Background: Fecal immunochemical tests (FITs) are recommended to screen average-risk adults for colorectal cancer (CRC). Little research has examined whether a two-sample FIT affects participant uptake, compared with a one-sample FIT. Examining participant uptake is important, as evidence suggests that a two-sample FIT may increase the sensitivity to detect CRC.
Objective: This study had two objectives: (i) to evaluate FIT completion in a population that received either a one-sample FIT kit (1-FIT) or a two-sample FIT kit (2-FIT) and (ii) to understand whether uptake varies by age, sex, or receipt of prior CRC screening.
Methods: We conducted a randomized controlled trial in which 3081 participants who were aged between 50 and 75 years and were at an average risk for CRC, and who had requested FITs, randomly received 1-FIT (n=1540) or 2-FIT (n=1541) kits. FIT completion was defined as the completion and return of a one-sample test by the patients in the 1-FIT group or of both sample tests by those in the 2-FIT group. Cox proportional hazard regression models were used to determine the independent effect of group type (2-FIT vs. 1-FIT) on the completion of the FIT, adjusting for age, sex, and receipt of prior CRC screening.
Results: The 2-FIT group had lower test completion rates (hazard ratio=0.87; 95% confidence interval=0.78-0.97; P=0.01) after adjusting for age, sex, and receipt of prior CRC screening. Participant uptake did not vary by age, sex, or receipt of prior CRC screening.
Conclusion: This unique, rigorous randomized controlled trial found that the 2-FIT regimen decreases completion of FIT. Further research is needed to understand whether decreases in participant uptake are offset by increased gains in test sensitivity.