750 results on '"Patel, Manish M."'
Search Results
2. Protection of mRNA vaccines against hospitalized COVID-19 in adults over the first year following authorization in the United States
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Tenforde, Mark W, Self, Wesley H, Zhu, Yuwei, Naioti, Eric A, Gaglani, Manjusha, Ginde, Adit A, Jensen, Kelly, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, ten Lohuis, Caitlin, Duggal, Abhijit, Wilson, Jennifer G, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Botros, Mena M, Lauring, Adam S, Shapiro, Nathan I, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, Turbyfill, Caitlin, Olson, Samantha, Murray, Nancy, Adams, Katherine, and Patel, Manish M
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Clinical Research ,Prevention ,Immunization ,Vaccine Related ,Good Health and Well Being ,Humans ,Middle Aged ,COVID-19 ,COVID-19 Vaccines ,Hospitalization ,mRNA Vaccines ,RNA ,Messenger ,SARS-CoV-2 ,United States ,Aged ,duration of protection ,waning ,vaccine effectiveness ,mRNA ,Influenza and Other Viruses in the Acutely Ill (IVY) Network ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
BackgroundCoronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines were authorized in the United States in December 2020. Although vaccine effectiveness (VE) against mild infection declines markedly after several months, limited understanding exists on the long-term durability of protection against COVID-19-associated hospitalization.MethodsCase-control analysis of adults (≥18 years) hospitalized at 21 hospitals in 18 states 11 March-15 December 2021, including COVID-19 case patients and reverse transcriptase-polymerase chain reaction-negative controls. We included adults who were unvaccinated or vaccinated with 2 doses of a mRNA vaccine before the date of illness onset. VE over time was assessed using logistic regression comparing odds of vaccination in cases versus controls, adjusting for confounders. Models included dichotomous time (
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- 2023
3. Absolute and Relative Vaccine Effectiveness of Primary and Booster Series of COVID-19 Vaccines (mRNA and Adenovirus Vector) Against COVID-19 Hospitalizations in the United States, December 2021–April 2022
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Lewis, Nathaniel M, Murray, Nancy, Adams, Katherine, Surie, Diya, Gaglani, Manjusha, Ginde, Adit A, McNeal, Tresa, Ghamande, Shekhar, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Ali, Harith, Prekker, Matthew E, Frosch, Anne E, Exline, Matthew C, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Lauring, Adam S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Bender, William, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Chappell, James D, Halasa, Natasha, Grijalva, Carlos G, Rice, Todd W, Stubblefield, William B, Baughman, Adrienne, Lindsell, Christopher J, Hart, Kimberly W, Rhoads, Jillian P, McMorrow, Meredith L, Tenforde, Mark W, Self, Wesley H, Patel, Manish M, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Steingrub, Jay, Kozikowski, Lori-Ann, Souza, Lesley De, Ouellette, Scott, Bolstad, Michael, Coviello, Brianna, Ciottone, Robert, Devilla, Arnaldo, Grafals, Ana, Higgins, Conor, Ottanelli, Carlo, Redman, Kimberly, Scaffidi, Douglas, Weingart, Alexander, Patel, Manish, Tenforde, Mark, Lewis, Nathaniel, Olson, Samantha, Stephenson, Meagan, McMorrow, Meredith, Tremarelli, Maraia, Turbyfill, Caitlin, Mehkri, Omar, Mitchell, Megan, Griffith, Zachary, Brennan, Connery, Ashok, Kiran, Poynter, Bryan, and Busse, Laurence
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Biomedical and Clinical Sciences ,Clinical Sciences ,Immunization ,Biotechnology ,Vaccine Related ,Prevention ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Good Health and Well Being ,absolute vaccine effectiveness ,booster vaccine series ,COVID-19 ,primary vaccine series ,relative vaccine effectiveness ,Influenza and Other Viruses in the Acutely Ill (IVY) Network ,Clinical sciences ,Medical microbiology - Abstract
BackgroundCoronavirus disease 2019 (COVID-19) vaccine effectiveness (VE) studies are increasingly reporting relative VE (rVE) comparing a primary series plus booster doses with a primary series only. Interpretation of rVE differs from traditional studies measuring absolute VE (aVE) of a vaccine regimen against an unvaccinated referent group. We estimated aVE and rVE against COVID-19 hospitalization in primary-series plus first-booster recipients of COVID-19 vaccines.MethodsBooster-eligible immunocompetent adults hospitalized at 21 medical centers in the United States during December 25, 2021-April 4, 2022 were included. In a test-negative design, logistic regression with case status as the outcome and completion of primary vaccine series or primary series plus 1 booster dose as the predictors, adjusted for potential confounders, were used to estimate aVE and rVE.ResultsA total of 2060 patients were analyzed, including 1104 COVID-19 cases and 956 controls. Relative VE against COVID-19 hospitalization in boosted mRNA vaccine recipients versus primary series only was 66% (95% confidence interval [CI], 55%-74%); aVE was 81% (95% CI, 75%-86%) for boosted versus 46% (95% CI, 30%-58%) for primary. For boosted Janssen vaccine recipients versus primary series, rVE was 49% (95% CI, -9% to 76%); aVE was 62% (95% CI, 33%-79%) for boosted versus 36% (95% CI, -4% to 60%) for primary.ConclusionsVaccine booster doses increased protection against COVID-19 hospitalization compared with a primary series. Comparing rVE measures across studies can lead to flawed interpretations of the added value of a new vaccination regimen, whereas difference in aVE, when available, may be a more useful metric.
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- 2023
4. Comparison of test-negative and syndrome-negative controls in SARS-CoV-2 vaccine effectiveness evaluations for preventing COVID-19 hospitalizations in the United States
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Turbyfill, Caitlin, Adams, Katherine, Tenforde, Mark W, Murray, Nancy L, Gaglani, Manjusha, Ginde, Adit A, McNeal, Tresa, Ghamande, Shekhar, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Frosch, Anne E, Exline, Matthew C, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Lauring, Adam S, Khan, Akram, Busse, Laurence W, Lohuis, Caitlin C ten, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Kwon, Jennie H, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Stubblefield, William B, Baughman, Adrienne, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, McMorrow, Meredith, Surie, Diya, Self, Wesley H, and Patel, Manish M
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Prevention ,Lung ,Pneumonia & Influenza ,Immunization ,Clinical Research ,Emerging Infectious Diseases ,Biodefense ,Infectious Diseases ,Vaccine Related ,Rehabilitation ,Good Health and Well Being ,Humans ,Adult ,United States ,Influenza ,Human ,COVID-19 Vaccines ,SARS-CoV-2 ,COVID-19 ,COVID-19 Testing ,Vaccine Efficacy ,Case-Control Studies ,Influenza Vaccines ,Hospitalization ,Syndrome ,Test-negative ,Vaccine effectiveness ,Case-control study ,Control groups ,Research design ,Biological Sciences ,Agricultural and Veterinary Sciences ,Medical and Health Sciences ,Virology - Abstract
BackgroundTest-negative design (TND) studies have produced validated estimates of vaccine effectiveness (VE) for influenza vaccine studies. However, syndrome-negative controls have been proposed for differentiating bias and true estimates in VE evaluations for COVID-19. To understand the use of alternative control groups, we compared characteristics and VE estimates of syndrome-negative and test-negative VE controls.MethodsAdults hospitalized at 21 medical centers in 18 states March 11-August 31, 2021 were eligible for analysis. Case patients had symptomatic acute respiratory infection (ARI) and tested positive for SARS-CoV-2. Control groups were test-negative patients with ARI but negative SARS-CoV-2 testing, and syndrome-negative controls were without ARI and negative SARS-CoV-2 testing. Chi square and Wilcoxon rank sum tests were used to detect differences in baseline characteristics. VE against COVID-19 hospitalization was calculated using logistic regression comparing adjusted odds of prior mRNA vaccination between cases hospitalized with COVID-19 and each control group.Results5811 adults (2726 cases, 1696 test-negative controls, and 1389 syndrome-negative controls) were included. Control groups differed across characteristics including age, race/ethnicity, employment, previous hospitalizations, medical conditions, and immunosuppression. However, control-group-specific VE estimates were very similar. Among immunocompetent patients aged 18-64 years, VE was 93 % (95 % CI: 90-94) using syndrome-negative controls and 91 % (95 % CI: 88-93) using test-negative controls.ConclusionsDespite demographic and clinical differences between control groups, the use of either control group produced similar VE estimates across age groups and immunosuppression status. These findings support the use of test-negative controls and increase confidence in COVID-19 VE estimates produced by test-negative design studies.
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- 2022
5. Ascertainment of vaccination status by self‐report versus source documentation: Impact on measuring COVID‐19 vaccine effectiveness
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Stephenson, Meagan, Olson, Samantha M, Self, Wesley H, Ginde, Adit A, Mohr, Nicholas M, Gaglani, Manjusha, Shapiro, Nathan I, Gibbs, Kevin W, Hager, David N, Prekker, Matthew E, Gong, Michelle N, Steingrub, Jay S, Peltan, Ithan D, Martin, Emily T, Reddy, Raju, Busse, Laurence W, Duggal, Abhijit, Wilson, Jennifer G, Qadir, Nida, Mallow, Christopher, Kwon, Jennie H, Exline, Matthew C, Chappell, James D, Lauring, Adam S, Baughman, Adrienne, Lindsell, Christopher J, Hart, Kimberly W, Lewis, Nathaniel M, Patel, Manish M, Tenforde, Mark W, and Investigators, IVY Network
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Immunization ,Vaccine Related ,Clinical Research ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Good Health and Well Being ,Adult ,COVID-19 ,COVID-19 Vaccines ,Documentation ,Humans ,Pandemics ,RNA ,Messenger ,SARS-CoV-2 ,Self Report ,Vaccination ,Vaccine Efficacy ,concordance ,registry ,self-report ,vaccine effectiveness ,IVY Network Investigators ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology - Abstract
BackgroundDuring the COVID-19 pandemic, self-reported COVID-19 vaccination might facilitate rapid evaluations of vaccine effectiveness (VE) when source documentation (e.g., immunization information systems [IIS]) is not readily available. We evaluated the concordance of COVID-19 vaccination status ascertained by self-report versus source documentation and its impact on VE estimates.MethodsHospitalized adults (≥18 years) admitted to 18 U.S. medical centers March-June 2021 were enrolled, including COVID-19 cases and SARS-CoV-2 negative controls. Patients were interviewed about COVID-19 vaccination. Abstractors simultaneously searched IIS, medical records, and other sources for vaccination information. To compare vaccination status by self-report and documentation, we estimated percent agreement and unweighted kappa with 95% confidence intervals (CIs). We then calculated VE in preventing COVID-19 hospitalization of full vaccination (2 doses of mRNA product ≥14 days prior to illness onset) independently using data from self-report or source documentation.ResultsOf 2520 patients, 594 (24%) did not have self-reported vaccination information to assign vaccination group; these patients tended to be more severely ill. Among 1924 patients with both self-report and source documentation information, 95.0% (95% CI: 93.9-95.9%) agreement was observed, with a kappa of 0.9127 (95% CI: 0.9109-0.9145). VE was 86% (95% CI: 81-90%) by self-report data only and 85% (95% CI: 81-89%) by source documentation data only.ConclusionsApproximately one-quarter of hospitalized patients could not provide self-report COVID-19 vaccination status. Among patients with self-report information, there was high concordance with source documented status. Self-report may be a reasonable source of COVID-19 vaccination information for timely VE assessment for public health action.
