Factors associated with anxiety during the first two years of the COVID-19 pandemic in the United States: An analysis of the COVID-19 Citizen Science study.

COVID-19 increased the prevalence of clinically significant anxiety in the United States. To investigate contributing factors we analyzed anxiety, reported online via monthly Generalized Anxiety Disorders-7 (GAD-7) surveys between April 2020 and May 2022, in association with self-reported worry about the health effects of COVID-19, economic difficulty, personal COVID-19 experience, and subjective social status. 333,292 anxiety surveys from 50,172 participants (82% non-Hispanic white; 73% female; median age 55, IQR 42-66) showed high levels of anxiety, especially early in the pandemic. Anxiety scores showed strong independent associations with worry about the health effects of COVID-19 for oneself or family members (GAD-7 score +3.28 for highest vs. lowest category; 95% confidence interval: 3.24, 3.33; p<0.0001 for trend) and with difficulty paying for basic living expenses (+2.06; 1.97, 2.15, p<0.0001) in multivariable regression models after adjusting for demographic characteristics, COVID-19 case rates and death rates, and personal COVID-19 experience. High levels of COVID-19 health worry and economic stress were each more common among participants reporting lower subjective social status, and median anxiety scores for those experiencing both were in the range considered indicative of moderate to severe clinical anxiety disorders. In summary, health worry and economic difficulty both contributed to high rates of anxiety during the first two years of the COVID-19 pandemic in the US, especially in disadvantaged socioeconomic groups. Programs to address both health concerns and economic insecurity in vulnerable populations could help mitigate pandemic impacts on anxiety and mental health.

Association of nirmatrelvir for acute SARS-CoV-2 infection with subsequent Long COVID symptoms in an observational cohort study.

Oral nirmatrelvir/ritonavir is approved as treatment for acute COVID-19, but the effect of treatment during acute infection on risk of Long COVID is unknown. We hypothesized that nirmatrelvir treatment during acute SARS-CoV-2 infection reduces risk of developing Long COVID and rebound after treatment is associated with Long COVID. We conducted an observational cohort study within the Covid Citizen Science (CCS) study, an online cohort study with over 100 000 participants. We included vaccinated, nonhospitalized, nonpregnant individuals who reported their first SARS-CoV-2 positive test March-August 2022. Oral nirmatrelvir/ritonavir treatment was ascertained during acute SARS-CoV-2 infection. Patient-reported Long COVID symptoms, symptom rebound and test-positivity rebound were asked on subsequent surveys at least 3 months after SARS-CoV-2 infection. A total of 4684 individuals met the eligibility criteria, of whom 988 (21.1%) were treated and 3696 (78.9%) were untreated; 353/988 (35.7%) treated and 1258/3696 (34.0%) untreated responded to the Long COVID survey (n = 1611). Among 1611 participants, median age was 55 years and 66% were female. At 5.4 ± 1.3 months after infection, nirmatrelvir treatment was not associated with subsequent Long COVID symptoms (odds ratio [OR]: 1.15; 95% confidence interval [CI]: 0.80-1.64; p = 0.45). Among 666 treated who answered rebound questions, rebound symptoms or test positivity were not associated with Long COVID symptoms (OR: 1.34; 95% CI: 0.74-2.41; p = 0.33). Within this cohort of vaccinated, nonhospitalized individuals, oral nirmatrelvir treatment during acute SARS-CoV-2 infection and rebound after nirmatrelvir treatment were not associated with Long COVID symptoms more than 90 days after infection.

Associations between tobacco and cannabis use and anxiety and depression among adults in the United States: Findings from the COVID-19 citizen science study.

