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2.
JAMA Netw Open ; 7(5): e2410763, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38739390

ABSTRACT

Importance: Individuals with congenital heart disease (CHD) are increasingly reaching childbearing age, are more prone to adverse pregnancy events, and uncommonly undergo recommended cardiac evaluations. Data to better understand resource allocation and financial planning are lacking. Objective: To examine health care use and costs for patients with CHD during pregnancy. Design, Setting, and Participants: This retrospective cohort study was performed from January 1, 2010, to December 31, 2016, using Merative MarketScan commercial insurance data. Participants included patients with CHD and those without CHD matched 1:1 by age, sex, and insurance enrollment year. Pregnancy claims were identified for all participants. Data were analyzed from September 2022 to March 2024. Exposures: Baseline characteristics (age, US region, delivery year, insurance type) and pregnancy-related events (obstetric, cardiac, and noncardiac conditions; birth outcomes; and cesarean delivery). Main Outcomes and Measures: Health service use (outpatient physician, nonphysician, emergency department, prescription drugs, and admissions) and costs (total and out-of-pocket costs adjusted for inflation to represent 2024 US dollars). Results: A total of 11 703 pregnancies (mean [SD] maternal age, 31.5 [5.4] years) were studied, with 2267 pregnancies in 1785 patients with CHD (492 pregnancies in patients with severe CHD and 1775 in patients with nonsevere CHD) and 9436 pregnancies in 7720 patients without CHD. Compared with patients without CHD, pregnancies in patients with CHD were associated with significantly higher health care use (standardized mean difference [SMD] range, 0.16-1.46) and cost (SMD range, 0.14-0.55) except for out-of-pocket inpatient and ED costs. After adjustment for covariates, having CHD was independently associated with higher total (adjusted cost ratio, 1.70; 95% CI, 1.57-1.84) and out-of-pocket (adjusted cost ratio, 1.40; 95% CI, 1.22-1.58) costs. The adjusted mean total costs per pregnancy were $15 971 (95% CI, $15 480-$16 461) for patients without CHD, $24 290 (95% CI, $22 773-$25 806) for patients with any CHD, $26 308 (95% CI, $22 788-$29 828) for patients with severe CHD, and $23 750 (95% CI, $22 110-$25 390) for patients with nonsevere CHD. Patients with vs without CHD incurred $8319 and $700 higher total and out-of-pocket costs per pregnancy, respectively. Conclusions and Relevance: This study provides novel, clinically relevant estimates for the cardio-obstetric team, patients with CHD, payers, and policymakers regarding health care and financial planning. These estimates can be used to carefully plan for and advocate for the comprehensive resources needed to care for patients with CHD.


Subject(s)
Health Care Costs , Heart Defects, Congenital , Insurance, Health , Humans , Female , Pregnancy , Heart Defects, Congenital/economics , Adult , Retrospective Studies , Insurance, Health/statistics & numerical data , Insurance, Health/economics , United States , Health Care Costs/statistics & numerical data , Health Expenditures/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Young Adult , Pregnancy Complications, Cardiovascular/economics , Pregnancy Complications, Cardiovascular/therapy
3.
Article in English | MEDLINE | ID: mdl-38592955

ABSTRACT

BACKGROUND: The prognosis for atrial fibrillation (AF) patients is based on data that is decades old. Given evolving standards of clinical practice, we sought to evaluate temporal trends in clinically important outcomes among patients with AF. METHODS: California's Department of Health Care Access and Information databases were used to identify adults aged ≥ 18 years with AF receiving hospital-based care in California. We compared 3 time-periods: 2005-2009, 2010-2014, and 2015-2019. ICD codes were used to identify chronic diseases and acute events. The outcomes were incident ischemic stroke, intracranial hemorrhage, and overall mortality. RESULTS: We included 2 009 832 patients with AF (52.7% males, 70.7% Whites, and mean age of 75.0 years), divided in 3 cohorts: 2005-2009 (n = 738 954), 2010-2014 (n = 609 447), and 2015-2019 (n = 661 431). Each outcome became substantially less common with time: compared to 2005-2009, AF patients diagnosed in 2015-2019 experienced a 34% (adjusted hazard ratio [HR] 0.66, 95% CI 0.64-0.69), 22% (HR 0.78, 0.75-0.82), and 24% (HR 0.76, 0.75-0.77) reduction in risk of incident ischemic stroke, intracranial hemorrhage, and mortality, respectively. Between 2005-2009 and 2015-2019, patients aged ≥ 65 years experienced more reductions in each outcome compared to younger patients (p < 0.001 for all), and declines in each outcome were significantly lower for Hispanics and Blacks compared to white patients. CONCLUSION: The risks of stroke, intracranial hemorrhage, and death have significantly declined among AF patients, although differences in the magnitude of improvement of these outcomes by demographic groups were observed. Commonly described estimates of the prognosis for AF patients should be updated to reflect contemporary care.