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- 2022
6. Effectiveness of the Ad26.COV2.S (Johnson & Johnson) COVID-19 Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States
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Lewis, Nathaniel M, Self, Wesley H, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Ghamande, Shekhar A, McNeal, Tresa A, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, amuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Busse, Laurence W, Lohuis, Caitlin C ten, Duggal, bhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Lauring, Adam S, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Rhoads, Jillian P, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Adams, Katherine, Patel, Manish M, Tenforde, Mark W, and Collaborators, IVY Network
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Rare Diseases ,Immunization ,Clinical Research ,Prevention ,Vaccine Related ,3.4 Vaccines ,Prevention of disease and conditions ,and promotion of well-being ,Good Health and Well Being ,Ad26COVS1 ,Adult ,COVID-19 ,COVID-19 Vaccines ,Hospitalization ,Humans ,Influenza Vaccines ,Influenza ,Human ,Severity of Illness Index ,United States ,vaccine effectiveness ,viral vector vaccines ,IVY Network Collaborators ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
Background . Adults in the United States (US) began receiving the adenovirus vector coronavirus disease 2019 (COVID-19) vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. Methods . In a multicenter case-control analysis of US adults (≥18 years) hospitalized 11 March to 15 December 2021, we estimated VE against susceptibility to COVID-19 hospitalization (VEs), comparing odds of prior vaccination with a single dose Ad26.COV2.S vaccine between hospitalized cases with COVID-19 and controls without COVID-19. Among hospitalized patients with COVID-19, we estimated VE against disease progression (VEp) to death or invasive mechanical ventilation (IMV), comparing odds of prior vaccination between patients with and without progression. Results . After excluding patients receiving mRNA vaccines, among 3979 COVID-19 case-patients (5% vaccinated with Ad26.COV2.S) and 2229 controls (13% vaccinated with Ad26.COV2.S), VEs of Ad26.COV2.S against COVID-19 hospitalization was 70% (95% confidence interval [CI]: 63-75%) overall, including 55% (29-72%) among immunocompromised patients, and 72% (64-77%) among immunocompetent patients, for whom VEs was similar at 14-90 days (73% [59-82%]), 91-180 days (71% [60-80%]), and 181-274 days (70% [54-81%]) postvaccination. Among hospitalized COVID-19 case-patients, VEp was 46% (18-65%) among immunocompetent patients. Conclusions . The Ad26.COV2.S COVID-19 vaccine reduced the risk of COVID-19 hospitalization by 72% among immunocompetent adults without waning through 6 months postvaccination. After hospitalization for COVID-19, vaccinated immunocompetent patients were less likely to require IMV or die compared to unvaccinated immunocompetent patients.
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- 2022
7. Clinical outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) variant and BA.1/BA.1.1 or BA.2 subvariant infection in Southern California
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Lewnard, Joseph A, Hong, Vennis X, Patel, Manish M, Kahn, Rebecca, Lipsitch, Marc, and Tartof, Sara Y
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Clinical Research ,Vaccine Related ,Lung ,Prevention ,Biodefense ,Emerging Infectious Diseases ,Infectious Diseases ,2.1 Biological and endogenous factors ,Aetiology ,Infection ,Good Health and Well Being ,COVID-19 ,California ,Humans ,Public Health ,SARS-CoV-2 ,Medical and Health Sciences ,Immunology - Abstract
Epidemiologic surveillance has revealed decoupling of Coronavirus Disease 2019 (COVID-19) hospitalizations and deaths from case counts after emergence of the Omicron (B.1.1.529) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant globally. However, assessment of the relative severity of Omicron variant infections presents challenges because of differential acquired immune protection against Omicron and prior variants and because longer-term changes have occurred in testing and healthcare practices. Here we show that Omicron variant infections were associated with substantially reduced risk of progression to severe clinical outcomes relative to time-matched Delta (B.1.617.2) variant infections within a large, integrated healthcare system in Southern California. Adjusted hazard ratios (aHRs) for any hospital admission, symptomatic hospital admission, intensive care unit admission, mechanical ventilation and death comparing individuals with Omicron versus Delta variant infection were 0.59 (95% confidence interval: 0.51-0.69), 0.59 (0.51-0.68), 0.50 (0.29-0.87), 0.36 (0.18-0.72) and 0.21 (0.10-0.44), respectively. This reduced severity could not be explained by differential history of prior infection among individuals with Omicron or Delta variant infection and was starkest among individuals not previously vaccinated against COVID-19 (aHR = 0.40 (0.33-0.49) for any hospital admission and 0.14 (0.07-0.28) for death). Infections with the Omicron BA.2 subvariant were not associated with differential risk of severe outcomes in comparison to BA.1/BA.1.1 subvariant infections. Lower risk of severe clinical outcomes among individuals with Omicron variant infection should inform public health response amid establishment of the Omicron variant as the dominant SARS-CoV-2 lineage globally.
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- 2022
8. Associations between persistent symptoms after mild COVID‐19 and long‐term health status, quality of life, and psychological distress
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Han, Jin H, Womack, Kelsey N, Tenforde, Mark W, Files, D Clark, Gibbs, Kevin W, Shapiro, Nathan I, Prekker, Matthew E, Erickson, Heidi L, Steingrub, Jay S, Qadir, Nida, Khan, Akram, Hough, Catherine L, Johnson, Nicholas J, Ely, E Wesley, Rice, Todd W, Casey, Jonathan D, Lindsell, Christopher J, Gong, Michelle N, Srinivasan, Vasisht, Lewis, Nathaniel M, Patel, Manish M, Self, Wesley H, and Network, for the Influenza and Other Viruses in the Acutely Ill
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Clinical Research ,Good Health and Well Being ,Adult ,COVID-19 ,Health Status ,Humans ,Prospective Studies ,Psychological Distress ,Quality of Life ,SARS-CoV-2 ,Post-Acute COVID-19 Syndrome ,COVID-19 outcomes ,long-COVID ,post-acute sequalae of COVID-19 ,post-COVID conditions ,Influenza and Other Viruses in the Acutely Ill (IVY) Network ,Clinical Sciences ,Public Health and Health Services ,Virology - Abstract
BackgroundWe sought to assess whether persistent COVID-19 symptoms beyond 6 months (Long-COVID) among patients with mild COVID-19 is associated with poorer health status, quality of life, and psychological distress.MethodsThis was a multicenter prospective cohort study that included adult outpatients with acute COVID-19 from eight sites during 2-week sampling periods from April 1 and July 28, 2020. Participants were contacted 6-11 months after their first positive SARS-CoV-2 to complete a survey, which collected information on the severity of eight COVID-19 symptoms using a 4-point scale ranging from 0 (not present) to 3 (severe) at 1 month before COVID-19 (pre-illness) and at follow-up; the difference for each was calculated as an attributable persistent symptom severity score. A total attributable persistent COVID-19 symptom burden score was calculated by summing the attributable persistent severity scores for all eight symptoms. Outcomes measured at long-term follow-up comprised overall health status (EuroQol visual analogue scale), quality of life (EQ-5D-5L), and psychological distress (Patient Health Questionnaire-4). The association between the total attributable persistent COVID-19 burden score and each outcome was analyzed using multivariable proportional odds regression.ResultsOf the 2092 outpatients with COVID-19, 436 (21%) responded to the survey. The median (IQR) attributable persistent COVID-19 symptom burden score was 2 (0, 4); higher scores were associated with lower overall health status (aOR 0.63; 95% CI: 0.57-0.69), lower quality of life (aOR: 0.65; 95%CI: 0.59-0.72), and higher psychological distress (aOR: 1.40; 95%CI, 1.28-1.54) after adjusting for age, race, ethnicity, education, and income.ConclusionsIn participants with mild acute COVID-19, the burden of persistent symptoms was significantly associated with poorer long-term health status, poorer quality of life, and psychological distress.
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- 2022
9. Effectiveness of mRNA Vaccines Against COVID-19 Hospitalization by Age and Chronic Medical Conditions Burden Among Immunocompetent US Adults, March-August 2021
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Lewis, Nathaniel M, Naioti, Eric A, Self, Wesley H, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Gaglani, Manjusha, Ghamande, Shekhar A, McNeal, Tresa A, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Hubel, Kinsley, Hough, Catherine L, Busse, Laurence W, Lohuis, Caitlin C ten, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra J, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Rhoads, Jillian P, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Schrag, Stephanie J, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Tenforde, Mark W, Collaborators, IVY Network, McNeal, Tresa, Ghamande, Shekhar, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Settele, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Tyler, Patrick, Mehkri, Omar, Mitchell, Meg, Brennan, Connery, Ashok, Kiran, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Caspers, Sean, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, and Khan, Maryiam
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Immunization ,Aging ,Vaccine Related ,Good Health and Well Being ,Adult ,COVID-19 ,COVID-19 Vaccines ,Chronic Disease ,Hospitalization ,Humans ,Vaccines ,Synthetic ,mRNA Vaccines ,chronic medical conditions ,preexisting conditions ,vaccine effectiveness ,IVY Network Collaborators ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
Vaccine effectiveness (VE) against COVID-19 hospitalization was evaluated among immunocompetent adults (≥18 years) during March-August 2021 using a case-control design. Among 1669 hospitalized COVID-19 cases (11% fully vaccinated) and 1950 RT-PCR-negative controls (54% fully vaccinated), VE was 96% (95% confidence interval [CI], 93%-98%) among patients with no chronic medical conditions and 83% (95% CI, 76%-88%) among patients with ≥ 3 categories of conditions. VE was similar between those aged 18-64 years versus ≥65 years (P > .05). VE against severe COVID-19 was very high among adults without chronic conditions and lessened with increasing comorbidity burden.
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- 2022
10. Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States
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Tenforde, Mark W, Patel, Manish M, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Gaglani, Manjusha, McNeal, Tresa, Ghamande, Shekhar, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Exline, Matthew C, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Gershengorn, Hayley B, Babcock, Hilary M, Kwon, Jennie H, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Olson, Samantha M, Stephenson, Meagan, Schrag, Stephanie J, Kobayashi, Miwako, Verani, Jennifer R, and Self, Wesley H
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Pneumonia & Influenza ,Immunization ,Biodefense ,Vaccine Related ,Clinical Research ,Lung ,Infectious Diseases ,Emerging Infectious Diseases ,Pneumonia ,Prevention ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Infection ,Good Health and Well Being ,Adult ,COVID-19 ,COVID-19 Vaccines ,Hospitalization ,Humans ,Middle Aged ,RNA ,SARS-CoV-2 ,United States ,mRNA Vaccines ,vaccine effectiveness ,mRNA vaccines ,hospitalized ,immunocompromised ,Influenza and Other Viruses in the Acutely Ill (IVY) Network ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
BackgroundAs severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination coverage increases in the United States, there is a need to understand the real-world effectiveness against severe coronavirus disease 2019 (COVID-19) and among people at increased risk for poor outcomes.MethodsIn a multicenter case-control analysis of US adults hospitalized March 11-May 5, 2021, we evaluated vaccine effectiveness to prevent COVID-19 hospitalizations by comparing odds of prior vaccination with a messenger RNA (mRNA) vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with COVID-19 and hospital-based controls who tested negative for SARS-CoV-2.ResultsAmong 1212 participants, including 593 cases and 619 controls, median age was 58 years, 22.8% were Black, 13.9% were Hispanic, and 21.0% had immunosuppression. SARS-CoV-2 lineage B0.1.1.7 (Alpha) was the most common variant (67.9% of viruses with lineage determined). Full vaccination (receipt of 2 vaccine doses ≥14 days before illness onset) had been received by 8.2% of cases and 36.4% of controls. Overall vaccine effectiveness was 87.1% (95% confidence interval [CI], 80.7-91.3). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.4%; 95% CI, 79.3-9.7). Among 45 patients with vaccine-breakthrough COVID hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (62.9%; 95% CI,20.8-82.6) than without immunosuppression (91.3%; 95% CI, 85.6-94.8).ConclusionDuring March-May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing COVID-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population.
