Search

Abstract Background Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. Methods This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs (“hospital-HHA” dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF’s implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. Discussion As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. Trial registration This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .

Abstract Background Fragmentation of care (that is, the use of multiple ambulatory providers without a dominant provider) may increase the risk of gaps in communication among providers. However, it is unclear whether people with fragmented care (as measured in claims) perceive more gaps in communication among their providers. It is also unclear whether people who perceive gaps in communication experience them as clinically significant (that is, whether they experience adverse events that they attribute to poor coordination). Methods We conducted a longitudinal study using data from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, including a survey on perceptions of healthcare (2017–2018) and linked fee-for-service Medicare claims (for the 12 months prior to the survey) (N = 4,296). We estimated correlation coefficients to determine associations between claims-based and self-reported numbers of ambulatory visits and ambulatory providers. We then used logistic regression to determine associations between claims-based fragmentation (measured with the reversed Bice-Boxerman Index [rBBI]) and self-reported gaps in care coordination and, separately, between claims-based fragmentation and self-reported adverse events that the respondent attributed to poor coordination. Results The correlation coefficient between claims-based and self-report was 0.37 for the number of visits and 0.38 for the number of providers (p

Abstract Background Among individuals with heart failure (HF), racial differences in comorbidities may be mediated by social determinants of health (SDOH). Methods Black and White US community-dwelling participants in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study aged ≥ 45 years with an adjudicated HF hospitalization between 2003 and 2017 were included in this cross-sectional analysis. We assessed whether higher prevalence of comorbidities in Black participants compared to White participants were mediated by SDOH in socioeconomic, environment/housing, social support, and healthcare access domains, using the inverse odds weighting method. Results Black (n = 240) compared to White (n = 293) participants with HF with preserved ejection fraction (HFpEF) had higher prevalence of diabetes [1.38 (95% CI 1.18–1.61)], chronic kidney disease [1.21 (95% CI 1.01–1.45)], and anemia [1.33 (95% CI 1.02–1.75)] and lower prevalence of atrial fibrillation [0.80 (95% CI (0.65–0.98)]. Black (n = 314) compared to White (n = 367) participants with HF with reduced ejection fraction (HFrEF) had higher prevalence of hypertension [1.04 (95% CI 1.02–1.07)] and diabetes [1.26 (95% CI 1.09–1.45)] and lower prevalence of coronary artery disease [0.86 (95% CI 0.78–0.94)] and atrial fibrillation [0.70 (95% CI 0.58–0.83)]. Socioeconomic status explained 14.5%, 26.5% and 40% of excess diabetes, anemia, and chronic kidney disease among Black adults with HFpEF; however; mediation was not statistically significant and no other SDOH substantially mediated differences in comorbidity prevalence. Conclusions Socioeconomic status partially mediated excess diabetes, anemia, and chronic kidney disease experienced by Black adults with HFpEF, but differences in other comorbidities were not explained by other SDOH examined.

Background Cognitive impairment is common among adults with heart failure (HF) and associated with poor outcomes. However, less is known about the trajectory of cognitive decline after a first HF hospitalization. We examined the rate of cognitive decline among adults with incident HF hospitalization compared with those without HF hospitalization. Methods and Results The REGARDS (Reasons for Geographic and Racial Differences in Stroke) study is a prospective longitudinal study of 23 894 participants aged ≥45 years free of HF at baseline. HF hospitalization was expert adjudicated. Changes in global cognitive function (primary outcome) were assessed with the Six‐Item Screener (range, 0–6). Secondary outcomes included change in Word List Learning (range, 0–30), Word List Delayed Recall (WLD; range, 0–10), and Animal Fluency Test (range, 0+). Segmented linear mixed‐effects regression models were used. Over 5 years, mean scores across all 4 cognitive tests declined for all participants regardless of HF status. Those with incident HF hospitalization experienced faster declines in the Six‐Item Screener versus those who were HF free (difference, −0.031 [95% CI, −0.047 to −0.016]; P

Background: Underprescribing of guideline-directed medical therapy (GDMT) for heart failure (HF) persists. Objectives: The purpose of this study was to assess polypharmacy as a barrier to GDMT. Methods: We examined participants hospitalized for HF with reduced ejection fraction and HF with mildly reduced ejection fraction between 2003 and 2017 from the Reasons for Geographic and Racial Differences in Stroke study. Participants were stratified by admission medication count—0 to 4, 5 to 9, and ≥10 medications. We examined GDMT use at admission, GDMT contraindications, and initiation of eligible indicated GDMT by medication count. We conducted a multivariable Poisson regression with robust standard errors to examine the association between medication count and GDMT initiation. GDMT included agents for HF with reduced ejection fraction/HF with mildly reduced ejection fraction, antiplatelet agents and statins for coronary artery disease, and anticoagulants for atrial fibrillation. Results: Among 545 participants with HF, 34% were not taking a beta-blocker, 39% were not taking an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, or hydralazine-isosorbide dinitrate, and 90% were not taking a mineralocorticoid receptor antagonist at admission; among participants with coronary artery disease, 36% were not taking an antiplatelet agent, and 38% were not taking a statin; and among participants with atrial fibrillation, 49% were not taking an anticoagulant. Polypharmacy was inversely associated with initiation of at least one indicated medication (5-9 medications: relative risk [RR]: 0.67; 95% CI: 0.56-0.82; P

Rationale and objective Disease-specific health-related quality of life (HRQOL) instruments enable us to capture domains that are most relevant to specific patient populations and are useful when a more individualised approach to patient assessment is desired. In this study, we assessed the validity and reliability of the first instrument specifically developed to measure HRQOL in hypersensitivity pneumonitis (HP). Methods A 39-item HP-HRQOL instrument and several anchors were collected from a cohort of patients with HP. Exploratory factor analysis and item reduction were utilised to construct a shortened version of the instrument. Several validity and reliability analyses were conducted on this version of the HP-HRQOL. Measurements and main results 59 patients with HP completed the study. The revised HP-HRQOL instrument comprises 15 items composing two factors (domains): 1) impacts on daily life; and 2) mental wellbeing. Internal consistency reliability was strong for Factor 1 (Cronbach's α=0.94, 95% CI 0.92–0.96) and Factor 2 (Cronbach's α=0.89, 95% CI 0.85–0.94). Test–retest reliability was strong (ICC 0.94, 95% CI 0.89–0.97). The HP-HRQOL strongly correlated with other validated patient-reported outcome measures and moderately correlated with % predicted forced vital capacity. The HP-HRQOL distinguished between those with different severities of HP as determined by lung function and supplemental oxygen use. Conclusions The HP-HRQOL, the first patient-reported outcome instrument specific to adults with HP, possesses strong validity and reliability characteristics for measuring disease-specific HRQOL and distinguishes among patients with different severities of disease.

Background We examined the association of multilevel social determinants of health with incident apparent treatment‐resistant hypertension (aTRH). Methods and Results We analyzed data from 2774 White and 2257 Black US adults from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study taking antihypertensive medication without aTRH at baseline to estimate the association of social determinants of health with incident aTRH. Selection of social determinants of health was guided by the Healthy People 2030 domains of education, economic stability, social context, neighborhood environment, and health care access. Blood pressure (BP) was measured during study visits, and antihypertensive medication classes were identified through a pill bottle review. Incident aTRH was defined as (1) systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, or systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg for those with diabetes or chronic kidney disease while taking ≥3 classes of antihypertensive medication or (2) taking ≥4 classes of antihypertensive medication regardless of BP level, at the follow‐up visit. Over a median 9.5 years of follow‐up, 15.9% of White and 24.0% of Black adults developed aTRH. A percent of the excess aTRH risk among Black versus White adults was mediated by low education (14.2%), low income (16.0%), not seeing a friend or relative in the past month (8.1%), not having someone to care for them if ill or disabled (7.6%), lack of health insurance (10.6%), living in a disadvantaged neighborhood (18.0%), and living in states with poor public health infrastructure (6.0%). Conclusions Part of the association between race and incident aTRH risk was mediated by social determinants of health.

