Between one-third and one-half of postmenopausal women in the United States suffer from vaginal symptoms such as dryness, soreness, itching, irritation, and pain and discomfort during sexual intercourse. These widespread symptoms can persist for many years after menopause, interfering with sexual activity and significantly affecting women's quality of life in older age. While clinical studies of new therapies for vaginal symptoms have tended to rely on physical or laboratory measures to assess the effects of treatment, these physical measures do not correlate well with the severity of women's symptoms or capture the impact of these symptoms on women's day-to-day functioning and wellbeing. We propose to develop and validate a sensitive and reliable self-administered instrument for assessing the impact of common postmenopausal vaginal symptoms on quality of life in women of diverse backgrounds. In preparation for this effort, we have developed and refined a conceptual framework for understanding the impact of vaginal symptoms on multiple domains of functioning and wellbeing, based on focus groups with racially/ethnically diverse, symptomatic postmenopausal women. We have also generated a preliminary, self- administered, structured-item instrument (the Day-to-day Impact of Vaginal Aging (DIVA) questionnaire) to assess the impact of these symptoms on these functional and quality-of-life domains and refined it through one-on-one, in-depth cognitive interviews with additional women. For the next stage of our work - psychometric evaluation, refinement, and validation of our instrument - we have arranged to distribute the preliminary DIVA instrument within a large, racially/ethnically diverse cohort of middle-aged and older women [N=2,000], and we have assembled a multidisciplinary team of outcome researchers experienced with developing and testing instruments to measure other sensitive urogenital conditions in older women. We will use data from this cohort to achieve the following specific aims: (1) Evaluate the factor structure and basic psychometric properties of our preliminary DIVA instrument in a large sample of postmenopausal women experiencing vaginal symptoms;(2) Examine the convergent-divergent validity of the DIVA questionnaire in terms of its association with related constructs such as sexual function;and (3) Assess the extent to which there are differences in the quality-of-life impact of vaginal symptoms as measured by the DIVA instrument by race/ethnicity, sexual activity status, and postmenopausal stage. Our research will address a major area of emphasis of the National Institute of Aging by facilitating evaluation and management of a class of symptoms that affect a large proportion of older U.S. women.
This research addresses the urgent need for a sensitive, reliable questionnaire to assess the impact of vaginal symptoms on quality of life in postmenopausal women. Development of this questionnaire will help to ensure that future efforts to develop new treatments for conditions such as vaginal appropriately address women's real-life experience of vaginal symptoms as they age.
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