Table 1.
Parameter | Phase one | Phase two |
---|---|---|
Control prevalence in the first measurement occasion | 30% | 30% |
Time trend | Linear, odds ratio = 1.05 for each measurement occasion (6 occasions for all trial designs) | Linear, odds ratio = 1.05 for each measurement occasion (6 occasions for all trial designs) |
Intervention effect | Odds ratio = 1.3 | Odds ratio = 1.3 |
ICC within measurement occasion () | 0.01, 0.1 | 0.01, 0.05, 0.1 |
Correlation structures between measurement occasions | Exchangeable | Exchangeable |
AR(1) r = 0.6 | AR(1) r = 0.6 | |
AR(1) r = 0.8 | AR(1) r = 0.8 | |
AR(1) r = 0.8 with 50% less correlation between control and intervention | AR(1) r = 0.8 with 50% less correlation between control and intervention | |
Number of sequences | 3,6 | 3,6 |
Number of clusters (C) | 18 | 6,12,18, 24, |
42,48, 54 | ||
Cluster size | 24, 60 | 24, 60,300a |
Coefficient of variation (CV) of cluster size | 0, 0.4 | 0, 0.4 |
aThe scenario with cluster size of 300 was only run with exchangeable within cluster correlation, 12, 24, and 42 clusters, and no variability in cluster size.