Development of the NIH PROMIS® Sexual Function and Satisfaction Measures in Patients with Cancer

Abstract

Introduction We describe the development and validation of the PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 for cancer populations. Aim 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 (PRO) 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. Main Outcome Measures The PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 include 79 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), 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 (inter-class correlations from 2 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.

Development and Validation of a Single-Item Screener for Self-Reporting Sexual Problems in U.S. Adults

“…[18][19][20] The PROMIS SexFS version 2.0 includes 17 domains. For individuals who had been sexually active in the past 30 days, we used the domains most closely corresponding to the response options in the checklist screener for comparisons (shown in Table 4).…”

“…Therefore, the availability of easily administered and interpreted tools to assess sexual concerns could improve clinical care and standardize data collection efforts for research. Multiple validated instruments are available for selfassessment of sexual function, but validated instruments designed for research (e.g., the International Index of Erectile Function 13 , the Female Sexual Function Index 14 , and the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction Sexual Function and Satisfaction [PROMIS® SexFS] measure 19 ) are typically too long to be practical in general clinical practice settings. Brief self-assessment of sexual problems in a clinical context has the potential to improve clinical care by tracking trends in sexual problems over time and facilitating patient-provider communication about sexual function.…”

Brief Report: Sexual Function, Satisfaction, and Use of Aids for Sexual Activity in Middle-Aged Adults with Long-Term Physical Disability

“…12 Using 5-or 6-point anchored scales, participants described their (a) satisfaction with their sex life, (b) ability to have a satisfying orgasm, and (c) ability to get and maintain an erection (men) or become lubricated during sex (women). Items also assessed use of aids to sexual functioning, including erectogenic medication, vacuum pump devices, personal lubricants, and hormones for sexual activity.…”

“…Items also assessed use of aids to sexual functioning, including erectogenic medication, vacuum pump devices, personal lubricants, and hormones for sexual activity. 12,13 All items referred to the previous 30 days.…”

An experience with the Patient-Reported Outcomes Measurement Information System: Pros and cons and unanswered questions

“…The PROMIS-Sexual Function (SexFS) measures have the potential to offer researchers and clinicians a comprehensive, reliable and valid set of tools to measure self-reported sexual function and satisfaction among men and women living with cancer (Flynn, Lin, Cyranowski, Reeve, Reese, Jeffery, Weinfurt, 2013). The internal consistency reliability (Cronbach alpha coefficients) for men and women range from 0.87–0.95, and test-retest reliability interclass correlation coefficients range from 0.71–.0.87.…”