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. 2021 Feb 19;6(1):I–LXII. doi: 10.1177/2396987321989865

Table 7.

GRADE evidence profile for PICO 9.1.

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 (six months in IST-3)
9 randomised trials not serious not serious seriousa not serious none 237/345(68.7%) 189/321(58.9%) OR 1.48(1.07–2.06) 91 more per 1 000(from 16 more to 158 more) ⨁⨁⨁◯MODERATE CRITICAL
Fatal ICH within seven days
9 randomised trials not serious not serious seriousa very seriousb strong association 3/345(0.9%) 0/321(0.0%) OR 3.90(1.46–10.44) 9 more per 1 000(from 4 more to 25 more) ⨁⨁◯◯LOW

Note: All results are based on the individual patient data meta-analysis by Emberson et al.aThis result is based on an analysis of subgroups of patients included in RCTs with various inclusion criteria. There was no clear definition of disabling stroke in patients with NIHSS 0–4.bThe number of events was extremely low.