Validation of the utility of a faecal immunochemical test for haemoglobin (FIT) in patients presenting to primary care with new bowel symptoms

2017 ◽  
Author(s):  
Jayne Digby
Keyword(s):  
Primary Care ◽  
Faecal Immunochemical Test ◽  
Bowel Symptoms ◽  
Immunochemical Test

scholarly journals 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

2019 ◽  
Vol 6 (1) ◽  
pp. e000293 ◽  
Author(s):  
Craig Mowat ◽  
Jayne Digby ◽  
Judith A Strachan ◽  
Rebecca McCann ◽  
Christopher Hall ◽  
...  
Keyword(s):  
Primary Care ◽  
Cohort Study ◽  
Prospective Cohort Study ◽  
Clinical Assessment ◽  
Bowel Disease ◽  
Record Linkage ◽  
Prospective Cohort ◽  
Faecal Immunochemical Test ◽  
Bowel Symptoms ◽  
Immunochemical Test

ObjectiveTo 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.DesignSingle-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.Results5422 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.ConclusionIn primary care, measurement of f-Hb, in conjunction with clinical assessment, can safely and objectively determine a patient’s risk of SBD.

scholarly journals Measurement of faecal haemoglobin with a faecal immunochemical test can assist in defining which patients attending primary care with rectal bleeding require urgent referral

2020 ◽  
Vol 57 (4) ◽  
pp. 325-327 ◽  
Author(s):  
Jayne Digby ◽  
Judith A Strachan ◽  
Rebecca McCann ◽  
Robert JC Steele ◽  
Callum G Fraser ◽  
...  
Keyword(s):  
Primary Care ◽  
Rectal Bleeding ◽  
Bowel Disease ◽  
Haemoglobin Concentration ◽  
Faecal Immunochemical Test ◽  
Alarm Symptom ◽  
Immunochemical Test ◽  
Inflammatory Bowel ◽  
Single Cancer ◽  
Current Guidelines

Background Current guidelines document persistent rectal bleeding as an alarm symptom in patients presenting to primary care. We studied whether a faecal immunochemical test could assist in their assessment. Methods From December 2015, faecal immunochemical tests were routinely available to primary care when assessing patients with new-onset bowel symptoms: general practitioners were encouraged to include faecal haemoglobin concentration (f-Hb) within any referral to secondary care. Results with f-Hb ≥10  μg Hb/g faeces were defined as positive. The incidence of significant bowel disease (SBD: colorectal cancer [CRC], higher-risk adenoma [HRA: any ≥1 cm, or three or more] and inflammatory bowel disease [IBD]) at subsequent colonoscopy, referred symptoms and f-Hb were recorded. Results Of 1447 patients with a faecal immunochemical test result and colonoscopy outcome, SBD was diagnosed in 296 patients (20.5%; 95 with CRC, 133 with HRA, and 68 with IBD). Four hundred and sixty-two patients (31.9%) reported rectal bleeding: 294 had f-Hb ≥10  μg Hb/g faeces. At colonoscopy, 105/294 had SBD versus 14/168 with rectal bleeding and f-Hb <10  μg Hb/g faeces ( P < 0.0001), comprising one case of CRC (0.6%), 12 HRA (7.1%) and one new case of IBD (0.6%); further, the single cancer and 8 of the 12 HRA were located in the descending colon. Conclusion Patients with rectal bleeding and f-Hb <10  μg Hb/g faeces are unlikely to have SBD and could be investigated by sigmoidoscopy alone. Using the faecal immunochemical test to guide investigation of patients with rectal bleeding is a rational and practical way forward.

scholarly journals EXPRESS: Faecal haemoglobin concentration thresholds for reassurance and urgent investigation for colorectal cancer based on a faecal immunochemical test (FIT) in symptomatic patients in primary care.

