Impact of the Final Rule on the Rate of Clinical Cardiac Arrest Research in the United States

Background: The federal government placed a moratorium on human emergency resuscitation research in 1993 due to concerns related to informed consent. In 1996, the Food and Drug Administration introduced the Final Rule in order to allow clinical resuscitation research to proceed in special cases without prospective informed consent. It is unclear, however, how this change has impacted the performance of this research. Objectives: To measure the potential impact of the Final Rule by determining the number of clinical cardiac arrest studies performed in the United States (US) before and after 1993, and to compare it with the number of studies performed in the European Union (EU) during the same periods. Methods: A MEDLINE search was performed for cardiac arrest studies that were prospective, interventional, randomized, and performed in the US or EU from 1983 through 2003. Results: Of the 3,115 cardiac arrest publications identified, 66 (2%) met inclusion criteria. Of the 40 studies conducted in the US, 24 (60%) were published prior to or during 1993, whereas of the 27 studies conducted in the EU, six (22%) were published prior to or during 1993 (odds ratio = 0.5; 95% confidence interval = 0.3 to 0.8). Conclusions: There has been a significant decrease in the number of published clinical cardiac arrest trials in the US since 1993. In contrast, there has been a significant increase in the number of published EU trials since 1993. The current informed consent requirements may have reduced the number of clinical cardiac arrest studies performed in the US.     

The Safety of a Field Termination-of-resuscitation Protocol

Background. A 1999 National Association of EMS Physicians position paper recommends that termination of resuscitation (TOR) be considered if the adult nontraumatic out-of-hospital cardiac arrest (OOHCA) patient receives cardiopulmonary resuscitation, definitive airway management, intravenous access, andat least 20 minutes of resuscitative efforts, yet remains in asystole or pulseless electrical activity with no return of spontaneous circulation (ROSC) in the field. Objective. To test the safety of this protocol, with survival to discharge as the primary endpoint. The study hypothesis was that the protocol is 100% specific: no patient who would be eligible for TOR survived to discharge. Methods. Utstein template data were collected prospectively for all OOHCA patients received at two academic emergency departments between August 1999 andJanuary 2003, andretrospective OOHCA data were collected at one of the hospitals covering the interval October 1993 to June 2002. Each case was examined to determine whether the patient would have been eligible for TOR, andwhether he or she survived. Results. Three hundred sixty-six prospective and135 retrospective cases were included. Twelve patients survived to discharge, but none were eligible for TOR, as all had ROSC in the field (specificity 100%, sensitivity 58%). Of the 63 patients who survived to admission, four were eligible for TOR (specificity 94%, sensitivity 64%). None of these four survived to discharge, andnot regained consciousness prior to death. Conclusions. The proposed protocol appears to be safe, with 100% specificity for lack of survival to discharge in this sample. A small number of patients eligible for TOR did survive to admission, but none survived to discharge.     

Conduct of emergency research in patients unable to give consent--experiences and perceptions of patients, their consent providing next of kin, and treating physicians following a prehospital resuscitation trial

Objective

According to a directive of the European Parliament, informed consent is required to conduct a clinical trial also in emergencies when the patient is unable to provide consent. In these cases surrogate consent can be obtained from the patient's next of kin. There are no reports describing how patients and their next of kin perceive this policy. The perceptions of patients and their spouses involved in an emergency trial conducted under surrogate consent were surveyed.

Methods

A survey was sent to survivors of prehospital cardiac arrest, to consent providers regardless of patient outcome, and to physicians who had recruited the patients.

Results

11 (92%) patients, 17 (68%) consent providers, and all physicians returned the survey. All held a positive attitude towards emergency research and were willing to participate without own consent in a trial approved by an institutional review board (IRB). Opinions among responding groups were similar albeit a significant difference regarding the perceived capability of the consent provider to decide upon patient's enrolment. Spouses felt able to provide consent, but physicians were sceptical of this. Patients and their spouses would have appreciated additional information regarding the index trial after the acute phase.

Conclusions

Emergency research was perceived positively by cardiac arrest victims and their spouses previously involved in a resuscitation trial. Possible own participation in an emergency trial without personal consent was considered acceptable. Patients and their spouses would prefer additional research information after enrolment.     

