Table 2.
Usual care group (n=6388) | Intervention group (n=6834) | Absolute difference in rates per 1000 person-years (95% CI) | Overall rate ratio (95% CI); p value |
Adjusted rate ratios (95% CI); p value |
|||
---|---|---|---|---|---|---|---|
Cluster randomised group | Patient-level randomised group | Overall* | |||||
Number of participants diagnosed with Barrett's oesophagus | 13 (<1%) | 140 (2%)† | .. | .. | .. | .. | .. |
Follow-up, person-years | 6579 | 6952 | .. | .. | .. | .. | .. |
Rate of Barrett's oesophagus, per 1000 person-years | 2·0 | 20·2‡ | 18·3 (14·8–21·8) | 10·2 (5·8–18·1) | 10·0 (5·0–20·0); p<0·0001 | 12·0 (4·3–33·2); p<0·0001 | 10·6 (6·0–18·8); p<0·0001 |
Data are n (%), unless otherwise specified.
Overall adjusted rate ratio is a combined rate ratio of the two randomisation groups (cluster randomisation and individual patient-level randomisation) and accounts for clustering.
Number of participants diagnosed with Barrett's oesophagus in the intervention group includes all participants who were offered the Cytosponge procedure.
The rate of Barrett's oesophagus in the intervention group was calculated as the weighted average of the rate in the first 4 months of follow-up and the rate in the following months, with a weight ratio of 1:2.