Fig. 7: Trial sequential analysis midazolam and diazepam therapeutic effect. | Pediatric Research

Fig. 7: Trial sequential analysis midazolam and diazepam therapeutic effect.

From: Efficacy, safety, route of administration of midazolam and diazepam for pediatric status epilepticus: systematic review, meta-analysis, and trial sequential analysis

Fig. 7: Trial sequential analysis midazolam and diazepam therapeutic effect.

Trial sequential analysis of the therapeutic success of Midazolam versus Diazepam was conducted using a Random-effects model (DL). The conventional meta-analysis showed a significant pooled effect (RR = 1.13, 95% CI: 1.02–1.26; P value: 0.0223), with observed heterogeneity (I2 = 0.62, Q = 21.33, P value: 0.0063) and diversity (D2 = 0.73). The TSA was based on a double-sided alpha of 0.05 and a beta of 0.20 (power of 80%). As shown in the TSA plot, the cumulative Z-curve (blue line) crossed both the conventional statistical significance boundary and the superiority boundary. With a Required Information Size (RIS) of 662 patients and an accrued information size of 572 patients, the cumulative evidence is considered conclusive and statistically sufficient to demonstrate a reliable benefit for Midazolam in therapeutic success.

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