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Special Communication |

Reporting of Noninferiority and Equivalence Randomized Trials:  An Extension of the CONSORT Statement

Gilda Piaggio, PhD; Diana R. Elbourne, PhD; Douglas G. Altman, DSc; Stuart J. Pocock, PhD; Stephen J. W. Evans, MSc; for the CONSORT Group
JAMA. 2006;295(10):1152-1160. doi:10.1001/jama.295.10.1152.
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The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.

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Figure. Possible Scenarios of Observed Treatment Differences for Adverse Outcomes (Harms) in Noninferiority Trials
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Error bars indicate 2-sided 95% confidence intervals (CIs). Tinted area indicates zone of inferiority. A, If the CI lies wholly to the left of zero, the new treatment is superior. B and C, If the CI lies to the left of Δ and includes zero, the new treatment is noninferior but not shown to be superior. D, If the CI lies wholly to the left of Δ and wholly to the right of zero, the new treatment is noninferior in the sense already defined, but it is also inferior in the sense that a null treatment difference is excluded. This puzzling case is rare, since it requires a very large sample size. It can also result from having too wide a noninferiority margin. E and F, If the CI includes Δ and zero, the difference is nonsignificant but the result regarding noninferiority is inconclusive. G, If the CI includes Δ and is wholly to the right of zero, the difference is statistically significant but the result is inconclusive regarding possible inferiority of magnitude Δ or worse. H, If the CI is wholly above Δ, the new treatment is inferior.22,43
*This CI indicates noninferiority in the sense that it does not include Δ, but the new treatment is significantly worse than the standard. Such a result is unlikely because it would require a very large sample size.
†This CI is inconclusive in that it is still plausible that the true treatment difference is less than Δ, but the new treatment is significantly worse than the standard.

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