5.
Heart Rhythm ; 2024 Mar 09.
Article in English | MEDLINE | ID: mdl-38461923

ABSTRACT

BACKGROUND: The epidemiology of atrial fibrillation (AF)-associated thromboembolic complications outside of ischemic strokes has not been thoroughly elucidated. OBJECTIVE: The aim of this study was to describe the epidemiology of AF-associated systemic infarcts and relevant interactions by sex and race/ethnicity. METHODS: Using the Office of Statewide Health Planning and Development, we performed a longitudinal analysis of patients aged ≥18 years who received ambulatory surgery, emergency, or inpatient medical care in California between 2005 and 2015. We determined the distribution of infarct locations and risks of systemic infarcts for patients with AF. Interaction analyses by sex and race/ethnicity were conducted. RESULTS: Of 1,321,694 patients with AF, the average annual rate of systemic infarct was 2.1% ± 0.18% compared with 0.56% ± 0.06% in the 22,944,488 patients without AF. The increased frequency of these infarcts was observed for every body area investigated. After adjustment for potential confounders and mediators, patients with AF experienced a 45% increased risk of a systemic infarct (hazard ratio, 1.45; 95% confidence interval, 1.44-1.47; P < .001). Women, Asians, Blacks, and Hispanics each exhibited a statistically significant heightened relative risk of systemic infarcts in the presence of AF. CONCLUSION: AF increases the risk of infarcts throughout the body. Susceptibility to these systemic infarcts varies by sex and race/ethnicity in patterns similar to differential risks for stroke. The presence of a systemic infarct in the absence of a clear cause should raise suspicion for AF, and the potential benefits of AF prevention and anticoagulation should be considered beyond only infarcts to the brain.

6.
PLoS One ; 19(2): e0297922, 2024.
Article in English | MEDLINE | ID: mdl-38319951

ABSTRACT

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.


Subject(s)
COVID-19 , Citizen Science , Humans , Female , United States , Middle Aged , Male , COVID-19/epidemiology , Pandemics , SARS-CoV-2 , Depression/epidemiology , Anxiety/psychology , Anxiety Disorders/epidemiology
7.
Sci Rep ; 14(1): 3304, 2024 02 08.
Article in English | MEDLINE | ID: mdl-38332308

ABSTRACT

Previous studies relying on alcohol sales, alcohol-related injuries, and surveys have suggested that alcohol consumption increased during the COVID-19 pandemic. We sought to leverage over 1 million Breath Alcohol Concentration (BrAC) measurements from Bluetooth-enabled breathalyzers to conduct an objective and longitudinal assessment of alcohol use during the pandemic. Serial BrAC measurements revealed a decrease in drinking between January 1, 2020 and March 30, 2020, an increase between March 30, 2020 and May 25, 2020, a statistically insignificant decrease between May 25, 2020 and January 1, 2021, and an increase again between January 1, 2021 and June 4, 2021. No statistically significant relationships between shelter-in-place orders and alcohol consumption were detected. These findings demonstrate the complex relationship between the pandemic and alcohol consumption patterns, providing insights that may be relevant to the use of this commonly consumed substance with implications relevant to long-term effects from the patterns observed.


Subject(s)
COVID-19 , Pandemics , Humans , Alcohol Drinking/epidemiology , Longitudinal Studies , COVID-19/epidemiology , Cohort Studies
9.
J Electrocardiol ; 83: 26-29, 2024.
Article in English | MEDLINE | ID: mdl-38295539

