Table 6.
GRADE evidence profile for PICO 7.2.
| Certainty assessment |
No of patients |
Effect |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | ultrasound augmentation of IVT with alteplase | IVT with alteplase alone | Relative(95% CI) | Absolute (95% CI) | ||
| mRS 0–1 at three months | ||||||||||||
| 5 | randomised trials | seriousa | seriousb | not seriousc | not serious | none | 167/472(35.4%) | 158/463(34.1%) | OR 1.07(0.77–1.50) | 15 more per 1 000(from 56 fewer to 96 more) | ⨁⨁◯◯LOW | CRITICAL |
aIn the CLOTBUST trial, 19% of the randomized patients were not eligible for the analysis of functional outcome at three months, which was a secondary endpoint. The two trials by Eggers et al. were very small. Furthermore, two phase III trials were stopped early.bTwo small trials by the same group (Eggers et al., 2003, 2008) and one larger study (CLOTBUST) suggested a strong benefit of sonothrombolysis, whereas two large trials did not.cSome trials only included patients with proven arterial occlusion (Eggers et al., CLOTBUST), whereas other studies did not (NOR-SASS, CLOTBUST-ER).