Patient-Reported Outcomes in Functioning for Female Pelvic Floor Disorders

Women And Infants Hospital-Rhode Island, Providence RI

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Abstract

Vivian Sung, MD, MPH is an Assistant Professor of Obstetrics and Gynecology and a urogynecologist whose career goal is to improve the quality of patient-reported outcome measures (PROs) and ultimately patient care in female pelvic floor disorders (PFDs). She is applying for a Mentored Patient-Oriented Research Career Development Award to gain advanced training in traditional and innovative survey methods necessary to become a successful independent investigator and national leader in outcomes research in PFDs and women's health. TOPIC: Female PFDs, including urinary incontinence, pelvic organ prolapse and fecal incontinence, are chronic conditions with a significant impact on multiple aspects of a woman's life. Symptom and quality of life (QOL) measures exist, but the impact of PFDs and treatments on a woman's real-world functioning have not been well studied in a theory driven, patient-centered fashion considering numerous mediators interacting in complex ways. Although symptoms and QOL are important, deficits in functioning are a significant component of illness burden and patients consistently identify aspects of improved functioning as important treatment goals. Recent WHO and DHHS initiatives also support the importance of functioning outcomes, distinct from QOL. Plan: Dr. Sung's multidisciplinary educational plan is built upon acquiring new skills in survey design, psychometrics (classical test and item response theory), innovative data collection and longitudinal data analysis to develop a high-quality PRO measure for functioning in women with PFDs. The most advanced available technology will be explored to measure this complex concept. We will start by developing a PFD-specific conceptual framework for functioning based on focus groups, NIH PROMIS and the WHO ICF (Aim 1). A PFD-specific item bank for functioning will be developed by re-writing existing items identified in a systematic review (Aim 2), writing new items, and using PROMIS items, based on our framework. This will result in a PFD-specific questionnaire for functioning (Aim 3), which will be validated in a small, longitudinal cohort study (Aim 4). The final questionnaire will have direct applicability in clinical studies and will significantly add to our current PRO measures. RELEVANCE (See instructions): The number of women seeking care for pelvic floor disorders is expected to increase with the aging U.S. population. A high-quality, disease-specific questionnaire measuring multi-dimensional aspects of functioning will better define treatment outcomes valued by women, identify mediators that may be modified to maximize a woman's functioning, and allow a more comprehensive assessment of patient burden.