Abstract
Opt-out strategies have been shown to improve participation in cancer screening; however, there are ethical concerns regarding the presumed consent. In this study, we tested an alternative opt-in strategy, called: "enhanced active choice," in which the response options summarize the consequences of the decision. The study was conducted as part of the Maltese colorectal cancer screening program, which offers men and women, aged 60-64, a "one-off" fecal immunochemical test (FIT). A total of 8349 individuals were randomly assigned to receive either an invitation letter that featured a standard opt-in strategy (control condition), or an alternative letter with a modified opt-in strategy (enhanced active choice condition). Our primary outcome was participation three months after the invitation was delivered. Additionally, we also compared the proportion who said they wanted to take part in screening. We used multivariable logistic regression for the analysis. Overall, 48.4% (N = 4042) accepted the invitation and 42.4% (N = 3542) did the screening test. While there were no statistically significant differences between the two conditions in terms of acceptance and participation, enhanced active choice did increase acceptance among men by 4.6 percentage points, which translated to a significant increase in participation of 3.4 percentage points. We conclude that enhanced active choice can improve male screening participation. Given the higher risk of CRC in men, as well as their lower participation screening, we believe this to be an important finding.