resuscitation OUTCOMES: Consortium (ROC). Patients were randomized through an emergency medical services (EMS) agency-level cluster randomization design to receive either 30:2 or CCC CPR. Case data were derived from prehospital patient care reports, digital defibrillator files, and hospital records. The primary analysis was an as-treated comparison of the proportion of patients with a rearrest for patients who received 30:2 versus those who received CCC. In addition, we assessed the association between rearrest and both survival to hospital discharge and favorable neurological outcome (Modified Rankin Score≤3) in patients with and without ROSC upon ED arrival using multivariable logistic regression adjusting for age, sex, initial rhythm and measures of CPR quality.

RESULTS There were 14,109 analyzable cases that were determined to have definitively received either CCC or 30:2 CPR. Of these, 4713 had prehospital ROSC and 2040 (43.2%) had at least one rearrest. Incidence of rearrest was not significantly different between patients receiving CCC and 30:2 (44.1% vs 41.8%; adjusted OR: 1.01; 95% CI: 0.88, 1.16). Rearrest was significantly associated with lower survival (23.3% vs 36.9%; adjusted OR: 0.46; 95%CI: 0.36-0.51) and worse neurological outcome (19.4% vs 30.2%; adjusted OR: 0.46; 95%CI: 0.38, 0.55).

CONCLUSION Rearrest occurrence was not significantly different between patients receiving CCC and 30:2, and was inversely associated with survival to hospital discharge and MRS.


Title

Time on the scene and interventions are associated with improved survival in pediatric out-of-hospital cardiac arrest.


Citation Tijssen JA, Prince DK, Morrison LJ, Atkins DL, Austin MA, Berg R, Brown SP, Christenson J, Egan D, Fedor PJ, Fink EL, Meckler GD, Osmond MH, Sims KA, Hutchison JS, and the ROC Investigators. Time on the scene and interventions are associated with improved survival in pediatric out-of-hospital cardiac arrest. Resuscitation 2015; 94:1-7. PMCID: PMC4540668

Abstract BACKGROUND Survival is less than 10% for pediatric patients following out-of-hospital cardiac arrest. It is not known if more time on the scene of the cardiac arrest and advanced life support interventions by emergency services personnel are associated with improved survival.

AIM This study was performed to determine which times on the scene and which prehospital interventions were associated with improved survival.

METHODS We studied patients aged 3 days to 19 years old with out-of-hospital cardiac arrest, using the Resuscitation Outcomes Consortium cardiac arrest database from 11 North American regions, from 2005 to 2012. We evaluated survival to hospital discharge according to on-scene times (<10, 10 to 35 and >35 min).

RESULTS Data were available for 2244 patients (1017 infants, 594 children and 633 adolescents). Infants had the lowest rate of survival (3.7%) compared to children (9.8%) and adolescents (16.3%). Survival improved over the 7 year study period especially among adolescents. Survival was highest in the 10 to 35 min on-scene time group (10.2%) compared to the >35 min. group (6.9%) and the <10 min. group (5.3%, p=0.01). Intravenous or intra-osseous access attempts and fluid administration were associated with improved survival, whereas advanced airway attempts were not associated with survival and resuscitation drugs were associated with worse survival.

CONCLUSIONS In this observational study, a scene time of 10 to 35 min was associated with the highest survival, especially among adolescents. Access for fluid resuscitation was associated with increased survival but advanced airway and resuscitation drugs were not.


Title

Incidence of rearrest after return of spontaneous circulation in out-of-hospital cardiac arrest.


Citation Salcido DD, Stephenson AM, Condle JP, Callaway CW, Menegazzi JJ. Incidence of rearrest after return of spontaneous circulation in out-of-hospital cardiac arrest. Prehospital Emergency Care 2010; 14(4):413-418. PMID: 20809686

Abstract BACKGROUND Return of spontaneous circulation (ROSC) occurs in 35.0 to 61.0% of emergency medical services (EMS)-treated out-of-hospital cardiac arrests (OHCAs); however, not all patients achieving ROSC survive to hospital arrival or discharge. Previous studies have estimated the incidence of some types of rearrest(RA) at 61.0 to 79.0%, and the electrocardiogram (ECG) waveform characteristics of prehospital RA rhythms have not been previously described.

OBJECTIVES We sought to determine the incidence of RA in OHCA, to classify RA events by type, and to measure the time from ROSC to RA. We also conducted a preliminary analysis of the relationship between first EMS-detected rhythms and RA, as well as the effect of RA on survival.

METHODS The Pittsburgh Regional Clinical Center of the National Heart, Lung, and Blood Institute (NHLBI) -sponsored Resuscitation Outcomes Consortium (ROC) provided cases from a population-based cardiac arrest surveillance program, ROC Epistry. Only OHCA cases of nontraumatic etiology with available and adequate ECG files were included. We analyzed defibrillator-monitor ECG tracings (Philips MRX), patient care reports (PCRs), and defibrillator audio recordings from EMS-treated cases of OHCA spanning the period from October 2006 to December 2008. We identified ROSC and RA through interpretation of ECG tracings and audio recordings. Rearrest events were categorized as ventricular fibrillation (VF), pulseless ventricular tachycardia (VT), asystole, and pulseless electrical activity (PEA) based on ECG waveform characteristics. Proportions of RA rhythms were stratified by first EMS rhythm and compared using Pearson's chi-square test. Logistic regression was used to test the predictive relationship between RA and survival to hospital discharge.

RESULTS Return of spontaneous circulation occurred in 329 of 1,199 patients (27.4% [95.0% confidence interval (CI): 25.0-30.0%]) treated for cardiac arrest. Of these, 113 had ECG tracings that were available and adequate for analysis. Rearrest occurred in 41 patients (36.0% [95.0% CI: 26.0-46.0%]), with a total of 69 RA events. Survival to hospital discharge in RA cases was 23.1% (95.0% CI: 11.1-39.3%), compared with 27.8% (95.0% CI: 17.9-39.6%) in cases without RA. Counts of RA events by type were as follows: 17 VF (24.6% [95% CI: 15.2-36.5%]), 20 pulseless VT (29.0% [95.0% CI: 18.7-41.2%]), 26 PEA (37.0% [95.0% CI: 26.3-50.2%]), and six asystole (8.8% [95.0% CI: 3.3-18.0%]). Rearrest was not predictive of survival to hospital discharge; however, initial EMS rhythm was predictive of RA shockability. The overall median (interquartile range) time from ROSC to RA among all events was 3.1 (1.6-6.3) minutes.

CONCLUSION In this sample, the incidence of RA was 38.0%. The most common type of RA was PEA. Shockability of first EMS rhythm was found to predict subsequent RA rhythm shockability.


Title

Socioeconomic status and incidence of sudden cardiac arrest.


Citation Reinier K, Thomas E, Andrusiek DL, Aufderheide TP, Brooks SC, Callaway CW, Pepe PE, Rea TD, Schmicker RH, Vaillancourt MD C, Chugh SS, ROC Investigators. Socioeconomic status and incidence of sudden cardiac arrest. Canadian Medical Association Journal 2011; 183(15):1705-12. PMCID: PMC3193117

Abstract BACKGROUND Low socioeconomic status is associated with poor cardiovascular health. We evaluated the association between socioeconomic status and the incidence of sudden cardiac arrest, a condition that accounts for a substantial proportion of cardiovascular-related deaths, in seven large North American urban populations.

METHODS Using a population-based registry, we collected data on out-of-hospital sudden cardiac arrests occurring at home or at a residential institution from Apr. 1, 2006, to Mar. 31, 2007. We limited the analysis to cardiac arrests in seven metropolitan areas in the United States (Dallas, Texas; Pittsburgh, Pennsylvania; Portland, Oregon; and Seattle-King County, Washington) and Canada (Ottawa and Toronto, Ontario; and Vancouver, British Columbia). Each incident was linked to a census tract; tracts were classified into quartiles of median household income.

RESULTS A total of 9235 sudden cardiac arrests were included in the analysis. For all sites combined, the incidence of sudden cardiac arrestin the lowest socioeconomic quartile was nearly double that in the highest quartile (incidence rate ratio [IRR] 1.9, 95% confidence interval [CI] 1.8-2.0). This disparity was greater among people less than 65 years old (IRR 2.7, 95% CI 2.5-3.0) than among those 65 or older (IRR 1.3, 95% CI 1.2-1.4). After adjustment for study site and for population age structure of each census tract, the disparity across socioeconomic quartiles for all ages combined was greater in the United States (IRR 2.0, 95% CI 1.9-2.2) than in Canada (IRR 1.8, 95% CI 1.6-2.0) (p<0.001 for interaction).

