Systematic Review of the “Pragmatism” of Pragmatic Critical Care Trials by Jessica A. Palakshappa, MD, MS, Kevin W. Gibbs, MD, Margo T. Lannan, MD, Anna R. Cranford, MS, Stephanie P. Taylor, MD, MS

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Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative by David A. Wohl, Stacey J. Adam, Kevin W. Gibbs, Ari L. Moskowitz, Thomas L. Ortel, Upinder Singh, Nikolaus Jilg, Teresa H. Evering, William A. Fischer, Babafemi O. Taiwo, Eric S. Daar, Christopher J. Lindsell, Susanna Naggie, Russell L. Rothman, Sarah E. Dunsmore, M. Patricia McAdams, Julia Vail, Dushyantha Jayaweera

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ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic by Maryam Keshtkar-Jahromi, Kevin J. Anstrom, Christina Barkauskas, Samuel M. Brown, Eric S. Daar, William Fischer, Kevin W. Gibbs, Elizabeth S. Higgs, Michael D. Hughes, Prasanna Jagannathan, Lisa LaVange, Christopher J. Lindsell, Seema U. Nayak, Roger Paredes, Mahesh Parmar, Ithan D. Peltan, Michael Proschan, Matthew S. Shotwell, David M. Vock, Tammy Yokum, Stacey J. Adam

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Neutralizing antibody responses in patients hospitalized with SARS-CoV-2 Delta or Omicron infection by Susanne L. Linderman, Lilin Lai, Estefany L. Bocangel Gamarra, Max S.Y. Lau, Srilatha Edupuganti, Diya Surie, Mark W. Tenforde, James D. Chappell, Nicholas M. Mohr, Kevin W. Gibbs, Jay S. Steingrub, Matthew C. Exline, Nathan I. Shapiro, Anne E. Frosch, Nida Qadir, Meredith E. Davis-Gardner, M. Juliana McElrath, Adam S. Lauring, Mehul S. Suthar, Manish M. Patel, Wesley H. Self, Rafi Ahmed

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Modeling clinical trajectory status of critically ill COVID-19 patients over time: A method for analyzing discrete longitudinal and ordinal outcomes by Michael J. Ward, David J. Douin, Wu Gong, Adit A. Ginde, Catherine L. Hough, Matthew C. Exline, Mark W. Tenforde, William B. Stubblefield, Jay S. Steingrub, Matthew E. Prekker, Akram Khan, D. Clark Files, Kevin W. Gibbs, Todd W. Rice, Jonathan D. Casey, Daniel J. Henning, Jennifer G. Wilson, Samuel M. Brown, Manish M. Patel, Wesley H. Self, Christopher J. Lindsell, for the Influenza and Other Viruses in the Acutely Ill (IVY) Network

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ICU Bed Utilization During the Coronavirus Disease 2019 Pandemic in a Multistate Analysis—March to June 2020 by David J. Douin, MD, Michael J. Ward, MD, PhD, Christopher J. Lindsell, PhD, Michelle P. Howell, BSN, Catherine L. Hough, MD, MSc, Matthew C. Exline, MD, Michelle N. Gong, MD, Michael S. Aboodi, MD, Mark W. Tenforde, MD, PhD, Leora R. Feldstein, PhD, William B. Stubblefield, MD, Jay S. Steingrub, MD, Matthew E. Prekker, MD, MPH, Samuel M. Brown, MD, Ithan D. Peltan, MD, MSc, Akram Khan, MD, D. Clark Files, MD, Kevin W. Gibbs, MD, Todd W. Rice, MD, MSc, Jonathan D. Casey, MD, David N. Hager, MD, PhD, Nida Qadir, MD, Daniel J. Henning, MD, Jennifer G. Wilson, MD, MS, Manish M. Patel, MD, Wesley H. Self, MD, MPH, Adit A. Ginde, MD, MPH

