Representation of Minority Groups in Key Pelvic Floor Disorder Trials

Abstract

Our examination of landmark trials in female pelvic medicine and reconstructive surgery demonstrates an overall overrepresentation of White study participants compared with the National Health and Nutritional Examination Survey prevalence data and a possible underrepresentation of Black and Hispanic subgroups that did not meet statistical significance. When stratified by pelvic floor condition, there was a significant underrepresentation of Black and Hispanic women in pelvic organ prolapse trials. In addition, reporting of minority subgroups is inconsistent across studies, especially for Asian and American Indian women. Pelvic floor disorder research may benefit from targeted sampling of minority groups, particularly in future trials on prolapse. Background Multicenter randomized clinical trials on pelvic floor disorders (PFDs) support evidence-based care. However, many of these studies include homogenous study populations lacking diversity. Heterogeneous sampling allows for greater generalizability while increasing knowledge regarding specific subgroups. The racial/ethnic makeup of key pelvic floor disorder (PFD) trials has not been examined. Objective This study aimed to investigate racial/ethnic representation in major PFD clinical trials in comparison to racial/ethnic distribution of PFD in the National Health and Nutritional Examination Survey (NHANES). Methods Demographic data were extracted from completed PFD Network (PFDN) and Urinary Incontinence Treatment Network studies, which have resulted in nearly 200 publications. Prevalence of PFD by race/ethnicity was obtained from the NHANES. A representative index (Observed “n” by PFD study/Expected “n” based on the NHANES-reported prevalence) was calculated as a measure of representation. Meta-analyses were performed for each outcome and overall with respect to race/ethnicity. Results Eighteen PFDN/Urinary Incontinence Treatment Network studies were analyzed. White women comprised 70%–89% of PFD literature; Black women, 6%–16%; Hispanic women, 9%–15%; Asians, 0.5%–6%; and American Indians, 0%–2%. Representation of White women was higher in 13 of 18 PFDN studies compared with the NHANES prevalence data. Representation of Black women was either decreased or not reported in 10 of 18 index studies compared with the NHANES prevalence data. Hispanic women were absent or underrepresented in 7 of 18 PFDN studies compared with the prevalence data. Conclusions Our examination of PFDN and other landmark trials demonstrates inconsistent reporting of minority subgroups, limiting applicability with respect to minority populations. Our study suggests that PFD research would benefit from targeted sampling of minority groups.