title: Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer.
abstract: BACKGROUND
  We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations.
  
  
  OBJECTIVE
  To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS Network.
  
  
  METHODS
  Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient-reported outcome measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item-response theory and evaluated for reliability and validity.
  
  
  METHODS
  The PROMIS SexFS measures, version 1.0, include 81 items in 11 domains: Interest in Sexual Activity, Lubrication, Vaginal Discomfort, Erectile Function, Global Satisfaction with Sex Life, Orgasm, Anal Discomfort, Therapeutic Aids, Sexual Activities, Interfering Factors, and Screener Questions.
  
  
  RESULTS
  In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different) and convergent validity (strong correlations between scores on PROMIS and scores on conceptually similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (interclass correlations from two administrations of the instrument, 1 month apart).
  
  
  CONCLUSIONS
  The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study.
authors: Department of Psychiatry and Behavioral Sciences, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27705, USA. kathryn.flynn@duke.edu
authors: Kathryn E
authors: KE
authors: Flynn
authors: Li
authors: L
authors: Lin
authors: Jill M
authors: JM
authors: Cyranowski
authors: Bryce B
authors: BB
authors: Reeve
authors: Jennifer Barsky
authors: JB
authors: Reese
authors: Diana D
authors: DD
authors: Jeffery
authors: Ashley Wilder
authors: AW
authors: Smith
authors: Laura S
authors: LS
authors: Porter
authors: Carrie B
authors: CB
authors: Dombeck
authors: Deborah Watkins
authors: DW
authors: Bruner
authors: Francis J
authors: FJ
authors: Keefe
authors: Kevin P
authors: KP
authors: Weinfurt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000534:rehabilitation*; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis* / Q000209:etiology / Q000517:prevention & control; D019529:Sexuality; D014481:United States
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