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Antigenic Characterization of Circulating and Emerging SARS-CoV-2 Variants in the U.S. throughout the Delta to Omicron Waves by Han Di, Elizabeth A. Pusch, Joyce Jones, Nicholas A. Kovacs, Norman Hassell, Mili Sheth, Kelly Sabrina Lynn, Matthew W. Keller, Malania M. Wilson, Lisa M. Keong, Dan Cui, So Hee Park, Reina Chau, Kristine A. Lacek, Jimma D. Liddell, Marie K. Kirby, Genyan Yang, Monique Johnson, Sharmi Thor, Natosha Zanders, Chenchen Feng, Diya Surie, Jennifer DeCuir, Sandra N. Lester, Lydia Atherton, Heather Hicks, Azaibi Tamin, Jennifer L. Harcourt, Melissa M. Coughlin, Wesley H. Self, Jillian P. Rhoads, Kevin W. Gibbs, David N. Hager, Nathan I. Shapiro, Matthew C. Exline, Adam S. Lauring, Benjamin Rambo-Martin, Clinton R. Paden, Rebecca J. Kondor, Justin S. Lee, John R. Barnes, Natalie J. Thornburg, Bin Zhou, David E. Wentworth, Charles Todd Davis

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Prophylactic Administration of Vasopressors Prior to Emergency Intubation in Critically Ill Patients: A Secondary Analysis of Two Multicenter Clinical Trials by Mikita Fuchita, MD, Jack Pattee, PhD, Derek W. Russell, MD, Brian E. Driver, MD, Matthew E. Prekker, MD, MPH, Christopher R. Barnes, MD, Joseph M. Brewer, DO, Kevin C. Doerschug, MD, John P. Gaillard, MD, Sheetal Gandotra, MD, Shekhar Ghamande, MD, Kevin W. Gibbs, MD, Christopher G. Hughes, MD, MS, David R. Janz, MD, MSc, Akram Khan, MD, Steven H. Mitchell, MD, David B. Page, MD, Todd W. Rice, MD, MSc, Wesley H. Self, MD, MPH, Lane M. Smith, MD, PhD, Susan B. Stempek, PA-C, MBA, MMSc, Stacy A. Trent, MD, MPH, Derek J. Vonderhaar, MD, Jason R. West, MD, Micah R. Whitson, MD, Kayla Williamson, MS, Matthew W. Semler, MD, MSc, Jonathan D. Casey, MD, MSc, Adit A. Ginde, MD, MPH, for the Pragmatic Critical Care Research Group

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Differential neutralization and inhibition of SARS-CoV-2 variants by antibodies elicited by COVID-19 mRNA vaccines by Li Wang, Markus H. Kainulainen, Nannan Jiang, Han Di, Gaston Bonenfant, Lisa Mills, Michael Currier, Punya Shrivastava-Ranjan, Brenda M. Calderon, Mili Sheth, Brian R. Mann, Jaber Hossain, Xudong Lin, Sandra Lester, Elizabeth A. Pusch, Joyce Jones, Dan Cui, Payel Chatterjee, M. Harley Jenks, Esther K. Morantz, Gloria P. Larson, Masato Hatta, Jennifer L. Harcourt, Azaibi Tamin, Yan Li, Ying Tao, Kun Zhao, Kristine Lacek, Ashley Burroughs, Wei Wang, Malania Wilson, Terianne Wong, So Hee Park, Suxiang Tong, John R. Barnes, Mark W. Tenforde, Wesley H. Self, Nathan I. Shapiro, Matthew C. Exline, D. Clark Files, Kevin W. Gibbs, David N. Hager, Manish Patel, Alison L. Halpin, Laura K. McMullan, Justin S. Lee, Hongjie Xia, Xuping Xie, Pei-Yong Shi, C. Todd Davis, Christina F. Spiropoulou, Natalie J. Thornburg, M. Steven Oberste, Vivien G. Dugan, SSEV Bioinformatics Working Group, David E. Wentworth, Bin Zhou

