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

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State: Public
Version: Author's accepted manuscript
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Serval ID
serval:BIB_1BF9D7DA76F5
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Overestimated Sensitivity of Fecal Immunochemical Tests in Screening Cohorts With Registry-Based Follow-up.
Journal
The American journal of gastroenterology
Author(s)
Brenner H., Gies A., Selby K.
ISSN
1572-0241 (Electronic)
ISSN-L
0002-9270
Publication state
Published
Issued date
11/2019
Peer-reviewed
Oui
Volume
114
Number
11
Pages
1795-1801
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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.
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.
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.
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.
Keywords
Colonoscopy/statistics & numerical data, Colorectal Neoplasms/diagnosis, Early Detection of Cancer/methods, Early Detection of Cancer/standards, Feces/chemistry, Humans, Immunohistochemistry/methods, Immunohistochemistry/standards, Medical Overuse/prevention & control, Medical Overuse/statistics & numerical data, Models, Theoretical, Reproducibility of Results, Sensitivity and Specificity
Pubmed
Web of science
Funding(s)
CHUV
Create date
05/11/2019 14:58
Last modification date
03/04/2020 6:19
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