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1. Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans

Author

Chen, Jason I., Bui, David, Iwashyna, Theodore J., Shahoumian, Troy A., Hickok, Alex, Shepherd-Banigan, Megan, Hawkins, Eric J., Naylor, Jennifer, Govier, Diana J., Osborne, Thomas F., Smith, Valerie A., Bowling, C. Barrett, Boyko, Edward J., Ioannou, George N., Maciejewski, Matthew L., O’Hare, Ann M., Viglianti, Elizabeth M., Bohnert, Amy S.-B., and Hynes, Denise M.

Published
2024
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3. Risk of Suicide-Related Outcomes After SARS-COV-2 Infection: Results from a Nationwide Observational Matched Cohort of US Veterans

Author

Hynes, Denise M., Niederhausen, Meike, Chen, Jason I., Shahoumian, Troy A., Rowneki, Mazhgan, Hickok, Alex, Shepherd-Banigan, Megan, Hawkins, Eric J., Naylor, Jennifer, Teo, Alan, Govier, Diana J., Berry, Kristin, McCready, Holly, Osborne, Thomas F., Wong, Edwin, Hebert, Paul L., Smith, Valerie A., Bowling, C. Barrett, Boyko, Edward J., Ioannou, George N., Iwashyna, Theodore J., Maciejewski, Matthew L., O’Hare, Ann M., Viglianti, Elizabeth M., and Bohnert, Amy S.-B.

Published
2024
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4. Effectiveness of COVID-19 Treatment With Nirmatrelvir-Ritonavir or Molnupiravir Among U.S. Veterans: Target Trial Emulation Studies With One-Month and Six-Month Outcomes.

Author

Bajema, Kristina L, Berry, Kristin, Streja, Elani, Rajeevan, Nallakkandi, Li, Yuli, Mutalik, Pradeep, Yan, Lei, Cunningham, Francesca, Hynes, Denise M, Rowneki, Mazhgan, Bohnert, Amy, Boyko, Edward J, Iwashyna, Theodore J, Maciejewski, Matthew L, Osborne, Thomas F, Viglianti, Elizabeth M, Aslan, Mihaela, Huang, Grant D, and Ioannou, George N

Subjects
Humans, Ritonavir, Antiviral Agents, Retrospective Studies, Aged, Veterans, Female, Male, COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Drug Treatment, Clinical Research, Clinical Trials and Supportive Activities, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundInformation about the effectiveness of oral antivirals in preventing short- and long-term COVID-19-related outcomes in the setting of Omicron variant transmission and COVID-19 vaccination is limited.ObjectiveTo measure the effectiveness of nirmatrelvir-ritonavir and molnupiravir for outpatient treatment of COVID-19.DesignThree retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir-ritonavir versus molnupiravir.SettingVeterans Health Administration (VHA).ParticipantsNonhospitalized veterans in VHA care who were at risk for severe COVID-19 and tested positive for SARS-CoV-2 during January through July 2022.InterventionNirmatrelvir-ritonavir or molnupiravir pharmacotherapy.MeasurementsIncidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days.ResultsEighty-seven percent of participants were male; the median age was 66 years, and 18% were unvaccinated. Compared with matched untreated control participants, those treated with nirmatrelvir-ritonavir (n = 9607) had lower 30-day risk for hospitalization (22.07 vs. 30.32 per 1000 participants; risk difference [RD], -8.25 [95% CI, -12.27 to -4.23] per 1000 participants) and death (1.25 vs. 5.47 per 1000 participants; RD, -4.22 [CI, -5.45 to -3.00] per 1000 participants). Among persons alive at day 31, reductions were seen in 31- to 180-day incidence of death (hazard ratio, 0.66 [CI, 0.49 to 0.89]) but not hospitalization (subhazard ratio, 0.90 [CI, 0.79 to 1.02]). Molnupiravir-treated participants (n = 3504) had lower 30-day and 31- to 180-day risks for death (3.14 vs. 13.56 per 1000 participants at 30 days; RD, -10.42 [CI, -13.49 to -7.35] per 1000 participants; hazard ratio at 31 to 180 days, 0.67 [CI, 0.48 to 0.95]) but not hospitalization. A difference in 30-day or 31- to 180-day risk for hospitalization or death was not observed between matched nirmatrelvir- or molnupiravir-treated participants.LimitationThe date of COVID-19 symptom onset for most veterans was unknown.ConclusionNirmatrelvir-ritonavir was effective in reducing 30-day hospitalization and death. Molnupiravir was associated with a benefit for 30-day mortality but not hospitalization. Further reductions in mortality from 31 to 180 days were observed with both antivirals.Primary funding sourceU.S. Department of Veterans Affairs.