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- 2022
11. Effectiveness of a Third Dose of Pfizer-BioNTech and Moderna Vaccines in Preventing COVID-19 Hospitalization Among Immunocompetent and Immunocompromised Adults — United States, August–December 2021
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Tenforde, Mark W, Patel, Manish M, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Duggal, Abhijit, Wilson, Jennifer G, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Botros, Mena, Lauring, Adam S, Shapiro, Nathan I, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Naioti, Eric A, Adams, Katherine, Lewis, Nathaniel M, Surie, Diya, McMorrow, Meredith L, Self, Wesley H, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, ten Lohuis, Caitlin, Stanley, Nicholas, Hendrickson, Audrey, Caspers, Sean, Tordsen, Walker, Kaus, Olivia, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Rothman, Richard E, Ali, Harith, Nair, Rahul, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, So, Preston, Krol, Olivia, Martinez, Jesus, Zouyed, Zachary, Acosta, Michael, and Bazyarboroujeni, Reihaneh
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Immunization ,Infectious Diseases ,Prevention ,Vaccine Related ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,2019-nCoV Vaccine mRNA-1273 ,Adult ,Aged ,BNT162 Vaccine ,COVID-19 ,Female ,Hospitalization ,Humans ,Immunization ,Secondary ,Immunocompetence ,Immunocompromised Host ,Male ,Middle Aged ,SARS-CoV-2 ,United States ,Vaccine Efficacy ,IVY Network ,General & Internal Medicine - Abstract
COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) provide protection against infection with SARS-CoV-2, the virus that causes COVID-19, and are highly effective against COVID-19-associated hospitalization among eligible persons who receive 2 doses (1,2). However, vaccine effectiveness (VE) among persons with immunocompromising conditions* is lower than that among immunocompetent persons (2), and VE declines after several months among all persons (3). On August 12, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third mRNA vaccine dose as part of a primary series ≥28 days after dose 2 for persons aged ≥12 years with immunocompromising conditions, and, on November 19, 2021, as a booster dose for all adults aged ≥18 years at least 6 months after dose 2, changed to ≥5 months after dose 2 on January 3, 2022 (4,5,6). Among 2,952 adults (including 1,385 COVID-19 case-patients and 1,567 COVID-19-negative controls) hospitalized at 21 U.S. hospitals during August 19-December 15, 2021, effectiveness of mRNA vaccines against COVID-19-associated hospitalization was compared between adults eligible for but who had not received a third vaccine dose (1,251) and vaccine-eligible adults who received a third dose ≥7 days before illness onset (312). Among 1,875 adults without immunocompromising conditions (including 1,065 [57%] unvaccinated, 679 [36%] 2-dose recipients, and 131 [7%] 3-dose [booster] recipients), VE against COVID-19 hospitalization was higher among those who received a booster dose (97%; 95% CI = 95%-99%) compared with that among 2-dose recipients (82%; 95% CI = 77%-86%) (p
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- 2022
12. Clinical severity of, and effectiveness of mRNA vaccines against, covid-19 from omicron, delta, and alpha SARS-CoV-2 variants in the United States: prospective observational study
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Lauring, Adam S, Tenforde, Mark W, Chappell, James D, Gaglani, Manjusha, Ginde, Adit A, McNeal, Tresa, Ghamande, Shekhar, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Exline, Matthew C, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Halasa, Natasha, Grijalva, Carlos G, Rice, Todd W, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Adams, Katherine, Schrag, Stephanie J, Olson, Samantha M, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, and Self, Wesley H
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Genetics ,Immunization ,Clinical Research ,Prevention ,Vaccine Related ,Comparative Effectiveness Research ,Good Health and Well Being ,COVID-19 ,COVID-19 Vaccines ,Case-Control Studies ,Hospitalization ,Humans ,Immunization Schedule ,Prospective Studies ,SARS-CoV-2 ,Severity of Illness Index ,United States ,Influenza and Other Viruses in the Acutely Ill (IVY) Network ,Clinical Sciences ,Public Health and Health Services ,General & Internal Medicine - Abstract
ObjectivesTo characterize the clinical severity of covid-19 associated with the alpha, delta, and omicron SARS-CoV-2 variants among adults admitted to hospital and to compare the effectiveness of mRNA vaccines to prevent hospital admissions related to each variant.DesignCase-control study.Setting21 hospitals across the United States.Participants11 690 adults (≥18 years) admitted to hospital: 5728 with covid-19 (cases) and 5962 without covid-19 (controls). Patients were classified into SARS-CoV-2 variant groups based on viral whole genome sequencing, and, if sequencing did not reveal a lineage, by the predominant circulating variant at the time of hospital admission: alpha (11 March to 3 July 2021), delta (4 July to 25 December 2021), and omicron (26 December 2021 to 14 January 2022).Main outcome measuresVaccine effectiveness calculated using a test negative design for mRNA vaccines to prevent covid-19 related hospital admissions by each variant (alpha, delta, omicron). Among patients admitted to hospital with covid-19, disease severity on the World Health Organization's clinical progression scale was compared among variants using proportional odds regression.ResultsEffectiveness of the mRNA vaccines to prevent covid-19 associated hospital admissions was 85% (95% confidence interval 82% to 88%) for two vaccine doses against the alpha variant, 85% (83% to 87%) for two doses against the delta variant, 94% (92% to 95%) for three doses against the delta variant, 65% (51% to 75%) for two doses against the omicron variant; and 86% (77% to 91%) for three doses against the omicron variant. In-hospital mortality was 7.6% (81/1060) for alpha, 12.2% (461/3788) for delta, and 7.1% (40/565) for omicron. Among unvaccinated patients with covid-19 admitted to hospital, severity on the WHO clinical progression scale was higher for the delta versus alpha variant (adjusted proportional odds ratio 1.28, 95% confidence interval 1.11 to 1.46), and lower for the omicron versus delta variant (0.61, 0.49 to 0.77). Compared with unvaccinated patients, severity was lower for vaccinated patients for each variant, including alpha (adjusted proportional odds ratio 0.33, 0.23 to 0.49), delta (0.44, 0.37 to 0.51), and omicron (0.61, 0.44 to 0.85).ConclusionsmRNA vaccines were found to be highly effective in preventing covid-19 associated hospital admissions related to the alpha, delta, and omicron variants, but three vaccine doses were required to achieve protection against omicron similar to the protection that two doses provided against the delta and alpha variants. Among adults admitted to hospital with covid-19, the omicron variant was associated with less severe disease than the delta variant but still resulted in substantial morbidity and mortality. Vaccinated patients admitted to hospital with covid-19 had significantly lower disease severity than unvaccinated patients for all the variants.
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- 2022
13. Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022
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Tenforde, Mark W, Self, Wesley H, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Frosch, Anne E, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Duggal, Abhijit, Wilson, Jennifer G, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Botros, Mena, Lauring, Adam S, Shapiro, Nathan I, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Adams, Katherine, Surie, Diya, McMorrow, Meredith L, Patel, Manish M, and Network, IVY
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Clinical Research ,Prevention ,Vaccine Related ,Immunization ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Good Health and Well Being ,2019-nCoV Vaccine mRNA-1273 ,BNT162 Vaccine ,COVID-19 ,Hospital Mortality ,Humans ,Respiration ,Artificial ,United States ,Vaccine Efficacy ,IVY Network ,General & Internal Medicine - Abstract
COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) are effective at preventing COVID-19-associated hospitalization (1-3). However, how well mRNA vaccines protect against the most severe outcomes of these hospitalizations, including invasive mechanical ventilation (IMV) or death is uncertain. Using a case-control design, mRNA vaccine effectiveness (VE) against COVID-19-associated IMV and in-hospital death was evaluated among adults aged ≥18 years hospitalized at 21 U.S. medical centers during March 11, 2021-January 24, 2022. During this period, the most commonly circulating variants of SARS-CoV-2, the virus that causes COVID-19, were B.1.1.7 (Alpha), B.1.617.2 (Delta), and B.1.1.529 (Omicron). Previous vaccination (2 or 3 versus 0 vaccine doses before illness onset) in prospectively enrolled COVID-19 case-patients who received IMV or died within 28 days of hospitalization was compared with that among hospitalized control patients without COVID-19. Among 1,440 COVID-19 case-patients who received IMV or died, 307 (21%) had received 2 or 3 vaccine doses before illness onset. Among 6,104 control-patients, 4,020 (66%) had received 2 or 3 vaccine doses. Among the 1,440 case-patients who received IMV or died, those who were vaccinated were older (median age = 69 years), more likely to be immunocompromised* (40%), and had more chronic medical conditions compared with unvaccinated case-patients (median age = 55 years; immunocompromised = 10%; p
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- 2022
14. Adults Hospitalized with COVID-19 —United States, March-June and October-December 2020: Implications for the Potential Effects of COVID-19 Tier-1 Vaccination on Future Hospitalizations and Outcomes
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Sami, Samira, Tenforde, Mark W, Talbot, H Keipp, Lindsell, Christopher J, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Douin, David J, Prekker, Matthew E, Erickson, Heidi L, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Rice, Todd W, Casey, Jonathan D, Grijalva, Carlos G, Stubblefield, William B, Womack, Kelsey N, Hager, David N, Qadir, Nida, Chang, Steven Y, Henning, Daniel J, Wilson, Jennifer G, Self, Wesley H, Patel, Manish M, and Investigators, The IVY Network
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Vaccine Related ,Clinical Research ,Infectious Diseases ,Immunization ,Good Health and Well Being ,Adolescent ,Adult ,COVID-19 ,COVID-19 Vaccines ,Hospitalization ,Humans ,SARS-CoV-2 ,United States ,Vaccination ,hospitalization ,vaccination ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences - Abstract
BackgroundBecause of the increased risk for severe coronavirus disease 2019 (COVID-19), the Advisory Committee on Immunization Practices (ACIP) initially prioritized COVID-19 vaccination for persons in long-term care facilities (LTCF), persons aged ≥65 years, and persons aged 16-64 years with high-risk medical conditions when there is limited vaccine supply. We compared characteristics and severe outcomes of hospitalized patients with COVID-19 in the United States between early and later in the pandemic categorized by groups at higher risk of severe COVID-19.MethodsObservational study of sampled patients aged ≥18 years who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and admitted to one of 14 academic hospitals in the United States during March-June and October-December 2020. Demographic and clinical information were gathered from electronic health record data.ResultsAmong 647 patients, 91% met ≥1 of the following risk factors for severe COVID-19 [91% March-June (n = 434); 90% October-December (n = 213)]; 19% were LTCF residents, 45% were aged ≥65-years, and 84% had ≥1 high-risk condition. The proportion of patients who resided in a LTCF declined significantly (25% vs 6%) from early to later pandemic periods. Compared with patients at lower risk for severe COVID-19, in-hospital mortality was higher among patients at high risk for severe COVID-19 (20% vs 7%); these differences were consistently observed between March-June and October-December.ConclusionsMost adults hospitalized with COVID-19 were those recommended to be prioritized for vaccination based on risk for developing severe COVID-19. These findings highlight the continued urgency to vaccinate patients at high risk for severe COVID-19 and monitor vaccination impact on hospitalizations and outcomes.
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- 2021
15. Theoretical Framework for Retrospective Studies of the Effectiveness of SARS-CoV-2 Vaccines.
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Lewnard, Joseph A, Patel, Manish M, Jewell, Nicholas P, Verani, Jennifer R, Kobayashi, Miwako, Tenforde, Mark W, Dean, Natalie E, Cowling, Benjamin J, and Lopman, Benjamin A
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Humans ,Vaccines ,Retrospective Studies ,COVID-19 ,SARS-CoV-2 ,COVID-19 Vaccines ,Clinical Research ,Immunization ,Biodefense ,Prevention ,Emerging Infectious Diseases ,Infectious Diseases ,Vaccine Related ,3.4 Vaccines ,Prevention of disease and conditions ,and promotion of well-being ,Infection ,Good Health and Well Being ,Causal inference ,Test-negative design ,Vaccine effectiveness ,Statistics ,Public Health and Health Services ,Epidemiology - Abstract
Observational studies of the effectiveness of vaccines to prevent COVID-19 are needed to inform real-world use. Such studies are now underway amid the ongoing rollout of SARS-CoV-2 vaccines globally. Although traditional case-control and test-negative design studies feature prominently among strategies used to assess vaccine effectiveness, such studies may encounter important threats to validity. Here, we review the theoretical basis for estimation of vaccine direct effects under traditional case-control and test-negative design frameworks, addressing specific natural history parameters of SARS-CoV-2 infection and COVID-19 relevant to these designs. Bias may be introduced by misclassification of cases and controls, particularly when clinical case criteria include common, nonspecific indicators of COVID-19. When using diagnostic assays with high analytical sensitivity for SARS-CoV-2 detection, individuals testing positive may be counted as cases even if their symptoms are due to other causes. The traditional case-control design may be particularly prone to confounding due to associations of vaccination with healthcare-seeking behavior or risk of infection. The test-negative design reduces but may not eliminate this confounding, for instance, if individuals who receive vaccination seek care or testing for less-severe illness. These circumstances indicate the two study designs cannot be applied naively to datasets gathered through public health surveillance or administrative sources. We suggest practical strategies to reduce bias in vaccine effectiveness estimates at the study design and analysis stages.
