Evidence map›Paper›PMID 25623162›Full record

Trial reportTrials2015

Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial.

Rebecca Palmer, Cindy Cooper, Pam Enderby, Marian Brady, Steven Julious, Audrey Bowen, Nicholas Latimer

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
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 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

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

  1. Speech and language therapy for aphasia following stroke.The Cochrane database of systematic reviews · 2016
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Design Considerations for Clinical Trials in Aphasia.Annals of Indian Academy of Neurology · 2020
    Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Aphasia Recovery: When, How and Who to Treat?Current neurology and neuroscience reports · 2018
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

7 authors.

Rebecca PalmerSchool of Health and Related Research, University of Sheffield, 107 Innovation Centre, 217 Portobello, Sheffield, S1 4DP, England. r.l.palmer@sheffield.ac.uk.
Cindy CooperSchool of Health and Related Research, University of Sheffield, 107 Innovation Centre, 217 Portobello, Sheffield, S1 4DP, England. c.l.cooper@sheffield.ac.uk.
Pam EnderbySchool of Health and Related Research, University of Sheffield, 107 Innovation Centre, 217 Portobello, Sheffield, S1 4DP, England. p.m.enderby@sheffield.ac.uk.
Marian BradyNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G40BA, England. M.Brady@gcu.ac.uk.
Steven JuliousMedical Statistics Group, School of Health and Related Research, University of Sheffield, Regent Court, Regent Street, Sheffield, S1 4DA, England. s.a.julious@sheffield.ac.uk.
Audrey BowenReader, School of Psychological Sciences, University of Manchester (MAHSC), Joint theme lead - Patient-Centred Care, NIHR CLAHRC Greater Manchester, Centre for Stroke and Vascular Research, CSB, Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, England. audrey.bowen@manchester.ac.uk.
Nicholas LatimerSenior Research Fellow in Health Economics, Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, England. n.latimer@shef.ac.uk.

Funding

Chief Scientist Office NMAHP2Department of Health 12/21/01
6 · The paper itself

Abstract

backgroundAphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. METHODS/

designA total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio will be calculated. Treatment fidelity will be monitored. DISCUSSION: This is the first fully powered trial of the clinical and cost effectiveness of computerised aphasia therapy. Specific challenges in designing the protocol are considered.

trial registrationRegistered with Current Controlled Trials ISRCTN68798818 on 18 February 2014.

Indexed as

Therapy, Computer-AssistedAdultAphasiaClinical Trials as TopicCost-Benefit AnalysisData Interpretation, StatisticalHumansQuality-Adjusted Life YearsResearch DesignSelf CareSingle-Blind MethodStroke

Identifiers

PMID25623162
PMCPMC4318176

What OpenQuestion holds

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LicenceCC BY
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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.