Published
2023

5. Correction to: Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans

Author

Chen, Jason I., Bui, David, Iwashyna, Theodore J., Shahoumian, Troy A., Hickok, Alex, Shepherd-Banigan, Megan, Hawkins, Eric J., Naylor, Jennifer, Govier, Diana J., Osborne, Thomas F., Smith, Valerie A., Bowling, C. Barrett, Boyko, Edward J., Ioannou, George N., Maciejewski, Matthew L., O’Hare, Ann M., Viglianti, Elizabeth M., Bohnert, Amy S.-B., and Hynes, Denise M.

Published
2024
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11. Correction: Design and analysis of outcomes following SARS-CoV-2 infection in veterans

Author

Smith, Valerie A., Berkowitz, Theodore S. Z., Hebert, Paul, Wong, Edwin S., Niederhausen, Meike, Pura, John A., Berry, Kristin, Green, Pamela, Korpak, Anna, Fox, Alexandra, Baraff, Aaron, Hickok, Alex, Shahoumian, Troy A, Bohnert, Amy S.B., Hynes, Denise M., Boyko, Edward J., Ioannou, George N., Iwashyna, Theodore J., Bowling, C. Barrett, O’Hare, Ann M., and Maciejewski, Matthew L.

Published
2023
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12. Design and analysis of outcomes following SARS-CoV-2 infection in veterans

Author

Smith, Valerie A., Berkowitz, Theodore S. Z., Hebert, Paul, Wong, Edwin S., Niederhausen, Meike, Pura, John A., Berry, Kristin, Green, Pamela, Korpak, Anna, Fox, Alexandra, Baraff, Aaron, Hickok, Alex, Shahoumian, Troy A, Bohnert, Amy S.B., Hynes, Denise M., Boyko, Edward J., Ioannou, George N., Iwashyna, Theodore J., Bowling, C. Barrett, O’Hare, Ann M., and Maciejewski, Matthew L.

Published
2023
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18. Regional Variation in Financial Hardship Among US Veterans During the COVID-19 Pandemic

Author

Hauschildt, Katrina E, primary, Bui, David P, additional, Govier, Diana J, additional, Eaton, Tammy L, additional, Viglianti, Elizabeth M, additional, Ettman, Catherine K, additional, McCready, Holly, additional, Smith, Valerie A, additional, O’Hare, Ann M, additional, Osborne, Thomas F, additional, Boyko, Edward J, additional, Ioannou, George N, additional, Maciejewski, Matthew L, additional, Bohnert, Amy S-B, additional, Hynes, Denise M, additional, and Iwashyna, Theodore J, additional

Published
2024
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20. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

Author

Moss, Marc, Huang, David T, Brower, Roy G, Ferguson, Niall D, Ginde, Adit A, Gong, MN, Grissom, Colin K, Gundel, Stephanie, Hayden, Douglas, Hite, R Duncan, Hou, Peter C, Hough, Catherine L, Iwashyna, Theodore J, Khan, Akram, Liu, Kathleen D, Talmor, Daniel, Thompson, B Taylor, Ulysse, Christine A, Yealy, Donald M, and Angus, Derek C

