TY - JOUR
T1 - Participation and Ease of Use in Colorectal Cancer Screening
T2 - A Comparison of 2 Fecal Immunochemical Tests
AU - De Klerk, Clasine M.
AU - Wieten, Els
AU - Van Der Steen, Annemieke
AU - Ramakers, Christian R.
AU - Kuipers, Ernst J.
AU - Hansen, Bettina E.
AU - Lansdorp-Vogelaar, Iris
AU - Bossuyt, Patrick M.
AU - Spaander, Manon C.W.
AU - Dekker, Evelien
N1 - Publisher Copyright:
© 2018 by The American College of Gastroenterology.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - 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.
AB - 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.
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U2 - 10.14309/ajg.0000000000000148
DO - 10.14309/ajg.0000000000000148
M3 - Article
C2 - 30789417
AN - SCOPUS:85062631860
SN - 0002-9270
VL - 114
SP - 511
EP - 518
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 3
ER -
