First randomised device | Non-inferiority | Superiority | |||
---|---|---|---|---|---|
Pulmojet vs. Diskus | Pulmojet | Diskus | Proportions of patients with no errors: Difference (95 % CI) | Serious error with Pulmojeta relative to comparator (1.00): Odds ratio (95 % CI) | p-value a |
(n = 277) | (n = 277) | ||||
Post-patient information leaflet alone | |||||
No definitely serious error, n (%) | 147 (53.1) | 129 (46.6) | 0.06 (−0.02 to 0.15) | -- | -- |
≥1 errors, n (%) | 130 (46.9) | 148 (53.4) | -- | 0.74 (0.51–1.06) | 0.099 |
Post-patient information leaflet and instructional video | |||||
No definitely serious error, n (%) | 229 (82.7) | 206 (74.4) | 0.08 (0.01–0.15) | -- | -- |
≥1 errors, n (%) | 48 (17.3) | 71 (25.6) | -- | 0.45 (0.26–0.78) | 0.004 |
Pulmojet vs. Turbohaler | Pulmojet (n = 144) | Turbohaler (n = 144) | |||
Post-patient information leaflet alone | |||||
No definitely serious error, n (%) | 78 (54.2) | 44 (30.6) | 0.24 (0.13–0.35) | -- | -- |
≥1 errors, n (%) | 66 (45.8) | 100 (69.4) | -- | 0.26 (0.14–0.49) | <0.001 |
Post-patient information leaflet and instructional video | |||||
No definitely serious error, n (%) | 115 (79.9) | 85 (59.0) | 0.21 (0.10–0.31) | -- | -- |
≥1 errors, n (%) | 29 (20.1) | 59 (41.0) | -- | 0.32 (0.17–0.58) | <0.001 |