BACKGROUND: Little is known about whether people who use both tobacco and cannabis (co-use) are more or less likely to have mental health disorders than single substance users or non-users. We aimed to examine associations between use of tobacco and/or cannabis with anxiety and depression. METHODS: We analyzed data from the COVID-19 Citizen Science Study, a digital cohort study, collected via online surveys during 2020-2022 from a convenience sample of 53,843 US adults (≥ 18 years old) nationwide. Past 30-day use of tobacco and cannabis was self-reported at baseline and categorized into four exclusive patterns: tobacco-only use, cannabis-only use, co-use of both substances, and non-use. Anxiety and depression were repeatedly measured in monthly surveys. To account for multiple assessments of mental health outcomes within a participant, we used Generalized Estimating Equations to examine associations between the patterns of tobacco and cannabis use with each outcome. RESULTS: In the total sample (mean age 51.0 years old, 67.9% female), 4.9% reported tobacco-only use, 6.9% cannabis-only use, 1.6% co-use, and 86.6% non-use. Proportions of reporting anxiety and depression were highest for the co-use group (26.5% and 28.3%, respectively) and lowest for the non-use group (10.6% and 11.2%, respectively). Compared to non-use, the adjusted odds of mental health disorders were highest for co-use (Anxiety: OR = 1.89, 95%CI = 1.64-2.18; Depression: OR = 1.77, 95%CI = 1.46-2.16), followed by cannabis-only use, and tobacco-only use. Compared to tobacco-only use, co-use (OR = 1.35, 95%CI = 1.08-1.69) and cannabis-only use (OR = 1.17, 95%CI = 1.00-1.37) were associated with higher adjusted odds for anxiety, but not for depression. Daily use (vs. non-daily use) of cigarettes, e-cigarettes, and cannabis were associated with higher adjusted odds for anxiety and depression. CONCLUSIONS: Use of tobacco and/or cannabis, particularly co-use of both substances, were associated with poor mental health. Integrating mental health support with tobacco and cannabis cessation may address this co-morbidity.

Cardiovascular health among persons with HIV without existing atherosclerotic cardiovascular disease.

OBJECTIVES: We sought to characterize atherosclerotic cardiovascular disease (ASCVD) risk and metrics of cardiovascular health in persons with HIV (PWH) eligible for primary prevention of ASCVD. DESIGN: A cross-sectional study of PWH 40 years and older without documented ASCVD who received care at three HIV clinics in San Francisco from 2019 to 2022. METHODS: We used ICD-10 codes and electronic health record data to assess ASCVD risk and cardiovascular health, as defined by the American Heart Association's Life's Essential 8 (LE8) metrics for nicotine exposure, BMI, lipids, glucose, and blood pressure (BP). RESULTS: Among 2567 PWH eligible for primary prevention of ASCVD, the median age was 55 years, 14% were women, and 95% were on antiretroviral therapy. Seventy-seven percent had undergone complete assessment of ASCVD risk factors, and 50% of these patients had intermediate-high ASCVD risk (≥7.5%). Of those with hypertension, 39% were prescribed an antihypertensive. Among those eligible, 43% were prescribed a statin. The mean LE8 cardiovascular health score [0--100 (best health)] was 55.1 for nicotine exposure, 71.3 for BMI, 70.4 for lipids, 81.2 for blood glucose, 56.0 for BP, with an average score of 66.2 across the five metrics. Patients with Medicare insurance, black patients, and those with sleep apnea and chronic kidney disease had on average lower cardiovascular health scores; patients with undetectable viral loads had higher cardiovascular health scores. CONCLUSION: We highlight opportunities for improving primary prevention of ASCVD among PWH, especially in the areas of guideline-based therapy, nicotine exposure, and BP control.

Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study.

