Fragility Index in Cardiovascular Randomized Controlled Trials.

ABSTRACT:

Background

Efficacy of an intervention is commonly evaluated using P values, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI.

Methods and results

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SUBMITTER: Khan MS 

PROVIDER: S-EPMC7962007 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature