Development and Psychometric Testing of an Electronic Patient-Reported Outcome Tool for Vulval Disorders (ePAQ-Vulva)

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Abstract

Objective

Development of an electronic patient-reported outcome measure (PROM) specifically designed for vulval disorders. Psychometric testing of the components of the questionnaire, which assess vulval symptoms, sexual function, and quality of life (QoL).

Materials and Method

Development and programming of the instrument (ePAQ-Vulva) was informed by national guidelines for the assessment of vulval disorders, an expert panel, and a survey of 61 vulval clinic patients. The PROM assesses frequency and impact of vulval symptoms, sexual function, and QoL. It also records conditions and behaviors related to vulval disorders and patient concerns/goals.

Materials and Method

Scale generation and psychometric testing were undertaken for the vulval symptoms, sexual function, and QoL components of the PROM with 91 participants; descriptive statistics, factor analysis and internal reliability of identified domains, and agreement between free-text and multiple-choice items to assess convergent validity and interrater reliability of picture items were assessed.

Results

Descriptive statistics showed high floor effects for seven questionnaire items. Factor analysis identified 5 principal components. These were reviewed and amended to provide a putative domain structure of 6 domains. Internal reliability of these domains was assessed using Cronbach α, producing values of 0.715 to 0.917. Interrater reliability of the picture items produced a κ statistic of 0.405. Spearman rank showed moderate correlation between multiple-choice answers and free-text concerns (r = 0.364–0.462) in 3 of the 6 domains (pain, sex, and dyspareunia).

Conclusions

ePAQ-Vulva offers the first patient-reported outcome tool, specifically designed for vulval disorders. The instrument requires further validation and testing, including evaluation of the stability, responsiveness, and reliability.

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