Empowering the Participant Voice (EPV): Design and implementation of collaborative infrastructure to collect research participant experience feedback at scale.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

Mode of delivery among women with maternal cardiac disease.

OBJECTIVE: To determine if maternal cardiac disease affects delivery mode and to investigate maternal morbidity. STUDY DESIGN: Retrospective cohort study performed using electronic medical record data. Primary outcome was mode of delivery; secondary outcomes included indication for cesarean delivery, and rates of severe maternal morbidity. RESULTS: Among 14,160 deliveries meeting inclusion criteria, 218 (1.5%) had maternal cardiac disease. Cesarean delivery was more common in women with maternal cardiac disease (adjusted odds ratio 1.63 [95% confidence interval 1.18-2.25]). Patients delivered by cesarean delivery in the setting of maternal cardiac disease had significantly higher rates of severe maternal morbidity, with a 24.38-fold higher adjusted odds of severe maternal morbidity (95% confidence interval: 10.56-54.3). CONCLUSION: While maternal cardiac disease was associated with increased risk of cesarean delivery, most were for obstetric indications. Additionally, cesarean delivery in the setting of maternal cardiac disease is associated with high rates of severe maternal morbidity.

Centralized registry for COVID-19 research recruitment: Design, development, implementation, and preliminary results.

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic has had substantial global morbidity and mortality. Clinical research related to prevention, diagnosis, and treatment of COVID-19 is a top priority. Effective and efficient recruitment is challenging even without added constraints of a global pandemic. Recruitment registries offer a potential solution to slow or difficult recruitment. OBJECTIVES: The purpose of this paper is to describe the design and implementation of a digital research recruitment registry to optimize awareness and participant enrollment for COVID-19-related research in Baltimore and to report preliminary results. METHODS: Planning began in March 2020, and the registry launched in July 2020. The primary recruitment mechanisms include electronic medical record data, postcards distributed at testing sites, and digital advertising campaigns. Following consent in a Research Electronic Data Capture survey, participants answer questions related to COVID-19 exposure, testing, and willingness to participate in research. Branching logic presents participants with studies they might be eligible for. RESULTS: As of March 24, 2021, 9010 participants have enrolled, and 64.2% are female, 80.6% are White, 9.4% are Black or African American, and 6% are Hispanic or Latino. Phone outreach has had the highest response rate (13.1%), followed by email (11.9%), text (11.4%), and patient portal message (9.4%). Eleven study teams have utilized the registry, and 4596 matches have been made between study teams and interested volunteers. CONCLUSION: Effective and efficient recruitment strategies are more important now than ever due to the time-limited nature of COVID-19 research. Pilot efforts have been successful in connecting interested participants with recruiting study teams.

Temperature patterns in the early postresuscitation period after pediatric inhospital cardiac arrest.

OBJECTIVE: To describe the prevalence of postarrest hyperthermia among children during the first 24 hrs after inhospital cardiac arrest and to determine the association of persistent postarrest hyperthermia with neurologic outcome and death before hospital discharge. DESIGN: Multicenter, national registry of inhospital cardiopulmonary resuscitation. SETTING: A total of 196 hospitals reporting to the American Heart Association's National Registry of Cardiopulmonary Resuscitation from January 1, 2005 to December 31, 2007. PATIENTS: A total of 547 pediatric patients who suffered inhospital pulseless cardiac arrests reported to the National Registry of Cardiopulmonary Resuscitation, who survived resuscitative efforts and who had the maximum and the minimum temperature in the first 24 hrs postresuscitation reported to the National Registry of Cardiopulmonary Resuscitation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 547 children with pulseless cardiac arrests, 238 (43.5%) had at least one temperature of ≥38°C, and 30 (5.5%) had "persistent hyperthermia" (i.e., both the minimum and the maximum temperature of ≥38°C) during the first 24 hrs postarrest. After adjusting for potential confounders by multivariate logistic regression, persistent hyperthermia in the first 24 hrs postarrest was associated with unfavorable neurologic outcome (adjusted odds ratio, 2.7; 95% confidence interval, 1.1-6.7), but not with death before hospital discharge (adjusted odds ratio, 1.2; 95% confidence interval, 0.4-3.4). CONCLUSIONS: Despite current guidelines to avoid postarrest hyperthermia, a temperature of ≥38°C occurred commonly among children in the first 24 hrs postarrest. Persistent postarrest hyperthermia was associated with unfavorable neurologic outcomes, even after controlling for potential confounding factors.