Independent Evaluation of an Out-of-hospital Termination of Resuscitation (TOR) Clinical Decision Rule

Objectives: Recently, investigators described a clinical decision rule for termination of resuscitation (TOR) designed to help determine whether to terminate emergency medical services (EMS) resuscitative efforts for out‐of‐hospital cardiac arrests (OOHCA). The authors sought to evaluate the hypothesis that TOR would predict no survival for patients in an independent cohort of patients with OOHCA. Methods: This was a retrospective cohort analysis conducted in the state of Arizona. Consecutive, adult, OOHCA were prospectively evaluated from October 2004 through October 2006. A statewide OOHCA database utilizing Utstein‐style reporting from 30 different EMS systems was used. Data were abstracted from EMS first care reports and hospital discharge records. The TOR guidelines predict that no survival to hospital discharge will occur if 1) an OOHCA victim does not have return of spontaneous circulation (ROSC), 2) no shocks are administered, and 3) the arrest is not witnessed by EMS personnel. Data were entered into a structured database. Continuous data are presented as means (±standard deviations [SD]) and categorical data as frequency of occurrence, and 95% confidence intervals (CIs) were calculated as appropriate. The primary outcome measure was to determine if any cohort member who met TOR criteria survived to hospital discharge. Results: There were 2,239 eligible patients; the study group included 2,180 (97.4%) patients for whom the data were complete; mean age was 64 (±11) years, and 35% were female. The majority of patients in the study group met at least one or more of the TOR criteria. A total of 2,047 (93.8%) patients suffered from cardiac arrest that was unwitnessed by EMS; 1,653 (75.8%) had an unwitnessed arrest and no ROSC. With respect to TOR, 1,160 of 2,180 (53.2%) patients met all three criteria; only one (0.09%; 95% CI = 0% to 0.5%) survived to hospital discharge. Conclusions: The authors evaluated TOR guidelines in an independent, statewide OOHCA database. The results are consistent with the findings of the TOR investigation and suggest that this algorithm is a promising tool for TOR decision‐making in the field.     

Thrombin-Antithrombin Appearance in Out-of-Hospital Cardiac Arrest

Objective. Intravascular thrombosis induced during out-of-hospital cardiac arrest (OOHCA) may contribute to the pathophysiology of cardiac arrest andcomplicate resuscitation. We characterized the prevalence of thrombogenesis during OOHCA by measuring plasma levels of thrombin-antithrombin complexes (TAT). Methods. An observational cohort study of medical OOHCA patients in an urban emergency medical services (EMS) system. Subjects were patients ≥18 years suffering medical OOHCA. Citrated blood samples were drawn in the prehospital setting either directly from venous blood or during the placement of a central venous catheter andfrozen (?70°C). The EMS physician documented age, gender, time intervals, return of spontaneous circulation (ROSC), therapies administered andtime of blood draw. TAT assays were performed by commercial ELISA. Results. Eighty-eight patients (58% male) aged 63.4 ± 15.9 years were enrolled in the study. Median [interquartile range IQR] TAT values in 80 samples (8 samples were grossly clotted andexcluded) were 159.2 [38, 2, 522, 8] andranged from 0.79 to 1,343.9. Patients transported to the hospital had lower TAT levels than those pronounced in the field (p = 0.014). Of four EMS-witnessed arrests, three had return of pulses with TAT values of 0.79, 6.8, and17.9. The fourth had a TAT over 525 after a long unsuccessful resuscitation. For subjects with TAT below 50 (n = 23), all but three were witnessed arrests or received bystander CPR. Conclusions. Except for a single case witnessed by EMS andimmediately defibrillated into a perfusing rhythm, all cases of OOHCA exhibited increased thrombotic state. Intravascular thrombosis may represent a global barrier to resuscitation andultimately, end-organ perfusion.     

An Approach to Community Consultation Prior to Initiating an Emergency Research Study Incorporating a Waiver of Informed Consent

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

Understanding Exception from Informed Consent in Planned Emergency Research

Many of the current accepted treatment practices provided to patients in the first critical hour after a traumatic injury, stroke, or cardiac arrest have not been rigorously tested in clinical research trials. The inability to obtain informed consent is often a barrier to research in emergency, time-sensitive situations in which the patient is not able to provide informed consent nor is their family member immediately available to provide consent on behalf of the patient. Planned emergency research, often with exception from informed consent, is a type of research study that involves a patient with a life-threatening medical condition that requires urgent interventions, wherein the current treatments may be unproven or suboptimal, and who, because of their current condition, is unable to provide informed consent. This article summarizes the necessary components for using exception from informed consent in planned emergency research. Understanding the research design, particularly research processes specific to time-critical emergency situations, will ensure that the care provided by stretcher-side emergency nurses will result in optimal patient outcomes and is an integral aspect of emergency nursing practice.     