ABSTRACT

BACKGROUND: Alcohol consumption is associated with a higher increased risk of atrial fibrillation (AF), but the acute effects on cardiac electrophysiology in humans remain poorly understood. The HOw ALcohol InDuces Atrial TachYarrhythmias (HOLIDAY) Trial revealed that alcohol shortened pulmonary vein atrial effective refractory periods, but more global electrophysiologic changes gleaned from the surface ECG have not yet been reported. METHODS: This was a secondary analysis of the HOLIDAY Trial. During AF ablation procedures, 100 adults were randomized to intravenous alcohol titrated to 0.08% blood alcohol concentration versus a volume and osmolarity-matched, masked, placebo. Intervals measured from 12­lead ECGs were compared between pre infusion and at infusion steady state (20 min). RESULTS: The average age was 60 years and 11% were female. No significant differences in the P-wave duration, PR, QRS or QT intervals, were present between alcohol and placebo arms. However, infusion of alcohol was associated with a statistically significant relative shortening of the JT interval (r: -14.73, p = 0.048) after multivariable adjustment. CONCLUSION: Acute exposure to alcohol was associated with a relative reduction in the JT interval, reflecting shortening of ventricular repolarization. These acute changes may reflect a more global shortening of refractoriness, suggesting immediate proarrhythmic effects pertinent to the atria and ventricles.


Subject(s)
Atrial Fibrillation , Electrocardiography , Adult , Female , Humans , Male , Middle Aged , Blood Alcohol Content , Heart Atria , Randomized Controlled Trials as Topic
10.
J Med Virol ; 96(1): e29333, 2024 01.
Article in English | MEDLINE | ID: mdl-38175151

ABSTRACT

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.


Subject(s)
COVID-19 , Post-Acute COVID-19 Syndrome , Female , Humans , Middle Aged , Male , Ritonavir , Cohort Studies , SARS-CoV-2
11.
J Am Coll Cardiol ; 83(1): 109-279, 2024 Jan 02.
Article in English | MEDLINE | ID: mdl-38043043

ABSTRACT

AIM: The "2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Patients With Atrial Fibrillation" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" and the "2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed.


Subject(s)
Atrial Fibrillation , Cardiology , Thromboembolism , Humans , United States/epidemiology , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/epidemiology , American Heart Association , Risk Factors
12.
J Cardiovasc Electrophysiol ; 35(3): 569-573, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37724798

ABSTRACT

Premature ventricular complexes (PVCs) are encountered frequently in clinical practice. While PVCs may have various causes, a small number of individuals with PVCs develop cardiomyopathy in the absence of other potential etiologies. When correctly identified, patients with PVC-incuded cardiomyopathy can have dramatic improvement of their cardiomyopathy with treatment of their PVCs. In this focused review, we discuss potential predictors of PVC-induced cardiomyopathy, including PVC frequency, PVC characteristics, and modifiable patient risk factors. We also review some proposed mechanisms of PVC-induced cardiomyopathy and conclude with future directions for research and clinical practice.


Subject(s)
Cardiomyopathies , Ventricular Premature Complexes , Humans , Ventricular Premature Complexes/diagnosis , Ventricular Premature Complexes/surgery , Ventricular Premature Complexes/complications , Risk Factors
13.
Circulation ; 149(1): e1-e156, 2024 01 02.
Article in English | MEDLINE | ID: mdl-38033089

ABSTRACT

AIM: The "2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation" provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the "2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" and the "2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed.


Subject(s)
Atrial Fibrillation , Cardiology , Thromboembolism , Humans , American Heart Association , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/therapy , Risk Factors , United States/epidemiology
14.
Circulation ; 149(6): 463-474, 2024 02 06.
Article in English | MEDLINE | ID: mdl-37994608

