Association between Study Factors and Enrollment by Race/Ethnicity in Pediatric Acute Care Research
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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
pediatric acute care research
enrollment by race and ethnicity
disparities in healthcare
clinical trials
diverse populations


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