BACKGROUND: Healthy diet and exercise can improve quality of life and prognosis among men with prostate cancer. Understanding the perceived barriers to lifestyle change and patient preferences in a diverse cohort of men with prostate cancer is necessary to inform mobile health (mHealth) lifestyle interventions and increase health equity. OBJECTIVE: We conducted a multisite study to understand the preferences, attitudes, and health behaviors related to diet and lifestyle in this patient population. This report focuses on the qualitative findings from 4 web-based focus groups comprising a racially and ethnically diverse group of patients with advanced prostate cancer who are on androgen deprivation therapy. METHODS: We used grounded theory analyses including open, axial, and selective coding to generate codes. Qualitative data were analyzed as a whole rather than by focus group to optimize data saturation and the transferability of results. We present codes and themes that emerged for lifestyle intervention design and provide recommendations and considerations for future mHealth intervention studies. RESULTS: Overall, 14 men participated in 4 racially and ethnically concordant focus groups (African American or Black: 3/14, 21%; Asian American: 3/14, 21%; Hispanic or Latino: 3/14, 21%; and White: 5/14, 36%). Analyses converged on 7 interwoven categories: context (home environment, access, competing priorities, and lifestyle programs), motivation (accountability, discordance, feeling supported, fear, and temptation), preparedness (health literacy, technological literacy, technological preferences, trust, readiness to change, identity, adaptability, and clinical characteristics), data-driven design (education, psychosocial factors, and quality of life), program mechanics (communication, materials, customization, and being holistic), habits (eg, dietary habits), and intervention impressions. These results suggest actionable pathways to increase program intuitiveness. Recommendations for future mHealth intervention design and implementation include but are not limited to assessment at the individual, household, and neighborhood levels to support a tailored intervention; prioritization of information to disseminate based on individuals' major concerns and the delivery of information based on health and technological literacy and communication preferences; prescribing a personalized intervention based on individuals' baseline responses, home and neighborhood environment, and support network; and incorporating strategies to foster engagement (eg, responsive and relevant feedback systems) to aid participant decision-making and behavior change. CONCLUSIONS: Assessing a patient's social context, motivation, and preparedness is necessary when tailoring a program to each patient's needs in all racial and ethnic groups. Addressing the patients' contexts and motivation and preparedness related to diet and exercise including the household, access (to food and exercise), competing priorities, health and technological literacy, readiness to change, and clinical characteristics will help to customize the intervention to the participant. These data support a tailored approach leveraging the identified components and their interrelationships to ensure that mHealth lifestyle interventions will engage and be effective in racially and ethnically diverse patients with cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT05324098; https://clinicaltrials.gov/ct2/show/NCT05324098.

The Association Between Mobile App Use and Change in Functional Capacity Among Cardiac Rehabilitation Participants: Cohort Study.

BACKGROUND: Cardiac rehabilitation (CR) is underused in the United States and globally, with participation disparities across gender, socioeconomic status, race, and ethnicities. The pandemic led to greater adoption of telehealth CR and mobile app use. OBJECTIVE: Our primary objective was to estimate the association between CR mobile app use and change in functional capacity from enrollment to completion in patients participating in a CR program that offered in-person, hybrid, and telehealth CR. Our secondary objectives were to study the association between mobile app use and changes in blood pressure (BP) or program completion. METHODS: We conducted a retrospective cohort study of participants enrolled in CR at an urban CR program in the United States. Participants were English speaking, at least 18 years of age, participated in the program between May 22, 2020, and May 21, 2022, and downloaded the CR mobile app. Mobile app use was quantified by number of exercise logs, vitals logs, and education material views. The primary outcome was change in functional capacity, measured by change in 6-minute walk distance (6MWD) from enrollment to completion. The secondary outcome was change in BP from enrollment to completion. We estimated associations using multivariable linear or logistic regression models adjusted for age, sex, race, ethnicity, socioeconomic status by ZIP code, insurance, and primary diagnosis for CR referral. RESULTS: A total of 107 participants (mean age 62.9, SD 13.02 years; 90/107, 84.1% male; and 57/105, 53.3% self-declared as White Caucasian) used the mobile app and completed the CR program. Participants had a mean 64.0 (SD 54.1) meter increase in 6MWD between enrollment and completion (P<.001). From enrollment to completion, participants with an elevated BP at baseline (≥130/80 mmHg) experienced a significant decrease in BP (systolic BP -11.5 mmHg; P=.002 and diastolic BP -7.7 mmHg; P=.003). We found no significant association between total app interactions and change in 6MWD (coefficient -0.03, 95% CI -0.1 to 0.07; P=.59) or change in BP (systolic coefficient 0.002, 95% CI -0.03 to 0.03; P=.87 and diastolic coefficient -0.005, 95% CI -0.03 to 0.02; P=.65). There was no significant association between total exercise logs and change in 6MWD (coefficient 0.1, 95% CI -0.3 to 0.4; P=.57) or total BP logs and change in BP (systolic coefficient -0.02, 95% CI -0.1 to 0.06; P=.63 and diastolic coefficient -0.02, 95% CI -0.09 to 0.04; P=.50). There was no significant association between total app interactions and completion of CR (adjusted odds ratio 1.00, 95% CI 0.99-1.01; P=.44). CONCLUSIONS: CR mobile app use as part of an in-person, hybrid, or telehealth CR program was not associated with greater improvement in functional capacity or BP or with program completion.

