Billot, L, Lindley, RI, Harvey, LA et al. (14 more authors) (2017) Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care. International Journal of Stroke, 12 (2). pp. 208-210. ISSN 1747-4930
Abstract
Background
In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke.
Objective
To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding.
Methods
Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data.
Results
The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting.
Conclusions
Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses.
Clinical Trial Registrations
India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Keywords: | Rehabilitation, statistical analysis plan, cost factors, India, clinical trial, disability, caregivers, developing countries |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Elderly Care and Rehabilitation (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 12 Aug 2021 11:31 |
Last Modified: | 12 Aug 2021 11:31 |
Status: | Published |
Publisher: | SAGE Publications |
Identification Number: | 10.1177/1747493016674956 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:176962 |