|
Outcome
|
Intervention group (%)
|
Control group (%)
|
Risk difference (%) (95% confidence interval)a
|
P
|
|---|
|
Treatment success/Intention to treat analysis
|
1,606/2,107 (76.2)
|
1,402/1,984 (70.7)
|
5.6 (−1.2, 12.3)
|
0.107
|
|
Treatment success/Exploratory analysis
|
1,051/1,294 (81.2)
|
1,402/1,984 (70.7)
|
10.6 (3.7, 17.5)
|
0.003
|
- The estimated intra-cluster correlation co-efficient for our study for the primary outcome was 0.033. This is very close to the intra-cluster correlation co-efficient assumed in the sample size calculation (0.03). aEstimate from generalized linear model.
