Representation of Hispanic Patients in Clinical Trials for Respiratory Failure: A Systematic Review

Hispanic individuals comprise one-fifth of the U.S. population and Hispanic patients with acute hypoxemic respiratory failure (AHRF) experience higher odds of death compared with non-Hispanic White patients. Representation of Hispanic patients in clinical trials for respiratory failure is critical to address this inequity. We conducted a systematic review to examine the inclusion of Hispanic patients in randomized controlled trials for AHRF and assessed language as a potential barrier to enrollment.

National Library of Medicine PubMed, Elsevier Embase, and Cochrane Central Register of Controlled Trials databases through January 2024.

Randomized controlled trials assessing AHRF interventions enrolling U.S. patients receiving mechanical ventilation, noninvasive mechanical ventilation, or high-flow nasal cannula were included. The systematic review was registered prospectively through PROSPERO (CRD42023437828).

Two authors independently screened studies and extracted data for each included study.

Ninety-four trials published from 1975 to 2023 were included; 33.0% (n = 31) of studies reported ethnicity, and 11.2% of participants in studies reporting race or ethnicity (1,320/11,780) were identified as Hispanic. The proportion of Hispanic-identified participants was significantly lower than the U.S. Hispanic population from 1996 to 2019 (p < 0.01). Starting in 2020, the proportion of Hispanic-identified participants was significantly higher than the U.S. population (27.8% vs. 19.1%; p < 0.01). Two studies (4.9%) reporting race or ethnicity excluded non-English speaking participants; the remainder did not specify language requirements for enrollment.

Hispanic-identified individuals were underrepresented in trials for AHRF until 2020 when Hispanic patient representation increased during COVID-19. Exclusion of participants who do not speak English may represent a barrier to trial enrollment.