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Whose outcomes are we measuring? review of patient-reported outcome study populations

      Objectives

      In 2020, the Pelvic Floor Disorders Consortium Working Group on Patient-Reported Outcomes evaluated patient-reported outcome (PRO) instruments in pelvic floor disorders. PROs measure patients’ lived experiences and are considered appropriate for use in populations where their validity properties have been evaluated. The social construct of race can impact lived experience. It is unclear if this is accounted for in existing PROs. This study describes the race and ethnicity characteristics of the validation study populations in cited PRO instruments.

      Materials and Methods

      Review of studies considered in “Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments: Proceedings of the Consensus Meeting of the Pelvic Floor Consortium of the American Society of Colon and Rectal Surgeons, the International Continence Society, the American Urogynecologic Society, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction.” Dates, locations, and participant race, ethnicity, and gender information was abstracted. Racial and ethnic representation was compared to census data for US-based studies. The primary outcome was the representation quotient of reported races and ethnicities, calculated as the reported percentage of the study population identifying with a race and/or ethnicity divided by the proportion of the US population identifying with that race and/or ethnicity during the study period.

      Results

      Forty-four studies with 21,035 participants were included. Mean age was 51 +8.4 years, with 13,957/21,035 (66.4%) female participants. Race was reported in 16/44 (36.4%) studies and ethnicity reported in 7/44 (15.9%). Studies did not specify how this information was collected, though 75.5% (10,011/13,263) of participants were reported as white and 8.7% (792/9,066) as Hispanic. For US-based studies, the representation quotient of white participants from 1995-2019 was 1.13, indicating overrepresentation, which did not change over time (Table 1). Indigenous American/Native American/American Indian/Alaska Natives had the lowest representation quotient (0.24; Figure 1). There was a trend toward increased reporting of ethnicity (p=0.001), but not race (p=0.06).

      Conclusion

      White patients may be over-represented in US-based validation studies for PRO instruments in pelvic floor disorders. Consideration should be given to whether these instruments appropriately capture the experiences of non-white populations.
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