Clinical Trial Racial and Ethnic Disparities in Minimally Invasive Gynecologic Surgery

Abstract

Study ObjectiveTo study racial and ethnicity disparities in randomized clinical trials (RCT) in Minimally Invasive Gynecologic Surgery (MIGS). DesignCross sectional study. SettingOnline review of all published MIGS RCTs in high-impact journals from 2012 to 2023. PatientsJournals included all Q1 Obstetrics & 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, robotic surgery InterventionsThe United States (US) Census Bureau data was used to estimate the expected number of participants. We calculated the enrollment ratio (ER) of actual to expected participants for US trials with race and ethnicity data available. Measurements and Main ResultsA 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 US, with a total of 4,645 participants. Of these RCTs only 8 (17.4%) reported ethnicity in addition to race. When comparing published RCT data to expected proportions of participants, White participants were overrepresented [70.8% versus 59.6%, ER 1.66, 95% confidence interval (CI) 1.52-1.81], as well as Black or African American participants (15.4% versus 13.7%, ER 1.15, 95% CI 1.03-1.29). Hispanic (6.7% versus 19.0%, ER 0.31, 95% CI 0.27-0.35), Asian (1.7% versus 6.1%, ER 0.26, 95% CI 0.20-0.34), Native Hawaiian or Other Pacific Islander (0.1% versus 0.3%, ER 0.21, 95% CI 0.06-0.74), and Indian or Alaska Native participants (0.2% versus 1.3%, ER 0.16, 95% CI 0.08-0.32) were underrepresented. When comparing race/ethnicity proportions to the 20 states where the RCTs were conducted, Black or African American participants were underrepresented. ConclusionIn MIGS RCTs conducted in the US, White and Black or African American participants are overrepresented compared to other races, and ethnicity is characterized in fewer than one fifth of trials. Efforts should be made to improve racial and ethnic recruitment equity as well as reporting in future MIGS RCTs.