Optimal diagnostic accuracy of quantitative faecal immunochemical test positivity thresholds for colorectal cancer detection in primary health care: A community‐based cohort study

Vieito, Noel Pin; Nimo, Laura García; Bujanda, Luís; Alonso, Begona Román; Gutiérrez-Stampa, María A.; Aguilar-Gama, Vanessa; Portillo, Isabel; Cubiella, Joaquín

doi:10.1177/2050640620949714

Cited by 18 publications

(27 citation statements)

References 38 publications

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“…Finally, other large service evaluation studies 10 , 14 have now demonstrated similar results to those from the present data set, and the recently published NICE FIT study 15 adds high-volume multicentre research data to this consensus. No test is perfect, but there is now a high volume of data to demonstrate that FIT adds significant value to symptoms alone in aiding the decision to refer.…”

Section: Discussionsupporting

confidence: 85%

Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation

et al. 2021

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Background A novel pathway incorporating faecal immunochemical testing (FIT) for rapid colorectal cancer diagnosis (RCCD) was introduced in 2017. This paper reports on the service evaluation after 2 years of pathway implementation. Methods The RCCD protocol was based on FIT, blood results and symptoms to stratify adult patients in primary care. Two-week-wait (2WW) investigation was indicated for patients with rectal bleeding, rectal mass and faecal haemoglobin (fHb) level of 10 µg Hb/g faeces or above or 4 µg Hb/g faeces or more in the presence of anaemia, low ferritin or thrombocytosis, in all other symptom groups. Patients with 100 µg Hb/g faeces or above had expedited investigation . A retrospective audit of colorectal cancer detected between 2017 and 2019 was conducted, fHb thresholds were reviewed and critically assessed for cancer diagnoses. Results In 2 years, 14788 FIT tests were dispatched with 13361 (90.4 per cent) completed returns. Overall, fHb was less than 4 µg Hb/g faeces in 9208 results (68.9 per cent), 4–9.9 µg Hb/g in 1583 (11.8 per cent), 10–99.9 µg Hb/g in 1850 (13.8 per cent) and 100 µg Hb/g faeces or above in 720 (5.4 per cent). During follow-up (median 10.4 months), 227 colorectal cancers were diagnosed. The cancer detection rate was 0.1 per cent in patients with fHb below 4 µg Hb/g faeces, 0.6 per cent in those with fHb 4–9.9 µg Hb/g faeces, 3.3 per cent for fHb 10–99.9 µg Hb/g faeces and 20.7 per cent for fHb 100 µg Hb/g faeces or above. The detection rate in the cohort with 10–19.9 µg Hb/g faeces was 1.4 per cent, below the National Institute for Health and Care Excellence threshold for urgent referral. The colorectal cancer rate in patients with fHb below 20 µg Hb/g faeces was less than 0.3 per cent. Conclusion Use of FIT to "rule out" urgent referral from primary care misses a small number of cases. The threshold for referral may be adjusted with blood results to improve stratification .

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Section: Discussionsupporting

confidence: 85%

Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation

et al. 2021

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“…The significant risk of CRC associated with a high FIT demonstrates the value of FIT for stratifying patients that need urgent investigation wherever diagnostic capacity is constrained, as well as in the challenging environment brought on by COVID-19. Conversely, a negative FIT corresponds with a 0.3% risk of CRC in this cohort which is consistent with previous service evaluation as well as emerging data from multicentre research studies [7,11]. FIT appears safe for "rule out" and our data confirm its utility across all groups including IDA.…”

Section: Discussionsupporting

confidence: 90%

Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population

et al. 2021

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Background Guidelines for urgent investigation of colorectal cancer (CRC) are based on age and symptom-based criteria. This study aims to compare the diagnostic value of clinical features and faecal immunochemical test (FIT) results to identify those at a higher risk of CRC, thereby facilitating effective triage of patients. Methods We undertook a review of all patients referred for investigation of CRC at our centre between September 2016 and June 2018. Patients were identified using a prospectively recorded local database. We performed a logistic regression analysis of factors associated with a diagnosis of CRC. Results One-thousand-and-seven-hundred-eighty-four patients with FIT results were included in the study. Change in bowel habit (CIBH) was the most common referring clinical feature (38.3%). Patients diagnosed with CRC were significantly older than those without malignancy (74.0 years vs 68.9 years, p = 0.0007). Male patients were more likely to be diagnosed with CRC than females (6.5% vs 2.5%, Chi-squared 16.93, p < 0.0001). CRC was diagnosed in 3.5% (24/684) with CIBH compared to 8.1% (6/74) with both CIBH and iron deficiency anaemia. No individual or combination of referring clinical features was associated with an increased diagnosis of CRC (Chi-squared, 8.03, p = 0.155). Three patients with negative FIT results (< 4 µg Hb/g faeces) were diagnosed with CRC (3/1027, 0.3%). The highest proportion of cancers detected was in the ≥ 100 µg Hb/g faeces group (55/181, 30.4%). Conclusion In a multivariate model, FIT outperforms age, sex and all symptoms prompting referral. FIT has greater stratification value than any referral symptoms. FIT does have value in patients with iron deficiency anaemia.

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“…The lower f-Hb values were chosen because 2 mg/g is the LoD, 7 mg/g is the LoQ, <10 mg/g was used as the value that was communicated to the GP as a robust indication that, with the exceptions noted earlier, further investigation was not generally required, as per NICE DG30 6 and <20 mg/g has been recommended as the most appropriate f-Hb value for the rather different clinical setting of asymptomatic population screening for CRC 23 and has been used in assessment of symptomatic patients in at least one other study. 24 Table 4 shows the characteristics of all the patients with a f-Hb <20 mg/g who were diagnosed with CRC, either as a result of their initial referral immediately after the f-Hb result, or subsequently identified by interrogating the available databases or linkage to the SCR.…”

Section: Resultsmentioning

confidence: 99%

“…The lower f-Hb values were chosen because 2 µg/g is the LoD, 7 µg/g is the LoQ, <10 µg/g was used as the value that was communicated to the GP as a robust indication that, with the exceptions noted earlier, further investigation was not generally required, as per NICE DG30 6 and <20 µg/g has been recommended as the most appropriate f-Hb value for the rather different clinical setting of asymptomatic population screening for CRC 23 and has been used in assessment of symptomatic patients in at least one other study. 24 …”

Section: Resultsmentioning

confidence: 99%

Faecal haemoglobin concentration thresholds for reassurance and urgent investigation for colorectal cancer based on a faecal immunochemical test in symptomatic patients in primary care

et al. 2021

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Background Faecal haemoglobin concentration (f-Hb), estimated using a faecal immunochemical test, 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 faecal immunochemical test 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 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.

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Optimal diagnostic accuracy of quantitative faecal immunochemical test positivity thresholds for colorectal cancer detection in primary health care: A community‐based cohort study

Cited by 18 publications

References 38 publications

Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation

Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation

Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population

Faecal haemoglobin concentration thresholds for reassurance and urgent investigation for colorectal cancer based on a faecal immunochemical test in symptomatic patients in primary care

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