ABSTRACT
Background: A higher incidence of myocarditis has been reported in those who have recently received mRNA SARS – CoV-2 vaccination.1 Canterbury District Health Board (CDHB) serves 578,290 people, including 441,852 adults, with one large tertiary referral hospital offering specialist cardiology services. In 2021 97% of eligible adults received at least one dose and 92% two doses of the BNT162b2 mRNA vaccine (Pfizer-BioNTech). During this time only 21 community cases of COVID-19 infection were reported. We investigated the incidence of myocarditis during the BNT162b2 mRNA vaccine rollout in comparison to the preceding 5 years assuming a stable population size. Methods: All adult patients admitted to our hospital who received a diagnostic code of acute myocarditis (ICD10 codes I40, I41 and I51.4) during admission between 2016 and 2021 were included. Demographics and peak troponin concentration (hsTnI) were recorded. Vaccine-associated myocarditis was defined as that leading to admitted within 28 days of BNT162b2 vaccination. Myocarditis-associated mortality was defined as death occurring within 28 days of hospital admission. Incidence of myocarditis before and during COVID-19 vaccination was tested using ANOVA. Results: Between 2016 and 2020 there were 178 total hospital admissions (annualised mean 35.6 [SD6.3] range 28–44) with myocarditis. The mean age was 47.8 [SD15.9] years, 38% were women, and median peak hsTnI 641 (IQR 95.25–8526) ng/L. One patient died within 28 days of admission. In 2021 there were 43 myocarditis admissions, mean age 49.7 [SD18] years, 42% women, with a median hsTnI 355 (IQR 106.5–1876.5) ng/L. Nine of these admissions were within 28 days of vaccination. They were 78% female, mean age 52.6 [SD24.8] years, median peak hsTnI 179 (IQR 52–528) ng/L. One patient died during admission. There was no variance in annual incidence of myocarditis during vaccine rollout (p=0.342). Conclusion: In a highly vaccinated adult population largely free of COVID-19 infection there were few cases of myocarditis within 28 days of vaccination and no increase in incidence overall compared to the preceding 5 years. Funding Acknowledgement: Type of funding sources: Foundation. Main funding source(s): Heart Foundation of New Zealand grant to C GreerFigure 1
ABSTRACT
Introduction Underrepresentation of minority groups, particularly Black patients, has been a major issue for most clinical trials. A commonly cited reason is mistrust amongst Black patients due to historical abuse. In a Historically Black College and University (HBCU) at a major metropolitan area with predominant Black patient population, we examined the patient participation rate in a clinical trial compared to other study sites with primarily White patient population. Methods In April 2021, a large prospective, multi-center clinical trial designed to validate a multiomics blood test for early detection of CRC (PREEMPTCRC) was initiated at a HBCU. To optimize study recruitment, culturally-sensitive methods were employed, including racially congruent recruitment staff, and synchronized timing of consent/study procedures with pre-endoscopy COVID testing and clinic visits. Information for all eligible participants screened for the study were recorded and evaluated for a 7- month period (April 1 - October 31, 2021). The enrollment numbers (defined as those consented to the study and had blood samples drawn) for the HBCU and across all other study sites were compared. Demographic and socio-economic data for patients who enrolled and not enrolled at the HBCU were collected to identify potential factors that affect participation. Results During the study period, the number of patients enrolled at the HBCU site (N=229) was significantly higher than the average number enrolled across the other 168 sites (N=90, p<0.0001). In fact, the HBCU site ranked at the top 11th percentile for patient enrollment across all study sites. The main difference between the HBCU site and other study site was race: participants at HBCU were 88.2% Black and 5.2% White, while at the other sites, the participants were 12.0% Black and 71.5% White (p< 0.0001). Comparison of demographic characteristics and socio-demographic data of the enrolled and not-enrolled subjects at the HBCU were similar (Table 1) and did not identify factors that affect participation in clinical trials. Discussion The enrollment of Black patients at a HBCU site was comparable to other study sites in a large prospective, multi-center study of a multiomics blood test for average-risk CRC screening. The findings of our study highlight the importance of providing access to Black patients to clinical trials to ensure adequate representation in research studies. (Table Presented) Table 1. Baseline Patient Demographic and Sociodemographic Information
