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

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 fa...

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Bibliographic Details
Published in:International Journal of Stroke 2017-02, Vol.12 (2), p.208-210
Main Authors: Billot, Laurent, Lindley, Richard I, Harvey, Lisa A, Maulik, Pallab K, Hackett, Maree L, Murthy, Gudlavalleti VS, Anderson, Craig S, Shamanna, Bindiganavale R, Jan, Stephen, Walker, Marion, Forster, Anne, Langhorne, Peter, Verma, Shweta J, Felix, Cynthia, Alim, Mohammed, Gandhi, Dorcas BC, Pandian, Jeyaraj Durai
Format: Article
Language:English
Subjects:
Caregivers
Data Interpretation, Statistical
Family
Follow-Up Studies
Humans
India
Patient Selection
Severity of Illness Index
Stroke - therapy
Stroke Rehabilitation - methods
Treatment Outcome
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Summary: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.
ISSN:1747-4930
1747-4949
DOI:10.1177/1747493016674956