In 1993, the National Institutes of Health Revitalization Act mandated increasing minority and women enrollment in clinical trials (CTs). This study aimed to investigate trends in race and ethnicity enrollment and reporting in US plastic and reconstructive surgery (PRS) CT.
Methods: A comprehensive systematic review was performed. All CTs in PRS from 2012 to 2022 were included. To assess racial and ethnic representation within CTs, a random-effects meta-analysis of proportion was conducted to pool the prevalence of the binomial data.
Results: A total of 3609 studies were initially identified in the search strategy, with 154 later classified as CTs in PRS. Only 36 met the eligibility criteria for reporting race and ethnicity and were included in the analysis. A total of 7281 participants were included: 446 (6.1%) males and 6835 (93.9%) females. From CTs that correctly reported race, the pooled prevalence of races were as follows: Whites 78% (95% confidence interval [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 minority representation were present among PRS CTs. This suggests clear limitations in generalizing PRS CT results to the population. Efforts to decrease the gap in minority enrollment and accurately report race and ethnicity are needed in all fields, including plastic surgery.
Keywords: Clinical trials in plastic surgery; Health disparities; Racial representation.
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