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Randomized Controlled Trial
. 2018 Mar;67(3):485-496.
doi: 10.1136/gutjnl-2016-312716. Epub 2016 Dec 14.

A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer

Basilio Passamonti  1 , Morena Malaspina  1 , Callum G Fraser  2 , Beatrice Tintori  1 , Angela Carlani  1 , Valentina D'Angelo  1 , Paola Galeazzi  1 , Eugenio Di Dato  1 , Loretta Mariotti  1 , Simonetta Bulletti  1 , Maria Rosaria D'Amico  1 , Daniela Gustinucci  1 , Nadia Martinelli  1 , Nicoletta Spita  1 , Elena Cesarini  1 , Tiziana Rubeca  3 , Mariadonata Giaimo  4 , Nereo Segnan  5 , Carlo Senore  5
Affiliations
Randomized Controlled Trial

A comparative effectiveness trial of two faecal immunochemical tests for haemoglobin (FIT). Assessment of test performance and adherence in a single round of a population-based screening programme for colorectal cancer

Basilio Passamonti et al. Gut. 2018 Mar.

Abstract

Aim: To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor).

Design: Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems.

Results: Screening uptake among the 48 888 invitees was the same for both systems among subjects invited in the first round and higher with OC-Sensor than with HM-JACKarc (relative risk (RR): 1.03; 95% CI 1.02 to 1.04) among those invited in subsequent rounds. Positivity rate (PR) was similar with OC-Sensor (6.5%) as with HM-JACKarc (6.2%) among subjects performing their first FIT screening and higher with OC-Sensor (5.6%, RR: 1.25, 95% CI 1.12 to 1.40) than with HM-JACKarc (4.4%) among those screened in previous rounds. Positive predictive value (PPV) (OC-Sensor: 25.9%, HM-JACKarc: 25.6%) and detection rate (DR) (OC-Sensor: 1.40%; HM-JACKarc: 1.42%) for advanced neoplasia (AN: CRC + advanced adenoma) were similar among subjects performing their first FIT screening. The differences in the AN PPV (OC-Sensor: 20.3%, HM-JACKarc: 22.6%) and DR (OC-Sensor: 0.96%, HM-JACKarc: 0.83%) among those screened in previous rounds were not statistically significant. The number needed to scope to detect one AN was 3.9 (95% CI 5.8 to 2.9) and 3.9 (95% CI 5.5 to 2.9) at first and 4.9 (95% CI 5.8 to 4.2) and 4.4 (95% CI 5.3 to 3.7) at subsequent screening, with OC-Sensor and HM-JACKarc, respectively.

Conclusions: Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.

Trial registration number: ISRCTN20086618; Results.

Keywords: CANCER PREVENTION; COLORECTAL CANCER SCREENING; SCREENING.

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Conflict of interest statement

Competing interests: CGF has undertaken paid consultancy with Immunostics and Kyowa Medex, and received funding for attendance at meetings from Alpha Labs. CS (past 2 years): received support by Medical System for travel and accommodation at a scientific meeting in Italy. His Institution receives PillCam Colon devices from Covidien-Given Imaging to conduct a study and, during 2014, it has received without charge, from EndoChoice, Fuse endoscopy systems to conduct a trial.

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