INTERPRETATION The incidence of sudden cardiac arrest at home or at a residential institution was higher in poorer neighbourhoods of the US and Canadian sites studied, although the association was attenuated in Canada. The disparity across socioeconomic quartiles was greatest among people younger than 65. The association between socioeconomic status and incidence of sudden cardiac arrest merits consideration in the development of strategies to improve survival from sudden cardiac arrest, and possibly to identify opportunities for prevention.


Title

Knowledge translation in emergency medical services: a qualitative survey of barriers to guideline implementation.


Citation Bigham BL, Aufderheide TP, Davis DP, Powell J, Donn S, Suffoletto B, Nafziger S, Stouffer J, Morrison LJ, ROC Investigators. Knowledge translation in emergency medical services: A qualitative survey of barriers to guideline implementation. Resuscitation 2010; 81(7):836-840. PMCID: PMC3209799

Abstract BACKGROUND The American Heart Association (AHA) released guidelines to improve survival rates from out-of-hospital cardiac arrest in 2005. We sought to identify what barriers delayed the implementation of these guidelines in EMS agencies.

METHODS We surveyed 178 EMS agencies as part of a larger quantitative survey regarding guideline implementation and conducted a single-question semi-structured interview using the Grounded Theory method. We asked "What barriers if any, delayed implementation of the (2005 AHA) guidelines in your EMS agency?" Data were coded and member validation was employed to verify our findings.

RESULTS 176/178 agencies completed the quantitative survey. Qualitative data collection ceased after reaching theoretical saturation with 34 interviews. Ten unique barriers were identified. We categorized these 10 barriers into three themes. The theme instruction delays (reported by 41% of respondents) included three barriers: booking/training instructors (9%), receiving training materials (15%), and scheduling staff for training (18%). The second theme, defibrillator delays (38%), included two barriers; reprogramming defibrillators (24%) and receiving new defibrillators to replace non-upgradeable units (15%). The third theme was decision-making (38%) and included five barriers; coordinating with allied agencies (9%), government regulators such as state and provincial health authorities (9%), medical direction and base hospitals (9%), ROC participation (9%), and internal crises (3%).

CONCLUSION Many barriers contributed to delays in the implementation of the 2005 AHA guidelines in EMS agencies. These identified barriers should be proactively addressed prior to the 2010 Guidelines to facilitate rapid translation of science into clinical practice.


Title

Severe traumatic injury: regional variation in incidence and outcome.


Citation Minei JP, Schmicker RH, Kerby JD, Stiell IG, Schreiber MA, Bulger E, Tisherman S, Hoyt DB, Nichol G. Severe traumatic injury: Regional variation in incidence and outcome. Annals of Surgery 2010; 252(1):149-157. PMCID: PMC4153828

Abstract OBJECTIVES The public health implications of regional variation in incidence and outcome of severe traumatic injury remain to be analyzed. The objective of this study was to determine whether the incidence and outcome associated with severe traumatic injury differs across geographic regions of North America.

METHODS A prospective, observational study was conducted of the Resuscitation Outcomes Consortium of all patients in 9 North American sites (6 US and 3 Canadian) sustaining severe traumatic injury from April 1, 2006 to March 31, 2007 followed to hospital discharge. Eligible patients were assessed by organized emergency medical services, and had field-based physiologic criteria including systolic blood pressure 29 per minute, advanced airway procedure, or traumatic death in the field. Census data were used to determine rates adjusted for age and sex. The main outcome measures were incidence rate, mortality rate, case fatality rate, and survival to discharge for patients sustaining severe traumatic injury assessed by EMS.

RESULTS The total catchment population of 20.5 million yielded 7080 cases of severe traumatic injury. Median age was 36 years and 67% were male. The median incidence of EMS-assessed severe traumatic injury per 100,000 population across sites was 37.4 (interquartile range [IQR] = 24.6-69.6); survival ranged from 39.8% to 80.8%, with a median of 64.5% (IQR = 55.5-78.4). About 942 cases were pronounced dead at the scene and 5857 patients were transported to hospital; 4477 (63.2%) were discharged alive. The median incidence of severe trauma due to a blunt mechanism, transported to hospital, was 25.8 (IQR = 13.1-44.3); survival ranged from 52.6% to 87.3%, with a median of 78.0% (IQR = 68.4-83.5). The median incidence of severe penetrating trauma, transported to hospital, was 2.6 (IQR = 1.5-10.4); survival ranged from 37.5% to 84.7%, with a median of 67.5% (IQR = 54.1-75.9). All P values for differences across sites for incidence and survival were <0.001.

CONCLUSIONS In this study involving 9 geographic regions in North America, there were significant and important regional differences in severe traumatic injury, incidence, and outcome. These differences were sustained for patients with either isolated blunt or penetrating injury mechanisms.


Title

Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 2: rationale and methodology for "Analyze Later vs. Analyze Early" protocol.


Citation Stiell I, Callaway C, Davis D, Terndrup T, Powell J, Cook A, Kudenchuk P, Daya M, Kerber R, Idris A, Morrison L, Aufderheide T, ROC Investigators. Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods. Part 2: Rationale and methodology for Analyze Later vs. Analyze Early protocol. Resuscitation 2008; 78(2):186-195. PMCID: PMC2614111

Abstract OBJECTIVE The primary objective of the trial is to compare survival to hospital discharge with modified Rankin score (MRS) < or =3 between a strategy that prioritizes a specified period of CPR before rhythm analysis (Analyze Later) versus a strategy of minimal CPR followed by early rhythm analysis (Analyze Early) in patients with out-of-hospital cardiac arrest.

METHODS Design-Cluster randomized trial with cluster units defined by geographic region, or monitor/defibrillator machine. Population-Adults treated by emergency medical service (EMS) providers for non-traumatic out-of-hospital cardiac arrest not witnessed by EMS. Setting-EMS systems participating in the Resuscitation Outcomes Consortium and agreeing to cluster randomization to the Analyze Later versus Analyze Early intervention in a crossover fashion. Sample size-Based on a two-sided significance level of 0.05, a maximum of 13,239 evaluable patients will allow statistical power of 0.996 to detect a hypothesized improvement in the probability of survival to discharge with MRS < or =3 rate from 5.41% after Analyze Early to 7.45% after Analyze Later (2.04% absolute increase in primary outcome).

CONCLUSION If this trial demonstrates a significant improvement in survival with a strategy of Analyze Later, it is estimated that 4000 premature deaths from cardiac arrest would be averted annually in North America alone.


Title

Association between survival and early versus later rhythm analysis in out-of-hospital cardiac arrest: do agency-level factors influence outcomes?


Citation Rea T, Prince D, Morrison L, Callaway C, Aufderheide T, Daya M, Stiell I, Christenson J, Powell J, Warden C, van Ottingham L, Kudenchuk P, Weisfeldt M, and the ROC Investigators. Association between survival and early versus later rhythm analysis in out-of-hospital cardiac arrest: do agency-level factors influence outcomes? Annals of Emergency Medicine 2014; 64(1):1-8. PMCID: PMC4196855

Abstract STUDY OBJECTIVE Effectiveness of a resuscitation strategy may vary across communities. We hypothesize that a strategy that prioritizes initial emergency medical services (EMS) rhythm analysis (analyze early) will be associated with survival advantage among EMS systems with lower baseline (pretrial) ventricular fibrillation survival, whereas a strategy that prioritizes initial EMS cardiopulmonary resuscitation (analyze late) will be associated with survival advantage among systems with higher ventricular fibrillation baseline survival.

METHODS We conducted a secondary, post hoc study of a randomized trial of out-of-hospital cardiac arrest. Subjects were stratified according to randomization status (analyze early versus analyze late) and EMS agency baseline ventricular fibrillation survival. We used a mixed-effects model to determine whether the association between favorable functional survival to hospital discharge and trial intervention (analyze late versus analyze early) differed according to EMS agency baseline ventricular fibrillation survival (<20% or >20%).

RESULTS Characteristics were similar among patients randomized to analyze early (n=4,964) versus analyze late (n=4,426). For EMS agencies with baseline ventricular fibrillation survival less than 20%, analyze late compared with analyze early was associated with a lower likelihood of favorable functional survival (3.8% versus 5.5%; odds ratio [OR]=0.67 [95% CI 0.50, 0.90]). Conversely, among agencies with a ventricular fibrillation survival greater than 20%, analyze late compared with analyze early was associated with higher likelihood of favorable functional survival (7.5% versus 6.1%; OR=1.22 [95% CI 0.98, 1.52]). In the multivariable-adjusted model, for every 10% increase in baseline ventricular fibrillation survival, analyze late versus analyze early was associated with a 34% increase in odds of favorable functional survival (OR=1.34 [95% CI 1.07 to 1.66]).

