Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

Association of Public Health Initiatives With Outcomes for Out-of-Hospital Cardiac Arrest at Home and in Public Locations.

Importance: Little is known about the influence of comprehensive public health initiatives according to out-of-hospital cardiac arrest (OHCA) location, particularly at home, where resuscitation efforts and outcomes have historically been poor. Objective: To describe temporal trends in bystander cardiopulmonary resuscitation (CPR) and first-responder defibrillation for OHCAs stratified by home vs public location and their association with survival and neurological outcomes. Design, Setting, and Participants: This observational study reviewed 8269 patients with OHCAs (5602 [67.7%] at home and 2667 [32.3%] in public) for whom resuscitation was attempted using data from the Cardiac Arrest Registry to Enhance Survival (CARES) from January 1, 2010, through December 31, 2014. The setting was 16 counties in North Carolina. Exposures: Patients were stratified by home vs public OHCA. Public health initiatives to improve bystander and first-responder interventions included training members of the general population in CPR and in the use of automated external defibrillators, teaching first responders about team-based CPR (eg, automated external defibrillator use and high-performance CPR), and instructing dispatch centers on recognition of cardiac arrest. Main Outcomes and Measures: Association of resuscitation efforts with survival and neurological outcomes from 2010 through 2014. Results: Among home OHCA patients (n = 5602), the median age was 64 years, and 62.2% were male; among public OHCA patients (n = 2667), the median age was 68 years, and 61.5% were male. After comprehensive public health initiatives, the proportion of patients receiving bystander CPR increased at home (from 28.3% [275 of 973] to 41.3% [498 of 1206], P < .001) and in public (from 61.0% [275 of 451] to 70.5% [424 of 601], P = .01), while first-responder defibrillation increased at home (from 42.2% [132 of 313] to 50.8% [212 of 417], P = .02) but not significantly in public (from 33.1% [58 of 175] to 37.8% [93 of 246], P = .17). Survival to discharge improved for arrests at home (from 5.7% [60 of 1057] to 8.1% [100 of 1238], P = .047) and in public (from 10.8% [50 of 464] to 16.2% [98 of 604], P = .04). Compared with emergency medical services-initiated CPR and resuscitation, patients with home OHCA were significantly more likely to survive to hospital discharge if they received bystander-initiated CPR and first-responder defibrillation (odds ratio, 1.55; 95% CI, 1.01-2.38). Patients with arrests in public were most likely to survive if they received both bystander-initiated CPR and defibrillation (odds ratio, 4.33; 95% CI, 2.11-8.87). Conclusions and Relevance: After coordinated and comprehensive public health initiatives, more patients received bystander CPR and first-responder defibrillation at home and in public, which was associated with improved survival.

Cardiopulmonary Resuscitation Training Disparities in the United States.

BACKGROUND: Bystander cardiopulmonary resuscitation (CPR) is associated with increased survival from cardiac arrest, yet bystander CPR rates are low in many communities. The overall prevalence of CPR training in the United States and associated individual-level disparities are unknown. We sought to measure the national prevalence of CPR training and hypothesized that older age and lower socioeconomic status would be independently associated with a lower likelihood of CPR training. METHODS AND RESULTS: We administered a cross-sectional telephone survey to a nationally representative adult sample. We assessed the demographics of individuals trained in CPR within 2 years (currently trained) and those who had been trained in CPR at some point in time (ever trained). The association of CPR training and demographic variables were tested using survey weighted logistic regression. Between September 2015 and November 2015, 9022 individuals completed the survey; 18% reported being currently trained in CPR, and 65% reported training at some point previously. For each year of increased age, the likelihood of being currently CPR trained or ever trained decreased (currently trained: odds ratio, 0.98; 95% CI, 0.97-0.99; P<0.01; ever trained: OR, 0.99; 95% CI, 0.98-0.99; P=0.04). Furthermore, there was a greater then 4-fold difference in odds of being currently CPR trained from the 30-39 to 70-79 year old age groups (95% CI, 0.10-0.23). Factors associated with a lower likelihood of CPR training were lesser educational attainment and lower household income (P<0.01 for each of these variables). CONCLUSIONS: A minority of respondents reported current training in CPR. Older age, lesser education, and lower income were associated with reduced likelihood of CPR training. These findings illustrate important gaps in US CPR education and suggest the need to develop tailored CPR training efforts to address this variability.

