The development of a rectovaginal fistula (RVF) Core Outcome Set (COS)
Research type
Research Study
Full title
Developing a Rectovaginal Fistula Core Outcome Set (RVF-COS)
IRAS ID
261031
Contact name
Phil Tozer
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
1 years, 2 months, 23 days
Research summary
A rectovaginal fistula is an abnormal tract between the vagina and the rectum. This results in distressing symptoms such as the uncontrolled passage of wind and stool through the vagina. This can affect all aspect of life; such as social, professional and sex life. The condition is rare and can be caused from obstetric trauma, inflammatory bowel disease, radiotherapy, complications from surgery and malignancy.
The rare nature of the condition has resulted in the lack of trials and guidelines and often the literature details the surgeon's personal experience. This makes it difficult to compare evidence and outcomes in different studies and highlights the need for a core outcome set (COS). A COS is the minimum standardised set of outcomes that should be measured and reported in all studies for a specific condition.The aim of this project is to develop a COS for RVF. This first step will involve a systematic review to identify all outcomes. We will then conduct qualitative patient interviews to capture additional outcomes and understand outcome measures from the patient's perspective.
These outcomes will then be prioritised by patients and healthcare professionals via multi web-based Delphi rounds, followed by a consensus meeting. This is likely to happen remotely via Skype, Zoom or Microsoft Teams. This will be done to decide on the definitive COS. Experts within this field will be invited to participate to ensure the final COS is relevant and representative of stakeholders.
A Delphi process is a well recognised method to derive a group opinion/ a consensus opinion. This is done by surveying a panel of experts (such as patients and clinicians). After the panel has answered several rounds of the questionnaires, the responses are aggregated and shared with the group after each round. Following the web-based Delphi round, participants will be invited to a consensus meeting.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0931
Date of REC Opinion
28 Oct 2020
REC opinion
Further Information Favourable Opinion