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Racial and ethnic minority participants in clinical trials of acute respiratory distress syndrome.
Pubmed ID: 37847403
Pubmed Central ID: PMC10709247
Journal: Intensive care medicine
Publication Date: Dec. 1, 2023
Affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Weill Cornell Medicine, New York, NY, USA. isiempos@yahoo.com.
MeSH Terms: Humans, United States, Randomized Controlled Trials as Topic, Oxygen, Respiratory Distress Syndrome, Ethnicity, Ethnic and Racial Minorities, Minority Groups
Grants: 80- 1/15.10.2020
Authors: Siempos II, Kotanidou A, Papoutsi E, Routsi C, Kremmydas P, Tsolaki V, Kyriakoudi A
Cite As: Papoutsi E, Kremmydas P, Tsolaki V, Kyriakoudi A, Routsi C, Kotanidou A, Siempos II. Racial and ethnic minority participants in clinical trials of acute respiratory distress syndrome. Intensive Care Med 2023 Dec;49(12):1479-1488. Epub 2023 Oct 17.
Studies:
- Acute Respiratory Distress Network (ARDSNet) Studies 01 and 03 Lower versus higher tidal volume, ketoconazole treatment and lisofylline treatment (ARMA/KARMA/LARMA)
- Acute Respiratory Distress Network (ARDSNet) Studies 06 and 08 Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo for the Treatment of Acute Lung Injury (ALTA)
- Acute Respiratory Distress Network (ARDSNet) Studies 07, 08, 09, 11, and 12 Early Versus Delayed Enteral Feeding to Treat People with Acute Lung Injury or Acute Respiratory Distress Syndrome (EDEN)
- Acute Respiratory Distress Network (ARDSNet) Studies 10 and 12 Statins for Acutely Injured Lungs from Sepsis (SAILS)
- Acute Respiratory Distress Network (ARDSNet) Study 04 Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury (ALVEOLI)
- Acute Respiratory Distress Network (ARDSNet) Study 05 Fluid and Catheter Treatment Trial (FACTT)
- Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)
- Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET)
Abstract
PURPOSE: There is growing interest in improving the inclusiveness of racial and ethnic minority participants in trials of acute respiratory distress syndrome (ARDS). With our study we aimed to examine temporal trends of representation and mortality of racial and ethnic minority participants in randomized controlled trials of ARDS. METHODS: We performed a secondary analysis of eight ARDS Network and PETAL Network therapeutic clinical trials, published between 2000 and 2019. We classified race/ethnicity into "White", "Black", "Hispanic", or "Other" (including Asian, American Indian or Alaskan Native, Native Hawaiian, or other Pacific Islander participants). RESULTS: Of 5375 participants with ARDS, 1634 (30.4%) were Black, Hispanic, or Other race participants. Representation of racial and ethnic minority participants in trials did not change significantly over time (p = 0.257). However, among participants with moderate to severe ARDS (i.e., partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 150), the difference in mortality between racial and ethnic minority participants and White participants decreased over time. In the five most recent trials, including 2923 participants with ARDS, there were no statistically significant differences in mortality between racial/ethnic groups, even after adjusting for potential confounders. In these five most recent trials, mortality was 31% for White, 31.9% for Black, 30.3% for Hispanic, and 37.1% for Other race participants (p = 0.633). CONCLUSION: Representation of racial and ethnic minority participants in ARDS trials from North America, published between 2000 and 2019, did not change over time. Black and Hispanic participants with ARDS may have similar mortality as White participants within trials.