ABSTRACT
The COVID-19 pandemic raised major concerns relating to hospital capacity and cross-infection patients and staff in the Emergency Department (ED) of a metropolitan hospital servicing a population of ~500,000. We determined to reduce length of stay and admissions in patients presenting with symptoms of possible myocardial infarction;the most common presentation group. After establishing stakeholder consensus, the existing accelerated diagnostic pathway (ADP) based on the ED Assessment of Chest-pain Score (EDACS), electrocardiogram, and troponin measurements with a high-sensitivity assay (hs-cTn) on presentation and two hours later (EDACS-ADP) was modified to stream patients following an initial troponin measure as follows: (i) to a very-low risk group who could be discharged home without follow-up or further testing, and (ii) to a low-risk group who could be discharged with next-day follow-up community troponin testing. Simulations were run in an extensive research database to determine appropriate hs-cTnI and EDACS thresholds for risk classification. This COVID-ADP was developed in ~2-weeks and was implemented in the ED within a further 3-weeks. A comparison of all chest pain presentations for the 3 months prior to implementation of the COVID-ADP to 3 months following implementation showed that there was a 64.7% increase in patients having only one troponin test in the ED, a 30-minute reduction of mean length of stay of people discharged home from the ED, and a 24.3% reduction in hospital admissions of patients ultimately diagnosed with non-cardiac chest pain. © 2021 International Federation of Clinical Chemistry and Laboratory Medicine. All rights reserved.
ABSTRACT
Introduction: Clinical trials often have low enrollment of minorities, particularly African-Americans (AAs), which may limit the generalizability of research findings. Previously identified barriers to AAs recruitment include historical abuses leading to mistrust, communication issues with providers, socio-economic factors, and a lack of access to clinical trials. In a Historically Black College and University (HBCU) serving a primarily AA population at a large safe-net hospital, we evaluated the enrollment of eligible AA patients for a colorectal cancer (CRC) screening clinical trial. This was compared to the enrollment rates across other study sites. Methods: A large, prospective, multi-centered clinical trial to validate a blood-based test for early detection of CRC (PREEMPT-CRC) was initiated at a HBCU, where 84% of patients are AAs. To maximize study recruitment, culturally sensitive methods were employed including racially congruent recruitment staff as well as synchronized timing of consent/study procedures with preendoscopy COVID testing/clinic visits. Detailed information for all eligible subjects was recorded. Demographic and socio-economic data including census information for enrolled and not enrolled subjects were compared. The enrollment rate (defined as enrolled/eligible patients) over the first 6 weeks at the HBCU and that of the other study sites providing screening logs was analyzed. Results: The enrollment rate at the HBCU was 55% (44 out of 80 eligible patients;95% CI 43.5- 66.2%), compared to 49.8% (258 out of 518 eligible patients;95% CI 45.4- 54.2%) at the other 26 study sites. While age and gender of enrolled patients at the HBCU were comparable to other sites, the main difference was race: at the HBCU the study participants were 79.5% AAs and 9.1% whites, while at the other sites the participants were 11.5% AAs and 82.8% whites (p< 0.001). At the HBCU, the demographic characteristics and socio-demographic data including income, marital status insurance status/type, and census tract median household income of the 44 enrolled and 36 notenrolled subjects were similar (Table 1). Conclusion: Contrary to conventional belief that AAs do not want to be involved in clinical trials, we find their enrollment is similar to a predominant white study population when offered the opportunity in a culturally sensitive setting. Future trials should consider including HBCU sites in order to attain adequate AA enrollment to improve the generalizability of research findings. (Table Presented).