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Showing content from https://pubmed.ncbi.nlm.nih.gov/30789417/ below:

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

Randomized Controlled Trial

Affiliations

• ¹ Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
• ² Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ³ Regional Organisation for Population Screening South-West Netherlands, Rotterdam, the Netherlands.
• ⁴ Department of Clinical Chemistry, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ⁵ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
• ⁶ Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, Canada.
• ⁷ Department of Public Health, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ⁸ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

• PMID: 30789417
• DOI: 10.14309/ajg.0000000000000148

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Randomized Controlled Trial

Clasine M de Klerk et al. Am J Gastroenterol. 2019 Mar.

• ¹ Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
• ² Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ³ Regional Organisation for Population Screening South-West Netherlands, Rotterdam, the Netherlands.
• ⁴ Department of Clinical Chemistry, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ⁵ Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
• ⁶ Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, Canada.
• ⁷ Department of Public Health, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
• ⁸ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

• PMID: 30789417
• 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.

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