Subjects
Clinical Research, Lung, Bioengineering, Cardiovascular, Acute Respiratory Distress Syndrome, Rare Diseases, Clinical Trials and Supportive Activities, Respiratory, Good Health and Well Being, Adult, Aged, Atracurium, Combined Modality Therapy, Conscious Sedation, Female, Hospital Mortality, Humans, Male, Middle Aged, Neuromuscular Blockade, Neuromuscular Blocking Agents, Positive-Pressure Respiration, Respiratory Distress Syndrome, Treatment Failure, National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.MethodsWe randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of

Published
2019

21. 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

22. The impact of distance on post-ICU disability

Author

D'Arcy, Jack, Haines, Kimberley, Paul, Eldho, Doherty, Zakary, Goodwin, Andrew, Bailey, Michael, Barrett, Jonathan, Bellomo, Rinaldo, Bucknall, Tracey, Gabbe, Belinda J., Higgins, Alisa M., Iwashyna, Theodore J., Murray, Lynne J., Myles, Paul S., Ponsford, Jennie, Pilcher, David, Udy, Andrew A., Walker, Craig, Young, Meredith, Cooper, D.J. (Jamie), and Hodgson, Carol L.

Published
2022
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28. Recovery after critical illness: putting the puzzle together-a consensus of 29.

Author

Azoulay, Elie, Vincent, Jean-Louis, Angus, Derek C, Arabi, Yaseen M, Brochard, Laurent, Brett, Stephen J, Citerio, Giuseppe, Cook, Deborah J, Curtis, Jared Randall, Dos Santos, Claudia C, Ely, E Wesley, Hall, Jesse, Halpern, Scott D, Hart, Nicholas, Hopkins, Ramona O, Iwashyna, Theodore J, Jaber, Samir, Latronico, Nicola, Mehta, Sangeeta, Needham, Dale M, Nelson, Judith, Puntillo, Kathleen, Quintel, Michael, Rowan, Kathy, Rubenfeld, Gordon, Van den Berghe, Greet, Van der Hoeven, Johannes, Wunsch, Hannah, and Herridge, Margaret

Subjects
Humans, Delirium, Critical Illness, Respiration, Artificial, Length of Stay, Consensus, Time Factors, Intensive Care Units, Deep Sedation, Pain Management, Long Term Adverse Effects, Cognitive dysfunction, Depression, Intensive care, Mechanical ventilation, Muscular disorder, Sedation, Traumatic stress, Weakness, Respiration, Artificial, Medical and Health Sciences, Emergency & Critical Care Medicine
Abstract

In this review, we seek to highlight how critical illness and critical care affect longer-term outcomes, to underline the contribution of ICU delirium to cognitive dysfunction several months after ICU discharge, to give new insights into ICU acquired weakness, to emphasize the importance of value-based healthcare, and to delineate the elements of family-centered care. This consensus of 29 also provides a perspective and a research agenda about post-ICU recovery.

Published
2017

31. In-person peer support for critical care survivors: The ICU REcovery Solutions cO-Led through surVivor Engagement (ICURESOLVE) pilot randomised controlled trial

Author

Haines, Kimberley J., primary, Hibbert, Elizabeth, additional, Skinner, Elizabeth H., additional, Leggett, Nina, additional, Holdsworth, Clare, additional, Ali Abdelhamid, Yasmine, additional, Bates, Samantha, additional, Bicknell, Erin, additional, Booth, Sarah, additional, Carmody, Jacki, additional, Deane, Adam M., additional, Emery, Kate, additional, Farley, K.J., additional, French, Craig, additional, Krol, Lauren, additional, MacLeod-Smith, Belinda, additional, Maher, Lynne, additional, Paykel, Melanie, additional, and Iwashyna, Theodore J., additional

Published
2024
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34. Patient and Caregiver-Derived Health Service Improvements for Better Critical Care Recovery

Author

Haines, Kimberley J., Leggett, Nina, Hibbert, Elizabeth, Hall, Tarli, Boehm, Leanne M., Bakhru, Rita N., Bastin, Anthony J., Butcher, Brad W., Eaton, Tammy L., Harris, Wendy, Hope, Aluko A., Jackson, James, Johnson, Annie, Kloos, Janet A., Korzick, Karen A., Mactavish, Pamela, Meyer, Joel, Montgomery-Yates, Ashley, Quasim, Tara, Slack, Andrew, Wade, Dorothy, Still, Mary, Netzer, Giora, Hopkins, Ramona O., Mikkelsen, Mark E., Iwashyna, Theodore J., McPeake, Joanne, and Sevin, Carla M.

