Evidence map›Paper›PMID 33892764›Full record

Trial reportTrials2021

Statistical analysis plan for the COMPARE trial: a 3-arm randomised controlled trial comparing the effectiveness of Constraint-induced Aphasia Therapy Plus and Multi-modality Aphasia Therapy to usual care in chronic post-stroke aphasia (COMPARE).

Miranda L Rose, Tapan Rai, David Copland, Lyndsey Nickels, Leanne Togher, Marcus Meinzer, Erin Godecke, Joosup Kim, Dominique A Cadilhac, Melanie Hurley and 2 more

Open access · goldAbstract readLetterRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 34% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Aphasia-specific or generic outcomes? a comparison of two health-related quality of life instruments for economic evaluations of aphasia treatments.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
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  6. Economic Evaluations of Speech and Language Therapy Interventions: A Scoping Review.International journal of language & communication disorders
    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

12 authors at 9 institutions in 2 countries.

Miranda L RoseSchool of Allied Health, Human Services and Sport, La Trobe University Melbourne, Kingsbury Drive, Bundoora, Victoria, 3084, Australia. m.rose@latrobe.edu.au.ORCID http://orcid.org/0000-0002-8892-0965
Tapan RaiUniversity of Technology Sydney, Ultimo, New South Wales, Australia.
David CoplandCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Lyndsey NickelsCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Leanne TogherCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Marcus MeinzerDepartment of Neurology, University Medicine Greifswald, Greifswald, Germany.
Erin GodeckeCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Joosup KimCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Dominique A CadilhacCentre of Research Excellence in Aphasia Recovery and Rehabilitation, Melbourne, Australia.
Melanie HurleySchool of Allied Health, Human Services and Sport, La Trobe University Melbourne, Kingsbury Drive, Bundoora, Victoria, 3084, Australia.
Cassie WilcoxSchool of Allied Health, Human Services and Sport, La Trobe University Melbourne, Kingsbury Drive, Bundoora, Victoria, 3084, Australia.
Marcella CarragherSchool of Allied Health, Human Services and Sport, La Trobe University Melbourne, Kingsbury Drive, Bundoora, Victoria, 3084, Australia.
La Trobe University · AUMonash Health · AUEdith Cowan University · AUMacquarie University · AUThe University of Melbourne · AUThe University of Queensland · AUThe University of Sydney · AUUniversitätsmedizin Greifswald · DEUniversity of Technology Sydney · AU

Funding

National Health and Medical Research Council 1083010
6 · The paper itself

Abstract

backgroundWhile high-quality meta-analyses have confirmed the effectiveness of aphasia therapy after stroke, there is limited evidence for the comparative effectiveness of different aphasia interventions. Two commonly used interventions, Constraint-induced Aphasia Therapy Plus (CIAT Plus) and Multi-modality Aphasia Therapy (M-MAT), are hypothesised to rely on diverse underlying neural mechanisms for recovery and may be differentially responsive to aphasia severity. COMPARE is a prospective randomised open-blinded end-point trial designed to determine whether, in people with chronic post-stroke aphasia living in the community, CIAT Plus and M-MAT provide greater therapeutic benefit compared to usual care, are differentially effective according to aphasia severity, and are cost-effective. This paper details the statistical analysis plan for the COMPARE trial developed prior to data analysis.

methodsParticipants (n = 216) are randomised to one of three arms, CIAT Plus, M-MAT or usual care, and undertake therapy with a study trained speech pathologist in groups of three participants stratified by aphasia severity. Therapy occurs for 3 h blocks per day for 10 days across 2 weeks. The primary clinical outcome is aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ) immediately post intervention. Secondary outcomes include WAB-R-AQ at 12-week follow-up, and functional communication, discourse efficiency, multimodal communication, and health-related quality of life immediately post intervention and at 12-week follow-up.

resultsLinear mixed models (LMMs) will be used to analyse differences between M-MAT and UC, and CIAT-Plus and UC on each outcome measure immediately and at 12 weeks post-intervention. The LMM for WAB-R-AQ will assess the differences in efficacy between M-MAT and CIAT-Plus. All analyses will control for baseline aphasia severity (fixed effect) and for the clustering effect of treatment groups (random effect). DISCUSSION: This trial will provide relative effectiveness data for two common interventions for people with chronic post-stroke aphasia, and highlight possible differential effects based on aphasia severity. Together with the health economic analysis data, the results will enable more informed personalised prescription for aphasia therapy after stroke.

trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN 12615000618550 . Registered on 15 June 2016.

Indexed as

AphasiaStrokeStroke RehabilitationAustraliaHumansProspective StudiesQuality of LifeTreatment OutcomeAphasiaChronicRandomised controlled trialStatistical analysis planStroke rehabilitation

Identifiers

PMID33892764
PMCPMC8062936
OpenAlexW3153743972

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.