Childhood obesity and survival after in-hospital pediatric cardiopulmonary resuscitation.

OBJECTIVE: We hypothesized that childhood obesity would be associated with decreased likelihood of survival to hospital discharge after in-hospital, pediatric cardiopulmonary resuscitation (CPR). METHODS: We reviewed 1477 consecutive, pediatric, CPR index events (defined as the first CPR event during a hospitalization in that facility for a patient <18 years of age) reported to the American Heart Association National Registry of Cardiopulmonary Resuscitation between January 2000 and July 2004. The primary outcome was survival to hospital discharge. A total of 1268 index subjects (86%) with complete registry data were included for analysis. Children were classified as obese (> or =95th weight-for-length percentile if <2 years of age or > or =95th BMI-for-age percentile if > or =2 years of age) or underweight (<5th weight-for-length percentile if <2 years of age or <5th BMI-for-age percentile if > or =2 years of age), with adjustment for gender. RESULTS: Obesity was noted for 213 (17%) of 1268 subjects and underweight for 571 (45%) of 1268 subjects. Obesity was more likely to be associated with male gender, noncardiac medical illness, and cancer and inversely associated with heart failure. Underweight was more likely to be associated with male gender, cardiac surgery, and prematurity and inversely associated with age and cancer. Self-reported, process-of-care, CPR quality was generally worse for obese children. With adjustment for important potential confounding factors, obesity was independently associated with worse odds of event survival (adjusted odds ratio: 0.58 [95% confidence interval: 0.35-0.76]) and survival to hospital discharge (adjusted odds ratio: 0.62 [95% confidence interval: 0.38-0.93]) after in-hospital, pediatric CPR. Underweight was not associated with worse outcomes. CONCLUSIONS: Childhood obesity is associated with a lower rate of survival to hospital discharge after in-hospital, pediatric CPR.

Time to invasive airway placement and resuscitation outcomes after inhospital cardiopulmonary arrest.

BACKGROUND: Clinicians often place high priority on invasive airway placement during cardiopulmonary resuscitation. The benefit of early vs. later invasive airway placement remains unknown. In this study we examined the association between time to invasive airway (TTIA) placement and patient outcomes after inhospital cardiopulmonary arrest (CPA). METHODS: We analyzed data from the National Registry of Cardiopulmonary Resuscitation (NRCPR). We included hospitalized adult patients receiving attempted invasive airway placement (endotracheal intubation, laryngeal mask airway, tracheostomy, and cricothyrotomy) after the onset of CPA. We excluded cases in which airway insertion was attempted after return of spontaneous circulation (ROSC). We defined TTIA as the elapsed time from CPA recognition to accomplishment of an invasive airway. The primary outcomes were ROSC, 24-h survival, and survival to hospital discharge. We used multivariable logistic regression to evaluate the association between the patient outcome and early (<5 min) vs. later (> or =5 min) TTIA, adjusted for hospital location, patient age and gender, first documented pulseless ECG rhythm, precipitating etiology and witnessed arrest. RESULTS: Of 82,649 CPA events, we studied the 25,006 cases in which TTIA was recorded and the inclusion criteria were met. Observations were most commonly excluded for not having an invasive airway emergently placed during resuscitation. The mean time to invasive airway placement was 5.9 min (95% CI: 5.8-6.0). Patient outcomes were: ROSC 50.3% (49.7-51.0%), 24-h survival 33.7% (33.1-34.3%), survival to discharge 15.3% (14.9-15.8%). Early TTIA was not associated with ROSC (adjusted OR: 0.96, 0.91-1.01) but was associated with better odds of 24-h survival (adjusted OR: 0.94, 0.89-0.99). The relationships between TTIA and survival to discharge could not be determined. CONCLUSIONS: Early invasive airway insertion was not associated with ROSC but was associated with slightly improved 24-h survival. Early invasive airway management may or may not improve inhospital cardiopulmonary resuscitation outcomes.

