Medical Student Department of Psychiatry, Rutgers New Jersey Medical School North Bergen, New Jersey, United States
Introduction: Underrepresentation of minoritized participants in clinical trials occurs frequently. We examined reporting of demographic variables in neurosurgery clinical trials. We hypothesized trials infrequently share socioeconomic characteristics and participants with disadvantaged socioeconomic status (SES) are underrepresented.
Methods: A systematic review of worldwide clinical trials from 2015 to 2020 in four top academic journals was conducted. Of 1822 studies, 144 non-post-hoc analysis clinical trials of patients receiving neurosurgery were included. Demographics of single-site studies were compared to local population demographics from U.S. census or citypopulation.de with chi-square tests.
Results: Of the trials, 79.2% were randomized. Mean study sites were 40±95, and participants 844±2195. Eight specialties were represented.
The majority reported age (97.9%, mean 57±14 years) and sex or gender (93.1%, mean 53.3±17.7% male). Two trials differentiated between sex and gender and none reported non-binary genders. Race was reported in 20.8% (mean 75.1% White, 19.2% Asian, 9.8% Black, and less than 9.7% from six additional categories), and ethnicity in 16.0%. These variables were poorly-defined and frequently-conflated. Nationality was described in 10.4%. Less than 2.0% of trials reported on educational, employment, income, or marital statuses. Reporting varied by journal and specialty, but not by year.
Males were significantly overrepresented (p < 0.05) in 22/45 trials (44%), compared to 7/45 (16%) for females. Those of White race and non-Hispanic ethnicity were also significantly overrepresented in more trials than participants of non-white race and Hispanic ethnicity, respectively.
Conclusion : Demographic reporting in clinical trials sparks conversations about scientific rationale, biologic basis, historical context, clinical utility, and health disparity. Similar to other surgical fields, recent neurosurgical clinical trials infrequently report participant SES. Members of minoritized populations are underrepresented. We recommend investigators follow current guidelines for demographic acquisition, collection, and reporting.
