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Epidemiology

Risk-stratified selection to colonoscopy in FIT colorectal cancer screening: development and temporal validation of a prediction model

British Journal of Cancer volume 126, pages 1229–1235 (2022)Cite this article

Subjects

Abstract

Background

Faecal immunochemical tests (FITs) yield many false positives and challenge colonoscopy capacity in colorectal cancer (CRC) screening programmes. We aimed to develop a risk-based selection of participants to undergo diagnostic colonoscopy.

Methods

The study was observational and used registry data from the Danish CRC screening programme. We included all participants invited 2014–2016 with a positive FIT (≥ 20 μg fHb/g) who underwent colonoscopy (n = 56,459). We predicted the risk of CRC or advanced neoplasia (AN) from age, gender and FIT value using logistic regression. We evaluated calibration and discrimination and conducted temporal validation. We compared the number of CRCs and adenomas identified by risk cut-offs and by a corresponding FIT cut-off.

Results

AUCs were 74.9% (95% CI: 73.6; 76.3) and 67.4% (95% CI: 66.8%; 68.0%) for the models predicting CRC and AN in the validation dataset. The cut-off of CRC risk calculated from age, gender and FIT value identified 1.03 times (95% CI: 1.02; 1.05) more CRCs and 1.01 times (95% CI: 1.01; 1.01) more medium/high-risk adenomas compared with the corresponding FIT cut-off.

Conclusions

With existing data, risk-stratified FIT screening using a risk cut-off instead of a FIT cut-off can slightly improve the selection to colonoscopy of those at highest risk of cancer and adenomas.

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Fig. 1: Flow diagram of the study population.
Fig. 2: Receiver-operator characteristic (ROC) curves.

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Data availability

The data for this study are not publicly available, but access to the data sources can be granted by the Danish Colorectal Cancer Screening database and Statistics Denmark, if certain criteria are fulfilled.

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Acknowledgements

We wish to thank Research Professor A. Cecile J.W. Janssens, Department of Epidemiology, Emory University, for initial advice and discussions on the conduct of prediction studies. We also thank colleagues Anne-Sofie Dam Laursen, Mette Lauge Kristensen and Carl Felix Jan Wittstrom for their valuable input on the presentation of results. Data on screening participants were kindly provided by the Danish Colorectal Cancer Screening database.

Funding

The study received funding from the Danish Cancer Society, Danish Health foundation, King Christian X Foundation, Inge and Jørgen Larsens Memorial Trust and, Else and Mogens Wedell-Wedellsborgs Foundation.

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Authors and Affiliations

  1. Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark

    Mette Kielsholm Thomsen, Lars Pedersen, Rune Erichsen, Timothy L. Lash, Henrik T. Sørensen & Ellen M. Mikkelsen

  2. Department of Surgery, Randers Regional Hospital, Randers, Denmark

    Rune Erichsen

  3. Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA

    Timothy L. Lash

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Contributions

The idea for the study was developed by MKT and further specified by MKT and EMM. MKT, RE, LP, HTS, TLL and EMM designed the study and protocol. MKT conducted the statistical analysis and LP and EMM were involved in developing the methodology. MKT and EMM drafted the manuscript. All authors contributed to the manuscript through critical revision of drafts and approved the final manuscript.

Corresponding author

Correspondence to Mette Kielsholm Thomsen.

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Competing interests

The authors declare no competing interests. Department of Clinical Epidemiology, Aarhus University, is involved in studies with institutional funding from regulators and from various pharmaceutical companies, as research grants to and administered by Aarhus University. None of these studies is related to this study.

Ethics approval and consent to participate

The registry data used in this study was made available to us in an anonymized form at the servers of Statistics Denmark. The study was included in the Danish Data Protection Agency data approval administered by Aarhus University (j. no. 2016-051-000001, 1193). Studies using registry data in Denmark do not require specific consent and does not require approval by a research ethics committee.

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Thomsen, M.K., Pedersen, L., Erichsen, R. et al. Risk-stratified selection to colonoscopy in FIT colorectal cancer screening: development and temporal validation of a prediction model. Br J Cancer 126, 1229–1235 (2022). https://doi.org/10.1038/s41416-022-01709-6

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