Participation and Ease of Use in Colorectal Cancer Screening: A Comparison of 2 Fecal Immunochemical Tests

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.