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1.
Am Heart J Plus ; 13: 100112, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1712409

ABSTRACT

SARS-CoV-2 accesses host cells via angiotensin-converting enzyme-2, which is also affected by commonly used angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), raising concerns that ACEI or ARB exposure may portend differential COVID-19 outcomes. In parallel cohort studies of outpatient and inpatient COVID-19-diagnosed adults with hypertension, we assessed associations between antihypertensive exposure (ACEI/ARB vs. non-ACEI/ARB antihypertensives, as well as between ACEI- vs. ARB) at the time of COVID-19 diagnosis, using electronic health record data from PCORnet health systems. The primary outcomes were all-cause hospitalization or death (outpatient cohort) or all-cause death (inpatient), analyzed via Cox regression weighted by inverse probability of treatment weights. From February 2020 through December 9, 2020, 11,246 patients (3477 person-years) and 2200 patients (777 person-years) were included from 17 health systems in outpatient and inpatient cohorts, respectively. There were 1015 all-cause hospitalization or deaths in the outpatient cohort (incidence, 29.2 events per 100 person-years), with no significant difference by ACEI/ARB use (adjusted HR 1.01; 95% CI 0.88, 1.15). In the inpatient cohort, there were 218 all-cause deaths (incidence, 28.1 per 100 person-years) and ACEI/ARB exposure was associated with reduced death (adjusted HR, 0.76; 95% CI, 0.57, 0.99). ACEI, versus ARB exposure, was associated with higher risk of hospitalization in the outpatient cohort, but no difference in all-cause death in either cohort. There was no evidence of effect modification across pre-specified baseline characteristics. Our results suggest ACEI and ARB exposure have no detrimental effect on hospitalizations and may reduce death among hypertensive patients diagnosed with COVID-19.

2.
Open Heart ; 9(1)2022 01.
Article in English | MEDLINE | ID: covidwho-1642906

ABSTRACT

BACKGROUND: Cardiac arrhythmias have been observed among patients hospitalised with acute COVID-19 infection, and palpitations remain a common symptom among the much larger outpatient population of COVID-19 survivors in the convalescent stage of the disease. OBJECTIVE: To determine arrhythmia prevalence among outpatients after a COVID-19 diagnosis. METHODS: Adults with a positive COVID-19 test and without a history of arrhythmia were prospectively evaluated with 14-day ambulatory electrocardiographic monitoring. Participants were instructed to trigger the monitor for palpitations. RESULTS: A total of 51 individuals (mean age 42±11 years, 65% women) underwent monitoring at a median 75 (IQR 34-126) days after a positive COVID-19 test. Median monitoring duration was 13.2 (IQR 10.5-13.8) days. No participant demonstrated atrial fibrillation, atrial flutter, sustained supraventricular tachycardia (SVT), sustained ventricular tachycardia or infranodal atrioventricular block. Nearly all participants (96%) had an ectopic burden of <1%; one participant had a 2.8% supraventricular ectopic burden and one had a 15.4% ventricular ectopic burden. While 47 (92%) participants triggered their monitor for palpitation symptoms, 78% of these triggers were for either sinus rhythm or sinus tachycardia. CONCLUSIONS: We did not find evidence of malignant or sustained arrhythmias in outpatients after a positive COVID-19 diagnosis. While palpitations were common, symptoms frequently corresponded to sinus rhythm/sinus tachycardia or non-malignant arrhythmias such as isolated ectopy or non-sustained SVT. While these findings cannot exclude the possibility of serious arrhythmias in select individuals, they do not support a strong or widespread proarrhythmic effect of COVID-19 infection after resolution of acute illness.


Subject(s)
Arrhythmias, Cardiac/epidemiology , COVID-19/diagnosis , Electrocardiography, Ambulatory/methods , Pandemics , Population Surveillance , SARS-CoV-2 , Adult , Arrhythmias, Cardiac/diagnosis , Arrhythmias, Cardiac/etiology , COVID-19/complications , COVID-19/virology , Female , Global Health , Humans , Incidence , Male , Prospective Studies
3.
JAMA Netw Open ; 4(12): e2140364, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1591621

ABSTRACT

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.


