Faecal immunochemical test accuracy in patients referred for surveillance colonoscopy: a multi-centre cohort study

Droste, Jochim S. Terhaar sive; Turenhout, Sietze T. van; Oort, Frank A.; Hulst, R. W. M. Van Der; Steeman, Vincent A; Coblijn, Usha K.; Eem, Lisette van der; Duijkers, Ruud; Bouman, A.; Meijer, Gerrit A.; Depla, Annekatrien; Scholten, Pieter; Loffeld, R. J. L. F.; Coupé, Veerle M.H.; Mulder, Chris J.

doi:10.1186/1471-230x-12-94

Cited by 33 publications

(31 citation statements)

References 30 publications

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“…Instead, they found a lower sensitivity probably owing to a smaller sample size and inclusion of patients with recent colonoscopy. 37 Furthermore, in a pilot study performed in Spain, FIT at a 50 ng/ml cutoff point showed a high sensitivity (83%) and specificity (91%) for detecting advanced adenomas in individuals with a family history of CRC. 6 Our main contribution is that we have specifically evaluated FIT diagnostic yield for CRC and AN in asymptomatic population with FDRs with CRC.…”

Section: Discussionmentioning

confidence: 94%

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Castro

Cubiella

Rivera

et al. 2013

Intl Journal of Cancer

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There is little information on fecal immunochemical test (FIT) in familial risk colorectal cancer (CRC) screening. Our study assesses FIT accuracy, number needed to scope (NNS) and cost to detect a CRC and an advanced neoplasia (AN) in this setting. We performed a multicentric, prospective, double-blind study of diagnostic tests on individuals with first-degree relatives (FDRs) with CRC submitted to screening colonoscopy. Two stool samples were collected and fecal hemoglobin in the first sample (FIT1) and the highest in both samples (FITmax) were determined. Areas under the curve (AUC) for CRC and AN as well as the best FIT1 and FITmax cutoff value for CRC were determined. At this threshold, NNS and the cost per lesion detected were calculated. A total of 595 individuals were included (one FDR > 60 years, 413; two FDR or one 60 years, 182). AN and CRC were found in 64 (10.8%) and six (1%) patients, respectively. For CRC diagnosis, FIT1 AUC was 0.96 [95% confidence interval (CI): 0.95-0.98] and FITmax AUC was 0.95 (95% CI: 0.93-0.97). For AN diagnosis, FIT1 and FITmax AUC were 0.74 (95% CI: 0.66-0.82). The best cutoff point for CRC was 115. At this threshold, the NNS to detect a CRC was 5.67 and 7.67, and the cost per CRC was 1,064e and 1591.33e on FIT1 and FITmax strategies, respectively. FIT shows high accuracy to detect CRC in familial CRC screening. Performing two tests does not improve diagnostic accuracy, but increases cost and NNS to detect a lesion.Colorectal cancer (CRC) is the third most common cancer worldwide and the second leading cause of cancer deaths in developed countries. 1 Several factors have been related to the risk of developing CRC. Age, sex and CRC familial history, especially if there are first-degree relatives (FDR) with CRC, are the strongest associated risk factors. 2 Furthermore, CRC risk is directly related to the number of FDRs and inversely related to the age of youngest FDRs. 3,4 Evidence on the best screening strategy in this population is limited and its quality is low. 5,6 At present, it is unclear which is the best screening strategy in individuals with a FDR with CRC. 7 Clinical practice guidelines recommend more aggressive screening than in average risk population, based on studies that have shown that endoscopic screening reduces CRC incidence and mortality in individuals with a FDR with CRC. 2,8 Screening is recommended from 40 years or 10 before the youngest proband. However, this approach has an empirical basis and no prospective controlled study has compared different screening strategies in this population. Furthermore, colonoscopy is an invasive technique that Key words: colorectal neoplasms, early detection of cancer, adenoma, occult blood, cost-benefit analysis Abbreviations: AN: advanced neoplasia; AUC: area under the curve; CI: confidence interval; CRC: colorectal cancer; FDR: first-degree relative; FIT: fecal immunochemical test; gFOBT: guaiac fecal occult blood tests; LLR: likelihood ratio; NNS: number needed to scope; NPV: negative predictive value; PPV: positi...

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Section: Discussionmentioning

confidence: 94%

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Castro

Cubiella

Rivera

et al. 2013

Intl Journal of Cancer

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“…Quantitative FIT enables the selection of a preferred faecal haemoglobin threshold level for positivity, allowing the adjustment of clinical sensitivity and specificity so that the test is clinically acceptable while not overwhelming endoscopy resources. [46][47][48] At a low haemoglobin threshold, FIT can detect lower levels of bleeding than gFOBT and, therefore, has a higher sensitivity for CRC and AAs. [49][50][51] Quantitative FIT provides the opportunity to incorporate haemoglobin concentration into a multivariable CRC risk score, rather than the binary risk (positive or negative) afforded by gFOBT.…”