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- 2021
16. The Modified Clinical Progression Scale for Pediatric Patients: Evaluation as a Severity Metric and Outcome Measure in Severe Acute Viral Respiratory Illness
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Leland, Shannon B., Staffa, Steven J., Newhams, Margaret M., Khemani, Robinder G., Marshall, John C., Young, Cameron C., Maddux, Aline B., Hall, Mark W., Weiss, Scott L., Schwarz, Adam J., Coates, Bria M., Sanders, Ronald C., Jr, Kong, Michele, Thomas, Neal J., Nofziger, Ryan A., Cullimore, Melissa L., Halasa, Natasha B., Loftis, Laura L., Cvijanovich, Natalie Z., Schuster, Jennifer E., Flori, Heidi, Gertz, Shira J., Hume, Janet R., Olson, Samantha M., Patel, Manish M., Zurakowski, David, and Randolph, Adrienne G.
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- 2023
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17. Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021
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Tenforde, Mark W, Self, Wesley H, Naioti, Eric A, Ginde, Adit A, Douin, David J, Olson, Samantha M, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Gaglani, Manjusha, McNeal, Tresa, Ghamande, Shekhar, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Stephenson, Meagan, Schrag, Stephanie J, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Settele, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Tyler, Patrick, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Maruggi, Ellen, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting Tina, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, and So, Preston
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Biomedical and Clinical Sciences ,Clinical Sciences ,Immunization ,Clinical Research ,Biodefense ,Vaccine Related ,Prevention ,3.4 Vaccines ,6.1 Pharmaceuticals ,Prevention of disease and conditions ,and promotion of well-being ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,COVID-19 ,COVID-19 Vaccines ,Female ,Hospitalization ,Humans ,Male ,Middle Aged ,Time Factors ,United States ,Vaccination ,Vaccines ,Synthetic ,Young Adult ,IVY Network Investigators ,IVY Network ,General & Internal Medicine - Abstract
Real-world evaluations have demonstrated high effectiveness of vaccines against COVID-19-associated hospitalizations (1-4) measured shortly after vaccination; longer follow-up is needed to assess durability of protection. In an evaluation at 21 hospitals in 18 states, the duration of mRNA vaccine (Pfizer-BioNTech or Moderna) effectiveness (VE) against COVID-19-associated hospitalizations was assessed among adults aged ≥18 years. Among 3,089 hospitalized adults (including 1,194 COVID-19 case-patients and 1,895 non-COVID-19 control-patients), the median age was 59 years, 48.7% were female, and 21.1% had an immunocompromising condition. Overall, 141 (11.8%) case-patients and 988 (52.1%) controls were fully vaccinated (defined as receipt of the second dose of Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines ≥14 days before illness onset), with a median interval of 65 days (range = 14-166 days) after receipt of second dose. VE against COVID-19-associated hospitalization during the full surveillance period was 86% (95% confidence interval [CI] = 82%-88%) overall and 90% (95% CI = 87%-92%) among adults without immunocompromising conditions. VE against COVID-19- associated hospitalization was 86% (95% CI = 82%-90%) 2-12 weeks and 84% (95% CI = 77%-90%) 13-24 weeks from receipt of the second vaccine dose, with no significant change between these periods (p = 0.854). Whole genome sequencing of 454 case-patient specimens found that 242 (53.3%) belonged to the B.1.1.7 (Alpha) lineage and 74 (16.3%) to the B.1.617.2 (Delta) lineage. Effectiveness of mRNA vaccines against COVID-19-associated hospitalization was sustained over a 24-week period, including among groups at higher risk for severe COVID-19; ongoing monitoring is needed as new SARS-CoV-2 variants emerge. To reduce their risk for hospitalization, all eligible persons should be offered COVID-19 vaccination.
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- 2021
18. Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
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Tenforde, Mark W, Olson, Samantha M, Self, Wesley H, Talbot, H Keipp, Lindsell, Christopher J, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Douin, David J, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Mohamed, Amira, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Stubblefield, William B, Casey, Jonathan D, Rice, Todd W, Grijalva, Carlos G, Hager, David N, Shehu, Arber, Qadir, Nida, Chang, Steven Y, Wilson, Jennifer G, Gaglani, Manjusha, Murthy, Kempapura, Calhoun, Nicole, Monto, Arnold S, Martin, Emily T, Malani, Anurag, Zimmerman, Richard K, Silveira, Fernanda P, Middleton, Donald B, Zhu, Yuwei, Wyatt, Dayna, Stephenson, Meagan, Baughman, Adrienne, Womack, Kelsey N, Hart, Kimberly W, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Amosu, Omowunmi, Armbruster, Brent, Aston, Valerie, Bernardo, Marianne, Bowers, Robert, De Souza, Leslie, Friedel, Jennifer, Gardner, Kevin, Goff, Jennifer, Gordon, Alexandra June, Hendrickson, Audrey, Hicks, Madeline, Howell, Michelle, Johnson, Jakea, Jorgensen, Jeffrey, Karow, Sarah, Kozikowski, Lori, Krol, Olivia, Landreth, Leigha, LaRose, Mary, Lopez, Brenda, York, New, Luong, Andrea, McClellan, Bob, Maruggi, Ellen, Miller, Karen, Nair, Rahul, Parks, Lisa, Peers, Jennifer, Perez, Cynthia, Rivera, Adreanne, Roque, Jonasel, Santana, Andres, Scharber, Tyler, Silverman, Emma, Tozier, Michael, Tzehaie, Hiwet, Zouyed, Zachary, Arroliga, Alejandro, Bagiatis, Alicia, Balasubramani, GK, Cheng, Caroline K, Eng, Heather, Ghamande, Shekhar, Herrick, Judy, Hoffman, Eric, Hughes, Kailey, Lamerato, Lois E, Lauring, Adam S, McKillop, Amanda, McNeal, Tresa, McSpadden, EJ, Midturi, John, Mutnal, Manohar, and Nowalk, Mary Patricia
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Immunization ,Vaccine Related ,3.4 Vaccines ,Prevention of disease and conditions ,and promotion of well-being ,Good Health and Well Being ,Aged ,COVID-19 ,COVID-19 Vaccines ,Female ,Hospitalization ,Humans ,Male ,Risk Assessment ,Treatment Outcome ,United States ,Vaccination Coverage ,Vaccines ,Synthetic ,IVY Network ,HAIVEN Investigators ,General & Internal Medicine - Abstract
Adults aged ≥65 years are at increased risk for severe outcomes from COVID-19 and were identified as a priority group to receive the first COVID-19 vaccines approved for use under an Emergency Use Authorization (EUA) in the United States (1-3). In an evaluation at 24 hospitals in 14 states,* the effectiveness of partial or full vaccination† with Pfizer-BioNTech or Moderna vaccines against COVID-19-associated hospitalization was assessed among adults aged ≥65 years. Among 417 hospitalized adults aged ≥65 years (including 187 case-patients and 230 controls), the median age was 73 years, 48% were female, 73% were non-Hispanic White, 17% were non-Hispanic Black, 6% were Hispanic, and 4% lived in a long-term care facility. Adjusted vaccine effectiveness (VE) against COVID-19-associated hospitalization among adults aged ≥65 years was estimated to be 94% (95% confidence interval [CI] = 49%-99%) for full vaccination and 64% (95% CI = 28%-82%) for partial vaccination. These findings are consistent with efficacy determined from clinical trials in the subgroup of adults aged ≥65 years (4,5). This multisite U.S. evaluation under real-world conditions suggests that vaccination provided protection against COVID-19-associated hospitalization among adults aged ≥65 years. Vaccination is a critical tool for reducing severe COVID-19 in groups at high risk.
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- 2021
19. Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021
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Self, Wesley H, Tenforde, Mark W, Rhoads, Jillian P, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Olson, Samantha M, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Mills, Lisa, Lester, Sandra N, Stumpf, Megan M, Naioti, Eric A, Kobayashi, Miwako, Verani, Jennifer R, Thornburg, Natalie J, Patel, Manish M, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Seattle, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Maruggi, Ellen, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting Tina, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, and Khan, Maryiam
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Biomedical and Clinical Sciences ,Clinical Sciences ,Prevention ,Immunization ,Vaccine Related ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,COVID-19 ,COVID-19 Vaccines ,Female ,Hospitalization ,Humans ,Immunocompromised Host ,Male ,Middle Aged ,United States ,Vaccines ,Synthetic ,Young Adult ,IVY Network ,General & Internal Medicine - Abstract
Three COVID-19 vaccines are authorized or approved for use among adults in the United States (1,2). Two 2-dose mRNA vaccines, mRNA-1273 from Moderna and BNT162b2 from Pfizer-BioNTech, received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in December 2020 for persons aged ≥18 years and aged ≥16 years, respectively. A 1-dose viral vector vaccine (Ad26.COV2 from Janssen [Johnson & Johnson]) received EUA in February 2021 for persons aged ≥18 years (3). The Pfizer-BioNTech vaccine received FDA approval for persons aged ≥16 years on August 23, 2021 (4). Current guidelines from FDA and CDC recommend vaccination of eligible persons with one of these three products, without preference for any specific vaccine (4,5). To assess vaccine effectiveness (VE) of these three products in preventing COVID-19 hospitalization, CDC and collaborators conducted a case-control analysis among 3,689 adults aged ≥18 years who were hospitalized at 21 U.S. hospitals across 18 states during March 11-August 15, 2021. An additional analysis compared serum antibody levels (anti-spike immunoglobulin G [IgG] and anti-receptor binding domain [RBD] IgG) to SARS-CoV-2, the virus that causes COVID-19, among 100 healthy volunteers enrolled at three hospitals 2-6 weeks after full vaccination with the Moderna, Pfizer-BioNTech, or Janssen COVID-19 vaccine. Patients with immunocompromising conditions were excluded. VE against COVID-19 hospitalizations was higher for the Moderna vaccine (93%; 95% confidence interval [CI] = 91%-95%) than for the Pfizer-BioNTech vaccine (88%; 95% CI = 85%-91%) (p = 0.011); VE for both mRNA vaccines was higher than that for the Janssen vaccine (71%; 95% CI = 56%-81%) (all p
