articleJAMADec 26, 2012Closed access

Reporting of Noninferiority and Equivalence Randomized Trials

GPGilda PiaggioDRDiana R ElbourneSPStuart PocockSEStephen EvansDGDouglas G. Altman

Elabora Consultoria (Brazil)

PubMed
Indexed incrossrefpubmed

Abstract

The CONSORT (Consolidated Standards of Reporting Trials) Statement, which includes a checklist and a flow diagram, is a guideline developed to help authors improve the reporting of the findings from randomized controlled trials. It was updated most recently in 2010. Its primary focus is on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another. The CONSORT Statement has been extended to other trial designs such as cluster randomization, and recommendations for noninferiority and equivalence trials were made in 2006. In this article, we present an updated extension of the CONSORT checklist for reporting noninferiority and equivalence…

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Topics & keywords

Topics
Keywords
  • Consolidated Standards of Reporting Trials
  • Checklist
  • Medicine
  • Randomized controlled trial
  • Randomization
  • Equivalence (formal languages)
  • Guideline
  • Cluster randomised controlled trial
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