Survival from in-hospital cardiac arrest during nights and weekends.

CONTEXT: Occurrence of in-hospital cardiac arrest and survival patterns have not been characterized by time of day or day of week. Patient physiology and process of care for in-hospital cardiac arrest may be different at night and on weekends because of hospital factors unrelated to patient, event, or location variables. OBJECTIVE: To determine whether outcomes after in-hospital cardiac arrest differ during nights and weekends compared with days/evenings and weekdays. DESIGN AND SETTING: We examined survival from cardiac arrest in hourly time segments, defining day/evening as 7:00 am to 10:59 pm, night as 11:00 pm to 6:59 am, and weekend as 11:00 pm on Friday to 6:59 am on Monday, in 86,748 adult, consecutive in-hospital cardiac arrest events in the National Registry of Cardiopulmonary Resuscitation obtained from 507 medical/surgical participating hospitals from January 1, 2000, through February 1, 2007. MAIN OUTCOME MEASURES: The primary outcome of survival to discharge and secondary outcomes of survival of the event, 24-hour survival, and favorable neurological outcome were compared using odds ratios and multivariable logistic regression analysis. Point estimates of survival outcomes are reported as percentages with 95% confidence intervals (95% CIs). RESULTS: A total of 58,593 cases of in-hospital cardiac arrest occurred during day/evening hours (including 43,483 on weekdays and 15,110 on weekends), and 28,155 cases occurred during night hours (including 20,365 on weekdays and 7790 on weekends). Rates of survival to discharge (14.7% [95% CI, 14.3%-15.1%] vs 19.8% [95% CI, 19.5%-20.1%], return of spontaneous circulation for longer than 20 minutes (44.7% [95% CI, 44.1%-45.3%] vs 51.1% [95% CI, 50.7%-51.5%]), survival at 24 hours (28.9% [95% CI, 28.4%-29.4%] vs 35.4% [95% CI, 35.0%-35.8%]), and favorable neurological outcomes (11.0% [95% CI, 10.6%-11.4%] vs 15.2% [95% CI, 14.9%-15.5%]) were substantially lower during the night compared with day/evening (all P values < .001). The first documented rhythm at night was more frequently asystole (39.6% [95% CI, 39.0%-40.2%] vs 33.5% [95% CI, 33.2%-33.9%], P < .001) and less frequently ventricular fibrillation (19.8% [95% CI, 19.3%-20.2%] vs 22.9% [95% CI, 22.6%-23.2%], P < .001). Among in-hospital cardiac arrests occurring during day/evening hours, survival was higher on weekdays (20.6% [95% CI, 20.3%-21%]) than on weekends (17.4% [95% CI, 16.8%-18%]; odds ratio, 1.15 [95% CI, 1.09-1.22]), whereas among in-hospital cardiac arrests occurring during night hours, survival to discharge was similar on weekdays (14.6% [95% CI, 14.1%-15.2%]) and on weekends (14.8% [95% CI, 14.1%-15.2%]; odds ratio, 1.02 [95% CI, 0.94-1.11]). CONCLUSION: Survival rates from in-hospital cardiac arrest are lower during nights and weekends, even when adjusted for potentially confounding patient, event, and hospital characteristics.

Outcomes of in-hospital ventricular fibrillation in children.