Subject(s)
/adverse effects , /adverse effects , COVID-19/prevention & control , /administration & dosage , Adult , Age Factors , Aged , Anaphylaxis/chemically induced , Drug Hypersensitivity/etiology , Female , Humans , Immunization Schedule , Logistic Models , Male , Middle Aged , SARS-CoV-2 , Sex Factors
5.
Gastroenterology ; 161(5): 1487-1501.e5, 2021 11.
Article in English | MEDLINE | ID: covidwho-1351990

ABSTRACT

BACKGROUND & AIMS: In patients with chronic liver disease (CLD) with or without cirrhosis, existing studies on the outcomes with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection have limited generalizability. We used the National COVID Cohort Collaborative (N3C), a harmonized electronic health record dataset of 6.4 million, to describe SARS-CoV-2 outcomes in patients with CLD and cirrhosis. METHODS: We identified all patients with CLD with or without cirrhosis who had SARS-CoV-2 testing in the N3C Data Enclave as of July 1, 2021. We used survival analyses to associate SARS-CoV-2 infection, presence of cirrhosis, and clinical factors with the primary outcome of 30-day mortality. RESULTS: We isolated 220,727 patients with CLD and SARS-CoV-2 test status: 128,864 (58%) were noncirrhosis/negative, 29,446 (13%) were noncirrhosis/positive, 53,476 (24%) were cirrhosis/negative, and 8941 (4%) were cirrhosis/positive patients. Thirty-day all-cause mortality rates were 3.9% in cirrhosis/negative and 8.9% in cirrhosis/positive patients. Compared to cirrhosis/negative patients, cirrhosis/positive patients had 2.38 times adjusted hazard of death at 30 days. Compared to noncirrhosis/positive patients, cirrhosis/positive patients had 3.31 times adjusted hazard of death at 30 days. In stratified analyses among patients with cirrhosis with increased age, obesity, and comorbid conditions (ie, diabetes, heart failure, and pulmonary disease), SARS-CoV-2 infection was associated with increased adjusted hazard of death. CONCLUSIONS: In this study of approximately 221,000 nationally representative, diverse, and sex-balanced patients with CLD; we found SARS-CoV-2 infection in patients with cirrhosis was associated with 2.38 times mortality hazard, and the presence of cirrhosis among patients with CLD infected with SARS-CoV-2 was associated with 3.31 times mortality hazard. These results provide an additional impetus for increasing vaccination uptake and further research regarding immune responses to vaccines in patients with severe liver disease.


Subject(s)
COVID-19/mortality , Liver Cirrhosis/mortality , Adolescent , Adult , Age Factors , Aged , COVID-19/epidemiology , Chronic Disease , Cohort Studies , Comorbidity , Diabetes Mellitus/epidemiology , Female , Heart Failure/epidemiology , Humans , Liver Cirrhosis/epidemiology , Male , Middle Aged , Obesity/epidemiology , SARS-CoV-2 , Survival Rate , United States/epidemiology , Young Adult
6.
JMIR Res Protoc ; 10(8): e28169, 2021 Aug 30.
Article in English | MEDLINE | ID: covidwho-1325493

