17 results on '"Dutcher, Sarah K."'
Search Results
2. Validity of inpatient electronic health record‐based measures of oxygen‐related therapy in the United States: Lessons applicable for studying COVID‐19 endpoints.
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Fuller, Candace C., Rosen, Edward, Rai, Ashish, Cosgrove, Austin, Miller, Karla, Bright, Patricia, Haffenreffer, Katherine, Poland, Russell E., Pratt, Natasha, Sands, Kenneth, Shinde, Mayura U., Platt, Richard, Cocoros, Noelle M., Klompas, Michael, and Dutcher, Sarah K.
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Introduction: During the COVID‐19 pandemic, inpatient electronic health records (EHRs) have been used to conduct public health surveillance and assess treatments and outcomes. Invasive mechanical ventilation (MV) and supplemental oxygen (O2) use are markers of severe illness in hospitalized COVID‐19 patients. In a large US system (n = 142 hospitals), we assessed documentation of MV and O2 use during COVID‐19 hospitalization in administrative data versus nursing documentation. Methods: We identified 319 553 adult hospitalizations with a COVID‐19 diagnosis, February 2020–October 2022, and extracted coded, administrative data for MV or O2. Separately, we developed classification rules for MV or O2 supplementation from semi‐structured nursing documentation. We assessed MV and O2 supplementation in administrative data versus nursing documentation and calculated ordinal endpoints of decreasing COVID‐19 disease severity. Nursing documentation was considered the gold standard in sensitivity and positive predictive value (PPV) analyses. Results: In nursing documentation, the prevalence of MV and O2 supplementation among COVID‐19 hospitalizations was 14% and 75%, respectively. The sensitivity of administrative data was 83% for MV and 41% for O2, with both PPVs above 91%. Concordance between sources was 97% for MV (κ = 0.85), and 54% for O2 (κ = 0.21). For ordinal endpoints, administrative data accurately identified intensive care and MV but underestimated hospitalizations with O2 requirements (42% vs. 18%). Conclusions: In comparison to nursing documentation, administrative data under‐ascertained O2 supplementation but accurately estimated severe endpoints such as MV. Nursing documentation improved ascertainment of O2 among COVID‐19 hospitalizations and can capture oxygen requirements in adults hospitalized with COVID‐19 or other respiratory illnesses. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.
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III, Vincent Lo Re, Cocoros, Noelle M, Hubbard, Rebecca A, Dutcher, Sarah K, Newcomb, Craig W, Connolly, John G, Perez-Vilar, Silvia, Carbonari, Dena M, Kempner, Maria E, Hernández-Muñoz, José J, Petrone, Andrew B, Pishko, Allyson M, Driscoll, Meighan E Rogers, Brash, James T, Burnett, Sean, Cohet, Catherine, Dahl, Matthew, DeFor, Terese A, Delmestri, Antonella, and Djibo, Djeneba Audrey
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COVID-19 ,COVID-19 pandemic ,GOVERNMENT agencies ,THROMBOEMBOLISM ,COVID-19 vaccines - Abstract
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09– 0.13%) in Canada to 1.01% (0.97– 1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21– 0.26%) in Canada to 0.84% (0.80– 0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06– 0.07%) in England to 1.04% (1.01– 1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24– 0.26%) in England to 1.02% (0.99– 1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability. Plain Language Summary: Cohort studies of patients diagnosed with COVID-19 in both the ambulatory and hospital settings have suggested that SARS-CoV-2 infection promotes hypercoagulability that could lead to arterial or venous thromboembolism. However, few studies have examined how the risk of thromboembolism with COVID-19 has evolved over time across different countries. A new collaboration was established among the regulatory authorities of Canada, Europe, and the US within the International Coalition of Medicines Regulatory Authorities to evaluate the 90-day risk of both arterial and venous thromboembolism after initial diagnosis of COVID-19 in the ambulatory or hospital setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. The study found that there was variability in the risk of both arterial and venous thromboembolism by month across the countries among patients initially diagnosed with COVID-19 in the ambulatory or hospital setting. Differences in the healthcare systems, prevalence of comorbidities in the study cohorts, and approaches to the case definitions of thromboembolism likely contributed to the variability in estimates of thromboembolism risk across the countries. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation
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Maro, Judith C., primary, Nguyen, Michael D., additional, Kolonoski, Joy, additional, Schoeplein, Ryan, additional, Huang, Ting‐Ying, additional, Dutcher, Sarah K., additional, Dal Pan, Gerald J., additional, and Ball, Robert, additional
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- 2023
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5. Switching patterns of immediate‐release forms of generic mixed amphetamine salts products among privately and publicly insured individuals aged 15–64 years in the United States, 2013–2019
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Perez‐Vilar, Silvia, primary, Kempner, Maria E., additional, Dutcher, Sarah K., additional, Menzin, Talia J., additional, Woods, Corinne, additional, Leishear, Kira, additional, Osterhout, James, additional, Adimadhyam, Sruthi, additional, Adereti, Modupeola, additional, Carruth, Amanda, additional, Hansbury, Aaron, additional, Sandhu, Sukhminder K., additional, and Lyons, Jennifer G., additional
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- 2023
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6. Risk of admission to hospital with arterial or venous thromboembolism among patients diagnosed in the ambulatory setting with covid-19 compared with influenza: retrospective cohort study
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Lo Re, Vincent, primary, Dutcher, Sarah K, additional, Connolly, John G, additional, Perez-Vilar, Silvia, additional, Carbonari, Dena M, additional, DeFor, Terese A, additional, Djibo, Djeneba Audrey, additional, Harrington, Laura B, additional, Hou, Laura, additional, Hennessy, Sean, additional, Hubbard, Rebecca A, additional, Kempner, Maria E, additional, Kuntz, Jennifer L, additional, McMahill-Walraven, Cheryl N, additional, Mosley, Jolene, additional, Pawloski, Pamala A, additional, Petrone, Andrew B, additional, Pishko, Allyson M, additional, Rogers Driscoll, Meighan, additional, Steiner, Claudia A, additional, Zhou, Yunping, additional, and Cocoros, Noelle M, additional
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- 2023
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7. Treatment and care received by children hospitalized with COVID-19 in a large hospital network in the United States, February 2020 to September 2021.
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Fuller, Candace C., Cosgrove, Austin, Shinde, Mayura, Rosen, Edward, Haffenreffer, Katie, Hague, Christian, McLean, Laura E., Perlin, Jonathan, Poland, Russell E., Sands, Kenneth E., Pratt, Natasha, Bright, Patricia, Platt, Richard, Cocoros, Noelle M., and Dutcher, Sarah K.
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HOSPITAL care of children ,LOW-molecular-weight heparin ,SARS-CoV-2 Omicron variant ,BLOOD diseases ,CHILD care - Abstract
We described care received by hospitalized children with COVID-19 or multi-system inflammatory syndrome (MIS-C) prior to the 2021 COVID-19 Omicron variant surge in the US. We identified hospitalized children <18 years of age with a COVID-19 or MIS-C diagnosis (COVID-19 not required), separately, from February 2020-September 2021 (n = 126 hospitals). We described high-risk conditions, inpatient treatments, and complications among these groups. Among 383,083 pediatric hospitalizations, 2,186 had COVID-19 and 395 had MIS-C diagnosis. Less than 1% had both COVID-19 and MIS-C diagnosis (n = 154). Over half were >6 years old (54% COVID-19, 70% MIS-C). High-risk conditions included asthma (14% COVID-19, 11% MIS-C), and obesity (9% COVID-19, 10% MIS-C). Pulmonary complications in children with COVID-19 included viral pneumonia (24%) and acute respiratory failure (11%). In reference to children with COVID-19, those with MIS-C had more hematological disorders (62% vs 34%), sepsis (16% vs 6%), pericarditis (13% vs 2%), myocarditis (8% vs 1%). Few were ventilated or