BACKGROUND: Ventricular fibrillation and ventricular tachycardia are less common causes of cardiac arrest in children than in adults. These tachyarrhythmias can also begin during cardiopulmonary resuscitation (CPR), presumably as reperfusion arrhythmias. We determined whether the outcome is better for initial than for subsequent ventricular fibrillation or tachycardia. METHODS: All cardiac arrests in persons under 18 years of age were identified from a large, multicenter, in-hospital cardiac-arrest registry. The results from children with initial ventricular fibrillation or tachycardia, children in whom ventricular fibrillation or tachycardia developed during CPR, and children with no ventricular fibrillation or tachycardia were compared by chi-square and multivariable logistic-regression analysis. RESULTS: Of 1005 index patients with in-hospital cardiac arrest, 272 (27 percent) had documented ventricular fibrillation or tachycardia during the arrest. In 104 patients (10 percent), ventricular fibrillation or tachycardia was the initial pulseless rhythm; in 149 patients (15 percent), it developed during the arrest. The time of initiation of ventricular fibrillation or tachycardia was not documented in 19 patients. Thirty-five percent of patients with initial ventricular fibrillation or tachycardia survived to hospital discharge, as compared with 11 percent of patients with subsequent ventricular fibrillation or tachycardia (odds ratio, 2.6; 95 percent confidence interval, 1.2 to 5.8). Twenty-seven percent of patients with no ventricular fibrillation or tachycardia survived to hospital discharge, as compared with 11 percent of patients with subsequent ventricular fibrillation or tachycardia (odds ratio, 3.8; 95 percent confidence interval, 1.8 to 7.6). CONCLUSIONS: In pediatric patients with in-hospital cardiac arrests, survival outcomes were highest among patients in whom ventricular fibrillation or tachycardia was present initially than among those in whom it developed subsequently. The outcomes for patients with subsequent ventricular fibrillation or tachycardia were substantially worse than those for patients with asystole or pulseless electrical activity.

First documented rhythm and clinical outcome from in-hospital cardiac arrest among children and adults.

CONTEXT: Cardiac arrests in adults are often due to ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT), which are associated with better outcomes than asystole or pulseless electrical activity (PEA). Cardiac arrests in children are typically asystole or PEA. OBJECTIVE: To test the hypothesis that children have relatively fewer in-hospital cardiac arrests associated with VF or pulseless VT compared with adults and, therefore, worse survival outcomes. DESIGN, SETTING, AND PATIENTS: A prospective observational study from a multicenter registry (National Registry of Cardiopulmonary Resuscitation) of cardiac arrests in 253 US and Canadian hospitals between January 1, 2000, and March 30, 2004. A total of 36,902 adults (> or =18 years) and 880 children (<18 years) with pulseless cardiac arrests requiring chest compressions, defibrillation, or both were assessed. Cardiac arrests occurring in the delivery department, neonatal intensive care unit, and in the out-of-hospital setting were excluded. MAIN OUTCOME MEASURE: Survival to hospital discharge. RESULTS: The rate of survival to hospital discharge following pulseless cardiac arrest was higher in children than adults (27% [236/880] vs 18% [6485/36,902]; adjusted odds ratio [OR], 2.29; 95% confidence interval [CI], 1.95-2.68). Of these survivors, 65% (154/236) of children and 73% (4737/6485) of adults had good neurological outcome. The prevalence of VF or pulseless VT as the first documented pulseless rhythm was 14% (120/880) in children and 23% (8361/36,902) in adults (OR, 0.54; 95% CI, 0.44-0.65; P<.001). The prevalence of asystole was 40% (350) in children and 35% (13 024) in adults (OR, 1.20; 95% CI, 1.10-1.40; P = .006), whereas the prevalence of PEA was 24% (213) in children and 32% (11,963) in adults (OR, 0.67; 95% CI, 0.57-0.78; P<.001). After adjustment for differences in preexisting conditions, interventions in place at time of arrest, witnessed and/or monitored status, time to defibrillation of VF or pulseless VT, intensive care unit location of arrest, and duration of cardiopulmonary resuscitation, only first documented pulseless arrest rhythm remained significantly associated with differential survival to discharge (24% [135/563] in children vs 11% [2719/24,987] in adults with asystole and PEA; adjusted OR, 2.73; 95% CI, 2.23-3.32). CONCLUSIONS: In this multicenter registry of in-hospital cardiac arrest, the first documented pulseless arrest rhythm was typically asystole or PEA in both children and adults. Because of better survival after asystole and PEA, children had better outcomes than adults despite fewer cardiac arrests due to VF or pulseless VT.