Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study

Hoepffner, N.; Shastri, Yogesh M.; Hanisch, E.; Rösch, Wolfgang; Mössner, Joachim; Caspary, W. F.; Stein, Jürgen M.

doi:10.1111/j.1365-2036.2006.02702.x

Cited by 31 publications

(20 citation statements)

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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%

“…38,40,45 Almost all of the studies reported that the specimens were collected at home while one study did not specify the location. 38 The studies listed in Table 1 recruited subjects by two methods: inclusion of patients undergoing colonoscopy for a variety of indications (e.g., FOBT positivity, GI symptoms, colon cancer screening, polyp surveillance) [31][32][33][34][35][36][37][38][39]41,[44][45][46][47] or selection of a group of known colorectal cancer patients and controls undergoing colonoscopy. 40,42,43,[48][49][50] Both of these methods contain potential verification bias as not all of the FOBT negative patients in the population underwent a confirmatory test.…”

Section: Included Studiesmentioning

confidence: 99%

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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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Section: Included Studiesmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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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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“…These ELISAbased IFOBTs (Allison et al, 1996) or automatically analysable IFOBT (Morikawa et al, 2005) have demonstrated sensitivity of around 60% and specificity of about 90%. Recently various 'office based or bedside' simple, convenient and cheap strip-based IFOBT have been validated for CRC screening with performance characteristics similar to that of an ELISA-based IFOBT (Hoepffner et al, 2006;Smith et al, 2006). In fact our group compared an office-based IFOBT with that of M2-PK to show that M2-PK and IFOBT had a sensitivity of 80.4 vs 72.3% for diagnosing CRN, whereas specificity for these tests were 76.3 vs 94.7%, respectively .…”

Section: Sirmentioning

confidence: 99%

New faecal tests for colorectal cancer screening: is tumour pyruvate kinase M2 one of the options?

Shastri

Stein

2007

Br J Cancer

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Cancer Research UK Sir,We read with great interest the article by Haug et al (2007) and must complement them for a nicely written work. We have certain comments to make about their study.Colorectal adenomas, the precursors of almost all of the sporadic colorectal cancer (CRC) could not be included in their study. The ability of various CRC screening programme (eg, colonoscopy) in reducing CRC mortality by diagnosing and removing these premalignant lesions cannot be overemphasised. It is agreed that the false positives due to these adenomas in the control group would have contributed to marginal increase in the specificity of faecal pyruvate kinase type M2 (M2-PK) in their study (Haug et al, 2007), as rightly mentioned by the authors.But what about the adenomas that could have been missed out by performing M2-PK assay in the controls? The prevalence of any adenomatous lesion in their control group would have been somewhere around 30% and roughly 8% would have been advanced adenomas (Anderson et al, 2003), usually described as villous adenomas, tubular adenomas 410 mm, high-grade dysplasia, malignant polyp or 43 adenomas (ie, around 73 out of these 917 control group patients (Haug et al, 2007)). The previous studies have reported sensitivity of M2-PK to be just 30% in diagnosing advanced adenomas and 40% by Koss et al (2005) (only as an abstract). Thus, assuming that a sensitivity of around 35% for diagnosing these advanced adenomas from the above two studies would be applied to the population studied, then there would be a marked decrease in the resulting sensitivity of M2-PK for diagnosing colorectal neoplasia (CRN), that is CRC with advanced adenomas. Thus, the estimated sensitivity of M2-PK in diagnosing CRN would decrease to 48% (26 þ 45/73 þ 74) as against 67% (45/74) reported in this study (Haug et al, 2007). This would be highly unacceptable for any CRC screening test and especially for M2-PK with such a poor specificity of around 80%, which is much lower than that of any of the faecal screening tests for CRC, in fact even lower than that of Guaiac-based faecal occult blood test (FOBTs).One of the limitations of their study was a retrospective study design with historical controls; these subjects did not undergo either any of the more accurate faecal screening test, for example, IFOBT (immunological FOBT) or a colonoscopy for confirming the results of M2-PK in detecting CRC. Thus, if the prevalence of CRC is taken to be 1% in the historical controls, there lies a possibility of missing out significant number of CRC in the control group considering such a low performance characteristics which is highly unacceptable.We agree with the authors that the poor performance characteristics (especially low specificity and poor PPV) of faecal tumour M2-pyruvate kinase (M2-PK) as has also been reported in previous prospective study does not warrant its use as a marker for CRC screening. This is particularly relevant when other better options are available for stool testing for CRC namely IFOBT (Allison et al, 1996;M...

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“…In einer prospektiven Multicenterstudie wurden drei verschiedene Tests für okkultes Blut im Stuhl miteinander verglichen [9]: der herkömmliche, auf der Gujak-Probe basierende Haemoccult-Test, der ebenfalls bereits etablierte immunochemische ELISA-Test auf okkultes Blut und eine neue immunochemische Bedside-Untersuchung mittels Teststreifen. Dabei zeigten sich für die immunochemischen Verfahren ähnliche Sensitivitäten und Spezifitäten, die in der Genauigkeit dem herkömmlichen Gujak-Test überlegen sind.…”

Section: Tests Auf Okkultes Blutunclassified

Diagnostik und Screening

Sailer

2007

Coloproctol

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Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study

Cited by 31 publications

References 50 publications

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

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

New faecal tests for colorectal cancer screening: is tumour pyruvate kinase M2 one of the options?

Diagnostik und Screening

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