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Reporting Noninferiority Trials

Scott Aberegg, MD, MPH
JAMA. 2013;309(15):1584-1585. doi:10.1001/jama.2013.3086.
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To the Editor: Dr Piaggio and colleagues1 presented an updated extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting noninferiority and equivalence trials. I believe the statement should be revised so that interpretation of noninferiority trials is not biased.

Because Figure 1 in the article has a zone of inferiority that is asymmetric (it lacks a negative delta on the left to mirror the positive delta on the right), superiority of the new treatment is more likely than inferiority, and an advantage is conferred to the therapy arbitrarily designated as new. For example, if a new anticoagulant is compared with warfarin (reference treatment) and the results statistically favor the new anticoagulant by any margin, it is declared superior (scenario A in Figure 1).


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April 17, 2013
Stuart J. Pocock, PhD; Gilda Piaggio, PhD; Douglas G. Altman, DSc; for the CONSORT Group
JAMA. 2013;309(15):1584-1585. doi:10.1001/jama.2013.3095.
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