Non-inferiority: Not a double negative

Abstract

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 inferior 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. They review the nature of non-inferiority trials, their role, in what settings they are to be considered, and how we are to interpret the data. It is especially important to consider the non-inferiority margin chosen by investigators. Kumar et al then provide an encyclopedic summary of current issues related to treating symptomatic patent ductus arteriosus, the many recent clinical trials, and the pros and cons of the current pharmacologic options. It makes great reading! Article page 79 ▸ Oral Paracetamol vs Oral Ibuprofen in Patent Ductus Arteriosus: A Randomized, Controlled, Noninferiority TrialThe Journal of PediatricsVol. 222PreviewTo test the hypothesis that oral paracetamol is non-inferior to oral ibuprofen in closing hemodynamically significant patent ductus arteriosus (hsPDA) with an a priori noninferiority (NI) margin of 15%. Full-Text PDF