Outcomes of a multi-community hypertension implementation study: the American Heart Association's Check. Change. Control. program.

Single-site, intensive, community-based blood pressure (BP) intervention programs have led to BP improvements. The authors examined the American Heart Association's Check. Change. CONTROL: (CCC) program (4069 patients/18 cities) to determine whether BP interventions can effectively be scaled to multiple communities, using a simplified template and local customization. Effectiveness was evaluated at each site via site percent enrollment goals, participant engagement, and BP change from first to last measurement. High-enrolling sites frequently recruited at senior residential institutions and service organizations held hypertension management classes and utilized established and new community partners. High-engagement sites regularly held hypertension education classes and followed up with participants. Top-performing sites commonly distributed BP cuffs, checked BP at engagement activities, and trained volunteers. CCC demonstrated that simplified community-based hypertension intervention programs may lead to BP improvements, but there was high outcomes variability among programs. Several factors were associated with BP improvement that may guide future program development.

Association Between Hospital Process Composite Performance and Patient Outcomes After In-Hospital Cardiac Arrest Care.

IMPORTANCE: Survival rates after in-hospital cardiac arrest (IHCA) vary significantly among US centers; whether this variation is owing to differences in IHCA care quality is unknown. OBJECTIVE: To evaluate hospital-level variation to determine whether hospital process composite performance measures of IHCA care quality are associated with patient outcomes. DESIGN, SETTING, AND PARTICIPANTS: Using data from the American Heart Association's Get With the Guidelines-Resuscitation (GWTG-R) program, we analyzed 35 283 patients 18 years or older with IHCA treated at 261 US hospitals from January 1, 2010, through December 31, 2012. We calculated the hospital process composite performance score for IHCA using 5 guideline-recommended process measures. Opportunity-based scores were calculated for all patients, aggregated at the hospital level, divided into quartiles, and then associated with risk-standardized survival and neurologic status by a test for trend. The scores were then evaluated through hierarchical logistic regression and reported as odds ratios per 10% increment in hospital process composite performance. INTERVENTIONS: Acute care treatments for IHCA. MAIN OUTCOMES AND MEASURES: The primary outcome was survival to discharge measured as risk standard survival rates, and the secondary outcome was favorable neurologic status at hospital discharge. RESULTS: Of the 35 283 adults included in this study, the median age was 67 years (interquartile range [IQR] 56-78 years), and 57.9% were male. The median IHCA hospital process composite performance was 89.7% (interquartile range, 85.4%-93.1%) and varied among hospital quartiles from 82.6% (lowest) to 94.8% (highest). The IHCA hospital process composite performance was linearly associated with risk-standardized hospital survival to discharge rates: 21.1%, 21.4%, 22.8%, and 23.4% from lowest to highest performance quartiles, respectively (P < .001). After adjustment, each 10% increase in a hospital's process composite performance was associated with a 22% higher odds of survival (adjusted odds ratio, 1.22; 95% CI, 1.08-1.37; P = .01). Hospital process composite quality performance was also associated with favorable neurologic status at discharge (P = .004). CONCLUSIONS AND RELEVANCE: The quality of guideline-based care for IHCA varies significantly among US hospitals and is associated with patient survival and neurologic outcomes.

Defibrillation time intervals and outcomes of cardiac arrest in hospital: retrospective cohort study from Get With The Guidelines-Resuscitation registry.

