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1. Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses — IVY Network, September 1, 2022–March 30, 2023

Author: Lewis, Nathaniel M., Harker, Elizabeth J., Leis, Aleda, Zhu, Yuwei, Talbot, H. Keipp, Grijalva, Carlos G., Halasa, Natasha, Chappell, James D., Johnson, Cassandra A., Rice, Todd W., Casey, Jonathan D., Lauring, Adam S., Gaglani, Manjusha, Ghamande, Shekhar, Columbus, Cristie, Steingrub, Jay S., Shapiro, Nathan I., Duggal, Abhijit, Felzer, Jamie, Prekker, Matthew E., Peltan, Ithan D., Brown, Samuel M., Hager, David N., Gong, Michelle N., Mohamed, Amira, Exline, Matthew C., Khan, Akram, Wilson, Jennifer G., Mosier, Jarrod, Qadir, Nida, Chang, Steven Y., Ginde, Adit A., Mohr, Nicholas M., Mallow, Christopher, Harris, Estelle S., Johnson, Nicholas J., Srinivasan, Vasisht, Gibbs, Kevin W., Kwon, Jennie H., Vaughn, Ivana A., Ramesh, Mayur, Safdar, Basmah, DeCuir, Jennifer, Surie, Diya, Dawood, Fatimah S., Ellington, Sascha, Self, Wesley H., and Martin, Emily T.
Published: 2025
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2. Protection of mRNA vaccines against hospitalized COVID-19 in adults over the first year following authorization in the United States

Author: 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
Subjects: 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 (
Published: 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

Author: 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
Subjects: 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.
Published: 2023

4. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19–Associated Hospitalization Among Immunocompetent Adults Aged ≥65 Years — IVY Network, 18 States, September 8–November 30, 2022

Author: Surie, Diya, DeCuir, Jennifer, Zhu, Yuwei, 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, Ali, Harith, Taghizadeh, Leyla, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, 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, Kwon, Jennie H, Exline, Matthew C, Lauring, Adam S, Shapiro, Nathan I, Columbus, Cristie, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Hart, Kimberly W, Swan, Sydney A, Lewis, Nathaniel M, McMorrow, Meredith L, Self, Wesley H, and Network, IVY
Subjects: Vaccine Related, Infectious Diseases, Immunization, Biodefense, Prevention, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Good Health and Well Being, Humans, Aged, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Vaccine Efficacy, Hospitalization, RNA, Messenger, Vaccines, Combined, IVY Network, General & Internal Medicine
Abstract: Monovalent COVID-19 mRNA vaccines, designed against the ancestral strain of SARS-CoV-2, successfully reduced COVID-19-related morbidity and mortality in the United States and globally (1,2). However, vaccine effectiveness (VE) against COVID-19-associated hospitalization has declined over time, likely related to a combination of factors, including waning immunity and, with the emergence of the Omicron variant and its sublineages, immune evasion (3). To address these factors, on September 1, 2022, the Advisory Committee on Immunization Practices recommended a bivalent COVID-19 mRNA booster (bivalent booster) dose, developed against the spike protein from ancestral SARS-CoV-2 and Omicron BA.4/BA.5 sublineages, for persons who had completed at least a primary COVID-19 vaccination series (with or without monovalent booster doses) ≥2 months earlier (4). Data on the effectiveness of a bivalent booster dose against COVID-19 hospitalization in the United States are lacking, including among older adults, who are at highest risk for severe COVID-19-associated illness. During September 8-November 30, 2022, the Investigating Respiratory Viruses in the Acutely Ill (IVY) Network§ assessed effectiveness of a bivalent booster dose received after ≥2 doses of monovalent mRNA vaccine against COVID-19-associated hospitalization among immunocompetent adults aged ≥65 years. When compared with unvaccinated persons, VE of a bivalent booster dose received ≥7 days before illness onset (median = 29 days) against COVID-19-associated hospitalization was 84%. Compared with persons who received ≥2 monovalent-only mRNA vaccine doses, relative VE of a bivalent booster dose was 73%. These early findings show that a bivalent booster dose provided strong protection against COVID-19-associated hospitalization in older adults and additional protection among persons with previous monovalent-only mRNA vaccination. All eligible persons, especially adults aged ≥65 years, should receive a bivalent booster dose to maximize protection against COVID-19 hospitalization this winter season. Additional strategies to prevent respiratory illness, such as masking in indoor public spaces, should also be considered, especially in areas where COVID-19 community levels are high (4,5).
Published: 2022

5. Comparison of test-negative and syndrome-negative controls in SARS-CoV-2 vaccine effectiveness evaluations for preventing COVID-19 hospitalizations in the United States

Author: 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
Subjects: 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.
Published: 2022

6. Ascertainment of vaccination status by self‐report versus source documentation: Impact on measuring COVID‐19 vaccine effectiveness

Author: 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
Subjects: 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.
Published: 2022

7. 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

Author: 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
Subjects: 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.
Published: 2022

8. Associations between persistent symptoms after mild COVID‐19 and long‐term health status, quality of life, and psychological distress

Author: 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
Subjects: 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.
Published: 2022

9. A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis

Author: Whitfield, Natalie N., Hogan, Catherine A., Chenoweth, James, Hansen, Jonathan, Hsu, Edbert B., Humphries, Roger, Mann, Edana, May, Larissa, Michelson, Edward A., Rothman, Richard, Self, Wesley H., Smithline, Howard A., Karita, Helen Cristina Stankiewicz, Steingrub, Jay S., Swedien, Daniel, Weissman, Alexandra, Wright, David W., Liesenfeld, Oliver, and Shapiro, Nathan I.
Published: 2024
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10. Effectiveness of mRNA Vaccines Against COVID-19 Hospitalization by Age and Chronic Medical Conditions Burden Among Immunocompetent US Adults, March-August 2021

Author: 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
Subjects: 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.
Published: 2022

11. Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States

Author: 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
Subjects: 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.
Published: 2022

12. 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

Author: 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
Subjects: 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
Published: 2022

13. 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

Author: 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
Subjects: 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.
Published: 2022

14. Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022

Author: 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
Subjects: 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
Published: 2022

15. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

Author: Sahner, David, Tierney, John, Vogel, Susan E., Herpin, Betsey R., Smolskis, Mary C., McKay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, Barrett, Kevin, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Currier, Judy, Hughes, Eric, Harrigan, Rachel H., Amos, Laura, Carlsen, Amy, Carter, Anita, Collins, Gary, Davis, Bionca, Denning, Eileen, DuChene, Alain, Eckroth, Kate, Engen, Nicole, Frase, Alex, Gandits, Greg, Grund, Birgit, Harrison, Merrie, Hurlbut, Nancy, Kaiser, Payton, Koopmeiners, Joseph, Larson, Gregg, Meger, Sue, Mistry, Shweta Sharma, Murray, Thomas, Nelson, Ray, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Siegel, Lianne, Thompson, Greg, Vock, David, Walski, Jamie, Gelijns, Annetine C., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Burris, Sarah, Bedoya, Gabriela, Gupta, Lola, Overbey, Jessica R., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Sandkovsky, Uriel, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samatha, Wang, Samatha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Vekstein, Andrew M., Ko, Emily R., Dreyer, Grace R., Stafford, Neil, Brooks, Megan, Der, Tatyana, Witte, Marie, Gamarallage, Ruwan, Franzone, John, Ivey, Noel, Lumsden, Rebecca H., Mosaly, Nilima, Mourad, Ahmaad, Holland, Thomas L., Motta, Mary, Lane, Kathleen, McGowan, Lauren M., Stout, Jennifer, Aloor, Heather, Bragg, Kennesha M., Toledo, Barvina, McLendon-Arvik, Beth, Bussadori, Barbara, Hollister, Beth A., Griffin, Michelle, Giangiacomo, Dana M., Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Johnathan, Vonderhaar, Derek, Nossaman, Bobby, Sylvia Laudun, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Perin, Emerson, Costello, Briana, Manian, Prasad, Sohail, M. Rizwan, Postalian, Alexander, Hinsu, Punit, Watson, Carolyn, Chen, James, Fink, Melyssa, Sturgis, Lydia, Walker, Kim, Mahon, Kim, Parenti, Jennifer, Kappenman, Casey, Knight, Aryn, Sturek, Jeffrey M., Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Adams, Amy, Badhwar, Vinay, Sharma, Sunil, Peppers, Briana, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresico, Lisa, Glaze, Chad, Evans, Raquel, Di, Fang, Carlson, Shawn, Aucremanne, Tanja, Tennant, Connie, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Williams, Roger, Bunner, Robin, Traverse, Jay H., Rhame, Frank, Huelster, Joshua, Kethireddy, Rajesh, Davies, Irena, Salamanca, Julianne, Majeski, Christine, Skelton, Paige, Zarambo, Maria, Sarafolean, Andrea, Bowdish, Michael E., Borok, Zea, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, Mary, Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Loxano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Quesada, Christine, Hamilton, Luke, Escobar, Jose, Leshnower, Brad, Bender, William, Sharifpour, Milad, Miller, Jeffrey, Farrington, Woodrow, Baio, Kim T., McBride, Mary, Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elisabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberly, Audette, Mathew, Fleischmann, Emily, Akbari, Kreshta, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nyguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Johnson, Haley, Newton, Crystallee, Parr, Doug, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Moroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Walker-Ignasiak, Rebecca, North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Muzikansky, Ariela, Morse, Richard, Fitzgerald, Laura, Morin, Haley D., Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Steingrub, Jay H., Hou, Peter K., Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Romain, Sarah, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Andromidas, Konstantinos, Banner-Goodspeed, Valerie, Bolstad, Michael, Boyle, Katherine L., Cabrera, Payton, deVilla, Arnaldo, Ellis, Joshua C., Grafals, Ana, Hayes, Sharon, Higgins, Conor, Kurt, Lisa, Kurtzman, Nicholas, Redman, Kimberly, Rosseto, Elinita, Scaffidi, Douglas, Filbin, Michael R., Hibbert, Kathryn A., Parry, Blair, Margolin, Justin, Hillis, Brooklynn, Hamer, Rhonda, Brait, Kelsey, Beakes, Caroline, McKaig, Brenna, Kugener, Eleonore, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah, Hendey, Gregory, Kangelaris, Kirsten, Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Yee, Kimberley J., Jauregui, Alejandra E., Zhuo, Hanjing, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Lim, George W., Chang, Steven Y., Lin, Michael Y., Vargas, Julia, Sihota, Hena, Beutler, Rebecca, Agarwal, Trisha, Wilson, Jennifer G., Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan H., Roque, Jonasel, Wang, Henry, Huebinger, Ryan M., Patel, Bela, Vidales, Elizabeth, Albertson, Timothy, Hardy, Erin, Harper, Richart, Moss, Marc A., Baduashvili, Amiran, Chauhan, Lakshmi, Douin, David J., Martinez, Flora, Finck, Lani L., Bastman, Jill, Howell, Michelle, Higgins, Carrie, McKeehan, Jeffrey, Finigan, Jay, Stubenrauch, Peter, Janssen, William J., Griesmer, Christine, VerBurg, Olivia, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jimenez, Jose, Olbrich, Norman, McDonough, Kelli, Jia, Shijing, Hanna, Sinan, Gong, Michelle N., Richardson, Lynne D., Nair, Rahul, Lopez, Brenda, Amosu, Omowunmi, Offor, Obiageli, Tzehaie, Hiwet, Nkemdirim, William, Boujid, Sabah, Mosier, Jarrod M., Hypes, Cameron, Campbell, Elizabeth Salvagio, Bixby, Billie, Gilson, Boris, Lopez, Anitza, Bime, Christian, Parthasarathy, Sairam, Cano, Ariana M., Hite, R. Duncan, Terndrup, Thomas E., Wiedemann, Herbert P., Hudock, Kristin, Tanzeem, Hammad, More, Harshada, Martinkovic, Jamie, Sellers, Susan, Houston, Judy, Burns, Mary, Kiran, Simra, Roads, Tammy, Kennedy, Sarah, Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Dugar, Siddharth, Sahoo, Debasis, Yealy, Donald M., Angus, Derek C., Weissman, Alexandra J., Vita, Tina M., Berryman, Emily, Hough, Catherine L., Khan, Akram, Krol, Olivia F., Mills, Emmanuel, Kinjal, Mistry, Briceno, Genesis, Reddy, Raju, Hubel, Kinsley, Jouzestani, Milad K., McDougal, Madeline, Deshmukh, Rupali, Johnston, Nicholas J., Robinson, Bryce H., Gundel, Staphanie J., Katsandres, Sarah C., Chen, Peter, Torbati, Sam S., Parimon, Tanyalak, Caudill, Antonina, Mattison, Brittany, Jackman, Susan E., Chen, Po-En, Bayoumi, Emad, Ojukwu, Cristabelle, Fine, Devin, Weissberg, Gwendolyn, Isip, Katherine, Choi-Kuaea, Yunhee, Mehdikhani, Shaunt, Dar, Tahir B., Fleury Augustin, Nsole Biteghe, Tran, Dana, Dukov, Jennifer Emilow, Matusov, Yuri, Choe, June, Hindoyan, Niree A., Wynter, Timothy, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Caudill, Antonia, O’Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Miller, Chadwick, Files, D. Clark, Gibbs, Kevin W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Palacios, D. Rafael, Parks, Lisa, Hicks, Madeline, Goodwin, Andrew J., Kilb, Edward F., Lematty, Caitlan T., Patti, Kerilyn, Grady, Abigail, Rasberry, April, Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sarah N., Mayer, Kirby P., Pharm.D., Brittany Bissel, Trott, Terren, Rehman, Shahnaz, de Wit, Marjolein, Mason, Jessica, Bledsoe, Joseph, Knowlton, Kirk U., Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Pelton, Ithan, Armbruster, Brent P., Montgomery, Quinn, Kumar, Naresh, Fergus, Melissa, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Klippel, Carolyn, Jensen, Hannah, Duckworth, Sarah, Gray, Andrew, Burke, Tyler, Knox, Dan, Lumpkin, Jenna, Aston, Valerie T., Applegate, Darrin, Serezlic, Erna, Brown, Katie, Merril, Mardee, Harris, Estelle S., Middleton, Elizabeth A., Barrios, Macy A.G., Greer, Jorden, Schmidt, Amber D., Webb, Melissa K., Paine, Roert, Callahan, Sean J., Waddoups, Lindsey J., Yamane, Misty B., Self, Wesley H., Rice, Todd W., Casey, Jonathan D., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Menon, Vidya, Kasubhai, Moiz, Pillai, Anjana, Daniel, Jean, Sittler, Daniel, Kanna, Balavenkatesh, Jilani, Nargis, Amaro, Francisco, Santana, Jessica, Lyakovestsky, Aleksandr, Madhoun, Issa, Desroches, Louis Marie, Amadon, Nicole, Bahr, Alaa, Ezzat, Imaan, Guerrero, Maryanne, Padilla, Joane, Fullmer, Jessie, Singh, Inderpreet, Ali Shah, Syed Hamad, Narang, Rajeev, Mock, Polly, Shadle, Melissa, Hernandez, Brenda, Welch, Kevin, Payne, Andrea, Ertl, Gabriela, Canario, Daniel, Barrientos, Isabel, Goss, Danielle, DeVries, Mattie, Folowosele, Ibidolapo, Garner, Dorothy, Gomez, Mariana, Price, Justin, Bansal, Ekta, Wong, Jim, Faulhaber, Jason, Fazili, Tasaduq, Yeary, Brian, Ndolo, Ruth, Bryant, Christina, Smigeil, Bridgette, Robinson, Philip, Najjar, Rana, Jones, Patrice, Nguyen, Julie, Chin, Christina, Taha, Hassan, Najm, Salah, Smith, Christopher, Moore, Jason, Nassar, Talal, Gallinger, Nick, Christian, Amy, Mauer, D’Amber, Phipps, Ashley, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Landazuri, Rosalynn, Pineda, Jacob, Uribe, Nicole, Garcia, Jose Ruiz, Barbabosa, Cecilia, Sandler, Kaitlyn, Overcash, J. Scott, Marquez, Adrienna, Chu, Hanh, Lee, Kia, Quillin, Kimberly, Garcia, Andrea, Lew, Pauline, Rogers, Ralph, Shehadeh, Fadi, Mylona, Evangelia K., Kaczynski, Matthew, Tran, Quynh-Lam, Benitez, Gregorio, Mishra, Biswajit, Felix, Lewis Oscar, Vafea, Maria Tsikala, Atalla, Eleftheria, Davies, Robin, Hedili, Salma, Monkeberg, Maria Andrea, Tabler, Sandra, Harrington, Britt, Meegada, Sreenath, Koripalli, Venkata Sandeep, Muddana, Prithvi, Jain, Lakshay, Undavalli, Chaitanya, Kavya, Parasa, Ibiwoye, Mofoluwaso, Akilo, Hameed, Lovette, Bryce D., Wylie, Jamie-Crystal, Smith, Diana M., Poon, Kenneth, Eckardt, Paula, Heysu, Rubio-Gomez, Sundararaman, Nithya, Alaby, Doris, Sareli, Candice, Sánchez, Adriana, Popielski, Laura, Kambo, Amy, Viens, Kimberley, Turner, Melissa, Vjecha, Michael J., Weintrob, Amy, Brar, Indira, Markowitz, Norman, Pastor, Erika, Corpuz, Roweena, Alangaden, George, McKinnon, John, Ramesh, Mayur, Herc, Erica, Yared, Nicholas, Lanfranco, Odaliz Abreu, Rivers, Emanuel, Swiderek, Jennifer, Gupta, Ariella Hodari, Pabla, Pardeep, Eliya, Sonia, Jazrawi, Jehan, Delor, Jeremy, Desai, Mona, Cook, Aaron, Jaehne, Anja Kathrina, Gill, Jasreen Kaur, Renaud, Sheri, Sarveswaran, Siva, Gardner, Edward, Scott, James, Bianchini, Monica, Melvin, Casey, Kim, Gina, Wyles, David, Kamis, Kevin, Miller, Rachel, Douglas, Ivor, Haukoos, Jason, Hicks, Carrie, Lazarte, Susana, Marines-Price, Rubria, Osuji, Alice, Agbor Agbor, Barbine Tchamba, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Garcia, Angie, Cha, Christine, Mozaffari, Azadeh, Hernandez, Rosa, Cutrell, James, Kim, Mina, DellaValle, Natalie, Gonzales, Sonia, Somboonwit, Charurut, Oxner, Asa, Guerra, Lucy, Hayes, Michael, Nguyen, Thi, Tran, Thanh, Pinto, Avenette, Hatlen, Timothy, Anderson, Betty, Zepeda-Gutierrez, Ana, Martin, Dannae, Temblador, Cindi, Cuenca, Avon, Tanoviceanu, Roxanne, Prieto, Martha, Guerrero, Mario, Daar, Eric, Correa, Ramiro, Hartnell, Gabe, Wortmann, Glenn, Doshi, Saumil, Moriarty, Theresa, Gonzales, Melissa, Garman, Kristin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Driver, Brian, Frank, Christine, Leviton, Tzivia, Prekker, Matthew, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Kunisaki, Ken