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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, Erin Rai, Tapan Cadihac, Dominique A. Armstrong, Elizabeth Middleton, Sandy Ciccone, Natalie Whitworth, Anne Rose, Miranda L. Holland, Audrey Ellery, Fiona
Godecke, Erin
Rai, Tapan
Cadihac, Dominique A.
Armstrong, Elizabeth
Middleton, Sandy
Ciccone, Natalie
Whitworth, Anne
Rose, Miranda L.
Holland, Audrey
Ellery, Fiona
Abstract
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.
Keywords
aphasia, stroke rehabilitation, statistical analysis plan, randomised controlled trial
Date
2018
Type
Journal article
Journal
International Journal of Stroke
Book
Volume
13
Issue
8
Page Range
863-880
Article Number
ACU Department
Nursing Research Institute
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
License
All rights reserved
File Access
Controlled