Published
2022
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36. Deep learning to detect acute respiratory distress syndrome on chest radiographs: a retrospective study with external validation

Author

Sjoding, Michael W, Taylor, Daniel, Motyka, Jonathan, Lee, Elizabeth, Co, Ivan, Claar, Dru, McSparron, Jakob I, Ansari, Sardar, Kerlin, Meeta Prasad, Reilly, John P, Shashaty, Michael G S, Anderson, Brian J, Jones, Tiffanie K, Drebin, Harrison M, Ittner, Caroline A G, Meyer, Nuala J, Iwashyna, Theodore J, Ward, Kevin R, and Gillies, Christopher E

Published
2021
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38. Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome.

Author

Huang, David T, Angus, Derek C, Moss, Marc, Thompson, B Taylor, Ferguson, Niall D, Ginde, Adit, Gong, Michelle Ng, Gundel, Stephanie, Hayden, Douglas L, Hite, R Duncan, Hou, Peter C, Hough, Catherine L, Iwashyna, Theodore J, Liu, Kathleen D, Talmor, Daniel S, Yealy, Donald M, and Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators

Subjects
Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators, Humans, Respiratory Distress Syndrome, Adult, Atracurium, Neuromuscular Blocking Agents, Respiration, Artificial, Positive-Pressure Respiration, Neuromuscular Blockade, Mortality, Cause of Death, Feasibility Studies, Mental Recall, Muscle Strength, adult, clinical trial, interdisciplinary communication, methods, respiratory distress syndrome, Respiratory Distress Syndrome, Rare Diseases, Clinical Research, Patient Safety, Prevention, Clinical Trials and Supportive Activities, Lung, Acute Respiratory Distress Syndrome, Respiratory
Abstract

The Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial is a multicenter, randomized trial designed to assess the efficacy and safety of early neuromuscular blockade in patients with moderate to severe acute respiratory distress syndrome. This document provides background for interpretation of the trial results, and highlights unique design approaches that may inform future trials of acute illness. We describe the process by which ROSE was chosen as the inaugural trial of the multidisciplinary Prevention and Early Treatment of Acute Lung Injury Network, provide the trial methodology using the Consolidated Standards of Reporting Trials framework, and discuss key design challenges and their resolution. Four key design issues proved challenging-feasibility, choice of sedation depth in the control group, impact of emphasizing early treatment on enrollment criteria and protocol execution, and choice of positive end-expiratory pressure strategy. We used literature, an iterative consensus model, and internal surveys of current practice to inform design choice. ROSE will provide definitive, Consolidated Standards of Reporting Trials adherent data on early neuromuscular blockade for future patients with acute respiratory distress syndrome. Our multidisciplinary approach to trial design may be of use to other trials of acute illness. Clinical trial registered with www.clinicaltrials.gov (NCT02509078).

