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Application of NICE guideline NG12 to the initial assessment of patients with lower gastrointestinal symptoms: not FIT for purpose?

  • Quyn, Aaron J1
  • Steele, Robert Jc1
  • Digby, Jayne1
  • Strachan, Judith A2
  • Mowat, Craig3
  • McDonald, Paula J2
  • Carey, Francis A4
  • Godber, Ian M5
  • Younes, Hakim B6
  • Fraser, Callum G1
  • 1 1 Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, UK.
  • 2 2 Blood Sciences, Ninewells Hospital and Medical School, Dundee, UK.
  • 3 3 Department of Gastroenterology, Ninewells Hospital and Medical School, Dundee, UK.
  • 4 4 Department of Pathology, Ninewells Hospital and Medical School, Dundee, UK.
  • 5 5 Department of Biochemistry, Monklands Hospital, Lanarkshire, UK.
  • 6 6 Department of Surgery, Wishaw General Hospital, Lanarkshire, UK.
Published Article
Annals of Clinical Biochemistry International Journal of Laboratory Medicine
SAGE Publications
Publication Date
Jan 01, 2017
DOI: 10.1177/0004563217707981
PMID: 28661203


Background The National Institute for Health and Care Excellence (NICE) published NG12 in 2015. The referral criteria for suspected colorectal cancer (CRC) caused controversy, because tests for occult blood in faeces were recommended. Faecal immunochemical tests for haemoglobin (FIT), which estimate faecal haemoglobin concentrations (f-Hb), might more than fulfil the intentions. Our aim was to compare the utility of f-Hb as the initial investigation with the NICE NG12 symptom-based guidelines. Methods Data from three studies were included. Patients had sex, age, symptoms, f-Hb and colonoscopy and histology data recorded. Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) of f-Hb and NG12 were calculated for all significant colorectal disease (SCD: CRC, higher risk adenoma and inflammatory bowel disease). Overall diagnostic accuracy was also estimated by the area under the receiver operating characteristic curve (AUC). Results A total of 1514 patients were included. At a cut-off of ≥10 µg Hb/g faeces, the sensitivity of f-Hb for CRC was 93.3% (95% confidence interval (CI): 80.7-98.3) with NPV of 99.7% (95%CI: 99.2-99.9). The sensitivity and NPV for SCD were 63.2% (95%CI: 56.6-69.4) and 96.0% (95%CI: 91.4-94.4), respectively. The NG12 sensitivity and NPV for SCD were 58.4% (95%CI: 51.8-64.8) and 87.6% (95%CI: 85.0-89.8), respectively. The AUC for CRC was 0.85 (95% CI: 0.87-0.90) for f-Hb versus 0.65 (95%CI: 0.58-0.73) for NG12 ( P < 0.005). For SCD, the AUC was 0.73 (95%CI: 0.69-0.77) for f-Hb versus 0.56 (95%CI: 0.52-0.60) for NG12 ( P < 0.0005). Conclusion f-Hb provides a good rule-out test for SCD and has significantly higher overall diagnostic accuracy than NG12.

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