Palmer, R. (2020) Design considerations for clinical trials in aphasia. Annals of Indian Academy of Neurology, 23 (8). S52-S56. ISSN 0972-2327
Abstract
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 Annals of Indian Academy of Neurology. Published by Wolters Kluwer. This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 Licence (http://creativecommons.org/licenses/by-nc-sa/4.0/), which allows others to remix, tweak and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. |
Keywords: | Aphasia; randomised controlled trials; trial design |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research The University of Sheffield > Sheffield Teaching Hospitals |
Funding Information: | Funder Grant number NATIONAL INSTITUTE FOR HEALTH RESEARCH 12/21/01 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 27 Oct 2020 16:35 |
Last Modified: | 28 Oct 2020 11:02 |
Status: | Published |
Publisher: | Wolters Kluwer |
Refereed: | Yes |
Identification Number: | 10.4103/aian.AIAN_453_20 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:167252 |
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