What question did this study set out to answer?

The aim is to create a specific tool to measure quality of life in women suffering from rectovaginal fistula.

January 23, 2026

P0369Development and validation of a patient reported outcome measure for rectovaginal fistula; The Vaginal Anal Fistula Quality of Life Scale (VaF-QoL)

Key Points

The aim is to create a specific tool to measure quality of life in women suffering from rectovaginal fistula.
Developed according to COSMIN guidelines.
Conducted unstructured interviews and a systematic review to generate a draft questionnaire.
Performed psychometric testing including cognitive interviews, test-retest reliability, and internal consistency.
Draft questionnaire consisted of 48 items after formative research.
Strong construct validity was established with significant correlations to established measures.
Finalized 20-item VaF-QoL with excellent internal consistency and strong responsiveness.

Abstract

Abstract Background A rectovaginal fistula (RVF) is a difficult condition to live with. Women often live in isolation facing daily struggles and challenges. An RVF extends beyond its clinical manifestations and impacts various aspects of quality of life (QoL). RVF related studies use different questionnaires to attempt to evaluate QoL in RVF patients, however, there is no disease specific patient reported outcome measure (PROM) for RVF. The aim of this study was to develop a measurement instrument to accurately assess QoL in RVF patients. Methods The PROM was developed in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. The process involved three phases; phase 1-generating a long list of items from unstructured interviews and systematic review that informed drafting of the questionnaire. This was refined by a study management group (SMG). Phase 2- psychometric testing with successive cognitive interviews gathering participants’ feedback on the draft questionnaire and item-level content validity index from experts. To determine the sensitivity and stability of the questionnaire, participants were invited to complete the draft questionnaire on a secure online platform on two separate time points two weeks apart for the test re-test phase. Internal consistency testing and construct validity 301 assessment were undertaken alongside validated questionnaires: Perianal disease activity index (PDAI), Hospital Anxiety Depression Scale (HADS), Short Form-12 (SF12). Results Phase 1 and 2 generated a 48-item draft questionnaire after a systematic review, unstructured interviews (n = 50) and psychometric testing (n = 20). Kaiser-Meyer-Olkin test confirmed sampling adequacy (KMO = 0.767) with Bartlett’s test of sphericity of sphericity (p 0.001). Four factors were identified: Emotional, physical symptoms, social/relationship and postpartum. Construct validity was excellent and clinically significant; PDAI- r = 0.728 (p 0.01), HADS- r = 0.539 (p 0.01) and SF-12- r = 0.455 (p 0.01). The instrument demonstrated excellent internal consistency (Cronbach’s α = 0.886). Stepwise regression yielded a concise 20- item questionnaire (VaFQoL), demonstrating strong responsiveness and reliability that represent more than then 95% of the total variance. Conclusion We developed a disease specific validated tool for RVF: the Vaginal anal fistula- QoL tool (VaF-QoL-20), suitable for use in both clinical practice and research. Conflict of interest: Ms. Sackitey, Charlene: No conflict of interest Al Rubaiy, Laith K Qassim: No conflict of interest Reza, Lillian: No conflict of interest Iqbal, Nusrat: No conflict of interest Lung, Phillip FC: No conflict of interest Vaizey, Carolynne: No conflict of interest Hart, Ailsa: No conflict of interest Tozer, Philip: No conflict of interest

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P0369Development and validation of a patient reported outcome measure for rectovaginal fistula; The Vaginal Anal Fistula Quality of Life Scale (VaF-QoL)

Key Points

Abstract

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