Redesigning A Faster Pathway to IBD Diagnosis
Research type
Research Study
Full title
REDESIGNING A FASTER PATHWAY TO IBD DIAGNOSIS: CAN DIRECT-TO-PUBLIC STOOL BIOMARKER TESTING REDUCE THE TIME TO DIANGOSIS OF IBD?
IRAS ID
343084
Contact name
Tariq Ahmad
Contact email
Sponsor organisation
Royal Devon University Healthcare
Clinicaltrials.gov Identifier
2411680, RDUH
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
One-quarter of patients report symptoms for more than a year before the diagnosis of IBD is made. Why people with IBD wait so long to present with gastrointestinal symptoms is unclear. Embarrassment and the apprehension of invasive tests are common. Recent reports in patients with sexually transmitted infections suggest that this barrier may be overcome by the anonymity of direct-to-public testing.
Direct-to-public tests require the individual to collect a specimen, such as stool, and send it to the laboratory for testing without the involvement of a health care professional. Whether using calprotectin or FIT to identify people at risk of IBD in this way is acceptable or effective is unknown: but it could, reduce patient-delay and its implementation is worthy of investigation.
We propose a two-stage approach to answer this question:
RAPID-1: In a prospective cohort of about 200 patients newly diagnosed with IBD, we will define the time to diagnosis, split into the time from symptom onset to first GP contact, and by the time taken to move through primary and secondary care services.
Patients will complete a series of questionnaires and a subset will be asked to undergo semi-structured interview. This interview will be conducted by a qualitative researcher and will be used to identify barriers to presentation with gastrointestinal symptoms and how best to market and distribute direct-to-public stool tests.
RAPID-2: We will then pilot direct-to-public stool testing in 5,000 aimed at those aged 16-49 who are experiencing lower gastrointestinal symptoms. We will define the positivity rate of FIT and calprotectin tests in this group.
Finally, by comparing the proportion of patients who wait more than 4 months to be diagnosed with IBD in this cohort to that reported in Study 1, we will test if stool biomarkers used in this ambitious way, reduces the time to diagnosis of IBD.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0114
Date of REC Opinion
7 Jun 2024
REC opinion
Further Information Favourable Opinion