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- 2021
20. ICU Bed Utilization During the Coronavirus Disease 2019 Pandemic in a Multistate Analysis-March to June 2020.
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Douin, David J, Ward, Michael J, Lindsell, Christopher J, Howell, Michelle P, Hough, Catherine L, Exline, Matthew C, Gong, Michelle N, Aboodi, Michael S, Tenforde, Mark W, Feldstein, Leora R, Stubblefield, William B, Steingrub, Jay S, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Khan, Akram, Files, D Clark, Gibbs, Kevin W, Rice, Todd W, Casey, Jonathan D, Hager, David N, Qadir, Nida, Henning, Daniel J, Wilson, Jennifer G, Patel, Manish M, Self, Wesley H, and Ginde, Adit A
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Patient Safety ,capacity ,coronavirus disease 2019 ,intensive care unit ,mechanical ventilation ,resource allocation - Abstract
ObjectivesGiven finite ICU bed capacity, knowledge of ICU bed utilization during the coronavirus disease 2019 pandemic is critical to ensure future strategies for resource allocation and utilization. We sought to examine ICU census trends in relation to ICU bed capacity during the rapid increase in severe coronavirus disease 2019 cases early during the pandemic.DesignObservational cohort study.SettingThirteen geographically dispersed academic medical centers in the United States.Patients/subjectsWe obtained daily ICU censuses from March 26 to June 30, 2020, as well as prepandemic ICU bed capacities. The primary outcome was daily census of ICU patients stratified by coronavirus disease 2019 and mechanical ventilation status in relation to ICU capacity.InterventionsNone.Measurements and main resultsPrepandemic overall ICU capacity ranged from 62 to 225 beds (median 109). During the study period, the median daily coronavirus disease 2019 ICU census per hospital ranged from 1 to 84 patients, and the daily ICU census exceeded overall ICU capacity for at least 1 day at five institutions. The number of critically ill patients exceeded ICU capacity for a median (interquartile range) of 17 (12-50) of 97 days at these five sites. All 13 institutions experienced decreases in their noncoronavirus disease ICU population, whereas local coronavirus disease 2019 cases increased. Coronavirus disease 2019 patients reached their greatest proportion of ICU capacity on April 12, 2020, when they accounted for 44% of ICU patients across all participating hospitals. Maximum ICU census ranged from 52% to 289% of overall ICU capacity, with three sites less than 80%, four sites 80-100%, five sites 100-128%, and one site 289%.ConclusionsFrom March to June 2020, the coronavirus disease 2019 pandemic led to ICU censuses greater than ICU bed capacity at fives of 13 institutions evaluated. These findings demonstrate the short-term adaptability of U.S. healthcare institutions in redirecting limited resources to accommodate a public health emergency.
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- 2021
21. Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network - 12 States, April-August 2020.
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Self, Wesley H, Tenforde, Mark W, Stubblefield, William B, Feldstein, Leora R, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Aboodi, Michael S, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Lindsell, Christopher J, Rice, Todd W, Jones, Ian D, Halasa, Natasha, Talbot, H Keipp, Grijalva, Carlos G, Casey, Jonathan D, Hager, David N, Qadir, Nida, Henning, Daniel J, Coughlin, Melissa M, Schiffer, Jarad, Semenova, Vera, Li, Han, Thornburg, Natalie J, Patel, Manish M, CDC COVID-19 Response Team, and IVY Network
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CDC COVID-19 Response Team ,IVY Network ,Humans ,Pneumonia ,Viral ,Coronavirus Infections ,Antibodies ,Viral ,Adult ,Middle Aged ,Personnel ,Hospital ,United States ,Female ,Male ,Pandemics ,Betacoronavirus ,COVID-19 ,SARS-CoV-2 ,Prevention ,Infectious Diseases ,Clinical Research ,Vaccine Related ,Lung ,Biodefense ,Emerging Infectious Diseases ,Infection ,Good Health and Well Being ,General & Internal Medicine - Abstract
Most persons infected with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), develop virus-specific antibodies within several weeks, but antibody titers might decline over time. Understanding the timeline of antibody decline is important for interpreting SARS-CoV-2 serology results. Serum specimens were collected from a convenience sample of frontline health care personnel at 13 hospitals and tested for antibodies to SARS-CoV-2 during April 3-June 19, 2020, and again approximately 60 days later to assess this timeline. The percentage of participants who experienced seroreversion, defined as an antibody signal-to-threshold ratio >1.0 at baseline and
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- 2020
22. Early Serial Echocardiographic and Ultrasonographic Findings in Critically Ill Patients With COVID-19
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Calhoun, Nicole, Herrick, Judy, Hoffman, Eric, McKillop, Amanda, Murthy, Kempapura, Smith, Michael, Zayed, Martha, De Souza, Lesley, Kindle, Ryan, Kozikowski, Lori-Ann, Ouellette, Scott, Thornton-Thompson, Sherell, Bolstad, Michael, Ciottone, Robert, Coviello, Brianna, Devilla, Arnaldo, Grafals, Ana, Higgins, Conor, Ottanelli, Carlo, Redman, Kimberly, Scaffidi, Douglas, Weingart, Alexander, Lewis, Nathaniel, Olson, Samantha, Ashok, Kiran, Brennan, Connery, Mehkri, Omar, Mitchell, Megan, Poynter, Bryan, Stanley, Nicholas, Lohuis, Caitlin ten, Caspers, Sean, Erikson, Heidi, Hendrickson, Audrey, Kaus, Olivia, Maruggi, Ellen, Scharber, Tyler, Tordsen, Walker, Aston, Valerie, Bowers, Robert, Jorgensen, Jeffrey, King, Jennifer, Ali, Harith, Rothman, Richard E., Nair, Rahul, Chen, Jen-Ting, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, So, Preston, Schwartz, Elizabeth, So, Madison, Weigand, Michael, Luong, Andrea, Martinez, Jesus, Huynh, Bao, Ibrahim, Habiba, Villanueva-Vargas, Cynthia, Jung, Haeun, Villanueva-Vargas, Juliana, Quadri, Suha, Gordon, Alexandra Jun, Levitt, Joe, Perez, Cynthia, Visweswaran, Anita, Roque, Jonasel, Rivera, Adreanne, Frankel, Trevor, Goff, Jennifer, Huynh, David, Jensen, Kelly, Driver, Conner, Chambers, Ian, Nassar, Paul, Stout, Lori, Sibenaller, Zita, Walter, Alicia, Mares, Jasmine, Olson, Logan, Clinansmith, Bradley, Gershengorn, Hayley, Rivas, Carolina, McSpadden, E.J., Truscon, Rachel, Kaniclides, Anne, Thomas, Lara, Bielak, Ramsay, Valvano, Weronika Damek, Fong, Rebecca, Fitzsimmons, William J., Blair, Christopher, Valesano, Andrew, Baker, Leigh, Gilbert, Julie, Crider, Christine D., Steinbock, Kyle A., Paulson, Thomas C., Anderson, Layla A., Kampe, Christy, Johnson, Jakea, Short, Laura L., Ezzell, Lauren J., Whitsett, Margaret E., McHenry, Rendie E., Hargrave, Samarian J., Blair, Marica, Luther, Jennifer L., Pulido, Claudia Guevara, Peterson, Bryan P.M., LaRose, Mary, Landreth, Leigha, Hicks, Madeline, Parks, Lisa, Bongu, Jahnavi, McDonald, David, Cass, Candice, Seiler, Sondra, Park, David, Hink, Tiffany, Wallace, Meghan, Burnham, Carey-Ann, Arter, Olivia G., Lanspa, Michael J., Dugar, Siddharth P., Prigmore, Heather L., Boyd, Jeremy S., Rupp, Jordan D., Lindsell, Chris J., Rice, Todd W., Qadir, Nida, Lim, George W., Shiloh, Ariel L., Dieiev, Vladyslav, Gong, Michelle N., Fox, Steven W., Hirshberg, Eliotte L., Khan, Akram, Kornfield, James, Schoeneck, Jacob H., Macklin, Nicholas, Files, D.Clark, Gibbs, Kevin W., Prekker, Matthew E., Parsons-Moss, Daniel, Bown, Mikaele, Olsen, Troy D., Knox, Daniel B., Cirulis, Meghan M., Duggal, Abhijit, Tenforde, Mark W., Patel, Manish M., Self, Wesley H., and Brown, Samuel M.
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- 2023
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23. Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network - 13 Academic Medical Centers, April-June 2020.
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Self, Wesley H, Tenforde, Mark W, Stubblefield, William B, Feldstein, Leora R, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Aboodi, Michael S, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Lindsell, Christopher J, Rice, Todd W, Jones, Ian D, Halasa, Natasha, Talbot, H Keipp, Grijalva, Carlos G, Casey, Jonathan D, Hager, David N, Qadir, Nida, Henning, Daniel J, Coughlin, Melissa M, Schiffer, Jarad, Semenova, Vera, Li, Han, Thornburg, Natalie J, Patel, Manish M, CDC COVID-19 Response Team, and IVY Network
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CDC COVID-19 Response Team ,IVY Network ,Humans ,Cross Infection ,Pneumonia ,Viral ,Coronavirus Infections ,Antibodies ,Viral ,Seroepidemiologic Studies ,Adult ,Middle Aged ,Personnel ,Hospital ,Academic Medical Centers ,United States ,Female ,Male ,Infectious Disease Transmission ,Professional-to-Patient ,Asymptomatic Diseases ,Pandemics ,Personal Protective Equipment ,Betacoronavirus ,Antibodies ,Viral ,Infectious Disease Transmission ,Professional-to-Patient ,Personnel ,Hospital ,Pneumonia ,General & Internal Medicine - Abstract
Health care personnel (HCP) caring for patients with coronavirus disease 2019 (COVID-19) might be at high risk for contracting SARS-CoV-2, the virus that causes COVID-19. Understanding the prevalence of and factors associated with SARS-CoV-2 infection among frontline HCP who care for COVID-19 patients are important for protecting both HCP and their patients. During April 3-June 19, 2020, serum specimens were collected from a convenience sample of frontline HCP who worked with COVID-19 patients at 13 geographically diverse academic medical centers in the United States, and specimens were tested for antibodies to SARS-CoV-2. Participants were asked about potential symptoms of COVID-19 experienced since February 1, 2020, previous testing for acute SARS-CoV-2 infection, and their use of personal protective equipment (PPE) in the past week. Among 3,248 participants, 194 (6.0%) had positive test results for SARS-CoV-2 antibodies. Seroprevalence by hospital ranged from 0.8% to 31.2% (median = 3.6%). Among the 194 seropositive participants, 56 (29%) reported no symptoms since February 1, 2020, 86 (44%) did not believe that they previously had COVID-19, and 133 (69%) did not report a previous COVID-19 diagnosis. Seroprevalence was lower among personnel who reported always wearing a face covering (defined in this study as a surgical mask, N95 respirator, or powered air purifying respirator [PAPR]) while caring for patients (5.6%), compared with that among those who did not (9.0%) (p = 0.012). Consistent with persons in the general population with SARS-CoV-2 infection, many frontline HCP with SARS-CoV-2 infection might be asymptomatic or minimally symptomatic during infection, and infection might be unrecognized. Enhanced screening, including frequent testing of frontline HCP, and universal use of face coverings in hospitals are two strategies that could reduce SARS-CoV-2 transmission.