Summary: Background: Eighty percent of global cardiovascular disease (CVD) is projected to occur in low- and middle -income countries (LMICs), yet local epidemiological data are scarce. We provide the first population-based, adjudicated CVD prevalence estimates in Port-au-Prince, Haiti to describe the spectrum of heart disease and investigate associated risk factors. Methods: Demographic, medical history, clinical, imaging and laboratory data were collected among adults recruited using multistage random sampling from 2019 to 2021. Prevalent CVD (heart failure, stroke, ischemic disease) were adjudicated using epidemiological criteria similar to international cohorts. Multivariable Poisson regressions assessed relationships between risk factors and prevalent CVD. Findings: Among 3003 participants, median age was 40 years, 58.1% were female, 70.2% reported income

Background Blood pressure (BP) trajectories from young adulthood through middle age are associated with cardiovascular risk. We examined the associations of hypertension risk factors with BP trajectories among a large diverse sample. Methods and Results We analyzed data from young adults, aged 18 to 39 years, with untreated BP

Abstract Background Practice facilitators (PFs) coach practices through quality improvement (QI) initiatives aimed at enhancing patient outcomes and operational efficiencies. Practice facilitation is a dynamic intervention that, by design, is tailored to practices’ unique needs and contexts. Little research has explored the amount of time PFs spend with practices on QI activities. This short report expands on previously published work that detailed a 12-month practice facilitation intervention as part of the Southeastern Collaboration to Improve Blood Pressure Control (SEC) trial, which focused on improving hypertension control among people living in rural settings in the southeastern USA. This report analyzes data on the time PFs spent to guide 32 primary care practices in implementing QI activities to support enhanced outcomes in patients with high blood pressure. Methods The SEC trial employed four certified PFs across all practice sites, who documented time spent: (1) driving to support practices; (2) working on-site with staff and clinicians; and (3) communicating remotely (phone, email, or video conference) with practice members. We analyzed the data using descriptive statistics to help understand time devoted to individual and aggregated tasks. Additionally, we explored correlations between practice characteristics and time spent with PFs. Results In aggregate, the PFs completed 416 visits to practices and spent an average of 130 (SD 65) min per visit driving to and from practices. The average time spent on-site per visit with practices was 87 (SD 37) min, while an average of 17 (SD 12) min was spent on individual remote communications. During the 12-month intervention, 1131 remote communications were conducted with practices. PFs spent most of their time with clinical staff members (n = 886 instances) or with practice managers alone (n = 670 instances) while relatively few on-site visits were conducted with primary care providers alone (n = 15). In 19 practices, no communications were solely with providers. No significant correlations were found between time spent on PF activities and a practices’ percent of Medicaid and uninsured patients, staff-provider ratio, or federally qualified health center (FQHC) status. Conclusions PFs working with practices serving rural patients with hypertension devote substantial time to driving, highlighting the importance of optimizing a balance between time spent on-site vs. communicating remotely. Most time spent was with clinical staff, not primary care providers. These findings may be useful to researchers and business leaders who design, test, and implement efficient facilitation services. Trial registration NIH ClinicalTrials.gov NCT02866669 . Registered on 15 August 2016. NHLBI AWARD number: PCS-1UH3HL130691.

Abstract Background Older adults hospitalized for heart failure (HF) are at risk for falls after discharge. One modifiable contributor to falls is fall risk-increasing drugs (FRIDs). However, the prevalence of FRIDs among older adults hospitalized for HF is unknown. We describe patterns of FRIDs use and examine predictors of a high FRID burden. Methods We used the national biracial REasons for Geographic and Racial Differences in Stroke (REGARDS) study, a prospective cohort recruited from 2003–2007. We included REGARDS participants aged ≥ 65 years discharged alive after a HF hospitalization from 2003–2017. We determined FRIDs –cardiovascular (CV) and non-cardiovascular (non-CV) medications – at admission and discharge from chart abstraction of HF hospitalizations. We examined the predictors of a high FRID burden at discharge via modified Poisson regression with robust standard errors. Results Among 1147 participants (46.5% women, mean age 77.6 years) hospitalized at 676 hospitals, 94% were taking at least 1 FRID at admission and 99% were prescribed at least 1 FRID at discharge. The prevalence of CV FRIDs was 92% at admission and 98% at discharge, and the prevalence of non-CV FRIDs was 32% at admission and discharge. The most common CV FRID at admission (88%) and discharge (93%) were antihypertensives; the most common agents were beta blockers (61% at admission, 75% at discharge), angiotensin-converting enzyme inhibitors (36% vs. 42%), and calcium channel blockers (32% vs. 28%). Loop diuretics had the greatest change in prevalence (53% vs. 72%). More than half of the cohort (54%) had a high FRID burden (Agency for Healthcare Research and Quality (AHRQ) score ≥ 6), indicating high falls risk after discharge. In a multivariable Poisson regression analysis, the factors strongly associated with a high FRID burden at discharge included hypertension (PR: 1.41, 95% CI: 1.20, 1.65), mood disorder (PR: 1.24, 95% CI: 1.10, 1.38), and hyperpolypharmacy (PR: 1.88, 95% CI: 1.64, 2.14). Conclusions FRID use was nearly universal among older adults hospitalized for HF; more than half had a high FRID burden at discharge. Further work is needed to guide the management of a common clinical conundrum whereby guideline indications for treating HF may contribute to an increased risk for falls.

Abstract Background Allostatic load (AL) is the physiologic “wear and tear” on the body from stress. Yet, despite stress being implicated in the development heart failure (HF), it is unknown whether AL is associated with incident HF events. Methods We examined 16,765 participants without HF at baseline from the REasons for Geographic and Racial Differences in Stroke (REGARDS) cohort. The main exposure was AL score quartile. AL was determined according to 11 physiologic parameters, whereby each parameter was assigned points (0–3) based on quartiles within the sample, and points were summed to create a total AL score ranging from 0–33. The outcome was incident HF event. We examined the association between AL quartile (Q1-Q4) and incident HF events using Cox proportional hazards models, adjusted for demographics, socioeconomic factors, and lifestyle. Results The mean age was 64 ± 9.6 years, 61.5% were women, and 38.7% were Black participants. Over a median follow up of 11.4 years, we observed 750 incident HF events (635 HF hospitalizations and 115 HF deaths). Compared to the lowest AL quartile (Q1), the fully adjusted hazards of an incident HF event increased in a graded fashion: Q2 HR 1.49 95% CI 1.12–1.98; Q3 HR 2.47 95% CI 1.89–3.23; Q4 HR 4.28 95% CI 3.28–5.59. The HRs for incident HF event in the fully adjusted model that also adjusted for CAD were attenuated, but remained significant and increased in a similar, graded fashion by AL quartile. There was a significant age interaction (p-for-interaction