died, but some required oxygen support (38% COVID-19, 45% MIS-C) or intensive care (42% COVID-19, 69% MIS-C). Treatments included: methylprednisolone (34% COVID-19, 75% MIS-C), dexamethasone (25% COVID-19, 15% MIS-C), remdesivir (13% COVID-19, 5% MIS-C). Antibiotics (50% COVID-19, 68% MIS-C) and low-molecular weight heparin (17% COVID-19, 34% MIS-C) were frequently administered. Markers of illness severity among hospitalized children with COVID-19 prior to the 2021 Omicron surge are consistent with previous studies. We report important trends on treatments in hospitalized children with COVID-19 to improve the understanding of real-world treatment patterns in this population. [ABSTRACT FROM AUTHOR]
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- 2023
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8. COVID-19 vs Influenza for Risk of Thrombotic Events in Hospitalized Patients—Reply
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Lo Re, Vincent, primary, Dutcher, Sarah K., additional, and Cocoros, Noelle M., additional
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- 2022
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9. Association of COVID-19 vs Influenza With Risk of Arterial and Venous Thrombotic Events Among Hospitalized Patients
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Lo Re, Vincent, primary, Dutcher, Sarah K., additional, Connolly, John G., additional, Perez-Vilar, Silvia, additional, Carbonari, Dena M., additional, DeFor, Terese A., additional, Djibo, Djeneba Audrey, additional, Harrington, Laura B., additional, Hou, Laura, additional, Hennessy, Sean, additional, Hubbard, Rebecca A., additional, Kempner, Maria E., additional, Kuntz, Jennifer L., additional, McMahill-Walraven, Cheryl N., additional, Mosley, Jolene, additional, Pawloski, Pamala A., additional, Petrone, Andrew B., additional, Pishko, Allyson M., additional, Driscoll, Meighan Rogers, additional, Steiner, Claudia A., additional, Zhou, Yunping, additional, and Cocoros, Noelle M., additional
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- 2022
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10. Evaluating Confounding Control in Estimations of Influenza Antiviral Effectiveness in Electronic Health Plan Data
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Htoo, Phyo T, primary, Measer, Gregory, additional, Orr, Robert, additional, Bohn, Justin, additional, Sorbello, Alfred, additional, Francis, Henry, additional, Dutcher, Sarah K, additional, Cosgrove, Austin, additional, Carruth, Amanda, additional, Toh, Sengwee, additional, and Cocoros, Noelle M, additional
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- 2022
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11. Validation of diagnosis codes to identify hospitalized COVID ‐19 patients in health care claims data
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Kluberg, Sheryl A., primary, Hou, Laura, additional, Dutcher, Sarah K., additional, Billings, Monisha, additional, Kit, Brian, additional, Toh, Sengwee, additional, Dublin, Sascha, additional, Haynes, Kevin, additional, Kline, Annemarie, additional, Maiyani, Mahesh, additional, Pawloski, Pamala A., additional, Watson, Eric S., additional, and Cocoros, Noelle M., additional
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- 2022
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12. Using inpatient electronic medical records to study influenza for pandemic preparedness
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Fuller, Candace C., primary, Cosgrove, Austin, additional, Sands, Kenneth, additional, Miller, Karla M., additional, Poland, Russell E., additional, Rosen, Edward, additional, Sorbello, Alfred, additional, Francis, Henry, additional, Orr, Robert, additional, Dutcher, Sarah K., additional, Measer, Gregory T., additional, and Cocoros, Noelle M., additional
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- 2021
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13. Who gets treated for influenza: A surveillance study from the US Food and Drug Administration’s Sentinel System
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Cocoros, Noelle M., Haug, Nicole, Cosgrove, Austin, Panozzo, Catherine A., Sorbello, Alfred, Francis, Henry, Garcia, Crystal, Orr, Robert, Toh, Sengwee, Dutcher, Sarah K., and Measer, Gregory T.
