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1. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design.

Author

Horwitz, Leora I, Reyes, Luis Felipe1, Horwitz, Leora I, Thaweethai, Tanayott, Brosnahan, Shari B, Cicek, Mine S, Fitzgerald, Megan L, Goldman, Jason D, Hess, Rachel, Hodder, SL, Jacoby, Vanessa L, Jordan, Michael R, Krishnan, Jerry A, Laiyemo, Adeyinka O, Metz, Torri D, Nichols, Lauren, Patzer, Rachel E, Sekar, Anisha, Singer, Nora G, Stiles, Lauren E, Taylor, Barbara S, Ahmed, Shifa, Algren, Heather A, Anglin, Khamal, Aponte-Soto, Lisa, Ashktorab, Hassan, Bassett, Ingrid V, Bedi, Brahmchetna, Bhadelia, Nahid, Bime, Christian, Bind, Marie-Abele C, Black, Lora J, Blomkalns, Andra L, Brim, Hassan, Castro, Mario, Chan, James, Charney, Alexander W, Chen, Benjamin K, Chen, Li Qing, Chen, Peter, Chestek, David, Chibnik, Lori B, Chow, Dominic C, Chu, Helen Y, Clifton, Rebecca G, Collins, Shelby, Costantine, Maged M, Cribbs, Sushma K, Deeks, Steven G, Dickinson, John D, Donohue, Sarah E, Durstenfeld, Matthew S, Emery, Ivette F, Erlandson, Kristine M, Facelli, Julio C, Farah-Abraham, Rachael, Finn, Aloke V, Fischer, Melinda S, Flaherman, Valerie J, Fleurimont, Judes, Fonseca, Vivian, Gallagher, Emily J, Gander, Jennifer C, Gennaro, Maria Laura, Gibson, Kelly S, Go, Minjoung, Goodman, Steven N, Granger, Joey P, Greenway, Frank L, Hafner, John W, Han, Jenny E, Harkins, Michelle S, Hauser, Kristine SP, Heath, James R, Hernandez, Carla R, Ho, On, Hoffman, Matthew K, Hoover, Susan E, Horowitz, Carol R, Hsu, Harvey, Hsue, Priscilla Y, Hughes, Brenna L, Jagannathan, Prasanna, James, Judith A, John, Janice, Jolley, Sarah, Judd, SE, Juskowich, Joy J, Kanjilal, Diane G, Karlson, Elizabeth W, Katz, Stuart D, Kelly, J Daniel, Kelly, Sara W, Kim, Arthur Y, Kirwan, John P, Knox, Kenneth S, Kumar, Andre, Lamendola-Essel, Michelle F, Lanca, Margaret, Lee-Lannotti, Joyce K, Lefebvre, R Craig, Levy, Bruce D, Horwitz, Leora I, Reyes, Luis Felipe1, Horwitz, Leora I, Thaweethai, Tanayott, Brosnahan, Shari B, Cicek, Mine S, Fitzgerald, Megan L, Goldman, Jason D, Hess, Rachel, Hodder, SL, Jacoby, Vanessa L, Jordan, Michael R, Krishnan, Jerry A, Laiyemo, Adeyinka O, Metz, Torri D, Nichols, Lauren, Patzer, Rachel E, Sekar, Anisha, Singer, Nora G, Stiles, Lauren E, Taylor, Barbara S, Ahmed, Shifa, Algren, Heather A, Anglin, Khamal, Aponte-Soto, Lisa, Ashktorab, Hassan, Bassett, Ingrid V, Bedi, Brahmchetna, Bhadelia, Nahid, Bime, Christian, Bind, Marie-Abele C, Black, Lora J, Blomkalns, Andra L, Brim, Hassan, Castro, Mario, Chan, James, Charney, Alexander W, Chen, Benjamin K, Chen, Li Qing, Chen, Peter, Chestek, David, Chibnik, Lori B, Chow, Dominic C, Chu, Helen Y, Clifton, Rebecca G, Collins, Shelby, Costantine, Maged M, Cribbs, Sushma K, Deeks, Steven G, Dickinson, John D, Donohue, Sarah E, Durstenfeld, Matthew S, Emery, Ivette F, Erlandson, Kristine M, Facelli, Julio C, Farah-Abraham, Rachael, Finn, Aloke V, Fischer, Melinda S, Flaherman, Valerie J, Fleurimont, Judes, Fonseca, Vivian, Gallagher, Emily J, Gander, Jennifer C, Gennaro, Maria Laura, Gibson, Kelly S, Go, Minjoung, Goodman, Steven N, Granger, Joey P, Greenway, Frank L, Hafner, John W, Han, Jenny E, Harkins, Michelle S, Hauser, Kristine SP, Heath, James R, Hernandez, Carla R, Ho, On, Hoffman, Matthew K, Hoover, Susan E, Horowitz, Carol R, Hsu, Harvey, Hsue, Priscilla Y, Hughes, Brenna L, Jagannathan, Prasanna, James, Judith A, John, Janice, Jolley, Sarah, Judd, SE, Juskowich, Joy J, Kanjilal, Diane G, Karlson, Elizabeth W, Katz, Stuart D, Kelly, J Daniel, Kelly, Sara W, Kim, Arthur Y, Kirwan, John P, Knox, Kenneth S, Kumar, Andre, Lamendola-Essel, Michelle F, Lanca, Margaret, Lee-Lannotti, Joyce K, Lefebvre, R Craig, and Levy, Bruce D

