Evidence map›Paper›PMID 26068449›Full record

Trial reportTrials2015

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

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

Open access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Content of Health Economics Analysis Plans (HEAPs) for Trial-Based Economic Evaluations: Expert Delphi Consensus Survey.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2021
    Article
  7. Article
  8. A comparison of the responsiveness of EQ-5D-5L and the QOLIE-31P and mapping of QOLIE-31P to EQ-5D-5L in epilepsy.The European journal of health economics : HEPAC : health economics in prevention and care · 2018
    Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Nicholas MagillDepartment 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.
Leone RidsdaleDepartment 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.
Laura H GoldsteinDepartment 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.
Paul McCroneDepartment 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.
Myfanwy MorganDivision 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.
Adam J NobleDepartment 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.
Gus BakerDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Ashton Street, Liverpool, L69 3GE, UK. g.baker@liverpool.ac.uk.
Mark RichardsonDepartment 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.
Stephanie TaylorBarts & 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.
Sabine LandauDepartment 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.
King's College London · GBUniversity of Liverpool · GBDepartment of Health and Social Care · GBQueen Mary University of London · GB

Funding

Department of Health 09/165/01
6 · The paper itself

Abstract

backgroundThere 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

designSMILE 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.

resultsA 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.

conclusionThis 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 registrationCurrent Controlled Trials ISRCTN57937389; date assigned: 27 March 2013.

Indexed as

Patient Education as TopicQualitative ResearchSelf CareAdultData Interpretation, StatisticalEpilepsyHumansOutcome Assessment, Health CareSample Size

Identifiers

PMID26068449
PMCPMC4488108
OpenAlexW1838399995

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.