A core measurement set for Pouch anal and vaginal fistula research
Research type
Research Study
Full title
Title: The development of a core measurement set for research in pouch anal and vaginal fistula (PAVF-COMS)
IRAS ID
337566
Contact name
Phillip Tozer
Contact email
Sponsor organisation
London North West University Healthcare NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We aim to develop a core measurement set (CMS) of instruments for each of the pre-defined items in the core outcome set (COS) that can be used in ileo-anal pouch fistula research. A COS is an agreed standardised set of outcomes that should be reported in research trials, increasing our ability to synthesise results from multiple studies(1). The Pouch anal and vaginal fistula COS is a list of 7 items that should be reported in clinical trials. This has been established by Reza et al. using an online Delphi consensus method involving patients, surgeons, gastroenterologists, and radiologists with expertise in pouch anal or vaginal fistulae. The CMS is a set of measurement instruments or tools including patient reported outcome measures (PROM) that should be used by researchers to qualify or quantify a patient’s response to treatment for pouch fistula(2). We aim to use an online Delphi consensus method to select an outcome measurement instrument (OMI) for each of the seven core outcomes detailed in the COS.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0042
Date of REC Opinion
11 Mar 2024
REC opinion
Further Information Favourable Opinion