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- 2020
24. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network — United States, March–June 2020
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Tenforde, Mark W, Kim, Sara S, Lindsell, Christopher J, Billig Rose, Erica, Shapiro, Nathan I, Files, D Clark, Gibbs, Kevin W, Erickson, Heidi L, Steingrub, Jay S, Smithline, Howard A, Gong, Michelle N, Aboodi, Michael S, Exline, Matthew C, Henning, Daniel J, Wilson, Jennifer G, Khan, Akram, Qadir, Nida, Brown, Samuel M, Peltan, Ithan D, Rice, Todd W, Hager, David N, Ginde, Adit A, Stubblefield, William B, Patel, Manish M, Self, Wesley H, Feldstein, Leora R, Hart, Kimberly W, McClellan, Robert, Dorough, Layne, Dzuris, Nicole, Griggs, Eric P, Kassem, Ahmed M, Marcet, Paula L, Ogokeh, Constance E, Sciarratta, Courtney N, Siddula, Akshita, Smith, Emily R, and Wu, Michael J
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Brain Disorders ,Prevention ,Behavioral and Social Science ,Clinical Research ,Lung ,Good Health and Well Being ,Adolescent ,Adult ,Ambulatory Care ,COVID-19 ,Coronavirus Infections ,Delivery of Health Care ,Female ,Humans ,Male ,Middle Aged ,Pandemics ,Pneumonia ,Viral ,Recovery of Function ,Risk Factors ,Time Factors ,Treatment Outcome ,United States ,Young Adult ,IVY Network Investigators ,CDC COVID-19 Response Team ,IVY Network Investigators ,General & Internal Medicine - Abstract
Prolonged symptom duration and disability are common in adults hospitalized with severe coronavirus disease 2019 (COVID-19). Characterizing return to baseline health among outpatients with milder COVID-19 illness is important for understanding the full spectrum of COVID-19-associated illness and tailoring public health messaging, interventions, and policy. During April 15-June 25, 2020, telephone interviews were conducted with a random sample of adults aged ≥18 years who had a first positive reverse transcription-polymerase chain reaction (RT-PCR) test for SARS-CoV-2, the virus that causes COVID-19, at an outpatient visit at one of 14 U.S. academic health care systems in 13 states. Interviews were conducted 14-21 days after the test date. Respondents were asked about demographic characteristics, baseline chronic medical conditions, symptoms present at the time of testing, whether those symptoms had resolved by the interview date, and whether they had returned to their usual state of health at the time of interview. Among 292 respondents, 94% (274) reported experiencing one or more symptoms at the time of testing; 35% of these symptomatic respondents reported not having returned to their usual state of health by the date of the interview (median = 16 days from testing date), including 26% among those aged 18-34 years, 32% among those aged 35-49 years, and 47% among those aged ≥50 years. Among respondents reporting cough, fatigue, or shortness of breath at the time of testing, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview. These findings indicate that COVID-19 can result in prolonged illness even among persons with milder outpatient illness, including young adults. Effective public health messaging targeting these groups is warranted. Preventative measures, including social distancing, frequent handwashing, and the consistent and correct use of face coverings in public, should be strongly encouraged to slow the spread of SARS-CoV-2.
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- 2020
25. Characteristics of Adult Outpatients and Inpatients with COVID-19 — 11 Academic Medical Centers, United States, March–May 2020
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Tenforde, Mark W, Billig Rose, Erica, Lindsell, Christopher J, Shapiro, Nathan I, Files, D Clark, Gibbs, Kevin W, Prekker, Matthew E, Steingrub, Jay S, Smithline, Howard A, Gong, Michelle N, Aboodi, Michael S, Exline, Matthew C, Henning, Daniel J, Wilson, Jennifer G, Khan, Akram, Qadir, Nida, Stubblefield, William B, Patel, Manish M, Self, Wesley H, Feldstein, Leora R, Kassem, Ahmed M, Sciarratta, Courtney N, Dzuris, Nicole, Marcet, Paula L, Siddula, Akshita, Griggs, Eric P, Smith, Emily R, Ogokeh, Constance E, Wu, Michael, and Kim, Sara S
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Lung ,Infectious Diseases ,Prevention ,Emerging Infectious Diseases ,Clinical Research ,Infection ,Good Health and Well Being ,Academic Medical Centers ,Adult ,Aged ,COVID-19 ,Coronavirus Infections ,Female ,Humans ,Inpatients ,Male ,Middle Aged ,Outpatients ,Pandemics ,Pneumonia ,Viral ,Risk Factors ,Socioeconomic Factors ,United States ,CDC COVID-19 Response Team ,General & Internal Medicine - Abstract
Descriptions of coronavirus disease 2019 (COVID-19) in the United States have focused primarily on hospitalized patients. Reports documenting exposures to SARS-CoV-2, the virus that causes COVID-19, have generally been described within congregate settings, such as meat and poultry processing plants (1) and long-term care facilities (2). Understanding individual behaviors and demographic characteristics of patients with COVID-19 and risks for severe illness requiring hospitalization can inform efforts to reduce transmission. During April 15-May 24, 2020, telephone interviews were conducted with a random sample of adults aged ≥18 years who had positive reverse transcription-polymerase chain reaction (RT-PCR) test results for SARS-CoV-2 in outpatient and inpatient settings at 11 U.S. academic medical centers in nine states. Respondents were contacted 14-21 days after SARS-CoV-2 testing and asked about their demographic characteristics, underlying chronic conditions, symptoms experienced on the date of testing, and potential exposures to SARS-CoV-2 during the 2 weeks before illness onset (or the date of testing among those who did not report symptoms at the time of testing). Among 350 interviewed patients (271 [77%] outpatients and 79 [23%] inpatients), inpatients were older, more likely to be Hispanic and to report dyspnea than outpatients. Fewer inpatients (39%, 20 of 51) reported a return to baseline level of health at 14-21 days than did outpatients (64%, 150 of 233) (p = 0.001). Overall, approximately one half (46%) of patients reported known close contact with someone with COVID-19 during the preceding 2 weeks. This was most commonly a family member (45%) or a work colleague (34%). Approximately two thirds (64%, 212 of 333) of participants were employed; only 35 of 209 (17%) were able to telework. These findings highlight the need for screening, case investigation, contact tracing, and isolation of infected persons to control transmission of SARS-CoV-2 infection during periods of community transmission. The need for enhanced measures to ensure workplace safety, including ensuring social distancing and more widespread use of cloth face coverings, are warranted (3).
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- 2020
26. Association of Asthma With Treatments and Outcomes in Children With Critical Influenza
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Kong, Michele, Murdock, Meghan, Sanders, Ronald C., Jr., Irby, Katherine, Hefley, Glenda, Maddux, Aline B., Mourani, Peter M., Van, Kevin A., Mansour, Rachel, Miller, Kristen R., Grunwell, Jocelyn R., Coates, Bria M., Shukla, Avani, Chavez, Jairo, Randolph, Adrienne G., Newhams, Margaret M., Chen, Sabrina R., Jung, Emily, Flori, Heidi R., Dahmer, Mary K., Jayachandran, Chaandini, Hume, Janet R., Goertzen, Lexie, Faanes, Brittany, Schuster, Jennifer E., Bledsoe, Megan C., Clark, Shannon E., Cullimore, Melissa L., Wellman, Rachel L., Gertz, Shira J., Nofziger, Ryan A., Twinem, Nicole, Shein, Steven L., Rasal, Rajashri, Hall, Mark W., Flowers, Maggie, Steele, Lisa, Weiss, Scott L., Bush, Jenny L., Burnett, Ryan H., Thomas, Neal J., Spear, Debra, Halasa, Natasha B., Stewart, Laura S., Lynch, Tricia L., Olson, Samantha M., Patel, Manish M., Miller, Kristen, Patel, Manish, Fitzpatrick, Anne M., and Phipatanakul, Wanda
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- 2023
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27. Contributors
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Abzug, Mark J., primary, Acharya, Priyamvada, additional, Acosta, Anna M., additional, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Annaliesa S., additional, Asturias, Edwin J., additional, Bachmann, Martin F., additional, Bahl, Sunil, additional, Bailey, Justin R., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Baric, Ralph S., additional, Barnett, Elizabeth D., additional, Barrett, Alan D.T., additional, Belser, Jessica A., additional, Berzofsky, Jay A., additional, Bethony, Jeffrey M., additional, Brewer-Jensen, Paul D., additional, Bubak, Andrew N., additional, Burns, Cara C., additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Chandran, Aruna, additional, Cherian, Thomas, additional, Clemens, John D., additional, Cochino, Emil, additional, Cohet, Catherine, additional, Cohn, Amanda, additional, Cortese, Margaret M., additional, Crowcroft, Natasha S., additional, Curtis, Nigel, additional, Damron, F. Heath, additional, Danchin, Margie, additional, Debbink, Kari, additional, Desai, Sachin N., additional, Davis, Emily H., additional, Decker, Michael D., additional, Denison, Mark R., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dreher-Lesnick, Sheila M., additional, Eberhardt, Christiane S., additional, Edmunds, W. John, additional, Edwards, Caitlin E., additional, Edwards, Kathryn M., additional, Eggers, Rudolf, additional, Ellis, Ronald, additional, Erdman, Dean D., additional, Ertl, Hildegund C.J., additional, Estivariz, Concepcion F., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison M., additional, Fitzwater, Sean Patrick, additional, Freedman, Mark S., additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Frumento, Nicole, additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Geris, Jennifer M., additional, Gershon, Anne A., additional, Gervier, Regis, additional, Gessner, Bradford D., additional, Gilbert, Peter B., additional, Gomez, Phillip Louis, additional, Ginsberg, Ann M., additional, Grabenstein, John D., additional, Graham, Rachel L., additional, Graham, Barney S., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Greenberg, David P., additional, Grohskopf, Lisa A., additional, Gruber, Marion F., additional, Guerena, Fernando B., additional, Havelange, Nicolas, additional, Halstead, Scott B., additional, Hanekom, Willem A., additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Haynes, Barton F., additional, Healy, C. Mary, additional, Hills, Susan L., additional, Hirabayashi, Kuniko, additional, Holmgren, Jan, additional, Hombach, Joachim M., additional, Hotez, Peter Jay, additional, Howe, Barbara J., additional, Hunegnaw, Ruth, additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jansen, Kathrin, additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Kahn, Geoffrey D., additional, Karron, Ruth A., additional, Katz, Jacqueline M., additional, Kennedy, Richard B., additional, Broojerdi, Alireza Khadem, additional, Khetsuriani, Nino, additional, Khudyakov, Yury, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kreimer, Aimée R., additional, Kroger, Andrew T., additional, Kwong, Peter D., additional, Lal, Manjari, additional, Levin, Myron J., additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Lindstrand, Ann, additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Macklin, Grace R., additional, Maeng, Hoyoung M., additional, Mahalingam, Ravi, additional, Malley, Richard, additional, Mallory, Michael L., additional, Marfin, Anthony A., additional, Markowitz, Lauri E., additional, Marshall, CDR Valerie, additional, McCollum, Andrea, additional, Meyer, Sarah, additional, McNamara, Lucy A., additional, Menning, Lisa, additional, Messacar, Kevin, additional, Miller, Mark A., additional, Milutinovic, Pavle, additional, Modlin, John F., additional, Monath, Thomas P., additional, Morabito, Kaitlyn M., additional, Moss, William J., additional, Mulholland, Kim, additional, Mura, Manuela, additional, Musher, Daniel M., additional, Nagel, Maria A., additional, Nair, G. Balakrish, additional, Nelson, Noele P., additional, Netea, Mihai G., additional, Neuzil, Kathleen Maletic, additional, Niemeyer, Christy S., additional, Nohynek, Hanna, additional, Norheim, Gunnstein, additional, Nussbaum, Lauren, additional, O’Brien, Katherine L., additional, O’Leary, Sean, additional, Ockenhouse, Christian, additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Olkhanud, Purevdorj B., additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Parashar, Umesh D., additional, Patel, Manish M., additional, Payne, Daniel C., additional, Pebody, Richard, additional, Pecetta, Simone, additional, Perlman, Stanley, additional, Pierson, Benjamin, additional, Pierson, Theodore C., additional, Pittet, Laure F., additional, Pittman, Phillip R., additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Sir Andrew John, additional, Poovorawan, Yong, additional, Proctor, Richard A., additional, Qadri, Firdausi, additional, Rao, Agam, additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Rogalewicz, Joseph A., additional, Robinson, James Michael, additional, Roesel, Sigrun, additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutter, Paul, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Samies, Nicole L., additional, Santosham, Mathuram, additional, Saunders, Kevin O., additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuerman, Lode, additional, Schwab, Jennifer, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Shapiro, Eugene D., additional, Shenoy, Erica S., additional, Shimabukuro, Tom T., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Sitrin, Robert D., additional, Skinner, Nicole E., additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Soeters, Heidi M., additional, Solomon, Tom, additional, Speiser, Daniel E., additional, Staples, J. Erin, additional, Steffen, Robert, additional, Stephens, David S., additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Takashima, Yoshihiro, additional, Tate, Jacqueline E., additional, Tayman, Alice, additional, Telford, Sam R., additional, Thombley, Melisa, additional, Thomsen, Isaac, additional, Tohme, Rania A., additional, Trabold, Malin, additional, El-Turabi, Aadil, additional, Vaughn, David W., additional, Verardi, Raffaello, additional, Vicari, Andrea S., additional, Vidor, Emmanuel J., additional, Villafana, Tonya, additional, Vogt, Matthew R., additional, Walker, Mark J., additional, Walsh, Nick M., additional, Wanlapakorn, Nasamon, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Watts, Lisa A., additional, Weber, David J., additional, Weiner, David B., additional, Weng, Mark K., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitley, Richard J., additional, Whitney, Cynthia G., additional, Wiehe, Kevin, additional, Williamson, E. Diane, additional, Wormser, Gary P., additional, Xia, Ningshao, additional, Yildirim, Inci, additional, Zehrung, Darin, additional, and Zweigart, Mark R., additional
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- 2023
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28. Preface
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Shah Hetalkumar N., Patel Manish M., and Mohanty Bibhabasu
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Information technology ,T58.5-58.64 - Published
- 2024
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29. Risk Factors for Multisystem Inflammatory Syndrome in Children: A Case-control Investigation
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Zambrano, Laura D., Wu, Michael J., Martin, Lora, Malloch, Lacy, Chen, Sabrina, Newhams, Margaret M., Kucukak, Suden, Son, Mary Beth, Sanders, Cameron, Patterson, Kayla, Halasa, Natasha, Fitzgerald, Julie C., Leroue, Matthew K., Hall, Mark, Irby, Katherine, Rowan, Courtney M., Wellnitz, Kari, Sahni, Leila C., Loftis, Laura, Bradford, Tamara T., Staat, Mary, Babbitt, Christopher, Carroll, Christopher L., Pannaraj, Pia S., Kong, Michele, Schuster, Jennifer E., Chou, Janet, Patel, Manish M., Randolph, Adrienne G., Campbell, Angela P., and Hobbs, Charlotte V.
