Trends and Rates of Reporting of Race, Ethnicity, and Social Determinants of Health in Spine Surgery Randomized Clinical Trials

Abstract

Study Design: A systematic review. Objective: We characterized the rates of sociodemographic data and social determinants of health (SDOH) reported in spinal surgery randomized control trials (RCTs) and the association between these RCTs' characteristics and their rates of reporting on race, ethnicity, and SDOH variables. Summary of Background Data: Although numerous institutions maintain guidelines and recommendations regarding the inclusion and reporting of sociodemographic and SDOH variables in RCTs, the proportion of studies that ultimately report such information is unclear, particularly in spine surgery. Materials and Methods: We searched the MEDLINE, PubMed, and Embase databases for published results from spinal surgery RCTs from January 2002 through December 2022, and screened studies according to prespecified inclusion criteria regarding analysis and reporting of sociodemographic and SDOH variables. Results: We analyzed 421 studies. Ninety-six studies (22.8%) reported race, ethnicity, or SDOH covariates. On multivariate analysis, study size [rate ratio (RR)=1.18; 95% CI, 1.06–1.32], public/institutional funding (RR=2.28; 95% CI, 1.29–4.04), and private funding (RR=3.27; 95% CI, 1.87–5.74) were significantly associated with reporting race, ethnicity, or SDOH variables. Study size (RR=1.26; 95% CI, 1.07–1.48) and North American region (RR=21.84; CI, 5.04–94.64) were associated with a higher probability of reporting race and/or ethnicity. Finally, study size (RR=1.27; 95% CI, 1.10–1.46), public/institutional funding (RR=2.68; 95% CI, 1.33–5.39), focus on rehabilitation/therapy intervention (RR=2.70; 95% CI, 1.40–5.21), and nonblinded study groups (RR=2.70; 95% CI, 1.40–5.21) were associated with significantly higher probability of reporting employment status. Conclusion: Rates of reporting race, ethnicity, and SDOH variables were lower in the spinal surgery RCTs in our study than in RCTs in other medical disciplines. These reporting rates did not increase over a 20-year period. Trial characteristics significantly associated with higher rates of reporting were larger study size, North American region, private or public funding, and a focus on behavioral/rehabilitation interventions. Level of Evidence: Level III.