Evidence map›Paper›PMID 25414095›Full record

Trial reportTrials2014

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

Marie-Anne Durand, Bob Gates, Georgina Parkes, Asif Zia, Karin Friedli, Garry Barton, Howard Ring, Linda Oostendorp, David Wellsted

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. 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

9 authors.

Marie-Anne DurandCentre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield AL10 9AB, UK. m.durand@herts.ac.uk.
Bob Gates
Georgina Parkes
Asif Zia
Karin Friedli
Garry Barton
Howard Ring
Linda Oostendorp
David Wellsted

Funding

Department of Health PB-PG-0110-21073Department of Health PB-PG-0213-30042Department of Health PB-PG-0909-19044Department of Health PB-PG-1112-29078
6 · The paper itself

Abstract

backgroundEpilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. METHODS/

designWe will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. DISCUSSION: The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities.

trial registrationhttp://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Indexed as

Health Knowledge, Attitudes, PracticePamphletsResearch DesignAdaptation, PsychologicalAdultClinical ProtocolsComprehensionCost of IllnessEnglandEpilepsyFeasibility StudiesFemaleHealth LiteracyHumansLearning DisabilitiesMale

Identifiers

PMID25414095
PMCPMC4289382

What OpenQuestion holds

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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.