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REducing Colonoscopies in patients without significant bowEl DiseasE : the RECEDE Study - protocol for a prospective diagnostic accuracy study
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Bradley, Christopher, Hee, Siew Wan, Andronis, Lazaros, Persaud, Krishna, Hull, Mark A, Todd, John, Taylor-Phillips, Sian, Smith, Steve, Constable, Rachel, Waugh, Norman and Arasaradnam, Ramesh P. (2022) REducing Colonoscopies in patients without significant bowEl DiseasE : the RECEDE Study - protocol for a prospective diagnostic accuracy study. BMJ Open, 12 (3). e058559. doi:10.1136/bmjopen-2021-058559 ISSN 2044-6055.
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WRAP-REducing-Colonoscopies-patients-without-significant-bowEl-DiseasE-Andronis-2022.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (695Kb) | Preview |
Official URL: http://dx.doi.org/10.1136/bmjopen-2021-058559
Abstract
ntroduction: Demand for colonoscopies and CT colonography (CTC) is exceeding capacity in National Health Service Trusts. In many patients colonoscopies and CTCs show no significant bowel disease (SBD). Faecal Immunochemical Testing (FIT) is being introduced to prioritise patients for colonoscopies but is insufficient to identify non-SBD patients meaning colonoscopy and CTC demand remains high. The REducing Colonoscopies in patients without significant bowEl DiseasE (RECEDE) study aims to test urine volatile organic compound (VOC) analysis alongside FIT to improve detection of SBD and to reduce the number of colonoscopies and CTCs.
Methods and analysis: This is a multicentre, prospective diagnostic accuracy study evaluating whether stool FIT plus urine VOC compared with stool FIT alone improves detection of SBD in patients referred for colonoscopy or CTC due to persistent lower gastrointestinal symptoms. To ensure SBD is not missed, the dual test requires a high sensitivity, set at 97% with 95% CI width of 5%. Our assumption is that to achieve this sensitivity requires 200 participants with SBD. Further assuming 19% of all participants will have SBD and 55% of all participants will return both stool and urine samples we will recruit 1915 participants. The thresholds for FIT and VOC results diagnosing SBD have been pre-set. If either FIT or VOC exceeds the respective threshold, the participant will be classed as having suspected SBD. As an exploratory analysis we will be testing different thresholds. The reference comparator will be a complete colonoscopy or CTC. Secondary outcomes will look at optimising the FIT and VOC thresholds for SBD detection. An economic evaluation, using a denovo decision analytic model, will be carried out determine the costs, benefits and overall cost-effectiveness of FIT +VOC vs FIT followed by colonoscopy.
| Item Type: | Journal Article | ||||||
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| Subjects: | Q Science > QP Physiology R Medicine > RB Pathology R Medicine > RC Internal medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||
| Library of Congress Subject Headings (LCSH): | Colonoscopy , Colon (Anatomy) -- Tomography, Intestines -- Diseases -- Diagnosis , Feces -- Examination, Volatile organic compounds -- Health aspects, Volatile organic compounds -- Analysis, Urine -- Analysis | ||||||
| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 30 March 2022 | ||||||
| Dates: |
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| Volume: | 12 | ||||||
| Number: | 3 | ||||||
| Article Number: | e058559 | ||||||
| DOI: | 10.1136/bmjopen-2021-058559 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 31 March 2022 | ||||||
| Date of first compliant Open Access: | 1 April 2022 | ||||||
| RIOXX Funder/Project Grant: |
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