ABSTRACT

BACKGROUND: The COVID-19 pandemic has catalyzed a global public response and innovation in clinical study methods. OBJECTIVE: The COVID-19 Citizen Science study was designed to generate knowledge about participant-reported COVID-19 symptoms, behaviors, and disease occurrence. METHODS: COVID-19 Citizen Science is a longitudinal cohort study launched on March 26, 2020, on the Eureka Research Platform. This study illustrates important advances in digital clinical studies, including entirely digital study participation, targeted recruitment strategies, electronic consent, recurrent and time-updated assessments, integration with smartphone-based measurements, analytics for recruitment and engagement, connection with partner studies, novel engagement strategies such as participant-proposed questions, and feedback in the form of real-time results to participants. RESULTS: As of February 2021, the study has enrolled over 50,000 participants. Study enrollment and participation are ongoing. Over the lifetime of the study, an average of 59% of participants have completed at least one survey in the past 4 weeks. CONCLUSIONS: Insights about COVID-19 symptoms, behaviors, and disease occurrence can be drawn through digital clinical studies. Continued innovation in digital clinical study methods represents the future of clinical research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28169.

7.
PLoS One ; 16(6): e0253120, 2021.
Article in English | MEDLINE | ID: covidwho-1278185

ABSTRACT

BACKGROUND: In the absence of universal testing, effective therapies, or vaccines, identifying risk factors for viral infection, particularly readily modifiable exposures and behaviors, is required to identify effective strategies against viral infection and transmission. METHODS: We conducted a world-wide mobile application-based prospective cohort study available to English speaking adults with a smartphone. We collected self-reported characteristics, exposures, and behaviors, as well as smartphone-based geolocation data. Our main outcome was incident symptoms of viral infection, defined as fevers and chills plus one other symptom previously shown to occur with SARS-CoV-2 infection, determined by daily surveys. FINDINGS: Among 14, 335 participants residing in all 50 US states and 93 different countries followed for a median 21 days (IQR 10-26 days), 424 (3%) developed incident viral symptoms. In pooled multivariable logistic regression models, female biological sex (odds ratio [OR] 1.75, 95% CI 1.39-2.20, p<0.001), anemia (OR 1.45, 95% CI 1.16-1.81, p = 0.001), hypertension (OR 1.35, 95% CI 1.08-1.68, p = 0.007), cigarette smoking in the last 30 days (OR 1.86, 95% CI 1.35-2.55, p<0.001), any viral symptoms among household members 6-12 days prior (OR 2.06, 95% CI 1.67-2.55, p<0.001), and the maximum number of individuals the participant interacted with within 6 feet in the past 6-12 days (OR 1.15, 95% CI 1.06-1.25, p<0.001) were each associated with a higher risk of developing viral symptoms. Conversely, a higher subjective social status (OR 0.87, 95% CI 0.83-0.93, p<0.001), at least weekly exercise (OR 0.57, 95% CI 0.47-0.70, p<0.001), and sanitizing one's phone (OR 0.79, 95% CI 0.63-0.99, p = 0.037) were each associated with a lower risk of developing viral symptoms. INTERPRETATION: While several immutable characteristics were associated with the risk of developing viral symptoms, multiple immediately modifiable exposures and habits that influence risk were also observed, potentially identifying readily accessible strategies to mitigate risk in the COVID-19 era.


Subject(s)
COVID-19/prevention & control , Fever/diagnosis , SARS-CoV-2/isolation & purification , Self Report/statistics & numerical data , Adult , COVID-19/epidemiology , COVID-19/virology , Female , Fever/epidemiology , Humans , Incidence , Logistic Models , Male , Middle Aged , Multivariate Analysis , Pandemics , Prospective Studies , Risk Factors , SARS-CoV-2/physiology , Smartphone , United States/epidemiology
8.
J Am Med Inform Assoc ; 28(8): 1765-1776, 2021 07 30.
Article in English | MEDLINE | ID: covidwho-1246728