CONCLUSION The findings suggest that system-level characteristics may influence resuscitation outcomes.


Title

Temporal compliance trends in a cluster randomization with crossover trial of out-of-hospital cardiac arrest.


Citation Schmicker RH, Leroux BG, Sears GK, Stiell I, Morrison LJ, Aufderheide TP, Fowler R, Lowe R, Morrow S, Plumlee E, Cheskes S. Temporal compliance trends in a cluster-randomization with crossover trial of out-of-hospital cardiac arrest. Clinical Trials 2012; 0:1-8. PMCID: PMC3515666

Abstract BACKGROUND Low compliance to randomized nondrug interventions can affect treatment estimates of clinical trials. Cluster-randomized crossover may be appropriate for increasing compliance in the out-of-hospital cardiac arrest setting.

PURPOSE The purpose was to determine whether the elapsed time from start of a nonblinded treatment period to episode enrollment date in a cluster-randomized crossover trial is associated with compliance to either a period of brief cardiopulmonary resuscitation (CPR) with electrocardiogram (ECG) rhythm analysis or a period of longer CPR with a delayed ECG rhythm analysis in patients with out-of-hospital cardiac arrest.

METHODS The Resuscitation Outcomes Consortium PRIMED Analyze Late (AL) versus Analyze Early (AE) trial was a cluster-randomized crossover trial at 10 North American regional sites. Clusters were created based on local service preference with treatment periods varying from 3 to 12 months depending on the expected enrollment rate of each randomizing unit. Episodes on the AL arm had a target of 180 s from CPR start to shock assessment and were deemed compliant if total time was between 150 and 210 s. Episodes on the AE arm had a target of <30 s from CPR start to shock assessment and were deemed compliant if total time was <60 s. We used logistic regression to examine the association between compliance (yes/no) and the elapsed number of days from the start of the treatment period to the episode in the framework of generalized estimating equations, controlling for randomized treatment (Late, reference = Early) and treatment period length (reference = 3, 4-5, 6, 7-11, and 12 months).

RESULTS We had 8769 episodes in our analysis population. Overall compliance to the randomized arm was 63.5%. After adjusting for treatment arm and treatment period length, the odds of compliance for episodes occurring >300 days from treatment period start were 33% lower (odds ratio (OR): 0.67; 95% confidence interval (CI): 0.52, 0.86) than for those <60 days from treatment period start. There was no significant difference in compliance between episodes before and immediately after a cluster crossed over to the opposite arm (OR: 0.81; 95% CI: 0.57, 1.16).

LIMITATIONS A major challenge was the lack of synchronicity between training cycles and agency crossover dates.

CONCLUSION We found a significant decrease in compliance to the AL versus AE cardiac arrest intervention as the elapsed time from start of treatment period increased. We did not find a difference in compliance immediately before and after a crossover. While these results suggest that future cluster with crossover trials in the out-of-hospital setting be designed with short treatment periods and frequent crossovers, provider logistical concerns must also be considered.


Title

Association of out-of-hospital advanced airway management with outcomes after traumatic brain injury and hemorrhagic shock in the ROC hypertonic saline trial.


Citation Wang HE, Brown SP, MacDonald RD, Dowling SK, Lin S, Davis D, Schreiber MA, Powell J, van Heest R, Daya M. Association of out-of-hospital advanced airway management with outcomes after traumatic brain injury and hemorrhagic shock in the ROC hypertonic saline trial. Emergency Medicine Journal 2013; 31(3):186-91. PMCID: PMC3841245

Abstract OBJECTIVE Prior studies suggest adverse associations between out-of-hospital advanced airway management (AAM) and patient outcomes after major trauma. This secondary analysis of data from the Resuscitation Outcomes Consortium Hypertonic Saline Trial evaluated associations between out-of-hospital AAM and outcomes in patients suffering isolated severe traumatic brain injury (TBI) or haemorrhagic shock.

METHODS This multicentre study included adults with severe TBI (GCS ≤8) or haemorrhagic shock (SBP ≤70 mm Hg, or (SBP 71-90 mm Hg and heart rate ≥108 bpm)). We compared patients receiving out-of-hospital AAM with those receiving emergency department AAM. We evaluated the associations between airway strategy and patient outcomes (28-day mortality, and 6-month poor neurologic or functional outcome) and airway strategy, adjusting for confounders. Analysis was stratified by (1) patients with isolated severe TBI and (2) patients with haemorrhagic shock with or without severe TBI.

RESULTS Of 2135 patients, we studied 1116 TBI and 528 shock; excluding 491 who died in the field, did not receive AAM or had missing data. In the shock cohort, out-of-hospital AAM was associated with increased 28-day mortality (adjusted OR 5.14; 95% CI 2.42 to 10.90). In TBI, out-of-hospital AAM showed a tendency towards increased 28-day mortality (adjusted OR 1.57; 95% CI 0.93 to 2.64) and 6-month poor functional outcome (1.63; 1.00 to 2.68), but these differences were not statistically significant. Out-of-hospital AAM was associated with poorer 6-month TBI neurologic outcome (1.80; 1.09 to 2.96).

CONCLUSIONS Out-of-hospital AAM was associated with increased mortality after haemorrhagic shock. The adverse association between out-of-hospital AAM and injury outcome is most pronounced in patients with haemorrhagic shock.


Title

Impact of prehospital mode of transport after severe injury: a multicenter evaluation from the Resuscitation Outcomes Consortium.


Citation Bulger EM, Guffey D, Guyette FX, MacDonald RD, Brase K, Kerby JD, Minei JP, Warden C, Rizoli S, Morrison LJ, Nichol G, ROC Investigators. Impact of prehospital mode of transport after severe injury: A multicenter evaluation from the Resuscitation Outcomes Consortium. Journal of Trauma and Acute Care Surgery 2012; 72(3):567-575. PMCID: PMC3495608

Abstract BACKGROUND There is ongoing controversy about the relative effectiveness of air medical versus ground transportation for severely injured patients. In some systems, air medical crews may provide a higher level of care but may require longer transport times. We sought to evaluate the impact of mode of transport on outcome based on analysis of data from two randomized trials of prehospital hypertonic resuscitation.

METHODS Injured patients were enrolled based on prehospital evidence of hypovolemic shock (systolic blood pressure ≤70 mm Hg or systolic blood pressure = 71-90 mm Hg with heart rate ≥108 bpm) or severe traumatic brain injury (TBI; Glasgow Coma Scale score ≤8). Patient demographics, injury severity, and physiology were compared based on mode of transport. Multivariate logistic regression was used to determine the impact of mode of transport on 24-hour and 28-day survival for all patients and 6-month extended Glasgow Outcome Scale for patients with TBI, adjusting for differences in injury severity.

RESULTS Included were 2,049 patients, of which 703 (34%) were transported by air. Patients transported by air were more severely injured (mean Injury Severity Score, 30.3 vs. 22.8; p < 0.001), more likely to be in the TBI cohort (70% vs. 55.4%; p < 0.001), and more likely blunt mechanism (94.0% vs. 78.1%; p < 0.001). Patients transported by air had higher rates of prehospital intubation (81% vs. 36%; p < 0.001), received more intravenous fluids (mean 1.3 L vs. 0.8 L; p < 0.001), and had longer prehospital times (mean 76.1 minutes vs. 43.5 minutes; p < 0.001). Adjusted analysis revealed no significant impact of mode of transport on survival or 6-month neurologic outcome (air transport-28-day survival: odds ratio, 1.11; 95% confidence interval, 0.82-1.51; 6-month extended Glasgow Outcome Scale score ≤4: odds ratio, 0.94; 95% confidence interval, 0.68-1.31).

CONCLUSION There was no difference in the adjusted clinical outcome according to mode of transport. However, air medical transported more severely injured patients with more advanced life support procedures and longer prehospital time.

LEVEL OF EVIDENCE III.


Title

The relationship between out-of-hospital airway management and outcome among trauma patients with Glasgow Coma Scale Scores of 8 or less.


Citation Davis DP, Koprowicz KM, Newgard CD, Daya M, Bulger EM, Stiell I, Nichol G, Stephens S, Dreyer J, Minei J, Kerby JD. The relationship between out-of-hospital airway management and outcome among trauma patients with Glasgow Coma Scale scores of 8 or less. Prehospital Emergency Care 2011; 15(2):184-92. PMCID: PMC4091894

Abstract BACKGROUND Airway management remains a fundamental component of optimal care of the severely injured patient, with endotracheal intubation representing the definitive strategy for airway control. However, multiple studies document an association between out-of-hospital intubation and increased mortality for severe traumatic brain injury.