M., Wendt, Chris, Melzer, Anne, Wetherbee, Erin, Drekonja, Dimitri, Pragman, Alexa, Hamel, Aimee, Thielen, Abbie, Hassler, Miranda, Walquist, Mary, Augenbraun, Michael, George, Jensen, Demeo, Lynette, Mishko, Motria, Thomas, Lorraine, Tatem, Luis, Dehovitz, Jack, Abassi, Mahsa, Leuck, Anne-Marie, Rao, Via, Pullen, Matthew, Luke, Darlette, LaBar, Derek, Christiansen, Theresa, Howard, Diondra, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Davis-Karim, Anne, Pittman, David, Vasudeva, Shikha S., Johnstone, Jaylynn R., Agnetti, Kate, Davis, Ruby, Trautner, Barbara, Hines-Munson, Casey, Van, John, Dillon, Laura, Wang, Yiqun, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Caldwell, Erin, Humerickhouse, Edward, Boone, David, McGraw, William, Looney, David J., Mehta, Sanjay R., Johns, Scott Thompson, St. John, Melissa, Raceles, Jacqueline, Sear, Emily, Funk, Stephen, Cesarini, Rosa, Fang, Michelle, Nicalo, Keith, Drake, Wonder, Jones, Beatrice, Holtman, Teresa, Nguyen, Hien H., Maniar, Archana, Johnson, Eric A., Nguyen, Lam, Tran, Michelle T., Barrett, Thomas W., Johnston, Tera, Huggins, John T., Beiko, Tatsiana Y., Hughes, Heather Y., McManigle, William C., Tanner, Nichole T., Washburn, Ronald G., Ardelt, Magdalena, Tuohy, Patricia A., Mixson, Jennifer L., Hinton, Charles G., Thornley, Nicola, Allen, Heather, Elam, Shannon, Boatman, Barry, Baber, Brittany J., Ryant, Rudell, Roller, Brentin, Nguyen, Chinh, Mikail, Amani Morgan, Research, Marivic Hansen, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Holodniy, Mark, Chary, Aarthi, Lu, Kan, Peters, Theresa, Lopez, Jessica, Tan, Susanna Yu, Lee, Robert H., Asghar, Aliya, Karyn Isip, Tasadduq Karim, Le, Katherine, Nguyen, Thao, Wong, Shinn, Raben, Dorthe, Murray, Daniel D., Jensen, Tomas O., Peters, Lars, Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Olsson, Christina, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esman, Frederik V.L., Benfield, Thomas, Clausen, Clara Lundetoft, Hovmand, Nichlas, Israelsen, Simone Bastrup, Iversen, Katrine, Leding, Caecilie, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Tingsgard, Sandra, Krohn-Dehli, Louise, Pedersen, Dorthe, Villadsen, Signe, Staehr Jensen, Jens-Ulrik, Overgaard, Rikke, Rastoder, Ema, Heerfordt, Christian, Hedsund, Caroline, Ronn, Christian Phillip, Kamstrup, Peter Thobias, Hogsberg, Dorthe Sandbaek, Bergsoe, Christina, Søborg, Christian, Hissabu, Nuria M.S., Arp, Bodil C., Ostergaard, Lars, Staerke, Nina Breinholt, Yehdego, Yordanos, Sondergaard, Ane, Johansen, Isik S., Pedersen, Andreas Arnholdt, Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Holden, Inge K., Lindvig, Susan O., Helleberg, Marie, Gerstoft, Jan, Kirk, Ole, Jensen, Tomas Ostergaard, Madsen, Birgitte Lindegaard, Pedersen, Thomas Ingemann, Harboe, Zitta Barrella, Roge, Birgit Thorup, Hansen, Thomas Michael, Glesner, Matilde Kanstrup, Lofberg, Sandra Valborg, Nielsen, Ariella Denize, Leicht von Huth, Sebastian, Nielsen, Henrik, Thisted, Rikke Krog, Petersen, Kristine Toft, Juhl, Maria Ruwald, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Clara Ellinor Lindnér, Cecilia Ebba, Wiese, Lothar, Knudsen, Lene Surland, Skrøder Nytofte, Nikolaj Julian, Havmøller, Signe Ravn, Expósito, Maria, Badillo, José, Martínez, Ana, Abad, Elena, Chamorro, Ana, Figuerola, Ariadna, Mateu, Lourdes, España, Sergio, Lucero, Maria Constanza, Santos, José Ramón, Lladós, Gemma, Lopez, Cristina, Carabias, Lydia, Molina-Morant, Daniel, Loste, Cora, Bracke, Carmen, Siles, Adrian, Fernández-Cruz, Eduardo, Di Natale, Marisa, Padure, Sergiu, Gomez, Jimena, Ausin, Cristina, Cervilla, Eva, Balastegui, Héctor, Sainz, Carmen Rodríguez, Lopez, Paco, Carbone, Javier, Escobar, Mariam, Balerdi, Leire, Legarda, Almudena, Roldan, Montserrat, Letona, Laura, Muñoz, José, Camprubí, Daniel, Arribas, Jose R., Sánchez, Rocio Montejano, Díaz-Pollán, Beatriz, Stewart, Stefan Mark, Garcia, Irene, Borobia, Alberto, Mora-Rillo, Marta, Estrada, Vicente, Cabello, Noemi, Nuñez-Orantos, M.J., Sagastagoitia, I., Homen, J.R., Orviz, E., Montalvá, Adrián Sánchez, Espinosa-Pereiro, Juan, Bosch-Nicolau, Pau, Salvador, Fernando, Burgos, Joaquin, Morales-Rull, Jose Luis, Moreno Pena, Anna Maria, Acosta, Cristina, Solé-Felip, Cristina, Horcajada, Juan P., Sendra, Elena, Castañeda, Silvia, López-Montesinos, Inmaculada, Gómez-Junyent, Joan, Gonzáles, Carlota Gudiol, Cuervo, Guilermo, Pujol, Miquel, Carratalà, Jordi, Videla, Sebastià, Günthard, Huldrych, Braun, Dominique L., West, Emily, M’Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, pharmacist, Goes pharmacist, Josefine, Fätkenheuer, Gerd, Malin, Jakob J., Tsertsvadze, Tengiz, Abutidze, Akaki, Chkhartishvili, Nikoloz, Metchurtchlishvili, Revaz, Endeladze, Marina, Paciorek, Marcin, Bursa, Dominik, Krogulec, Dominika, Pulik, Piotr, Ignatowska, Anna, Horban, Andrzej, Bakowska, Elzbieta, Kowaska, Justyna, Bednarska, Agnieszka, Jurek, Natalia, Skrzat-Klapaczynska, Agata, Bienkowski, Carlo, Hackiewicz, Malgorzata, Makowiecki, Michal, Platowski, Antoni, Fishchuk, Roman, Kobrynska, Olena, Levandovska, Khrystyna, Kirieieva, Ivanna, Kuziuk, Mykhailo, Naucler, Pontus, Perlhamre, Emma, Mazouch, Lotta, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina C., Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David C., Ong, Sean W.X., Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Yeo, He Ping, Eriobu, Nnakelu, Kwaghe, Vivian, Zaiyad, Habib, Idoko, Godwin, Uche, Blessing, Selvamuthu, Poongulali, Kumarasamy, Nagalingeswaran, Beulah, Faith Ester, Govindarajan, Narayan, Mariyappan, Kowsalya, Losso, Marcelo H., Abela, Cecilia, Moretto, Renzo, Belloc, Carlos G., Ludueña, Jael, Amar, Josefina, Toibaro, Javier, Macias, Laura Moreno, Fernandez, Lucia, Frare, Pablo S., Chaio, Sebastian R., Pachioli, Valeria, Timpano, Stella M., Sanchez, Marisa del Lujan, de Paz Sierra, Mariana, Stanek, Vanina, Belloso, Waldo, Cilenti, Flavia L., Valentini, Ricardo N., Stryjewski, Martin E., Locatelli, Nicolas, Soler Riera, Maria C., Salgado, Clara, Baeck, Ines M., Di Castelnuovo, Valentina, Zarza, Stella M., Hudson, Fleur, Parmar, Mahesh K.B., Goodman, Anna L., Dphil, Badrock, Jonathan, Gregory, Adam, Goodall, Katharine, Harris, Nicola, Wyncoll, James, Bhagani, S., Rodger, A., Luntiel, A., Patterson, C., Morales, J., Witele, E., Preston, A.-M., Nandani, A., Price, D.A., Hanrath, Aiden, Nell, Jeremy, Patel, Bijal, Hays, Carole, Jones, Geraldine, Davidson, Jade, Bawa, T., Mathews, M., Mazzella, A., Bisnauthsing, K., Aguilar-Jimenez, L., Borchini, F., Hammett, S., Touloumi, Giota, Pantazis, Nikos, Gioukari, Vicky, Souliou, Tania, Antoniadou, A., Protopapas, K., Kavatha, D., Grigoropoulou, S., Oikonomopoulo, C., Moschopoulos, C., Koulouris, N.G., Tzimopoulos, K., Koromilias, A., Argyraki, K., Lourida, P., Bakakos, P., Kalomenidis, I., Vlachakos, V., Barmparessou, Z., Balis, E., Zakynthinos, S., Sigala, I., Gianniou, N., Dima, E., Magkouta, S., Synolaki, E., Konstanta, S., Vlachou, M., Stathopoulou, P., Panagopoulos, P., Petrakis, V., Papazoglou, D., Tompaidou, E., Isaakidou, E., Poulakou, G., Rapti, V., Leontis, K., Nitsotolis, T., Athanasiou, K., Syrigos, K., Kyriakoulis, K., Trontzas, I., Arfara-Melanini, M., Kolonis, V., Kityo, Cissy, Mugerwa, Henry, Kiweewa, Francis, Kimuli, Ivan, Lukaakome, Joseph, Nsereko, Christoher, Lubega, Gloria, Kibirige, Moses, Nakahima, William, Wangi, Deus, Aguti, Evelyne, Generous, Lilian, Massa, Rosemary, Nalaki, Margaret, Magala, Felix, Nabaggala, Phiona Kaweesi, Kidega, Robert, Faith, Oryem Daizy, Florence, Apio, Emmanuel, Ocung, Beacham, Mugoonyi Paul, Geoffrey, Amone, Nakiboneka, Dridah, Apiyo, Paska, Kirenga, Bruce, Atukunda, Angella, Muttamba, Winters, Remmy, Kyeyume, Segawa, Ivan, Pheona, Nsubuga, Kigere, David, Mbabazi, Queen Lailah, Boersalino, Ledra, Nyakoolo, Grace, Fred, Aniongo, Alupo, Alice, Ebong, Doryn, Monday, Edson, Nalubwama, Ritah Norah, Kainja, Milton, Ambrose, Munu, Kwehayo, Vanon, Nalubega, Mary Grace, Ongoli, Augustine, Obbo, Stephen, Sebudde, Nicholus, Alaba, Jeniffer, Magombe, Geoffrey, Tino, Harriet, Obonya, Emmanuel, Lutaakome, Joseph, Kitonsa, Jonathan, Onyango, Martin, Naboth, Tukamwesiga, Naluyinda, Hadijah, Nanyunja, Regina, Irene, Muttiibwa, Jane, Biira, Wimfred, Kyobejja, Leonard, Ssemazzi, Deus, Tkiinomuhisha, Babra, Namasaba, Taire, Paul, Nabankema, Evelyn, Ogavu, Joseph, Mugerwa, Oscar, Okoth, Ivan, Mwebaze, Raymond, Mugabi, Timothy, Makhoba, Anthony, Arikiriza, Phiona, Theresa, Nabuuma, Nakayima, Hope, Frank, Kisuule, Ramgi, Patrícia, Pereira, Kássia, Osinusi, Anu, Cao, Huyen, Klekotka, Paul, Price, Karen, Nirula, Ajay, Osei, Suzette, Tipple, Craig, Wills, Angela, Peppercorn, Amanda, Watson, Helen, Gupta, Rajesh, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Margolis, David, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Zhu, Quing, Seegobin, Seth, Gibbs, Michael, Latchman, Mickel, Hasior, Katarzyna, Bouquet, Jerome, Wei, Jianxin, Streicher, Katie, Schmelzer, Albert, Brooks, Dennis, Butcher, Jonny, Tonev, Dimitar, Arbetter, Douglas, Damstetter, Philippe, Legenne, Philippe, Stumpp, Michael, Goncalves, Susana, Ramanathan, Krishnan, Chandra, Richa, Baseler, Beth, Teitelbaum, Marc, Schechner, Adam, Holley, H. Preston, Jankelevich, Shirley, Becker, Nancy, Dolney, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Asomah, Mabel, Jato, Yvonne, Stottlemyer, April, Tang, Olivia, Vanderpuye, Sharon, Yeon, Lindsey, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonald, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Schaffhauser, Marylu, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, C.K., Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Kopka, Stacey, Shelley, Denise M., Mendez, Gregg, Brown, Shawn, Albert, Sara, Balde, Abby, Baracz, Michelle, Bielica, Mona, Billouin-Frazier, Shere, Choudary, Jay, Dixon, Mary, Eyler, Carolyn, Frye, Leanne, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hogarty, Debi, Huber, Lynda, Krauss, Gary, Lake, Eileen, Manandhar, Meryan, Rudzinski, Erin, Sandrus, Jen, Suders, Connie, Natarajan, Ven, Rupert, Adam W., Baseler, Michael, Lynam, Danielle, Imamichi, Tom, Laverdure, Sylvain, McCormack, Ashley, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Khan, Ayub, Hazen, Allison, Badralmaa, Yunden, Smith, Kenneth, Patel, Bhakti, Kubernac, Amanda, Kubernac, Robert, Hoover, Marie L., Solomon, Courtney, Rashid, Marium, Murphy, Joseph, Brown, Craig, DuChateau, Nadine, Ellis, Sadie, Flosi, Adam, Fox, Lisa, Johnson, Les, Nelson, Rich, Stojanovic, Jelena, Treagus, Amy, Wenner, Christine, Williams, Richard, Jensen, Tomas O, Murray, Thomas A, Grandits, Greg A, Jain, Mamta K, Shaw-Saliba, Kathryn, Matthay, Michael A, Baker, Jason V, Dewar, Robin L, Goodman, Anna L, Hatlen, Timothy J, Highbarger, Helene C, Lallemand, Perrine, Leshnower, Bradley G, Looney, David, Moschopoulos, Charalampos D, Murray, Daniel D, Mylonakis, Eleftherios, Rehman, M Tauseef, Rupert, Adam, Stevens, Randy, Turville, Stuart, Wick, Katherine, Lundgren, Jens, and Ko, Emily R
Published: 2024
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16. Variation in Early Management Practices in Moderate-to-Severe ARDS in the United States The Severe ARDS: Generating Evidence Study

