Impact of introducing a faecal immunochemical test (FIT) for haemoglobin into primary care on the outcome of patients with new bowel symptoms: a prospective cohort study

Objective To determine whether a faecal immunochemical test (FIT) for faecal haemoglobin concentration (f-Hb) can be safely implemented in primary care as a rule-out test for significant bowel disease (SBD) (colorectal cancer (CRC), higher risk adenoma (HRA) and inflammatory bowel disease (IBD)) when used as an adjunct to the clinical assessment of new bowel symptoms. Design Single-centre prospective cohort study of all patients who attended primary care and submitted a FIT in the first calendar year of the service beginning December 2015. f-Hb was estimated using HM-JACKarc (Kyowa Medex) with a clinical cut-off of >= 10 mu g Hb/g faeces. Incident cases of CRC were verified via anonymised record linkage to the Scottish Cancer Registry. Results 5422 patients submitted 5660 FIT specimens, of which 5372 were analysed (positivity: 21.9%). 2848 patients were referred immediately to secondary care and three with f-Hb < 10 mu g/g presented acutely within days with obstructing CRC. 1447 completed colonoscopy in whom overall prevalence of SBD was 20.5% (95 CRC (6.6%), 133 HRA (9.2%) and 68 IBD (4.7%)); 6.6% in patients with f-Hb < 10 mu g/g vs 32.3% in patients with f-Hb >= 10 mu g/g. One CRC was detected at CT colonoscopy. 2521 patients were not immediately referred (95.3% had f-Hb < 10 mu g/g) of which four (0.2%) later developed CRC. Record linkage identified no additional CRC cases within a follow-up period of 23-35 months. Conclusion In primary care, measurement of f-Hb, in conjunction with clinical assessment, can safely and objectively determine a patient's risk of SBD.