Abstract Aims To optimize guideline‐directed medical therapy for heart failure, patients may require the initiation of multiple neurohormonal antagonists (NHAs) during and following hospitalization. The safety of this approach for older adults is not well established. Methods and results We conducted an observational cohort study of 207 223 Medicare beneficiaries discharged home following a hospitalization for heart failure with reduced ejection fraction (HFrEF) (2008–2015). We performed Cox proportional hazards regression to examine the association between the count of NHAs initiated within 90 days of hospital discharge (as a time‐varying exposure) and all‐cause mortality, all‐cause rehospitalization, and fall‐related adverse events over the 90 day period following hospitalization. We calculated inverse probability‐weighted hazard ratios (IPW‐HRs) with 95% confidence intervals (CIs) comparing initiation of 1, 2, or 3 NHAs vs. 0. The IPW‐HRs for mortality were 0.80 [95% CI (0.78–0.83)] for 1 NHA, 0.70 [95% CI (0.66–0.75)] for 2, and 0.94 [95% CI (0.83–1.06)] for 3. The IPW‐HRs for readmission were 0.95 [95% CI (0.93–0.96)] for 1 NHA, 0.89 [95% CI (0.86–0.91)] for 2, and 0.96 [95% CI (0.90–1.02)] for 3. The IPW‐HRs for fall‐related adverse events were 1.13 [95% CI (1.10–1.15)] for 1 NHA, 1.25 [95% CI (1.21–1.30)] for 2, and 1.64 [95% CI (1.54–1.76)] for 3. Conclusions Initiating 1–2 NHAs among older adults within 90 days of HFrEF hospitalization was associated with lower mortality and lower readmission. However, initiating 3 NHAs was not associated with reduced mortality or readmission and was associated with a significant risk for fall‐related adverse events.

Abstract Background Moving Well is a behavioral intervention for patients with knee osteoarthritis (KOA) scheduled for a total knee replacement (TKR). The objective of this intervention is to help patients with KOA mentally and physically prepare for and recover from TKR. Methods This is an open-label pilot randomized clinical trial that will test the feasibility and effectiveness of the Moving Well intervention compared to an attention control group, Staying Well, to reduce symptoms of anxiety and depression in patients with KOA undergoing TKR. The Moving Well intervention is guided by Social Cognitive Theory. During this 12-week intervention, participants will receive 7 weekly calls before surgery and 5 weekly calls after surgery from a peer coach. During these calls, participants will be coached to use principles of cognitive behavioral therapy (CBT), stress reduction techniques, and will be assigned an online exercise program, and self-monitoring activities to complete on their own time throughout the program. Staying Well participants will receive weekly calls of similar duration from research staff to discuss a variety of health topics unrelated to TKR, CBT, or exercise. The primary outcome is the difference in levels of anxiety and/or depression between participants in the Moving Well and Staying Well groups 6 months after TKR. Discussion This study will pilot test the feasibility and effectiveness of Moving Well, a peer coach intervention, alongside principles of CBT and home exercise, to help patients with KOA mentally and physically prepare for and recover from TKR. Trial registration Clinicaltrials.gov. NCT05217420; Registered: January 31, 2022.

Objective To examine associations between myocardial infarction (MI) and multiple physical function metrics.Methods Among participants aged≥45 years in the REasons for Geographic And Racial Differences in Stroke prospective cohort study, instrumental activities of daily living (IADL), activities of daily living (ADL), gait speed, chair stands and Short Form-12 physical component summary (PCS) were assessed after approximately 10 years of follow-up. We examined associations between MI and physical function (no MI (n=9472), adjudicated MI during follow-up (n=288, median 4.7 years prior to function assessment), history of MI at baseline (n=745), history of MI at baseline and adjudicated MI during follow-up (n=70, median of 6.7 years prior to function assessment)). Models were adjusted for sociodemographic characteristics, health behaviours, depressive symptoms, cognitive impairment, body mass index, diabetes, hypertension and urinary albumin to creatinine ratio. We examined subgroups defined by age, gender and race.Results The average age at baseline was 62 years old, 56% were women and 35% were black. MI was significantly associated with worse IADL and ADL scores, IADL dependency, chair stands and PCS, but not ADL dependency or gait speed. For example, compared with participants without MI, IADL scores (possible range 0–14, higher score represents worse function) were greater for participants with MI during follow-up (difference: 0.37 (95% CI 0.16 to 0.59)), MI at baseline (0.26 (95% CI 0.12 to 0.41)) and MI at baseline and follow-up (0.71 (95% CI 0.15 to 1.26)), p

Abstract Objective To compare cardiovascular disease (CVD) rates in rheumatoid arthritis (RA) beneficiaries of the Social Security Disability Insurance (SSDI) with commercially insured RA patients. Method We created three cohorts of RA patients aged

Background: Peer coaching interventions are effective in helping individuals with chronic conditions understand their disease. Most peer coach training programs occur in person, which has become an obstacle during the COVID pandemic. We describe our experiences with virtual training for future peer coach interventions. Methods: Individuals with rheumatoid arthritis (RA) between 40 and 75 years of age were recruited and interviewed by the research team. We conducted seven virtual training sessions focused on four main points: Listen, Discuss, Practice, and Certify. The peer coaches provided feedback throughout the program, which was used to refine the training and intervention. A post-training focus group assessed satisfaction with the training program and intervention development process. Results: Four peer coaches (3 women, 1 man) were trained, including 2 Black and 2 White individuals with advanced degrees. Their ages ranged from 52 to 57, and their RA duration ranged from 5 to 15 years. An iterative process with the coaches and researchers resulted in a nine-week training program. Peer coaches reported satisfaction, confidence, and a preference for the virtual training format. Conclusion: This virtual peer coach training program was feasible and acceptable for coaches with advanced degrees during the global COVID-19 pandemic. Our approach represents an opportunity to adapt training that has been traditionally done in person. By doing so, our approach facilitates the recruitment and training of a diverse group of coaches and promotes sustainability.

Abstract Background Older US adults often receive care from multiple ambulatory providers. Seeing multiple providers may be clinically appropriate but creates challenges for communication. Whether frailty is a risk factor for gaps in communication among older adults and subsequent preventable adverse events is unknown. Methods We conducted a cross-sectional analysis of community-dwelling US adults ≥ 65 years of age in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study who attended an in-home study examination in 2013–2016 and completed a survey on experiences with healthcare in 2017–2018 (n = 5,024). Using 5 frailty indicators (low body mass index, exhaustion, slow walk, weakness, and history of falls), we characterized participants into 3 mutually exclusive groups: not frail (0 indicators), intermediate-frail (1–2 indicators), and frail (3–5 indicators). We used survey data on self-reported gaps in care coordination and self-reported adverse events that participants attributed to poor communication among providers (a drug-drug interaction, repeat testing, an emergency department visit, or a hospital admission). Results Overall, 2,398 (47.7%) participants were not frail, 2,436 (48.5%) were intermediate-frail, and 190 (3.8%) were frail. The prevalence of any gap in care coordination was 37.0%, 40.8%, and 51.1% among participants who were not frail, intermediate-frail and frail, respectively. The adjusted prevalence ratio (PR) for any gap in care coordination among intermediate-frail and frail versus not frail participants was 1.09 (95% confidence interval [95%CI] 1.02–1.18) and 1.34 (95%CI 1.15–1.56), respectively. The prevalence of any preventable adverse event was 7.0%, 11.3% and 20.0% among participants who were not frail, intermediate-frail and frail, respectively. The adjusted PR for any preventable adverse event among those who were intermediate-frail and frail versus not frail was 1.47 (95%CI 1.22–1.77) and 2.24 (95%CI 1.60–3.14), respectively. Conclusion Among older adults, frailty is associated with an increased prevalence for self-reported gaps in care coordination and preventable adverse events. Targeted interventions to address patient-reported concerns regarding care coordination among intermediate-frail and frail older adults may be warranted.

