Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy
© 2018 World Stroke Organization. Background: Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeuti...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal Article |
| Published: |
Wiley-Blackwell Publishing Asia
2018
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| Online Access: | http://hdl.handle.net/20.500.11937/72814 |
| _version_ | 1848762849046822912 |
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| author | Godecke, E. Rai, T. Cadilhac, D. Armstrong, E. Middleton, S. Ciccone, N. Whitworth, Anne Rose, M. Holland, A. Ellery, F. Hankey, G. Bernhardt, J. |
| author_facet | Godecke, E. Rai, T. Cadilhac, D. Armstrong, E. Middleton, S. Ciccone, N. Whitworth, Anne Rose, M. Holland, A. Ellery, F. Hankey, G. Bernhardt, J. |
| author_sort | Godecke, E. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | © 2018 World Stroke Organization. Background: Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective: To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results: The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions: Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130. |
| first_indexed | 2025-11-14T10:54:06Z |
| format | Journal Article |
| id | curtin-20.500.11937-72814 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| last_indexed | 2025-11-14T10:54:06Z |
| publishDate | 2018 |
| publisher | Wiley-Blackwell Publishing Asia |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-728142018-12-13T09:34:10Z Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy Godecke, E. Rai, T. Cadilhac, D. Armstrong, E. Middleton, S. Ciccone, N. Whitworth, Anne Rose, M. Holland, A. Ellery, F. Hankey, G. Bernhardt, J. © 2018 World Stroke Organization. Background: Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective: To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results: The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions: Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130. 2018 Journal Article http://hdl.handle.net/20.500.11937/72814 10.1177/1747493018790055 Wiley-Blackwell Publishing Asia restricted |
| spellingShingle | Godecke, E. Rai, T. Cadilhac, D. Armstrong, E. Middleton, S. Ciccone, N. Whitworth, Anne Rose, M. Holland, A. Ellery, F. Hankey, G. Bernhardt, J. Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title | Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title_full | Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title_fullStr | Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title_full_unstemmed | Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title_short | Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| title_sort | statistical analysis plan (sap) for the very early rehabilitation in speech (verse) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy |
| url | http://hdl.handle.net/20.500.11937/72814 |