跳至主要内容
临床试验/NCT07250490
NCT07250490已完成不适用

Validation of the DIVAS-Q (Day to Day Impact of Vulvovaginal Atrophic Symptoms Questionnaire) A Portuguese Patient-Reported Outcome Measure

Instituto Politécnico de Leiria2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Psychometric validation of Day to Day Impact of Vaginal Ageing Questionnaire (DIVA) to Portuguese Woman from Portugal Country. The methodological approach is a descriptive cross-sectional study of qualitative and quantitative variables.

研究概览

简要总结

To determine the reliability and validity of the Portuguese version of the DIVA questionnaire in Portuguese women. This validation will support its use both in research and in routine clinical practice in this population.

详细描述

Prior to the initiation of this research protocol, the DIVA questionnaire was translated into European Portuguese following recommended best-practice guidelines. The process included the following sequential steps: (1) forward translation by two independent investigators; (2) reconciliation of the translations; (3) back-translation by two certified translators fluent in English; (4) unification and harmonization of the Portuguese version; (5) expert review by a panel of specialists in gynecology and sexology; and (6) pretesting in a group of patients, with final cultural adaptation of the DIVA scale into European Portuguese.

Symptoms that cannot be directly quantified but significantly affect quality of life can be assessed through self-reported health questionnaires. These clinical instruments play a key role: not only in identifying the clinical problem, but also in evaluating its individual impact across multiple psychological and physical dimensions, thereby helping to determine the effectiveness of therapeutic strategies in improving such subjective symptoms. For research to be valid, these instruments must be both appropriate and accurate in order to ensure the quality of the results.

Ageing in women has a significant impact on genital health, giving rise to a set of symptoms and signs collectively referred to as the genitourinary syndrome of menopause (GSM).

This clinical condition affects approximately 50% of postmenopausal women. While the urinary component of GSM can be quantified through validated diagnostic tests, vulvovaginal atrophy cannot be objectively measured. Its severity increases with advancing age, impacting self-esteem, well-being, and sexuality. Nevertheless, it often remains a taboo subject-stigmatized by women and under recognized by physicians. In this context, the DIVA questionnaire (Day-to-Day Impact of Vaginal Aging) combines the advantages of being practical for use in population-based studies, of transforming subjective measures into objective, quantifiable and analyzable data, and of assessing the relative weight of each domain or component of female genital atrophy on quality of life.

Other advantages of this questionnaire lie in the fact that it is a well-studied and validated instrument, with the ability to assess therapeutic interventions. It has also been adapted into languages other than English-including Spanish, Italian, German and Turkish-and has been validated within these cultural contexts.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • To present at least one symptom related to genital atrophy, referring to the external genitalia (vulva or vagina):
  • irritation
  • discomfort on urination or during intercourse
  • pain on urination or during intercourse
  • bleeding during intercourse

排除标准

  • pregnancy
  • active cancer
  • inability to speak Portuguese
  • mental or physical condition that prevents providing coherent responses to the questionnaire.

结局指标

主要结局

Psychometric validation of Day to Day Impact of Vaginal Ageing Questionnaire (DIVA) to Portuguese Woman from Portugal Country. The methodological approach is a descriptive cross-sectional study of qualitative and quantitative variables.

时间窗: Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.

Primary outcome measure focuses on the psychometric validation of the portuguese version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, including the evaluation of its internal consistency, factorial structure, construct validity, and test-retest reliability. The DIVA assesses the impact of vaginal aging symptoms in the daily activities, sexual function, emotional well-being, and self-concept/body image domains, with scores ranging from 0 to 92 (higher scores = worse impact). Two versions of the questionnaire are available: the full version with 23 items, which includes four items within the sexual function construct that can only be answered by women who are sexually active; and a shorter version with 19 items, which can be applied regardless of sexual activity status. Each item is rated on a five-point Likert scale, and the score for each dimension is calculated as the Mean of the corresponding items.

次要结局

  • Psychometric validation of Day to Day Impact of Vaginal Aging Questionnaire to Portuguese Woman with confirmatory factor analyses with other constructs(Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AndreiaAntunes

affiliated investigator, PhD Student, Consultant of Gynecology and Obstetrics

Instituto Politécnico de Leiria

研究点 (2)

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