OBJECTIVE: To describe temporal trends in the time interval between first and second attempts at defibrillation and the association between this time interval and outcomes in patients with persistent ventricular tachycardia or ventricular fibrillation (VT/VF) arrest in hospital. DESIGN: Retrospective cohort study SETTING: 172 hospitals in the United States participating in the Get With The Guidelines-Resuscitation registry, 2004-12. PARTICIPANTS: Adults who received a second defibrillation attempt for persistent VT/VF arrest within three minutes of a first attempt. INTERVENTIONS: Second defibrillation attempts categorized as early (time interval of up to and including one minute between first and second defibrillation attempts) or deferred (time interval of more than one minute between first and second defibrillation attempts). MAIN OUTCOME MEASURE: Survival to hospital discharge. RESULTS: Among 2733 patients with persistent VT/VF after the first defibrillation attempt, 1121 (41%) received a deferred second attempt. Deferred second defibrillation for persistent VT/VF increased from 26% in 2004 to 57% in 2012 (P<0.001 for trend). Compared with early second defibrillation, unadjusted patient outcomes were significantly worse with deferred second defibrillation (57.4% v 62.5% for return of spontaneous circulation, 38.4% v 43.6% for survival to 24 hours, and 24.7% v 30.8% for survival to hospital discharge; P<0.01 for all comparisons). After risk adjustment, deferred second defibrillation was not associated with survival to hospital discharge (propensity weighting adjusted risk ratio 0.89, 95% confidence interval 0.78 to 1.01; P=0.08; hierarchical regression adjusted 0.92, 0.83 to 1.02; P=0.1). CONCLUSIONS: Since 2004, the use of deferred second defibrillation for persistent VT/VF in hospital has doubled. Deferred second defibrillation was not associated with improved survival.

Regional Variation in Out-of-Hospital Cardiac Arrest Survival in the United States.

BACKGROUND: Although previous studies have shown marked variation in out-of-hospital cardiac arrest survival across US regions, factors underlying this survival variation remain incompletely explained. METHODS AND RESULTS: Using data from the Cardiac Arrest Registry to Enhance Survival, we identified 96 662 adult patients with out-of-hospital cardiac arrest in 132 US counties. We used hierarchical regression models to examine county-level variation in rates of survival and survival with functional recovery (defined as Cerebral Performance Category score of 1 or 2) and examined the contribution of demographics, cardiac arrest characteristics, bystander cardiopulmonary resuscitation, automated external defibrillator use, and county-level sociodemographic factors in survival variation across counties. A total of 9317 (9.6%) patients survived to discharge, and 7176 (7.4%) achieved functional recovery. At a county level, there was marked variation in rates of survival to discharge (range, 3.4%-22.0%; median odds ratio, 1.40; 95% confidence interval, 1.32-1.46) and survival with functional recovery (range, 0.8%-21.0%; median odds ratio, 1.53; 95% confidence interval, 1.43-1.62). County-level rates of bystander cardiopulmonary resuscitation and automated external defibrillator use were positively correlated with both outcomes (P<0.0001 for all). Patient demographic and cardiac arrest characteristics explained 4.8% and 27.7% of the county-level variation in survival, respectively. Additional adjustment of bystander cardiopulmonary resuscitation and automated external defibrillator explained 41% of the survival variation, and this increased to 50.4% after adjustment of county-level sociodemographic factors. Similar findings were noted in analyses of survival with functional recovery. CONCLUSIONS: Although out-of-hospital cardiac arrest survival varies significantly across US counties, a substantial proportion of the variation is attributable to differences in bystander response across communities.