Physician responses to apple watch-detected irregular rhythm alerts.

BACKGROUND: While the US Food and Drug Administration (FDA) has cleared smartwatch software for detecting atrial fibrillation (AF), there is lack of guidance on management by physicians. We sought to evaluate the approach to management of Apple Watch alerts for AF by physicians and assess whether respondent and case characteristics were associated with their approach. METHODS: We conducted a case-based survey of physicians practicing primary care, emergency medicine, and cardiology at 2 large academic centers (Yale and University of California San Francisco) between September and December 2021. Cases described asymptomatic patients receiving Apple Watch AF alerts; cases varied in sex, race, medical history, and notification frequency. We evaluated physician responses among prespecified diagnostic testing, referral, and treatment options. RESULTS: We emailed 636 physicians, of whom 95 (14.9%) completed the survey, including 39 primary care, 25 emergency medicine, and 31 cardiology physicians. Among a total of 192 cases (16 unique scenarios), physicians selected at least one diagnostic test in 191 (99.5%) cases and medications in 48 (25.0%). Physicians in primary care, emergency medicine, and cardiology reported varying preference for patient referral (14%, 30%, and 16%, respectively; P=.048), rhythm monitoring (84%, 46%, and 94%, respectively; P<.001), measurement of BNP (8%, 20%, and 2%; P=.003), and use of antiarrhythmics (16%, 4%, and 23%; P=.023). There were few physician differences in reported practices across patient demographics (sex and race), clinical complexity, and alert frequency of the clinical case. CONCLUSIONS: In hypothetical cases of patients presenting without clinical symptoms, physicians opted for further diagnostic testing and often to medical intervention based on Apple Watch irregular rhythm notifications. There was also considerable variation across physician specialties, suggesting a need for uniform clinical practice guidelines. Additional study is required before irregular rhythm notifications should be used in clinical settings.

Geographic Variation in Access to Cardiac Rehabilitation.

BACKGROUND: There is marked geographic variation in cardiac rehabilitation (CR) initiation, ranging from 10% to 40% of eligible patients at the state level. The potential causes of this variation, such as patient access to CR centers, are not well studied. OBJECTIVES: The authors sought to determine how access to CR centers affects CR initiation in Medicare beneficiaries. METHODS: The authors used Medicare files to identify CR-eligible Medicare beneficiaries and calculate CR initiation rates at the hospital referral region (HRR) level. We used linear regression to evaluate the percent variation in CR initiation accounted for by CR access across HRRs. We then employed geospatial hotspot analysis to identify CR deserts, or counties in which patient load per CR center is disproportionately high. RESULTS: A total of 1,133,657 Medicare beneficiaries were eligible for CR from 2014 to 2017, of whom 263,310 (23%) initiated CR. The West North Central Census Division had the highest adjusted CR initiation rate (35.4%) and the highest density of CR programs (6.58 per 1,000 CR-eligible Medicare beneficiaries). Density of CR programs accounted for 21.2% of geographic variation in CR initiation at the HRR level. A total of 40 largely urban counties comprising 14% of the United States population age ≥65 years had disproportionately low CR access and were identified as CR deserts. CONCLUSIONS: A substantial proportion of geographic variation in CR initiation was related to access to CR programs, with a significant amount of the U.S. population living in CR deserts. These data invite further study on interventions to increase CR access.

Factors Associated With Long COVID Symptoms in an Online Cohort Study.

