A Systematic Literature Review of Health-related Quality of Life Measures for Women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder

Introduction: Hypoactive Sexual Desire Disorder (HSDD) / Female Sexual Interest/Arousal Disorder (FSIAD) impacts health-related quality of life (HRQoL) of women and their partners, yet existing measures fail to ade-quately capture relevant concepts (ie, what is essential to measure including symptoms/impacts) important to women with HSDD/FSIAD. Objectives: To identify HRQoL tools used to assess women with HSDD/FSIAD, and to evaluate their psycho-metric properties (ie, reliability, validity, and responsiveness). Methods: We conducted searches in PubMed, Embase and PsychINFO from June 5, 1989 to September 30, 2020 for studies in women with HSDD/FSIAD and psychometric analyses (English only). Principles of the Pre-ferred Reporting Items for Systematic reviews and Meta-Analyses, the COnsensus-based Standards for the selec-tion of health Measurement INstruments Risk of Bias Checklist and other psychometric criteria were applied. Based on this search, 56 papers were evaluated including 15 randomized-controlled trials, 11 observational/single arm/open label studies, and 30 psychometric studies. Results: Of the 18 measures identified, the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) were included in most studies (> 50%). General HRQoL instruments were not used in any of the clinical trials; the SF-12, SF-36 and EQ-5D-5L were reported in two observational studies. No instru-ments achieved positive quality ratings across all psychometric criteria. The FSFI, FSDS-R, Sexual Event Diary (SED) and the Sexual Desire Relationship Distress Scale (SDRDS), were the only measures to receive a positive rating for content validity. Conclusion: Reliable and valid HRQoL measures that include sexual desire and distress are needed to provide a more systematic and comprehensive assessment of HRQoL and treatment benefits in women with HSDD/ FSIAD. While inferences about HRQoL are limited due to the lack of uniformity in concepts assessed and lim-ited psychometric evaluation of these measures in women with HSDD/FSIAD, opportunities exist for the devel-opment of reliable and validated tools that comprehensively measure the most relevant and important concepts in women with HSDD/FSIAD. Copyright (C) 2021, International Society of Sexual Medicine. Published by Elsevier Inc. All rights reserved.