Clinical Trial Racial and Ethnic Disparities in Minimally Invasive Gynecologic Surgery

Abstract

Study objective: To study racial and ethnic disparities in randomized controlled trials (RCTs) in minimally invasive gynecologic surgery (MIGS).

Design: Cross-sectional study.

Setting: Online review of all published MIGS RCTs in high-impact journals from 2012 to 2023.

Patients: Journals included all first quartile obstetrics and gynecology journals, as well as The New England Journal of Medicine, The Lancet, The British Medical Journal, and The Journal of the American Medical Association. The National Institutes of Health's PubMed and the ClinicalTrials.gov websites were queried using the following search terms from the American Board of Obstetrics and Gynecology's certifying examination bulletin 2022 to obtain relevant trials: adenomyosis, adnexal surgery, abnormal uterine bleeding, cystectomy, endometriosis, fibroids, gynecology, hysterectomy, hysteroscopy, laparoscopy, leiomyoma, minimally invasive gynecology, myomectomy, ovarian cyst, and robotic surgery.

Interventions: The US Census Bureau data were used to estimate the expected number of participants. We calculated the enrollment ratio (ER) of actual to expected participants for US trials with available race and ethnicity data.

Measurements and main results: A total of 352 RCTs were identified. Of these, race and/or ethnicity data were available in 65 studies (18.5%). We analyzed the 46 studies that originated in the United States, with a total of 4645 participants. Of these RCTs, only 8 (17.4%) reported ethnicity in addition to race. When comparing published RCT data with expected proportions of participants, White participants were overrepresented (70.8% vs. 59.6%; ER, 1.66; 95% confidence interval [CI], 1.52-1.81), as well as Black or African American participants (15.4% vs. 13.7%; ER, 1.15; 95% CI, 1.03-1.29). Hispanic (6.7% vs. 19.0%; ER, 0.31; 95% CI, 0.27-0.35), Asian (1.7% vs. 6.1%; ER, 0.26; 95% CI, 0.20-0.34), Native Hawaiian or other Pacific Islander (0.1% vs. 0.3%; ER, 0.21; 95% CI, 0.06-0.74), and Indian or Alaska Native participants (0.2% vs. 1.3%; ER, 0.16; 95% CI, 0.08-0.32) were underrepresented. When comparing race/ethnicity proportions in the 20 states where the RCTs were conducted, Black or African American participants were underrepresented.

Conclusion: In MIGS RCTs conducted in the United States, White and Black or African American participants are overrepresented compared with other races, and ethnicity is characterized in fewer than one-fifth of trials. Efforts should be made to improve racial and ethnic recruitment equity and reporting in future MIGS RCTs.

Keywords: Clinical trial; Disparities; Ethnicity; Minimally invasive gynecologic surgery; Race.