Author: Qadir, Nida, Bartz, Raquel R, Cooter, Mary L, Hough, Catherine L, Lanspa, Michael J, Banner-Goodspeed, Valerie M, Chen, Jen-Ting, Giovanni, Shewit, Gomaa, Dina, Sjoding, Michael W, Hajizadeh, Negin, Komisarow, Jordan, Duggal, Abhijit, Khanna, Ashish K, Kashyap, Rahul, Khan, Akram, Chang, Steven Y, Tonna, Joseph E, Anderson, Harry L, Liebler, Janice M, Mosier, Jarrod M, Morris, Peter E, Genthon, Alissa, Louh, Irene K, Tidswell, Mark, Stephens, R Scott, Esper, Annette M, Dries, David J, Martinez, Anthony, Schreyer, Kraftin E, Bender, William, Tiwari, Anupama, Guru, Pramod K, Hanna, Sinan, Gong, Michelle N, Park, Pauline K, Investigators, the Severe ARDS Generating Evidence Study, Steingrub, Jay S, Brierley, Kristin, Larson, Julia L, Mueller, Ariel, Pinkhasova, Tereza, Talmor, Daniel, Aisiku, Imoigele, Baron, Rebecca, Fredenburgh, Lauren, Hou, Peter, Massaro, Anthony, Seethala, Raghu, Hite, Duncan, Brodie, Daniel, Short, Briana, Bartz, Raquel, Komisarow, Jordan C, Blum, James, Esper, Annette, Martin, Greg S, Bulger, Eileen, Ungar, Anna, Brown, Samuel M, Grissom, Colin K, Hirshberg, Eliotte L, Peltan, Ithan D, Brower, Roy G, Sahetya, Sarina K, Bohman, John K, Coville, Hongchuan, Gajic, Ognjen, O’Horo, John C, Ataucuri-Vargas, Jorge-Bleik, Mastroianni, Fiore, Hirsch, Jamie, Qui, Michael, Stewart, Molly, Haq, Ebaad, Kamel, Makrina, Krol, Olivia, Lerner, Kimberly, Marini, John, and Amaral, Valentina Chiara Bistolfi
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Patient Safety, Rare Diseases, Acute Respiratory Distress Syndrome, Lung, Good Health and Well Being, Adult, Aged, Cohort Studies, Early Medical Intervention, Extracorporeal Membrane Oxygenation, Female, Glucocorticoids, Guideline Adherence, Hospital Mortality, Humans, Male, Middle Aged, Neuromuscular Blockade, Patient Positioning, Positive-Pressure Respiration, Practice Guidelines as Topic, Practice Patterns, Physicians', Prone Position, Quality of Health Care, Respiration, Artificial, Respiratory Distress Syndrome, Severity of Illness Index, United States, Vasodilator Agents, Ventilator-Induced Lung Injury, ARDS, corticosteroids, extracorporeal membrane oxygenation, mechanical ventilation, neuromuscular blockade, prone positioning, Severe ARDS: Generating Evidence (SAGE) Study Investigators, Society of Critical Care Medicine's Discovery Network, Respiratory System, Cardiovascular medicine and haematology, Clinical sciences
Abstract: BackgroundAlthough specific interventions previously demonstrated benefit in patients with ARDS, use of these interventions is inconsistent, and patient mortality remains high. The impact of variability in center management practices on ARDS mortality rates remains unknown.Research questionWhat is the impact of treatment variability on mortality in patients with moderate to severe ARDS in the United States?Study design and methodsWe conducted a multicenter, observational cohort study of mechanically ventilated adults with ARDS and Pao2 to Fio2 ratio of ≤ 150 with positive end-expiratory pressure of ≥ 5 cm H2O, who were admitted to 29 US centers between October 1, 2016, and April 30, 2017. The primary outcome was 28-day in-hospital mortality. Center variation in ventilator management, adjunctive therapy use, and mortality also were assessed.ResultsA total of 2,466 patients were enrolled. Median baseline Pao2 to Fio2 ratio was 105 (interquartile range, 78.0-129.0). In-hospital 28-day mortality was 40.7%. Initial adherence to lung protective ventilation (LPV; tidal volume, ≤ 6.5 mL/kg predicted body weight; plateau pressure, or when unavailable, peak inspiratory pressure, ≤ 30 mm H2O) was 31.4% and varied between centers (0%-65%), as did rates of adjunctive therapy use (27.1%-96.4%), methods used (neuromuscular blockade, prone positioning, systemic steroids, pulmonary vasodilators, and extracorporeal support), and mortality (16.7%-73.3%). Center standardized mortality ratios (SMRs), calculated using baseline patient-level characteristics to derive expected mortality rate, ranged from 0.33 to 1.98. Of the treatment-level factors explored, only center adherence to early LPV was correlated with SMR.InterpretationSubstantial center-to-center variability exists in ARDS management, suggesting that further opportunities for improving ARDS outcomes exist. Early adherence to LPV was associated with lower center mortality and may be a surrogate for overall quality of care processes. Future collaboration is needed to identify additional treatment-level factors influencing center-level outcomes.Trial registryClinicalTrials.gov; No.: NCT03021824; URL: www.clinicaltrials.gov.
Published: 2021

