The analysis of continuous data from n-of-1 trials using paired cycles: a simple tutorial

Abstract

N-of-1 trials are defined and the popular paired cycle design is introduced, together with an explanation as to how suitable sequences may be constructed.

Various approaches to analysing such trials are explained and illustrated using a simulated data set. It is explained how choosing an appropriate analysis depends on the question one wishes to answer. It is also shown that for a given question, various equivalent approaches to analysis can be found, a fact which may be exploited to expand the possible software routines that may be used.

Sets of N-of-1 trials are analogous to sets of parallel group trials. This means that software for carrying out meta-analysis can be used to combine results from N-of-1 trials. In doing so, it is necessary to make one important change, however. Because degrees of freedom for estimating variances for individual subjects will be scarce, it is advisable to estimate local standard errors using pooled variances. How this may be done is explained and fixed and random effect approaches to combining results are illustrated.

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Item Type:	Article
Authors/Creators:	Senn, S. https://orcid.org/0000-0002-7558-8473
Copyright, Publisher and Additional Information:	© The Author(s) 2024. Open Access: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Dates:	Published: 16 February 2024 Published (online): 16 February 2024 Accepted: 1 February 2024 Submitted: 14 June 2023
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health
Depositing User:	Symplectic Sheffield
Date Deposited:	21 Feb 2024 15:37
Last Modified:	21 Feb 2024 15:37
Status:	Published
Publisher:	Springer Science and Business Media LLC
Refereed:	Yes
Identification Number:	10.1186/s13063-024-07964-7
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:209400

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The analysis of continuous data from n-of-1 trials using paired cycles: a simple tutorial

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