OBJECTIVES To explore the relationship between out-of-hospital intubation attempts and outcome among trauma patients with Glasgow Coma Scale (GCS) scores ≤ 8 across sites participating in the Resuscitation Outcomes Consortium (ROC).

METHODS The ROC Epistry-Trauma, an epidemiologic database of prehospital encounters with critically injured trauma victims, was used to identify emergency medical services (EMS)-treated patients with GCS scores ≤ 8. Multiple logistic regression was used to explore the association between intubation attempts and vital status at discharge, adjusting for the following covariates: age, gender, GCS score, hypotension, mechanism of injury, and ROC site. Sites were then stratified by frequency of intubation attempts and chi-square test for trend was used to associate the frequency of intubation attempts with outcome.

RESULTS A total of 1,555 patients were included in this analysis; intubation was attempted in 758 of these. Patients in whom intubation was attempted had higher mortality (adjusted odds ratio [OR] 2.91, 95% confidence interval [CI] 2.13-3.98, p < 0.01). However, sites with higher rates of attempted intubation had lower mortality across all trauma victims with GCS scores ≤ 8 (OR 1.40, 95% CI 1.15-1.72, p < 0.01).

CONCLUSIONS Patients in whom intubation is attempted have higher adjusted mortality. However, sites with a higher rate of attempted intubation have lower adjusted mortality across the entire cohort of trauma patients with GCS scores ≤ 8. Coma Scale score.


Title

Variation in out-of-hospital cardiac arrest resuscitation and transport practices in the Resuscitation Outcomes Consortium: ROC Epistry-Cardiac Arrest.


Citation Zive D, Koprowicz K, Schmidt T, Stiell I, Sears G, Van Ottingham L, Idris A, Stephens S, Daya M, ROC Investigators. Variation in out-of-hospital cardiac arrest resuscitation and transport practices in the Resuscitation Outcomes Consortium: ROC Epistry-Cardiac Arrest. Resuscitation 2011; 82(3):277-284. PMCID: PMC3039085

Abstract OBJECTIVES To identify variation in patient, event, and scene characteristics of out-of-hospital cardiac arrest (OOHCA) patients assessed by emergency medical services (EMS), and to investigate variation in transport practices in relation to documented prehospital return of spontaneous circulation (ROSC) within eight regional clinical centers participating in the Resuscitation Outcomes Consortium (ROC) Epistry-Cardiac Arrest.

METHODS OOHCA patient, event, and scene characteristics were compared to identify variation in treatment and transport practices across sites. Findings were adjusted for site and standard Utstein covariates. Using logistic regression, these covariates were modeled to identify factors related to the initiation of transport without documented prehospital ROSC as well as survival in these patients.

SETTING Eight US and Canadian sites participating in the ROC Epistry-Cardiac Arrest.

POPULATION Persons ≥ 20 years with OOHCA who (a) received compressions or shock by EMS providers and/or received bystander AED shock or (b) were pulseless but received no EMS compressions or shock between December 2005 and May 2007.

RESULTS 23,233 OOHCA cases were assessed by EMS in the defined period. Resuscitation (treatment) was initiated by EMS in 13,518 cases (58%, site range: 36-69%, p < 0.0001). Of treated cases, 59% were transported (site range: 49-88%, p < 0.0001). Transport was initiated in the absence of documented ROSC for 58% of transported cases (site range: 14-95%, p < 0.0001). Of these transported cases, 8% achieved ROSC before hospital arrival (site range: 5-21%, p < 0.0001) and 4% survived to hospital discharge (site range: 1-21%, p < 0.0001). In cases with transport from the scene initiated after documented ROSC, 28% survived to hospital discharge (site range: 18-44%, p < 0.0001).

CONCLUSION Initiation of resuscitation and transport of OOHCA and the reporting of ROSC prior to transport markedly varies among ROC sites. This variation may help clarify reported differences in survival rates among sites and provide a target for identifying EMS practices most likely to enhance survival from OOHCA.


Title

What is the role of chest compression depth during out-of-hospital cardiac arrest resuscitation?.


Citation Stiell IG, Brown SP, Christenson J, Cheskes S, Nichol G, Powell J, Bigham B, Morrison LJ, Larsen J, Hess E, Vaillancourt C, David DP, Callaway CW, ROC Investigators. What is the role of chest compression depth during out-of-hospital cardiac arrest resuscitation? Critical Care Medicine 2012; 40(4):1192-98. PMCID: PMC3307954

Abstract BACKGROUND The 2010 international guidelines for cardiopulmonary resuscitation recently recommended an increase in the minimum compression depth from 38 to 50 mm, although there are limited human data to support this. We sought to study patterns of cardiopulmonary resuscitation compression depth and their associations with patient outcomes in out-of-hospital cardiac arrest cases treated by the 2005 guideline standards.

DESIGN Prospective cohort.

SETTING Seven U.S. and Canadian urban regions.

PATIENTS We studied emergency medical services treated out-of-hospital cardiac arrest patients from the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest for whom electronic cardiopulmonary resuscitation compression depth data were available, from May 2006 to June 2009.

MEASUREMENTS We calculated anterior chest wall depression in millimeters and the period of active cardiopulmonary resuscitation (chest compression fraction) for each minute of cardiopulmonary resuscitation. We controlled for covariates including compression rate and calculated adjusted odds ratios for any return of spontaneous circulation, 1-day survival, and hospital discharge.

MAIN RESULTS We included 1029 adult patients from seven U.S. and Canadian cities with the following characteristics: Mean age 68 yrs; male 62%; bystander witnessed 40%; bystander cardiopulmonary resuscitation 37%; initial rhythms: Ventricular fibrillation/ventricular tachycardia 24%, pulseless electrical activity 16%, asystole 48%, other nonshockable 12%; outcomes: Return of spontaneous circulation 26%, 1-day survival 18%, discharge 5%. For all patients, median compression rate was 106 per minute, median compression fraction 0.65, and median compression depth 37.3 mm with 52.8% of cases having depth <38 mm and 91.6% having depth <50 mm. We found an inverse association between depth and compression rate ( p < .001). Adjusted odds ratios for all depth measures (mean values, categories, and range) showed strong trends toward better outcomes with increased depth for all three survival measures.

CONCLUSIONS We found suboptimal compression depth in half of patients by 2005 guideline standards and almost all by 2010 standards as well as an inverse association between compression depth and rate. We found a strong association between survival outcomes and increased compression depth but no clear evidence to support or refute the 2010 recommendations of >50 mm. Although compression depth is an important component of cardiopulmonary resuscitation and should be measured routinely, the most effective depth is currently unknown.


Title

Post-discharge outcomes after resuscitation from out-of-hospital cardiac arrest: A ROC PRIMED substudy.


Citation Nichol G, Guffey D, Stiell IG, Leroux B, Cheskes S, Idris A, Kudenchuk PJ, MacPhee R, Wittwer L, Rittenberger JC, Rea TD, Sheehan K, Rac VE, Raina K, Gorman KR, Aufderheide T, and the ROC Investigators. Post-discharge outcomes after resuscitation from out-of-hospital cardiac arrest: a ROC PRIMED substudy. Resuscitation 2015; 93:74-81

Abstract IMPORTANCE Assessment of morbidity is an important component of evaluating interventions for patients with out-of-hospital cardiac arrest (OHCA).

OBJECTIVE We evaluated among survivors of OHCA cognition, functional status, health-related quality of life and depression as functions of patient and emergency medical services (EMS) factors.

DESIGN Prospective cohort sub-study of a randomized trial.

SETTING The parent trial studied two comparisons in persons with non-traumatic OHCA treated by EMS personnel participating in the Resuscitation Outcomes Consortium.

PARTICIPANTS Consenting survivors to discharge.

MAIN OUTCOME MEASURES Telephone assessments up to 6 months after discharge included neurologic function (modified Rankin score, MRS), cognitive impairment (Adult Lifestyle and Function Mini Mental Status Examination, ALFI-MMSE), health-related quality of life (Health Utilities Index Mark 3, HUI3) and depression (Telephone Geriatric Depression Scale, T-GDS).

RESULTS Of 15,794 patients enrolled in the parent trial, 729 (56% of survivors) consented. About 644 respondents (88% of consented) completed ≥ 1 assessment. Likelihood of assessment was associated with baseline characteristics and study site. Most respondents had MRS ≤ 3 (82.7%), no cognitive impairment (82.7% ALFI-MMSE ≥ 17), no severe impairment in health (71.6%, HUI3 ≥ 0.7) and no depression (90.1% T-GDS≤10). Outcomes did not differ by trial intervention or time from hospital discharge.