Section: Faecal Immunochemical Tests and Guaiac Faecal Occult Blood Tmentioning

confidence: 99%

Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study

Atkin

Cross

Kralj-Hans

et al. 2019

Health Technol Assess

105

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Background In the UK, patients with one or two adenomas, of which at least one is ≥ 10 mm in size, or three or four small adenomas, are deemed to be at intermediate risk of colorectal cancer (CRC) and referred for surveillance colonoscopy 3 years post polypectomy. However, colonoscopy is costly, can cause discomfort and carries a small risk of complications. Objectives To determine whether or not annual faecal immunochemical tests (FITs) are effective, acceptable and cost saving compared with colonoscopy surveillance for detecting CRC and advanced adenomas (AAs). Design Diagnostic accuracy study with health psychology assessment and economic evaluation. Setting Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England. Participants Men and women, aged 60–72 years, deemed to be at intermediate risk of CRC following adenoma removal after a positive guaiac faecal occult blood test were invited to participate. Invitees who consented and returned an analysable FIT were included. Intervention We offered participants quantitative FITs at 1, 2 and 3 years post polypectomy. Participants testing positive with any FIT were referred for colonoscopy and not offered further FITs. Participants testing negative were offered colonoscopy at 3 years post polypectomy. Acceptibility of FIT was assessed using discussion groups, questionnaires and interviews. Main outcome measures The primary outcome was 3-year sensitivity of an annual FIT versus colonoscopy at 3 years for detecting advanced colorectal neoplasia (ACN) (CRC and/or AA). Secondary outcomes included participants’ surveillance preferences, and the incremental costs and cost-effectiveness of FIT versus colonoscopy surveillance. Results Of 8008 invitees, 5946 (74.3%) consented and returned a round 1 FIT. FIT uptake in rounds 2 and 3 was 97.2% and 96.9%, respectively. With a threshold of 40 µg of haemoglobin (Hb)/g faeces (hereafter referred to as µg/g), positivity was 5.8% in round 1, declining to 4.1% in round 3. Over three rounds, 69.2% (18/26) of participants with CRC, 34.3% (152/443) with AAs and 35.6% (165/463) with ACN tested positive at 40 µg/g. Sensitivity for CRC and AAs increased, whereas specificity decreased, with lower thresholds and multiple rounds. At 40 µg/g, sensitivity and specificity of the first FIT for CRC were 30.8% and 93.9%, respectively. The programme sensitivity and specificity of three rounds at 10 µg/g were 84.6% and 70.8%, respectively. Participants’ preferred surveillance strategy was 3-yearly colonoscopy plus annual FITs (57.9%), followed by annual FITs with colonoscopy in positive cases (31.5%). FIT with colonoscopy in positive cases was cheaper than 3-yearly colonoscopy (£2,633,382), varying from £485,236 (40 µg/g) to £956,602 (10 µg/g). Over 3 years, FIT surveillance could miss 291 AAs and eight CRCs using a threshold of 40 µg/g, or 189 AAs and four CRCs using a threshold of 10 µg/g. Conclusions Annual low-threshold FIT with colonoscopy in positive cases achieved high sensitivity for CRC and would be cost saving compared with 3-yearly colonoscopy. However, at higher thresholds, this strategy could miss 15–30% of CRCs and 40–70% of AAs. Most participants preferred annual FITs plus 3-yearly colonoscopy. Further research is needed to define a clear role for FITs in surveillance. Future work Evaluate the impact of ACN missed by FITs on quality-adjusted life-years. Trial registration Current Controlled Trials ISRCTN18040196. Funding National Institute for Health Research (NIHR) Health Technology Assessment programme, NIHR Imperial Biomedical Research Centre and the Bobby Moore Fund for Cancer Research UK. MAST Group Ltd provided FIT kits.

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“…10,48–50 Periodic FITs have been suggested as an alternative to the use of frequent surveillance colonoscopies. 20 …”

Section: Discussionmentioning

confidence: 99%

“…15 Although studies using FIT followed by colonoscopy have been conducted in populations outside the United States 16–20 , we found none conducted in the United States directly comparing these methods. Quintero, et al compared over 50,000 individuals randomized to one-time FIT or colonoscopy in a Spanish population.…”

Section: Introductionmentioning

confidence: 94%

Test Characteristics of Faecal Immunochemical Tests (FIT) Compared with Optical Colonoscopy

Levy

Bay

et al. 2014

J Med Screen

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Background Faecal occult blood tests are often the initial test in population-based screening. We aimed to: 1) compare the results of single sample faecal immunochemical tests (FITs) with colonoscopy, and 2) calculate the sensitivity for proximal vs. distal adenomatous polyps or cancer. Methods Individuals scheduled for a colonoscopy were invited to complete a FIT prior to their colonoscopy preparation. FIT results were classified as positive, negative, or invalid. Colonoscopy reports were reviewed and abstracted. Because of product issues, four different FIT manufacturers were used. The test characteristics for each FIT manufacturer were calculated for advanced adenomatous polyps or cancer according to broad reason for colonoscopy (screening or surveillance/diagnostic). Results Of those invited, 1,026 individuals (43.9%) completed their colonoscopy and had a valid FIT result. The overall sensitivity of the FITs (95% confidence intervals) was 0.18 (0.10 to 0.28) and specificity was 0.90 (0.87 to 0.91) for advanced adenomas or cancer. The sensitivity for distal lesions was 0.23 (0.11 to 0.38) and for proximal lesions was 0.09 (0.02 to 0.25). The odds ratio of an individual with a distal advanced adenoma or cancer testing positive was 2.68 (1.20 to 5.99). The two individuals with colorectal cancer tested negative, as did one individual with high-grade dysplasia. Conclusions The sensitivity of a single-sample FIT for advanced adenomas or cancer was low. Individuals with distal adenomas had a higher odds of testing positive than those with proximal lesions or no lesions.

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Faecal immunochemical test accuracy in patients referred for surveillance colonoscopy: a multi-centre cohort study

Cited by 33 publications

References 30 publications

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Fecal immunochemical test accuracy in familial risk colorectal cancer screening

Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study

Test Characteristics of Faecal Immunochemical Tests (FIT) Compared with Optical Colonoscopy

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