Enhancing Diversity in Spine Disease Trials: Impact on Equitable Surgical Outcomes

A peer-reviewed analysis of multicenter spine-disease clinical trials shows persistent racial, ethnic, and sex representation gaps that threaten the generalizability of trial-derived outcomes in spine surgery.

The study analysis compared enrollment across multiple multicenter trials against population and disease-burden benchmarks and evaluated clinical endpoints such as postoperative recovery, complication rates, and functional outcomes.

Across heterogeneous sites and clinical phenotypes, specific racial and ethnic groups were underrepresented relative to benchmarks, and sex distribution varied by condition with inconsistent female enrollment.

Diversity shortfalls can undermine trial validity in several ways: differing comorbidity profiles change baseline risk, variable treatment response alters effect-size estimates, and social determinants affect recovery and follow-up retention. When underrepresented groups are not enrolled or analyzed adequately, efficacy and safety estimates—and thus guideline applicability—become less reliable.

The authors translate these findings into practical, trial-level tactics: prioritize sites that serve underrepresented communities, build community partnerships for targeted recruitment, adopt inclusive eligibility criteria, use culturally tailored consent materials, collect and transparently report race/ethnicity/sex data, and apply enrollment targets or stratified sampling to reach balance. These operational steps are feasible and can increase the validity and applicability of future spine-surgery trials.