- Abstract
AbstractObjective:We describe the baseline characteristics and complications of individuals with influenza in the US FDA’s Sentinel System by antiviral treatment timing.Design:Retrospective cohort design.Patients:Individuals aged ≥6 months with outpatient diagnoses of influenza in June 2014–July 2017, 3 influenza seasons.Methods:We identified the comorbidities, vaccination history, influenza testing, and outpatient antiviral dispensings of individuals with influenza using administrative claims data from 13 data partners including the Centers for Medicare and Medicaid Services, integrated delivery systems, and commercial health plans. We assessed complications within 30 days: hospitalization, oxygen use, mechanical ventilation, critical care, ECMO, and death.Results:There were 1,090,333 influenza diagnoses in 2014–2015; 1,005,240 in 2016–2017; and 578,548 in 2017–2018. Between 49% and 55% of patients were dispensed outpatient treatment within 5 days. In all periods >80% of treated individuals received treatment on the day of diagnosis. Those treated on days 1–5 after diagnosis had higher prevalences of diabetes, chronic obstructive pulmonary disease, asthma, and obesity compared to those treated on the day of diagnosis or not treated at all. They also had higher rates of hospitalization, oxygen use, and critical care. In 2014–2015, among those aged ≥65 years, the rates of hospitalization were 45 per 1,000 diagnoses among those treated on day 0; 74 per 1,000 among those treated on days 1–5; and 50 per 1,000 among those who were untreated.Conclusions:In a large, national analysis, approximately half of people diagnosed with influenza in the outpatient setting were treated with antiviral medications. Delays in outpatient dispensed treatment were associated with higher prevalence of comorbidities and higher rates of complication.
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- 2022
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14. Using inpatient electronic medical records to study influenza for pandemic preparedness.
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Fuller, Candace C., Cosgrove, Austin, Sands, Kenneth, Miller, Karla M., Poland, Russell E., Rosen, Edward, Sorbello, Alfred, Francis, Henry, Orr, Robert, Dutcher, Sarah K., Measer, Gregory T., and Cocoros, Noelle M.
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PANDEMICS ,ELECTRONIC health records ,INFLUENZA ,SEASONAL influenza ,INTENSIVE care units ,PREPAREDNESS ,PUBLIC health surveillance - Abstract
Background: We assessed the ability to identify key data relevant to influenza and other respiratory virus surveillance in a large‐scale US‐based hospital electronic medical record (EMR) dataset using seasonal influenza as a use case. We describe characteristics and outcomes of hospitalized influenza cases across three seasons. Methods: We identified patients with an influenza diagnosis between March 2017 and March 2020 in 140 US hospitals as part of the US FDA's Sentinel System. We calculated descriptive statistics on the presence of high‐risk conditions, influenza antiviral administrations, and severity endpoints. Results: Among 5.1 million hospitalizations, we identified 29,520 hospitalizations with an influenza diagnosis; 64% were treated with an influenza antiviral within 2 days of admission, and 25% were treated >2 days after admission. Patients treated >2 days after admission had more comorbidities than patients treated within 2 days of admission. Patients never treated during hospitalization had more documentation of cardiovascular and other diseases than treated patients. We observed more severe endpoints in patients never treated (death = 3%, mechanical ventilation [MV] = 9%, intensive care unit [ICU] = 26%) or patients treated >2 days after admission (death = 2%, MV = 14%, ICU = 32%) than in patients treated earlier (treated on admission: death = 1%, MV = 5%, ICU = 23%, treated within 2 days of admission: death = 1%, MV = 7%, ICU = 27%). Conclusions: We identified important trends in influenza severity related to treatment timing in a large inpatient dataset, laying the groundwork for the use of this and other inpatient EMR data for influenza and other respiratory virus surveillance. [ABSTRACT FROM AUTHOR]
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- 2022
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15. Determinants of Generic Drug Substitution in the United States
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Segal, Jodi B., Onasanya, Oluwadamilola, Daubresse, Matthew, Lee, Chia-Ying, Moechtar, Mischka, Pu, Xia, Dutcher, Sarah K., and Romanelli, Robert J.