CONCLUSIONS AND RELEVANCE The majority of patients in this large cohort who survived cardiac arrest and were interviewed had no, mild or moderate health impairment. Concern about poor quality of life is not a valid reason to abandon efforts to improve an EMS system's response to cardiac arrest.


Title

Hypertonic resuscitation: design and implementation of a prehospital intervention trial.


Citation Brasel K, Bulger E, Cook A, Morrison, L, Newgard C, Tisherman, S, Kerby J, Coimbra R, Hata S, Hoyt D, ROC Investigators. Hypertonic resuscitation: Design and implementation of a prehospital intervention trial. Journal of the American College of Surgeons 2008; 206(2): 220-232.

Abstract 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.


Title

Chest compression rates and survival following out-of-hospital cardiac arrest.


Citation Idris AH, Guffey D, Pepe PP, Brown, SP, Brooks S, Callaway C, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi J, Sheehan K, Sopko G, Stiell IG, Nichol G, Aufderheide TP, and the ROC Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Critical Care Medicine 2015; 43(4):840-848

Abstract OBJECTIVE Guidelines for cardiopulmonary resuscitation recommend a chest compression rate of at least 100 compressions/min. A recent clinical study reported optimal return of spontaneous circulation with rates between 100 and 120/min during cardiopulmonary resuscitation for out-of-hospital cardiac arrest. However, the relationship between compression rate and survival is still undetermined.

DESIGN Prospective, observational study.

SETTING Data is from the Resuscitation Outcomes Consortium Prehospital Resuscitation IMpedance threshold device and Early versus Delayed analysis clinical trial.

PARTICIPANTS Adults with out-of-hospital cardiac arrest treated by emergency medical service providers.

INTERVENTIONS None.

MEASUREMENTS MAIN RESULTS Data were abstracted from monitor-defibrillator recordings for the first five minutes of emergency medical service cardiopulmonary resuscitation. Multiple logistic regression assessed odds ratio for survival by compression rate categories (<80, 80-99, 100-119, 120-139, ≥140), both unadjusted and adjusted for sex, age, witnessed status, attempted bystander cardiopulmonary resuscitation, location of arrest, chest compression fraction and depth, first rhythm, and study site. Compression rate data were available for 10,371 patients; 6,399 also had chest compression fraction and depth data. Age (mean±SD) was 67±16 years. Chest compression rate was 111±19 per minute, compression fraction was 0.70±0.17, and compression depth was 42±12 mm. Circulation was restored in 34%; 9% survived to hospital discharge. After adjustment for covariates without chest compression depth and fraction (n=10,371), a global test found no significant relationship between compression rate and survival (p=0.19). However, after adjustment for covariates including chest compression depth and fraction (n=6,399), the global test found a significant relationship between compression rate and survival (p=0.02), with the reference group (100-119 compressions/min) having the greatest likelihood for survival.

CONCLUSIONS After adjustment for chest compression fraction and depth, compression rates between 100 and 120 per minute were associated with greatest survival to hospital discharge.


Title

Preliminary experience with social media for community consultation and public disclosure in exception from informed consent trials.


Citation Stephens SW, Williams C, Gray R, Kerby JD, Wang HE. Preliminary experience with social media for community consultation and public disclosure in exception from informed consent trials. Circulation 2013; 128:267-270.

Abstract

Title

Receiving hospital characteristics associated with survival after out-of-hospital cardiac arrest.


Citation Callaway C, Schmicker R, Kampmeyer M, Powell J., Rea T, Daya M, Aufderheide T, Davis D, Rittenberger J, Idris A, Nichol G, ROC Investigators. Receiving hospital characteristics associated with survival after out-of-hospital cardiac arrest. Resuscitation 2010; 81(6) 524-529. PMCID: PMC2856722

Abstract AIM Survival after out-of-hospital cardiac arrest (OOHCA) varies between regions, but the contribution of different factors to this variability is unknown. This study examined whether survival to hospital discharge was related to receiving hospital characteristics, including bed number, capability of performing cardiac catheterization and hospital volume of OOHCA cases.

MATERIAL AND METHODS Prospective observational database of non-traumatic OOHCA assessed by emergency medical services was created in 8 US and 2 Canadian sites from December 1, 2005 to July 1, 2007. Subjects received hospital care after OOHCA, defined as either (1) arriving at hospital with pulses, or (2) arriving at hospital without pulses, but discharged or died > or =1 day later.

RESULTS A total of 4087 OOHCA subjects were treated at 254 hospitals, and 32% survived to hospital discharge. A majority of subjects (68%) were treated at 116 (46%) hospitals capable of cardiac catheterization. Unadjusted survival to discharge was greater in hospitals performing cardiac catheterization (34% vs. 27%, p=0.001), and in hospitals that received > or =40 patients/year compared to those that received <40 (37% vs. 30%, p=0.01). Survival was not associated with hospital bed number, teaching status or trauma center designation. Length of stay (LOS) for surviving subjects was shorter at hospitals performing cardiac catheterization (p<0.01). After adjusting for all variables, there were no independent associations between survival or LOS and hospital characteristics.

CONCLUSIONS Some subsets of hospitals displayed higher survival and shorter LOS for OOHCA subjects but there was no independent association between hospital characteristics and outcome.


Title

Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial.


Citation Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB, ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. Journal of the American Medical Association 2010; 304(13):1455-1464. PMCID: 3015143

Abstract 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.


Title

A quantitative analysis of out-of-hospital pediatric and adolescent resuscitation quality--A report from the ROC epistry-cardiac arrest.


Citation Sutton RM, Case E, Brown SP, Atkins DL, Nadkarni VM, Kaltman J, Callaway C, Idris A, Nichol G, Hutchison J, Drennan IR, Austin M, Daya M, Cheskes S, Nuttall J, Herren H, Christenson J, Andrusiek D, Vaillancourt C, Menegazzi JJ, Rea TD, Berg RA, and the ROC Investigators. A quantitative analysis of out-of-hospital pediatric and adolescent resuscitation quality--a report from the ROC epistry-cardiac arrest. Resuscitation 2015; 93:150-157. PMCID: PMC4506865

Abstract AIM High-quality cardiopulmonary resuscitation (CPR) may improve survival. The quality of CPR performed during pediatric out-of-hospital cardiac arrest (p-OHCA) is largely unknown. The main objective of this study was to describe the quality of CPR performed during p-OHCA resuscitation attempts.

METHODS Prospective observational multi-center cohort study of p-OHCA patients ≥ 1 and < 19 years of age registered in the Resuscitation Outcomes Consortium (ROC) Epistry database. The primary outcome was an a priori composite variable of compliance with American Heart Association (AHA) guidelines for both chest compression (CC) rate and CC fraction (CCF). Event compliance was defined as a case with 60% or more of its minute epochs compliant with AHA targets (rate 100-120 min(-1); depth ≥ 38 mm; and CCF ≥ 0.80). In a secondary analysis, multivariable logistic regression was used to evaluate the association between guideline compliance and return of spontaneous circulation (ROSC).

RESULTS Between December 2005 and December 2012, 2564 pediatric events were treated by EMS providers, 390 of which were included in the final cohort. Of these events, 22% achieved AHA compliance for both rate and CCF, 36% for rate alone, 53% for CCF alone, and 58% for depth alone. Over time, there was a significant increase in CCF (p < 0.001) and depth (p = 0.03). After controlling for potential confounders, there was no significant association between AHA guideline compliance and ROSC.

CONCLUSIONS In this multi-center study, we have established that there are opportunities for professional rescuers to improve prehospital CPR quality. Encouragingly, CCF and depth both increased significantly over time.


Title

Ventricular tachyarrhythmias after cardiac arrest in public versus at home.


Citation Weisfeldt ML, Everson-Stewart S, Sitlani C, Rea T, Aufderheide TP, Atkins DL, Bigham B, Brooks SC, Foerster C, Gray R, Ornato JP, Powell J, Kudenchuk PJ, Morrison LJ, ROC Investigators. Ventricular tachyarrythmias following cardiac arrest in public versus home. New England Journal of Medicine 2011; 364:313-21. PMCID: PMC3062845

Abstract BACKGROUND The incidence of ventricular fibrillation or pulseless ventricular tachycardia as the first recorded rhythm after out-of-hospital cardiac arrest has unexpectedly declined. The success of bystander-deployed automated external defibrillators (AEDs) in public settings suggests that this may be the more common initial rhythm when out-of-hospital cardiac arrest occurs in public. We conducted a study to determine whether the location of the arrest, the type of arrhythmia, and the probability of survival are associated.

METHODS Between 2005 and 2007, we conducted a prospective cohort study of out-of-hospital cardiac arrest in adults in 10 North American communities. We assessed the frequencies of ventricular fibrillation or pulseless ventricular tachycardia and of survival to hospital discharge for arrests at home as compared with arrests in public.

