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

 

References

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