Estimation of the Optimal Cut Off Point in a New Immunological Faecal Occult Blood Test in a Corporate Colorectal Cancer Screening Programme

Itoh, Masato; Takahashi, Ken; Nishida, Hiroshi; Sakagami, Kiyonobu; Okubo, Toshiteru

doi:10.1177/096914139600300204

Cited by 43 publications

(29 citation statements)

References 11 publications

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“…The 2008 USPSTF report (9) included 9 studies in its systematic review (31–39); our literature search identified 1771 additional new potential sources (Figure 1). After abstract review, we identified 53 articles for full-text review; of these, 18 unique articles satisfied all inclusion criteria and were included in our analysis (14, 15, 31–46).…”

Section: Resultsmentioning

confidence: 99%

Accuracy of Fecal Immunochemical Tests for Colorectal Cancer

Lee¹,

Liles²,

Bent³

et al. 2014

Ann Intern Med

546

452

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Background Performance characteristics of fecal immunochemical tests (FITs) to screen for colorectal cancer (CRC) have been inconsistent. Purpose To synthesize data about the diagnostic accuracy of FITs for CRC and identify factors affecting its performance characteristics. Data Sources Online databases, including MEDLINE and EMBASE, and bibliographies of included studies from 1996 to 2013. Study Selection All studies evaluating the diagnostic accuracy of FITs for CRC in asymptomatic, average-risk adults. Data Extraction Two reviewers independently extracted data and critiqued study quality. Data Synthesis Nineteen eligible studies were included and meta-analyzed. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of FITs for CRC were 0.79 (95% CI, 0.69 to 0.86), 0.94 (CI, 0.92 to 0.95), 13.10 (CI, 10.49 to 16.35), 0.23 (CI, 0.15 to 0.33), respectively, with an overall diagnostic accuracy of 95% (CI, 93% to 97%). There was substantial heterogeneity between studies in both the pooled sensitivity and specificity estimates. Stratifying by cutoff value for a positive test result or removal of discontinued FIT brands resulted in homogeneous sensitivity estimates. Sensitivity for CRC improved with lower assay cutoff values for a positive test result (for example, 0.89 [CI, 0.80 to 0.95] at a cutoff value less than 20 μg/g vs. 0.70 [CI, 0.55 to 0.81] at cutoff values of 20 to 50 μg/g) but with a corresponding decrease in specificity. A single-sample FIT had similar sensitivity and specificity as several samples, independent of FIT brand. Limitations Only English-language articles were included. Lack of data prevented complete subgroup analyses by FIT brand. Conclusion Fecal immunochemical tests are moderately sensitive, are highly specific, and have high overall diagnostic accuracy for detecting CRC. Diagnostic performance of FITs depends on the cutoff value for a positive test result. Primary Funding Source National Institute of Diabetes and Digestive and Kidney Diseases and National Cancer Institute.

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Section: Resultsmentioning

confidence: 99%

Accuracy of Fecal Immunochemical Tests for Colorectal Cancer

Lee¹,

Liles²,

Bent³

et al. 2014

Ann Intern Med

546

452

View full text Add to dashboard Cite

show abstract

“…Indeed, the problem tends to be just the opposite, and involves the need to ascertain the probability of the patient being healthy (or diseased) in a case where the test result is negative (or positive). Hence, strategies for selecting the optimal cutpoint based on predictive values can be more useful in certain situations (see Vermont et al 1991;Itoh, Takahashi, Nishida, Sakagami, and Okubo 1996;Gallop, Crits-Christoph, Muenz, and Tu 2003, among others).…”

Section: Others)mentioning

confidence: 99%

OptimalCutpoints: AnRPackage for Selecting Optimal Cutpoints in Diagnostic Tests

López-Ratón¹,

et al. 2014

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Continuous diagnostic tests are often used for discriminating between healthy and diseased populations. For the clinical application of such tests, it is useful to select a cutpoint or discrimination value c that defines positive and negative test results. In general, individuals with a diagnostic test value of c or higher are classified as diseased. Several search strategies have been proposed for choosing optimal cutpoints in diagnostic tests, depending on the underlying reason for this choice. This paper introduces an R package, known as OptimalCutpoints, for selecting optimal cutpoints in diagnostic tests. It incorporates criteria that take the costs of the different diagnostic decisions into account, as well as the prevalence of the target disease and several methods based on measures of diagnostic test accuracy. Moreover, it enables optimal levels to be calculated according to levels of given (categorical) covariates. While the numerical output includes the optimal cutpoint values and associated accuracy measures with their confidence intervals, the graphical output includes the receiver operating characteristic (ROC) and predictive ROC curves. An illustration of the use of OptimalCutpoints is provided, using a real biomedical dataset.

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“…Earlier studies (Itoh et al, 1996;Nakama et al, 1999Nakama et al, , 2000Castiglione et al, 2002;Edwards, 2005;Chen et al, 2007;Levi et al, 2007) have evaluated the impact of using different IFOBT positivity thresholds and single vs multiple sampling in terms of sensitivity/ specificity ratio. The aim of this study is to provide further information on the diagnostic accuracy and colonoscopy workload of LAT-based screening using different positivity thresholds (X80, X100 and X120 ng ml À1 ), and single vs multiple samplings (1 vs 2 days).…”

mentioning

confidence: 99%

Immunochemical faecal occult blood test: number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening?

et al. 2009

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Immunochemical faecal occult blood tests have shown a greater sensitivity than guaiac test in colorectal cancer screening, but optimal number of samples and cutoff have still to be defined. The aim of this multicentric study was to evaluate the performance of immunochemical-based screening strategies according to different positivity thresholds (80, 100, 120 ng ml À1 ) and single vs double sampling (one, at least one, or both positive samples) using 1-day sample with cutoff at 100 ng ml À1 as the reference strategy. A total of 20 596 subjects aged 50 -69 years were enrolled from Italian population-based screening programmes. Positivity rate was 4.5% for reference strategy and 8.0 and 2.0% for the most sensitive and the most specific strategy, respectively. Cancer detection rate of reference strategy was 2.8%, and ranged between 2.1 and 3.4% in other strategies; reference strategy detected 15.6% advanced adenomas (range ¼ 10.0 -22.5%). The number needed to scope to find a cancer or an advanced adenoma was lower than 2 (1.5 -1.7) for the most specific strategies, whereas it was 2.4 -2.7, according to different thresholds, for the most sensitive ones. Different strategies seem to have a greater impact on adenomas rather than on cancer detection rate. The study provides information when deciding screening protocols and to adapt them to local resources.

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Estimation of the Optimal Cut Off Point in a New Immunological Faecal Occult Blood Test in a Corporate Colorectal Cancer Screening Programme

Abstract: The optimal cut off point of the new immunological method of FOBT was estimated to be about 200 ng/ml, a value which, more than the current cut off value, favours specificity over sensitivity.

Cited by 43 publications

References 11 publications

Accuracy of Fecal Immunochemical Tests for Colorectal Cancer

Accuracy of Fecal Immunochemical Tests for Colorectal Cancer

OptimalCutpoints: AnRPackage for Selecting Optimal Cutpoints in Diagnostic Tests

Immunochemical faecal occult blood test: number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening?

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