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Background: Some classes of drugs have lower than optimal uptake of generic products. We aimed to understand the determinants of generic drug substitution across classes.Methods: We conducted a cross-sectional analysis of data from the 2013 MarketScan Commercial Claims and Encounters Database from Truven Health Analytics. We quantified generic substitution rates (GSR) for 26 drug classes, choosing one representative week in November 2013. We used mixed-effects logistic regression to estimate the independent relationship between the determinants of interest and generic substitution for 8 classes with low generic utilization.Results: The GSRs for most classes exceeded 90%, although some were much lower including thyroid hormones (64%), androgens (74%), estrogens (71%), and hydantoin-type anticonvulsants (72%). The determinants of generic substitution varied across classes, albeit with important patterns. Patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies for 5 of the 8 studied classes; two additional classes showed no relationship between pharmacy type and generic use. Men relative to women and patients taking more medications were more likely to use generics for most classes. State substitution laws and patient consent laws were largely inconsequential regarding generic substitution.Conclusions: Policies are needed to support the use of safe, effective and often lower cost generic drugs, when available. Mail order pharmacies, as often required by pharmacy benefits managers, lessen generic use for many classes. These pharmacies may require additional regulatory oversight if this adversely impacts patients.
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- 2024
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16. Targeted Learning with an Undersmoothed Lasso Propensity Score Model for Large-Scale Covariate Adjustment in Healthcare Database Studies.
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Wyss R, van der Laan M, Gruber S, Shi X, Lee H, Dutcher SK, Nelson JC, Toh S, Russo M, Wang SV, Desai RJ, and Lin KJ
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Lasso regression is widely used for large-scale propensity score (PS) estimation in healthcare database studies. In these settings, previous work has shown that undersmoothing (overfitting) Lasso PS models can improve confounding control, but it can also cause problems of non-overlap in covariate distributions. It remains unclear how to select the degree of undersmoothing when fitting large-scale Lasso PS models to improve confounding control while avoiding issues that can result from reduced covariate overlap. Here, we used simulations to evaluate the performance of using collaborative-controlled targeted learning to data-adaptively select the degree of undersmoothing when fitting large-scale PS models within both singly and doubly robust frameworks to reduce bias in causal estimators. Simulations showed that collaborative learning can data-adaptively select the degree of undersmoothing to reduce bias in estimated treatment effects. Results further showed that when fitting undersmoothed Lasso PS-models, the use of cross-fitting was important for avoiding non-overlap in covariate distributions and reducing bias in causal estimates., (Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2024.)
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- 2024
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17. Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.
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Lo Re Iii V, Cocoros NM, Hubbard RA, Dutcher SK, Newcomb CW, Connolly JG, Perez-Vilar S, Carbonari DM, Kempner ME, Hernández-Muñoz JJ, Petrone AB, Pishko AM, Rogers Driscoll ME, Brash JT, Burnett S, Cohet C, Dahl M, DeFor TA, Delmestri A, Djibo DA, Duarte-Salles T, Harrington LB, Kampman M, Kuntz JL, Kurz X, Mercadé-Besora N, Pawloski PA, Rijnbeek PR, Seager S, Steiner CA, Verhamme K, Wu F, Zhou Y, Burn E, Paterson JM, and Prieto-Alhambra D
- Abstract
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability., Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE., Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US., Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability., Competing Interests: VLR III reports research grants to his institution from the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH); consulting fees from Entasis, Takeda, and Urovant Sciences; and participation on the FDA Drug Safety and Risk Management Advisory Committee. NMC reports research funding from FDA via a Department of Health and Human Services (HHS) contract during the conduct of the study and funding from HPHCI (a non-profit organization that conducts work for government and private organizations, including pharmaceutical companies) outside the submitted work. RAH reports grants from FDA, NIH, and Merck. AMP reports royalties from UpToDate (including for an article on anticoagulation), consulting fees via advisory board from BioMarin LLC outside the submitted work, and speaker honorarium from the American Society of Hematology. DAD reports stock options in CVS Health. JLK reports unrelated research grants to her institution from Vir Biotechnology, Pfizer, Novartis, and the Centers for Disease Control and Prevention. PRR reports unrelated research grants to his institution from Chiesi, UCB, Amgen, Johnson & Johnson, Innovative Medicines Initiative, and the European Medicines Agency. KV reports unrelated research grants to her institution from Chiesi, UCB, Amgen, Johnson & Johnson, and the European Medicines Agency. DPA reports research grants to his institution from Amgen, Chiesi-Taylor, Lilly, Janssen, Novartis, and UCB Biopharma as well as consulting fees from Astra Zeneca and UCB Biopharma. The authors report no other conflicts of interest in this work., (© 2024 Lo Re III et al.)
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- 2024
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