Background: Racial disparities related to hypertension prevalence and control persist, with Black persons continuing to have both high prevalence and suboptimal control. The Black Belt region of the US Southeast is characterized by multiple critical priority populations: rural, low-income, and minority (Black). Methods: In a cluster-randomized, controlled, pragmatic implementation trial, the Southeastern Collaboration to Improve Blood Pressure Control evaluated two multi-component, multi-level functional interventions – peer coaching (PC) and practice facilitation (PF) (separately and combined) – as adjuncts to usual care to improve blood pressure control in the Black Belt. The overall goal was to randomize 80 primary care practices (later reduced to 69 practices) in Alabama and North Carolina to one of four interventions: 1) enhanced usual care (EUC); 2) EUC plus PC; 3) EUC plus PF; or 4) EUC plus both PC and PF. Several measures to facilitate recruitment and retention of practices were employed, including practice readiness assessment. Results: Contact was initiated with 248 practices during the study enrollment period. Of these, 99 declined participation, 39 were ineligible, and 41 were being evaluated for inclusion when the target number of practices was reached. The remaining 69 practices eventually were enrolled, with 18 practices randomized to EUC, 19 to PC, 16 to PF, and 16 to PC plus PF. Only two practices (2.9%) were withdrawn during the study. Several facilitators of and barriers to practice recruitment and retention were identified. Conclusion: Our findings underscore the importance of a structured approach to recruiting primary care practices in a pragmatic implementation trial.ClinicalTrials.gov registration number NCT02866669

Background: Hypertension (HTN) is the leading cardiovascular disease (CVD) risk factor in Haiti and is likely driven by poverty-related social and dietary factors. Salt consumption in Haiti is hypothesized to be high but has never been rigorously quantified. Methods: We used spot urine samples from a subset of participants in the population-based Haiti Cardiovascular Disease Cohort to estimate population mean daily sodium intake. We compared three previously validated formulas for estimating dietary sodium intake using urine sodium, urine creatinine, age, sex, height, and weight. We explored the association between dietary sodium intake and blood pressure, stratified by age group. Results: A total of 1,240 participants had spot urine samples. Median age was 38 years (range 18–93), and 48% were female. The mean dietary sodium intake was 3.5–5.0 g/day across the three estimation methods, with 94.2%–97.9% of participants consuming above the World Health Organization (WHO) recommended maximum of 2 g/day of sodium. Among young adults aged 18–29, increasing salt intake from the lowest quartile of consumption (5.88 g/day) was associated with a mean 8.71 mmHg higher systolic blood pressure (SBP) (95% confidence interval: 3.35, 14.07; p = 0.001). An association was not seen in older age groups. Among participants under age 40, those with SBP ≥120 mmHg consumed 0.5 g/day more sodium than those with SBP

Abstract Background Cardiovascular diseases (CVD) are rapidly increasing in low-middle income countries (LMICs). Accurate risk assessment is essential to reduce premature CVD by targeting primary prevention and risk factor treatment among high-risk groups. Available CVD risk prediction models are built on predominantly Caucasian risk profiles from high-income country populations, and have not been evaluated in LMIC populations. We aimed to compare six existing models for predicted 10-year risk of CVD and identify high-risk groups for targeted prevention and treatment in Haiti. Methods We used cross-sectional data within the Haiti CVD Cohort Study, including 1345 adults ≥ 40 years without known history of CVD and with complete data. Six CVD risk prediction models were compared: pooled cohort equations (PCE), adjusted PCE with updated cohorts, Framingham CVD Lipids, Framingham CVD Body Mass Index (BMI), WHO Lipids, and WHO BMI. Risk factors were measured during clinical exams. Primary outcome was continuous and categorical predicted 10-year CVD risk. Secondary outcome was statin eligibility. Results Sixty percent were female, 66.8% lived on a daily income of ≤ 1 USD, 52.9% had hypertension, 14.9% had hypercholesterolemia, 7.8% had diabetes mellitus, 4.0% were current smokers, and 2.5% had HIV. Predicted 10-year CVD risk ranged from 3.6% in adjusted PCE (IQR 1.7–8.2) to 9.6% in Framingham-BMI (IQR 4.9–18.0), and Spearman rank correlation coefficients ranged from 0.86 to 0.98. The percent of the cohort categorized as high risk using model specific thresholds ranged from 1.8% using the WHO-BMI model to 41.4% in the PCE model (χ2 = 1416, p value

BackgroundCOVID-19 is associated with cardiac dysfunction. This study tested the relative prognostic role of left (LV), right and bi- (BiV) ventricular dysfunction on mortality in a large multicenter cohort of patients during and after acute COVID-19 hospitalization.Methods/resultsAll hospitalized COVID-19 patients who underwent clinically indicated transthoracic echocardiography within 30 days of admission at four NYC hospitals between March 2020 and January 2021 were studied. Images were re-analyzed by a central core lab blinded to clinical data. Nine hundred patients were studied (28% Hispanic, 16% African-American), and LV, RV and BiV dysfunction were observed in 50%, 38% and 17%, respectively. Within the overall cohort, 194 patients had TTEs prior to COVID-19 diagnosis, among whom LV, RV, BiV dysfunction prevalence increased following acute infection (pConclusionsLV, RV and BiV function declines during acute COVID-19 infection with each contributing to increased in- and out-patient mortality risk. RV dysfunction independently increases mortality risk.

Abstract Background Understanding health care experiences during the COVID-19 pandemic may provide insights into patient needs and inform policy. The objective of this study was to describe health care experiences by race and social determinants of health. Methods We conducted a telephone survey (July 6, 2020-September 4, 2021) among 9492 Black and White participants in the longitudinal REasons for Geographic And Racial Differences in Stroke cohort study, age 58–105 years, from the continental United States. Among participants with symptoms of COVID-19, outcomes were: 1. Sought care or advice for the illness; 2. Received a SARS-CoV-2 test for the illness; and 3. Tested positive. Among participants without symptoms of COVID-19, outcomes were: 1. Wanted a test; 2. Wanted and received a test; 3. Did not want but received a test; and 4. Tested positive. We examined these outcomes overall and in subgroups defined by race, household income, marital status, education, area-level poverty, rural residence, Medicaid expansion, public health infrastructure ranking, and residential segregation. Results The average age of participants was 76.8 years, 36% were Black, and 57% were female. Among participants with COVID-19 symptoms (n = 697), 74% sought care or advice for the illness, 50% received a SARS-CoV-2 test, and 25% had a positive test (50% of those tested). Among participants without potential COVID-19 symptoms (n = 8795), 29% wanted a SARS-CoV-2 test, 22% wanted and received a test, 8% did not want but received a test, and 1% tested positive; a greater percentage of participants who were Black compared to White wanted (38% vs 23%, p

Abstract Background Chronic hypersensitivity pneumonitis (CHP) is an interstitial lung disease (ILD) caused by long term exposure to an offending antigen. Antigen avoidance is associated with improved outcomes. We are unable to identify the antigen source in approximately half of patients. When an antigen is successfully identified, patients have difficulty with avoidance. Methods We conducted three structured group discussions with US based ILD specialists utilizing the nominal group technique (NGT). Participants listed barriers to antigen detection and avoidance in CHP. Each participant ranked what they perceived to be the top three barriers in the list in terms of importance. The master list of barriers was consolidated across the three groups into themes that were prioritized based on receiving the highest rankings by participants. Results Twenty-five physicians participated; 56% had experience caring for CHP patients for ≥ 16 years. Sixty barriers to antigen detection were categorized into seven themes of which the top three were: 1. unclear significance of identified exposures; 2. gaps in clinical knowledge and testing capabilities; 3. there are many unknown and undiscovered antigens. Twenty-eight barriers to antigen avoidance were categorized into five themes of which the top three were: 1. patient limitations, financial barriers and lack of resources; 2. individual patient beliefs, emotions and attachments to the antigen source; and 3. gaps in clinical knowledge and testing capabilities. Conclusions This study uncovered challenges at the individual patient, organizational, and societal levels and ranked them in terms of level of importance. These findings provide information to guide development and validation of multidisciplinary support and interventions geared towards antigen identification and avoidance in CHP.