2020 ◽  
pp. 000456322098554
Author(s):  
Craig Mowat ◽  
Jayne Digby ◽  
Judith A Strachan ◽  
Rebecca Katherine McCann ◽  
Francis A Carey ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Care ◽  
Gastrointestinal Disease ◽  
Haemoglobin Concentration ◽  
Individual Risk ◽  
First Year ◽  
Faecal Immunochemical Test ◽  
Persistent Symptoms ◽  
Immunochemical Test ◽  
Hb Concentration

Background Faecal haemoglobin concentration (f-Hb), estimated using a faecal immunochemical test (FIT), can be safely implemented in primary care to assess risk of colorectal cancer (CRC). Clinical outcomes of patients presenting with symptoms of lower gastrointestinal disease were examined using an extensive range of f-Hb thresholds to decide on reassurance or referral for further investigation. Methods All patients who attended primary care and submitted a single faecal specimen FIT in the first year of the routine service had f-Hb estimated using HM-JACKarc: f-Hb thresholds from <2 to > 400 µg Hb/g faeces (µg/g) were examined. Results Low f-Hb thresholds of <2, <7, <10 and <20 µg/g gave respective CRC risks of 0.1, 0.3, 0.3 and 0.4%, numbers needed to scope (NNS) for one CRC of 871, 335, 300 and 249, and “false negative” rates of 2.9, 11.4, 13.3 and 17.1%. With thresholds of <2, <7, <10, and <20 µg/g, 48.6, 74.6, 78.1 and 83.2% respectively of symptomatic patients could be managed without further investigation. With reassurance thresholds of <2 µg/g, <7 µg/g and <10 µg/g, the thresholds for referral for urgent investigation would be >400 µg/g, >200 µg/g and >100 µg/g. However, patients with a f-Hb concentration of <10 or <20 µg/g with iron deficiency anaemia, or with severe or persistent symptoms, should not be denied further investigation. Conclusions In primary care, f-Hb, in conjunction with clinical assessment, can safely and objectively determine individual risk of CRC and decide on simple reassurance or urgent, or routine referral.

scholarly journals Diagnostic performance of a faecal immunochemical test for patients with low-risk symptoms of colorectal cancer in primary care: an evaluation in the South West of England

2021 ◽  
Author(s):  
Sarah E. R. Bailey ◽  
Gary A. Abel ◽  
Alex Atkins ◽  
Rachel Byford ◽  
Sarah-Jane Davies ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Care ◽  
Predictive Value ◽  
Low Risk ◽  
The South ◽  
Faecal Immunochemical Test ◽  
Urgent Referral ◽  
South West ◽  
Immunochemical Test ◽  
Risk Of Cancer

Abstract Background The faecal immunochemical test (FIT) was introduced to triage patients with low-risk symptoms of possible colorectal cancer in English primary care in 2017, underpinned by little primary care evidence. Methods All healthcare providers in the South West of England (population 4 million) participated in this evaluation. 3890 patients aged ≥50 years presenting in primary care with low-risk symptoms of colorectal cancer had a FIT from 01/06/2018 to 31/12/2018. A threshold of 10 μg Hb/g faeces defined a positive test. Results Six hundred and eighteen (15.9%) patients tested positive; 458 (74.1%) had an urgent referral to specialist lower gastrointestinal (GI) services within three months. Forty-three were diagnosed with colorectal cancer within 12 months. 3272 tested negative; 324 (9.9%) had an urgent referral within three months. Eight were diagnosed with colorectal cancer within 12 months. Positive predictive value was 7.0% (95% CI 5.1–9.3%). Negative predictive value was 99.8% (CI 99.5–99.9%). Sensitivity was 84.3% (CI 71.4–93.0%), specificity 85.0% (CI 83.8–86.1%). The area under the ROC curve was 0.92 (CI 0.86–0.96). A threshold of 37 μg Hb/g faeces would identify patients with an individual 3% risk of cancer. Conclusions FIT performs exceptionally well to triage patients with low-risk symptoms of colorectal cancer in primary care; a higher threshold may be appropriate in the wake of the COVID-19 crisis.

scholarly journals Diagnostic performance of the faecal immunochemical test for patients with low-risk symptoms of colorectal cancer in primary care: a service evaluation in the South West of England

