Assessing Disparities Amongst Landmark Studies and Clinical Trials in Neurosurgery

Introduction: Evidence-based medicine, governed by peer reviewed studies and randomized clinical trials, establishes the standard of neurosurgical treatment for patients across the globe. While these trials often represent the most rigorous methods of establishing treatment guidelines, the extent to which disparities may exist in clinical trial recruitment and study participation is unclear and of the utmost importance. The objective of this study is to evaluate demographic characteristics in neurosurgical clinical trial and study participation. We suspect significant inequities among the demographic makeup of these landmark studies, which could have costly effects for those underrepresented.

Methods: This cohort study, designed to capture the most relevant studies in neurosurgery, spans across decades and uses publicly available research data. Studies were selected from the book “Landmark Papers in Neurosurgery.” Only main studies were included for this initial analysis. Data collection included study intrinsic details and demographics of patient populations. The main outcomes include neurosurgical trial participation, exclusion criteria, and reporting of demographic characteristics. Paired t-test was used to compare study demographic percentages to corresponding census data for each year.

Results: Of 131 main studies, 101 were included in our analysis. All studies included some form of demographic information such as age however only 15 included information regarding race or ethnicity. The percentage of underrepresented individuals included in these 15 studies (mean, 13.75) is significantly less than the percentage of underrepresented individuals in corresponding census data (mean, 25.01) for each study (p < 0.001). The most common exclusion criteria included age, presence of comorbidities, and pregnancy. Very few studies reported socioeconomic status, insurance status, or language.

Conclusion : Our findings outline the disparities present in neurosurgical trial participation. Further, given the lack of reporting of demographic data across most studies, even greater inequities may be present.