Abstract COVID-19-associated respiratory failure offers the unprecedented opportunity to evaluate the differential host response to a uniform pathogenic insult. Understanding whether there are distinct subphenotypes of severe COVID-19 may offer insight into its pathophysiology. Sequential Organ Failure Assessment (SOFA) score is an objective and comprehensive measurement that measures dysfunction severity of six organ systems, i.e., cardiovascular, central nervous system, coagulation, liver, renal, and respiration. Our aim was to identify and characterize distinct subphenotypes of COVID-19 critical illness defined by the post-intubation trajectory of SOFA score. Intubated COVID-19 patients at two hospitals in New York city were leveraged as development and validation cohorts. Patients were grouped into mild, intermediate, and severe strata by their baseline post-intubation SOFA. Hierarchical agglomerative clustering was performed within each stratum to detect subphenotypes based on similarities amongst SOFA score trajectories evaluated by Dynamic Time Warping. Distinct worsening and recovering subphenotypes were identified within each stratum, which had distinct 7-day post-intubation SOFA progression trends. Patients in the worsening suphenotypes had a higher mortality than those in the recovering subphenotypes within each stratum (mild stratum, 29.7% vs. 10.3%, p = 0.033; intermediate stratum, 29.3% vs. 8.0%, p = 0.002; severe stratum, 53.7% vs. 22.2%, p

Background It is unclear whether lipoprotein(a) is associated with coronary heart disease (CHD) and ischemic stroke events in White and Black adults with atherosclerotic cardiovascular disease (ASCVD). Methods and Results We conducted a case‐cohort analysis, including Black and White REGARDS (Reasons for Geographic and Racial Differences in Stroke) study participants ≥45 years of age with prevalent ASCVD (ie, CHD or stroke) at baseline between 2003 and 2007. Baseline lipoprotein(a) molar concentration was measured in participants with ASCVD who experienced a CHD event by December 2017 (n=1166) or an ischemic stroke by September 2019 (n=492) and in a random subcohort of participants with prevalent ASCVD (n=1948). The hazard ratio (HR) for CHD events per 1 SD (1.5 units) higher log‐transformed lipoprotein(a) was 1.26 (95% CI, 1.02–1.56) among Black participants and 1.16 (95% CI, 1.02–1.31) among White participants (P value comparing HRs, 0.485). The HR for CHD events per 1 SD higher log‐lipoprotein(a) within subgroups with hs‐CRP (high‐sensitivity C‐reactive protein) ≥2 and

Abstract Background Adults who have experienced multiple cardiovascular disease (CVD) events have a very high risk for additional events. Diabetes and chronic kidney disease (CKD) are each associated with an increased risk for recurrent CVD events following a myocardial infarction (MI). Methods We compared the risk for recurrent CVD events among US adults with health insurance who were hospitalized for an MI between 2014 and 2017 and had (1) CVD prior to their MI but were free from diabetes or CKD (prior CVD), and those without CVD prior to their MI who had (2) diabetes only, (3) CKD only and (4) both diabetes and CKD. We followed patients from hospital discharge through December 31, 2018 for recurrent CVD events including coronary, stroke, and peripheral artery events. Results Among 162,730 patients, 55.2% had prior CVD, and 28.3%, 8.3%, and 8.2% had diabetes only, CKD only, and both diabetes and CKD, respectively. The rate for recurrent CVD events per 1000 person-years was 135 among patients with prior CVD and 110, 124 and 171 among those with diabetes only, CKD only and both diabetes and CKD, respectively. Compared to patients with prior CVD, the multivariable-adjusted hazard ratio for recurrent CVD events was 0.92 (95%CI 0.90–0.95), 0.89 (95%CI: 0.85–0.93), and 1.18 (95%CI: 1.14–1.22) among those with diabetes only, CKD only, and both diabetes and CKD, respectively. Conclusion Following MI, adults with both diabetes and CKD had a higher risk for recurrent CVD events compared to those with prior CVD without diabetes or CKD.

Abstract Background More fragmented ambulatory care (i.e., care spread across many providers without a dominant provider) has been associated with more subsequent healthcare utilization (such as more tests, procedures, emergency department visits, and hospitalizations) than less fragmented ambulatory care. It is not known if race and socioeconomic status are associated with fragmented ambulatory care. Methods We conducted a longitudinal analysis of data from the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, using the REGARDS baseline visit plus the first year of follow-up. We included participants ≥65 years old, who had linked fee-for-service Medicare claims, and ≥ 4 ambulatory visits in the first year of follow-up. We used Tobit regression to determine the associations between race, annual household income, and educational attainment at baseline and fragmentation score in the subsequent year (as measured with the reversed Bice-Boxerman Index). Covariates included other demographic characteristics, medical conditions, medication use, health behaviors, and psychosocial variables. Additional analyses categorized visits by the type of provider (primary care vs. specialist). Results The study participants (N = 6799) had an average age of 73.0 years, 53% were female, and 30% were black. Nearly half had low annual household income (

Abstract Background Chronic Hypersensitivity Pneumonitis (CHP) is caused by an immune mediated response in the lung tissue after exposure to an inhaled environmental antigenic stimulant. We previously documented the ways in which CHP impacts patients’ lives and have now developed a disease-specific instrument, the CHP-HRQOL instrument, to measure health-related quality of life (HRQOL). The objective of this study was to assess content validity for the CHP-HRQOL. Methods Cognitive interviews were conducted among adults with CHP. The instrument was revised and refined between each round of interviews. Feedback was obtained on the instructions, items, response options, and recall period. Items where participants had difficulty with comprehension, wording, or misinterpretation were marked by the interviewer and participant feedback was reviewed to make revisions, add or delete items when appropriate. Readability statistics were calculated using Flesch-Kincaid grade level and reading ease scores. Results Ten participants were interviewed over three rounds, with revisions made to the questionnaire in an iterative process. In the initial 39 item instrument, we identified 7 items where two or more participants reported difficulty. Participants preferred a four-week recall period (compared to a two-week recall period) and response options with a 5-point response scale. The final version of the CHP-HRQOL includes 40 items with a median reading level between 6th and 7th grade. Conclusion The CHP-HRQOL instrument demonstrated high content validity and is ready for psychometric testing in further validation studies.

