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Underrepresentation of Racial and Ethnic Diversity in Research Informing the American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Stress Urinary Incontinence Guideline

Open AccessPublished:September 14, 2021DOI:https://doi.org/10.1016/j.urology.2021.08.038

      Abstract

      Objective

      To characterize the racial/ethnic representation in the studies used in the American Urological Association/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction stress urinary incontinence guideline.

      Methods

      Cited studies were reviewed using inclusion and exclusion criteria. The inclusion criteria focused on United States literature to allow for demographic comparison with census data. To compare the racial representation in a study to the diversity in the surrounding city, we calculated the differences between county census data and the study race reported data and performed regression analyses.

      Results

      Eighty-seven cited studies were reviewed, of which 33 were excluded and 52 studies were further evaluated. Seventeen studies were US studies, nine of which reported race. Eighty percent of the women included in the 9 studies were non-Hispanic white women. A diverse geographic region did not correlate with increased study enrollment of non-White patients.

      Conclusion

      The majority of cited studies used to develop the stress urinary incontinence management guidelines did not report the race/ethnicity of participants. Among those studies that did, Asian, Black, and Hispanic women were included at lower rates than non-Hispanic white women, identifying an area of opportunity to improve research recruitment and promote health equity. Non-Hispanic women were consistently overrepresented while other women were either under-represented or completely excluded.
      Stress urinary incontinence (SUI) is defined by the International Continence Society as leakage of urine with physical exertion, cough, laugh or sneeze.
      • Haylen BT
      • De Ridder D
      • Freeman RM
      • et al.
      An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic floor dysfunction.
      An estimated 200,000 anti-incontinence procedures for SUI are performed annually in the United States, many of which are mid-urethral slings.
      • Wu JM
      • Matthews CA
      • Conover MM
      • Pate V
      • Jonsson Funk M
      Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery.
      ,
      • Chughtai BI
      • Elterman DS
      • Vertosick E
      • Maschino A
      • Eastham JA
      • Sandhu JS.
      Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying american urologists.
      Chughtai et al analyzed the case logs of American urologists applying for certification between 2003 and 2012 and found that 93% of all urologists treating female incontinence reported any use of slings and 53% reported exclusive use of slings. While 37% reported any use of endoscopic injections and 10% reported any use of traditional repairs such as the Burch colposuspension.
      • Chughtai BI
      • Elterman DS
      • Vertosick E
      • Maschino A
      • Eastham JA
      • Sandhu JS.
      Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying american urologists.
      Although SUI is not life threatening, it affects up to 56% of women, and the management strategies continue to evolve.
      • Milsom I
      • Coyne KS
      • Nicholson S
      • Kvasz M
      • Chen CI
      • Wein AJ.
      Global prevalence and economic burden of urgency urinary incontinence: a systematic review.
      Prior social media analysis of SUI posts identified the negative effect of incontinence on intimate relationships and self-esteem.
      • Souders CP
      • Eilber KS
      • McClelland L
      • et al.
      The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics.
      Online discussions focused on negative emotions and surgical decision-making for treatment of SUI in the context of mesh use and concomitant prolapse repair.
      • Souders CP
      • Eilber KS
      • McClelland L
      • et al.
      The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics.
      There has been mounting scrutiny of the use of mesh for pelvic floor disorders over the past fifteen year and most recently with the Food and Drug Administration warning.
      • Souders CP
      • Eilber KS
      • McClelland L
      • et al.
      The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics.
      The American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) created a guideline statement in 2017 delineating available treatment techniques for the management of SUI.
      • Kobashi KC
      • Albo ME
      • Dmochowski RR
      • et al.
      Surgical treatment of female stress urinary incontinence: AUA/SUFU Guideline.
      One of the few studies that included a diverse patient population by Thom et al demonstrated that Black women have higher urgency incontinence rates and Hispanic women were twice as likely to experience daily incontinence.
      • Thom DH
      • van den Eeden SK
      • Ragins AI
      • et al.
      Differences in prevalence of urinary incontinence by race/ethnicity.
      Studies focusing on minority women are limited, and the data available suggests that urinary incontinence disproportionately affects women of color. Considering the higher prevalence of female SUI and high rates of surgical sling procedures among Hispanic women, identifying racial representation, which is currently unspecified in the research studies upon which society-endorsed guidelines are created is paramount.
      • Anger JT
      • Rodríguez LV
      • Wang Q
      • Chen E
      • Pashos CL
      • Litwin MS
      Racial disparities in the surgical management of stress incontinence among female medicare beneficiaries.
      Yet, the majority of SUI prevalence studies include homogenous convenience sample populations.
      • Mckellar K
      • Abraham N.
      Prevalence, risk factors, and treatment for women with stress urinary incontinence in a racially and ethnically diverse population.
      ,
      • Wu JM
      • Stinnett S
      • Jackson RA
      • Jacoby A
      • Learman LA
      • Kuppermann M.
      Prevalence and incidence of urinary incontinence in a diverse population of women with noncancerous gynecologic conditions.
      Research studies should be congruent with the patients we treat. Brown et al examined the studies used to develop the 2019 AUA/SUFU overactive bladder (OAB) guidelines and concluded that most OAB research used to construct that guideline lacked specification of race/ethnicity and was consequently not reflective of United States (US) demographics.
      • Brown O
      • Siddique M
      • Mou T
      • Boniface ER
      • Volpe KA
      • Cichowski S.
      Disparity of racial/ethnic representation in publications contributing to overactive bladder diagnosis and treatment guidelines.
      Similarly, to elucidate the racial and ethnic representation of patients in SUI studies, our objective was to characterize racial demographics in the cited studies used to develop the 2017 AUA/SUFU SUI guideline statement and determine if racial/ethnic distributions were congruent with study geography.