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Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trialResearch in context by D. Clark Files, Neil Aggarwal, Timothy Albertson, Sara Auld, Jeremy R. Beitler, Paul Berger, Ellen L. Burnham, Carolyn S. Calfee, Nathan Cobb, Alessio Crippa, Andrea Discacciati, Martin Eklund, Laura Esserman, Eliot Friedman, Sheetal Gandotra, Kashif Khan, Jonathan Koff, Santhi Kumar, Kathleen D. Liu, Thomas R. Martin, Michael A. Matthay, Nuala J. Meyer, Timothy Obermiller, Philip Robinson, Derek Russell, Karl Thomas, Se Fum Wong, Richard G. Wunderink, Mark M. Wurfel, Albert Yen, Fady A. Youssef, Anita Darmanian, Amy L. Dzierba, Ivan Garcia, Katarzyna Gosek, Purnema Madahar, Aaron M. Mittel, Justin Muir, Amanda Rosen, John Schicchi, Alexis L. Serra, Romina Wahab, Kevin W. Gibbs, Leigha Landreth, Mary LaRose, Lisa Parks, Adina Wynn, Caroline A.G. Ittner, Nilman S. Mangalmurti, John P. Reilly, Donna Harris, Abhishek Methukupally, Siddharth Patel, Lindsie Boerger, John Kazianis, Carrie Higgins, Jeff McKeehan, Brian Daniel, Scott Fields, James Hurst-Hopf, Alejandra Jauregui, Lamorna Brown Swigart, Daniel Blevins, Catherine Nguyen, Alexis Suarez, Maged A. Tanios, Farjad Sarafian, Usman Shah, Max Adelman, Christina Creel-Bulos, Joshua Detelich, Gavin Harris, Katherine Nugent, Christina Spainhour, Philip Yang, Angela Haczku, Erin Hardy, Richart Harper, Brian Morrissey, Christian Sandrock, G. R. Scott Budinger, Helen K. Donnelly, Benjamin D. Singer, Ari Moskowitz, Melissa Coleman, Joseph Levitt, Ruixiao Lu, Paul Henderson, Adam Asare, Imogene Dunn, Alejandro Botello Barragan

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BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial by Li Wang, Tamer Hudali, Megan Moore, Robert Mitchell, Wesley H Self, Todd W Rice, Matthew W Semler, Kate O’Connor, David B Page, Christopher Hughes, Swati Gulati, Jonathan D Casey, Derek W Russell, Derek J Vonderhaar, William S Stigler, John Whittle, Jason R West, Kevin W Gibbs, Janna S Landsperger, Sarah W Robison, Itay Bentov, Matthew E Prekker, Christopher John Lindsell, David Janz, John P Gaillard, Bradley Lloyd, Sheetal Gandotra, Anna Altz-Stamm, Cristina Bardita, Mary Clay Boone, Joe W Chiles, Kristina Collins, Abby Drescher, Kevin G Dsouza, Janna Dunn, Stacy Ejem, Josh Gautney, Nicole Harris, Savannah Herder, R Chad Wade, Rutwij Joshi, Daniel Kelmenson, Anne Merrill Mason, Scott R Merriman, Takudzwa Mkorombindo, Jada Nowak, Lisa Sarratt, Tabitha Stewart, Kadambari Vijaykumar, Gina White, Micah R Whitson, Christopher Barnes, Andrew M Walters, Adit A Ginde, Brian Driver, Stacy A Trent, Lane M Smith, AM Joffe, Michelle P Howell, Steven Mitchell, Andrew Latimer, Kevin Doerschug, Vikas Koppurapu, Alicia K Cupelo, Paige DeVries, Sally Dye, Andrea Fletcher, Christopher S Gray, Kevin High, Michael C Kurz, Carol L Lyle, Justin Oeth, Erika LW Rice, Alexandra Schick, Jamie Stang, Nathaniel D Westphal, Tak Watase, Vijay Krishnamoorthy, Raquel R Bartz, William C Fox, Bret D Alvis, Stephanie C Demasi, Laura E Goyack, Kristy K Ford, Trevor S Mattox, Sheylan D Patel, G Bruno Pereira, Anthony Defebio, Jennifer Friedel, Feysel Mohamed, Karina Nava, Angela Otoo, Christian Perez, Cori Withers