17. 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

Author: 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
Subjects: 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.
Published: 2021

18. Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021

Author: 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
Subjects: 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.
Published: 2021

19. Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021

Author: 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
Subjects: 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.
Published: 2021

20. 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

Author: 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
Subjects: 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
Published: 2021

21. ICU Bed Utilization During the Coronavirus Disease 2019 Pandemic in a Multistate Analysis-March to June 2020.

Author: 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
Subjects: 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.
Published: 2021

22. 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: 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
Subjects: 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
Published: 2020

23. Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network - 13 Academic Medical Centers, April-June 2020.

Author: 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
Subjects: 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.
Published: 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

Author: 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
Subjects: 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.
Published: 2020

25. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author: Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford
Published: 2023
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26. Characteristics of Adult Outpatients and Inpatients with COVID-19 — 11 Academic Medical Centers, United States, March–May 2020

Author: 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
Subjects: 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).
Published: 2020

27. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author: Ginde, Adit A., Paredes, Roger, Murray, Thomas A., Engen, Nicole, Grandits, Greg, Vekstein, Andrew, Ivey, Noel, Mourad, Ahmad, Sandkovsky, Uriel, Gottlieb, Robert L., Berhe, Mezgebe, Jain, Mamta K., Marines-Price, Rubria, Agbor Agbor, Barbine Tchamba, Mateu, Lourdes, España-Cueto, Sergio, Lladós, Gemma, Mylonakis, Eleftherios, Rogers, Ralph, Shehadeh, Fadi, Filbin, Michael R., Hibbert, Kathryn A., Kim, Kami, Tran, Thanh, Morris, Peter E., Cassity, Evan P., Trautner, Barbara, Pandit, Lavannya M., Knowlton, Kirk U., Leither, Lindsay, Matthay, Michael A., Rogers, Angela J., Drake, Wonder, Jones, Beatrice, Poulakou, Garyfallia, Syrigos, Konstantinos N., Fernández-Cruz, Eduardo, Natale, Marisa Di, Almasri, Eyad, Balerdi-Sarasola, Leire, Bhagani, Sanjay R., Boyle, Katherine L., Casey, Jonathan D., Chen, Peter, Douin, David J., Files, D. Clark, Günthard, Huldrych F., Hite, R. Duncan, Hyzy, Robert C., Khan, Akram, Kibirige, Moses, Kidega, Robert, Kiweewa, Francis, Jensen, Jens-Ulrik, Leshnower, Bradley G., Lutaakome, Joseph K., Manian, Prasad, Menon, Vidya, Morales-Rull, Jose Luis, O'Mahony, D. Shane, Overcash, J. Scott, Ramachandruni, Srikant, Steingrub, Jay S., Taha, Hassan S., Waters, Michael, Young, Barnaby E., Phillips, Andrew N., Murray, Daniel D., Jensen, Tomas O., Padilla, Maria L., Sahner, David, Shaw-Saliba, Katy, Dewar, Robin L., Teitelbaum, Marc, Natarajan, Ven, Rehman, M. Tauseef, Pett, Sarah, Hudson, Fleur, Touloumi, Giota, Brown, Samuel M., Self, Wesley H., Chang, Christina C., Sánchez, Adriana, Weintrob, Amy C., Hatlen, Timothy, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S., Garbes, Pedro, Esser, Mark T., Templeton, Alison, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Higgs, Elizabeth S., Kan, Virginia, Matthews, Gail, Thompson, B. Taylor, Neaton, James D., Lane, H. Clifford, and Lundgren, Jens D.
Published: 2022
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28. 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

Author: IVY Network, 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., Lohuis, Caitlin C. ten, 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., and Patel, Manish M.
Published: 2021

29. Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021

Author: IVY Network Investigators, 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., and Patel, Manish M.
Published: 2021

30. Effectiveness of the Original Monovalent Messenger RNA Coronavirus Disease 2019 (COVID-19) Vaccination Series Against Hospitalization for COVID-19–Associated Venous Thromboembolism.

