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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
4.
Sci Rep ; 11(1): 23959, 2021 12 14.
Article in English | MEDLINE | ID: covidwho-1585800

ABSTRACT

Evidence that patients may avoid healthcare facilities for fear of COVID-19 infection has heightened the concern that true rates of myocardial infarctions have been under-ascertained and left untreated. We analyzed data from the National Emergency Medical Services Information System (NEMSIS) and incident COVID-19 infections across the United States (US) between January 1, 2020 and April 30, 2020. Grouping events by US Census Division, multivariable adjusted negative binomial regression models were utilized to estimate the relationship between COVID-19 and EMS cardiovascular activations. After multivariable adjustment, increasing COVID-19 rates were associated with less activations for chest pain and non-ST-elevation myocardial infarctions. Simultaneously, increasing COVID-19 rates were associated with more activations for cardiac arrests, ventricular fibrillation, and ventricular tachycardia. Although direct effects of COVID-19 infections may explain these discordant observations, these findings may also arise from patients delaying or avoiding care for myocardial infarction, leading to potentially lethal consequences.


Subject(s)
Arrhythmias, Cardiac/epidemiology , COVID-19/epidemiology , Chest Pain/epidemiology , Arrhythmias, Cardiac/etiology , COVID-19/complications , Chest Pain/etiology , Humans , Models, Theoretical , Non-ST Elevated Myocardial Infarction/epidemiology , Non-ST Elevated Myocardial Infarction/genetics , United States/epidemiology
5.
BMJ Open ; 11(9): e052025, 2021 09 21.
Article in English | MEDLINE | ID: covidwho-1435056

ABSTRACT

OBJECTIVE: Until effective treatments and vaccines are made readily and widely available, preventative behavioural health measures will be central to the SARS-CoV-2 public health response. While current recommendations are grounded in general infectious disease prevention practices, it is still not entirely understood which particular behaviours or exposures meaningfully affect one's own risk of incident SARS-CoV-2 infection. Our objective is to identify individual-level factors associated with one's personal risk of contracting SARS-CoV-2. DESIGN: Prospective cohort study of adult participants from 26 March 2020 to 8 October 2020. SETTING: The COVID-19 Citizen Science Study, an international, community and mobile-based study collecting daily, weekly and monthly surveys in a prospective and time-updated manner. PARTICIPANTS: All adult participants over the age of 18 years were eligible for enrolment. PRIMARY OUTCOME MEASURE: The primary outcome was incident SARS-CoV-2 infection confirmed via PCR or antigen testing. RESULTS: 28 575 unique participants contributed 2 479 149 participant-days of data across 99 different countries. Of these participants without a history of SARS-CoV-2 infection at the time of enrolment, 112 developed an incident infection. Pooled logistic regression models showed that increased age was associated with lower risk (OR 0.98 per year, 95% CI 0.97 to 1.00, p=0.019), whereas increased number of non-household contacts (OR 1.10 per 10 contacts, 95% CI 1.01 to 1.20, p=0.024), attending events of at least 10 people (OR 1.26 per 10 events, 95% CI 1.07 to 1.50, p=0.007) and restaurant visits (OR 1.95 per 10 visits, 95% CI 1.42 to 2.68, p<0.001) were associated with significantly higher risk of incident SARS-CoV-2 infection. CONCLUSIONS: Our study identified three modifiable health behaviours, namely the number of non-household contacts, attending large gatherings and restaurant visits, which may meaningfully influence individual-level risk of contracting SARS-CoV-2.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , Humans , Middle Aged , Prospective Studies , Treatment Outcome
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.
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
9.
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.

11.
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
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