Long-Term Post-Discharge Risks in Older Survivors of Myocardial Infarction With and Without Out-of-Hospital Cardiac Arrest.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) associated with acute myocardial infarction (MI) confers high in-hospital mortality; however, among those patients who survive, little is known regarding their post-discharge mortality and health care use rates. OBJECTIVES: The purpose of this study was to determine 1-year survival and readmission rates after hospital discharge of older MI survivors with and without OHCA. METHODS: Using linked Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines and Medicare data, this study analyzed 54,860 patients with MI who were older than 65 years of age and who had been discharged alive from 545 U.S. hospitals between April 2011 and December 2012. Multivariable models examined the associations between MI-associated OHCA and 1-year post-discharge mortality or all-cause readmission rates. Patients discharged to hospice were excluded, given their known poor prognosis. RESULTS: Following hospital discharge, compared with older MI survivors without OHCA (n = 54,219), those with OHCA (n = 641, 1.2%) were more likely to be younger, male, and smokers, but less likely to have diabetes, heart failure, or prior revascularization. OHCA patients presented more often with ST-segment elevation myocardial infarction (63.2% vs. 29.6%) and cardiogenic shock (29.0% vs. 2.2%); however, among in-hospital MI survivors, OHCA was not associated with 1-year post-discharge mortality (unadjusted 13.8% vs. 15.8%, p = 0.17, adjusted hazard ratio [HR]: 0.89; 95% confidence interval [CI]: 0.68 to 1.15). In contrast, MI survivors with OHCA actually had lower unadjusted and adjusted risk of the composite outcome of 1-year mortality or all-cause readmission than patients without OHCA (44.0% vs. 50.0%, p = 0.03, adjusted HR: 0.84; 95% CI: 0.72 to 0.97). CONCLUSIONS: Among older patients with MI who survived to hospital discharge and were not discharged to hospice, those presenting with OHCA did not have higher 1-year mortality or health care use rates compared with those MI survivors without OHCA. These findings show that the early risk of adverse events in patients with OHCA does not persist after hospital discharge, and they support efforts to improve initial survival rates of older patients with MI and OHCA.

The Food and Drug Administration and pragmatic clinical trials of marketed medical products.

Pragmatic clinical trials can help answer questions of comparative effectiveness for interventions routinely used in medical practice. Pragmatic clinical trials may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity of the data upon which approval of medical products is made. The Food and Drug Administration has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable Food and Drug Administration regulations. While many pragmatic clinical trials will meet the criteria for an exemption from the requirements for an investigational new drug application or investigational device exemption, in general, all clinical investigations of medical products that fall under Food and Drug Administration jurisdiction must adhere to regulations for informed consent and review by an institutional review board. We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the Food and Drug Administration. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk pragmatic clinical trials. We recommend that the Food and Drug Administration establish a risk-based approach to obtaining informed consent in pragmatic clinical trials that would facilitate the conduct of pragmatic clinical trials without compromising the protection of enrolled individuals or the integrity of the resulting data.

Association of Bystander and First-Responder Intervention With Survival After Out-of-Hospital Cardiac Arrest in North Carolina, 2010-2013.

