Abstract

Multidimensional self-report measures of sexual function for women do not include the assessment of vulvar discomfort, limiting our understanding of its prevalence. In an effort to improve the measurement of patient-reported health, the National Institutes of Health funded the creation of the Patient Reported Outcomes Measurement Information System (PROMIS). This included the development of the PROMIS Sexual Function and Satisfaction measure, and version 2.0 of the Sexual Function and Satisfaction measure included 2 scales to measure vulvar discomfort with sexual activity. The objectives of the study were to describe thedevelopment of 2 self-reported measures of vulvar discomfort with sexual activity, describe the relationships between these scalesand scales for lubrication and vaginal discomfort, and reportthe prevalence of vulvar discomfort with sexual activity inalarge, nationally representative sample of US women. We followed PROMIS measure development standards, including qualitative development work with patients and clinicians and psychometric evaluation of candidate items based on item response theory, in a probability sample of 1686 English-speaking US adult women. We tested 16 candidate items on vulvar discomfort. We present descriptive statistics for these items, correlation coefficients among the vulvar and vaginal scales, and mean PROMIS scores with 95% confidence intervals separately by menopausal status for the 1046 women who reported sexual activity in the past 30days. Based on the psychometric evaluation of the candidate items, we created 2 separate 4 item scales, one to measure labial discomfort and pain and one to measure clitoral discomfort and pain. Additional items not included in the scales assess pain quality, numbness, and bleeding. The correlations between the lubrication, vaginal discomfort, and the 2 vulvar discomfort measures ranged from 0.46 to 0.77, suggesting that these measures represent related yet distinct concepts. In our nationally representative sample, 1 in 5 US women endorsed some degree of vulvar discomfort with sexual activity in the past 30 days. Menopausal status was associated with lower lubrication and higher vaginal discomfort but not with vulvar discomfort. The PROMIS Vulvar Discomfort with Sexual Activity-Labial and Vulvar Discomfort with Sexual Activity-Clitoral scales are publicly available for use in research and clinical settings. There is limited overlap between vulvar discomfort and lubrication or vaginal discomfort. The importance of measuring vulvar discomfort as part of a comprehensive assessment of sexual function is underscored by its prevalence.

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