Regulatory challenges for the resuscitation outcomes consortium.
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ABSTRACT:
SUBMITTER: Tisherman SA
PROVIDER: S-EPMC2757627 | biostudies-literature | 2008 Oct
REPOSITORIES: biostudies-literature
Publications
Regulatory challenges for the resuscitation outcomes consortium.
Tisherman Samuel A SA Powell Judy L JL Schmidt Terri A TA Aufderheide Tom P TP Kudenchuk Peter J PJ Spence Julie J Climer Dixie D Kelly Donna D Marcantonio Angela A Brown Todd T Sopko George G Kerber Richard R Sugarman Jeremy J Hoyt David D
Circulation 20081001 15
Similar Datasets
Project description: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.
| S-EPMC4792760 | biostudies-literature
Project description:ObjectiveTo describe the development, design and consequent scientific implications of the Resuscitation Outcomes Consortium (ROC) population-based registry; ROC Epistry-Cardiac Arrest.MethodsThe 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.ConclusionWe 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.
| S-EPMC4159466 | biostudies-literature
Project description:Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation on Helicopter Study (PROHS)(ROC-PROHS-BioLINCC)
| PRJNA1181038 | ENA
Project description:Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation on Helicopter Study (PROHS)(ROC-PROHS-BioLINCC)
| PRJNA1181039 | ENA
Project description:BACKGROUND/OBJECTIVES: To investigate the effect of the occurrence of early hyperchloremia on death or severe disability at 180 days in patients with severe traumatic brain injury (TBI). DESIGN: Post hoc analysis of Resuscitation Outcomes Consortium Hypertonic Saline (ROC HS)-TBI trial. SETTING: A total of 114 North American emergency medical services agencies in the ROC. PATIENTS: A total of 991 patients with severe TBI and Glasgow Coma Scale score of less than or equal to 8. INTERVENTIONS: Prehospital resuscitation with single IV dose (250 cc) of 7.5% saline in 6% dextran-70, 7.5% saline (no dextran), or crystalloid. MEASUREMENTS AND MAIN RESULTS: Patients with increased serum chloride concentrations (110 mmol/L or greater) 24 hours after randomization were identified. Hyperchloremia was graded into one or greater than or equal to 2 occurrences in the first 24 hours. Logistic regression analyses were performed to determine the effects of hyperchloremia on: 1) death or severe disability at 180 days and 2) death within 180 days after adjusting for confounders. Compared with patients without hyperchloremia, patients with greater than or equal to 2 occurrences of hyperchloremia had significantly higher odds of death or severe disability at 180 days (odds ratio [OR], 1.81; 95% CI, 1.19–2.75) and death within 180 days (OR, 1.89; 95% CI, 1.14–3.08) after adjustment for confounders. However, the total volume of fluids administered during the first 24 hours was an independent predictor of death within 180 days; therefore, after adding an interaction term between the total volume of fluids administered during the first 24 hours and greater than or equal to 2 occurrences of hyperchloremia, patients with greater than or equal to 2 occurrences of hyperchloremia had significantly higher odds of death within 180 days (OR, 2.35; 95% CI, 1.21–4.61 d) but not of composite outcome of death or severe disability at 180 days. CONCLUSIONS: After modifying for the effect of the total volume of fluids administered during the first 24 hours, multiple occurrences of hyperchloremia in the first 24 hours were associated with higher odds of death within 180 days in patients with severe TBI.
| S-EPMC9726372 | biostudies-literature
Project description:BackgroundTraumatic 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.MethodsThis 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.ResultsWe 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.ConclusionsSurvival 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 evidencePrognostic study, level IV.
| S-EPMC4961534 | biostudies-literature
Project description:BackgroundOut-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).MethodsObservational 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).ResultsMean 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).ConclusionsROC-wide survival increased significantly between 2006 and 2010. Additional research efforts are warranted to identify specific factors associated with this improvement.
| S-EPMC4433591 | biostudies-literature
Project description: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.
| S-EPMC2562032 | biostudies-literature
Project description:BackgroundInnovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint reviews the IDEA-FAST perspective on developing digital measures for multiple diseases and the advice provided by the EMA.SummaryThe EMA considered a cross-disease measure an interesting and arguably feasible concept. Developers should account for the need for a strong rationale that the clinical features to be measured are similar across diseases. In addition, they may expect increased complexity of study design, challenges when managing differences within and between disease populations, and the need for validation in both heterogeneous and homogeneous populations.Key messagesEMA highlighted the challenges teams may encounter when developing a cross-disease measure, though benefits potentially include reduced resources for the technology developer and health authority, faster access to innovation across different therapeutic fields, and feasibility of cross-disease comparisons. The insights included here can be used by project teams to guide them in the development of cross-disease digital measures intended for regulatory qualification.
| S-EPMC10601930 | biostudies-literature
Project description:Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis (PRIMED)(ROC-PRIMED-BioLINCC)
| PRJNA1180127 | ENA