IMPORTANCE: Out-of-hospital cardiac arrest is associated with low survival, but early cardiopulmonary resuscitation (CPR) and defibrillation can improve outcomes if more widely adopted. OBJECTIVE: To examine temporal changes in bystander and first-responder resuscitation efforts before arrival of the emergency medical services (EMS) following statewide initiatives to improve bystander and first-responder efforts in North Carolina from 2010-2013 and to examine the association between bystander and first-responder resuscitation efforts and survival and neurological outcome. DESIGN, SETTINGS, AND PARTICIPANTS: We studied 4961 patients with out-of-hospital cardiac arrest for whom resuscitation was attempted and who were identified through the Cardiac Arrest Registry to Enhance Survival (2010-2013). First responders were dispatched police officers, firefighters, rescue squad, or life-saving crew trained to perform basic life support until arrival of the EMS. EXPOSURES: Statewide initiatives to improve bystander and first-responder interventions included training members of the general population in CPR and in use of automated external defibrillators (AEDs), training first responders in team-based CPR including AED use and high-performance CPR, and training dispatch centers in recognition of cardiac arrest. MAIN OUTCOMES AND MEASURES: The proportion of bystander and first-responder resuscitation efforts, including the combination of efforts between bystanders and first responders, from 2010 through 2013 and the association between these resuscitation efforts and survival and neurological outcome. RESULTS: The combination of bystander CPR and first-responder defibrillation increased from 14.1% (51 of 362; 95% CI, 10.9%-18.1%) in 2010 to 23.1% (104 of 451; 95% CI, 19.4%-27.2%) in 2013 (P < .01). Survival with favorable neurological outcome increased from 7.1% (82 of 1149; 95% CI, 5.8%-8.8%) in 2010 to 9.7% (129 of 1334; 95% CI, 8.2%-11.4%) in 2013 (P = .02) and was associated with bystander-initiated CPR. Adjusting for age and sex, bystander and first-responder interventions were associated with higher survival to hospital discharge. Survival following EMS-initiated CPR and defibrillation was 15.2% (30 of 198; 95% CI, 10.8%-20.9%) compared with 33.6% (38 of 113; 95% CI, 25.5%-42.9%) following bystander-initiated CPR and defibrillation (odds ratio [OR], 3.12; 95% CI, 1.78-5.46); 24.2% (83 of 343; 95% CI, 20.0%-29.0%) following bystander CPR and first-responder defibrillation (OR, 1.70; 95% CI, 1.06-2.71); and 25.2% (109 of 432; 95% CI, 21.4%-29.6%) following first-responder CPR and defibrillation (OR, 1.77; 95% CI, 1.13-2.77). CONCLUSIONS AND RELEVANCE: Following a statewide educational intervention on rescusitation training, the proportion of patients receiving bystander-initiated CPR and defibrillation by first responders increased and was associated with greater likelihood of survival. Bystander-initiated CPR was associated with greater likelihood of survival with favorable neurological outcome.

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

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.

Cardiac arrest and clinical characteristics, treatments and outcomes among patients hospitalized with ST-elevation myocardial infarction in contemporary practice: A report from the National Cardiovascular Data Registry.

BACKGROUND: Cardiac arrest (CA) is a major complication of patients with ST-elevation myocardial infarction (STEMI). Its prevalence and prognostic impact in contemporary US practice has not been well assessed. METHODS: We evaluated STEMI patients included in the National Cardiovascular Data Registry (NCDR) Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) from 4/1/11 to 6/30/12. Patient clinical characteristics, treatments, and inhospital outcomes were compared by the presence or absence of CA on first medical contact-either before hospital arrival or upon presentation to the ACTION hospital. RESULTS: Of the 49,279 STEMI patients included, 3,716 (7.5%) had CA. Cardiac arrest patients were more likely to have heart failure (15.5% vs 6.9%) and shock (42.9% vs 4.9%) on presentation and higher median (25th and 75th percentiles) ACTION Registry-GWTG mortality risk scores (42 [32, 54] vs 32 [26, 38]) than non-CA patients (all P < .001). Primary percutaneous coronary intervention was performed in most patients with and without CA (76.7% vs 79.1%). Inhospital mortality was significantly higher in patients with than without CA (28.8% vs 4.0%; P < .001), both in patients who presented with cardiogenic shock (46.9% vs 27.1%; P < .001) and those without shock (15.4% vs 2.9%; P < .001). The ACTION Registry-GWTG inhospital mortality model underestimated mortality risk in CA patients; however, prediction significantly improved after adding CA to the model. CONCLUSIONS: Almost 8% of STEMI patients present with CA. More than 25% die during the hospitalization, despite high use of primary percutaneous coronary intervention. Cardiogenic shock and CA frequently coexist. Our results suggest that development of systems of care and treatments for both STEMI and CA is needed to reduce the high mortality in these patients.

Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.

Compliance with results reporting at ClinicalTrials.gov.

BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. METHODS: Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. RESULTS: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. CONCLUSIONS: Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).

Association of neighborhood characteristics with incidence of out-of-hospital cardiac arrest and rates of bystander-initiated CPR: implications for community-based education intervention.

