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Published in: Trials 1/2015

Open Access 01-12-2015 | Update

Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial

Authors: Nicholas Magill, Leone Ridsdale, Laura H. Goldstein, Paul McCrone, Myfanwy Morgan, Adam J. Noble, Gus Baker, Mark Richardson, Stephanie Taylor, Sabine Landau

Published in: Trials | Issue 1/2015

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Abstract

Background

There is a need to test the effectiveness of new educational interventions for people with poorly controlled epilepsy. The SMILE (self-management education for adults with poorly controlled epilepsy) trial evaluates a complex service intervention that involves a 2-day self-management course with the aim of improving quality of life and clinical outcomes. This article describes the statistical, economic, and qualitative analysis plan for the trial.

Methods and design

SMILE is a pragmatic, parallel design, two-arm, multi-centre randomised controlled superiority trial of a group-based interactive course compared with treatment as usual for people who have experienced two or more seizures in the past 12 months.

Results

A summary of the objectives and design of the trial are reported as well as the manner in which the data will be summarised and inferentially analysed. This includes the type of modelling that will be employed for each of the primary and secondary outcomes and the methods by which the assumptions of these models will be checked. Strategies are described for handling clustering of outcome data, missing observations, and treatment non-compliance.

Conclusion

This update to the previously published trial protocol provides a description of the trial analysis which is transparent and specified before any outcome data are available. It also provides guidance to those planning the analysis of similar trials.

Trial registration

Current Controlled Trials ISRCTN57937389; date assigned: 27 March 2013.
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Metadata
Title
Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial
Authors
Nicholas Magill
Leone Ridsdale
Laura H. Goldstein
Paul McCrone
Myfanwy Morgan
Adam J. Noble
Gus Baker
Mark Richardson
Stephanie Taylor
Sabine Landau
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0788-9

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