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- 2023
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30. Factors Associated with Positive SARS-CoV-2 Test Results in Outpatient Health Facilities and Emergency Departments Among Children and Adolescents Aged
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CDC COVID-19 Response Team, Hobbs, Charlotte V., Martin, Lora M., Kim, Sara S., Kirmse, Brian M., Haynie, Lisa, McGraw, Sarah, Byers, Paul, Taylor, Kathryn G., Patel, Manish M., and Flannery, Brendan
- Published
- 2020
31. Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network — 12 States, April–August 2020
- Author
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CDC COVID-19 Response Team; IVY Network, Self, Wesley H., Tenforde, Mark W., Stubblefield, William B., Feldstein, Leora R., Steingrub, Jay S., Shapiro, Nathan I., Ginde, Adit A., Prekker, Matthew E., Brown, Samuel M., Peltan, Ithan D., Gong, Michelle N., Aboodi, Michael S., Khan, Akram, Exline, Matthew C., Files, D. Clark, Gibbs, Kevin W., Lindsell, Christopher J., Rice, Todd W., Jones, Ian D., Halasa, Natasha, Talbot, H. Keipp, Grijalva, Carlos G., Casey, Jonathan D., Hager, David N., Qadir, Nida, Henning, Daniel J., Coughlin, Melissa M., Schiffer, Jarad, Semenova, Vera, Li, Han, Thornburg, Natalie J., and Patel, Manish M.
- Published
- 2020
32. Telework Before Illness Onset Among Symptomatic Adults Aged ≥18 Years With and Without COVID-19 in 11 Outpatient Health Care Facilities — United States, July 2020
- Author
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IVY Network Investigators; CDC COVID-19 Response Team, Fisher, Kiva A., Olson, Samantha M., Tenforde, Mark W., Feldstein, Leora R., Lindsell, Christopher J., Shapiro, Nathan I., Files, D. Clark, Gibbs, Kevin W., Erickson, Heidi L., Prekker, Matthew E., Steingrub, Jay S., Exline, Matthew C., Henning, Daniel J., Wilson, Jennifer G., Brown, Samuel M., Peltan, Ithan D., Rice, Todd W., Hager, David N., Ginde, Adit A., Talbot, H. Keipp, Casey, Jonathan D., Grijalva, Carlos G., Flannery, Brendan, Patel, Manish M., and Self, Wesley H.
- Published
- 2020
33. Community and Close Contact Exposures Associated with COVID-19 Among Symptomatic Adults ≥18 Years in 11 Outpatient Health Care Facilities — United States, July 2020
- Author
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IVY Network Investigators, CDC COVID-19 Response Team, Fisher, Kiva A., Tenforde, Mark W., Feldstein, Leora R., Lindsell, Christopher J., Shapiro, Nathan I., Files, D. Clark, Gibbs, Kevin W., Erickson, Heidi L., Prekker, Matthew E., Steingrub, Jay S., Exline, Matthew C., Henning, Daniel J., Wilson, Jennifer G., Brown, Samuel M., Peltan, Ithan D., Rice, Todd W., Hager, David N., Ginde, Adit A., Talbot, H. Keipp, Casey, Jonathan D., Grijalva, Carlos G., Flannery, Brendan, Patel, Manish M., and Self, Wesley H.
- Published
- 2020
34. Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network — 13 Academic Medical Centers, April–June 2020
- Author
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CDC COVID-19 Response Team, IVY Network, Self, Wesley H., Tenforde, Mark W., Stubblefield, William B., Feldstein, Leora R., Steingrub, Jay S., Shapiro, Nathan I., Ginde, Adit A., Prekker, Matthew E., Brown, Samuel M., Peltan, Ithan D., Gong, Michelle N., Aboodi, Michael S., Khan, Akram, Exline, Matthew C., Files, D. Clark, Gibbs, Kevin W., Lindsell, Christopher J., Rice, Todd. W., Jones, Ian D., Halasa, Natasha, Talbot, H. Keipp, Grijalva, Carlos G., Casey, Jonathan D., Hager, David N., Qadir, Nida, Henning, Daniel J., Coughlin, Melissa M., Schiffer, Jarad, Semenova, Vera, Li, Han, Thornburg, Natalie J., and Patel, Manish M.
- Published
- 2020
35. Data-driven clustering identifies features distinguishing multisystem inflammatory syndrome from acute COVID-19 in children and adolescents
- Author
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Geva, Alon, Patel, Manish M., Newhams, Margaret M., Young, Cameron C., Son, Mary Beth F., Kong, Michele, Maddux, Aline B., Hall, Mark W., Riggs, Becky J., Singh, Aalok R., Giuliano, John S., Hobbs, Charlotte V., Loftis, Laura L., McLaughlin, Gwenn E., Schwartz, Stephanie P., Schuster, Jennifer E., Babbitt, Christopher J., Halasa, Natasha B., Gertz, Shira J., Doymaz, Sule, Hume, Janet R., Bradford, Tamara T., Irby, Katherine, Carroll, Christopher L., McGuire, John K., Tarquinio, Keiko M., Rowan, Courtney M., Mack, Elizabeth H., Cvijanovich, Natalie Z., Fitzgerald, Julie C., Spinella, Philip C., Staat, Mary A., Clouser, Katharine N., Soma, Vijaya L., Dapul, Heda, Maamari, Mia, Bowens, Cindy, Havlin, Kevin M., Mourani, Peter M., Heidemann, Sabrina M., Horwitz, Steven M., Feldstein, Leora R., Tenforde, Mark W., Newburger, Jane W., Mandl, Kenneth D., and Randolph, Adrienne G.
- Published
- 2021
- Full Text
- View/download PDF
36. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network — United States, March–June 2020
- Author
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IVY Network Investigators: CDC COVID-19 Response Team, Tenforde, Mark W., Kim, Sara S., Lindsell, Christopher J., Rose, Erica Billig, Shapiro, Nathan I., Files, D. Clark, Gibbs, Kevin W., Erickson, Heidi L., Steingrub, Jay S., Smithline, Howard A., Gong, Michelle N., Aboodi, Michael S., Exline, Matthew C., Henning, Daniel J., Wilson, Jennifer G., Khan, Akram, Qadir, Nida, Brown, Samuel M., Peltan, Ithan D., Rice, Todd W., Hager, David N., Ginde, Adit A., Stubblefield, William B., Patel, Manish M., Self, Wesley H., and Feldstein, Leora R.
- Published
- 2020
37. Characteristics of Adult Outpatients and Inpatients with COVID-19 — 11 Academic Medical Centers, United States, March–May 2020
- Author
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CDC COVID-19 Response Team, Tenforde, Mark W., Rose, Erica Billig, Lindsell, Christopher J., Shapiro, Nathan I., Files, D. Clark, Gibbs, Kevin W., Prekker, Matthew E., Steingrub, Jay S., Smithline, Howard A., Gong, Michelle N., Aboodi, Michael S., Exline, Matthew C., Henning, Daniel J., Wilson, Jennifer G., Khan, Akram, Qadir, Nida, Stubblefield, William B., Patel, Manish M., Self, Wesley H., and Feldstein, Leora R.
- Published
- 2020
38. Interim Estimates of 2019–20 Seasonal Influenza Vaccine Effectiveness — United States, February 2020
- Author
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Dawood, Fatimah S., Chung, Jessie R., Kim, Sara S., Zimmerman, Richard K., Nowalk, Mary Patricia, Jackson, Michael L., Jackson, Lisa A., Monto, Arnold S., Martin, Emily T., Belongia, Edward A., McLean, Huong Q., Gaglani, Manjusha, Dunnigan, Kayan, Foust, Angie, Sessions, Wendy, DaSilva, Juliana, Le, Shoshona, Stark, Thomas, Kondor, Rebecca J., Barnes, John R., Wentworth, David E., Brammer, Lynnette, Fry, Alicia M., Patel, Manish M., and Flannery, Brendan
- Published
- 2020
39. Maternal Vaccination and Risk of Hospitalization for Covid-19 Among Infants
- Author
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Halasa, Natasha B., Olson, Samantha M., Staat, Mary A., Newhams, Margaret M., Price, Ashley M., Pannaraj, Pia S., Boom, Julie A., Sahni, Leila C., Chiotos, Kathleen, Cameron, Melissa A., Bline, Katherine E., Hobbs, Charlotte V., Maddux, Aline B., Coates, Bria M., Michelson, Kelly N., Heidemann, Sabrina M., Irby, Katherine, Nofziger, Ryan A., Mack, Elizabeth H., Smallcomb, Laura, Schwartz, Stephanie P., Walker, Tracie C., Gertz, Shira J., Schuster, Jennifer E., Kamidani, Satoshi, Tarquinio, Keiko M., Bhumbra, Samina S., Maamari, Mia, Hume, Janet R., Crandall, Hillary, Levy, Emily R., Zinter, Matt S., Bradford, Tamara T., Flori, Heidi R., Cullimore, Melissa L., Kong, Michele, Cvijanovich, Natalie Z., Gilboa, Suzanne M., Polen, Kara N., Campbell, Angela P., Randolph, Adrienne G., and Patel, Manish M.
- Published
- 2023
- Full Text
- View/download PDF
40. Neutralizing antibody responses in patients hospitalized with SARS-CoV-2 Delta or Omicron infection
- Author
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Linderman, Susanne L., Lai, Lilin, Gamarra, Estefany L. Bocangel, Lau, Max S.Y., Edupuganti, Srilatha, Surie, Diya, Tenforde, Mark W., Chappell, James D., Mohr, Nicholas M., Gibbs, Kevin W., Steingrub, Jay S., Exline, Matthew C., Shapiro, Nathan I., Frosch, Anne E., Qadir, Nida, Davis-Gardner, Meredith E., McElrath, M. Juliana, Lauring, Adam S., Suthar, Mehul S., Patel, Manish M., Self, Wesley H., and Ahmed, Rafi
- Subjects
Immunological research ,Immune response -- Research ,Hospital patients -- Care and treatment ,Health care industry - Abstract
To the Editor: Humoral and cellular immune responses contribute to overall protective immunity against SARS-CoV-2, with neutralizing antibody playing a key role in preventing viral infection. This is evident from [...]
