Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies

Abstract

Objective: We aimed to further validate the German version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire.Methods: Data were collected in the context of two intervention studies. Forty-two women participated in clinical trial VMP-03/2018 (NCT04222647) and 79 women in clinical trial VFCrC-01/2021 (NCT05211505). Internal consistency was calculated using Cronbach α. Correlations with other outcome measures such as a subjective assessment of symptoms and dyspareunia, the Vaginal Health Index, and the Vaginal Maturation Index were calculated regarding construct validity. A priori hypotheses were formulated for construct validity. Responsiveness was assessed after 43 (±3) and after 38 (±1) days in the two clinical trials.Results: Strong internal consistency in all of the DIVA domains was found (α ≥ 0.80). Regarding construct validity (at baseline and over time), many hypotheses were confirmed. Furthermore, all of the DIVA domains were able to detect changes over time ( P ≤ 0.006). Moderate to strong effect sizes were found (≥0.460). The data supported the responsiveness of the DIVA.Conclusions: Our findings from two independent intervention studies support internal consistency, construct validity, and responsiveness of the German version of the DIVA (domains).