Abstract

ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC sympto

Published
2023

2. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.

Author

Ortega-Villa, Ana M, Ortega-Villa, Ana M, Hynes, Noreen A, Levine, Corri B, Yang, Katherine, Wiley, Zanthia, Jilg, Nikolaus, Wang, Jing, Whitaker, Jennifer A, Colombo, Christopher J, Nayak, Seema U, Kim, Hannah Jang, Iovine, Nicole M, Ince, Dilek, Cohen, Stuart H, Langer, Adam J, Wortham, Jonathan M, Atmar, Robert L, El Sahly, Hana M, Jain, Mamta K, Mehta, Aneesh K, Wolfe, Cameron R, Gomez, Carlos A, Beresnev, Tatiana, Mularski, Richard A, Paules, Catharine I, Kalil, Andre C, Branche, Angela R, Luetkemeyer, Annie, Zingman, Barry S, Voell, Jocelyn, Whitaker, Michael, Harkins, Michelle S, Davey, Richard T, Grossberg, Robert, George, Sarah L, Tapson, Victor, Short, William R, Ghazaryan, Varduhi, Benson, Constance A, Dodd, Lori E, Sweeney, Daniel A, Tomashek, Kay M, Ortega-Villa, Ana M, Ortega-Villa, Ana M, Hynes, Noreen A, Levine, Corri B, Yang, Katherine, Wiley, Zanthia, Jilg, Nikolaus, Wang, Jing, Whitaker, Jennifer A, Colombo, Christopher J, Nayak, Seema U, Kim, Hannah Jang, Iovine, Nicole M, Ince, Dilek, Cohen, Stuart H, Langer, Adam J, Wortham, Jonathan M, Atmar, Robert L, El Sahly, Hana M, Jain, Mamta K, Mehta, Aneesh K, Wolfe, Cameron R, Gomez, Carlos A, Beresnev, Tatiana, Mularski, Richard A, Paules, Catharine I, Kalil, Andre C, Branche, Angela R, Luetkemeyer, Annie, Zingman, Barry S, Voell, Jocelyn, Whitaker, Michael, Harkins, Michelle S, Davey, Richard T, Grossberg, Robert, George, Sarah L, Tapson, Victor, Short, William R, Ghazaryan, Varduhi, Benson, Constance A, Dodd, Lori E, Sweeney, Daniel A, and Tomashek, Kay M

Abstract

BackgroundClinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined.MethodsWe evaluated the utility of the Centers for Disease Control and Prevention's COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots.ResultsUS ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets.ConclusionsAlthough surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease.

Published
2023

3. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Author

Wolfe, Cameron R, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan LF, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-Don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, Kalil, Andre C, ACTT-4 Study Group, Wolfe, Cameron R, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan LF, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-Don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, Kalil, Andre C, and ACTT-4 Study Group

Abstract

BackgroundBaricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19.MethodsIn this randomised, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites in the USA (60 sites), South Korea (two sites), Mexico (two sites), Singapore (two sites), and Japan (one site). Hospitalised adults (≥18 years) with COVID-19 who required supplemental oxygen administered by low-flow (≤15 L/min), high-flow (>15 L/min), or non-invasive mechanical ventilation modalities who met the study eligibility criteria (male or non-pregnant female adults ≥18 years old with laboratory-confirmed SARS-CoV-2 infection) were enrolled in the study. Patients were randomly assigned (1:1) to receive either baricitinib, remdesivir, and placebo, or dexamethasone, remdesivir, and placebo using a permuted block design. Randomisation was stratified by study site and baseline ordinal score at enrolment. All patients received remdesivir (≤10 days) and either baricitinib (or matching oral placebo) for a maximum of 14 days or dexamethasone (or matching intravenous placebo) for a maximum of 10 days. The primary outcome was the difference in mechanical ventilation-free survival by day 29 between the two treatment groups in the modified intention-to-treat population. Safety analyses were done in the as-treated population, comprising all participants who received one dose of the study drug. The trial is registered with ClinicalTrials.gov, NCT04640168.FindingsBetween Dec 1, 2020, and April 13, 2021, 1047 patients were assessed for eligibility. 1010 patients were enrolled and randomly assigned, 516 (51%) to baricitinib plus remdesivir plus placebo and 494 (49%) to dexamethasone plus remdesivir plus placebo. The mean age of the patient

Published
2022

4. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial.

Author

Wolfe, Cameron R, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan LF, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-Don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, Kalil, Andre C, ACTT-4 Study Group, Wolfe, Cameron R, Wolfe, Cameron R, Tomashek, Kay M, Patterson, Thomas F, Gomez, Carlos A, Marconi, Vincent C, Jain, Mamta K, Yang, Otto O, Paules, Catharine I, Palacios, Guillermo M Ruiz, Grossberg, Robert, Harkins, Michelle S, Mularski, Richard A, Erdmann, Nathaniel, Sandkovsky, Uriel, Almasri, Eyad, Pineda, Justino Regalado, Dretler, Alexandra W, de Castilla, Diego Lopez, Branche, Angela R, Park, Pauline K, Mehta, Aneesh K, Short, William R, McLellan, Susan LF, Kline, Susan, Iovine, Nicole M, El Sahly, Hana M, Doernberg, Sarah B, Oh, Myoung-Don, Huprikar, Nikhil, Hohmann, Elizabeth, Kelley, Colleen F, Holodniy, Mark, Kim, Eu Suk, Sweeney, Daniel A, Finberg, Robert W, Grimes, Kevin A, Maves, Ryan C, Ko, Emily R, Engemann, John J, Taylor, Barbara S, Ponce, Philip O, Larson, LuAnn, Melendez, Dante Paolo, Seibert, Allan M, Rouphael, Nadine G, Strebe, Joslyn, Clark, Jesse L, Julian, Kathleen G, de Leon, Alfredo Ponce, Cardoso, Anabela, de Bono, Stephanie, Atmar, Robert L, Ganesan, Anuradha, Ferreira, Jennifer L, Green, Michelle, Makowski, Mat, Bonnett, Tyler, Beresnev, Tatiana, Ghazaryan, Varduhi, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, Beigel, John H, Kalil, Andre C, and ACTT-4 Study Group

Abstract

BackgroundBaricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19.MethodsIn this randomised, double-blind, double placebo-controlled trial, patients were enrolled at 67 trial sites in the USA (60 sites), South Korea (two sites), Mexico (two sites), Singapore (two sites), and Japan (one site). Hospitalised adults (≥18 years) with COVID-19 who required supplemental oxygen administered by low-flow (≤15 L/min), high-flow (>15 L/min), or non-invasive mechanical ventilation modalities who met the study eligibility criteria (male or non-pregnant female adults ≥18 years old with laboratory-confirmed SARS-CoV-2 infection) were enrolled in the study. Patients were randomly assigned (1:1) to receive either baricitinib, remdesivir, and placebo, or dexamethasone, remdesivir, and placebo using a permuted block design. Randomisation was stratified by study site and baseline ordinal score at enrolment. All patients received remdesivir (≤10 days) and either baricitinib (or matching oral placebo) for a maximum of 14 days or dexamethasone (or matching intravenous placebo) for a maximum of 10 days. The primary outcome was the difference in mechanical ventilation-free survival by day 29 between the two treatment groups in the modified intention-to-treat population. Safety analyses were done in the as-treated population, comprising all participants who received one dose of the study drug. The trial is registered with ClinicalTrials.gov, NCT04640168.FindingsBetween Dec 1, 2020, and April 13, 2021, 1047 patients were assessed for eligibility. 1010 patients were enrolled and randomly assigned, 516 (51%) to baricitinib plus remdesivir plus placebo and 494 (49%) to dexamethasone plus remdesivir plus placebo. The mean age of the patient

Published
2022

5. Wellness and Coping of Physicians Who Worked in ICUs During the Pandemic: A Multicenter Cross-Sectional North American Survey.

