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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

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Trial Sequential Analysis on serious adverse events (maximum follow‐up) with participants receiving enteral nutrition in 49 high risk of bias trials. The diversity‐adjusted required information size (RIS) was calculated based on an incidence rate of serious adverse event in the control group of 17.2%; risk ratio reduction of 20% in the experimental group; type I error of 2.5%; and type II error of 20% (80% power). No diversity was noted. The required information size was 4444 participants. The cumulative Z‐curve (blue line) did cross the trial sequential monitoring boundaries for benefit (red inward sloping lines) indicating that enteral nutrition may result in a 20% or greater risk ratio reduction of serious adverse events at maximum follow‐up. The cumulative Z‐curve did not cross the inner‐wedge futility line (red outward sloping lines). The green dotted line shows conventional boundaries (2.5%).