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.     

Cardiac arrest diagnostic accuracy of 9-1-1 dispatchers: A prospective multi-center study

IntroductionWe sought to determine the ability of 9-1-1 dispatchers to accurately determine the presence of out-of-hospital cardiac arrest (OOHCA) over the telephone, and to determine the frequency with which CPR instructions are initiated and chest compressions delivered in patients not in cardiac arrest.MethodsWe conducted a multi-center, prospective cohort study of adult OOHCA patients not witnessed by EMS for which resuscitation was attempted. Dispatchers were not health care professionals and received 6 weeks of training followed by a 6-month preceptorship. We reviewed 9-1-1 call digital recordings for all unconscious patients for which the possibility of cardiac arrest was considered using a piloted standardized data collection sheet.ResultsWe reviewed 2260 recordings occurring between January 2008 and October 2009. Among those, 1536 were confirmed OOHCA, and 724 were not. Among the 1536 confirmed OOHCA cases, 1012 were recognized by dispatchers and 524 were not. Among the 724 cases not in cardiac arrest, dispatchers suspected cardiac arrest was present in 490 and absent in 234. OOHCA diagnostic accuracy characteristics were: sensitivity 65.9% (95%CI 63.5–68.2%), specificity 32.3% (95%CI 29.0–35.9%), PPV 67.4%, and NPV 30.9%. Dispatchers believed that OOHCA was present in 490/2260 (21.7%) cases when it was not, resulting in 54/490 (11.0%) patients inappropriately receiving chest compressions, or 54/2260 (2.4%) of the whole cohort.ConclusionsDispatchers had a fair sensitivity and modest specificity for the recognition of OOHCA. We found a very small number of patients receiving CPR when not in cardiac arrest, supporting the current use of dispatch-assisted CPR instructions.     

Modifying a Standard Industry Clinical Trial Consent Form Improves Patient Information Retention as Part of the Informed Consent Process

OBJECTIVE: Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period. METHODS: This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined. RESULTS: The population had a mean age (+/-SD) of 39.4 +/- 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (+/-2.0), range 2-12 (maximum 12). The MF score was 10.6 (+/-1.4) vs the IF score of 8.6 (+/-2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = -6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%). CONCLUSIONS: Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.     

Personal Preferences Regarding Family Member Presence during Resuscitation

OBJECTIVES: Previous studies have shown that family members wish to be present during the resuscitation of a family member. No studies have addressed whether the patient would want family members present if he or she required resuscitation. The authors wanted to determine patients' preferences regarding family member presence during their own resuscitation. METHODS: A seven-item survey was administered to a sample of patients and their family members older than 17 years of age on six randomly chosen shifts in an academic community hospital emergency department. Responses were analyzed using chi-square and t-tests. Subjective comments were also recorded. RESULTS: A total of 266 subjects were asked to participate in the study; 200 subjects agreed to complete the survey. Most (72%) wanted a family member present. However, 21% did not wish any family member to be present. Positive responders (family present) tended to be younger (mean, 39.4 years; 95% confidence interval = 36.7 to 42.2) than negative responders (mean, 50.5 years; 95% confidence interval = 42.9 to 55.7; p < 0.001). Positive responders were also more likely to be nonwhite (chi2 = 6.29, p < 0.05). Gender, education, or health status was not associated with responder type. Of positive responders, 56% stated they wanted only certain members present, and these preferences were variable. CONCLUSIONS: Patients preferred to have family members present during their resuscitation. However, most of the positive responders wanted only certain members present, and approximately one in five patients, who tended to be older and white, did not want any family present. This study does not support an open policy of allowing family members into a resuscitation without prior knowledge of the patient's preferences.     

Now That We Have the Utstein Style,Are We Using It?

