Sheikh-Oleslami, Sara

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.

Hypertension (HTN) is the most common comorbidity seen in patients who sustain a major burn. HTN causes increased responsiveness of the autonomic nervous system to stressful stimuli, activation of RAAS, arterial and myocardial hypertrophy, and impaired vasodilation. Changes to these pathways are also seen in response to major burns. Given this common pathophysiology, patients with pre-existing HTN may demonstrate different mortality risk after major burn than those without HTN. The objective of this study is to compare the risk of in-hospital mortality among adult patients with and without pre-existing HTN admitted to the intensive care unit (ICU) with a major burn. In addition, we sought to determine the association of pre-existing HTN with the need for vasoactive agents, fluid resuscitation and urine output in the first 48-hours of ICU admission