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

Objectives: 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.

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

Study selection: 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).

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

Data synthesis: 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.

Conclusions: 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.