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Identifying Disparities in the Racial and Ethnic Representation of Patients Enrolled in Breast Reconstruction-Related Clinical Trials
Raeesa Kabir
*6, Michael Hernandez
6, Bryan Torres
2, Maheen F. Akhter
3, Elizabeth A. Cox
4, Lauren Powell
1, Rahim Nazerali
4, Clifford C. Sheckter
4, Haripriya Ayyala
51Division of Plastic and Reconstructive Surgery, University of Minnesota Medical School, Minneapolis, MN; 2Tulane University School of Medicine, New Orleans, LA; 3Central Michigan University College of Medicine, Saginaw, MI; 4Division of Plastic and Reconstructive Surgery, Stanford University School of Medicine, Stanford, CA; 5Division of Plastic and Reconstructive Surgery, Yale University, New Haven, CT; 6University of Minnesota Medical School, Minneapolis, MN
Background: Inadequately recorded race and ethnicity data in breast reconstruction-related clinical trials (BRRCT) suggests that studies may inaccurately represent the US population. Disproportionately high enrollment of white patients may also skew results. Clinical trials that reflect the racial makeup of the US population is fundamental in improving breast reconstruction accessibility and outcomes. We aim to 1) evaluate race and ethnicity reporting in BRRCT and 2) determine whether reported race/ethnicity are reflective of US populations.
Methods: All completed, US-based BRRCTs were retrospectively reviewed via clinicaltrials.gov in February 2024. Age, race, ethnicity, and BRRCT funding source were collected. Enrollment rates were compared to US Census Bureau race and ethnicity data for 2022. Descriptive statistics and univariate analyses were performed.
Results: Twenty-five studies representing 2,432 patients were included. The mean age of enrollees was 49.4 ± 2.2 years. Seven (27.0%) reported enrollees' race, and five (19.2%) reported both race and ethnicity. Most enrollees were white (90.8%), followed by black (3.4%) and Asian (1.5%). Native Hawaiian/Pacific Islander patients were not represented in any studies. Fewer enrollees identified as Hispanic/Latino than non-Hispanic/Latino (4.5% vs 54.0%, p=0.02). Enrollment rates of minority groups were lower than their respective US census estimates (black: 3.5% vs 13.6%, p<0.05; Asian: 1.5% vs 6.3%, p<0.05). No such differences were found among white enrollees (90.8% vs 75.5%; p=0.12). Similar disparities were observed among Hispanic/Latino enrollees (4.51% vs 19.1%, p<0.05). BRRCTs' reporting of race did not vary by source of funding.
Conclusion: Over 70% of BRRCTs did not report race or ethnicity of enrollees. When reported, racial and ethnic minorities were significantly underrepresented in BRRCTs. More diligent reporting is needed to strengthen the validity of BRRCTs; otherwise, we cannot reliably draw conclusions on the diverse lived experiences of enrollees, obscuring advancements in breast reconstruction.
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