Published
2017

42. Tackling Brain and Muscle Dysfunction in Acute Respiratory Distress Syndrome Survivors: NHLBI Workshop Report.

Author

Palakshappa, Jessica A., Batt, Jane A. E., Bodine, Sue C., Connolly, Bronwen A., Doles, Jason, Falvey, Jason R., Ferrante, Lauren E., Files, D. Clark, Harhay, Michael O., Harrell, Kirsten, Hippensteel, Joseph A., Iwashyna, Theodore J., Jackson, James C., Lane-Fall, Meghan B., Monje, Michelle, Moss, Marc, Needham, Dale M., Semler, Matthew W., Lahiri, Shouri, and Larsson, Lars

Subjects
ADULT respiratory distress syndrome, RESPIRATORY distress syndrome
Abstract

Acute respiratory distress syndrome (ARDS) is associated with long-term impairments in brain and muscle function that significantly impact the quality of life of those who survive the acute illness. The mechanisms underlying these impairments are not yet well understood, and evidence-based interventions to minimize the burden on patients remain unproved. The NHLBI of the NIH assembled a workshop in April 2023 to review the state of the science regarding ARDS-associated brain and muscle dysfunction, to identify gaps in current knowledge, and to determine priorities for future investigation. The workshop included presentations by scientific leaders across the translational science spectrum and was open to the public as well as the scientific community. This report describes the themes discussed at the workshop as well as recommendations to advance the field toward the goal of improving the health and well-being of ARDS survivors. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Rural–Urban Differences in Mortality among Mechanically Ventilated Patients in Intensive and Intermediate Care.

Author

Harlan, Emily A., Venkatesh, Shrathinth, Morrison, Jean, Cooke, Colin R., Iwashyna, Theodore J., Ford, Dee W., Moscovice, Ira S., Sjoding, Michael W., and Valley, Thomas S.

Subjects
INTENSIVE care patients, RURAL-urban differences, INTERMEDIATE care, INTENSIVE care units, URBAN hospitals
Abstract

Rationale: Intermediate care (also termed "step-down" or "moderate care") has been proposed as a lower cost alternative to care for patients who may not clearly benefit from intensive care unit admission. Intermediate care units may be appealing to hospitals in financial crisis, including those in rural areas. Outcomes of patients receiving intermediate care are not widely described. Objectives: To examine relationships among rurality, location of care, and mortality for mechanically ventilated patients. Methods: Medicare beneficiaries aged 65 years and older who received invasive mechanical ventilation between 2010 and 2019 were included. Multivariable logistic regression was used to estimate the association between admission to a rural or an urban hospital and 30-day mortality, with separate analyses for patients in general, intermediate, and intensive care. Models were adjusted for age, sex, area deprivation index, primary diagnosis, severity of illness, year, comorbidities, and hospital volume. Results: There were 2,752,492 hospitalizations for patients receiving mechanical ventilation from 2010 to 2019, and 193,745 patients (7.0%) were in rural hospitals. The proportion of patients in rural intermediate care increased from 4.1% in 2010 to 6.3% in 2019. Patient admissions to urban hospitals remained relatively stable. Patients in rural and urban intensive care units had similar adjusted 30-day mortality, at 46.7% (adjusted absolute risk difference −0.1% [95% confidence interval, −0.7% to 0.6%]; P = 0.88). However, adjusted 30-day mortality for patients in rural intermediate care was significantly higher (36.9%) than for patients in urban intermediate care (31.3%) (adjusted absolute risk difference 5.6% [95% confidence interval, 3.7% to 7.6%]; P < 0.001). Conclusions: Hospitalization in rural intermediate care was associated with increased mortality. There is a need to better understand how intermediate care is used across hospitals and to carefully evaluate the types of patients admitted to intermediate care units. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Rates of ICD-10 Code U09.9 Documentation and Clinical Characteristics of VA Patients With Post–COVID-19 Condition

Author

Wander, Pandora L., primary, Baraff, Aaron, additional, Fox, Alexandra, additional, Cho, Kelly, additional, Maripuri, Monika, additional, Honerlaw, Jacqueline P., additional, Ho, Yuk-Lam, additional, Dey, Andrew T., additional, O’Hare, Ann M., additional, Bohnert, Amy S. B., additional, Boyko, Edward J., additional, Maciejewski, Matthew L., additional, Viglianti, Elizabeth, additional, Iwashyna, Theodore J., additional, Hynes, Denise M., additional, Osborne, Thomas F., additional, and Ioannou, George N., additional

Published
2023
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