Abstract

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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AR052186-09S2
Application #
8705692
Study Section
Special Emphasis Panel (ZRG1-RPHB-A (54))
Program Officer
Serrate-Sztein, Susana
Project Start
2009-09-30
Project End
2014-07-31
Budget Start
2012-08-01
Budget End
2014-07-31
Support Year
9
Fiscal Year
2013
Total Cost
$200,000
Indirect Cost
$61,217

  Institution

Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705

  Publications

Reeve, Bryce B; Edwards, Lloyd J; Jaeger, Byron C et al. (2018) Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease. Qual Life Res 27:249-257
Zhao, Yue (2017) Impact of IRT item misfit on score estimates and severity classifications: an examination of PROMIS depression and pain interference item banks. Qual Life Res 26:555-564
Flynn, Kathryn E; Carter, Jeanne; Lin, Li et al. (2017) Assessment of vulvar discomfort with sexual activity among women in the United States. Am J Obstet Gynecol 216:391.e1-391.e8
Morgan, Esi M; Mara, Constance A; Huang, Bin et al. (2017) Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers. Qual Life Res 26:565-586
Bevans, Katherine B; Riley, Anne W; Landgraf, Jeanne M et al. (2017) Children's family experiences: development of the PROMIS® pediatric family relationships measures. Qual Life Res 26:3011-3023
Lee, Augustine C; Driban, Jeffrey B; Price, Lori Lyn et al. (2017) Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain 18:1096-1110
Moinpour, Carol M; Donaldson, Gary W; Davis, Kimberly M et al. (2017) The challenge of measuring intra-individual change in fatigue during cancer treatment. Qual Life Res 26:259-271
Cunningham, Natoshia R; Kashikar-Zuck, Susmita; Mara, Constance et al. (2017) Development and validation of the self-reported PROMIS pediatric pain behavior item bank and short form scale. Pain 158:1323-1331
Hedrick, Traci L; Harrigan, Amy M; Thiele, Robert H et al. (2017) A pilot study of patient-centered outcome assessment using PROMIS for patients undergoing colorectal surgery. Support Care Cancer 25:3103-3112
Brandon, Timothy G; Becker, Brandon D; Bevans, Katherine B et al. (2017) Patient-Reported Outcomes Measurement Information System Tools for Collecting Patient-Reported Outcomes in Children With Juvenile Arthritis. Arthritis Care Res (Hoboken) 69:393-402

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