Citations

African American (AA) churches are valuable partners in implementing health promotion programming (HPP) to combat health disparities. The study purpose was to evaluate AA church characteristics associated with enrollment into the FAITH! (Fostering African American Improvement in Total Health) Trial, a community-based, cluster randomized controlled trial (RCT) of a mobile health intervention for cardiovascular health promotion among AA churches. Churches located in Minneapolis-St. Paul and Rochester, Minnesota were invited to complete an electronic screening survey and follow-up telephone interview including the PREACH (Predicting Readiness to Engage African American Churches in Health) tool to assess church characteristics and infrastructure for HPP. The primary outcome was church enrollment in the FAITH! Trial. Key predictors included overall PREACH scores and its subscales (Personnel, Physical Structure, Faith-based Approach, Funding), congregation size, and mean congregation member age. Of the 26 churches screened, 16 (61.5%) enrolled in the trial. The enrolled churches had higher overall mean PREACH scores (36.1 vs. 30.2) and subscales for Personnel (8.8 vs. 5.6), Faith-based Approach (11.0 vs. 9.6), and Funding (7.3 vs. 4.8) compared with non-enrolled churches; all differences were not statistically significant due to small sample size. Twelve (75.0%) of the enrolled churches had >75 members versus six (60.0%) of the non-enrolled churches. Twelve (80.0%) of the enrolled churches had an average congregation member age ≤54 years versus six (67.0%) of the non-enrolled churches. AA churches enrolling into a community-based RCT reported greater infrastructure for HPP, larger congregations, and members of younger age. These characteristics may be helpful to consider among researchers partnering with AA churches for HPP studies.

68 Background: Accrual of racial and ethnic minority patients (pts) to clinical trials has been an ongoing challenge in research. Barriers exist at many levels of engagement including trial availability, screening biases, strict enrollment criteria, and structural racism. Lack of trial diversity has led to less generalizable medical evidence, suboptimal data for toxicity and efficacy of cancer treatments, poorer outcomes and continued mistrust by communities of color in research processes that exclude or marginalize them. Site factors and study design strategies associated with successful recruitment of diverse study populations are understudied. Methods: Alliance A191901 is an RCT testing combinations of text and telephone support to promote endocrine therapy adherence among breast cancer survivors. It oversamples Black participants and those < 50 years at thresholds of 30% each. Administrative enrollment data was used to track and describe monthly accrual trajectory by race among the initial 50% of participants (n = 590) and to examine associations between % Black participants accrued and accruing site characteristics, including site type, geographic region, % Black population in the site’s zip code and volume of pts by race accrued to recent (2018-2019) Alliance trials, using χ2 tests. We also examined patterns of Black participant accrual before and after closure of the A191901 study to non-Black participants. Results: At 50% accrual, 124 sites had enrolled at least 1 participant. Among 590 participants, 9.7% were Black and 22.5% were < 50 years. Neither site type nor volume was associated with % Black participants recruited. Sites in the South recruited higher proportions of Blacks (19.0% vs 5.6% for Midwest, the lowest region, p < 0.001). Neighborhood racial composition was positively associated with accrual of Black participants (17.2% at sites from highest Black composition vs. 2.3% in lowest, p < 0.001). Recruitment trajectories of Black participants consistently lagged those of non-Black participants in the first half of the study; however, Black participants recruited per month numerically increased after the study reached target accrual of non-Blacks and closed to non-Black participants. Conclusions: Sites in neighborhoods and geographic regions with larger Black populations recruited higher proportions of Black participants, but site type and volume were not associated with recruitment of Black participants. Closure of non-Black study strata based on predetermined accrual targets may positively impact recruitment trajectories of Black participants, but further study is needed. Site selection based on neighborhood composition and geography may be an appropriate tool for increasing trial diversity. Support: UG1CA189823. Clinical trial information: NCT04379570.

