Journal
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Volume 308, Issue 24, Pages 2594-2604Publisher
AMER MEDICAL ASSOC
DOI: 10.1001/jama.2012.87802
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Funding
- UK Medical Research Council
- Cancer Research UK [C5529]
- Medical Research Council [MR/J004871/1] Funding Source: researchfish
- MRC [MR/J004871/1] Funding Source: UKRI
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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. JAMA. 2012;308(24).2594-2604 www.jama.com
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