Effect of the intervention on the primary and secondary outcomes (measured per 1000 days of hospitalisation)
| Rates per 1000 days of hospitalisation (95% CI) | Rate of rates Intervention/control (95% CI) | P value | ||
| Intervention | Control | |||
| Primary outcome | ||||
| Preventable adverse events | 60.4 (33.2 to 109.9) | 60.4 (37.5 to 97.4) | 1.0 (0.74 to 1.34) | 0.998 |
| Secondary outcomes | ||||
| Total adverse events | 93.7 (57.9 to 151.6) | 86.0 (60.0 to 123.3) | 1.09 (0.84 to 1.42) | 0.521 |
| Preventable AE with temporary damage to the patient with intervention requirement | 17.8 (7.8 to 41.0) | 18.8 (10.2 to 34.8) | 0.95 (0.6 to 1.51) | 0.820 |
| Preventable AE with temporary damage to the patient requiring admission to/prolongation of the hospitalisation | 20.2 (10.0 to 40.7) | 26.0 (16.1 to 42.0) | 0.78 (0.51 to 1.18) | 0.233 |
| Preventable AE with permanent damage to the patient | 5 events | 1 event | – | – |
| Preventable AE which required intervention to maintain life | 16.0 (3.5 to 72.4) | 8.5 (2.8 to 26.2) | 1.88 (0.82 to 4.31) | 0.136 |
| Preventable AE with patient death | 5 events | 3 events | – | – |
| Medication related | 10.8 (3.3 to 36.0) | 10.4 (4.5 to 24.0) | 1.04 (0.52 to 2.09) | 0.910 |
| Related to procedures | 7.7 (2.1 to 28.0) | 9.7 (4.2 to 22.3) | 0.79 (0.35 to 1.77) | 0.569 |
| Care related (no medications or procedures) | 9.9 (3.6 to 27.1) | 11.7 (5.2 to 26.0) | 0.85 (0.52 to 1.39) | 0.520 |
| Related to diagnosis | 5.4 (0.6 to 48.5) | 1.6 (0.3 to 7.8) | 3.39 (0.93 to 12.35) | 0.064 |
| Hospital-acquired infections | 19 (9.8 to 36.6) | 20.9 (14.4 to 30.3) | 0.91 (0.58 to 1.41) | 0.666 |
| Falls | 0 event | 0 event | – | – |
| Others | 0 event | 0 event | – | – |
AE, adverse event.;