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Observational Study
. 2021 Mar;10(5):1872-1879.
doi: 10.1002/cam4.3761. Epub 2021 Feb 3.

The optimal cut-off value in fit-based colorectal cancer screening: An observational study

Sisse Helle Njor  1   2   3 , Berit Andersen  1   2   3 , Lennart Friis-Hansen  3   4 , Niels de Haas  3   5 , Dorte Linnemann  3   6 , Henrik Nørgaard  3   7 , Ole Roikjaer  3   8 , Bo Søndergaard  3   9 , Morten Rasmussen  3   10
Affiliations
Observational Study

The optimal cut-off value in fit-based colorectal cancer screening: An observational study

Sisse Helle Njor et al. Cancer Med. 2021 Mar.

Abstract

Background: Colorectal cancer (CRC) screening programs using fecal immunochemical test (FIT) have to choose a cut-off value to decide which citizens to recall for colonoscopy. The evidence on the optimal cut-off value is sparse and based on studies with a low number of cancer cases.

Methods: This observational study used data from the Danish Colorectal Cancer Screening Database. Sensitivity and specificity were estimated for various cut-off values based on a large number of cancers. Traditionally optimal cut-off values are found by weighting sensitivity and specificity equally. As this might result in too many unnecessary colonoscopies we also provide optimal cut-off values for different weighting of sensitivity and specificity/number of needed colonoscopies to detect one cancer.

Results: Weighting sensitivity and specificity equally gives an optimal cut-off value of 45 ng Hb/ml. This, however, means making 24 colonoscopies to detect one cancer. Weighting sensitivity lower and for example, aiming at making about 16 colonoscopies to detect one cancer, gives an optimal cut-off value of 125 ng Hb/ml.

Conclusions: The optimal cut-off value in an FIT population-based screening program is 45 ng Hb/ml, when as traditionally sensitivity and specificity are weighted equally. If, however, 24 colonoscopies needed to detect one cancer is too huge a burden on the health care system and the participants, 80, 125, 175, and 350 ng Hb/ml are optimal cut-off values when only 19/16/14/10 colonoscopies are accepted to find one cancer.

Keywords: capacity building; colorectal neoplasms; mass screening; sensitivity; specificity.

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Conflict of interest statement

Sisse Njor has received a speaking fee for giving a speech in a colorectal cancer symposium sponsored by Norgine. The money obtained through this has not been used to finance this manuscript. Berit Andersen is head of the colorectal cancer screening programme in Central Denmark Region, but has no other conflicts of interest. Lennart Friis‐Hansen was head of the colorectal cancer screening programme in Region Zealand (March 2014–September 2016), but has no other conflicts of interest. Niels de Haas, Dorte Linnemann, Henrik Nørgaard, Ole Roikjær, Bo Søndergaard have no conflict of interest. Morten Rasmussen is head of the colorectal cancer screening programme in the capital Region and has received speaking fees from Norgine and Ferring Pharmaceuticals for giving speeches at sponsored meetings and symposiums. The money obtained through this has not been used to finance this manuscript.

Figures

FIGURE 1
FIGURE 1
The assumed ratio between number of true positive cases and number of false negative cases for cut‐off values 0–1000 ng Hb/ml
FIGURE 2
FIGURE 2
Flowchart of study population and exclusions
FIGURE 3
FIGURE 3
ROC curve for various cut‐off values of FIT
See this image and copyright information in PMC

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