title: Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN57937389; date assigned: 27 March 2013.
authors.affiliation: Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 20, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. nicholas.magill@kcl.ac.uk.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Magill
authors.affiliation: Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 43, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. leone.ridsdale@kcl.ac.uk.
authors.forename: Leone
authors.initials: L
authors.lastname: Ridsdale
authors.affiliation: Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 77, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. aura.goldstein@kcl.ac.uk.
authors.forename: Laura H
authors.initials: LH
authors.lastname: Goldstein
authors.affiliation: Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 24, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. paul.mccrone@kcl.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: Division of Health and Social Care Research, School of Medicine, King's College London, 7th Floor Capital House, 42 Weston Street, London, SE1 3QD, UK. myfanwy.morgan@kcl.ac.uk.
authors.forename: Myfanwy
authors.initials: M
authors.lastname: Morgan
authors.affiliation: Department of Psychological Sciences, Institute of Psychology, Health and Society, The Whelan Building, University of Liverpool, Brownlow Hill, Liverpool, L69 3GB, UK. adam.noble@liverpool.ac.uk.
authors.forename: Adam J
authors.initials: AJ
authors.lastname: Noble
authors.affiliation: Department of Molecular and Clinical Pharmacology, University of Liverpool, Ashton Street, Liverpool, L69 3GE, UK. g.baker@liverpool.ac.uk.
authors.forename: Gus
authors.initials: G
authors.lastname: Baker
authors.affiliation: Department of Basic and Clinical Neurosciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 43, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. mark.richardson@kcl.ac.uk.
authors.forename: Mark
authors.initials: M
authors.lastname: Richardson
authors.affiliation: Barts & The London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Blizard Institute, Abernethy Building, 2 Newark Street, London, E1 2AT, UK. s.j.c.taylor@qmul.ac.uk.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Taylor
authors.affiliation: Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO 20, , Denmark Hill Campus, 16 De Crespigny Park, London, SE5 8AF, UK. sabine.landau@kcl.ac.uk.
authors.forename: Sabine
authors.initials: S
authors.lastname: Landau
mesh_terms: D000328:Adult; D003627:Data Interpretation, Statistical; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic; D036301:Qualitative Research; D018401:Sample Size; D012648:Self Care