AbstractIntroductionAvailable evidence is mixed concerning associations between smoking status and COVID-19 clinical outcomes. Effects of nicotine replacement therapy (NRT) and vaccination status on COVID-19 outcomes in smokers are unknown.MethodsElectronic health record data from 104 590 COVID-19 patients hospitalized February 1, 2020 to September 30, 2021 in 21 U.S. health systems were analyzed to assess associations of smoking status, in-hospital NRT prescription, and vaccination status with in-hospital death and ICU admission.ResultsCurrent (n = 7764) and never smokers (n = 57 454) did not differ on outcomes after adjustment for age, sex, race, ethnicity, insurance, body mass index, and comorbidities. Former (vs never) smokers (n = 33 101) had higher adjusted odds of death (aOR, 1.11; 95% CI, 1.06–1.17) and ICU admission (aOR, 1.07; 95% CI, 1.04–1.11). Among current smokers, NRT prescription was associated with reduced mortality (aOR, 0.64; 95% CI, 0.50–0.82). Vaccination effects were significantly moderated by smoking status; vaccination was more strongly associated with reduced mortality among current (aOR, 0.29; 95% CI, 0.16–0.66) and former smokers (aOR, 0.47; 95% CI, 0.39–0.57) than for never smokers (aOR, 0.67; 95% CI, 0.57, 0.79). Vaccination was associated with reduced ICU admission more strongly among former (aOR, 0.74; 95% CI, 0.66–0.83) than never smokers (aOR, 0.87; 95% CI, 0.79–0.97).ConclusionsFormer but not current smokers hospitalized with COVID-19 are at higher risk for severe outcomes. SARS-CoV-2 vaccination is associated with better hospital outcomes in COVID-19 patients, especially current and former smokers. NRT during COVID-19 hospitalization may reduce mortality for current smokers.ImplicationsPrior findings regarding associations between smoking and severe COVID-19 disease outcomes have been inconsistent. This large cohort study suggests potential beneficial effects of nicotine replacement therapy on COVID-19 outcomes in current smokers and outsized benefits of SARS-CoV-2 vaccination in current and former smokers. Such findings may influence clinical practice and prevention efforts and motivate additional research that explores mechanisms for these effects.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &amp;lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &amp;lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &amp;lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Background Religiosity/spirituality is a major coping mechanism for African Americans, but no prior studies have analyzed its association with the American Heart Association Life's Simple 7 (LS7) indicators in this group. Methods and Results This cross‐sectional study using Jackson Heart Study (JHS) data examined relationships between religiosity (religious attendance, private prayer, religious coping) and spirituality (theistic, nontheistic, total) with LS7 individual components (eg, physical activity, diet, smoking, blood pressure) and composite score among African Americans. Multivariable logistic regression assessed the odds of achieving intermediate/ideal (versus poor) LS7 levels adjusted for sociodemographic, behavioral, and biomedical factors. Among the 2967 participants (mean [SD] age=54.0 [12.3] years; 65.7% women), higher religious attendance was associated with increased likelihood (reported as odds ratio [95% CI]) of achieving intermediate/ideal levels of physical activity (1.16 [1.06–1.26]), diet (1.10 [1.01–1.20]), smoking (1.50 [1.34–1.68]), blood pressure (1.12 [1.01–1.24]), and LS7 composite score (1.15 [1.06–1.26]). Private prayer was associated with increased odds of achieving intermediate/ideal levels for diet (1.12 [1.03–1.22]) and smoking (1.24 [1.12–1.39]). Religious coping was associated with increased odds of achieving intermediate/ideal levels of physical activity (1.18 [1.08–1.28]), diet (1.10 [1.01–1.20]), smoking (1.32 [1.18–1.48]), and LS7 composite score (1.14 [1.04–1.24]). Total spirituality was associated with increased odds of achieving intermediate/ideal levels of physical activity (1.11 [1.02–1.21]) and smoking (1.36 [1.21–1.53]). Conclusions Higher levels of religiosity/spirituality were associated with intermediate/ideal cardiovascular health across multiple LS7 indicators. Reinforcement of religiosity/spirituality in lifestyle interventions may decrease overall cardiovascular disease risk among African Americans.

Abstract Background: There is mixed evidence about the relations of current versus past cancer with severe COVID-19 outcomes and how they vary by patient and cancer characteristics. Methods: Electronic health record data of 104,590 adult hospitalized patients with COVID-19 were obtained from 21 United States health systems from February 2020 through September 2021. In-hospital mortality and ICU admission were predicted from current and past cancer diagnoses. Moderation by patient characteristics, vaccination status, cancer type, and year of the pandemic was examined. Results: 6.8% of the patients had current (n = 7,141) and 6.5% had past (n = 6,749) cancer diagnoses. Current cancer predicted both severe outcomes but past cancer did not; adjusted odds ratios (aOR) for mortality were 1.58 [95% confidence interval (CI), 1.46–1.70] and 1.04 (95% CI, 0.96–1.13), respectively. Mortality rates decreased over the pandemic but the incremental risk of current cancer persisted, with the increment being larger among younger vs. older patients. Prior COVID-19 vaccination reduced mortality generally and among those with current cancer (aOR, 0.69; 95% CI, 0.53–0.90). Conclusions: Current cancer, especially among younger patients, posed a substantially increased risk for death and ICU admission among patients with COVID-19; prior COVID-19 vaccination mitigated the risk associated with current cancer. Past history of cancer was not associated with higher risks for severe COVID-19 outcomes for most cancer types. Impact: This study clarifies the characteristics that modify the risk associated with cancer on severe COVID-19 outcomes across the first 20 months of the COVID-19 pandemic. See related commentary by Egan et al., p. 3