      METHODS

      The 2017 AUA/SUFU SUI management guideline citations were reviewed to identify publications that reported the race/ethnicity of study participants (Supplementary Fig. 1). The full-text article was obtained for each cited study. We excluded literature classified as systematic reviews, literature reviews, meta-analyses, secondary analyses, analytic, and research modeling techniques. We reviewed the main study objectives, geographic location where the study was conducted, year of publication, funding source, reporting of race/ethnicity demographics, total number and age of participants, and the questionnaires used. Race categories were defined using the National Institutes of Health Office of Management and Budget standards, which include Black, White, Asian, and American Indian/Alaska Native (AIAN). Office of Management and Budget classifies Hispanics or Latinos as an ethnic category.
      According to the Pew Research Center, despite federal policy defining Hispanic as an ethnicity, the majority of Latinos believe their Hispanic background represents both their ethnic and racial background.

      Gonzalez-Barrera, A, Hugo, LM. Is being Hispanic a matter of race, ethnicity or both (2015). Available at:https://www.pewresearch.org/fact-tank/2015/06/15/is-being-hispanic-a-matter-of-race-ethnicity-or-both/. Retrieved June 1, 2021.

      However, the studies that included Hispanics reported this population as a race, so for consistency we included it as a racial demographic. We use the terms Hispanic and Latina women interchangeably, as both are pan-ethnic terms that describe the people living in the US of that background. However, there is significant variation in how individuals chose to identify.

      Parker K, Menasece J, Morin R, Hugo LM. The many dimensions of hispanic racial identity (201). Available at: https://www.pewresearch.org/social-trends/2015/06/11/chapter-7-the-many-dimensions-of-hispanic-racial-identity/. Retrieved June 1, 2021.

      We focused on American studies reporting race in order to compare racial representation of patients in studies to their respective representation in US census data.
      We compared the average study race reported data to the average census data in studies to investigate the relative recruitment of participants based on geographic location. The average census data was calculated using the 2019 county specific race data (www.census.gov) for each respective location. Of note, we calculated the average census data for the years 2010, 2011, 2015, and 2019 which were available online. The census race distribution data was consistent throughout the years and did not change significantly over the 10-year period. For consistency, in multicenter studies, we combined race specific percentages and divided the total percentage by the total number of research locations as institution specific recruitment data was not available. To investigate whether a region's census racial demographics influenced the demographics of a study from that location, we created two sets of simple linear regression models. Our first model aimed to measure the correlation between the study demographics and the census demographics where the respective study was conducted. We investigated whether or not a diverse geographic region leads to increased study enrollment of non-White patients. The independent variable was the proportion of people of a specific race in a given region, and the dependent variable was designated as the predicted proportion of that race in a given study.
      We hypothesized that those studies with recruitment from more diverse areas would have study enrollment congruent with the racial census representation for a specific region. For consistency, we omitted the “other” demographic. Since most publications we reviewed had low proportions of minority women, our methods would result in studies having smaller differences between the average census data and the reported demographics. In other words, anytime a population is larger, the absolute difference between reported and census data will appear magnified. Therefore, we attempted to control for census proportion and created a second set of simple linear regression models. In this set, the independent variable was the race-specific proportion using census information, and the dependent variable was the difference between the study's reported racial breakdown and regional census-based data.

