Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 4/5
Leuppi JD, et al.
JAMA. 2013 Jun 5;309(21):2223-31.
This multicenter, double blinded trial demonstrated non-inferiority of a 5-day course of 40mg prednisone versus a 14-day course of 40mg prednisone in the treatment of patients admitted to hospital for acute exacerbation of COPD (AECOPD). Although the patient population was not identical to the ED population, the group agrees that these results should encourage ED physicians to prescribe a 5 day course of prednisone for uncomplicated AECOPD.
By: Dr. Christopher Mong
(Presented April 2014)
Epi lesson: Non-inferiority Trials
Non-inferiority trials are distinct from superiority trials such that they are designed to determine whether a given intervention is non-inferior by a pre-specified margin compared to a control. This is not the same as equivalence and a key section of the methods to examine is the sample size calculation where the non-inferiority margin is specified. Ideally, researchers explain how this margin was determined (based on previous placebo controlled trials, consensus of experts). The critical reader will ask themselves if they feel this margin is truly clinically significant.
By: Lisa Calder