A Prospective Multicenter Evaluation of New Fecal Occult Blood Tests in Patients Undergoing Colonoscopy

Greenberg, Paul D.; Bertario, Lucio; Gnauck, R; Kronborg, O; Hardcastle, J. D.; Epstein, Michael; Sadowski, Dan; Sudduth, Robert H.; Zuckerman, Gary R.; Rockey, Don C.

doi:10.1111/j.1572-0241.2000.02032.x

Cited by 91 publications

(35 citation statements)

References 24 publications

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“…In view of the recent implementation of several nationwide screening programs using FIT in Western countries, it is important to address potential factors which may affect performance of these tests, as this knowledge may help to design tailored screening strategies. In our study conducted in subjects with average risk, the adenoma detection rate, one of the quality indicators for colonoscopy, was 26% and is in line with previously published data ranging from 21% to 29% (23)(24)(25). It should be acknowledged that colonoscopy has a miss rate of up to 22% for polyps of any size, as has been reported by a recent meta-analysis of back-to-back colonoscopy studies (26).…”

Section: Discussionsupporting

confidence: 76%

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Bakker

Jonkers

Sanduleanu

et al. 2011

Cancer Prevention Research

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Given the current increase in colorectal cancer screening, information on performance of screening tests is needed, especially in groups with a presumed lower test performance. We compared test performance of immunologic fecal occult blood testing (FIT) and pseudosigmoidoscopy with colonoscopy for detection of advanced adenomas in an average risk screening population. In addition, we explored the influence of gender, age, and location on test performance. FIT was collected prior to colonoscopy with a 50 ng/mL cutoff point. FIT results and complete colonoscopy findings were available from 329 subjects (mean age: 54.6 AE 3.7 years, 58.4% women). Advanced adenomas were detected in 38 (11.6%) of 329 subjects. Sensitivity for advanced adenomas of FIT and sigmoidoscopy were 15.8% (95% CI: 6.0-31.3) and 73.7% (95% CI: 56.9-86.6), respectively. No sensitivity improvement was obtained using the combination of sigmoidoscopy and FIT. Mean fecal hemoglobin in FIT positives was significantly lower for participants with only proximal adenomas versus those with distal ones (P ¼ 0.008), for women versus men (P ¼ 0.023), and for younger (<55 years) versus older (!55 years) subjects (P ¼ 0.029). Sensitivities of FIT were 0.0% (95% CI: 0.0-30.9) in subjects with only proximal versus 21.4% (95% CI: 8.3-41.0) in those with distal nonadvanced adenomas; 5.3% (95% CI: 0.0-26.0) in women versus 26.3% (95% CI: 9.2-51.2) in men; 9.5% (95% CI: 1.2-30.4) in younger versus 23.5% (95% CI: 6.8-49.9) in older subjects. Sigmoidoscopy had a significantly higher sensitivity for advanced adenomas than FIT. A single FIT showed very low sensitivity, especially in subjects with only proximal nonadvanced adenomas, in women, and in younger subjects. This points to the existence of "low" FIT performance in subgroups and the need for more tailored screening strategies. Cancer Prev Res; 4(10); 1563-71. Ó2011 AACR.

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Section: Discussionsupporting

confidence: 76%

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Bakker

Jonkers

Sanduleanu

et al. 2011

Cancer Prevention Research

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“…This effect is augmented by a higher attendance rate to FIT than to gFOBT screening (van Rossum et al, 2008;Hol et al, 2008). Thus, FIT screening enables a more efficient screening with increased participation (Cole et al, 2003;van Rossum et al, 2008;Hol et al, 2008) and improved test performances (Allison et al, 1996(Allison et al, , 2007Greenberg et al, 2000;Zappa et al, 2001;Smith et al, 2006;Guittet et al, 2007;van Rossum et al, 2008), potentially allowing a decrease in screening intensity by lengthening the screening interval.…”

