N-of-1 Trials

N-of-1 Trials

N-of-1 trials provide a mechanism for making evidence based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A CONSORT extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist and recommends a diagram for depicting an individual N-of-1 trial and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document, as well as a CENT pictorial.

Available Downloads

Document Word  PDF 
Statement Document n/a Download
Checklist Download Download
Participant Flow Diagram (series) n/a Download
Trial Pictorial n/a Download
Explanation & Elaboration n/a Download

 

Reference

Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT group. CONSORT extension forreporting N-of-1 trials (CENT) 2015 Statement. BMJ. 2015 May 14;350:h1738. doi:10. 1136/bmj. h1738. Click here

Vohra S, Shamseer L, Sampson M, Bukutu C, Schmid CH, Tate R, Nikles J, Zucker DR, Kravitz R, Guyatt G, Altman DG, Moher D; CENT group. CONSORT extension forreporting N-of-1 trials (CENT) 2015 Statement. J Clin Epidemiol. 2016; 76:9-17. doi: 10.1016/j.jclinepi.2015.05.004 Click here

Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC,Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENTgroup. CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and Elaboration. BMJ. 2015 May 14;350:h1793 doi: 10. 1136/bmj. h1793. Click here

Shamseer L, Sampson M, Bukutu C, Schmid CH, Nikles J, Tate R, Johnston BC,Zucker D, Shadish WR, Kravitz R, Guyatt G, Altman DG, Moher D, Vohra S; CENTgroup. CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and Elaboration. J Clin Epidemiol. 2016; 76: 18-46. doi:  10.1016/j.jclinepi.2015.05.018 Click here

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    
Pilot and Feasibility Trials