SCCM Resource Library-Association between Study Factors and Enrollment by Race/Ethnicity in Pediatric Acute Care Research

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Video Summary

Dr. Erin Paquette, a pediatric intensivist at the Ann and Robert H. Lurie Children's Hospital of Chicago, discusses her research on the association between study level factors and enrollment by race and ethnicity in pediatric acute care research. The aim of the research is to ensure that minority children are proportionally represented in research to avoid disparities in healthcare. The study found that enrollment in clinical trials is not randomly distributed by race and ethnicity, and there are various factors that contribute to differential enrollment. The findings highlight the need for prospective evaluation and interventions to improve enrollment of diverse populations in pediatric research. Further research will involve a mixed methods approach to better understand the reasons for enrollment decisions and develop interventions to address the issue.

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Pediatrics, Quality and Patient Safety, Research, 2022

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INTRODUCTION: The pediatric literature shows under- and over- representation of diverse groups in research based on participant factors such as race/ethnicity (R/E). R/E is a social construct acting as a proxy for social factors underlying such associations. We hypothesize that study factors correlate with differential enrollment of Black v White participants (BP v WP) and Hispanic v White participants (HP v WP). METHODS: Retrospective review of enrollment in 2 pediatric trials networks. Study factors included: consent mechanism (CM) (written/assent/verbal/waiver); study type (ST) (interventional/observational); study procedures (SP) (blood draw/genetic information/study drug/survey/chart review/other); recruitment site (RS) (ED/PICU). Models accounting for clustering of participants in studies estimated odds ratios (OR, 95% confidence interval) for enrolling BP v WP and HP v WP by study factor. Multivariable analysis included significant factors. RESULTS: 63434 enrolled participants were evaluated in 8 studies. Factors associated with having enrolled a BP v WP (p < 0.0001 unless stated) were CM (written OR 0.70, 0.62-0.79; assent OR 0.65, 0.57-0.75; verbal OR 1.48, 1.27-1.72; waiver OR 1.39; 1.24-1.57); ST (observational OR 1.46, 1.21-1.75) & SP (Blood draw OR 0.72, 0.64-0.81; genetic information OR 0.73, 0.65-0.82; study drug OR 0.75, 0.65-0.86; survey OR 1.38, 1.23-1.55; chart review OR 1.53, 1.33-1.77; other OR 1.41, 1.25-1.59) & RS (PICU OR 0.69, 0.54-0.71). On multivariable analysis, CM (written OR 0.724, 0.653-0.80) and SP (blood draw OR 1.21, 1.09-1.36, p = 0.0006) remained significant. Factors associated with having enrolled a HP v WP included CM (written OR 2.36, 1.855-3.003); waiver OR 0.4; 0.35-0.45); ST (observational OR 0.69, 0.50-0.95, p = 0.02) & SP (blood draw OR 2.52, 2.23-2.86; genetic information OR 2.60, 2.4-2.82; survey OR 0.40, 0.35-0.47; other OR 0.43, 0.33-0.55). On multivariable analysis, CM (written OR 1.771, 1.60-1.96) remained significant. CONCLUSION: Study factors correlate with differential enrollment by R/E in pediatric multisite studies. This may reflect participant preferences, implicit bias or systemic racism. Prospective work could clarify the relationship between social and study-level factors affecting enrollment and identify opportunities to mitigate bias and systemic racism.

Meta Tag

Content Type Presentation

Knowledge Area Pediatrics

Knowledge Area Quality and Patient Safety

Knowledge Area Research

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Tag Pediatrics

Tag Evidence Based Medicine

Tag Outcomes Research

Year 2022

Keywords

pediatric acute care research

enrollment by race and ethnicity

disparities in healthcare

clinical trials

diverse populations

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