Sample size
ADVERSE EVENT
Statistical analysis determined that a sample size of 14 clusters, or around 1120 patients, would be needed to identify a 15.5% decrease in clinically significant SAEs (Clavien-Dindo ≥ 3). The results showed that this sample size would achieve 87% power with a two-sided test at a 5% significance level. These calculations were based on pilot data that showed a 43% adverse event rate in the control group and a 27.5% rate in the intervention group [