• Intensive care medicine · Dec 2023

    Racial and ethnic minority participants in clinical trials of acute respiratory distress syndrome.

    • Eleni Papoutsi, Panagiotis Kremmydas, Vasiliki Tsolaki, Anna Kyriakoudi, Christina Routsi, Anastasia Kotanidou, and Ilias I Siempos.
    • First Department of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, National and Kapodistrian University of Athens Medical School, 45-47 Ipsilantou Street, 10676, Athens, Greece.
    • Intensive Care Med. 2023 Dec 1; 49 (12): 147914881479-1488.

    PurposeThere 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.MethodsWe 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).ResultsOf 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).ConclusionRepresentation 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.© 2023. The Author(s).

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