Background: Few prospective studies of Long COVID risk factors have been conducted. The purpose of this study was to determine whether sociodemographic factors, lifestyle, or medical history preceding COVID-19 or characteristics of acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are associated with Long COVID. Methods: In March 26, 2020, the COVID-19 Citizen Science study, an online cohort study, began enrolling participants with longitudinal assessment of symptoms before, during, and after SARS-CoV-2 infection. Adult participants who reported a positive SARS-CoV-2 test result before April 4, 2022 were surveyed for Long COVID symptoms. The primary outcome was at least 1 prevalent Long COVID symptom greater than 1 month after acute infection. Exposures of interest included age, sex, race/ethnicity, education, employment, socioeconomic status/financial insecurity, self-reported medical history, vaccination status, variant wave, number of acute symptoms, pre-COVID depression, anxiety, alcohol and drug use, sleep, and exercise. Results: Of 13 305 participants who reported a SARS-CoV-2 positive test, 1480 (11.1%) responded. Respondents' mean age was 53 and 1017 (69%) were female. Four hundred seventy-six (32.2%) participants reported Long COVID symptoms at a median 360 days after infection. In multivariable models, number of acute symptoms (odds ratio [OR], 1.30 per symptom; 95% confidence interval [CI], 1.20-1.40), lower socioeconomic status/financial insecurity (OR, 1.62; 95% CI, 1.02-2.63), preinfection depression (OR, 1.08; 95% CI, 1.01-1.16), and earlier variants (OR = 0.37 for Omicron compared with ancestral strain; 95% CI, 0.15-0.90) were associated with Long COVID symptoms. Conclusions: Variant wave, severity of acute infection, lower socioeconomic status, and pre-existing depression are associated with Long COVID symptoms.

A New Era in Cardiac Rehabilitation Delivery: Research Gaps, Questions, Strategies, and Priorities.

Cardiac rehabilitation (CR) is a guideline-recommended, multidisciplinary program of exercise training, risk factor management, and psychosocial counseling for people with cardiovascular disease (CVD) that is beneficial but underused and with substantial disparities in referral, access, and participation. The emergence of new virtual and remote delivery models has the potential to improve access to and participation in CR and ultimately improve outcomes for people with CVD. Although data suggest that new delivery models for CR have safety and efficacy similar to traditional in-person CR, questions remain regarding which participants are most likely to benefit from these models, how and where such programs should be delivered, and their effect on outcomes in diverse populations. In this review, we describe important gaps in evidence, identify relevant research questions, and propose strategies for addressing them. We highlight 4 research priorities: (1) including diverse populations in all CR research; (2) leveraging implementation methodologies to enhance equitable delivery of CR; (3) clarifying which populations are most likely to benefit from virtual and remote CR; and (4) comparing traditional in-person CR with virtual and remote CR in diverse populations using multicenter studies of important clinical, psychosocial, and cost-effectiveness outcomes that are relevant to patients, caregivers, providers, health systems, and payors. By framing these important questions, we hope to advance toward a goal of delivering high-quality CR to as many people as possible to improve outcomes in those with CVD.

Development of text messages for primary prevention of cardiovascular disease in persons with HIV.

Objective: Persons with HIV (PWH) have increased risk for atherosclerotic cardiovascular disease (CVD). Despite this increased risk, perceived cardiovascular risk among PWH is low, and interventions that are known to be beneficial in the general population, such as statins, have low uptake in this population. We sought to develop a bank of text messages about (1) the association between HIV and CVD and (2) advice on reducing cardiovascular risk. Methods: We developed an initial bank of 162 messages. We solicited feedback from 29 PWH recruited from outpatient clinics providing HIV care at a large urban tertiary medical center and a public hospital in San Francisco, California. Participants reviewed 7-10 messages each and rated message usefulness, readability, and potential impact on behavior on a scale from 1 (least) to 5 (most). We also collected open-ended feedback on the messages and data on preferences about message timing. Results: The average score for the messages was 4.4/5 for usefulness, 4.4/5 for readability, and 4.0/5 for potential impact on behavior. The text messages were iteratively revised based on participant feedback, and lowest-rated messages were removed from the message bank. The final message bank included 116 messages on diet (30.2%), physical activity (24.8%), tobacco (11.2%), the association between HIV and cardiovascular disease (9.5%), general heart health (6.9%), cholesterol (5.2%), blood pressure (4.3%), blood sugar (2.6%), sleep (2.6%), and weight (2.6%). Conclusion: We describe an approach for developing educational text messages on primary prevention of cardiovascular disease among PWH.

Factors Associated with Long Covid Symptoms in an Online Cohort Study.

