Urinary incontinence (UI) disproportionately affects women over men and is associated with embarrassment, social and functional decline. Treatments are primarily aimed at improving aspects of a woman's quality of life and function;therefore, high quality patient-reported outcomes (PRO) that cover multiple dimensions are paramount to inform treatment progress. Limitations of existing UI PRO measures include their inflexibility, significant respondent burden, and inability to be personalized. The overarching goal of this proposal is to make a major advance in UI PRO measures by developing an innovative measurement system that is multi- dimensional, flexible, and efficient, can be tailored to individuals, yet also decreases respondent burden. Such a system is likely to be accepted by patients, clinicians, researchers, and industry for evaluating treatment outcomes from the patient perspective and can streamline research findings and patient care. Using item response theory and computerized adaptive testing, The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) has developed core PRO item banks relevant to a wide range of chronic diseases. As comprehensive as PROMIS is, it does not fully address the needs of women with UI. To fill this need, we will build on our previous work to continue validation and calibration of UI-specific item banks based on an expanded PROMIS conceptual framework that is sensitive to the outcomes valued by women with UI. Specifically, our aims are to: 1) confirm face and content validity of our UI item banks and conceptual framework through cognitive-based interviews and expert review;2) calibrate and field-test the item banks using item response theory in 700 women with UI recruited across two hospital settings;and 3) develop and pilot-test a web-based UI-computerized adaptive test prototype (UI-CAT). We will evaluate item/model/person fit, compare item discrimination power, and assess differential item functioning across demographic variables, UI severity and type, and co-existing pelvic floor disorders. We have convened an interdisciplinary team of experts in female UI, PRO development, PROMIS methodology, item response theory, computerized adaptive testing, and informatics. The application of modern psychometrics and computerized adaptive technology can dramatically improve our PRO measurement capabilities in female UI and women's health. The UI-CAT can be used to help tailor our treatments to the needs and values of women with UI, improve the specificity of our treatments, and improve the delivery of personalized care to women.

Public Health Relevance

With the aging population, the number of women seeking care for urinary incontinence (UI) will increase. High- quality, patient-important outcomes that can be tailored, are efficient and monitor treatment outcomes from the patient perspective are critical to improving scientific knowledge and the care of women who suffer from UI.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Exploratory/Developmental Grants (R21)
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Health Services Organization and Delivery Study Section (HSOD)
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Meikle, Susan
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Women and Infants Hospital-Rhode Island
United States
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