ABSTRACT

BACKGROUND: Frequent premature atrial complexes (PACs) are associated with future incident atrial fibrillation (AF), but whether PACs contribute to development of AF through adverse atrial remodeling has not been studied. This study aimed to explore the effect of frequent PACs from different sites on atrial remodeling in a swine model. METHODS: Forty swine underwent baseline electrophysiologic studies and echocardiography followed by pacemaker implantations and paced PACs (50% burden) at 250-ms coupling intervals for 16 weeks in 4 groups: (1) lateral left atrium (LA) PACs by the coronary sinus (Lat-PAC; n=10), (2) interatrial septal PACs (Sep-PAC; n=10), (3) regular LA pacing at 130 beats/min (Reg-130; n=10), and (4) controls without PACs (n=10). At the final study, repeat studies were performed, followed by tissue histology and molecular analyses focusing on fibrotic pathways. RESULTS: Lat-PACs were associated with a longer P-wave duration (93.0±9.0 versus 74.2±8.2 and 58.8±7.6 ms; P<0.001) and greater echocardiographic mechanical dyssynchrony (57.5±11.6 versus 35.7±13.0 and 24.4±11.1 ms; P<0.001) compared with Sep-PACs and controls, respectively. After 16 weeks, Lat-PACs led to slower LA conduction velocity (1.1±0.2 versus 1.3±0.2 [Sep-PAC] versus 1.3±0.1 [Reg-130] versus 1.5±0.2 [controls] m/s; P<0.001) without significant change in atrial ERP. The Lat-PAC group had a significantly increased percentage of LA fibrosis and upregulated levels of extracellular matrix proteins (lysyl oxidase and collagen 1 and 8), as well as TGF-ß1 (transforming growth factor-ß1) signaling proteins (latent and monomer TGF-ß1 and phosphorylation/total ratio of SMAD2/3; P<0.05). The Lat-PAC group had the longest inducible AF duration (terminal to baseline: 131 [interquartile range 30, 192] seconds versus 16 [6, 26] seconds [Sep-PAC] versus 22 [11, 64] seconds [Reg-130] versus -1 [-16, 7] seconds [controls]; P<0.001). CONCLUSIONS: In this swine model, frequent PACs resulted in adverse atrial structural remodeling with a heightened propensity to AF. PACs originating from the lateral LA produced greater atrial remodeling and longer induced AF duration than the septal-origin PACs. These data provide evidence that frequent PACs can cause adverse atrial remodeling as well as AF, and that the location of ectopic PACs may be clinically meaningful.


Subject(s)
Atrial Fibrillation , Atrial Premature Complexes , Atrial Remodeling , Animals , Swine , Transforming Growth Factor beta1 , Heart Atria/diagnostic imaging , Fibrosis
15.
JACC Clin Electrophysiol ; 10(1): 56-64, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37921790

ABSTRACT

BACKGROUND: Chronic sleep disruption is associated with incident atrial fibrillation (AF), but it is unclear whether poor sleep quality acutely triggers AF. OBJECTIVES: The aim of this study was to characterize the relationship between a given night's sleep quality and the risk of a discrete AF episode. METHODS: Patients with symptomatic paroxysmal AF in the I-STOP-AFIB (Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation) trial reported sleep quality on a daily basis. Participants were also queried daily regarding AF episodes and were provided smartphone-based mobile electrocardiograms (ECGs) (KardiaMobile, AliveCor). RESULTS: Using 15,755 days of data from 419 patients, worse sleep quality on any given night was associated with a 15% greater odds of a self-reported AF episode the next day (OR: 1.15; 95% CI: 1.10-1.20; P < 0.0001) after adjustment for the day of the week. No statistically significant associations between worsening sleep quality and mobile ECG-confirmed AF events were observed (OR: 1.04; 95% CI: 0.95-1.13; P = 0.43), although substantially fewer of these mobile ECG-confirmed events may have limited statistical power. Poor sleep was also associated with longer self-reported AF episodes, with each progressive category of worsening sleep associated with 16 (95% CI: 12-21; P < 0.001) more minutes of AF the next day. CONCLUSIONS: Poor sleep was associated with an immediately heightened risk for self-reported AF episodes, and a dose-response relationship existed such that progressively worse sleep was associated with longer episodes of AF the next day. These data suggest that sleep quality may be a potentially modifiable trigger relevant to the near-term risk of a discrete AF episode.


Subject(s)
Atrial Fibrillation , Humans , Atrial Fibrillation/epidemiology , Sleep Quality , Electrocardiography
16.
Heart Rhythm ; 21(4): 370-377, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38142832

ABSTRACT

BACKGROUND: Cannabis use is increasing worldwide. While prior studies have reported an association between cannabis use and a higher risk of atrial fibrillation (AF), most were cross-sectional and generally relied on diagnostic coding to identify cannabis users, which may not be representative of the typical recreational cannabis user. OBJECTIVE: The purpose of this study was to examine the association between recreational cannabis use and lifetime AF risk. METHODS: We evaluated the AF risk of participants of the UK Biobank cohort who completed the cannabis use lifestyle questionnaire. Cannabis exposure was categorized as "Occasional Use" for less than 100 times used, "Frequent Use" for more than 100 times used, and "Never" users. AF events were identified using International Classification of Diseases codes. Cox models were used to estimate the hazard ratios (HRs) between cannabis use and incident AF and were subsequently adjusted for age, sex, race, alcohol, coffee, smoking, education, and baseline cardiovascular comorbidities. RESULTS: A total of 150,554 participants (mean age 63.4 ± 7.7 years; 86,487 (57.4%) female; and 33,442 (22.2%) using cannabis at least once) were followed for a mean period of 6.1 ± 0.6 years. After multivariable adjustment, there were no statistically significant differences in incident AF among occasional users (HR 0.98; 95% confidence interval 0.89-1.08) nor frequent users (HR 1.03; 95% confidence interval 0.81-1.32) as compared with never users. CONCLUSION: In a large prospective cohort study, there was no evidence that cannabis use was associated with a higher risk of incident AF. An evaluation of cannabis ingestion methods and quantification was not possible using the current data set.