Author: Hager, David N, Zhu, Yuwei, Sohn, Ine, Stubblefield, William B, Streiff, Michael B, Gaglani, Manjusha, Steingrub, Jay S, Duggal, Abhijit, Felzer, Jamie R, O'Rourke, Mary, Peltan, Ithan D, Mohamed, Amira, Stiller, Robin, Wilson, Jennifer G, Qadir, Nida, Ginde, Adit A, Zepeski, Anne E, Mallow, Christopher, Lauring, Adam S, and Johnson, Nicholas J
Subjects: SARS-CoV-2, COVID-19, VACCINE effectiveness, SARS-CoV-2 Omicron variant, DISEASE risk factors
Abstract: Background Coronavirus disease 2019 (COVID-19) is a strong risk factor for venous thromboembolism (VTE). Few studies have evaluated the effectiveness of COVID-19 vaccination in preventing hospitalization for COVID-19 with VTE. Methods Adults hospitalized at 21 sites between March 2021 and October 2022 with symptoms of acute respiratory illness were assessed for COVID-19, completion of the original monovalent messenger RNA (mRNA) COVID-19 vaccination series, and VTE. Prevalence of VTE was compared between unvaccinated and vaccinated patients with COVID-19. The vaccine effectiveness (VE) in preventing COVID-19 hospitalization with VTE was calculated using a test-negative design. The VE was also stratified by predominant circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant. Results Among 18 811 patients (median age [interquartile range], 63 [50–73] years; 49% women; 59% non-Hispanic white, 20% non-Hispanic black, and 14% Hispanic; and median of 2 comorbid conditions [interquartile range, 1–3]), 9792 were admitted with COVID-19 (44% vaccinated), and 9019 were test-negative controls (73% vaccinated). Among patients with COVID-19, 601 had VTE diagnosed by hospital day 28, of whom 170 were vaccinated. VTE was more common among unvaccinated than vaccinated patients with COVID-19 (7.8% vs 4.0%; P =.001). The VE against COVID-19 hospitalization with VTE was 84% overall (95% confidence interval, 80%–87%), and VE stratified by predominant circulating variant was 88% (73%–95%) for Alpha, 93% (90%–95%) for Delta, and 68% (58%–76%) for Omicron variants. Conclusions Vaccination with the original monovalent mRNA series was associated with a decrease in COVID-19 hospitalization with VTE, though data detailing prior history of VTE and use of anticoagulation were not available. These findings will inform risk-benefit considerations for those considering vaccination. [ABSTRACT FROM AUTHOR]
Published: 2025
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31. Predicting Severe Sepsis Using Text from the Electronic Health Record

Author: Culliton, Phil, Levinson, Michael, Ehresman, Alice, Wherry, Joshua, Steingrub, Jay S., and Gallant, Stephen I.
Subjects: Computer Science - Computers and Society, Computer Science - Learning
Abstract: Employing a machine learning approach we predict, up to 24 hours prior, a diagnosis of severe sepsis. Strongly predictive models are possible that use only text reports from the Electronic Health Record (EHR), and omit structured numerical data. Unstructured text alone gives slightly better performance than structured data alone, and the combination further improves performance. We also discuss advantages of using unstructured EHR text for modeling, as compared to structured EHR data., Comment: Accepted at workshop on Machine Learning For Health at the conference on Neural Information Processing Systems, 2017. Near-final draft version
Published: 2017

32. Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021

Author: IVY Network, HAIVEN Investigators, Tenforde, Mark W., Olson, Samantha M., Self, Wesley H., Talbot, 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., and Patel, Manish M.
Published: 2021

33. Prospective Assessment of the Feasibility of a Trial of Low-Tidal Volume Ventilation for Patients with Acute Respiratory Failure.

Author: Lanspa, Michael J, Gong, Michelle Ng, Schoenfeld, David A, Lee, Kathleen Tiffany, Grissom, Colin K, Hou, Peter C, Serpa-Neto, Ary, Brown, Samuel M, Iwashyna, Theodore J, Yealy, Donald M, Hough, Catherine L, Brower, Roy G, Calfee, Carolyn S, Hyzy, Robert C, Matthay, Michael A, Miller, Russell R, Steingrub, Jay S, Thompson, B Taylor, Miller, Chadwick D, Clemmer, Terry P, Hendey, Gregory W, Huang, David T, Mathews, Kusum S, Qadir, Nida, Tidswell, Mark, and The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network
Subjects: The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network, Humans, Respiratory Insufficiency, Acute Disease, Tidal Volume, Treatment Outcome, Respiration, Artificial, Incidence, Hospital Mortality, Survival Rate, Follow-Up Studies, Prospective Studies, Feasibility Studies, Middle Aged, Intensive Care Units, United States, Female, Male, Clinical Trials as Topic, acute respiratory distress syndrome, low-stretch ventilation, low–tidal volume ventilation, lung-protective ventilation, mechanical ventilation, Clinical Trials and Supportive Activities, Acute Respiratory Distress Syndrome, Clinical Research, Rare Diseases, Patient Safety, Lung, Respiratory, Good Health and Well Being, low-tidal volume ventilation
Abstract: RationaleLow-tidal volume ventilation (LTVV; 6 ml/kg) benefits patients with acute respiratory distress syndrome and may aid those with other causes of respiratory failure. Current early ventilation practices are poorly defined.ObjectivesWe observed patients with acute respiratory failure to assess the feasibility of a pragmatic trial of LTVV and to guide experimental design.MethodsWe prospectively enrolled consecutive patients with acute respiratory failure admitted to intensive care units expected to participate in the proposed trial. We collected clinical data as well as information on initial and daily ventilator settings and inpatient mortality. We estimated the benefit of LTVV using predictive linear and nonlinear models. We simulated models to estimate power and feasibility of a cluster-randomized trial of LTVV versus usual care in acute respiratory failure.ResultsWe included 2,484 newly mechanically ventilated patients (31% with acute respiratory distress syndrome) from 49 hospitals. Hospital mortality was 28%. Mean initial tidal volume was 7.1 ml/kg predicted body weight (95% confidence interval, 7.1-7.2), with 78% of patients receiving tidal volumes less than or equal to 8 ml/kg. Our models estimated a mortality benefit of 0-2% from LTVV compared with usual care. Simulation of a stepped-wedged cluster-randomized trial suggested that enrollment of 106,361 patients would be necessary to achieve greater than 90% power.ConclusionsUse of initial tidal volumes less than 8 ml/kg predicted body weight was common at hospitals participating in the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury (PETAL) Network. After considering the size and budgetary requirement for a cluster-randomized trial of LTVV versus usual care in acute respiratory failure, the PETAL Network deemed the proposed trial infeasible. A rapid observational study and simulations to model anticipated power may help better design trials.
Published: 2019

