Abstract

It is estimated that over 40% of women worldwide have Female Sexual Dysfunction (FSD). Of the various sexual dysfunctions, the majority of women with FSD have Hypoactive Sexual Desire Disorder (HSDD). The diagnosis of HSDD relies on a time-consuming extensive interview by an expert clinician, utilizing a history that focuses on sexual activity (often incorporating instruments such as the Female Sexual Function Index, the Changes in Sexual Function Questionnaire, or others) and physical exam. Many women with HSDD are consequently undiagnosed and untreated due to limited access to such experts. Two trials are presented in which the Decreased Sexual Desire Screener (DSDS), a brief screening instrument for the diagnosis of HSDD, was used and results compared to an extensive, standardized interview conducted by an expert clinician with specific FSD diagnostic training. The DSDS consists of five questions: four concerning a woman’s history of sexual desire to assess symptoms of generalized, acquired HSDD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, and one multi-point question concerning seven medical and psychological factors to rule out items that could confound the diagnosis of HSDD. In a non-treatment validation study at 27 centers in the United States (US) & Canada, 263 women were asked to complete the DSDS at their screening visit and their answers were then reviewed with a non-expert clinician. Afterwards, a second clinician, certified as an expert in HSDD and unaware of the first clinician’s diagnosis, conducted an extensive, standardized interview and diagnosed either: i) HSDD, ii) another form of FSD, or iii) no FSD. The diagnoses of the two groups of clinicians were compared. In addition, cognitive debriefing was performed in a sub-set of 89 women and all participating clinicians. Subsequently, a treatment trial was conducted using similar diagnostic procedures in over 800 women with complaints of low sexual desire at 67 centers in the US & Canada. In the non-treatment trial, the DSDS had a sensitivity of 83.6%, specificity of 87.8%, and accuracy of 85.2%. Of the 150 women diagnosed with HSDD by the DSDS, 138 (92%) were also diagnosed with HSDD by the extensive, standardized interview conducted by the expert clinician. Cognitive debriefing demonstrated that each question and answer set was understood by and acceptable to the patients and clinicians. Rare misunderstandings regarding timeframes or multiple diagnoses were addressed before use in the treatment trial by two minor revisions in the clinician’s instructions. Using the DSDS and the revised clinician’s instructions in the treatment trial, the agreement between DSDS and the extensive interview was 97%. Anecdotally, the extensive, standardized interview was reported to take approximately an hour to complete while the DSDS took less than 15 minutes for the woman to complete and review with the clinician. Validation of a new diagnostic instrument is presented. While expert diagnosis of HSDD is often time-consuming, poorly accessible, and performed by few clinicians using current methodology, the Decreased Sexual Desire Screener (DSDS) enabled non-expert clinicians to quickly and accurately diagnose generalized, acquired HSDD in women. Additional research is needed in order to further support these results.

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