OBJECTIVES: To examine the extent to which the Utstein style has been used for out-of-hospital cardiac arrest (OOHCA) research since its publication in 1991. The style was developed in an effort to standardize OOHCA research and reporting. METHODS: To locate all OOHCA research papers published between 1992 and 1997, all issues of six emergency medicine/emergency medical services (EM/ EMS) journals were examined manually, and papers from other journals were located using computerized searches. All located articles were examined by the first author to determine whether use of the Utstein style was indicated and if so, whether it had actually been used. When either of these was uncertain, all three authors reviewed the paper, and a consensus was reached. The Pearson chi-square test was used to compare rates of use from U.S. and non-U.S. institutions, and from the EM/EMS and non-EM/EMS literature, with significance set at p < 0.05. RESULTS: All 143 OOHCA research articles identified by the search were examined. The Utstein style was found to be not applicable to 41 (29%), and these were eliminated. The Utstein style was indicated for the remaining 102 studies. Of these, 41 (40%) used the Utstein style, and 61 (60%) did not. There was no difference in rates between papers from sites in the United States (18/48, 38%) and elsewhere (23/54, 43%), or between papers from the EM/EMS literature (17/44, 39%) and non-EM/EMS literature (25/59, 42%). Despite an upward trend in the use of the Utstein style seen from 1992 to 1994, use leveled off from 1994 to 1997, and has not exceeded 60% in any given calendar year studied. CONCLUSIONS: Six years after the release of the Utstein style for OOHCA research, fewer than 60% of OOHCA research articles actually use the style.     

Impact of the 2005 American Heart Association Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Guidelines on Out-of-Hospital Cardiac Arrest Survival

Objective. To describe changes in out-of-hospital cardiac arrest (OOHCA) survival before and after the release of the 2005 American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC). Methods. Data were extracted from an OOHCA registry for 1,681 adult cases of cardiac arrest treated by one emergency medical services (EMS) system between April 1, 2004, and December 31, 2007, in a large city (2005 population 730,657). The primary endpoint was survival to hospital discharge. A convenience sample of 69 electronic electrocardiogram (ECG) recordings was reviewed to assess CPR quality parameters using impedance waveform analysis during corresponding time periods. Intervention. Implementation of the 2005 AHA guidelines for CPR and ECC in spring 2006. Results. The annual treated OOHCA incidence rate was 68/100,000; and the treated ventricular fibrillation (VF) incidence rate was 15/100,000. Bystanders performed CPR in 28% of cases. Public automated external defibrillator (AED) use was < 2% over the entire study, and few patients received hypothermia therapy. Unadjusted OOHCA survival rates were significantly higher in the postguidelines period at 9.4% (n = 1,021) than in the preguidelines period at 6.1% (n = 660), despite similarities in all major predictors of outcome (odds ratio [OR] 1.6; 95% confidence interval [CI] 1.1 to 2.4). Bystander-witnessed OOHCA survival for victims in VF on EMS arrival was 19 of 78 (24%) in the preguidelines period versus 34 of 112 (30%) in the postguidelines period (OR 1.4; 95% CI 0.7 to 2.6). CPR quality measures showed significant improvement in the postguidelines period. The mean no-flow fraction in the preguidelines group was 0.46 and dropped to 0.34 in the postguidelines group, a difference of 0.12 (95% CI 0.05 to 0.19). Multivariate regression analysis adjusting for significant predictors of survival showed that OOHCA in the postguidelines period was associated with 1.8 greater odds of survival than in the preguidelines period (95% CI 1.2 to 2.7). Conclusion. In this large city, substantial improvement occurred in overall OOHCA survival rates following the implementation of the 2005 AHA guidelines for CPR and ECC. These changes were associated with improvements in the quality of CPR.     

Locating AED Enabled Medical Drones to Enhance Cardiac Arrest Response Times

Background: Out-of-hospital cardiac arrest (OOHCA) is prevalent in the United States. Each year between 180,000 and 400,000 people die due to cardiac arrest. The automated external defibrillator (AED) has greatly enhanced survival rates for OOHCA. However, one of the important components of successful cardiac arrest treatment is emergency medical services (EMS) response time (i.e., the time from EMS “wheels rolling” until arrival at the OOHCA scene). Unmanned Aerial Vehicles (UAV) have regularly been used for remote sensing and aerial imagery collection, but there are new opportunities to use drones for medical emergencies. Objective: The purpose of this study is to develop a geographic approach to the placement of a network of medical drones, equipped with an automated external defibrillator, designed to minimize travel time to victims of out-of-hospital cardiac arrest. Our goal was to have one drone on scene within one minute for at least 90% of demand for AED shock therapy, while minimizing implementation costs. Methods: In our study, the current estimated travel times were evaluated in Salt Lake County using geographical information systems (GIS) and compared to the estimated travel times of a network of AED enabled medical drones. We employed a location model, the Maximum Coverage Location Problem (MCLP), to determine the best configuration of drones to increase service coverage within one minute. Results: We found that, using traditional vehicles, only 4.3% of the demand can be reached (travel time) within one minute utilizing current EMS agency locations, while 96.4% of demand can be reached within five minutes using current EMS vehicles and facility locations. Analyses show that using existing EMS stations to launch drones resulted in 80.1% of cardiac arrest demand being reached within one minute Allowing new sites to launch drones resulted in 90.3% of demand being reached within one minute. Finally, using existing EMS and new sites resulted in 90.3% of demand being reached while greatly reducing estimated overall costs. Conclusion: Although there are still many factors to consider, drone networks show potential to greatly reduce life-saving equipment travel times for victims of cardiac arrest.     