Objective To describe the clinical outcomes of COVID-19 in a racially diverse sample from the US Southeast and examine the association of renin–angiotensin–aldosterone system (RAAS) inhibitor use with COVID-19 outcome.Design, Setting, Participants This study is a retrospective cohort of 1024 patients with reverse-transcriptase PCR-confirmed COVID-19 infection, admitted to a 1242-bed teaching hospital in Alabama. Data on RAAS inhibitors use, demographics and comorbidities were extracted from hospital medical records.Primary outcomes In-hospital mortality, a need of intensive care unit, respiratory failure, defined as invasive mechanical ventilation (iMV) and 90-day same-hospital readmissions.Results Among 1024 patients (mean (SD) age, 57 (18.8) years), 532 (52.0%) were African Americans, 514 (50.2%) male, 493 (48.1%) had hypertension, 365 (36%) were taking RAAS inhibitors. During index hospitalisation (median length of stay of 7 (IQR (4–15) days) 137 (13.4%) patients died; 170 (19.2%) of survivors were readmitted. RAAS inhibitor use was associated with lower in-hospital mortality (adjusted HR, 95% CI (0.56, (0.36 to 0.88), p=0.01) and no effect modification by race was observed (p for interaction=0.81). Among patients with hypertension, baseline RAAS use was associated with reduced risk of iMV, adjusted OR, 95% CI (aOR 0.58, 95% CI 0.36 to 0.95, p=0.03). Patients with heart failure were twice as likely to die from COVID-19, compared with patients without heart failure.Conclusions In a retrospespective study of racially diverse patients, hospitalised with COVID-19, prehospitalisation use of RAAS inhibitors was associated with 40% reduction in mortality irrespective of race.

Background Depressive symptoms are risk factors for several forms of cardiovascular disease including coronary heart disease (CHD). However, it is unclear whether depressive symptoms are associated with incident heart failure (HF), including hospitalization for HF overall or by subtype: HF with preserved (HFpEF) or reduced ejection fraction (HFrEF). Methods and Results Among 26 268 HF‐free participants in the REGARDS (Reasons for Geographic And Racial Differences in Stroke) study, a prospective biracial cohort of US community‐dwelling adults ≥45 years, baseline depressive symptoms were defined as a score ≥4 on the 4‐item Center for Epidemiologic Studies Depression scale. Incident HF hospitalizations were expert‐adjudicated and categorized as HFpEF (EF ≥50%) and HFrEF, including mid‐range EF (EF

Objective: The association between neighborhood disadvantage and health is well-documented. However, whether these associations may differ across rural and urban areas is unclear. This study examines the association between a multi-item neighborhood social and economic environment (NSEE) measure and diabetes prevalence across urban and rural communities in the US. Methods: This study included 27,159 Black and White participants aged ≥45 years at baseline (2003–2007) from the REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Each participant's residential address was geocoded. NSEE was calculated as the sum of z-scores for six US Census tract variables (% of adults with less than high school education; % of adults unemployed; % of households earning

Abstract Background Patients with inflammatory arthritis (IA), defined as rheumatoid arthritis (RA) and psoriatic arthritis (PsA), are at increased risk for cardiovascular disease (CVD). The frequency of screening and treatment of hyperlipidemia, a modifiable CVD risk factor, is low in these patients. The reasons for low screening and treatment rates in this population are poorly understood. Our objective was to elicit the barriers and facilitators for screening and treatment of hyperlipidemia from the perspective of patients with IA. Methods We conducted a qualitative study using focus groups of patients with IA, guided by Bandura’s Social Cognitive Theory. We recruited patients with IA aged 40 years and older from a single academic center. Data were analyzed thematically. Results We conducted three focus groups with 17 participants whose mean age was 56 (range 45–81) years; 15 were women. Four themes emerged as barriers: 1) need for more information about arthritis, prognosis, and IA medications prior to discussing additional topics like CVD risk; 2) lack of knowledge about how IA increases CVD risk; 3) lifestyle changes to reduce overall CVD risk rather than medications; and 4) the need to improve doctor-patient communication about IA, medications, and CVD risk. One theme emerged as a facilitator: 5) potential for peer coaches (patients with IA who are trained about concepts of CVD risk and IA) to help overcome barriers to screening and treatment of hyperlipidemia to lower CVD risk. Conclusion Patients with IA identified educational needs about IA, increased CVD risk in IA and the need for improved doctor-patient communication about screening for hyperlipidemia and its treatment. Patients were receptive to working with peer coaches to facilitate achievement of these goals.

Abstract Background Gout has been associated with a higher risk for coronary heart disease (CHD) and stroke in some prior studies. Few studies have assessed the association of gout with incident heart failure (HF). Methods We analyzed data from 5713 black and white men and women ≥ 65.5 years of age in the population-based REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort study who had Medicare coverage without a history of HF, CHD, or stroke at baseline between 2003 and 2007. Gout was defined by ≥ 1 hospitalization or ≥ 2 outpatient visits with a diagnosis code for gout in Medicare claims prior to each participant’s baseline study examination. REGARDS study participants were followed for HF hospitalization, CHD, stroke, and all-cause mortality as separate outcomes through December 31, 2016. Analyses were replicated in a random sample of 839,059 patients ≥ 65.5 years of age with Medicare coverage between January 1, 2008, and June 30, 2015, who were followed through December 31, 2017. Results Among REGARDS study participants included in the current analysis, the mean age at baseline was 72.6 years, 44.9% were men, 31.4% were black, and 3.3% had gout. Over a median follow-up of 10.0 years, incidence rates per 1000 person-years among participants with and without gout were 13.1 and 4.4 for HF hospitalization, 16.0 and 9.3 for CHD, 9.3 and 8.2 for stroke, and 55.0 and 37.1 for all-cause mortality, respectively. After multivariable adjustment for sociodemographic variables and cardiovascular risk factors, hazard ratios (95% CI) comparing participants with versus without gout were 1.97 (1.22, 3.19) for HF hospitalization, 1.21 (0.79, 1.84) for CHD, 0.83 (0.48, 1.43) for stroke, and 1.08 (0.86, 1.35) for all-cause mortality. The multivariable-adjusted hazard ratio for HF hospitalization with reduced and preserved left ventricular ejection fraction among participants with versus without gout was 1.77 (95% CI 0.83, 3.79) and 2.32 (95% CI 1.12, 4.79), respectively. The multivariable-adjusted hazard ratio for heart failure hospitalization associated with gout among the 839,059 Medicare beneficiaries was 1.32 (95% CI 1.25, 1.39). Conclusion Among older adults, gout was associated with an increased risk for incident HF but not for incident CHD, incident stroke, or all-cause mortality.

Abstract Background Despite high risk for cardiovascular disease (CVD) mortality, screening and treatment of hyperlipidemia in patients with rheumatoid arthritis (RA) is suboptimal. We asked primary care physicians (PCPs) and rheumatologists to identify barriers to screening and treatment for hyperlipidemia among patients with RA. Methods We recruited rheumatologists and PCPs nationally to participate in separate moderated structured group teleconference discussions using the nominal group technique. Participants in each group generated lists of barriers to screening and treatment for hyperlipidemia in patients with RA, then each selected the three most important barriers from this list. The resulting barriers were organized into physician-, patient- and system-level barriers, informed by the socioecological framework. Results Twenty-seven rheumatologists participated in a total of 3 groups (group size ranged from 7 to 11) and twenty PCPs participated in a total of 3 groups (group size ranged from 4 to 9). Rheumatologists prioritized physician level barriers (e.g. ‘ownership’ of hyperlipidemia screening and treatment), whereas PCPs prioritized patient-level barriers (e.g. complexity of RA and its treatments). Conclusion Rheumatologists were conflicted about whether treatment of CVD risk among patients with RA should fall within the role of the rheumatologist or the PCP. All participating PCPs agreed that CVD risk reduction was within their role. Factors that influenced PCPs’ decisions for screening and treatment for CVD risk in patients with RA were mainly related to their concern about how treatment for CVD risk could influence RA symptomatology (myalgia from statins) or how inflammation from RA and RA medications influences lipid profiles.

