Addition of an online, validated family history questionnaire to the Dutch FIT-based screening programme did not improve its diagnostic yield

Victorine H Roos,Patrick M M Bossuyt,Cora M Aalfs,Frank G J Kallenberg,Evelien J C Bongers,Evelien Dekker,Manon Van Der Vlugt

doi:10.1038/s41416-020-0832-8

Victorine H Roos, Patrick M M Bossuyt + Show 5 more

Open Access

https://doi.org/10.1038/s41416-020-0832-8

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Abstract

BackgroundFaecal immunochemical testing (FIT) is suboptimal in detecting advanced neoplasia (AN). To increase the sensitivity and yield of a FIT-based screening programme, FIT could be combined with risk factors for AN. We evaluated the incremental yield of adding a family history questionnaire (FHQ) on colorectal cancer (CRC) and Lynch syndrome-associated tumours to the Dutch FIT-based screening programme.MethodsSix thousand screen-naive individuals, aged 59–75 years, were invited to complete a FIT (FOB-Gold, cut-off 47 µg Hb/g faeces) and a validated online FHQ. Participants with a positive FIT and/or positive FHQ, confirmed after genetic counselling, were referred for colonoscopy. Yield of detecting AN per 1000 invitees for the combined strategy was compared with the FIT-only strategy.ResultsOf the 5979 invitees, 1952 (32.6%) completed the FIT only, 2379 (39.8%) completed both the FIT and FHQ and 95 (1.6%) completed the FHQ only. Addition of the FHQ to FIT-based screening resulted in one extra case of AN detected after 16 additional colonoscopies, resulting in a yield of 19.6 (95% CI, 16.4–23.5) for the combined strategy versus 19.5 (95% CI, 16.3–23.3) for the FIT-only strategy (p = 1.0).ConclusionsThe addition of an FHQ to one round of FIT screening did not increase the detection of AN compared with FIT only (ClinicalTrials.gov NCT02698462).

Highlights

Faecal immunochemical testing (FIT) is suboptimal in detecting advanced neoplasia (AN)
As participants depend on their health insurance for reimbursement of the genetic follow-up examination, and financial reasons were often reported as a reason for declining genetic testing, costs may have been a reason for lower socioeconomic status (SES) invitees not to return the family history questionnaire (FHQ)
A strength of this study is that it is the first to evaluate the addition of an online FHQ to a national organised FIT-based screening programme assessing the effect in participants with a positive as well as those with negative FIT result

Summary

Introduction

Faecal immunochemical testing (FIT) is suboptimal in detecting advanced neoplasia (AN). To increase the sensitivity and yield of a FIT-based screening programme, FIT could be combined with risk factors for AN. We evaluated the incremental yield of adding a family history questionnaire (FHQ) on colorectal cancer (CRC) and Lynch syndrome-associated tumours to the Dutch FIT-based screening programme. Yield of detecting AN per 1000 invitees for the combined strategy was compared with the FIT-only strategy. Addition of the FHQ to FIT-based screening resulted in one extra case of AN detected after 16 additional colonoscopies, resulting in a yield of 19.6 (95% CI, 16.4–23.5) for the combined strategy versus 19.5 (95% CI, 16.3–23.3) for the FITonly strategy (p = 1.0). Faecal immunochemical testing (FIT) is a screening method that selects individuals at high risk of having advanced adenomas or CRC, the combination referred to as advanced neoplasia (AN). Depending on the faecal haemoglobin concentration cut-off level and brand, pooled sensitivity was 79% for CRC and 6–56% for AN.[5,6]

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