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Special Communication
December 26, 2012

Reporting of Noninferiority and Equivalence Randomized Trials: Extension of the CONSORT 2010 Statement

Author Affiliations

Author Affiliations: Statistika Consultoria, São Paulo, Brazil, and Divonne-les-Bains, France (Dr Piaggio); Medical Statistics Department, London School of Hygiene and Tropical Medicine, London, United Kingdom (Drs Piaggio, Elbourne and Pocock and Mr Evans); and Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom (Dr Altman).

JAMA. 2012;308(24):2594-2604. doi:10.1001/jama.2012.87802

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 trials, based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and provide illustrative examples and explanations for those items that differ from the main 2010 CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the reliability of their results and conclusions.