2020 ◽  
Author(s):  
Sarah ER Bailey ◽  
Gary A Abel ◽  
Alex Atkins ◽  
Rachel Byford ◽  
Sarah-Jane Davies ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Care ◽  
Predictive Value ◽  
Secondary Care ◽  
Diagnostic Performance ◽  
Low Risk ◽  
Faecal Immunochemical Test ◽  
South West ◽  
Immunochemical Test ◽  
Risk Of Cancer

Objectives To evaluate the faecal immunochemical test (FIT) for primary care clinicians to triage patients with low-risk symptoms of possible colorectal cancer, and to estimate its diagnostic performance. Design Service delivery evaluation. Setting All primary and secondary care providers in the South West of England, approximate population 4 million. Participants 3890 patients aged ≥50 years presenting in primary care with low-risk symptoms of colorectal cancer, following NICE NG12 and DG30, with a FIT (HM-JACKarc assay) analysed from 01/06/2018 to 31/12/2018. Main outcome measures Diagnosis of colorectal cancer. Results 618 (15.9%) patients tested positive at a threshold of 10μg Hb/g faeces (median 36μg Hb/g faeces (IQR 17 to 149)); 458 (74.1%) of these had an urgent referral to specialist lower gastrointestinal (GI) services within three months. 43 were diagnosed with colorectal cancer within 12 months. 3272 patients tested negative; 324 (9.9%) were referred on an urgent lower GI pathway in secondary care within three months. 8 were diagnosed with colorectal cancer within 12 months. The positive predictive value of FIT for colorectal cancer in the low-risk symptomatic population was 7.0% (95% CI 5.1% to 9.3%) and the negative predictive value was 99.8% (CI 99.5% to 99.9%). Sensitivity was 84.3% (CI 71.4% to 93.0%), and specificity 85.0% (CI 83.8% to 86.1%). The area under the ROC curve was 0.92 (CI 0.86 to 0.96). A threshold of 37μg Hb/g faeces would identify patients with an individual 3% risk of cancer. Conclusions FIT performs exceptionally well to triage patients with low-risk symptoms of colorectal cancer in primary care. The threshold value of 10μg Hb/g faeces represents a risk of cancer below 3% used in current NICE guidance; however, this lower value may be appropriate to meet the national aspiration of improving cancer diagnostics.

scholarly journals Combining the quantitative faecal immunochemical test and full blood count reliably rules out colorectal cancer in a symptomatic patient referral pathway

2021 ◽  
Author(s):  
Mark S. Johnstone ◽  
Paul Burton ◽  
Georgios Kourounis ◽  
Jack Winter ◽  
Emilia Crighton ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Primary Care ◽  
Blood Count ◽  
Binary Logistic Regression ◽  
Symptomatic Patient ◽  
Full Blood Count ◽  
Faecal Immunochemical Test ◽  
Immunochemical Test ◽  
Male Sex

Abstract Purpose Faecal Immunochemical Test (FIT) has proven utility for Colorectal Cancer (CRC) detection in symptomatic patients. Most studies have examined FIT in symptomatic patients subsequently referred from primary care. We investigated associations between CRC and FIT in both referred and non-referred symptomatic patients. Methods A retrospective, observational study of all patients with a FIT submitted Aug 2018 to Jan 2019 in NHS GG&C was performed. Referral to colorectal/gastroenterology and decision to perform colonoscopy were recorded. FIT results were grouped as f-Hb < 10/10–149/150–399/ ≥ 400 μg/g. The MCN cancer registry identified new cases of CRC. Covariables were compared using the χ2 test. Multivariate binary logistic regression identified independent predictors of CRC. Results A total of 4968 patients were included. Raised FIT correlated with decision to refer (p < 0.001) and scope (p < 0.001). With 23-month median follow-up, 61 patients were diagnosed with CRC. These patients were older (median 69 vs 59 years, cancer and no cancer respectively, p = 0.001), more likely to be male (55.7% vs 42.1%, p = 0.033), and to report rectal bleeding (51.7% vs 36.1%, p = 0.013). FIT (< 10 µg/g 8.2% vs 76.7% and ≥ 400 µg/g 55.7% vs 3.8%, p < 0.001) and anaemia (45.9% vs 19.7%, p < 0.001) were associated with CRC. On multivariate analysis, age (p = 0.023), male sex (p = 0.04), FIT (≥ 400 OR 54.256 (95% CI:20.683–142.325; p < 0.001)), and anaemia (OR 1.956 (1.071–3.574; p = 0.029)) independently predicted CRC. One patient (0.04%) with a negative FIT and normal haemoglobin had CRC. Conclusion GP referral and secondary care investigation patterns were influenced by FIT. The combination of normal Hb and f-Hb excluded CRC in 99.96% of cases, providing excellent reassurance to those prioritising access to endoscopy services.