      RESULTS

      We reviewed all 87 studies, 35 studies of which were excluded based on upon our pre-established criteria. Fifty-two studies were further analyzed. Thirty-five (67%) of the included studies published between 1987 and 2016 were not based in the US. Seventeen (33%) of the included studies published between 1998 and 2015 were conducted in major US metropolitan locations with minimal geographic variation (Supplementary Fig. 2). Thirty US institutions, of which 56% were public, were involved in the 52 publications that were utilized.
      Table 1 demonstrates the study characteristics for the 52 studies meeting our inclusion criteria. Prospective enrollment of patients occurred in 34 (65%) of the total studies and 59% of the US specific studies. Additionally, no US studies mentioned the use of bilingual recruitment materials or questionnaires. Forty-seven percent of the US research sites received government funding (National Institute of Health, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development, and Office of Research in Women's Health), and 12% were funded by academic sponsorship. Sixty-seven percent of US studies reporting race were conducted with government funds.
      Table 1Characteristics of the studies referenced in the 2017 AUA/SUFU surgical treatment of female stress urinary incontinence guideline
      Study CharacteristicsN = 52 Studies
      Study type, n (%)
       Randomized Trial26 (50%)
       Retrospective cohort9 (17%)
       Prospective cohort8 (15%)
       Cross-sectional3 (6%)
       Other6 (12%)
      Study focus, n (%)
       Midurethral Sling outcomes (TVT, TOT, Biologic, AFS)22 (42%)
       Post-operative outcomes9 (17%)
       Diagnostics6 (11%)
       Perioperative risk factors5 (10%)
       Quality of life4 (8%)
       Prophylactic Midurethral Slings3 (6%)
       Other3 (6%)
      Study size, n (%)
       <9913 (25%)
       100-49931 (60%)
       500-10006 (12%)
       >7002 (4%)
      Geographic location and Race reported, n (%)
       US based17 (37%)
       Race reported9/17
       Non-US based35 (67%)
       Race reported0/35
      Race/Ethnicity, n (%)N = 3536 Participants
       Non-Hispanic white2846 (80%)
       Hispanic256 (7%)
       Black138 (4%)
       Asian7 (1%)
       Other289 (8%)
      AUA, American Urological Association; SUFU, Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction.
      Only 9 (53%) US studies reported racial parameters (Table 1). Out of the nine studies reporting race, all studies included non-Hispanic white women, 7 included Black women, 5 included Hispanic women, and 2 included Asian women. Out of the total 3,536 women included in the nine studies, the majority (80%) were non-Hispanic white women, 7% were Hispanic, 4% were Black, 1% were Asian, and the remaining 8% were classified as “other.” Of note, studies did not specify which demographics were included in the “other” category and AIAN were not represented.
      Table 2 demonstrates the comparison of the study reported racial demographics and the average racial census representation for multicenter and single-center studies. There was significant representation discrepancy between those two respective values. The first linear model (Table 3) revealed that, as might be expected, a census with a higher proportion of Black individuals was significantly associated with an increased trial proportion of Black women (0.46, 95% CI: 0.10; 0.81, P = .041). However, the census breakdown for all the other groups were not significantly associated with that region's demographics. In the second linear model, an increase in a region's census proportion of a particular race/ethnicity was significantly negatively associated with the absolute difference between the study reported and census demographic data for Blacks, Hispanics, and Asians, meaning the more of one race/ethnicity, the less likely they were to participate in a study (Table 4).
      Table 2Comparison of reported study and census demographic data of the nine US studies reporting race
      Subject Characteristics
      StudyNon-Hispanic WhiteBlackHispanicAsian
      1Reported data79%3%12%0%
      Average census data53%17%22%8%
      Absolute difference26%14%10%8%
      2Reported data100%0%0%0%
      Average census data26%9%49%15%
      Absolute difference74%9%49%15%
      3Reported data71%7%14%1%
      Average census data50%22%19%8%
      Absolute difference21%15%5%7%
      4Reported data87%6%0%0%
      Average census data50%23%19%7%
      Absolute difference37%17%19%7%
      5Reported data90%5%3%0%
      Average census data57%20%14%7%
      Absolute difference33%15%11%7%
      6Reported data96%1%0%3%
      Average census data68%16%8%7%
      Absolute difference28%15%8%4%
      7Reported data75%6%11%0%
      Average census data54%17%21%7%
      Absolute difference21%11%10%7%
      8Reported data79%3%12%0%
      Average census data55%18%18%7%
      Absolute difference24%15%6%7%
      9Reported data76%0%0%0%
      Average census data55%19%18%7%
      Absolute difference21%19%18%7%
      Total average difference32%14%15%8%
      Table 3Correlation between regional census proportion race/ethnicity and reported study proportion of race and ethnicity
      Effect is from simple linear regression models where the independent variable is the proportion of the census data made up of that particular Race/Ethnicity and the dependent variable is the study proportion made up of that Race/Ethnicity.
      Race/EthnicityEffect (95% CI)P value
      White (Non-Hispanic)−0.24 (−0.88; 0.41).492
      Black0.46 (0.10; 0.81).041
      Hispanic−0.07 (−0.47; 0.34).762
      Asian−0.06 (−0.35; 0.22).677
      low asterisk Effect is from simple linear regression models where the independent variable is the proportion of the census data made up of that particular Race/Ethnicity and the dependent variable is the study proportion made up of that Race/Ethnicity.
      Table 4Correlation of difference between regional census proportion race/ethnicity and reported study proportion of race and ethnicity and regional census proportion race/ethnicity
      Effect is from simple linear regression models where the independent variable is the proportion of the census population made up of the particular race/ethnicity and the dependent variable is the difference between the study proportion of a particular Race/Ethnicity and the proportion of the census data's population made up of that particular Race/Ethnicity.
      Race/EthnicityEffect (95% CI)P value
      Black−0.56 (−0.90; −0.19).020
      Hispanic−1.07 (−1.47; −0.66).001
      Asian−1.06 (−1.35; −0.78)<.001
      low asterisk Effect is from simple linear regression models where the independent variable is the proportion of the census population made up of the particular race/ethnicity and the dependent variable is the difference between the study proportion of a particularRace/Ethnicity and the proportion of the census data's population made up of that particular Race/Ethnicity.