Importance: Prolonged symptoms following SARS-CoV-2 infection, or Long COVID, is common, but few prospective studies of Long COVID risk factors have been conducted. Objective: To determine whether sociodemographic factors, lifestyle, or medical history preceding COVID-19 or characteristics of acute SARS-CoV-2 infection are associated with Long COVID. Design: Cohort study with longitudinal assessment of symptoms before, during, and after SARS-CoV-2 infection, and cross-sectional assessment of Long COVID symptoms using data from the COVID-19 Citizen Science (CCS) study. Setting: CCS is an online cohort study that began enrolling March 26, 2020. We included data collected between March 26, 2020, and May 18, 2022. Participants: Adult CCS participants who reported a positive SARS-CoV-2 test result (PCR, Antigen, or Antibody) more than 30 days prior to May 4, 2022, were surveyed. Exposures: Age, sex, race/ethnicity, education, employment, socioeconomic status/financial insecurity, self-reported medical history, vaccination status, time of infection (variant wave), number of acute symptoms, pre-COVID depression, anxiety, alcohol and drug use, sleep, exercise. Main Outcome: Presence of at least 1 Long COVID symptom greater than 1 month after acute infection. Sensitivity analyses were performed considering only symptoms beyond 3 months and only severe symptoms. Results: 13,305 participants reported a SARS-CoV-2 positive test more than 30 days prior, 1480 (11.1% of eligible) responded to a survey about Long COVID symptoms, and 476 (32.2% of respondents) reported Long COVID symptoms (median 360 days after infection).Respondents' mean age was 53 and 1017 (69%) were female. Common Long COVID symptoms included fatigue, reported by 230/476 (48.3%), shortness of breath (109, 22.9%), confusion/brain fog (108, 22.7%), headache (103, 21.6%), and altered taste or smell (98, 20.6%). In multivariable models, number of acute COVID-19 symptoms (OR 1.30 per symptom, 95%CI 1.20-1.40), lower socioeconomic status/financial insecurity (OR 1.62, 95%CI 1.02-2.63), pre-infection depression (OR 1.08, 95%CI 1.01-1.16), and earlier variants (OR 0.37 for Omicron compared to ancestral strain, 95%CI 0.15-0.90) were associated with Long COVID symptoms. Conclusions and Relevance: Variant wave, severity of acute infection, lower socioeconomic status and pre-existing depression are associated with Long COVID symptoms. Key Points: Question: What are the patterns of symptoms and risk factors for Long COVID among SARS-CoV-2 infected individuals?Findings: Persistent symptoms were highly prevalent, especially fatigue, shortness of breath, headache, brain fog/confusion, and altered taste/smell, which persisted beyond 1 year among 56% of participants with symptoms; a minority of participants reported severe Long COVID symptoms. Number of acute symptoms during acute SARS-CoV-2 infection, financial insecurity, pre-existing depression, and infection with earlier variants are associated with prevalent Long COVID symptoms independent of vaccination, medical history, and other factors.Meaning: Severity of acute infection, SARS-CoV-2 variant, and financial insecurity and depression are associated with Long COVID symptoms.

Cardiac Rehabilitation and the COVID-19 Pandemic: Persistent Declines in Cardiac Rehabilitation Participation and Access Among US Medicare Beneficiaries.

BACKGROUND: The impact of the COVID-19 pandemic on participation in and availability of cardiac rehabilitation (CR) is unknown. METHODS: Among eligible Medicare fee-for-service beneficiaries, we evaluated, by month, the number of CR sessions attended per 100 000 beneficiaries, individuals eligible to initiate CR, and centers offering in-person CR between January 2019 and December 2021. We compared these outcomes between 2 periods: December 1, 2019 through February 28, 2020 (period 1, before declaration of the pandemic-related national emergency) and October 1, 2021 through December 31, 2021 (period 2, the latest period for which data are currently available). RESULTS: In period 1, Medicare beneficiaries participated in (mean±SD) 895±84 CR sessions per 100 000 beneficiaries each month. After the national emergency was declared, CR participation sharply declined to 56 CR sessions per 100 000 beneficiaries in April 2020. CR participation recovered gradually through December 2021 but remained lower than prepandemic levels (period 2: 698±29 CR sessions per month per 100 000 beneficiaries, P=0.02). Declines in CR participation were most marked among dual Medicare and Medicaid enrollees and patients residing in rural areas or socially vulnerable communities. There was no statistically significant change in CR eligibility between the 2 periods. Compared with 2618±5 CR centers in period 1, there were 2464±7 in period 2 (P<0.01). Compared with CR centers that survived the pandemic, 220 CR centers that closed were more likely to be affiliated with public hospitals, located in rural areas, and serve the most socially vulnerable communities. CONCLUSIONS: The COVID-19 pandemic was associated with a persistent decline in CR participation and the closure of CR centers, which disproportionately affected rural and low-income patients and the most socially vulnerable communities. Innovation in CR financing and delivery is urgently needed to equitably enhance CR participation among Medicare beneficiaries.

