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Participation and Ease of Use in Colorectal Cancer Screening

A Comparison of 2 Fecal Immunochemical Tests

de Klerk, Clasine M., MD1; Wieten, Els, MD2; van der Steen, Annemieke, MSc3; Ramakers, Christian R., PhD4; Kuipers, Ernst J., MD, PhD2; Hansen, Bettina E., PhD2,5,6; Lansdorp-Vogelaar, Iris, PhD7; Bossuyt, Patrick M., PhD8; Spaander, Manon C.W., MD, PhD2; Dekker, Evelien, MD, PhD1

American Journal of Gastroenterology: March 2019 - Volume 114 - Issue 3 - p 511–518
doi: 10.14309/ajg.0000000000000148
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INTRODUCTION: The impact of fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening on disease incidence and mortality is affected by participation, which might be influenced by ease of use of the FIT. We compared the participation rates and ease of use of 2 different FITs in a CRC screening program.

METHODS: There were two study designs within the Dutch CRC screening program. In a paired cohort study, all invitees received 2 FITs (OC-Sensor, Eiken, Japan, and FOB-Gold, Sentinel, Italy) and were asked to sample both from the same stool. Ease of use of both FITs was evaluated by a questionnaire. In a randomized controlled trial, invitees were randomly allocated to receive one of the 2 FITs to compare participation and analyzability.

RESULTS: Of 42,179 invitees in the paired cohort study, 21,078 (50%) completed 2 tests and 20,727 (98%) returned the questionnaire. FOB-Gold was reported significantly easier to use. More participants preferred FOB-Gold (36%) than OC-Sensor (5%), yet most had no preference (59%; P < 0.001). In the randomized trial, 936 of 1,923 invitees (48.7%) returned the FOB-Gold and 940 of 1,923 invitees (48.9%) returned the OC-Sensor, a difference of −0.2% (confidence interval, −3.4% to 3.0%), well within the pre-specified 5% noninferiority margin (P = 0.001). Only one FOB-Gold (0.1%) and 4 OC-Sensors (0.4%) were not analyzable (P = 0.18).

CONCLUSIONS: Although FOB-Gold was significantly but marginally considered easier to use than OC-Sensor, the number of analyzable tests and the participation rates in organized CRC screening are not affected when either of the FITs is implemented as a primary screening test.

1Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands;

2Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands;

3Regional Organisation for Population Screening South-West Netherlands, Rotterdam, the Netherlands;

4Department of Clinical Chemistry, Erasmus MC University Medical Center, Rotterdam, the Netherlands;

5Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada;

6Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, Canada;

7Department of Public Health, Erasmus MC University Medical Center, Rotterdam, the Netherlands;

8Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Correspondence: Evelien Dekker, MD, PhD. E-mail: e.dekker@amc.uva.nl.

SUPPLEMENTARY MATERIAL accompanies this paper at http://links.lww.com/AJG/A62

Received September 01, 2018

Accepted December 10, 2018

© The American College of Gastroenterology 2019. All Rights Reserved.
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