Non-inferiority and Equivalence Trials

The CONSORT extension for reporting noninferiority and equivalence trials was updated in 2012 to be in-line with CONSORT 2010, and can be downloaded below.

The main CONSORT Statement provides recommendations for reporting randomized controlled trials, which aim to determine whether one intervention is superior to another. Equivalence trials, on the other hand, aim to determine whether one intervention is therapeutically similar to another. Also non-inferiority trials aim to determine whether one treatment is no worse than another. For example, a new antenatal care model with fewer clinic visits and lower costs might be compared with a standard model in terms of maternal and neonatal outcomes.

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 medical literature. The quality of reporting of those that are published is often inadequate.

Available Downloads

The main CONSORT flow diagram should be used.

Document Word Format PDF Format
Checklist Download n/a
Explanation & Elaboration n/a Download

Reference

Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604. doi:10.1001/jama.2012.87802. PMID:  23268518

 

Extensions of the CONSORT Statement

The main CONSORT Statement is based on the "standard" two-group parallel design. However, there are several variations to the standard trial methodology, including different design aspects (e.g., cluster), interventions (e.g., herbals) and data (e.g., harms).

To help improve the reporting of these trials the main CONSORT Statement has been extended and modified by members of the CONSORT group for application in these various areas. The resulting CONSORT extensions are presented in this section. This list is, by no means, exhaustive; and work is constantly in progress.

Please note that modifications to the CONSORT checklist or flow diagram that are not developed with the involvement of the CONSORT Group do not have permission to name their work "CONSORT".

Some work, however, has been done to modify the CONSORT Statement without the involvement of the Group. These unofficial extensions of the CONSORT Statement can be found here.

 

Finding the Appropriate Extension

The table below lists the current official extensions of the CONSORT statement.  You can click on each extension to learn more about it or to explore that extension in the checklist viewer application.

 

Designs
Interventions
Data
Cluster Trials Herbal Medicinal Interventions CONSORT-PRO
Non-Inferiority and Equivalence Trials Non-Pharmacologic Treatment Interventions Harms
Pragmatic Trials Acupuncture Interventions

Abstracts

N-of-1 Trials Chinese Herbal Medicine Formulas  
Pilot and Feasibility Trials     
Within Person Trials