scholarly journals Quantitation of faecalFusobacteriumimproves faecal immunochemical test in detecting advanced colorectal neoplasia

Gut ◽  
2016 ◽  
Vol 66 (8) ◽  
pp. 1441-1448 ◽  
Author(s):  
Sunny H Wong ◽  
Thomas N Y Kwong ◽  
Tai-Cheong Chow ◽  
Arthur K C Luk ◽  
Rudin Z W Dai ◽  
...  
Keyword(s):  
Colorectal Neoplasia ◽  
Faecal Immunochemical Test ◽  
Advanced Colorectal Neoplasia ◽  
Immunochemical Test

scholarly journals Long-term effectiveness of faecal immunochemical test screening for proximal and distal colorectal cancers

Gut ◽  
2021 ◽  
pp. gutjnl-2020-322545
Author(s):  
Han-Mo Chiu ◽  
Grace Hsiao-Hsuan Jen ◽  
Ying-Wei Wang ◽  
Jean Ching-Yuan Fann ◽  
Chen-Yang Hsu ◽  
...  
Keyword(s):  
Large Scale ◽  
Distal Colon ◽  
Population Based ◽  
Proximal Colon ◽  
Advanced Stage ◽  
Site Specific ◽  
Faecal Immunochemical Test ◽  
Immunochemical Test ◽  
Selection Factors

ObjectiveTo measure the effects of faecal immunochemical test (FIT) for colorectal cancer (CRC) screening on overall and site-specific long-term effectiveness of population-based organised service screening.DesignA prospective cohort study of Taiwanese nationwide biennial FIT screening was performed. A total of 5 417 699 eligible subjects were invited to attend screening from 2004 through 2009 and were followed up until 2014. We estimated the adjusted relative rates (aRRs) on the effectiveness of reducing advanced-stage CRC (stage II+) and CRC death by Bayesian Poisson regression models with the full adjustment for a cascade of self-selection factors (including the screening rate and the colonoscopy rate) and the completeness of colonoscopy together with demographic features.ResultsFIT screening (exposed vs unexposed) reduced the incidence of advanced-stage CRC (48.4 vs 75.7 per 100 000) and mortality (20.3 vs 41.3 per 100 000). Statistically significant reductions of both incidence of advanced-stage CRCs (aRR=0.66, 95% CI 0.63 to 0.70) and deaths from CRC (aRR=0.60, 95% CI 0.57 to 0.64) were noted. FIT screening was more effective in reducing distal advanced-stage CRCs (aRR=0.61, 95% CI 0.58 to 0.64) and CRC mortality (aRR=0.56, 95% CI 0.53 to 0.69) than proximal advanced CRCs (aRR=0.84, 95% CI 0.77 to 0.92) and CRC mortality (aRR=0.72, 95% CI 0.66 to 0.80).ConclusionA large-scale population-based biennial FIT screening demonstrates 34% significant reduction of advanced-stage CRCs and 40% reduction of death from CRC with larger long-term effectiveness in the distal colon than the proximal colon. Our findings provide a strong and consistent evidence-based policy for supporting a sustainable population-based FIT organised service screening worldwide. The disparity of site-specific long-term effectiveness also provides an insight into the remedy for lower effectiveness of FIT screening in the proximal colon.

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