Background:
There is currently no defined core outcome set for pouch anal or vaginal fistulae. A modified Delphi process has been performed in order to address this, resulting in a core outcome set (Reza et al. – unpublished at time of writing) that will improve research in this debilitating complication of ileo-anal pouch surgery. A core measurement set of instruments is subsequently required to ensure the individual items of the core outcome set can be appropriately measured in clinical research.
Aim: We aim to develop a core measurement set of instruments for each of the items in the core outcome set that can be used in pouch fistula research.
Method: The target population is defined by all adult patients with ileoanal pouch anal and vaginal fistulae. A systematic review of outcome measurement instruments used in pouch anal and vaginal fistula research will be performed using MEDLINE, EMBASE and Cochrane databases. We will use the COSMIN (Consensus-based standards for the selection of health status measurement instruments) checklist to assess the methodological quality of these tools or outcome measurement instruments (OMI). Generic recommendations will then be made on the selection of outcome measurement instruments with one OMI for each outcome, using a Delphi consensus methodology involving patients, surgeons, gastroenterologists, and radiologists experienced in the management of pouch fistulae. Each OMI must demonstrate good content validity, good internal consistency and represent a feasible outcome measurement. Where there is no suitable measurement for any of the core outcomes, we will recommend further work to develop and validate an appropriate measurement tool.
Conclusion: Pouch anal and vaginal fistulae are a rare but significant complication of pouch surgery and treatments currently available are associated with a high rate of recurrence. A core measurement set specifically developed for a core outcome set will standardise reporting outcomes in trials for this condition, with the aim of improving the quality and outcomes for patients.
Principal Investigator :
Mr Phil Tozer, Consultant Colorectal surgeon, St Mark's Academic institute/Imperial college London
Co-investigators:
Professor Sue Clark, Consultant Colorectal surgeon,St Mark's Academic institute/Imperial college London
Professor Ailsa Hart, Consultant Gastroenterologist,St Mark's Academic institute/Imperial college London
Dr Phillip Lung, Consultant Radiologist,St Mark's Academic institute/Imperial college London
Clinical Research fellow (St Mark's Academic institute/Imperial college London)
Mr Easan Anand
Miss Shivani Joshi
Disease Category: Gastroenterology
Disease Name: Pouch anal fistula, Vaginal fistula
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Drug, Surgery
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Systematic review
The target population is defined by all adult patients with ileoanal pouch anal and vaginal fistulae. A systematic review of outcome measurement instruments used in pouch anal and vaginal fistula research will be performed using MEDLINE, EMBASE and Cochrane databases. We will use the COSMIN (Consensus-based standards for the selection of health status measurement instruments) checklist to assess the methodological quality of these tools or outcome measurement instruments (OMI).
Generic recommendations will then be made on the selection of outcome measurement instruments with one OMI for each outcome, using a Delphi consensus methodology involving patients, surgeons, gastroenterologists, and radiologists experienced in the management of pouch fistulae. Each OMI must demonstrate good content validity, good internal consistency and represent a feasible outcome measurement. Where there is no suitable measurement for any of the core outcomes, we will recommend further work to develop and validate an appropriate measurement tool.