Australian guidelines recommend that all people aged 50-70 years old consider taking aspirin for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC).(1) This trial, SITA, is a randomised controlled trial with general practice patients that aims to test the efficacy of a health consultation and use of a sex-specific decision aid, to present the benefits and harms of taking low dose aspirin, on two co-primary outcomes including informed decision-making at one-month and uptake of aspirin at six-months.
Methods
Patients who weren’t currently taking aspirin were invited to participate in the trial. Participants were talked through either a decision aid or the control brochure before their GP appointments. We used multiple imputation to handle the missing trial data for the co-primary outcomes and present the complete case analysis as a sensitivity analysis.
Results
261 participants (87% of eligible patients) were randomised (129 intervention, 132 control). Baseline characteristics were balanced between the control and intervention groups. For informed choice at one-month the odds were 2.42 (0.92 to 6.36) p = 0.040. There was a 10.9% absolute increase in informed choice at 1 month in the intervention group for the complete case analysis [OR 2.76 (1.03 to 7.42) p = 0.021], (113 intervention, 118 control). The odds were 0.72 (0.29 to 1.77) p = 0.408, for aspirin uptake at six-months. A -4.1% difference between the groups for the complete case analysis [OR 0.71 (0.29 to 1.77) p = 0.417], (intervention 118, control 116).
A decision aid, presenting the aspirin guidelines increased informed choice but there was no difference in aspirin uptake between the intervention and control groups. As participants in both study groups were taking aspirin over time, there was contamination as this was an individually randomised trial and the control group was an active control.