Core Outcome Measurement Set for fistulising perianal Crohn's disease
Research type
Research Study
Full title
Development of a Core Measurement Set for fistulising perianal Crohn's disease
IRAS ID
336306
Contact name
Phil Tozer
Contact email
Sponsor organisation
London North West University NHS Trust
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Perianal fistulising disease is a condition that can significantly impact an individual’s ability to work and function within society. It is important that clinical studies are conducted to improve outcomes for this subset of patients, in order to improve decision-making and overall patient care.
Clinical studies are undertaken to compare interventions for a health condition and decide which is better for the patient. There are currently multiple studies that test the same intervention, thus allowing researchers to collate and combine results to reach a more confident conclusion. However, for this to be possible, the same outcomes must have been used across studies.
A core outcome set for fistulising perianal Crohn’s disease has been developed to determine which outcomes should be measured in a clinical trial for the condition. We aim to create a core measurement set for fistulising perianal Crohn’s disease that will outline the optimal measurement instruments to be used for each outcome and the time point at which the measurement should be undertaken. This will be generated by consensus involving patients with fistulising perianal Crohn’s disease and healthcare professionals who treat the condition. The study will be undertaken from St Mark’s hospital, the national hospital specialising in bowel conditions.
The initial phase will involve a literature review to identify all measurement instruments that have been used to assess fistulising perianal Crohn’s disease and an assessment of their methodological quality.
The next phase will involve a Delphi consensus exercise; this will include up to three rounds of questionnaires over approximately three months. This will involve patients and clinician stakeholders. Participants will be asked to rank measurement instruments in order of preference and justify their answers. The process will culminate with a 2-hour consensus meeting with interactive voting to determine the final core measurement set.
REC name
London - Harrow Research Ethics Committee
REC reference
23/PR/1532
Date of REC Opinion
16 Jan 2024
REC opinion
Further Information Favourable Opinion