Journal Article

A Cross-Sectional Study of Sex, Race, and Ethnic Representation in Burn Registered Clinical Trials

Luthra, Shreya, Papp, Bettina, Papp, Anthony, Tao, Brendan, Sheikh-Oleslami, Sara

2025

Overview

Purpose The demographic proportions of plastic surgery trials approximating real-world disease have not well been studied. Judicious trial representation is essential in evaluation of treatments across diverse patient populations. Herein, we investigate sex, racial, and ethnic disparities in patient enrollment across burn trials. Methods Cross-sectional analysis of participants enrolled in high-quality, with reduced risk of bias, randomized controlled trials (RCT) on burns registered on clinicaltrials.gov under the query “burn.” Completed RCTs reporting at least two demographic groups, employing double masking or greater, and with results accessible through the registry or publications were included. Trial characteristics (sponsor country, site location, initiation year, study phase, masking) and demographic data (sex, race, ethnicity per US reporting guidelines) were collected. The Global Burden of Disease database provided sex-based burn disease burdens. The primary outcome was the population-to-prevalence ratio of enrolled female participants. Secondary outcomes included representation of racial and ethnic populations as related to study blinding, phase, and study/sponsor locations. Results Of 546 records, 39 trials met the inclusion criteria (2919 participants). All trials reported sex demographics, with females comprising 37.02% of all participants (PPR = 0.71, 95% CI [0.59, 0.82], likely indicating underrepresentation against their empiric disease burden). Only 7 and 9 trials reported ethnicity and race, respectively, although not comprehensively. Among trials reporting race or ethnicity, Caucasians and Black persons comprised 57.52% and 21.80% of participants, respectively, while only 9.80% had Hispanic/Latino ethnicity. Severe underreporting of race and ethnicity precluded much of secondary significance testing across study variables. Conclusions Females are likely underrepresented in high-quality, US-registered burn trials, unreflective of their real-world disease burden. Further, severe underreporting of race and ethnicity was noted. Future trials should enroll diverse demographics and equitable populations for promotion of study generalizability.

• Publisher: Springer International Publishing,Springer Nature B.V
• Subject: Black people / Burns / Burns - ethnology / Burns - surgery / Clinical research / Clinical trials / Cross-Sectional Studies / Demographic variables / Demographics / Demography / Disease / Enrollments / Epidemiology / Ethnic differences / Ethnic groups / Ethnicity / Ethnicity - statistics & numerical data / Female / Females / Generalizability / Hispanic Americans / Humans / Injuries / Male / Males / Marginality / Marginalized groups / Masking / Medical research / Medicine / Medicine & Public Health / Minority & ethnic groups / Patient Selection / Patients / Plastic surgery / Population studies / Populations / Quality of Life Research / Race / Racial differences / Racial Groups - statistics & numerical data / Racial inequality / Randomized Controlled Trials as Topic - statistics & numerical data / Registries / Representation / Representations / Risk management / Sex / Sex Factors / Site location / Social Inequality / Social Structure / Socioeconomic factors / Surgery / Treatment methods / Underreporting / White people