Academic Journal
Statistical analysis plan for the COMPARE trial: A 3-arm randomised controlled trial comparing the effectiveness of constraint-induced aphasia therapy plus and multimodality aphasia therapy to usual care in chronic post-stroke aphasia (COMPARE)
| Title: | Statistical analysis plan for the COMPARE trial: A 3-arm randomised controlled trial comparing the effectiveness of constraint-induced aphasia therapy plus and multimodality aphasia therapy to usual care in chronic post-stroke aphasia (COMPARE) |
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| Authors: | Rose, Miranda L., Rai, Tapan, Copland, David, Nickels, Lyndsey, Togher, Leanne, Meinzer, Marcus, Godecke, Erin, Kim, Joosup, Cadilhac, Dominique A., Hurley, Melanie, Wilcox, Cassie, Carragher, Marcella |
| Source: | Research outputs 2014 to 2021 |
| Publisher Information: | Edith Cowan University, Research Online, Perth, Western Australia |
| Publication Year: | 2021 |
| Collection: | Edith Cowan University (ECU, Australia): Research Online |
| Subject Terms: | Aphasia, chronic, stroke rehabilitation, statistical analysis plan, randomised controlled trial, Medical Sciences, Medicine and Health Sciences, Neurosciences |
| Description: | Background While 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. Methods Participants (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. Results Linear 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 ... |
| Document Type: | text |
| File Description: | application/pdf |
| Language: | unknown |
| Relation: | https://ro.ecu.edu.au/ecuworkspost2013/10265; https://ro.ecu.edu.au/context/ecuworkspost2013/article/11271/viewcontent/Statistical_analysis_plan_for_the_COMPARE_trial.pdf |
| DOI: | 10.1186/s13063-021-05238-0 |
| Availability: | https://ro.ecu.edu.au/ecuworkspost2013/10265 https://doi.org/10.1186/s13063-021-05238-0 https://ro.ecu.edu.au/context/ecuworkspost2013/article/11271/viewcontent/Statistical_analysis_plan_for_the_COMPARE_trial.pdf |
| Rights: | http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.1D193A8C |
| Database: | BASE |
| DOI: | 10.1186/s13063-021-05238-0 |
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