RESULTS Of 12,930 evaluated out-of-hospital cardiac arrests, 2042 occurred in public and 9564 at home. For cardiac arrests at home, the incidence of ventricular fibrillation or pulseless ventricular tachycardia was 25% when the arrest was witnessed by emergency-medical-services (EMS) personnel, 35% when it was witnessed by a bystander, and 36% when a bystander applied an AED. For cardiac arrests in public, the corresponding rates were 38%, 60%, and 79%. The adjusted odds ratio for initial ventricular fibrillation or pulseless ventricular tachycardia in public versus at home was 2.28 (95% confidence interval [CI], 1.96 to 2.66; P < 0.001) for bystander-witnessed arrests and 4.48 (95% CI, 2.23 to 8.97; P<0.001) for arrests in which bystanders applied AEDs. The rate of survival to hospital discharge was 34% for arrests in public settings with AEDs applied by bystanders versus 12% for arrests at home (adjusted odds ratio, 2.49; 95% CI, 1.03 to 5.99; P = 0.04).

CONCLUSIONS Regardless of whether out-of-hospital cardiac arrests are witnessed by EMS personnel or bystanders and whether AEDs are applied by bystanders, the proportion of arrests with initial ventricular fibrillation or pulseless ventricular tachycardia is much greater in public settings than at home. The incremental value of resuscitation strategies, such as the ready availability of an AED, may be related to the place where the arrest occurs.


Title

Regional variations in early and late survival after out-of-hospital cardiac arrest.


Citation Wang HE, Devlin SM, Sears GK, Vaillancourt C, Morrison LJ, Weisfeldt M, Callaway CW, ROC Investigators. Regional variations in early and late survival after out-of-hospital cardiac arrest. Resuscitation 2012; 83(11):1343-48. PMCID: PMC3470746

Abstract BACKGROUND While prior studies highlight regional variations in out-of-hospital cardiac arrest (OHCA) survival, the underlying reasons remain unknown. We sought to characterize regional variations early and later survival to hospital discharge after OHCA.

METHODS We studied adult, non-traumatic OHCA treated by 10 regional sites of the Resuscitation Outcomes Consortium (ROC) during 12/01/2005-6/30/2007. We compared (1) early survival (up to one calendar day after arrest) and (2) later conditional survival to hospital discharge (early survivors progressing to eventual hospital discharge) between ROC regional sites.

RESULTS Among 3763 VF/VT with complete covariates, site unadjusted early survival varied from 11.3 to 54.3%, and site unadjusted later survival varied from 33.3 to 70.5%. Compared with the largest site, adjusted VF/VT survival varied across sites: early survival OR 0.33 (95% CI: 0.17, 0.65) to 2.87 (2.20, 3.73), overall site variation p<0.001; later survival OR 0.29 (0.14, 0.59) to 1.21 (0.73, 2.00), p<0.001. Among 10,879 non-VF/VT with complete covariates, site unadjusted early survival varied from 6.6 to 14.3%, and site unadjusted later survival varied from 4.5 to 39.6%. Compared with the largest site, adjusted non-VF/VT survival varied across sites: early survival OR 1.02 (0.63, 1.64) to 2.43 (1.91, 3.12), p<0.001; later survival OR 0.11 (0.01, 0.82) to 1.56 (0.90, 2.70), p=0.02.

CONCLUSIONS In this prospective multicenter North American series, there were regional disparities in early and later survival after OHCA, suggesting that there are underlying regional differences in out-of-hospital and post-arrest care beyond traditional Utstein predictors. Community efforts to improve OHCA survival must address both out-of-hospital and in-hospital care.


Title

Wide variability in drug use in out-of-hospital cardiac arrest: a report from the resuscitation outcomes consortium.


Citation Glover BM, Brown SP, Morrison L, Davis D, Kudenchuk PJ, Van Ottingham L, Vaillancourt C, Cheskes S, Atkins DL, Dorian P, ROC Investigators. Wide variability in drug use in out-of-hospital cardiac arrest: a report from the resuscitation outcomes consortium. Resuscitation 2012; 83(11):1324-30. PMCID: PMC3827891

Abstract BACKGROUND Despite the publication and dissemination of the Advanced Cardiac Life Support guidelines, variability in the use of drugs during resuscitation from out-of-hospital cardiac arrest may exist between different Emergency Medical Services throughout North America. The purpose of this study was to characterize the use of such drugs and evaluate their relationship to cardiac arrest outcomes.

METHODS AND RESULTS The Resuscitation Outcomes Consortium Registry-Cardiac Arrest collects out-of-hospital cardiac arrest data from 264 Emergency Medical Services agencies in 11 geographical locations in the U.S. and Canada. Multivariable logistic regression was used to assess the association between drug use, characteristics of the cardiac arrest and a pulse at emergency department arrival and survival to discharge. A total of 16,221 out-of-hospital cardiac arrests were attended by 74 Emergency Medical Services agencies. There was a considerable variability in the administration of amiodarone and lidocaine for the treatment of shock resistant ventricular tachycardia/ventricular fibrillation. For non-shockable rhythms, atropine use ranged from 29 to 95% and sodium bicarbonate use ranged from 0.2 to 73% across agencies in the 89% of agencies that used the drug. Epinephrine use ranged from 57 to 98% within agencies. Neither lidocaine nor amiodarone was associated with a survival benefit while there was an inverse relationship between the administration of epinephrine, atropine and sodium bicarbonate and survival to hospital discharge.

CONCLUSIONS There is considerable variability among Emergency Medical Services agencies in their use of pharmacological therapy for out-of-hospital cardiac arrests which may be resolved by performing large randomized trials examining effects on survival.


Title

Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million.


Citation Weisfeldt M, Sitlani C, Ornato J, Rea T, Aufderheide T, Davis D, Dryer J, Hess E, Jui J, Maloney J, Sopko G, Powell J, Nichol G, Morrison L. Survival after application of automatic external defibrillators before arrival of the emergency medical system: Evaluation in the Resuscitation Outcomes Consortium population of 21 million. Journal of the American College of Cardiology 2010; 55(16):1713-1720. PMCID: 3008654

Abstract OBJECTIVES The purpose of this study was to assess the effectiveness of contemporary automatic external defibrillator (AED) use.

BACKGROUND In the PAD (Public Access Defibrillation) trial, survival was doubled by focused training of lay volunteers to use an AED in high-risk public settings.

METHODS We performed a population-based cohort study of persons with nontraumatic out-of-hospital cardiac arrest before emergency medical system (EMS) arrival at Resuscitation Outcomes Consortium (ROC) sites between December 2005 and May 2007. Multiple logistic regression was used to assess the independent association between AED application and survival to hospital discharge.

RESULTS Of 13,769 out-of-hospital cardiac arrests, 4,403 (32.0%) received bystander cardiopulmonary resuscitation but had no AED applied before EMS arrival, and 289 (2.1%) had an AED applied before EMS arrival. The AED was applied by health care workers (32%), lay volunteers (35%), police (26%), or unknown (7%). Overall survival to hospital discharge was 7%. Survival was 9% (382 of 4,403) with bystander cardiopulmonary resuscitation but no AED, 24% (69 of 289) with AED application, and 38% (64 of 170) with AED shock delivered. In multivariable analyses adjusting for: 1) age and sex; 2) bystander cardiopulmonary resuscitation performed; 3) location of arrest (public or private); 4) EMS response interval; 5) arrest witnessed; 6) initial shockable or not shockable rhythm; and 7) study site, AED application was associated with greater likelihood of survival (odds ratio: 1.75; 95% confidence interval: 1.23 to 2.50; p < 0.002). Extrapolating this greater survival from the ROC EMS population base (21 million) to the population of the U.S. and Canada (330 million), AED application by bystanders seems to save 474 lives/year.

CONCLUSIONS Application of an AED in communities is associated with nearly a doubling of survival after out-of-hospital cardiac arrest. These results reinforce the importance of strategically expanding community-based AED programs.


Title

A randomized trial of continuous versus interrupted chest compressions in out-of-hospital cardiac arrest: rationale for and design of the Resuscitation Outcomes Consortium Continuous Chest Compressions Trial.