34. Liberal Versus Restrictive Intravenous Fluid Therapy for Early Septic Shock: Rationale for a Randomized Trial

Author: Self, Wesley H, Semler, Matthew W, Bellomo, Rinaldo, Brown, Samuel M, deBoisblanc, Bennett P, Exline, Matthew C, Ginde, Adit A, Grissom, Colin K, Janz, David R, Jones, Alan E, Liu, Kathleen D, Macdonald, Stephen PJ, Miller, Chadwick D, Park, Pauline K, Reineck, Lora A, Rice, Todd W, Steingrub, Jay S, Talmor, Daniel, Yealy, Donald M, Douglas, Ivor S, Shapiro, Nathan I, and Investigators, CLOVERS Protocol Committee and NHLBI Prevention and Early Treatment of Acute Lung Injury Network
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Hematology, Clinical Trials and Supportive Activities, Clinical Research, Lung, Physical Injury - Accidents and Adverse Effects, Cardiovascular, Sepsis, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Inflammatory and immune system, Drug Administration Schedule, Fluid Therapy, Humans, Infusions, Intravenous, Randomized Controlled Trials as Topic, Research Design, Shock, Septic, Vasoconstrictor Agents, CLOVERS Protocol Committee and NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Network Investigators, Emergency & Critical Care Medicine, Clinical sciences
Abstract: Prompt intravenous fluid therapy is a fundamental treatment for patients with septic shock. However, the optimal approach for administering intravenous fluid in septic shock resuscitation is unknown. Two competing strategies are emerging: a liberal fluids approach, consisting of a larger volume of initial fluid (50 to 75 mL/kg [4 to 6 L in an 80-kg adult] during the first 6 hours) and later use of vasopressors, versus a restrictive fluids approach, consisting of a smaller volume of initial fluid (≤30 mL/kg [≤2 to 3 L]), with earlier reliance on vasopressor infusions to maintain blood pressure and perfusion. Early fluid therapy may enhance or maintain tissue perfusion by increasing venous return and cardiac output. However, fluid administration may also have deleterious effects by causing edema within vital organs, leading to organ dysfunction and impairment of oxygen delivery. Conversely, a restrictive fluids approach primarily relies on vasopressors to reverse hypotension and maintain perfusion while limiting the administration of fluid. Both strategies have some evidence to support their use but lack robust data to confirm the benefit of one strategy over the other, creating clinical and scientific equipoise. As part of the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network, we designed a randomized clinical trial to compare the liberal and restrictive fluids strategies, the Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis trial. The purpose of this article is to review the current literature on approaches to early fluid resuscitation in adults with septic shock and outline the rationale for the upcoming trial.
Published: 2018

35. 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: 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

36. 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: 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

37. 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: 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

38. Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network — 13 Academic Medical Centers, April–June 2020

Author: 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

39. 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: 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

40. Characteristics of Adult Outpatients and Inpatients with COVID-19 — 11 Academic Medical Centers, United States, March–May 2020

Author: 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

41. Variation in Early Management Practices in Moderate-to-Severe ARDS in the United States: The Severe ARDS: Generating Evidence Study

Author: Steingrub, Jay S., Tidswell, Mark, Banner-Goodspeed, Valerie M., Brierley, Kristin, Larson, Julia L., Mueller, Ariel, Pinkhasova, Tereza, Talmor, Daniel, Aisiku, Imoigele, Baron, Rebecca, Fredenburgh, Lauren, Genthon, Alissa, Hou, Peter, Massaro, Anthony, Seethala, Raghu, Duggal, Abhijit, Hite, Duncan, Khanna, Ashish K., Brodie, Daniel, Louh, Irene K., Short, Briana, Bartz, Raquel, Cooter, Mary L., Komisarow, Jordan C., Tiwari, Anupama, Bender, William, Blum, James, Esper, Annette, Martin, Greg S., Bulger, Eileen, Hough, Catherine L., Ungar, Anna, Brown, Samuel M., Grissom, Colin K., Hirshberg, Eliotte L., Lanspa, Michael J., Peltan, Ithan D., Brower, Roy G., Sahetya, Sarina K., Stephens, R Scott, Guru, Pramod K., Bohman, John K., Coville, Hongchuan, Gajic, Ognjen, Kashyap, Rahul, O’Horo, John C., Ataucuri-Vargas, Jorge-Bleik, Chen, Jen-Ting, Gong, Michelle N., Mastroianni, Fiore, Hajizadeh, Negin, Hirsch, Jamie, Qui, Michael, Stewart, Molly, Khan, Akram, Haq, Ebaad, Kamel, Makrina, Krol, Olivia, Lerner, Kimberly, Dries, David J., Marini, John, Bistolfi Amaral, Valentina Chiara, Martinez, Anthony, Anderson, Harry L., III, Brown, Jill, Brozik, Michael, Kemmer, Heidi, Obear, Janet, Gentile, Nina, Shreyer, Kraftin E., Cairns, Charles, Hypes, Cameron, Malo, Josh, Mosier, Jarrod, Natt, Bhupinder, Chang, Steven Y., Hu, Scott, Mehta, Ishan, Qadir, Nida, Branson, Richard, Gomaa, Dina, Tsuei, Betty, Dhar, Sanjay, Montgomery-Yates, Ashley, Morris, Peter, Chen, Tina, Hanna, Sinan, Park, Pauline K., Sjoding, Michael W., Chang, Alfredo Lee, Cobb, Perren, Liebler, Janice M., Harris, Estelle, Hatton, Nate, Lewis, Gia, McKellar, Stephen, Raman, Sanjeev, Tonna, Joseph, Caldwell, Ellen, Dean, Sarah, Giovanni, Shewit, Bartz, Raquel R., Komisarow, Jordan, Tonna, Joseph E., Mosier, Jarrod M., Morris, Peter E., Stephens, R. Scott, Esper, Annette M., and Schreyer, Kraftin E.
Published: 2021
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42. Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalization Among Immunocompetent Adults Aged [greater than or equal to]18 Years--VISION and IVY Networks, September 2023- January 2024

Author: DeCuir, Jennifer, Payne, Amanda B., Self, Wesley H., Rowley, Elizabeth A.K., Dascomb, Kristin, DeSilva, Malini B., Irving, Stephanie A., Grannis, Shaun J., Ong, Toan C., Klein, Nicola P., Weber, Zachary A., Reese, Sarah E., Ball, Sarah W., Barron, Michelle A., Naleway, Allison L., Dixon, Brian E., Essien, Inih, Bride, Daniel, Natarajan, Karthik, Fireman, Bruce, Shah, Ami B., Okwuazi, Erica, Wiegand, Ryan, Zhu, Yuwei, Lauring, Adam S., Martin, Emily T., Gaglani, Manjusha, Peltan, Ithan D., Brown, Samuel M., Ginde, Adit A., Mohr, Nicholas M., Gibbs, Kevin W., Hager, David N., Prekker, Matthew, Mohamed, Amira, Srinivasan, Vasisht, Steingrub, Jay S., Khan, Akram, Busse, Laurence W., Duggal, Abhijit, Wilson, Jennifer G., Chang, Steven Y., Mallow, Christopher, Kwon, Jennie H., Exline, Matthew C., Columbus, Cristie, Vaughn, Ivana A., Safdar, Basmah, Mosier, Jarrod M., Harris, Estelle S., Casey, Jonathan D., Chappell, James D., Grijalva, Carlos G., Swan, Sydney A., Johnson, Cassandra, Lewis, Nathaniel M., Ellington, Sascha, Adams, Katherine, Tenforde, Mark W., Paden, Clinton R., Dawood, Fatimah S., Fleming-Dutra, Katherine E., Surie, Diya, and Link-Gelles, Ruth
Subjects: Vanderbilt University. Medical Center, Vaccines, Hospital emergency services, Medical research, Vaccination, Emergency medicine, COVID-19, Adults, Medicine, Experimental, Hospitals -- Emergency service
Abstract: Introduction On September 12, 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 COVID-19 vaccination with a monovalent XBB.1.5--derived vaccine for all persons aged [greater than or equal to]6 [...]
Published: 2024

43. Effectiveness of Updated 2023–2024 (Monovalent XBB.1.5) COVID-19 Vaccination Against SARS-CoV-2 Omicron XBB and BA.2.86/JN.1 Lineage Hospitalization and a Comparison of Clinical Severity — IVY Network, 26 Hospitals, October 18, 2023–March 9, 2024

