Reporting of Noninferiority and Equivalence Randomized Trials

TLDR

The CONSORT Statement was created to improve reporting of randomized trials, originally focusing on superiority designs, but it is now being extended to noninferiority and equivalence trials, which have distinct methodological challenges and are often inadequately reported. This article aims to improve reporting of noninferiority and equivalence trials by providing an adapted CONSORT checklist. The authors present an adapted CONSORT checklist for these trials, including illustrative examples and explanations of the amended items.

Abstract

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.