Citation Brown SP, Wang H, Aufderheide TP, Vaillancourt C, Schmicker RH, Cheskes S, Straight R, Kudenchuk P, Morrison L, Colella MR, Condle J, Gamez G, Hostler D, Kayea T, Ragsdale S, Stephens S, Nichol G, and the ROC Investigators. A randomized trial of continuous versus interrupted chest compressions in out-of-hospital cardiac arrest: Rationale for and design of the Resuscitation Outcomes Consortium Continuous Chest Compressions Trial. American Heart Journal 2015; 169(3):334-341. PMCID: PMC4363111

Abstract The Resuscitation Outcomes Consortium is conducting a randomized trial comparing survival with hospital discharge after continuous chest compressions without interruption for ventilation versus currently recommended American Heart Association cardiopulmonary resuscitation with interrupted chest compressions in adult patients with out-of-hospital cardiac arrest without obvious trauma or respiratory cause. Emergency medical services perform study cardiopulmonary resuscitation for 3 intervals of manual chest compressions (each ~2 minutes) or until restoration of spontaneous circulation. Patients randomized to the continuous chest compression intervention receive 200 chest compressions with positive pressure ventilations at a rate of 10/min without interruption in compressions. Those randomized to the interrupted chest compression study arm receive chest compressions interrupted for positive pressure ventilations at a compression:ventilation ratio of 30:2. In either group, each interval of compressions is followed by rhythm analysis and defibrillation as required. Insertion of an advanced airway is deferred for the first ≥6 minutes to reduce interruptions in either study arm. The study uses a cluster randomized design with every-6-month crossovers. The primary outcome is survival to hospital discharge. Secondary outcomes are neurologically intact survival and adverse events. A maximum of 23,600 patients (11,800 per group) enrolled during the post-run-in phase of the study will provide ≥90% power to detect a relative change of 16% in the rate of survival to discharge, 8.1% to 9.4% with overall significance level of 0.05. If this trial demonstrates improved survival with either strategy, >3,000 premature deaths from cardiac arrest would be averted annually.


Title

Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial.


Citation Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, OKeeffe T, Rizoli S, Robinson BRH, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet J-F, Hoyt DB, Pearson GD, Leroux B, van Belle G for the PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs. a 1:1:2 ratio and mortality in patients with severe trauma: The PROPPR Randomized Clinical Trial. JAMA 2015; 313(5):471-482. PMCID: PMC4374744

Abstract IMPORTANCE Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials.

OBJECTIVE To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio.

DESIGN, SETTING, AND PARTICIPANTS Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013.

INTERVENTIONS Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled).

MAIN OUTCOMES AND MEASURES Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status.

RESULTS No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, -4.2% [95% CI, -9.6% to 1.1%]; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, -3.7% [95% CI, -10.2% to 2.7%]; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, -5.4% [95% CI, -10.4% to -0.5%]; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications.

CONCLUSIONS AND RELEVANCE Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups.

TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01545232.


Title

Transfusion of red blood cells in patients with a prehospital Glasgow Coma Scale score of 8 or less and no evidence of shock is associated with worse outcomes.


Citation Elterman J, Brasel K, Brown S, Bulger E, Christenson J, Kerby JD, Kannas D, Lin S, Minei JP, Rizoli S, Tisherman S, Schreiber MA, and the ROC Investigators.Transfusion of red blood cells in patients with a prehospital Glasgow Coma Scale score of 8 or less and no evidence of shock is associated with worse outcomes. Journal of Trauma and Acute Care Surgery 2013; 75(1):8-14; discussion 14. PMCID: PMC3828641

Abstract BACKGROUND Red blood cell transfusion practices vary, and the optimal hemoglobin for patients with traumatic brain injury has not been established.

METHODS A retrospective review of data collected prospectively as part of a randomized, controlled trial involving emergency medical service agencies within the Resuscitation Outcomes Consortium was conducted. In patients with a Glasgow Coma Scale (GCS) score of 8 or less without evidence of shock (defined by a systolic blood pressure [SBP] < 70 or SBP of 70 to 90 with a heart rate ≥108), the association of red blood cell transfusion with 28-day survival, adult respiratory distress syndrome-free survival, Multiple Organ Dysfunction Score (MODs), and 6-month Extended Glasgow Outcome Scale (GOSE) score was modeled using multivariable logistic regression with robust SEs adjusting for age, sex, injury severity (Injury Severity Score [ISS]), initial GCS score, initial SBP, highest field heart rate, penetrating injury, fluid use, study site, and hemoglobin (Hgb) level.

RESULTS A total of 1,158 patients had a mean age of 40, 76% were male, and 98% experienced blunt trauma. The initial mean GCS score was 5, and the initial mean SBP was 134. The mean head Abbreviated Injury Scale (AIS) score was 3.5. A categorical interaction of red blood cell transfusion stratified by initial Hgb showed that when the first Hgb was greater than 10 g/dL, volume of packed red blood cell was associated with a decreased 28-day survival (odds ratio, 0.83; 95% confidence interval [CI], 0.74-0.93; p < 0.01) and decreased adult respiratory distress syndrome-free survival (odds ratio, 0.82; 95% CI, 0.74-0.92; p < 0.01). When the initial Hgb was greater than 10, each unit of blood transfused increased the MODs by 0.45 (coefficient 95% CI, 0.19-0.70; p < 0.01).

CONCLUSION In patients with a suspected traumatic brain injury and no evidence of shock, transfusion of red blood cells was associated with worse outcomes when the initial Hgb was greater than 10.

LEVEL OF EVIDENCE Therapeutic study, level III.


Title

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


Citation Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB, and the ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypootensive trauma patients: results of a prospective randomized pilot trial. Journal of Trauma and Acute Care Surgery 2015; 78(4):687-697. PMCID: PMC4375962

Abstract 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.


Title

Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 1: rationale and methodology for the impedance threshold device (ITD) protocol.


Citation Aufderheide TP, Kudenchuk PJ, Hedges JR, Nichol G, Kerber RE, Dorian P, Davis DP, Idris AH, Callaway CW, Emerson, Stiell IG, Terndrup TE, ROC Investigators. Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods. Part 1: Rationale and methodology for the impedance threshold device (ITD) protocol. Resuscitation 2008; 78:179-185. PMCID: PMC3797446

Abstract AIM The primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS)< or =3 between standard cardiopulmonary resuscitation (CPR) plus an active impedance threshold device (ITD) versus standard CPR plus a sham ITD in patients with out-of-hospital cardiac arrest. Secondary aims are to compare functional status and depression at discharge and at 3 and 6 months post-discharge in survivors.

MATERIALS AND METHODS

DESIGN Prospective, double-blind, randomized, controlled, clinical trial.

POPULATION Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers.

SETTING EMS systems participating in the Resuscitation Outcomes Consortium.

SAMPLE SIZE Based on a one-sided significance level of 0.025, power=0.90, a survival with MRS< or =3 to discharge rate of 5.33% with standard CPR and sham ITD, and two interim analyses, a maximum of 14,742 evaluable patients are needed to detect a 6.69% survival with MRS< or =3 to discharge with standard CPR and active ITD (1.36% absolute survival difference).

CONCLUSION If the ITD demonstrates the hypothesized improvement in survival, it is estimated that 2700 deaths from cardiac arrest per year would be averted in North America alone.


Title

A critical assessment of the out-of-hospital trauma triage guidelines for physiologic abnormality.


Citation Newgard CD, Rudser K, Hedges JR, Kerby JD, Stiell IG, Davis DP, Morrison LJ, Bulger E, Terndrup T, Minei JP, Bardarson B, Emerson S, ROC Investigators. A critical assessment of the out-of-hospital trauma triage guidelines for physiologic abnormality. Journal of Trauma 2010; 68(2):452-62. PMCID: PMC3785297

Abstract BACKGROUND It remains unclear whether the American College of Surgeons Committee on Trauma (ACSCOT) "step 1" field physiologic criteria could be further restricted without substantially sacrificing sensitivity. We assessed whether more restrictive physiologic criteria would improve the specificity of this triage step without missing high-risk patients.

METHODS We analyzed an out-of-hospital, consecutive patient, prospective cohort of injured adults >or=15 years collected from December 1, 2005, to February 28, 2007, by 237 emergency medical service agencies transporting to 207 acute care hospitals in 11 sites across the United States and Canada. Patients were included based on ACSCOT field decision scheme physiologic criteria systolic blood pressure 29 breaths/min, Glasgow Coma Scale score 2 days.

RESULTS Of 7,127 injured persons, 6,259 had complete outcome information and were included in the analysis. There were 3,631 (58.0%) persons with death or LOS >2 days. Using only physiologic measures, the derived rule included advanced airway intervention, shock index >1.4, Glasgow Coma Scale <11, and pulse oximetry <93%. Rule validation demonstrated sensitivity 72% (95% confidence interval: 70%-74%) and specificity 69% (95% confidence interval: 67%-72%). Inclusion of demographic and mechanism variables did not significantly improve performance measures.

CONCLUSIONS We were unable to omit or further restrict any ACSCOT step 1 physiologic measures in a decision rule practical for field use without missing high-risk trauma patients.


