Non-inferiority: Not a double negative

In this volume of The Journal, Kumar et al report the results of a “non-inferiority trial” designed to compare the effectiveness of oral paracetamol with oral ibuprofen in the setting of a symptomatic patent ductus arteriosus. Key elements of this study are that this was a randomized, controlled, head-to-head trial. They found that oral paracetamol was not infe rior to oral ibuprofen. The choice of a “non-inferiority” design is an important element of the investigators' strategy. In an accompanying editorial, Hicks et al provide an outstanding overview of how we should interpret this study design and these findings.
Source: The Journal of Pediatrics - Category: Pediatrics Authors: Tags: The Editors' Perspectives Source Type: research
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