Diagnostic yield of a risk model versus faecal immunochemical test only: a randomised controlled trial in a colorectal cancer screening programme

Tim L. Kortlever, Manon van der Vlugt, Floor A.M. Duijkers, Ad Masclee, Roderik Kraaijenhagen, Manon C.W. Spaander, Iris Lansdorp-Vogelaar, Patrick M. Bossuyt, Evelien Dekker*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review



Combining the faecal immunochemical test (FIT) result with risk factors for advanced neoplasia (AN) may increase the yield of colorectal cancer (CRC) screening without increasing the number of colonoscopies. We conducted a randomised controlled trial in the Dutch CRC screening programme to evaluate a previously developed risk model including FIT, age, sex, smoking status, and CRC family history. 


A total of 22,748 individuals aged 56–75 years were pre-randomised to the risk-model group or the FIT-only group. Both groups received the FIT; those allocated to the risk-model group also received a single-page questionnaire. Study participants with a positive result (FIT ≥ 15 µg Hb/g faeces and/or risk ≥0.10) were referred for colonoscopy. The primary outcome measure was the proportion of invitees in whom AN was detected. 


In the risk-model group, 3113/11,364 invitees (27%) returned the FIT and questionnaire versus 3061/11,384 invitees (27%) in the FIT-only group (p = 0.40). The yield of AN was 3.70/1000 invitees in the risk-model group versus 3.43/1000 in the FIT-only group (absolute difference: 0.27/1000, 95%CI: −1.30 to 1.82, p = 0.82). 


Combining FIT with risk factors for CRC did not increase the yield of AN compared to FIT-only in an existing CRC screening programme. There was no difference in participation between groups. Clinical trial registration: NCT04490551 (ClinicalTrials.gov).

Original languageEnglish
Pages (from-to)791-796
Number of pages6
JournalBritish Journal of Cancer
Issue number5
Early online date19 Jul 2023
Publication statusPublished - 21 Sept 2023

Bibliographical note

Funding Information:
This study was supported by the Netherlands Organisation for Health Research and Development (ZonMw). ZonMw had no role in the study design; data collection, analysis, or interpretation; in the writing of the report, and in the decision to submit the paper for publication.

Funding Information:
AM received financial support from Pentax Europe. MS received material and financial support from Sentinel, Sysmex, and Medtronic. ED received endoscopic equipment on loan from FujiFilm and Olympus, received a research grant from FujiFilm, received honorarium for consultancy from FujiFilm, Olympus, GI Supply, CPP-FAP, PAION, and Ambu, and speakers’ fees from Olympus, GI Supply, Norgine, IPSEN, PAION, and FujiFilm. The remaining authors disclose no conflicts.

Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer Nature Limited.


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