Abstract Background Claims-based algorithms are commonly used to identify sepsis in health services research because the laboratory features required to define clinical criteria may not be available in administrative data. Methods We evaluated claims-based sepsis algorithms among adults in the US aged ≥65 years with Medicare health insurance enrolled in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. Suspected infections from baseline (2003–2007) through December 31, 2012 were analyzed. Two claims-based algorithms were evaluated: (1) infection plus organ dysfunction diagnoses or sepsis diagnoses (Medicare-Implicit/Explicit) and (2) Centers for Medicare and Medicaid Services Severe Sepsis/Septic Shock Measure diagnoses (Medicare-CMS). Three classifications based on clinical criteria were used as standards for comparison: (1) the sepsis-related organ failure assessment (SOFA) score (REGARDS-SOFA), (2) “quick” SOFA (REGARDS-qSOFA), and (3) Centers for Disease Control and Prevention electronic health record criteria (REGARDS-EHR). Results There were 2217 suspected infections among 9522 participants included in the current study. The total number of suspected infections classified as sepsis was 468 for Medicare-Implicit/Explicit, 249 for Medicare-CMS, 541 for REGARDS-SOFA, 185 for REGARDS-qSOFA, and 331 for REGARDS-EHR. The overall agreement between Medicare-Implicit/Explicit and REGARDS-SOFA, REGARDS-qSOFA, and REGARDS-EHR was 77, 79, and 81%, respectively, sensitivity was 46, 53, and 57%, and specificity was 87, 82, and 85%. Comparing Medicare-CMS and REGARDS-SOFA, REGARDS-qSOFA, and REGARDS-EHR, agreement was 77, 87, and 85%, respectively, sensitivity was 27, 41, and 36%, and specificity was 94, 92, and 93%. Events meeting the REGARDS-SOFA classification had a lower 90-day mortality rate (140.7 per 100 person-years) compared with the Medicare-CMS (296.1 per 100 person-years), REGARDS-qSOFA (238.6 per 100 person-years), Medicare-Implicit/Explicit (219.4 per 100 person-years), and REGARDS-EHR classifications (201.8 per 100 person-years). Conclusion Claims-based sepsis algorithms have high agreement and specificity but low sensitivity when compared with clinical criteria. Both claims-based algorithms identified a patient population with similar 90-day mortality rates as compared with classifications based on qSOFA and EHR criteria but higher mortality relative to SOFA criteria.

Abstract Background Studies examining incident heart failure (HF) have been limited to select populations. To examine incident HF with broader generalizability, there is need to assemble a HF-free cohort using a geographically-diverse sample. We aimed to develop and validate a simple medication-based strategy for assembling a HF-free cohort from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. Methods We examined REGARDS participants with ≥6 months of Medicare inpatient and outpatient claims data at the time of the baseline in-home study examination. To assemble a HF-free cohort, we identified and excluded participants taking HF-specific medications. To validate this approach, we evaluated event rates among this cohort and assessed diagnostic performance using Medicare claims-based definitions of HF as the referent standard. Results Among 28,884 eligible participants, 3125 were excluded from the proposed HF-free cohort, leaving a total of 25,759 (89%) participants. Depending on the Medicare definition used as the referent, the negative predictive value of this approach ranged from 95.0–99.2%. Negative predictive value was stable across age, sex, and race strata. Conclusions The approach to assemble a HF-free cohort in REGARDS can serve as the basis for future studies to examine incident HF in REGARDS and similar studies.

BackgroundAlpha globin is expressed in the endothelial cells of human resistance arteries where it binds to endothelial nitric oxide synthase and limits release of the vasodilator nitric oxide. Genomic deletion of the alpha globin gene (HBA) is common among Black Americans and could lead to increased endothelial nitric oxide signaling and reduced risk of hypertension.MethodsCommunity-dwelling US adults aged 45 years or older were enrolled and examined from 2003 to 2007, followed by telephone every 6 months, and reexamined from 2013 to 2016. At both visits, trained personnel performed standardized, in-home blood pressure measurements and pill bottle review. Prevalent hypertension was defined as systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg or anti-hypertensive medication use. Droplet digital PCR was used to determine HBA copy number. The associations of HBA copy number with prevalent hypertension, resistant hypertension, and incident hypertension were estimated using multivariable regression.ResultsAmong 9,684 Black participants, 7,439 (77%) had hypertension at baseline and 1,044 of those had treatment-resistant hypertension. 1,000 participants were not hypertensive at baseline and participated in a follow up visit; 517 (52%) developed hypertension over median 9.2 years follow-up. Increased HBA copy number was not associated with prevalent hypertension (PR = 1.00; 95%CI 0.98,1.02), resistant hypertension (PR = 0.95; 95%CI 0.86,1.05), or incident hypertension (RR = 0.96; 95%CI 0.86,1.07).ConclusionsThere were no associations between increased HBA copy number and risk of hypertension. These findings suggest that variation in alpha globin gene copy number does not modify the risk of hypertension among Black American adults.

Background It is unknown if stroke symptoms in the absence of a stroke diagnosis are a sign of subtle cardioembolic phenomena. The objective of this study was to examine associations between atrial fibrillation (AF) and stroke symptoms among adults with no clinical history of stroke or transient ischemic attack (TIA). Methods and Results We evaluated associations between AF and self‐reported stroke symptoms in the national, prospective REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort. We conducted cross‐sectional (n=27 135) and longitudinal (n=21 932) analyses over 8 years of follow‐up of REGARDS participants without stroke/transient ischemic attack and stratified by anticoagulant or antiplatelet agent use. The mean age was 64.4 (SD±9.4) years, 55.3% were women, and 40.8% were Black participants; 28.6% of participants with AF reported stroke symptoms. In the cross‐sectional analysis, comparing participants with and without AF, the risk of stroke symptoms was elevated for adults with AF taking neither anticoagulants nor antiplatelet agents (odds ratio [OR], 2.22; 95% CI, 1.89–2.59) or antiplatelet agents only (OR, 1.92; 95% CI, 1.61–2.29) but not for adults with AF taking anticoagulants (OR, 1.08; 95% CI, 0.71–1.65). In the longitudinal analysis, the risk of stroke symptoms was also elevated for adults with AF taking neither anticoagulants nor antiplatelet agents (hazard ratio [HR], 1.41; 95% CI, 1.21–1.66) or antiplatelet agents only (HR, 1.23; 95% CI, 1.04–1.46) but not for adults with AF taking anticoagulants (HR, 0.86; 95% CI, 0.62–1.18). Conclusions Stroke symptoms in the absence of a stroke diagnosis may represent subclinical cardioembolic phenomena or “whispering strokes.” Future studies examining the benefit of stroke symptom screening may be warranted.

