Table 8.
GRADE evidence profile for PICO 10.1 – Clinically severe stroke.
| Certainty assessment |
No of patients |
Effect |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IVT with alteplase | no IVT | Relative(95% CI) | Absolute(95% CI) | ||
| mRS 0–1 at three months | ||||||||||||
| 9 | randomised trials | seriousa | not serious | seriousb | not serious | strong association | 22/309(7.1%) | 8/313(2.6%) | OR 3.25(1.42–7.47) | 53 more per 1 000(from 10 more to 138 more) | ⨁⨁⨁◯MODERATE | CRITICAL |
| Fatal ICH with seven days | ||||||||||||
| 9 | randomised trials | seriousa | not serious | seriousb | seriousc | very strong association | 21/309(6.8%) | 2/313(0.6%) | OR 10.94(2.54–47.15) | 59 more per 1 000(from 10 more to 226 more) | ⨁⨁⨁◯MODERATE | CRITICAL |
Note: All results are based on the individual participant data meta-analysis by Emberson et al.8aAlthough the 9 RCTs included in the individual patient data meta-analysis had patients with NIHSS ≥22, in many trials, patients with clinically very severe stroke (e.g. NIHSS >25 in ECASS-3) or radiologically severe stroke (e.g. attenuation of >1/3 of the MCA in ECASS 2 and ATLANTIS B) were excluded. Therefore, a selection bias is likely: patients with clinically severe stroke were not indiscriminately randomized in those trials.bThis result is based on an independent patient data meta-analysis of subgroups of 9 trials, and was restricted to patients with NIHSS ≥ 22. It is uncertain whether those results would also apply to patients with very severe stroke (e.g., NIHSS >25 or coma).cThe confidence interval is very wide