Author

Burns, Karen EA, Burns, Karen EA, Moss, Marc, Lorens, Edmund, Jose, Elizabeth Karin Ann, Martin, Claudio M, Viglianti, Elizabeth M, Fox-Robichaud, Alison, Mathews, Kusum S, Akgun, Kathleen, Jain, Snigdha, Gershengorn, Hayley, Mehta, Sangeeta, Han, Jenny E, Martin, Gregory S, Liebler, Janice M, Stapleton, Renee D, Trachuk, Polina, Vranas, Kelly C, Chua, Abigail, Herridge, Margaret S, Tsang, Jennifer LY, Biehl, Michelle, Burnham, Ellen L, Chen, Jen-Ting, Attia, Engi F, Mohamed, Amira, Harkins, Michelle S, Soriano, Sheryll M, Maddux, Aline, West, Julia C, Badke, Andrew R, Bagshaw, Sean M, Binnie, Alexandra, Carlos, W Graham, Çoruh, Başak, Crothers, Kristina, D'Aragon, Frederick, Denson, Joshua Lee, Drover, John W, Eschun, Gregg, Geagea, Anna, Griesdale, Donald, Hadler, Rachel, Hancock, Jennifer, Hasmatali, Jovan, Kaul, Bhavika, Kerlin, Meeta Prasad, Kohn, Rachel, Kutsogiannis, D James, Matson, Scott M, Morris, Peter E, Paunovic, Bojan, Peltan, Ithan D, Piquette, Dominique, Pirzadeh, Mina, Pulchan, Krishna, Schnapp, Lynn M, Sessler, Curtis N, Smith, Heather, Sy, Eric, Thirugnanam, Subarna, McDonald, Rachel K, McPherson, Katie A, Kraft, Monica, Spiegel, Michelle, Dodek, Peter M, Diversity-Related Research Committee of the Women in Critical Care (WICC) Interest Group of the American Thoracic Society, Burns, Karen EA, Burns, Karen EA, Moss, Marc, Lorens, Edmund, Jose, Elizabeth Karin Ann, Martin, Claudio M, Viglianti, Elizabeth M, Fox-Robichaud, Alison, Mathews, Kusum S, Akgun, Kathleen, Jain, Snigdha, Gershengorn, Hayley, Mehta, Sangeeta, Han, Jenny E, Martin, Gregory S, Liebler, Janice M, Stapleton, Renee D, Trachuk, Polina, Vranas, Kelly C, Chua, Abigail, Herridge, Margaret S, Tsang, Jennifer LY, Biehl, Michelle, Burnham, Ellen L, Chen, Jen-Ting, Attia, Engi F, Mohamed, Amira, Harkins, Michelle S, Soriano, Sheryll M, Maddux, Aline, West, Julia C, Badke, Andrew R, Bagshaw, Sean M, Binnie, Alexandra, Carlos, W Graham, Çoruh, Başak, Crothers, Kristina, D'Aragon, Frederick, Denson, Joshua Lee, Drover, John W, Eschun, Gregg, Geagea, Anna, Griesdale, Donald, Hadler, Rachel, Hancock, Jennifer, Hasmatali, Jovan, Kaul, Bhavika, Kerlin, Meeta Prasad, Kohn, Rachel, Kutsogiannis, D James, Matson, Scott M, Morris, Peter E, Paunovic, Bojan, Peltan, Ithan D, Piquette, Dominique, Pirzadeh, Mina, Pulchan, Krishna, Schnapp, Lynn M, Sessler, Curtis N, Smith, Heather, Sy, Eric, Thirugnanam, Subarna, McDonald, Rachel K, McPherson, Katie A, Kraft, Monica, Spiegel, Michelle, Dodek, Peter M, and Diversity-Related Research Committee of the Women in Critical Care (WICC) Interest Group of the American Thoracic Society

Abstract

ObjectivesFew surveys have focused on physician moral distress, burnout, and professional fulfilment. We assessed physician wellness and coping during the COVID-19 pandemic.DesignCross-sectional survey using four validated instruments.SettingSixty-two sites in Canada and the United States.SubjectsAttending physicians (adult, pediatric; intensivist, nonintensivist) who worked in North American ICUs.InterventionNone.Measurements and main resultsWe analysed 431 questionnaires (43.3% response rate) from 25 states and eight provinces. Respondents were predominantly male (229 [55.6%]) and in practice for 11.8 ± 9.8 years. Compared with prepandemic, respondents reported significant intrapandemic increases in days worked/mo, ICU bed occupancy, and self-reported moral distress (240 [56.9%]) and burnout (259 [63.8%]). Of the 10 top-ranked items that incited moral distress, most pertained to regulatory/organizational ( n = 6) or local/institutional ( n = 2) issues or both ( n = 2). Average moral distress (95.6 ± 66.9), professional fulfilment (6.5 ± 2.1), and burnout scores (3.6 ± 2.0) were moderate with 227 physicians (54.6%) meeting burnout criteria. A significant dose-response existed between COVID-19 patient volume and moral distress scores. Physicians who worked more days/mo and more scheduled in-house nightshifts, especially combined with more unscheduled in-house nightshifts, experienced significantly more moral distress. One in five physicians used at least one maladaptive coping strategy. We identified four coping profiles (active/social, avoidant, mixed/ambivalent, infrequent) that were associated with significant differences across all wellness measures.ConclusionsDespite moderate intrapandemic moral distress and burnout, physicians experienced moderate professional fulfilment. However, one in five physicians used at least one maladaptive coping strategy. We highlight potentially modifiable factors at individual, institutional, and regulatory levels to enhance physi

Published
2022

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