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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.

Original publication

DOI

10.1001/jama.295.10.1152

Type

Journal article

Journal

JAMA

Publication Date

03/2006

Volume

295

Pages

1152 - 1160

Addresses

Statistics and Informatics Services Group, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.

Keywords

CONSORT Group, Therapeutic Equivalency, Research Design, Quality Control, Publishing, Randomized Controlled Trials as Topic