Representation of Minority Groups in Key Pelvic Floor Disorder Trials

Abstract

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.

Adapting to Challenging Circumstances: Pessary Care in a Racially Diverse Urban Population Within a U.S. Epicenter of the COVID-19 Pandemic

“… 44 , 45 As such, generalizability of the results of studies that do not investigate these women could be affected and treatment outcomes may not be optimized, as suggested by an analysis of landmark urogynecology trials revealing underrepresentation of Black and Hispanic women and overrepresentation of White women. 46 Although we did not note an association between race and pessary outcomes in our study, we provide unique data on adverse pessary outcomes in a population of underrepresented minority groups that could serve as useful information for future prospective studies.…”

Health disparities and access to advanced therapy for overactive bladder

“…Smaller studies have demonstrated similar results, with prevalence rates ranging between 25% and 46% in Black/AA women, 30%–41% in White women, 19%–28% in Asian women, and 30‐36% in Hispanic and Latina women. Most data entirely neglect the Indigenous American population, thus it is difficult to estimate OAB burden in this group 6,9,12–16 . Furthermore, most OAB prevalence data are based on relatively small cohorts of non‐White participants, potentially painting an incomplete picture of true disease burden.…”

“…An overarching concern in accurately presenting the prevalence of OAB is the homogeneity of study populations in urogynecology research in general. Recently, several publications have highlighted the need for more accurate reporting of race, as well as increased representation of a diverse cohort of patients in therapeutic OAB trials 7–9 . Repetitive sampling of skewed populations results in the false over or underrepresentation of certain groups.…”

“…Findings are inconsistent, with some studies demonstrating a disproportionately higher prevalence of OAB in Hispanic and Black women, 5 and others finding little difference between races 6 . A notable limitation of most studies regarding prevalence, evaluation, and treatment of OAB is the underrepresentation of Black, Hispanic, and Indigenous American/Alaska Native populations, especially in studies used to develop society guidelines 7–9 …”

“…6 A notable limitation of most studies regarding prevalence, evaluation, and treatment of OAB is the underrepresentation of Black, Hispanic, and Indigenous American/Alaska Native populations, especially in studies used to develop society guidelines. [7][8][9] As a note, throughout this review, the term "marginalized populations" will be used when referring collectively to patients of color. This terminology is chosen to highlight the underrepresentation of these groups in the literature and underscore the disparate care they receive, while recognizing that underserved patients span different races and ethnicities.…”