Author: Ma, Kevin C., primary, Surie, Diya, additional, Lauring, Adam S., additional, Martin, Emily T., additional, Leis, Aleda M., additional, Papalambros, Leigh, additional, Gaglani, Manjusha, additional, Columbus, Christie, additional, Gottlieb, Robert L., additional, Ghamande, Shekhar, additional, Peltan, Ithan D., additional, Brown, Samuel M., additional, Ginde, Adit A., additional, Mohr, Nicholas M., additional, Gibbs, Kevin W., additional, Hager, David N., additional, Saeed, Safa, additional, Prekker, Matthew E., additional, Gong, Michelle Ng, additional, Mohamed, Amira, additional, Johnson, Nicholas J., additional, Srinivasan, Vasisht, additional, Steingrub, Jay S., additional, Khan, Akram, additional, Hough, Catherine L., additional, Duggal, Abhijit, additional, Wilson, Jennifer G., additional, Qadir, Nida, additional, Chang, Steven Y., additional, Mallow, Christopher, additional, Kwon, Jennie H., additional, Parikh, Bijal, additional, Exline, Matthew C., additional, Vaughn, Ivana A., additional, Ramesh, Mayur, additional, Safdar, Basmah, additional, Mosier, Jarrod, additional, Harris, Estelle S., additional, Shapiro, Nathan I., additional, Felzer, Jamie, additional, Zhu, Yuwei, additional, Grijalva, Carlos G., additional, Halasa, Natasha, additional, Chappell, James D., additional, Womack, Kelsey N., additional, Rhoads, Jillian P., additional, Baughman, Adrienne, additional, Swan, Sydney A., additional, Johnson, Cassandra A., additional, Rice, Todd W., additional, Casey, Jonathan D., additional, Blair, Paul W., additional, Han, Jin H., additional, Ellington, Sascha, additional, Lewis, Nathaniel M., additional, Thornburg, Natalie, additional, Paden, Clinton R., additional, Atherton, Lydia J., additional, Self, Wesley H., additional, Dawood, Fatimah S., additional, and DeCuir, Jennifer, additional
Published: 2024
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44. Neutralizing antibody responses in patients hospitalized with SARS-CoV-2 Delta or Omicron infection

Author: 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: Care and treatment, Research, Patient outcomes, Hospital patients -- Care and treatment, SARS-CoV-2 variants -- Research, COVID-19 vaccines -- Patient outcomes, Immunologic research, Immune response -- Research, COVID-19 -- Care and treatment -- Patient outcomes, Immunological research
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

45. A Multicenter Study of Key Stakeholders’ Perspectives on Communicating with Surrogates about Prognosis in Intensive Care Units

Author: Anderson, Wendy G, Cimino, Jenica W, Ernecoff, Natalie C, Ungar, Anna, Shotsberger, Kaitlin J, Pollice, Laura A, Buddadhumaruk, Praewpannarai, Carson, Shannon S, Curtis, J Randall, Hough, Catherine L, Lo, Bernard, Matthay, Michael A, Peterson, Michael W, Steingrub, Jay S, and White, Douglas B
Subjects: Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Clinical Research, Health Services, Behavioral and Social Science, 7.3 Management and decision making, Adult, Aged, Attitude of Health Personnel, Attitude to Health, Communication, Critical Care, Critical Illness, Decision Making, Family, Female, Humans, Intensive Care Units, Male, Middle Aged, Nurses, Physicians, Practice Guidelines as Topic, Professional-Family Relations, Prognosis, Proxy, Qualitative Research, Social Work, Truth Disclosure, critical care, communication, prognosis, Cardiovascular medicine and haematology, Clinical sciences
Abstract: RationaleSurrogates of critically ill patients often have inaccurate expectations about prognosis. Yet there is little research on how intensive care unit (ICU) clinicians should discuss prognosis, and existing expert opinion-based recommendations give only general guidance that has not been validated with surrogate decision makers.ObjectiveTo determine the perspectives of key stakeholders regarding how prognostic information should be conveyed in critical illness.MethodsThis was a multicenter study at three academic medical centers in California, Pennsylvania, and Washington. One hundred eighteen key stakeholders completed in-depth semistructured interviews. Participants included 47 surrogates of adult patients with acute respiratory distress syndrome; 45 clinicians working in study ICUs, including physicians, nurses, social workers, and spiritual care providers; and 26 experts in health communication, decision science, ethics, family-centered care, geriatrics, healthcare disparities, palliative care, psychology, psychiatry, and critical care.Measurements and main resultsThere was broad support among surrogates for existing expert recommendations, including truthful prognostic disclosure, emotional support, tailoring the disclosure strategy to each family's needs, and checking for understanding. In addition, stakeholders offered suggestions that add specificity to existing recommendations, including: (1) In addition to conveying prognostic estimates, clinicians should help families "see the prognosis for themselves" by showing families radiographic images and explaining the clinical significance of physical manifestations of severe disease at the bedside. (2) Many physicians did not support using numeric estimates to convey prognosis to families, whereas many surrogates, clinicians from other disciplines, and experts believed numbers could be helpful. (3) Clinicians should conceptualize prognostic communication as an iterative process that begins with a preliminary mention of the possibility of death early in the ICU stay and becomes more detailed as the clinical situation develops. (4) Although prognostic information should be initially disclosed by physicians, other members of the multidisciplinary team-nurses, social workers, and spiritual care providers-should be given explicit role responsibilities to reinforce physicians' prognostications and help families process a poor prognosis emotionally.ConclusionsFamily members, clinicians, and experts identified specific communication behaviors that clinicians should use to discuss prognosis in the critical care setting. These findings extend existing opinion-based recommendations and should guide interventions to improve communication about prognosis in ICUs.
Published: 2015

46. A scoring system derived from electronic health records to identify patients at high risk for noninvasive ventilation failure

Author: Stefan, Mihaela S., Priya, Aruna, Pekow, Penelope S., Steingrub, Jay S., Hill, Nicholas S., Lagu, Tara, Raghunathan, Karthik, Bhat, Anusha G., and Lindenauer, Peter K.
Published: 2021
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47. Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

Author: Stefan, Mihaela S., Pekow, Penelope S., Shea, Christopher M., Hughes, Ashley M., Hill, Nicholas S., Steingrub, Jay S., Farmer, Mary Jo S., Hess, Dean R., Riska, Karen L., Clark, Taylar A., and Lindenauer, Peter K.
Published: 2021
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48. An analysis of homeless patients in the United States requiring ICU admission

Author: Nathanson, Brian H., Higgins, Thomas L., Stefan, Mihaela, Lagu, Tara, Lindenauer, Peter K., and Steingrub, Jay S.
Published: 2019
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49. Effectiveness of Monovalent mRNA COVID-19 Vaccination in Preventing COVID-19--Associated Invasive Mechanical Ventilation and Death Among Immunocompetent Adults During the Omicron Variant Period--IVY Network, 19 U.S. States, February 1, 2022-January 31, 2023

Author: DeCuir, Jennifer, Surie, Diya, Zhu, Yuwei, Gaglani, Manjusha, Ginde, Adit A., Douin, David J., Talbot, H. Keipp, Casey, Jonathan D., Mohr, Nicholas M., McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W., Files, D. Clark, Hager, David N., Phan, Minh, Prekker, Matthew E., Gong, Michelle N., Mohamed, Amira, Johnson, Nicholas J., Steingrub, Jay S., Peltan, Ithan D., Brown, Samuel M., Martin, Emily T., Monto, Arnold S., Khan, Akram, Bender, William S., Duggal, Abhijit, Wilson, Jennifer G., Qadir, Nida, Chang, Steven Y., Mallow, Christopher, Kwon, Jennie H., Exline, Matthew C., Lauring, Adam S., Shapiro, Nathan I., Columbus, Cristie, Gottlieb, Robert, Vaughn, Ivana A., Ramesh, Mayur, Lamerato, Lois E., Safdar, Basmah, Halasa, Natasha, Chappell, James D., Grijalva, Carlos G., Baughman, Adrienne, Womack, Kelsey N., Rhoads, Jillian P., Hart, Kimberly W., Swan, Sydney A., Lewis, Nathaniel, McMorrow, Meredith L., and Self, Wesley H.
Subjects: United States. National Institutes of Health -- Analysis, Analysis, Vaccination -- Analysis, COVID-19 -- Analysis, Messenger RNA -- Analysis, Adults -- Analysis
Abstract: As of April 2023, the COVID-19 pandemic has resulted in 1.1 million deaths in the United States, with approximately 75% of deaths occurring among adults aged [greater than or equal [...]
Published: 2023

50. The comparative effectiveness of noninvasive and invasive ventilation in patients with pneumonia

Author: Stefan, Mihaela S., Priya, Aruna, Pekow, Penelope S., Lagu, Tara, Steingrub, Jay S., Hill, Nicholas S., Nathanson, Brian H., and Lindenauer, Peter K.
Published: 2018
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