Key result
Higher SVI linked to ~90% lower odds of stroke clinical trial enrollment.
Why the study?
Neurological clinical trials often underrepresent diverse populations, and trials seldom capture social determinants of health or their impact on trial recruitment.
Does higher social vulnerability index and older age reduce the odds of enrollment in stroke clinical trials among eligible patients?
Does higher social vulnerability index and older age reduce the odds of enrollment in stroke clinical trials among eligible patients?
Higher social vulnerability and older age are significant barriers to clinical trial enrollment in stroke patients, highlighting the need to address social determinants of health to improve trial generalizability.
Higher SVI was associated with lower stroke trial enrollment; leaves open whether targeted strategies improve representation.
Background: Neurological clinical trials often underrepresent the diversity of those affected.Patients with higher social vulnerability index (SVI), driven by poverty, limited transportation, and crowded housing, may face barriers potentially restricting participation. Additionally,trials seldomly capture social determinants of health (SDOH) or their impact on trial recruitment thereby limiting generalizability of results. Objective: This study seeks to examine how social vulnerability influences trial enrollment and demographic differences amongst eligible patients.We aim to identify potential patterns in declination to enroll in stroke clinical trials to inform strategies for inclusive participation,thereby improving trial access&generalizability. Methods: We retrospectively analyzed patients eligible for a large longitudinal stroke recovery trial (2017-2024), comparing those enrolled(N=283) versus non-enrolled(N=58). Patient’s SVI were derived from 2022 CDC/ATSDR SVI data using ESRI ArcGIS.Rstudio was used for descriptive and inferential analyses like logistic regression on age,race, sex and SVI and Mann Whitney U tests(W) with bootstrapping for 95% confidence interval estimates on age and SVI. Results: Age and SVI were statistically significant predictors of enrollment.Higher SVI reduced enrollment odds (OR=0.10;95%CI [0.01;0.62],(p=0.015)) with enrolled patients demonstrating a statistically significant lower SVI median 0.565 (95%CI,0.5406,0.5730) versus non-enrolled with median SVI 0.692 (95%CI,0.5646,0.7686), with significant group differences (W=6203,p=0.004). Older age also reduced enrollment odds (OR=0.93;95%CI [0.9;0.96],(p<0.001)) with median age 67 amongst enrollees (95%CI,65,69) versus 78.6 amongst non-enrollees (95%CI,74.5,81.5) with statistically significant group differences (W=11137,p<0.0001). While not statistically significant, race and sex were underrepresented when compared to national and local inpatient ischemic stroke demographics amongst Black and female patients. Conclusion: Older age and higher SVI negatively impacted enrollment of eligible patients in this small longitudinal stroke recovery clinical trial,highlighting underrecruitment of disadvantaged populations. SDOH, while rarely captured in trials, pose barriers to participation thus prospectively incorporating them into future studies can facilitate targeted recruitment and retention thus critically promoting equitable participation and enhancing trial accuracy and generalizability.
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Le et al. (2026) studied this question. Higher social vulnerability index (SVI) reduced enrollment odds in stroke clinical trials (OR=0.10) compared to those with lower SVI.
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