Establishing the optimum threshold value for haemoglobin in faecal immunochemical tests (FITs) for use in the primary care symptomatic population: South West Cancer Alliance FIT programme evaluation
Bailey, SER; Van Melle, M; Hamilton, W; et al.Walter, F
Date: 20 August 2018
Publisher
University of Exeter
Abstract
Colorectal cancer is the fourth most common cancer in the UK, and the second leading cause of
cancer-related deaths. Diagnosing colorectal cancer is difficult, as the symptoms are the same as
many non-cancerous conditions.
The NICE guideline NG12 (2015) recommends that patients consulting their GP with ‘alarm’
symptoms of colorectal ...
Colorectal cancer is the fourth most common cancer in the UK, and the second leading cause of
cancer-related deaths. Diagnosing colorectal cancer is difficult, as the symptoms are the same as
many non-cancerous conditions.
The NICE guideline NG12 (2015) recommends that patients consulting their GP with ‘alarm’
symptoms of colorectal cancer are urgently referred for colonoscopy. However, not all patients with
colorectal cancer have these alarm symptoms. Many have vague low-risk symptoms that do not
warrant a colonoscopy under NG12. In 2017, a new NICE guidance DG30 suggested that faecal
immunochemical tests (FITs) are used for patients with these vague symptoms that could suggest
colorectal cancer, but do not represent a great enough risk for an urgent referral. FITs measure the
amount of haemoglobin (Hb) in a stool sample. A high level of Hb in a stool sample may suggest
bleeding in the bowel caused by cancer. However, we don’t know how high Hb in the stool should be
before the patient is offered a colonoscopy, when the patient has these vague symptoms.
In this study, our primary aims are 1) to determine the optimum cut off point for Hb in FITs in a
symptomatic primary care population, and 2) to estimate the diagnostic performance of FITs at
detecting cancer in a symptomatic primary care population.
In the South West, FITs have been in use since June 2018. We will collect data on all FITs performed
in the region during the 18-month study period. This will include the amount of Hb present in the
patients’ samples, whether or not they were referred for colonoscopy, patient demographic data,
the type of FIT used, and whether or not the patient was diagnosed with colorectal cancer within
one year of their FIT. We will also collect data on the number and type of referrals and diagnoses in
the region during the study period, and the number of FITs ordered from primary care during that
time. We estimate that around 30,000 FITs will be performed during the data collection period.
This study will be complemented by a narrative review providing an overview of FIT use across the
globe in primary care symptomatic patients, and a health economics study to evaluate the cost
implications of FITs.
Institute of Health Research
Collections of Former Colleges
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