Design considerations for clinical trials in aphasia

The use of the randomised controlled trial (RCT) design to evaluate the effectiveness of new interventions in aphasia has increased in recent years in response to calls for high quality evidence of the effectiveness of interventions for this population. This view-point article highlights some of the...

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Main Author: Rebecca Palmer
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2020-01-01
Series:Annals of Indian Academy of Neurology
Subjects:
Online Access:http://www.annalsofian.org/article.asp?issn=0972-2327;year=2020;volume=23;issue=8;spage=52;epage=56;aulast=Palmer
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author Rebecca Palmer
author_facet Rebecca Palmer
author_sort Rebecca Palmer
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description The use of the randomised controlled trial (RCT) design to evaluate the effectiveness of new interventions in aphasia has increased in recent years in response to calls for high quality evidence of the effectiveness of interventions for this population. This view-point article highlights some of the important considerations when designing a trial for an aphasia intervention, illustrated with decisions made when designing the Big CACTUS RCT for self-managed computer-based word finding therapy in aphasia. Considerations outlined include whether an RCT is needed, readiness for conducting an RCT, choice of comparators, randomisation options, blinding/masking, selection of outcome measures, pragmatic versus explanatory approaches, and fidelity measurement.
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spelling doaj.art-b1fc35ccd7284d868b8ff2d23cfdfdd72022-12-21T23:31:29ZengWolters Kluwer Medknow PublicationsAnnals of Indian Academy of Neurology0972-23271998-35492020-01-01238525610.4103/aian.AIAN_453_20Design considerations for clinical trials in aphasiaRebecca PalmerThe use of the randomised controlled trial (RCT) design to evaluate the effectiveness of new interventions in aphasia has increased in recent years in response to calls for high quality evidence of the effectiveness of interventions for this population. This view-point article highlights some of the important considerations when designing a trial for an aphasia intervention, illustrated with decisions made when designing the Big CACTUS RCT for self-managed computer-based word finding therapy in aphasia. Considerations outlined include whether an RCT is needed, readiness for conducting an RCT, choice of comparators, randomisation options, blinding/masking, selection of outcome measures, pragmatic versus explanatory approaches, and fidelity measurement.http://www.annalsofian.org/article.asp?issn=0972-2327;year=2020;volume=23;issue=8;spage=52;epage=56;aulast=Palmeraphasiarandomised controlled trialstrial design
spellingShingle Rebecca Palmer
Design considerations for clinical trials in aphasia
Annals of Indian Academy of Neurology
aphasia
randomised controlled trials
trial design
title Design considerations for clinical trials in aphasia
title_full Design considerations for clinical trials in aphasia
title_fullStr Design considerations for clinical trials in aphasia
title_full_unstemmed Design considerations for clinical trials in aphasia
title_short Design considerations for clinical trials in aphasia
title_sort design considerations for clinical trials in aphasia
topic aphasia
randomised controlled trials
trial design
url http://www.annalsofian.org/article.asp?issn=0972-2327;year=2020;volume=23;issue=8;spage=52;epage=56;aulast=Palmer
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