      DISCUSSION

      Overall, we found that very few cited studies supporting the 2017 AUA/SUFU SUI management guideline statement reported racial demographics. Indeed, the guidelines, do not specifically acknowledge the lack of attention to race and ethnicity. Studies did not include equal representation of women from different racial backgrounds, and researchers did not identify which patients were classified as “other.” The underrepresentation of historically marginalized communities in clinical research studies has been well documented.
      • Loree JM
      • Anand S
      • Dasari A
      • et al.
      Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018.
      ,
      • Wilkins CH
      • Schindler SE
      • Morris JC.
      Addressing health disparities among minority populations.
      Yet, studies do not acknowledge the homogeneity of their study populations. Society-supported management guidelines should highlight the external validity challenges created by the inclusion of homogenous research participants. The majority of included US based studies prospectively enrolled participants. Unlike retrospective cohorts, prospective studies provide more opportunity to specifically recruit a diverse population of patients.
      Our regression modeling allowed us to analyze and understand how the geographic location of a study might have influenced variation in the race of women recruited. First, surprisingly, an increase in a region's census breakdown by race/ethnicity did not correlate with an absolute increase in trial representation for that particular race/ethnicity. The one exception was from Black women, where an increase the census proportion of Black people correlated with a higher trial proportion of Black participants. Translation of consent forms and recruiting patients in other languages could increase enrollment among other racial groups which may include recent immigrants to the US and who might not speak English.
      Furthermore, higher census proportions of Black, Hispanic and Asian persons were actually correlated with lower representation (a greater difference between the repost study demographics and census data) in a study from that region. This means that Caucasians are actually overrepresented in SUI research studies. These two findings together suggest that minority groups are not necessarily better represented in trials from regions where that particular minority group is better represented. There are several reasons why simply conducting research in a diverse city is not enough to improve representation in clinical research. Mistrust and fear of the medical community among minority patients is well documented.
      • George S
      • Duran N
      • Norris K.
      A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders.
      Other barriers may include language, cultural, and lack of leisure time for working patients. These findings suggest that researchers need to be intentional about designing their studies and recruitment strategies to maximize diverse representation.
      Although prevalence studies have identified weekly incontinence to be highest among Hispanic women (36%), the cited guideline studies only included 7% of Hispanic women in the data.
      • Thom DH
      • van den Eeden SK
      • Ragins AI
      • et al.
      Differences in prevalence of urinary incontinence by race/ethnicity.
      Khan et al identified language and cultural norms as barriers for Latina women seeking urinary incontinence care.
      • Khan AA
      • Sevilla C
      • Wieslander CK
      • et al.
      Communication barriers among Spanish-speaking women with pelvic floor disorders.
      If it is challenging for Latinas to establish care at baseline, these barriers likely also make research participation difficult. Additionally, none of the studies reported using non-English language questionnaires, even though 75% of the questionnaires that were used in the studies have been validated in Spanish. The available validated Spanish questionnaires include: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence Questionnaire (MESA), Pelvic Floor Distress Inventory (PFDI), and Pelvic Floor Impact Questionnaire (PFIQ) surveys. One-third of all Hispanics in the US are monolingual Spanish speakers and 57% are older Hispanic women, who are at high risk for SUI and are likely not represented in the SUI literature reviewed,