ABSTRACT

OBJECTIVE: To utilize, in an individual and institutional privacy-preserving manner, electronic health record (EHR) data from 202 hospitals by analyzing answers to COVID-19-related questions and posting these answers online. MATERIALS AND METHODS: We developed a distributed, federated network of 12 health systems that harmonized their EHRs and submitted aggregate answers to consortia questions posted at https://www.covid19questions.org. Our consortium developed processes and implemented distributed algorithms to produce answers to a variety of questions. We were able to generate counts, descriptive statistics, and build a multivariate, iterative regression model without centralizing individual-level data. RESULTS: Our public website contains answers to various clinical questions, a web form for users to ask questions in natural language, and a list of items that are currently pending responses. The results show, for example, that patients who were taking angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, within the year before admission, had lower unadjusted in-hospital mortality rates. We also showed that, when adjusted for, age, sex, and ethnicity were not significantly associated with mortality. We demonstrated that it is possible to answer questions about COVID-19 using EHR data from systems that have different policies and must follow various regulations, without moving data out of their health systems. DISCUSSION AND CONCLUSIONS: We present an alternative or a complement to centralized COVID-19 registries of EHR data. We can use multivariate distributed logistic regression on observations recorded in the process of care to generate results without transferring individual-level data outside the health systems.


Subject(s)
Algorithms , COVID-19 , Computer Communication Networks , Confidentiality , Electronic Health Records , Information Storage and Retrieval/methods , Natural Language Processing , Common Data Elements , Female , Humans , Logistic Models , Male , Registries
9.
JAMA Netw Open ; 4(5): e218500, 2021 05 03.
Article in English | MEDLINE | ID: covidwho-1210565

ABSTRACT

Importance: Active SARS-CoV-2 (coronavirus) transmission continues in the US. It is unclear whether better access to coronavirus testing and more consistent use of testing could substantially reduce transmission. Objective: To describe coronavirus testing in persons with new onset of febrile illness and analyze whether there are changes over time and differences by race and ethnicity. Design, Setting, and Participants: This cohort study used data from the COVID-19 Citizen Science Study, launched in March 2020, which recruited participants via press release, word-of-mouth, and partner organizations. Participants completed daily surveys about COVID-19 symptoms and weekly surveys about coronavirus testing. All adults (aged at least 18 years) with a smartphone were eligible to join. For this analysis, US participants with new onset of febrile illness from April 2020 to October 2020 were included. Data analysis was performed from November 2020 to March 2021. Main Outcomes and Measures: Receipt of a coronavirus test result within 7 days of febrile illness onset. Results: Of the 2679 participants included in this analysis, the mean (SD) age was 46.3 (13.4) years, 1983 were female (74%), 2017 were college educated (75%), and a total of 3865 distinct new febrile illness episodes were reported (300 episodes [7.8%] from Hispanic participants, 71 episodes [1.8%] from Black participants, and 3494 episodes [90.4%] from not Black, not Hispanic participants) between April 2 and October 23, 2020. In weekly surveys delivered during the 14 days after fever onset, 12% overall (753 participants) indicated receipt of a test result. Using serial survey responses and parametric time-to-event modeling, it was estimated that by 7 days after onset of febrile illness, a total of 20.5% (95% CI, 19.1%-22.0%) had received a test result. This proportion increased from 9.8% (95% CI, 7.5%-12.0%) early in the epidemic to 24.1% (95% CI, 21.5%-26.7%) at the end of July, but testing rates did not substantially improve since then, increasing to 25.9% (95% CI; 21.6%-30.3%) in late October at the start of the winter surge. Black participants reported receiving a test result about half as often as others (7% [7 of 103] of survey responses vs 12% [53 of 461] for Hispanic vs 13% [693 of 5516] for not Black, not Hispanic; P = .03). This association was not statistically significant in adjusted time-to-event models (hazard ratio = 0.59 vs not Black, not Hispanic participants; 95% CI, 0.26-1.34). Conclusions and Relevance: Systematic underuse of coronavirus testing was observed in this cohort study through late October 2020, at the beginning of the winter COVID-19 surge, which may have contributed to preventable coronavirus transmission.


