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

IF 2.9 Q2 HEALTH CARE SCIENCES & SERVICES
Andreia Antunes, Patrício Costa, Ana Alves, Alexandra Colaço, Maria Guarino, Cristina Nogueira-Silva
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引用次数: 0

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.

验证DIVAS-Q(外阴阴道萎缩症状的日常影响问卷):葡萄牙患者报告的结果测量。
葡萄牙语是世界上第五大语言。然而,没有有效的患者报告的结果测量(PROM)可用于评估外阴阴道萎缩(VVA)症状对葡语妇女的影响。本研究旨在文化适应和心理测量验证欧洲葡萄牙语版阴道老化的日常影响问卷(DIVA),在此更名为DIVAS-Q(外阴阴道萎缩症状的日常影响问卷),以反映不同年龄组的外阴阴道萎缩症状。此外,有意扩大了葡萄牙各生育阶段有症状成年妇女的概念范围。设计和方法:在葡萄牙进行了一项多中心观察性研究,包括报告至少一种外阴阴道萎缩症状的绝经前和绝经后妇女。参与者从四个临床环境(公立和私立医院、私人诊所和初级卫生保健)招募。翻译遵循一个标准化的、多步骤的、向前向后的文化适应协议。心理测量学评价包括描述性分析、验证性因子分析(CFA)和序数指标的WLSMV/DWLS估计、内部一致性(Cronbach's alpha和McDonald's omega)、项目-总相关性、使用类内相关系数(ICCs)的重测信度、聚合效度和判别效度,以及基于外阴阴道症状问卷(VSQ)症状负担组的已知组效度。结果:共有291名女性完成了短版(19项),243名性活跃女性完成了长版(23项)。使用WLSMV/DWLS估计的CFA支持两个版本的原始四因素结构(日常活动、情绪幸福感、性功能和自我概念/身体形象),模型拟合良好(短版本的CFI/TLI = 0.981/0.978, RMSEA = 0.027;长版本的CFI/TLI = 0.973/0.970, RMSEA = 0.033; SRMR = 0.035-0.040)。所有领域的内部一致性都很好(Cronbach's alpha = 0.856-0.960),项目-总相关性很强,平均方差提取值高于推荐阈值。重测信度极好(ICC = 0.982 ~ 0.994, 95% ci均在0.95以上)。在VSQ症状负担较高的女性中,DIVAS-Q得分显著较高,支持已知组效度,跨域效应量大。结论:欧洲葡萄牙DIVAS-Q在评估葡萄牙成年女性外阴阴道萎缩相关症状的日常影响方面表现出良好的心理测量特性。研究结果支持其在葡萄牙的临床和研究背景下的使用,但在将其推广到其他葡语人群或使用它来监测临床有意义的变化之前,还需要进一步的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Patient-Reported Outcomes
Journal of Patient-Reported Outcomes Health Professions-Health Information Management
CiteScore
3.80
自引率
7.40%
发文量
120
审稿时长
20 weeks
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