      Krogstad J, Steepler R, and Lopez M. English proficiency on the rise among latinos. Available at:https://www.pewresearch.org/hispanic/2015/05/12/english-proficiency-on-the-rise-among-latinos/. Retrieved March 1, 2021

      We previously identified Latina and non-Hispanic women as being more likely than Black and Asian women to undergo a sling surgery when analyzing Medicare claims, yet these women remain underrepresented in clinical outcome studies.
      • Anger JT
      • Rodríguez LV
      • Wang Q
      • Chen E
      • Pashos CL
      • Litwin MS
      Racial disparities in the surgical management of stress incontinence among female medicare beneficiaries.
      Prior analysis of the Office of Statewide Health Planning and Development from the State of California administrative database for women undergoing a mid-urethral slings procedure found that Black race and Medicaid insurance status were independently associated with an increased risk of a 30-day adverse event.
      • Dallas KB
      • Sohlberg EM
      • Elliott CS
      • Rogo-Gupta L
      Racial and socioeconomic disparities in short-term urethral sling surgical outcomes.
      Black women only represented 4% of the participants in the cited SUI studies reporting race.
      Racial disparities have been recognized in the management of other benign female urologic conditions such as OAB and pelvic organ prolapse. A prior similar study found poor diverse racial representation in studies used to develop the 2019 AUA/SUFU OAB treatment guideline.
      • Wu JM
      • Stinnett S
      • Jackson RA
      • Jacoby A
      • Learman LA
      • Kuppermann M.
      Prevalence and incidence of urinary incontinence in a diverse population of women with noncancerous gynecologic conditions.
      Additionally, Syan et al identified Asians as having the lowest usage rate of oral agents, and non-White race as being associated with a lower rate of advanced therapy (onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation) use for the management of OAB.
      • Syan R
      • Zhang CA
      • Enemchukwu EA.
      Racial and socioeconomic factors influence utilization of advanced therapies in commercially insured OAB patients: an analysis of over 800,000 OAB patients.
      Likewise, Cardenas-Trowers et al analyzed pelvic organ prolapse and patient race association using the American College of Surgeons National Surgical Quality Improvement Program database.
      • Cardenas-Trowers OO
      • Gaskins JT
      • Francis SL.
      Association of patient race with type of pelvic organ prolapse surgery performed and adverse events.
      They discovered that apical suspension procedures are less often performed for Hispanic women, and Black women and other minority women are more likely to undergo an obliterative procedure for treatment of their high grade prolapse.
      • Cardenas-Trowers OO
      • Gaskins JT
      • Francis SL.
      Association of patient race with type of pelvic organ prolapse surgery performed and adverse events.
      Although our article highlights an important topic that can be easily overlooked, it is not a comprehensive review of all published SUI clinical studies as we only reviewed the cited studies used to develop the AUA/SUFU SUI guideline. Another limitation of this study is our analysis of multicenter data, as studies did not report the specific proportion of patients recruited by individual sites and we did not contact authors for this information. Also, some of the research sites are large tertiary centers and may have patients from various counties. Furthermore, although we found that the publicly available average census data was consistent over the 10-year period using our methods, it may underestimate racial representation. We hope that our efforts increase awareness of the current SUI research engagement disparities and encourage academic urologists to prioritize scholarly work that equitably represents our patients. Understandably, there may be recruitment challenges beyond the immediate actions of researchers to increase diversity. However, the published literature should highlight these shortcomings and their implications.

      CONCLUSION

      SUI is a highly prevalent condition that disproportionately impacts non-White populations. However, the studies used to develop the AUA/SUFU guidelines failed to include research participants that proportionately match the patients we treat. Overall, non-Hispanic women were overrepresented, while other groups of women were underrepresented and completely excluded in the case of AIAN women. Possible solutions to help improve the representation of diverse participants include actively recruiting underrepresented patients in research studies, crafting research materials in a variety of languages, enforcing racial recruitment thresholds, requiring reporting of racial/ethnic data, and building organizational partnerships with historically marginalized communities. Additionally, including diverse expert panel members in the development of future AUA/SUFU guideline recommendations will better allow for representation of different perspectives and will better match our patient populations.

      Appendix. SUPPLEMENTARY MATERIALS

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