Clinical Outcomes and Qualitative Perceptions of In-person, Hybrid, and Virtual Cardiac Rehabilitation.

PURPOSE: Cardiac rehabilitation (CR) is evolving to include both in-person and virtual delivery. Our objective was to compare, in CR patients, the association of in-person, hybrid, and virtual CR with change in performance on the 6-min walk test (6MWT) between enrollment and completion. METHODS: Patients enrolled in CR between October 22, 2019, and May 10, 2021, were categorized into in-person, hybrid, or virtual groups by number of in-person and virtual visits. All patients received individualized exercise training and health behavior counseling. Cardiac rehabilitation was delivered to patients in the hybrid and virtual cohorts using synchronous video exercise and/or asynchronous telephone visits. Measurements at CR enrollment and completion included the 6MWT, blood pressure (BP), depression, anxiety, waist-to-hip ratio, and cardiac self-efficacy. RESULTS: Of 187 CR patients, 37/97 (38.1%) were in-person patients and 58/90 (64.4%) were hybrid/virtual patients ( P = .001). Compared to in-person (51.5 ± 59.4 m) improvement in the 6MWT was similar in hybrid (63.4 ± 55.6; P = .46) and virtual (63.2 ± 59.6; P = .55) compared with in-person (51.5 ± 59.4). Hybrid and virtual patients experienced similar improvements in BP control and anxiety. Virtual patients experienced less improvement in depression symptoms. There were no statistically significant changes in waist-to-hip ratio or cardiac self-efficacy. Qualitative themes included the adaptability of virtual CR, importance of relationships between patients and CR staff, and need for training and organizational adjustments to adopt virtual CR. CONCLUSIONS: Hybrid and virtual CR were associated with similar improvements in functional capacity to in-person. Virtual and hybrid CR have the potential to expand availability without compromising outcomes.

Digital platforms for clinical trials: The Eureka experience.

Clinical trials are critically necessary for evaluating new medical drugs, devices, and other interventions designed to improve health. Digital methods have the potential to dramatically reduce the time and expense involved in clinical research, though they also pose new challenges for investigators. The Eureka Research Platform was developed as a national resource for digitizing and mobilizing health research. Platforms like Eureka enable innovation in trial design and methods, enabling remote recruitment strategies, mobile health data collection through connected devices and apps, geofencing for event ascertainment and location-based data collection, ecological momentary assessments, and intervention delivery. Here we describe our cumulative Eureka experience across more than 50 studies launched to date and offer perspectives on emerging opportunities.

A Review of the Design and Implementation of a Hybrid Cardiac Rehabilitation Program: AN EXPANDING OPPORTUNITY FOR OPTIMIZING CARDIOVASCULAR CARE.

PURPOSE: This review describes the considerations for the design and implementation of a hybrid cardiac rehabilitation (HYCR) program, a patient-individualized combination of facility-based cardiac rehabilitation (FBCR) with virtual cardiac rehabilitation (CR) and/or remote CR. REVIEW METHODS: To help meet the goal of the Millions Hearts Initiative to increase CR participation to 70% by 2022, a targeted review of the literature was conducted to identify studies pertinent to the practical design and implementation of an HYCR program. Areas focused upon included the current use of HYCR, exercise programming considerations (eligibility and safety, exercise prescription, and patient monitoring), program assessments and outcomes, patient education, step-by-step instructions for billing and insurance reimbursement, patient and provider engagement strategies, and special considerations. SUMMARY: A FBCR is the first choice for patient participation in CR, as it is supported by an extensive evidence base demonstrating effectiveness in decreasing cardiac and overall mortality, as well as improving functional capacity and quality of life. However, to attain the CR participation rate goal of 70% set by the Million Hearts Initiative, CR programming will need to be expanded beyond the confines of FBCR. In particular, HYCR programs will be necessary to supplement FBCR and will be particularly useful for the many patients with geographic or work-related barriers to participation in an FBCR program. Research is ongoing and needed to develop optimal programming for HYCR.

