Development and validation of the genitourinary syndrome of menopause symptoms and vaginal treatments acceptability questionnaire (GSM-SVTAQ): An electronic patient-reported outcomes measure

Abstract

Objectives: To develop and validate an electronic, patient-reported outcomes measure (PROM) specific for genitourinary syndrome of menopause (GSM) patients. The PROM aimed to accurately assess the burden of GSM symptoms, their impact on health-related and sexual quality of life, and the acceptability of vaginal treatments.

Methods: The study encompassed a comprehensive three-stage approach to the development and validation of the PROM. Initially, during the preliminary design stage, the necessity for a new PROM was recognized, an expert panel was formed, and semi-structured qualitative interviews were carried out with GSM patients. In the second stage, the study used the five-step pre-validation methodology established by Prior et al. to generate and refine the PROM items. The third and final stage encompassed the determination of scale and item content validity indexes to ensure validity. Additionally, the reliability of each construct was evaluated using Cronbach's α.

Results: The resulting PROM was named GSM-SVTAQ (GSM-symptoms and vaginal treatments acceptability questionnaire). It demonstrated excellent validity in assessing symptoms burden, health-related and sexual quality of life, and vaginal treatment acceptability, with high content validity indices and strong internal consistency. The scale content validity indices and Cronbach's α coefficients for the three domains were (0.926, 0.939), (0.875, 0.947), and (0.824, 0.855), respectively.

Conclusion: The GSM-SVTAQ stands as the first GSM-specific, valid, and reliable PROM capable of comprehensively measuring the three components of GSM and the acceptability of vaginal treatments. Its implementation has the potential to significantly enhance patient care and outcomes in GSM management.

Keywords: Cronbach's α coefficient; dyspareunia; genitourinary syndrome of menopause; menopause; patient-reported outcome measures; reliability; scale validation; sexual activity.