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I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations by Carolyn S Calfee, Michael A Matthay, Paul Henderson, Martin Eklund, Laura J Esserman, Chirag Patel, Angela Haczku, Michelle Jung, Tony Oliver, Alessio Crippa, Andrea Discacciati, Kathleen D Liu, Ellen L Burnham, Nuala J Meyer, Fady A Youssef, Derek W Russell, Julie Lang, Kevin W Gibbs, Daniel C Files, Sheetal Gandotra, Purnema Madahar, Nathan K Cobb, Timothy E Albertson, Rajiv Sonti, John P Reilly, Alejandra Jauregui, Iván García, Luis E Huerta, Daniel Clark Files, Neil R Aggarwal, Adam L Asare, Jeremy R Beitler, Paul A Berger, George Cimino, Melissa H Coleman, Paul T Henderson, Caroline A G Ittner, Kashif T Khan, Jonathan L Koff, Mary LaRose, Joe Levitt, Ruixiao Lu, Jeffrey D McKeehan, Karl W Thomas, Aaron M Mittel, Albert F Yen, Alexis E Suarez, Alexis L Serra, Alpesh N Amin, Amanda Rosen, Amy L Dzierba, Anna D Barker, Ariel R Weisman, Brian M Daniel, Brian M Morrissey, Caroline AG Ittner, Chayse Jones, Christina Creel-Bulos, Christina M Angelucci, Diana Ng, Fredy Chaparro-Rojas, Gavin H Harris, Harsh V Barot, Heny Su, Jacqueline B Sutter, Jamal Dodin, Jerry S Lee, John Kazianis, Joshua F Detelich, Julie E Lang, Justin Muir, Katarzyna Gosek, Katherine L Nugent, Kimberly Yee, Laura G Rodrigues, Laura R Macias, Lindsey A Orr, Lindsie L Boerger, Lissette Rosario-Remigio, Lucia Kufa, Maged Tanios, Maria B Reyes, Max W Adelman, Maya M Juarez, Michelle Meyers, Mitchell P Sternlieb, Neil Aggarwal, Nilam S Mangalmurti, Patrice Jones, Paul L Saban, Peter S Marshall, Philiip A Robinson, Philip Yang, Rahul Nair, Richard Anthony Lee, Richard G Wunderink, Romina Wahab, Roxana A Lupu, Santhi I Kumar, Sara C Auld, Scott Fields, Se Fum Wong, Skyler J Pearson, Spencer Whealon, Timothy F Obermiller, Anita Darmanian, John Schicchi, Esmeralda Martinez, Farjad Sarafian, Julie Nguyen, Bethany Weiler-Lisowski, Jaime Wyatt, Daniel Blevins, Marylee Melendrez, Brenda Lopez, Hiwet Tzehaie, Omowunmi Amosu, Austin Simonson, Erin Hardy, Brett Lindgren, Gregory Peterfreund, Leigha Landreth, Lisa Parks

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Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial by Philip Yang, MD, MSc, Neal W. Dickert, MD, PhD, Angela Haczku, MD, PhD, Christine Spainhour, RN, CCRC, Sara C. Auld, MD, MSc, the I-SPY COVID Consortium, Neil R. Aggarwal, MD, MHSc, Timothy Albertson, MD, Sara Auld, MD, Jeremy R. Beitler, MD, MPH, Paul Berger, DO, Ellen L. Burnham, MD, Carolyn S. Calfee, MD, MAS, Nathan Cobb, MD, Alessio Crippa, PhD, Andrea Discacciati, PhD, Martin Eklund, PhD, Laura Esserman, MD, MBA, D. Clark Files, MD, Eliot Friedman, MD, Sheetal Gandotra, MD, Kashif Khan, MD, Jonathan Koff, MD, Santhi Kumar, MD, Kathleen D. Liu, MD, PhD, Thomas R. Martin, MD, Michael A. Matthay, MD, Nuala J. Meyer, MD, Timothy Obermiller, MD, MS, Philip Robinson, MD, Derek Russell, MD, Karl Thomas, MD, Se Fum Wong, MD, Richard G. Wunderink, MD, Mark M. Wurfel, PhD, MD, Albert Yen, MD, Fady A. Youssef, MD, Anita Darmanian, MD, Amy L. Dzierba, PharmD, Ivan Garcia, RRT, Katarzyna Gosek, PharmD, Purnema Madahar, MD, MS, Aaron M. Mittel, MD, Justin Muir, PharmD, Amanda Roden, MD, John Schicchi, MD, Alexis L. Serra, MD, MPH, Romina Wahab, MD, Kevin W. Gibbs, MD, Leigha Landreth, RN, Mary LaRose, RN, Lisa Parks, RN, Adina Wynn, MPH, CCRP, Caroline A. G. Ittner, PhD, Nilam S. Mangalmurti, MD, John P. Reilly, MD, MS, Donna Harris, BSN, Abhishek Methukupally, MBBS, Siddharth Patel, MBBS, MPH, Lindsie Boerger, BA, John Kazianis, MD, Carrie Higgins, Jeff McKeehan, MS, Brian Daniel, RCP, RRT, Scott Fields, PharmD, James Hurst-Hopf, MS, Alejandra Jauregui, BA, Lamorna Brown Swigart, PhD, Daniel Belvins, CCRP, Catherine Nguyen, MD, Alexis Suarez, MS, Maged A. Tanios, MD, Farjad Sarafian, MD, Usman Shah, MD, Max Adelman, MD, MSc, Christina Creel-Bulos, MD, Joshua Detelich, MD, Gavin Harris, MD, Katherine Nugent, MD, Christine Spainhour, RN, CCRC, Philip Yang, MD, Angela Haczku, MD, PhD, Erin Hardy, Richart Harper, MD, Brian Morrissey, MD, Christian Sandrock, MD, MPH, G. R. Scott Budinger, MD, Helen K. Donnelly, RN, BSN, Benjamin D. Singer, MD, Ari Moskowitz, MD, Melissa Coleman, MD, Joseph Levitt, MD, Ruixiao Lu, PhD, Paul Henderson, PhD, Adam Asare, PhD, Imogene Dunn, PhD, Alejandro Botello Barragan