Section: Discussionmentioning

confidence: 98%

Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels

et al. 2009

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Immunochemical faecal occult blood testing (FIT) provides quantitative test results, which allows optimisation of the cut-off value for follow-up colonoscopy. We conducted a randomised population-based trial to determine test characteristics of FIT (OC-Sensor micro, Eiken, Japan) screening at different cut-off levels and compare these with guaiac-based faecal occult blood test (gFOBT) screening in an average risk population. A representative sample of the Dutch population (n ¼ 10 011), aged 50 -74 years, was 1 : 1 randomised before invitation to gFOBT and FIT screening. Colonoscopy was offered to screenees with a positive gFOBT or FIT (cut-off 50 ng haemoglobin/ml). When varying the cut-off level between 50 and 200 ng ml À1 , the positivity rate of FIT ranged between 8.1% (95% CI: 7.2 -9.1%) and 3.5% (95% CI: 2.9 -4.2%), the detection rate of advanced neoplasia ranged between 3.2% (95% CI: 2.6 -3.9%) and 2.1% (95% CI: 1.6 -2.6%), and the specificity ranged between 95.5% (95% CI: 94.5 -96.3%) and 98.8% (95% CI: 98.4 -99.0%). At a cut-off value of 75 ng ml À1 , the detection rate was two times higher than with gFOBT screening (gFOBT: 1.2%; FIT: 2.5%; Po0.001), whereas the number needed to scope (NNscope) to find one screenee with advanced neoplasia was similar (2.2 vs 1.9; P ¼ 0.69). Immunochemical faecal occult blood testing is considerably more effective than gFOBT screening within the range of tested cut-off values. From our experience, a cut-off value of 75 ng ml À1 provided an adequate positivity rate and an acceptable trade-off between detection rate and NNscope.

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“…The studies that evaluated the standard guaiac-based FOBT that did not correct for verification bias are listed in Table 1. [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50] In the last study, the data was presented in two separate publications. These 19 studies included 713 subjects with colorectal cancer and 4181 controls.…”

Section: Included Studiesmentioning

confidence: 99%

“…Both control-and cancersubjects underwent a confirmatory test, usually a colonoscopy though some of the older studies also utilized barium enema and sigmoidoscopy, particularly if FOBT negative. Most studies included subjects who submitted 3 stool specimens [31][32][33][34]36,37,39,41,44,[46][47][48][49][50] while some studies included subjects who only submitted one specimen 35,42,43 or the number was not specified. 38,40,45 Almost all of the studies reported that the specimens were collected at home while one study did not specify the location.…”

Section: Included Studiesmentioning

confidence: 99%

Effect of Verification Bias on the Sensitivity of Fecal Occult Blood Testing: a Meta-Analysis

Rosman

Korsten

2010

J GEN INTERN MED

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OBJECTIVES: There is controversy regarding the sensitivity of fecal occult blood tests (FOBT) for detecting colorectal cancer. Many of the published studies failed to correct for verification bias which may have increased the sensitivity. METHODS: A meta-analysis of published studies evaluating the sensitivity and specificity of chemical-based FOBT for colorectal cancer was performed. Studies were included if both cancer and control subjects underwent confirmatory testing. We also included studies that attempted to correct for verification bias by either performing colonoscopy on all subjects regardless of the FOBT result or by using longitudinal follow-up. We then compared the sensitivity, specificity, and other diagnostic characteristics of the studies that attempted to correct for verification (n=10) vs. those that did not correct for this bias (n=19). RESULTS: The pooled sensitivity of guaiac-based FOBT for colorectal cancer of studies without verification bias was significantly lower than those studies with this bias There was no significant difference in the area under the summary receiver operating characteristic curves. More sensitive chemical-based FOBT methods (e.g., Hemoccult® SENSA®) had a higher sensitivity but a lower specificity than standard guaiac methods. CONCLUSIONS: The sensitivity of guaiac-based FOBT for colorectal cancer has been overestimated as a result of verification bias. This test may not be sensitive enough to serve as an effective screening option for colorectal cancer.KEY WORDS: fecal occult blood; guaiac; colorectal cancer; summary receiver operating characteristic curve; meta-analysis.

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A Prospective Multicenter Evaluation of New Fecal Occult Blood Tests in Patients Undergoing Colonoscopy

Cited by 91 publications

References 24 publications

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels

Effect of Verification Bias on the Sensitivity of Fecal Occult Blood Testing: a Meta-Analysis

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