Implementing the Food and Drug Administration's Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances

In 1996, the Food and Drug Administration released its Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances (the Final Rule). The Department of Health and Human Services (DHHS) also released an update of its regulations related to waiver of informed consent in emergency research. These new regulations allow resuscitation research to proceed with a waiver of informed consent under very narrow and specific clinical research circumstances. Waiving informed consent for research participation has profound ethical and scientific implications. However, in unpredictable life-threatening clinical situations for which current therapy is unproven or unsatisfactory, patients usually are unable to consent on their own behalf to participate in clinical trials of potentially beneficial but experimental interventions. Because of the time-dependent nature of most resuscitation interventions, it is usually not feasible to identify and contact the legally authorized representative who can speak on behalf of the patient within the presumed therapeutic window of the intervention under investigation. For such clinical trials to proceed, a waiver of informed consent is usually necessary. Patients who are critically ill or injured and unable to provide meaningful prospective informed consent because of their current life-threatening condition are vulnerable and require additional protections beyond those for research subjects who can speak on their own behalf. The Final Rule and the DHHS-updated regulations incorporate a number of additional patient safeguards that must occur if a clinical trial is to proceed with waiver of informed consent. Specific means of adequately meeting these requirements are not described in the regulations. Although this was intentional on the part of the federal regulators so that individual protocols and research environments would direct the development of these patient safeguards, the lack of specific guidance has led to confusion on the appropriate implementation of the new regulations. This article reviews some of the key concepts of the Final Rule, with suggestions on their purpose and meaning. It also reviews the studies that have been approved to date to proceed with waiver of informed consent, and offers suggestions for the process of implementing the requirements of the Final Rule for research involving patients who are unable to give prospective informed consent.     

Out‐of‐hospital Cardiac Arrest in Denver,Colorado: Epidemiology and Outcomes

Objectives: The annual incidence of out‐of‐hospital cardiac arrest (OOHCA) in the United States is approximately 6 per 10,000 population and survival remains low. Relatively little is known about the performance characteristics of a two‐tiered emergency medical services (EMS) system split between fire‐based basic life support (BLS) dispersed from fixed locations and hospital‐based advanced life support (ALS) dispersed from nonfixed locations. The objectives of this study were to describe the incidence of OOHCA in Denver, Colorado, and to define the prevalence of survival with good neurologic function in the context of this particular EMS system. Methods: This was a retrospective cohort study using standardized abstraction methodology. A two‐tiered hospital‐based EMS system for the County of Denver and 10 receiving hospitals were studied. Consecutive adult patients who experienced nontraumatic OOHCA from January 1, 2003, through December 31, 2004, were enrolled. Demographic, prehospital arrest characteristics, treatment data, and survival data using the Utstein template were collected. Good neurologic survival was defined by a Cerebral Performance Categories (CPC) score of 1 or 2. Results: During the study period, 1,985 arrests occurred. Of these, 715 (36%) had attempted resuscitation by paramedics and constitute our study sample. The median age was 65 years (interquartile range = 52–78 years), 69% were male, 41% had witnessed arrest, 25% had bystander cardiopulmonary resuscitation (CPR) performed, and 30% had ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) as their initial rhythm. Of the 715 patients, 545 (76%) were transported to a hospital, 223 (31%) had return of spontaneous circulation (ROSC), 175 (25%) survived to hospital admission, 58 (8%) survived to hospital discharge, and 42 (6%, 95% confidence interval [CI] = 4% to 8%) had a good neurologic outcome. Conclusions: Out‐of‐hospital cardiac arrest survival in Denver, Colorado, is similar to that of other United States communities. This finding provides the basis for future epidemiologic and health services research in the out‐of‐hospital and ED settings in our community. ACADEMIC EMERGENCY MEDICINE 2010; 17:391–398 © 2010 by the Society for Academic Emergency Medicine     

