Table 11.
GRADE evidence profile for PICO 13.5.
| Certainty assessment |
No of patients |
Effect |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No ofstudies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IVT with alteplase | no IVT | Relative(95% CI) | Absolute(95% CI) | ||
| Favourable functional outcome at 3–6 months | ||||||||||||
| 4 | randomised trials | not serious | not serious | seriousa | not seriousb | none | 376/1105(34.0%) | 323/1129(28.6%) | OR 1.33(1.05–1.67) | 62 more per 1 000(from 10 more to 115 more) | ⨁⨁⨁◯MODERATE | CRITICAL |
| sICH | ||||||||||||
| 4 | randomised trials | not serious | not serious | seriousa | not seriousc | very strong association | 87/1105(7.9%) | 15/1129(1.3%) | OR 5.50(2.49–12.13) | 56 more per 1 000(from 19 more to 127 more) | ⨁⨁⨁⨁HIGH | CRITICAL |
Note: Results based on data from NINDS, ECASS 1 and 2 and IST-3.aThis result corresponds to presence or absence of leukoaraiosis. It therefore does not directly address the situation of patients with extensive leukoaraiosis.bOf note, there was no evidence that presence of leukoaraiosis modifies the effect of IVT on functional outcome in IST-3 (P for interaction = 0.24).cThere was no evidence in IST-3 that presence of leukoaraiosis significantly modifies the effect of IVT on siCH (P for interaction = 0.14)