Informed choice of colorectal cancer (CRC) screening tests and adherence with screening programme: a multi-centre randomised controlled trial in four cities
Problem
Colorectal cancer (CRC) screening has been proven effective to reduce CRC-related mortality. Faecal immunochemical tests (FITs) and colonoscopy are two most commonly used modalities. Currently, international guidelines do not specifically recommend a preferred screening modality and the screening test choice may be decided by physicians, patients or a combination of both. It remains controversial whether choice of screening test should be offered to prospective screening participants. Some researchers suggested to offer only one test in order not to introduce patient confusion and indecision, while others proposed that physicians should consider patient preferences and provide choices to improve patient engagement. We aim to compare the rate of adherence with CRC screening programme in asymptomatic participants who are offered informed choice of screening tests vs. those who are offered a single test.Hypothesis to be tested: The rate of adherence with faecal immunochemical tests (FIT) and colonoscopy is significantly higher among screening participants who are offered test choice than those without.
Approach
Design and subjects: This is a prospective, randomised, parallel group controlled trial of asymptomatic screening participants in primary care screening practices in Beijing, Shanghai (2 sites), Guangzhou and Hong Kong. Eligible individuals include asymptomatic subjects: (i) age 50-70 years; (ii). with no personal history of colonic neoplasia, inflammatory bowel disease, and (ii) with no contraindications for colonoscopy. We will randomly allocate 1,146 recruited subjects into one of the 3 groups that offer: (1). informed choice of FIT vs. colonoscopy; (2). yearly FIT for 3 rounds; and (3). one direct colonoscopy only with a 1:1:1 ratio.Intervention group: Informed choice of screening tests (FIT vs. colonoscopy).
Findings
Main Outcome Measures: The overall adherence rate with CRC screening, defined as the proportion of subjects who complete three rounds of FIT and proportion of subjects who attend colonoscopy appointment.Data Analysis: The demographic characteristics between those offered informed choice vs. no choices are compared by Student’s t-tests and Chi-square tests for continuous and categorical variables, respectively. The outcome variables between group (1) vs. group (3) and group (1) vs. group (3) are compared by chi-square tests. To test the association between informed choice and adherence, a multivariate regression model for overall adherence, FIT adherence and colonoscopy adherence, respectively, will be constructed with adherence as the outcome, controlling for all covariates with univariate analysis p<0.20.
Consequences
Potential impact of this study: if adherence is found to be significantly higher in the informed choice group, the study findings will bear potential to 1). change clinical practice in screening services; 2). uphold autonomy and informed decision making among screening participants based on their preferences, capabilities and personal beliefs; 3). inform guidelines and healthcare services on strategies to enhance adherence; and 4). maximise the benefits of CRC screening.