Longitudinal Association Between Angina Pectoris and Quality of Life.

Angina is a common symptom in patients with coronary artery disease (CAD); however, its impact on patients' quality of life over time is not well understood. We sought to determine the longitudinal association of angina frequency with quality of life and functional status over a 5-year period. We used data from the Heart and Soul Study, a prospective cohort study of 1,023 outpatients with stable CAD. Participants completed the Seattle Angina Questionnaire (SAQ) at baseline and annually for 5 years. We evaluated the population effect of angina frequency on disease-specific quality of life (SAQ Disease Perception), physical function (SAQ Physical Limitation), perceived overall health, and overall quality of life, with adjusted models. We evaluated these associations within the same year and with a time-lagged association between angina and quality of life reported 1 year later. Generalized estimating equation models were used to account for repeated measures and within-subject correlation of responses. Over 5 years of follow-up, patients with daily or weekly angina symptoms had lower quality of life scores (52 vs 89, p <0.001) and greater physical limitation (61 vs 86, p <0.001) after adjustment. Compared with patients with daily or weekly angina symptoms, those with no angina symptoms had 2-fold greater odds of better quality of life (odds ratio 2.39, 95% confidence interval 1.76 to 3.25) and 5-fold greater odds of better perceived overall health (odds ratio 5.45, 95% confidence interval 3.85 to 7.73). In conclusion, angina frequency is strongly associated with quality of life and physical function in patients with CAD. Even after modeling to adjust for both clinical risk factors and repeated measures within subjects, we found that less frequent angina symptoms were associated with better quality of life.

Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination.

Importance: Little is known about the factors associated with COVID-19 vaccine adverse effects in a real-world population. Objective: To evaluate factors potentially associated with participant-reported adverse effects after COVID-19 vaccination. Design, Setting, and Participants: The COVID-19 Citizen Science Study, an online cohort study, includes adults aged 18 years and older with a smartphone or internet access. Participants complete daily, weekly, and monthly surveys on health and COVID-19-related events. This analysis includes participants who provided consent between March 26, 2020, and May 19, 2021, and received at least 1 COVID-19 vaccine dose. Exposures: Participant-reported COVID-19 vaccination. Main Outcomes and Measures: Participant-reported adverse effects and adverse effect severity. Candidate factors in multivariable logistic regression models included age, sex, race, ethnicity, subjective social status, prior COVID-19 infection, medical conditions, substance use, vaccine dose, and vaccine brand. Results: The 19 586 participants had a median (IQR) age of 54 (38-66) years, and 13 420 (68.8%) were women. Allergic reaction or anaphylaxis was reported in 26 of 8680 participants (0.3%) after 1 dose of the BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna) vaccine, 27 of 11 141 (0.2%) after 2 doses of the BNT162b2 or mRNA-1273 vaccine or 1 dose of the JNJ-78436735 (Johnson & Johnson) vaccine. The strongest factors associated with adverse effects were vaccine dose (2 doses of BNT162b2 or mRNA-1273 or 1 dose of JNJ-78436735 vs 1 dose of BNT162b2 or mRNA-1273; odds ratio [OR], 3.10; 95% CI, 2.89-3.34; P < .001), vaccine brand (mRNA-1273 vs BNT162b2, OR, 2.00; 95% CI, 1.86-2.15; P < .001; JNJ-78436735 vs BNT162b2: OR, 0.64; 95% CI, 0.52-0.79; P < .001), age (per 10 years: OR, 0.74; 95% CI, 0.72-0.76; P < .001), female sex (OR, 1.65; 95% CI, 1.53-1.78; P < .001), and having had COVID-19 before vaccination (OR, 2.17; 95% CI, 1.77-2.66; P < .001). Conclusions and Relevance: In this real-world cohort, serious COVID-19 vaccine adverse effects were rare and comparisons across brands could be made, revealing that full vaccination dose, vaccine brand, younger age, female sex, and having had COVID-19 before vaccination were associated with greater odds of adverse effects. Large digital cohort studies may provide a mechanism for independent postmarket surveillance of drugs and devices.