Title

Delayed prehospital implementation of the 2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiac care.


Citation Bigham BL, Koprowicz K, Aufderheide TP, Davis DP, Donn S, Powell J, Suffoletto B, Nafziger S, Stouffer J, Idris A, Morrison LJ, ROC Investigators. Delayed prehospital implementation of the 2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiac care. Prehospital Emergency Care 2010; 14(3):355-60. PMCID: PMC3209500

Abstract INTRODUCTION In 2005, the American Heart Association (AHA) released guidelines to improve survival rates from out-of-hospital cardiac arrest (OHCA).

OBJECTIVE To determine if, and when, emergency medical services (EMS) agencies participating in the Resuscitation Outcomes Consortium (ROC) implemented these guidelines.

METHODS We contacted 178 EMS agencies and completed structured telephone interviews with 176 agencies. The survey collected data on specific treatment protocols before and after implementation of the 2005 guidelines as well as the date of implementation crossover (the "crossover date"). The crossover date was then linked to a database describing the size, type, and structure of each agency. Descriptive statistics and regression were used to examine patterns in time to crossover.

RESULTS The 2005 guidelines were implemented by 174 agencies (99%). The number of days from guideline release to implementation was as follows: mean 416 (standard deviation 172), median 415 (range 49-750). There was no difference in time to implementation in fire-based agencies (mean 432), nonfire municipal agencies (mean 365), and private agencies (mean 389, p = 0.31). Agencies not providing transport took longer to implement than agencies that transported patients (463 vs. 384 days, p = 0.004). Agencies providing only basic life support (BLS) care took longer to implement than agencies who provided advanced life support (ALS) care (mean 462 vs. 397 days, p = 0.03). Larger agencies (>10 vehicles) were able to implement the guidelines more quickly than smaller agencies (mean 386 vs. 442 days, p = 0.03). On average, it took 8.9 fewer days to implement the guidelines for every 50% increase in EMS-treated runs/year to which an agency responded.

CONCLUSION ROC EMS agencies required an average of 416 days to implement the 2005 AHA guidelines for OHCA. Small EMS agencies, BLS-only agencies, and nontransport agencies took longer than large agencies, agencies providing ALS care, and transport agencies, respectively, to implement the guidelines. Causes of delays to guideline implementation and effective methods for rapid EMS knowledge translation deserve investigation.


Title

The impact of peri-shock pause on survival from out-of-hospital shockable cardiac arrest during the Resuscitation Outcomes Consortium PRIMED trial.


Citation Cheskes S, Schmicker RG, Verbeek PR, Salvido DD, Brown SP, Brooks S, Menegazzi JJ, Vaillancourt C, Powell J, May S, Berg RA, Sell R, Idris A, Kampp M, Schmidt T, Christenson J, and the ROC investigators. The impact of peri-shock pause of survival from out-of-hospital shockable cardiac arrest during the Resuscitation Outcomes Consortium PRIMED trial. Resuscitation 2014; 85:336-342. PMCID: PMC3944081

Abstract BACKGROUND Previous research has demonstrated significant relationships between peri-shock pause and survival to discharge from out-of-hospital shockable cardiac arrest (OHCA).

OBJECTIVE To determine the impact of peri-shock pause on survival from OHCA during the ROC PRIMED randomized controlled trial.

METHODS We included patients in the ROC PRIMED trial who suffered OHCA between June 2007 and November 2009, presented with a shockable rhythm and had CPR process data for at least one shock. We used multivariable logistic regression to determine the association between peri-shock pause duration and survival to hospital discharge.

RESULTS Among 2006 patients studied, the median (IQR) shock pause duration was: pre-shock pause 15s (8, 22); post-shock pause 6s (4, 9); and peri-shock pause 22.0 s (14, 31). After adjusting for Utstein predictors of survival as well as CPR quality measures, the odds of survival to hospital discharge were significantly higher for patients with pre-shock pause <10s (OR: 1.52, 95% CI: 1.09, 2.11) and peri-shock pause <20s (OR: 1.82, 95% CI: 1.17, 2.85) when compared to patients with pre-shock pause ≥ 20s and peri-shock pause ≥ 40s. Post-shock pause was not significantly associated with survival to hospital discharge. Results for neurologically intact survival (Modified Rankin Score ≤ 3) were similar to our primary outcome.

CONCLUSIONS In patients with cardiac arrest presenting in a shockable rhythm during the ROC PRIMED trial, shorter pre- and peri-shock pauses were significantly associated with higher odds of survival. Future cardiopulmonary education and technology should focus on minimizing all peri-shock pauses.


Title

Incidence and outcomes of rearrest following out-of-hospital cardiac arrest.


Citation Salcido DD, Koller AC, Sundermann ML, Callaway CW, Menegazzi JJ. Incidence and outcomes of rearrest following out-of-hospital cardiac arrest. Resuscitation 2015; 86:19-24. PMCID: PMC4408205

Abstract INTRODUCTION Rearrest occurs when a patient experiences cardiac arrest after successful resuscitation. The incidence and outcomes of rearrest following out-of-hospital cardiac arrest have been estimated in limited local studies. We sought provide a large-scale estimate of rearrest incidence and its effect on survival.

METHODS We obtained case data from emergency medical services-treated, out-of-hospital cardiac arrest from the Resuscitation Outcomes Consortium, a multi-site clinical research network with clinical centers in 11 regions in the US and Canada. The cohort comprised all cases captured between 2006 and 2008 at 10 of 11 regions with prehospital return of spontaneous circulation. We used three methods to ascertain rearrest via direct signal analysis, indirect signal analysis, and emergency department arrival vital status. Rearrest incidence was estimated as the proportion of cases with return of spontaneous circulation that experience rearrest. Regional rearrest incidence estimates were compared with the χ(2)-squared test. Multivariable logistic regression was used to assess the relationship between rearrest and survival to hospital discharge.

RESULTS Out of 18,937 emergency medical services-assessed cases captured between 2006 and 2008, 11,456 (60.5%) cases were treated by emergency medical services and 4396 (38.4%) had prehospital return of spontaneous circulation. Of these, rearrest ascertainment data was available in 3253 cases, with 568 (17.5%) experiencing rearrest. Rearrest differed by region (10.2% to 21.2%, p < 0.001). Rearrest was inversely associated with survival (OR: 0.19, 95% CI: 0.14-0.26).

CONCLUSIONS Rearrest was found to occur frequently after resuscitation and was inversely related to survival.


Title

Classification of cardiopulmonary resuscitation chest compression patterns: manual versus automated approaches.


Citation Wang HE, Schmicker RH, Herren H, Brown S, Donnelly JP, Gray R, Ragsdale S, Gleeson A, Byers A, Jasti J, Aguirre C, Owens P, Condle J, Leroux B. Classification of cardiopulmonary resuscitation chest compression patterns: Manual versus automated approaches. Academic Emergency Medicine 2015; 22(2):204-211. PMCID: PMC4329029

Abstract OBJECTIVES New chest compression detection technology allows for the recording and graphical depiction of clinical cardiopulmonary resuscitation (CPR) chest compressions. The authors sought to determine the inter-rater reliability of chest compression pattern classifications by human raters. Agreement with automated chest compression classification was also evaluated by computer analysis.

METHODS This was an analysis of chest compression patterns from cardiac arrest patients enrolled in the ongoing Resuscitation Outcomes Consortium (ROC) Continuous Chest Compressions Trial. Thirty CPR process files from patients in the trial were selected. Using written guidelines, research coordinators from each of eight participating ROC sites classified each chest compression pattern as 30:2 chest compressions, continuous chest compressions (CCC), or indeterminate. A computer algorithm for automated chest compression classification was also developed for each case. Inter-rater agreement between manual classifications was tested using Fleiss's kappa. The criterion standard was defined as the classification assigned by the majority of manual raters. Agreement between the automated classification and the criterion standard manual classifications was also tested.

RESULTS The majority of the eight raters classified 12 chest compression patterns as 30:2, 12 as CCC, and six as indeterminate. Inter-rater agreement between manual classifications of chest compression patterns was κ = 0.62 (95% confidence interval [CI] = 0.49 to 0.74). The automated computer algorithm classified chest compression patterns as 30:2 (n = 15), CCC (n = 12), and indeterminate (n = 3). Agreement between automated and criterion standard manual classifications was κ = 0.84 (95% CI = 0.59 to 0.95).

CONCLUSIONS In this study, good inter-rater agreement in the manual classification of CPR chest compression patterns was observed. Automated classification showed strong agreement with human ratings. These observations support the consistency of manual CPR pattern classification as well as the use of automated approaches to chest compression pattern analysis.