Subject(s)
Atrial Fibrillation , Cannabis , Humans , Female , Middle Aged , Aged , Male , Atrial Fibrillation/epidemiology , Atrial Fibrillation/etiology , Prospective Studies , Risk Factors , Incidence
17.
J Med Internet Res ; 25: e51238, 2023 12 22.
Article in English | MEDLINE | ID: mdl-38133910

ABSTRACT

BACKGROUND: Web- or app-based digital health studies allow for more efficient collection of health data for research. However, remote recruitment into digital health studies can enroll nonrepresentative study samples, hindering the robustness and generalizability of findings. Through the comprehensive evaluation of an email-based campaign on recruitment into the Health eHeart Study, we aim to uncover key sociodemographic and clinical factors that contribute to enrollment. OBJECTIVE: This study sought to understand the factors related to participation, specifically regarding enrollment, in the Health eHeart Study as a result of a large-scale remote email recruitment campaign. METHODS: We conducted a cohort analysis on all invited University of California, San Francisco (UCSF) patients to identify sociodemographic and clinical predictors of enrollment into the Health eHeart Study. The primary outcome was enrollment, defined by account registration and consent into the Health eHeart Study. The email recruitment campaign was carried out from August 2015 to February 2016, with electronic health record data extracted between September 2019 and December 2019. RESULTS: The email recruitment campaign delivered at least 1 email invitation to 93.5% (193,606/206,983) of all invited patients and yielded a 3.6% (7012/193,606) registration rate among contacted patients and an 84.1% (5899/7012) consent rate among registered patients. Adjusted multivariate logistic regression models analyzed independent sociodemographic and clinical predictors of (1) registration among contacted participants and (2) consent among registered participants. Odds of registration were higher among patients who are older, women, non-Hispanic White, active patients with commercial insurance or Medicare, with a higher comorbidity burden, with congestive heart failure, and randomized to receive up to 2 recruitment emails. The odds of registration were lower among those with medical conditions such as dementia, chronic pulmonary disease, moderate or severe liver disease, paraplegia or hemiplegia, renal disease, or cancer. Odds of subsequent consent after initial registration were different, with an inverse trend of being lower among patients who are older and women. The odds of consent were also lower among those with peripheral vascular disease. However, the odds of consent remained higher among patients who were non-Hispanic White and those with commercial insurance. CONCLUSIONS: This study provides important insights into the potential returns on participant enrollment when digital health study teams invest resources in using email for recruitment. The findings show that participant enrollment was driven more strongly by sociodemographic factors than clinical factors. Overall, email is an extremely efficient means of recruiting participants from a large list into the Health eHeart Study. Despite some improvements in representation, the formulation of truly diverse studies will require additional resources and strategies to overcome persistent participation barriers.


Subject(s)
Electronic Mail , Medicare , Humans , Female , Aged , United States , Patient Selection , Data Collection , Cohort Studies
18.
J Med Internet Res ; 25: e47475, 2023 11 10.
Article in English | MEDLINE | ID: mdl-37948098

