Validation of the DIVAS-Q (Day-to-Day Impact of Vulvovaginal Atrophic Symptoms Questionnaire): a Portuguese patient-reported outcome measure

Abstract

Abstract Introduction Portuguese is the fifth most spoken language worldwide. However, no validated patient-reported outcome measure (PROM) is available to assess the impact of vulvovaginal atrophy (VVA) symptoms in Portuguese-speaking women. This study aimed to culturally adapt and psychometrically validate the European Portuguese version of the Day-to-Day Impact of Vaginal Ageing questionnaire (DIVA), herein renamed DIVAS-Q (Day-to-Day Impact of Vulvovaginal Atrophy Symptoms Questionnaire), to reflect vulvovaginal atrophy Symptoms across different age groups. Also, deliberately broadened the conceptual scope for symptomatic adult women across reproductive stages in Portugal. Design and methods A multicentre observational study was conducted in Portugal, including pre- and post-menopausal women reporting at least one symptom of vulvovaginal atrophy. Participants were recruited from four clinical settings (public and private hospitals, private practice, and primary health care). Translation followed a standardised, multistep forward-backwards cultural adaptation protocol. Psychometric evaluation comprised descriptive analysis, confirmatory factor analysis (CFA) with WLSMV/DWLS estimation for ordinal indicators, internal consistency (Cronbach’s alpha and McDonald’s omega), item-total correlations, test-retest reliability using intraclass correlation coefficients (ICCs), convergent and discriminant validity, and known-groups validity based on the Vulvovaginal Symptom Questionnaire (VSQ) symptom-burden groups. Results A total of 291 women completed the short version (19 items), and 243 sexually active women completed the long version (23 items) of the DIVAS-Q. CFA with WLSMV/DWLS estimation supported the original four-factor structure (daily activities, emotional well-being, sexual function, and self-concept/body image) for both versions, with good model fit (scaled CFI/TLI = 0.981/0.978 and RMSEA = 0.027 for the short version; scaled CFI/TLI = 0.973/0.970 and RMSEA = 0.033 for the long version; SRMR = 0.035-0.040). Internal consistency was excellent across all domains (Cronbach’s alpha = 0.856-0.960), with strong item-total correlations and average variance extracted values above recommended thresholds. Test-retest reliability was excellent (ICC = 0.982-0.994; 95% CIs consistently above 0.95). Known-groups validity was supported by significantly higher DIVAS-Q scores among women with higher VSQ symptom burden, with large effect sizes across domains. Conclusions The European Portuguese DIVAS-Q demonstrated good psychometric properties for assessing the day-to-day impact of vulvovaginal atrophy-related symptoms among symptomatic adult women in Portugal. The findings support its use in clinical and research contexts in Portugal, but further studies are needed before extending its use to other Portuguese-speaking populations or using it to monitor clinically meaningful change over time.