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Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised... by Li Wang, Tamer Hudali, Shekhar Ghamande, Megan Moore, Bruno Pereira, Christopher J Lindsell, Wesley H Self, Todd W Rice, Matthew W Semler, Kate O’Connor, David B Page, Victor E Ortega, Aaron M Joffe, Swati Gulati, G Patel, Heath D White, Muhammad Ali, Jonathan D Casey, David R Janz, Derek W Russell, Derek J Vonderhaar, Kevin M Dischert, William S Stigler, Emily Adams, Kevin W Gibbs, James M Dargin, A M Joffe, Akram Khan, Simanta Dutta, Janna S Landsperger, Sarah W Robison, Itay Bentov, Joanne M Wozniak, Susan Stempek, Olivia F Krol, Matthew E Prekker, Brian E Driver, Joseph M Brewer, Christopher John Lindsell, David Janz, Stephen P Peters, Rita N Bakhru, Scott Bauer, Christina R Bellinger, Amanda M Brown, Blair Brown, Jerri Brown, Caitlin Bumgarner, Wendy Butcher, Megan Caudle, Arjun B Chatterjee, David J Chodos, Gerardo Corcino, Nathan S Cutler, Travis L Dotson, Daniel C Files, Jonathan L Forbes, John P Gaillard, Katherine A Gershner, Shannon Ginty, Kiadrick R Hood, April Hazelwood, Katherine Hendricks, Kelly Jacobus, Jonathan T Jaffe, Stacy Kay, Chad A Kloefkorn, Jennifer Krall, Margo T Lannan, Cornelia Lane, Cynthia Lanning, Jessica Lyons, William I Mariencheck, Chad R Marion, Matthew A Maslonka, Sara McClintock, Nathaniel M Meier, Matthew C Miles, Peter J Miller, Sophia Mitchell, Wendy C Moore, Katherine Moss, Andrew M Namen, Dustin L Norton, Stella B Ogake, Jill A Ohar, Jessica A Palakshappa, Rodolfo M Pascual, Sandi Pascual, Aaron Pickens, Adam R Schertz, Matt Strong, Alexander O Sy, Braghadheeswar Thyagarajan, Amy Townsend, Russell Worthen, Michael Wlodarski, Charles Yarbrough, Caroline York, Bradley Lloyd, James Dargin, Joanne Wozniak, Christopher Adler, Ahmed Agameya, Michael Colancecco, Daniel Fitelson, Joshua Giaccotto, Gena Han, Louise Kane, Ezra Miller, Timothy Noland, Jaqueline Price, Joseph Plourde, Fraser Mackay, Laura Mahoney, Avignat Patel, Michael Plourde, Zena Saadeh, Sara Shadchehr, Sandeep Somalaraju, Eleanor Summerhill, Ryan Webster, Jordan Winnicki, Ekaterina Yavarovich, Sheetal Gandotra, Anna Altz-Stamm, Cristina Bardita, Mary Clay Boone, Joe W Chiles, Kristina Collins, Abby Drescher, Kevin G Dsouza, Janna Dunn, Stacy Ejem, Josh Gautney, Nicole Harris, Savannah Herder, R Chad Wade, Rutwij Joshi, Daniel Kelmenson, Anne Merrill Mason, Scott R Merriman, Takudzwa Mkorombindo, Jada Nowak, D Sheylan, Lisa Sarratt, Tabitha Stewart, Kadambari Vijaykumar, Gina White, Micah R Whitson, Christopher Barnes, Andrew M Walters, Alejandro C Arroliga, Tasnim Lat, Stephanie Nonas, Milad K Jouzestani, Raya Adi, Chandani Anandkat, Hanae Benchbani, Matthew G Drake, Makrina N Kamel, Ramanpreet Randhawa, Jessica L Tsui

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