ABSTRACT

BACKGROUND: Accurate, timely ascertainment of clinical end points, particularly hospitalizations, is crucial for clinical trials. The Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) Digital Study extended the main TAILOR-PCI trial's follow-up to 2 years, using a smartphone-based research app featuring geofencing-triggered surveys and routine monthly mobile phone surveys to detect cardiovascular (CV) hospitalizations. This pilot study compared these digital tools to conventional site-coordinator ascertainment of CV hospitalizations. OBJECTIVE: The objectives were to evaluate geofencing-triggered notifications and routine monthly mobile phone surveys' performance in detecting CV hospitalizations compared to telephone visits and health record reviews by study coordinators at each site. METHODS: US and Canadian participants from the TAILOR-PCI Digital Follow-Up Study were invited to download the Eureka Research Platform mobile app, opting in for location tracking using geofencing, triggering a smartphone-based survey if near a hospital for ≥4 hours. Participants were sent monthly notifications for CV hospitalization surveys. RESULTS: From 85 participants who consented to the Digital Study, downloaded the mobile app, and had not previously completed their final follow-up visit, 73 (85.8%) initially opted in and consented to geofencing. There were 9 CV hospitalizations ascertained by study coordinators among 5 patients, whereas 8 out of 9 (88.9%) were detected by routine monthly hospitalization surveys. One CV hospitalization went undetected by the survey as it occurred within two weeks of the previous event, and the survey only allowed reporting of a single hospitalization. Among these, 3 were also detected by the geofencing algorithm, but 6 out of 9 (66.7%) were missed by geofencing: 1 occurred in a participant who never consented to geofencing, while 5 hospitalizations occurred among participants who had subsequently turned off geofencing prior to their hospitalization. Geofencing-detected hospitalizations were ascertained within a median of 2 (IQR 1-3) days, monthly surveys within 11 (IQR 6.5-25) days, and site coordinator methods within 38 (IQR 9-105) days. The geofencing algorithm triggered 245 notifications among 39 participants, with 128 (52.2%) from true hospital presence and 117 (47.8%) from nonhospital health care facility visits. Additional geofencing iterative improvements to reduce hospital misidentification were made to the algorithm at months 7 and 12, elevating the rate of true alerts from 35.4% (55 true alerts/155 total alerts before month 7) to 78.7% (59 true alerts/75 total alerts in months 7-12) and ultimately to 93.3% (14 true alerts/5 total alerts in months 13-21), respectively. CONCLUSIONS: The monthly digital survey detected most CV hospitalizations, while the geofencing survey enabled earlier detection but did not offer incremental value beyond traditional tools. Digital tools could potentially reduce the burden on study coordinators in ascertaining CV hospitalizations. The advantages of timely reporting via geofencing should be weighed against the issue of false notifications, which can be mitigated through algorithmic refinements.


Subject(s)
Percutaneous Coronary Intervention , Humans , Clopidogrel/therapeutic use , Follow-Up Studies , Pilot Projects , Canada , Hospitalization
20.
JAMA Netw Open ; 6(9): e2333182, 2023 09 05.
Article in English | MEDLINE | ID: mdl-37698861

ABSTRACT

Importance: Alcohol biomarkers can improve detection of heavy alcohol use in clinical care, yet cutoffs for phosphatidylethanol (PEth), a blood biomarker, have not been established. Objective: To determine the optimal cutoff for PEth for heavy alcohol consumption in a study of middle-age and older adults. Design, Setting, and Participants: This was a 4-week diagnostic study of adults with paroxysmal atrial fibrillation (AF) and current alcohol consumption, recruited from general cardiology and cardiac electrophysiology outpatient clinics from September 2014 to September 2019. Data were analyzed from October 2021 to March 2022. Main Outcomes and Measures: The main aim was to determine the optimal PEth cutoff for heavy alcohol consumption, using the Secure Continuous Remote Alcohol Monitor (SCRAM) to measure transdermal alcohol. Area under the curve (AUC) for PEth-detected compared with SCRAM-detected heavy alcohol consumption in any week over the prior 4 weeks (ie, ≥3 [women] and ≥4 [men] episodes) or any estimated breath alcohol of 0.08% or greater in any week, and the PEth cutoff was calculated using the Youden J statistic. Similar analyses were conducted comparing PEth with individual drinks reported by pressing an event monitor, retrospective self-report via the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), and using 2-week look-backs. Results: In this diagnostic study of 64 patients with both PEth and SCRAM measures over 4 weeks (54 [84.4%] men; mean age, 65.5 [95% CI, 62.6-68.5] years; 51 [79.7%] White), 31 (48.4%) had any SCRAM-detected heavy alcohol consumption over the 4 weeks, and the median (IQR) PEth at 4 weeks was 23 ng/mL (

Subject(s)
Alcoholism , Middle Aged , Humans , Female , Male , Aged , Alcoholism/diagnosis , Alcoholism/epidemiology , Retrospective Studies , Ethanol , Alcohol Drinking/epidemiology
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