Background: African Americans continue to have suboptimal cardiovascular health (CVH) based on the American Heart Association Life’s Simple 7 (LS7), 7 health-promoting behaviors and biological risk factors (eg, physical activity, blood pressure). Innovative, community-level interventions in partnership with trusted institutions such as African American churches are potential means to improve CVH in this population. Methods: Using a community-based participatory research approach, the FAITH! Trial (Fostering African American Improvement in Total Health) rigorously assessed the feasibility and preliminary efficacy of a refined, community-informed, mobile health intervention (FAITH! App) for promoting CVH among African Americans in faith communities using a cluster randomized controlled trial. Participants from 16 churches in Rochester and Minneapolis-St Paul, MN, were randomized to receive the FAITH! App (immediate intervention) or were assigned to a delayed intervention comparator group. The 10-week intervention core features included culturally relevant and LS7-focused education modules, diet/physical activity self-monitoring, and a group sharing board. Data were collected via electronic surveys and health assessments. Primary outcomes were average change in mean LS7 score (continuous measure of CVH ranging from poor to ideal [0–14 points]) from baseline to 6 months post-intervention (using generalized estimating equations) and app engagement/usability (by the Health Information Technology Usability Evaluation Scale; range, 0–5). Results: Of 85 enrolled participants (randomized to immediate [N=41] and delayed [control] intervention [N=44] groups), 76 and 68 completed surveys/health assessments at baseline and 6 months post-intervention, respectively (80% retention rate with assessments at both baseline and 6-month time points); immediate intervention [N=30] and control [N=38] groups). At baseline, the majority of participants (mean age [SD], 54.2 [12.3] years, 71% female) had <4-year college education level (39/66, 59%) and poor CVH (44% in poor category; mean LS7 score [SD], 6.8 [1.9]). The mean LS7 score of the intervention group increased by 1.9 (SD 1.9) points compared with 0.7 (SD 1.7) point in the control group (both P <0.0001) at 6 months. The estimated difference of this increase between the groups was 1.1 (95% CI, 0.6–1.7; P <0.0001). App engagement/usability was overall high (100% connection to app; >75% completed weekly diet/physical activity tracking; Health Information Technology Usability Evaluation Scale, mean [SD], 4.2 [0.7]). Conclusions: On the basis of preliminary findings, the refined FAITH! App appears to be an efficacious mobile health tool to promote ideal CVH among African Americans. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03777709.

Background African-Americans are underrepresented in mobile health intervention research studies which can perpetuate health inequities and the digital divide. A community-based, user-centered approach to designing mobile health interventions may increase their sociocultural relevance and effectiveness, especially with increased smartphone use during the coronavirus disease 2019 pandemic. We aimed to refine an existing mobile health intervention via a virtual focus group series. Methods African-American community members (n = 15) from churches in Minneapolis-St. Paul and Rochester, Minnesota were enrolled in a virtual (via videoconferencing), three-session focus group series over five months to refine a cardiovascular health-focused mobile health application (FAITH! [Fostering African-American Improvement in Total Health!] App). Participants accessed the app via their smartphones and received a Fitbit synced to the app. Participants engaged with multimedia cardiovascular health-focused education modules, a sharing board for social networking, and diet/physical activity self-monitoring. Participant feedback on app features prompted iterative revisions to the FAITH! App. Primary outcomes were app usability (assessed via Health Information Technology Usability Evaluation Scale range: 0–5) and user satisfaction. Results Participants (mean age [SD]: 56.9 [12.3] years, 86.7% female) attended a mean 2.8 focus groups (80% attended all sessions). The revised FAITH! App exceeded the goal Health Information Technology Usability Evaluation Scale score threshold of ≥4 (mean: 4.39, range: 3.20–4.95). Participants positively rated updated app content, visual appeal, and use of social incentives to maintain engagement. Increasing user control and refinement of the moderated sharing board were identified as areas for future improvement. Conclusions Community-partnered, virtual focus groups can optimize usability and increase participant satisfaction of mobile health lifestyle interventions that aim to promote cardiovascular health in African-Americans.

AbstractIntroductionEpidemiological studies report an association between traumatic brain injury (TBI) and post‐traumatic stress disorder (PTSD) and clinically diagnosed Alzheimer's disease (AD). We examined the association between TBI/PTSD and biomarker‐defined AD.MethodsWe identified 289 non‐demented veterans with TBI and/or PTSD and controls who underwent clinical evaluation, cerebrospinal fluid (CSF) collection, magnetic resonance imaging (MRI), amyloid beta (Aβ) and tau positron emission tomography, and apolipoprotein E testing. Participants were followed for up to 5.2 years.ResultsExposure groups (TBI, PTSD, and TBI + PTSD) had higher prevalence of mild cognitive impairment (MCI: P < .0001) and worse Mini‐Mental State Examination scores (PTSD: P = .008; TBI & PTSD: P = .009) than controls. There were no significant differences in other cognitive scores, MRI volumes, Aβ or tau accumulation, or in most longitudinal measures.DiscussionTBI and/or PTSD were not associated with elevated AD biomarkers. The poorer cognitive status of exposed veterans may be due to other comorbid pathologies.