OBJECTIVE: A 10-fold regional variation in survival after out-of-hospital cardiac arrest (OHCA) has been reported in the United States, which partly relates to variability in bystander cardiopulmonary resuscitation (CPR) rates. In order for resources to be focused on areas of greatest need, we conducted a geospatial analysis of variation of CPR rates. METHODS: Using 2010-2011 data from Durham, Mecklenburg, and Wake counties in North Carolina participating in the Cardiac Arrest Registry to Enhance Survival (CARES) program, we included all patients with OHCA for whom resuscitation was attempted. Geocoded data and logistic regression modeling were used to assess incidence of OHCA and patterns of bystander CPR according to census tracts and factors associated herewith. RESULTS: In total, 1466 patients were included (median age, 65 years [interquartile range 25]; 63.4% men). Bystander CPR by a layperson was initiated in 37.9% of these patients. High-incidence OHCA areas were characterized partly by higher population densities and higher percentages of black race as well as lower levels of education and income. Low rates of bystander CPR were associated with population composition (percent black: OR, 3.73; 95% CI, 2.00-6.97 per 1% increment in black patients; percent elderly: 3.25; 1.41-7.48 per 1% increment in elderly patients; percent living in poverty: 1.77, 1.16-2.71 per 1% increase in patients living in poverty). CONCLUSIONS: In 3 counties in North Carolina, areas with low rates of bystander CPR can be identified using geospatial data, and education efforts can be targeted to improve recognition of cardiac arrest and to augment bystander CPR rates.

Rates of cardiopulmonary resuscitation training in the United States.

IMPORTANCE: Prompt bystander cardiopulmonary resuscitation (CPR) improves the likelihood of surviving an out-of-hospital cardiac arrest. Large regional variations in survival after an out-of-hospital cardiac arrest have been noted. OBJECTIVES: To determine whether regional variations in county-level rates of CPR training exist across the United States and the factors associated with low rates in US counties. DESIGN, SETTING, AND PARTICIPANTS: We used a cross-sectional ecologic study design to analyze county-level rates of CPR training in all US counties from July 1, 2010, through June 30, 2011. We used CPR training data from the American Heart Association, the American Red Cross, and the Health & Safety Institute. Using multivariable logistic regression models, we examined the association of annual rates of adult CPR training of citizens by these 3 organizations (categorized as tertiles) with a county's geographic, population, and health care characteristics. EXPOSURE: Completion of CPR training. MAIN OUTCOME AND MEASURES: Rate of CPR training measured as CPR course completion cards distributed and CPR training products sold by the American Heart Association, persons trained in CPR by the American Red Cross, and product sales data from the Health & Safety Institute. RESULTS During the study period, 13.1 million persons in 3143 US counties received CPR training. Rates of county training ranged from 0.00% to less than 1.29% (median, 0.51%) in the lower tertile, 1.29% to 4.07% (median, 2.39%) in the middle tertile, and greater than 4.07% or greater (median, 6.81%) in the upper tertile. Counties with rates of CPR training in the lower tertile were more likely to have a higher proportion of rural areas (adjusted odds ratio, 1.12 [95% CI, 1.10-1.15] per 5-percentage point [PP] change), higher proportions of black (1.09 [1.06-1.13] per 5-PP change) and Hispanic (1.06 [1.02-1.11] per 5-PP change) residents, a lower median household income (1.18 [1.04-1.34] per $10 000 decrease), and a higher median age (1.28 [1.04-1.58] per 10-year change). Counties in the South, Midwest, and West were more likely to have rates of CPR training in the lower tertile compared with the Northeast (adjusted odds ratios, 7.78 [95% CI, 3.66-16.53], 5.56 [2.63-11.75], and 5.39 [2.48-11.72], respectively). CONCLUSIONS AND RELEVANCE: Annual rates of US CPR training are low and vary widely across communities. Counties located in the South, those with higher proportions of rural areas and of black and Hispanic residents, and those with lower median household incomes have lower rates of CPR training than their counterparts. These data contribute to known geographic disparities in survival of cardiac arrest and offer opportunities for future community interventions.

Differences in the profile, treatment, and prognosis of patients with cardiogenic shock by myocardial infarction classification: A report from NCDR.

