To promote health equity within the field of trauma and injury treatment, clinical trials should strive for unbiased representation.

Methods

A systematic review of randomized clinical trials recruiting US adults for trauma and injury treatment, and initiated between 2008 and 2019, was performed using four databases: Medline, Embase, Central, and the US Clinical Trial registry. The Cochrane Handbook of Systematic Reviews of Interventions and PRISMA guidelines were used to identify trials. Meta-analyses were performed to obtain summary proportions and 95% confidence intervals (CI) of gender, ethnicity, and race groups. Summary proportions were compared with the corresponding Census proportions based on the 2010 US Census.

Results

The systematic review identified 56 trials (total participants, n=9125). All trials reported gender, 23% reported ethnicity (13 trials), and 39% reported race (22 trials). The female proportion (35.5%, 95% CI 27.8-43.6) was lower than Census proportion (51.5%, p<0.001). The proportions of Hispanics (12.9%, 95% CI 2.5-29.5), blacks (20.0%, 95% CI 9.0-33.4), and whites (76.9%, 95% CI 63.2-88.3) were similar to Census proportions (14.2%; 13.9%; 79.8%). Proportions of American Indians (0.00%, 95% CI 0.00-0.14), Asians (0.01%, 95% CI 0.00-0.16), and multiracial individuals (0.18%, 95% CI 0.01-0.57) were lower than Census proportions (1.1%, p=0.030; 5.0%, p<0.001; 1.6%, p<0.001). The proportion of Native Hawaiians and Pacific Islanders (1.2%, 95% CI 0.7-2.1) was higher than Census proportion (0.2%, p<0.001).

Conclusion

These results highlight recruitment disparities in trials relating to trauma and injury treatment. Overall, clinical trials may not reflect the demographics of the populations sought to be served.