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Overestimated Sensitivity of Fecal Immunochemical Tests in Screening Cohorts With Registry-Based Follow-up

Brenner, Hermann MD1,2,3; Gies, Anton RPh2,4; Selby, Kevin MD5

American Journal of Gastroenterology: November 2019 - Volume 114 - Issue 11 - p 1795–1801
doi: 10.14309/ajg.0000000000000412

OBJECTIVES: Several recent studies have reported very high estimates of sensitivity and specificity of fecal immunochemical tests (FITs) at seemingly high levels of precision using registry-based follow-up of participants in very large FIT-based screening programs. We aimed to assess the validity of estimates of diagnostic performance parameters derived by this indirect approach.

METHODS: We modeled expected values of sensitivity and specificity of colorectal cancer detection in studies using the indirect approach and their deviation from true values under a broad range of plausible assumptions, and we compared these expected values with recently reported estimates of FIT sensitivity and specificity from such studies.

RESULTS: Using a sensitivity of 75% and specificity of 93.6% (from studies using a direct approach, i.e., colonoscopy follow-up of all participants), the indirect approach would be expected to yield sensitivities between 84.5% and 91.1% and specificities between 93.4% and 93.6% under a range of realistic assumptions regarding colonoscopic follow-up rates of positive FITs and clinical manifestation rates of preclinical colorectal cancer.

DISCUSSION: Very high sensitivities of FITs recently reported with seemingly very high levels of precision by several large-scale registry-based studies, which are in line with expected results based on our model calculations, are likely to be strongly overestimated and need to be interpreted with due caution.

1Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany;

2Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany;

3German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany;

4Medical Faculty Heidelberg, University of Heidelberg, Heidelberg, Germany;

5Center for Primary Care and Public Health (unisanté), University of Lausanne, Lausanne, Switzerland.

Correspondence: Hermann Brenner, MD. E-mail:

Received April 09, 2019

Accepted August 26, 2019

Online date: October 21, 2019

© The American College of Gastroenterology 2019. All Rights Reserved.
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