Development and Initial Validation of the PROMIS(®) Sexual Function and Satisfaction Measures Version 2.0.
BACKGROUND
The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations.


OBJECTIVE
The aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity.


METHODS
Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity.


RESULTS
The final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported.


CONCLUSIONS
The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.|Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
Kevin P
KP
Weinfurt
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Li
L
Lin
Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.
Deborah Watkins
DW
Bruner
Departments of Psychiatry and Psychology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Jill M
JM
Cyranowski
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Carrie B
CB
Dombeck
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.|Center for Patient-Centered Outcomes, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Elizabeth A
EA
Hahn
Department of Defense-Health Affairs, TRICARE Management Activity, Falls Church, VA, USA.
Diana D
DD
Jeffery
Department of Educational Research Methodology, School of Education, University of North Carolina at Greensboro, Chicago, IL, USA.
Richard M
RM
Luecht
Department of Occupational Therapy, University of Illinois at Chicago, Chicago, IL, USA.
Susan
S
Magasi
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
Laura S
LS
Porter
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.
Jennifer Barsky
JB
Reese
Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Bryce B
BB
Reeve
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
Rebecca A
RA
Shelby
Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
Ashley Wilder
AW
Smith
Department of Educational Research Methodology, School of Education, University of North Carolina at Greensboro, Chicago, IL, USA.
John T
JT
Willse
Center for Patient Care and Outcomes Research, Medical College of Wisconsin, Milwaukee, WI, USA.
Kathryn E
KE
Flynn
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000453:epidemiology*; D003863:Depression / Q000453:epidemiology*; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D008875:Middle Aged; D009948:Orgasm; D010410:Penile Erection / Q000523:psychology*; D010549:Personal Satisfaction; D011594:Psychometrics; D015203:Reproducibility of Results; D012725:Sexual Behavior / Q000523:psychology*; D011795:Surveys and Questionnaires
Patient-Reported Outcome Measures; Quality of Life; Sexual Function