Validation of the German Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire in Peri- and Postmenopausal Women

Background: The Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire is a validated patient-reported outcome measure (PROM) capturing the impacts of vaginal symptoms in postmenopausal women. Aim: We aimed to psychometrically validate the German version of the DIVA questionnaire. Methods: Data was collected online and by paper-pencil. We ran confirmatory factor analyses to confirm the a priori four-factor structure of the DIVA. Internal consistency was calculated using Cronbach's alpha. Correlations with other outcome measures such as the Patient Health Questionnaire-4 (PHQ-4), the SF-12 SOEP (socio-economic panel) version and self-created anchor questions were calculated regarding convergent validity. Known groups regarding age, home country and disease severity were analyzed. Test-retest reliability after 1 week and responsiveness after 4 weeks were only descriptively assessed due to low sample sizes. Main Outcome Measures: The DIVA questionnaire, the Menopause Rating Scale (MRS II), the PHQ-4 and the SF-12 SOEP version were the main outcome measures. Results: 185 postmenopausal women reporting vaginal complaints participated in the survey. The mode of administration did not influence the severity of vaginal symptoms. The four-factor structure of the DIVA could be confirmed and the model fit indicated sufficient structural validity. Furthermore, strong internal consistency in all of the DIVA domains was found. Regarding convergent validity, no hypothesis has failed completely. The results regarding known groups validity were mostly in line with our a priori hypotheses. Descriptive evidence for sufficient test-retest reliability and responsiveness was given, however, the sample size for the assessment of those two measurement properties was low. Conclusion: This study supports the excellent structural validity, internal consistency and construct validity of the German version of the DIVA questionnaire. It can be recommended for the assessment of the impacts of vaginal symptoms in postmenopausal women in future clinical GSM trials. Copyright (C) 2021 The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.