Validating and Extending the PROMIS Sexual Function Measure for Clinical Research

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DESCRIPTION (provided by applicant): The National Institutes of Health (NIH) established the Patient-Reported Outcomes Measurement Information System (PROMIS) Network with the goal of developing a comprehensive, standardized, and efficient means of measuring patient-reported outcomes in persons with chronic diseases. As one of the 7 original research sites, Duke University led the development of 2 domains of measurement for patients with cancer, including sexual function. Sexual function and satisfaction are strong determinants of overall quality of life and are affected by many chronic diseases and their treatments. Yet little work has been done to measure sexual function across chronic diseases using consistent, high quality measurement approaches. The first phase of PROMIS supported research toward the development of the sexual function domain for cancer populations. Early testing suggests the PROMIS measure is superior to many alternatives in terms of understandability, comprehensiveness, and appropriateness for many types of people. In the next phase of PROMIS, we wish to broaden the applicability of the measure to chronic diseases beyond cancer. The work proposed in this application will ensure that the initial investment by NIH in the PROMIS sexual function domain will result in a measure that is useful across therapeutic areas and meets all of the PROMIS standards. The proposed work will advance the development of the sexual function domain by pursuing 4 Specific Aims: Aim 1: To assess the validity (including responsiveness) of the PROMIS sexual function measure in men and women undergoing treatment for prostate or gynecologic cancers. Aim 2: To evaluate and ensure the appropriateness of the PROMIS sexual function measure in patients with heart failure, diabetes mellitus, and mood and anxiety disorders. Aim 3: To collect and analyze responses to the PROMIS sexual function measure from a nationally representative sample of the US population. Aim 4: To produce a Spanish-language version of the PROMIS sexual function measure. PUBLIC HEALTH RELEVANCE: Many chronic diseases affect sexual functioning, which in turn has been shown to influence overall quality of life. The measurement of sexual function is thus critical to understanding the effects of chronic diseases and their treatments. The proposed research will provide investigators and patients with an efficient, comprehensive, and sensitive measure of sexual function for use in clinical research.