Subject(s)
COVID-19 Testing , COVID-19 , Disease Transmission, Infectious/prevention & control , Fever , Health Services Accessibility , Health Services Misuse , Patient Acceptance of Health Care , SARS-CoV-2/isolation & purification , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/transmission , COVID-19 Testing/methods , COVID-19 Testing/statistics & numerical data , Female , Fever/diagnosis , Fever/epidemiology , Fever/etiology , Health Services Accessibility/standards , Health Services Accessibility/statistics & numerical data , Health Services Misuse/prevention & control , Health Services Misuse/statistics & numerical data , Humans , Male , Middle Aged , Patient Acceptance of Health Care/ethnology , Patient Acceptance of Health Care/statistics & numerical data , Symptom Assessment/methods , Symptom Assessment/statistics & numerical data , United States/epidemiology
10.
Int J Gen Med ; 14: 1063-1067, 2021.
Article in English | MEDLINE | ID: covidwho-1167198

ABSTRACT

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (Covid-19), has been a serious threat to global health. Previous work has focused primarily on hospitalized patients or on identifying risk factors for disease severity and mortality once the infection has taken place. We sought to leverage the ubiquity of smartphones and mobile applications to study risk factors for Covid-19 infection in a large, geographically heterogenous cohort. METHODS: We analyzed data obtained from the Covid-19 Citizen Science (CCS) Study, a worldwide, mobile application-based cohort. After employing forward selection to identify variables with p values < 0.1, multivariable logistic regression models were utilized to identify independent risk factors associated with prevalent SARS-CoV-2 infection. RESULTS: Among 36,041 participants in 113 countries and all 50 states in the US, 484 participants had prevalent SARS-CoV-2 infection. After multivariable adjustment, being a healthcare worker, living with at least one school-aged child, having pets at home, and having immunodeficiency were each associated with an increased odds of SARS-CoV-2. The association between pets and prevalent SARS-CoV-2 was driven by dog ownership. After adjustment for the same covariates, Asian or Pacific Islander race, receiving a flu shot within the past year, increased level of education, and smoking or vaping marijuana within the last 30 days were each associated with a lower odds of SARS-CoV-2. CONCLUSION: We identified various characteristics and behaviors, many of which are potentially modifiable, associated with prevalent SARS-CoV-2 infection in a world-wide mobile application-based cohort.

12.
Am Heart J ; 232: 84-93, 2021 02.
Article in English | MEDLINE | ID: covidwho-893407

ABSTRACT

BACKGROUND: Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described. METHODS: A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame. CONCLUSIONS: The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.


Subject(s)
Internet-Based Intervention , Multicenter Studies as Topic , Patient Generated Health Data , Randomized Controlled Trials as Topic , Registries , COVID-19/epidemiology , Clopidogrel/therapeutic use , Continuity of Patient Care , Feasibility Studies , Follow-Up Studies , Genotype , Geographic Information Systems , Health Surveys/methods , Humans , Ischemia/drug therapy , Mobile Applications , Patient Compliance , Patient Participation , Percutaneous Coronary Intervention , Postoperative Complications/drug therapy , Pragmatic Clinical Trials as Topic , Purinergic P2Y Receptor Antagonists/therapeutic use , Research Design , SARS-CoV-2 , Telephone
13.
medRxiv ; 2020 Sep 23.
Article in English | MEDLINE | ID: covidwho-808753

ABSTRACT

There is an urgent need to answer questions related to COVID-19's clinical course and associations with underlying conditions and health outcomes. Multi-center data are necessary to generate reliable answers, but centralizing data in a single repository is not always possible. Using a privacy-protecting strategy, we launched a public Questions & Answers web portal (https://covid19questions.org) with analyses of comorbidities, medications and laboratory tests using data from 202 hospitals (59,074 COVID-19 patients) in the USA and Germany. We find, for example, that 8.6% of hospitalizations in which the patient was not admitted to the ICU resulted in the patient returning to the hospital within seven days from discharge and that, when adjusted for age, mortality for hospitalized patients was not significantly different by gender or ethnicity.

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