Re-examining outcomes after unsuccessful out-of-hospital resuscitation in the era of field termination of resuscitation guidelines and regionalized post-resuscitation care

BackgroundDismal prognosis after failed out-of-hospital resuscitation has previously been demonstrated. Changes in resuscitation and post-resuscitation care may affect patient outcomes. We describe characteristics and outcomes of patients with out-of-hospital cardiac arrest (OOHCA) transported to specialty cardiac centers after failure of out-of-hospital interventions.MethodsIn Los Angeles (LA) County, patients with non-traumatic OOHCA with return of spontaneous circulation (ROSC) are transported to specialized cardiac care centers. Outcomes are reported to a registry maintained by the LA County Emergency Medical Services (EMS) Agency. We report patient characteristics and outcomes for the subset of patients treated at these specialty centers in whom initial ROSC was achieved in the ED. The primary outcome was neurologically intact survival, defined by a cerebral performance category (CPC) score of 1 or 2.Results105 patients transported to the SRC after failure to achieve ROSC with out-of-hospital resuscitation were successfully resuscitated in the ED. The median age was 68 years (IQR 57–78); 74 (70%) were male. The presenting rhythm was ventricular fibrillation or ventricular tachycardia in 40 patients (38%) and 86 (82%) were witnessed. Twenty-two patients (21%) survived to hospital discharge. Of the 103 patients with known CPC scores, 13 (13% [95% CI 7–21%]) survived to hospital discharge with a CPC score of 1 or 2. No patient who survived with good neurologic outcome met criteria for termination of resuscitation in the field.ConclusionFailure of out-of-hospital resuscitation is not universally predictive of poor neurologic outcome.     

International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey

BackgroundResearch in an emergency setting such as that with an acute cardiovascular event is challenging because the window of opportunity to treat may be short and may preclude time to obtain informed consent from the patient or their representative. Some perceive that requiring informed consent in emergency situations has limited improvements in care. Vulnerable populations including minorities or residents of low-income countries are at greatest risk of need for resuscitation. Lack of enrollment of such patients would increase uncertainties in treatment benefit or harm in those at greater risk of need for resuscitation. We sought to assess international variation in policies and procedures related to exception from informed consent (EFIC) or deferred consent for emergency research.MethodsA brief survey instrument was developed and modified by consensus among the investigators. Included were multiple choice and open-ended responses. The survey included an illustrative example of a hypothetical randomized study. Elicited information included the possibility of conducting such a study in the respondent's country, as well as approvals required to conduct the study. The population of interest was emergency physicians or other practitioners of acute cardiovascular event research.ResultsUsable responses were obtained from 44 countries (76% of surveyed). Community opposition to EFIC was noted in 6 (14%) countries. Emergency Medical Services (EMS) providers in 8 (20%) countries were judged unable or unwilling to participate. A majority of countries (36, 82%) required approval by a Research Ethics Committee or similar. Government approval was required in 25 (57%) countries.ConclusionThere is international variation in practices and polices related to consent for emergency research. There is an ongoing need to converge regulations based on the usefulness of multinational emergency research to benefit both affluent and disadvantaged populations.     

Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial

This study was undertaken to measure potential research subjects' participation in a survey research design, based on level and type of informed consent required before enrollment. In this prospective, randomized trial, 300 eligible Emergency Department participants were randomized to one of three groups: verbal consent (n = 100), limited written consent (n = 100), and detailed written consent with signature (n = 100). The consent was related to a self-administered patient satisfaction survey. The primary outcome was level of participation, where participation was categorized as full, limited, or refusal. Ninety-five percent confidence intervals (CI) constructed about proportions were used to assess differences in participation rates between the three consent groups. Among 300 participants, no demographic differences were found between groups for age or gender. Participants who were randomized to complete the detailed written consent had a significantly lower rate of full participation (72%) when compared to those randomized to verbal consent (85%; mean difference between groups 13%, 95% CI 2% to 24%) and to those with limited written consent (84%; mean difference between groups 12%, 95% CI 1% to 23%). Participants randomized to detailed written consent also had a significantly higher refusal rate (23%) when compared to those in the limited written group (12%; mean difference between groups -11%, 95% CI -21% to -1%). The length and type of informed consent required affected potential research subject participation in a survey research design. Participants who were asked to sign a detailed written informed consent document had a lower rate of participation compared to those with verbal or limited written consent.