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  • 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

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Colorectal disease
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
  1. Craig Mowat1,
  2. Jayne Digby2,
  3. Judith A Strachan3,
  4. Rebecca McCann3,
  5. Christopher Hall4,
  6. Duncan Heather4,
  7. Francis Carey5,
  8. Callum G Fraser2,
  9. Robert J C Steele2
  1. 1Department of Gastroenterology, Ninewells Hospital and Medical School, Dundee, UK
  2. 2Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK
  3. 3Department of Blood Sciences, Ninewells Hospital and Medical School, Dundee, UK
  4. 4Health Informatics Centre, University of Dundee, Dundee, UK
  5. 5Department of Pathology, Ninewells Hospital and Medical School, Dundee, UK
  1. Correspondence to Dr Craig Mowat; craig.mowat{at}nhs.net

Abstract

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 µg 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 µg/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 µg/g vs 32.3% in patients with f-Hb ≥10 µg/g. One CRC was detected at CT colonoscopy. 2521 patients were not immediately referred (95.3% had f-Hb <10 µg/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.

  • bowel disease
  • colorectal disease
  • faecal biomarkers
  • faecal immunochemical test
  • faecal haemoglobin
  • colorectal cancer
  • primary care

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjgast-2019-000293

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    Footnotes

    • Contributors CM, JAS and RJCS designed, planned and conducted the study. RM analysed the faecal samples. CH and DH performed the record linkage. JD performed the statistical analysis and produced the figures and tables. All authors contributed to data interpretation and writing of the paper. CM wrote the final draft which was approved by all authors.

    • Funding This study has been funded by Detect Cancer Early initiative (Scottish Government) and Chief Scientist Office.

    • Competing interests CGF has undertaken paid consultancy with Immunostics, Ocean, NJ, USA, and Kyowa Medex, Tokyo, Japan, and has received support for attendance at conferences from Alpha Labs, Eastleigh, Hants, UK.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.