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.
Keywords
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