Older individuals with chronic health conditions are at highest risk of adverse clinical outcomes from COVID-19, but there is widespread belief that risk to younger, relatively lower-risk individuals is negligible. We assessed the rate and predictors of life-threatening complications among relatively lower-risk adults hospitalized with COVID-19. Of 3766 adults hospitalized with COVID-19 to three hospitals in New York City from March to May 2020, 963 were relatively lower-risk based on absence of preexisting health conditions. Multivariable logistic regression models examined in-hospital development of life-threatening complications (major medical events, intubation, or death). Covariates included age, sex, race/ethnicity, hypertension, weight, insurance type, and area-level sociodemographic factors (poverty, crowdedness, and limited English proficiency). In individuals ≥55 years old (n = 522), 33.3% experienced a life-threatening complication, 17.4% were intubated, and 22.6% died. Among those

BackgroundPractice facilitators (PFs) provide tailored support to primary care practices to improve the quality of care delivery. Often used by PFs, the "Key Driver Implementation Scale" (KDIS) measures the degree to which a practice implements quality improvement activities from the Chronic Care Model, but the scale's psychometric properties have not been investigated. We examined construct validity, reliability, floor and ceiling effects, and a longitudinal trend test of the KDIS items in the Southeastern Collaboration to Improve Blood Pressure Control trial.MethodsThe KDIS items assess a practice's progress toward implementing: a clinical information system (using their own data to drive change); standardized care processes; optimized team care; patient self-management support; and leadership support. We assessed construct validity and estimated reliability with a multilevel confirmatory factor analysis (CFA). A trend test examined whether the KDIS items increased over time and estimated the expected number of months needed to move a practice to the highest response options.ResultsPFs completed monthly KDIS ratings over 12 months for 32 primary care practices, yielding a total of 384 observations. Data was fitted to a unidimensional CFA model; however, parameter fit was modest and could be improved. Reliability was 0.70. Practices started scoring at the highest levels beginning in month 5, indicating low variability. The KDIS items did show an upward trend over 12 months (all p < .001), indicating that practices were increasingly implementing key activities. The expected time to move a practice to the highest response category was 9.1 months for standardized care processes, 10.2 for clinical information system, 12.6 for self-management support, 13.1 for leadership, and 14.3 months for optimized team care.ConclusionsThe KDIS items showed acceptable reliability, but work is needed in larger sample sizes to determine if two or more groups of implementation activities are being measured rather than one.

Purpose To evaluate the association between body mass index (BMI) and clinical outcomes other than death in patients hospitalised and intubated with COVID-19.Methods This is a single-centre cohort study of adults with COVID-19 admitted to New York Presbyterian Hospital-Weill Cornell Medicine from 3 March 2020 through 15 May 2020. Baseline and outcome variables, as well as lab and ventilatory parameters, were generated for the admitted and intubated cohorts after stratifying by BMI category. Linear regression models were used for continuous, and logistic regression models were used for categorical outcomes.Results The study included 1337 admitted patients with a subset of 407 intubated patients. Among admitted patients, hospital length of stay (LOS) and home discharge was not significantly different across BMI categories independent of demographic characteristics and comorbidities. In the intubated cohort, there was no difference in in-hospital events and treatments, including renal replacement therapy, neuromuscular blockade and prone positioning. Ventilatory ratio was higher with increasing BMI on days 1, 3 and 7. There was no significant difference in ventilator free days (VFD) at 28 or 60 days, need for tracheostomy, hospital LOS, and discharge disposition based on BMI in the intubated cohort after adjustment.Conclusions In our COVID-19 population, there was no association between obesity and morbidity outcomes, such as hospital LOS, home discharge or VFD. Further research is needed to clarify the mechanisms underlying the reported effects of BMI on outcomes, which may be population dependent.

Objective: Black adults are less likely than White adults to present with adverse lipid profiles and more likely to present with low-grade inflammation. The impact of race on the association between atherogenic lipid profiles, inflammation, and coronary heart disease (CHD) is unknown. Methods: We evaluated the association between high levels (>50th percentile) of high-sensitivity C-reactive protein (hsCRP) and of triglycerides to high density lipoprotein ratio (TG/HDL-C) and CHD events by race in the REasons for Geographic and Racial Differences in Stroke (REGARDS) cohort with 30,239 Black and White participants aged 45 and older. Results: Participants with both high hsCRP and high TG/HDL-C had highest rates of CHD (HR 1.84; 95% CI: 1.48, 2.29 vs HR 1.52; 95% CI: 1.19, 1.94 in White vs Black participants respectively). Whereas isolated high hsCRP was associated with increased CHD risk in both races (HR 1.68; 95% CI: 1.31, 2.15 and HR 1.43; 95% CI: 1.13, 1.81 for White and Black participants respectively), isolated high TG/HDL was associated with increased CHD risk only in White participants (HR 1.44; 95% CI: 1.15, 1.79 vs HR 1.01; 95% CI: 0.74, 1.38). Further, the effects of high hsCRP and high TG/HDL-C were additive, with inflammation being the driving variable for the association in both races. Conclusion: In both races, higher inflammation combined with adverse lipid profile is associated with greater CHD risk. Therefore, inflammation increases CHD risk in both races whereas dyslipidemia alone is associated with a greater risk in White but not in Black adults. hsCRP testing should be a standard feature of CHD risk assessment, particularly in Black patients.

Study objective: To determine whether recurrent myocardial infarction (MI) is associated with increased risk of mortality, long-term nursing home placement, and impoverishment. Design: Retrospective cohort study. Setting: United States Medicare program. Participants: Individuals age > 65 years with recurrent MI hospitalizations (n = 228,826) between January 1, 2007 and June 30, 2017 and controls with initial but not recurrent MI (n = 915,304). Main outcome measures: Death, nursing home placement, and impoverishment (Medicaid enrollment or subsidies for low-income and -resource individuals) through December 31, 2017. Results: In the recurrent MI and control cohorts, 47% and 41% of individuals were age > 80 years, respectively, and 56% of both cohorts were women. After 1 year, 48% of the recurrent MI cohort and 16% of the control cohort died, 9% and 7% experienced nursing home placement, and 4% and 2% experienced impoverishment. Multivariable-adjusted hazard ratios (95% confidence intervals) comparing the recurrent MI and control cohorts were 2.04 (2.03–2.06) for death, 0.89 (0.88–0.91) for nursing home placement, and 1.32 (1.28–1.36) for impoverishment. Conclusions: Older US adults with recurrent MI had higher risk of death and impoverishment than controls who had experienced an initial MI. Unadjusted, recurrent MI was associated with higher risk of nursing home placement; however, after adjusting for sociodemographic characteristics and comorbidities, individuals with recurrent MI had slightly lower risk of nursing home placement. Preventing recurrent MI may also reduce the risk of death and impoverishment among older US adults.

Background Sudden cardiac death (SCD) is a common cause of death in the United States. Few previous studies have investigated the associations of diet scores and dietary patterns with risk of SCD. We investigated the associations of the Mediterranean diet score and various dietary patterns with risk of SCD in participants in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study cohort. Methods and Results Diet was assessed with a food frequency questionnaire administered at baseline in REGARDS. The Mediterranean diet score was derived based on the consumption of specific food groups considered beneficial or detrimental components of that diet. Dietary patterns were derived previously using factor analysis, and adherence to each pattern was scored. SCD events were ascertained through regular contacts. Cox proportional hazards regression was used to examine the risk of SCD events associated with the Mediterranean diet score and adherence to each of the 5 dietary patterns overall and stratifying on history of coronary heart disease at baseline. The analytic sample included 21 069 participants with a mean 9.8±3.8 years of follow‐up. The Mediterranean diet score showed a trend toward an inverse association with risk of SCD after multivariable adjustment (hazard ratio [HR] comparing highest with lowest group, 0.74; 95% CI, 0.55–1.01; Ptrend=0.07). There was a trend toward a positive association of the Southern dietary pattern with risk of SCD (HR comparing highest with lowest quartile of adherence, 1.46; 95% CI, 1.02–2.10; Ptrend=0.06). Conclusions In REGARDS participants, we identified trends toward an inverse association of the Mediterranean diet score and a positive association of adherence to the Southern dietary pattern with risk of SCD.