BACKGROUND: Cardiogenic shock is a deadly complication of an acute myocardial infarction (MI). We sought to characterize differences in patient features, treatments, and outcomes of cardiogenic shock by MI classification: ST-segment-elevation MI (STEMI) versus non-ST-segment elevation MI (NSTEMI). METHODS AND RESULTS: We compared differences in care by the shock status of 235 541 patients with STEMI and NSTEMI treated at 392 US hospitals from 2007 to 2011. Cardiogenic shock occurred in 12.2% of patients with STEMI versus 4.3% of patients with NSTEMI. Compared with STEMI shock, NSTEMI shock was more likely in patients who were older and predominantly women; had diabetes mellitus, hypertension, previous heart failure, MI, or peripheral arterial disease; and who received coronary artery bypass grafting (11.6% versus 21.2%; P<0.0001) but less likely to have received percutaneous coronary intervention (84.2% versus 35.3%; P<0.0001). Compared with patients with STEMI presenting with shock at admission, patients with NSTEMI presenting with shock had longer delays to percutaneous coronary intervention (1.2 versus 3.2 hours) and coronary artery bypass grafting (7.9 versus 55.9 hours). Cardiogenic shock in patients with STEMI was associated with a lower mortality risk (33.1% shock versus 2.0% no shock; adjusted odds ratio, 14.1; 95% confidence interval, 13.0-15.4; interaction P value <0.0001) compared with patients with NSTEMI (40.8% shock versus 2.3% no shock, odds ratio, 19.0; 95% confidence interval, 17.1-21.2). CONCLUSIONS: Cardiogenic shock is associated with high mortality in patients with STEMI and NSTEMI. However, urgent revascularization is more commonly pursued in patients with STEMI presenting with shock than in patients with NSTEMI. More research is needed to improve the outcomes for patients with MI presenting with shock, particularly those presenting with NSTEMI.

Short- and long-term outcomes of coronary stenting in women versus men: results from the National Cardiovascular Data Registry Centers for Medicare & Medicaid services cohort.

BACKGROUND: Conflicting evidence exists on sex-based outcomes after coronary stenting. METHODS AND RESULTS: Data on 426 996 patients ≥65 years old (42.3% women) from the National Cardiovascular Data Registry CathPCI Registry (2004-2008) were linked to Medicare inpatient claims to compare in-hospital outcomes by sex and long-term outcomes by sex and stent type. In-hospital complications were more frequent in women than in men: death (3869 [2.2%] versus 3737 [1.6%]; adjusted odds ratio, 1.41; 95% confidence interval [CI], 1.33-1.49), myocardial infarction (2365 [1.3%] versus 2858 [1.2%]; odds ratio, 1.19; 95% CI, 1.11-1.27), bleeding (7860 [4.4%] versus 5627 [2.3%]; odds ratio, 1.86; 95% CI, 1.79-1.93), and vascular complications (2381 [1.3%] versus 1648 [0.7%]; odds ratio, 1.85; 95% CI, 1.73-1.99). At 20.4 months, women had a lower adjusted risk of death (hazard ratio [HR], 0.92; 95% CI, 0.90-0.94) but similar rates of myocardial infarction, revascularization, and bleeding. Relative to bare metal stent use, drug-eluting stent use was associated with similar improved long-term outcomes in both sexes: death (women: adjusted HR, 0.78; 95% CI, 0.76-0.81; men: HR, 0.77; 95% CI, 0.74-0.79), myocardial infarction (women: HR, 0.79; 95% CI, 0.74-0.84; men: HR, 0.81; 95% CI, 0.77-0.85), and revascularization (women: HR, 0.93; 95% CI, 0.90-0.97; men: HR, 0.91; 95% CI, 0.88-0.94). There was no interaction between sex and stent type for long-term outcomes. CONCLUSIONS: In contemporary coronary stenting, women have a slightly higher procedural risk than men but have better long-term survival. In both sexes, use of a drug-eluting stent is associated with lower long-term likelihood for death, myocardial infarction, and revascularization.