Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder

Dennis A. Revicki, Stanley E. Althof, Leonard R. Derogatis, Sheryl A. Kingsberg, Hilary Wilson, Amama Sadiq, Julie Krop, Robert Jordan, Johna Lucas

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials. Methods: Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit. Results: At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001). Conclusions: The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire. Trial registration: NCT02338960 and NCT02333071 (RECONNECT studies).

Original languageEnglish (US)
Article number82
JournalJournal of Patient-Reported Outcomes
Volume4
Issue number1
DOIs
StatePublished - Dec 1 2020
Externally publishedYes

Keywords

  • Bremelanotide
  • Female sexual dysfunction
  • Hypoactive sexual desire disorder
  • Patient-reported outcomes
  • Validation

ASJC Scopus subject areas

  • Health Informatics
  • Health Information Management

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