Disparities in Stroke Clinical Trial Enrollment by Geographic Social Vulnerability
Mahnoor Islam1, Alexander Vorobyev1, Todd LeMatty1, Caitlan LeMatty1, Christine Holmstedt1
1Medical University of South Carolina
Objective:
To quantify disparities in stroke clinical trial enrollment by geographic social vulnerability within South Carolina (SC).
Background:
Geographic marginalization may limit the access of vulnerable populations to practice-changing treatments available through clinical trials, even in regions with a high stroke burden.
Design/Methods:
Patient demographic data (zip code, race/ethnicity, sex) were obtained from the participating institute’s trial database for 5 multicenter clinical trials assessing interventions for the prevention/treatment of acute ischemic stroke. Using the CDC/ATSDR SVI database, each SC county was assigned a level on the social vulnerability index (SVI) among “high,” “medium-high,” “low-medium,” and “low.” The yearly numbers of hospital discharges for stroke patients from each county were extracted from the SC Revenue and Fiscal Affairs Office database – we then compared the proportion of trial participants enrolled at each SVI level (among all trial participants) to the proportion of hospitalized patients from the respective counties (among all counties), calculated as the enrollment-hospitalization ratio (EHR).
Results:
Among 79 trial participants, only 6 (7.59%) were enrolled from high-SVI counties. Fifty-four participants (68.35%) originated from low-SVI counties, 11 (13.92%) from low-medium-SVI counties, and 8 (10.13%) from medium-high-SVI counties. The proportion of Black participants remained consistent within the high-SVI (n=2; 33.3%) and low-SVI (n=17; 31.5%) groups, as did the proportion of women (n=3; 50.0% in high-SVI counties vs. n=26; 48.1% in low-SVI counties). No Hispanic patients were enrolled from any county. Comparing enrollment with hospitalization, patients from low-SVI counties were over-enrolled across all years (EHR: 1.48 in 2016-2017, 1.44 in 2018-2019, 1.95 in 2020-2021; 1.31 in 2022-2024). Patients from high-SVI counties were initially over-enrolled compared with hospitalization (EHR: 2.87 in 2016-2017), however, this decreased sharply in 2018-2019 (EHR: 0.64) and 2020-2021 (EHR: 0.0), and increased again in 2022-2024 (EHR: 1.40).
Conclusions:
Recruitment from regions with high social vulnerability lags behind in stroke clinical trials.
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