- Published
- 2022
41. Interim Estimates of 2018–19 Seasonal Influenza Vaccine Effectiveness — United States, February 2019
- Author
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Doyle, Joshua D., Chung, Jessie R., Kim, Sara S., Gaglani, Manjusha, Raiyani, Chandni, Zimmerman, Richard K., Nowalk, Mary Patricia, Jackson, Michael L., Jackson, Lisa A., Monto, Arnold S., Martin, Emily T., Belongia, Edward A., McLean, Huong Q., Foust, Angie, Sessions, Wendy, Berman, LaShondra, Garten, Rebecca J., Barnes, John R., Wentworth, David E., Fry, Alicia M., Patel, Manish M., and Flannery, Brendan
- Published
- 2019
42. Serial Thromboelastography and the Development of Venous Thromboembolism in Critically Ill Patients With COVID-19
- Author
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Marvi, Tanya K., Stubblefield, William B., Tillman, Benjamin F., Tenforde, Mark W., Patel, Manish M., Lindsell, Christopher J., Self, Wesley H., Grijalva, Carlos G., and Rice, Todd W.
- Published
- 2022
- Full Text
- View/download PDF
43. Maternal Vaccine Effectiveness Against Influenza-Associated Hospitalizations and Emergency Department Visits in Infants.
- Author
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Sahni, Leila C., Olson, Samantha M., Halasa, Natasha B., Stewart, Laura S., Michaels, Marian G., Williams, John V., Englund, Janet A., Klein, Eileen J., Staat, Mary A., Schlaudecker, Elizabeth P., Selvarangan, Rangaraj, Schuster, Jennifer E., Weinberg, Geoffrey A., Szilagyi, Peter G., Boom, Julie A., Patel, Manish M., and Muñoz, Flor M.
- Published
- 2024
- Full Text
- View/download PDF
44. Vaccine Effectiveness Against Influenza A(H3N2)–Associated Hospitalized Illness: United States, 2022
- Author
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Tenforde, Mark W, Patel, Manish M, Lewis, Nathaniel M, Adams, Katherine, Gaglani, Manjusha, Steingrub, Jay S, Shapiro, Nathan I, Duggal, Abhijit, Prekker, Matthew E, Peltan, Ithan D, Hager, David N, Gong, Michelle N, Exline, Matthew C, Ginde, Adit A, Mohr, Nicholas M, Mallow, Christopher, Martin, Emily T, Talbot, H Keipp, Gibbs, Kevin W, Kwon, Jennie H, Chappell, James D, Halasa, Natasha, Lauring, Adam S, Lindsell, Christopher J, Swan, Sydney A, Hart, Kimberly W, Womack, Kelsey N, Baughman, Adrienne, Grijalva, Carlos G, and Self, Wesley H
- Subjects
Microbiology (medical) ,Infectious Diseases ,Major Article - Abstract
Background The COVID-19 pandemic was associated with historically low influenza circulation during the 2020–2021 season, followed by an increase in influenza circulation during the 2021–2022 US season. The 2a.2 subgroup of the influenza A(H3N2) 3C.2a1b subclade that predominated was antigenically different from the vaccine strain. Methods To understand the effectiveness of the 2021–2022 vaccine against hospitalized influenza illness, a multistate sentinel surveillance network enrolled adults aged ≥18 years hospitalized with acute respiratory illness and tested for influenza by a molecular assay. Using the test-negative design, vaccine effectiveness (VE) was measured by comparing the odds of current-season influenza vaccination in influenza-positive case-patients and influenza-negative, SARS-CoV-2–negative controls, adjusting for confounders. A separate analysis was performed to illustrate bias introduced by including SARS-CoV-2–positive controls. Results A total of 2334 patients, including 295 influenza cases (47% vaccinated), 1175 influenza- and SARS-CoV-2–negative controls (53% vaccinated), and 864 influenza-negative and SARS-CoV-2–positive controls (49% vaccinated), were analyzed. Influenza VE was 26% (95% CI: −14% to 52%) among adults aged 18–64 years, −3% (−54% to 31%) among adults aged ≥65 years, and 50% (15–71%) among adults aged 18–64 years without immunocompromising conditions. Estimated VE decreased with inclusion of SARS-CoV-2–positive controls. Conclusions During a season where influenza A(H3N2) was antigenically different from the vaccine virus, vaccination was associated with a reduced risk of influenza hospitalization in younger immunocompetent adults. However, vaccination did not provide protection in adults ≥65 years of age. Improvements in vaccines, antivirals, and prevention strategies are warranted.
- Published
- 2022
45. Case-control vaccine effectiveness studies: Data collection, analysis and reporting results
- Author
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Verani, Jennifer R., Baqui, Abdullah H., Broome, Claire V., Cherian, Thomas, Cohen, Cheryl, Farrar, Jennifer L., Feikin, Daniel R., Groome, Michelle J., Hajjeh, Rana A., Johnson, Hope L., Madhi, Shabir A., Mulholland, Kim, O'Brien, Katherine L., Parashar, Umesh D., Patel, Manish M., Rodrigues, Laura C., Santosham, Mathuram, Scott, J. Anthony, Smith, Peter G., Sommerfelt, Halvor, Tate, Jacqueline E., Victor, J. Chris, Whitney, Cynthia G., Zaidi, Anita K., and Zell, Elizabeth R.
- Published
- 2017
- Full Text
- View/download PDF
46. Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls
- Author
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Verani, Jennifer R., Baqui, Abdullah H., Broome, Claire V., Cherian, Thomas, Cohen, Cheryl, Farrar, Jennifer L., Feikin, Daniel R., Groome, Michelle J., Hajjeh, Rana A., Johnson, Hope L., Madhi, Shabir A., Mulholland, Kim, O'Brien, Katherine L., Parashar, Umesh D., Patel, Manish M., Rodrigues, Laura C., Santosham, Mathuram, Scott, J. Anthony, Smith, Peter G., Sommerfelt, Halvor, Tate, Jacqueline E., Victor, J. Chris, Whitney, Cynthia G., Zaidi, Anita K., and Zell, Elizabeth R.
- Published
- 2017
- Full Text
- View/download PDF
47. Effectiveness of Monovalent mRNA Vaccines Against COVID-19--Associated Hospitalization Among Immunocompetent Adults During BA.1/BA.2 and BA.4/BA.5 Predominant Periods of SARS-CoV-2 Omicron Variant in the United States--IVY Network, 18 States, December 26, 2021-August 31, 2022
- Author
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Surie, Diya, Bonnell, Levi, Adams, Katherine, Gaglani, Manjusha, Ginde, Adit A., Douin, David J., Talbot, H. Keipp, Casey, Jonathan D., Mohr, Nicholas M., Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W., Files, D. Clark, Hager, David N., Shehu, Arber, Frosch, Anne P., Erickson, Heidi L., Gong, Michelle N., Mohamed, Amira, Johnson, Nicholas J., Srinivasan, Vasisht, Steingrub, Jay S., Peltan, Ithan D., Brown, Samuel M., Martin, Emily T., Khan, Akram, Bender, William S., Duggal, Abhijit, Wilson, Jennifer G., Qadir, Nida, Chang, Steven Y., Mallow, Christopher, Rivas, Carolina, Kwon, Jennie H., Exline, Matthew C., Lauring, Adam S., Shapiro, Nathan I., Halasa, Natasha, Chappell, James D., Grijalva, Carlos G., Rice, Todd W., Stubblefield, William B., Baughman, Adrienne, Womack, Kelsey N., Hart, Kimberly W., Swan, Sydney A., Zhu, Yuwei, DeCuir, Jennifer, Tenforde, Mark W., Patel, Manish M., McMorrow, Meredith L., and Self, Wesley H.
- Subjects
United States. Department of Defense ,United States. Food and Drug Administration ,United States. National Institutes of Health ,Pfizer Inc. ,Medical research -- Health aspects ,Medicine, Experimental -- Health aspects ,Messenger RNA -- Health aspects ,Infection -- Health aspects ,Adults -- Health aspects ,Vaccines -- Health aspects ,Pharmaceutical industry -- Health aspects ,Health ,Washington University ,Cleveland Clinic ,Vanderbilt University. Medical Center - Abstract
The SARS-CoV-2 Omicron variant (B.1.1.529 or BA.1) became predominant in the United States by late December 2021 (1). BA.1 has since been replaced by emerging lineages BA.2 (including BA.2.12.1) in [...]
- Published
- 2022
48. Association of Asthma With Treatments and Outcomes in Children With Critical Influenza
- Author
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Maddux, Aline B., primary, Grunwell, Jocelyn R., additional, Newhams, Margaret M., additional, Chen, Sabrina R., additional, Olson, Samantha M., additional, Halasa, Natasha B., additional, Weiss, Scott L., additional, Coates, Bria M., additional, Schuster, Jennifer E., additional, Hall, Mark W., additional, Nofziger, Ryan A., additional, Flori, Heidi R., additional, Gertz, Shira J., additional, Kong, Michele, additional, Sanders, Ronald C., additional, Irby, Katherine, additional, Hume, Janet R., additional, Cullimore, Melissa L., additional, Shein, Steven L., additional, Thomas, Neal J., additional, Miller, Kristen, additional, Patel, Manish, additional, Fitzpatrick, Anne M., additional, Phipatanakul, Wanda, additional, Randolph, Adrienne G., additional, Murdock, Meghan, additional, Hefley, Glenda, additional, Maddux, Aline B., additional, Mourani, Peter M., additional, Van, Kevin A., additional, Mansour, Rachel, additional, Miller, Kristen R., additional, Shukla, Avani, additional, Chavez, Jairo, additional, Jung, Emily, additional, Dahmer, Mary K., additional, Jayachandran, Chaandini, additional, Goertzen, Lexie, additional, Faanes, Brittany, additional, Bledsoe, Megan C., additional, Clark, Shannon E., additional, Wellman, Rachel L., additional, Twinem, Nicole, additional, Rasal, Rajashri, additional, Flowers, Maggie, additional, Steele, Lisa, additional, Bush, Jenny L., additional, Burnett, Ryan H., additional, Spear, Debra, additional, Stewart, Laura S., additional, Lynch, Tricia L., additional, and Patel, Manish M., additional
- Published
- 2023
- Full Text
- View/download PDF
49. Early serial echocardiographic and ultrasonographic findings in critically ill patients with COVID-19
- Author
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Lanspa, Michael J., primary, Dugar, Siddharth P., additional, Prigmore, Heather L., additional, Boyd, Jeremy S., additional, Rupp, Jordan D., additional, Lindsell, Chris J., additional, Rice, Todd W., additional, Qadir, Nida, additional, Lim, George W., additional, Shiloh, Ariel L., additional, Dieiev, Vladyslav, additional, Gong, Michelle N., additional, Fox, Steven W., additional, Hirshberg, Eliotte L., additional, Khan, Akram, additional, Kornfield, James, additional, Schoeneck, Jacob H., additional, Macklin, Nicholas, additional, Files, D.Clark, additional, Gibbs, Kevin W., additional, Prekker, Matthew E., additional, Parsons-Moss, Daniel, additional, Bown, Mikaele, additional, Olsen, Troy D., additional, Knox, Daniel B., additional, Cirulis, Meghan M., additional, Mehkri, Omar, additional, Duggal, Abhijit, additional, Tenforde, Mark W., additional, Patel, Manish M., additional, Self, Wesley H., additional, and Brown, Samuel M., additional
- Published
- 2023
- Full Text
- View/download PDF
50. Use of Patients With Diarrhea Who Test Negative for Rotavirus as Controls to Estimate Rotavirus Vaccine Effectiveness Through Case-Control Studies
- Author
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Tate, Jacqueline E., Patel, Manish M., Cortese, Margaret M., Payne, Daniel C., Lopman, Benjamin A., Yen, Catherine, and Parashar, Umesh D.
- Published
- 2016
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