Inequity in Racial and Ethnic Representation in United States Plastic Surgery Clinical Trials

BACKGROUND: Racial diversity in clinical trials (CTs) serves as a metric of equality of access to health care, but unfortunately, trials frequently lack or misreport representation of the population they are intended to emulate. In 1993, the National Institutes of Health Revitalization Act mandated an increase in minority and women enrollment in CTs. Further, in 2016 the Food and Drug Administration released guidelines on collecting and reporting race and ethnicity in an effort to achieve meaningful diversity in racial and ethnic representation. The purpose of this study was to investigate trends in race and ethnicity enrollment and reporting in US plastic and reconstructive surgery (PRS) clinical trials and compare representation in clinical trials to the US population census. METHODS: A comprehensive systematic review of several databases was performed. The search strategy was designed and conducted by an experienced librarian using controlled vocabulary with keywords. Inclusion criteria encompassed all clinical trials in PRS from 2012 to 2022. A two-stage screening process was conducted to select articles that met the inclusion criteria. To assess racial and ethnic representation within CTs, a random-effects meta-analysis of proportion was performed to pool the prevalence of the binomial data. RESULTS: A total of 3,609 studies were initially identified in the search strategy with 154 of them later classified as clinical trials in PRS. Overall, 118 (76%) of the CTs did not report race or ethnicity. 36 met eligibility criteria of reporting race and ethnicity and were included in the analysis. From those, 29 (80.6%) and 27 (75%) of included CTs correctly reported race and ethnicity, respectively. A total of 7281 participants were present in the included studies, 446 (6.1%) males and 6835 (93.9%) females. Geographically, 28.5% of all CTs were done in the West, followed by the Midwest with 25%. Further, 38.9% of the CTs were in the field of reconstruction, while 33.3% were cosmetic. From CTs that correctly reported race, the pooled prevalence of races were as follows: Whites 78% (95% CI 73-82%), Black or African Americans 8% (95% CI 5-11%), Asians 1% (95% CI <1-2%), American Indians <1% (95% CI <1-<1%), and Pacific Islanders <1% (95% CI <1-<1%). From the studies that reported ethnicity correctly, the pooled prevalence of Hispanics was 7% (95% CI 5-9%) and Non-Hispanics was 12% (<1-38%). CONCLUSIONS: Disparities in the representation of minorities were present among PRS clinical trials. This suggests clear limitations in the generalization of PRS clinical trials’ results to the general population. Efforts to decrease the gap in minority enrollment and correctly report race and ethnicity are much needed within the field.