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

Billot, L. et al. (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. (doi:10.1177/1747493016674956) (PMID:28134056)

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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.

Item Type:Articles
Additional Information:This study is funded by the National Health and Medical Research Council of Australia (Project grant no. APP1045391).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Langhorne, Professor Peter
Authors: Billot, L., Lindley, R. I., Harvey, L. A., Maulik, P. K., Hackett, M. L., Murthy, G. V., Anderson, C. S., Shamanna, B. R., Jan, S., Walker, M., Forster, A., Langhorne, P., Verma, S. J., Felix, C., Alim, M., Gandhi, D. B., and Pandian, J. D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:International Journal of Stroke
Publisher:SAGE Publications
ISSN:1747-4930
ISSN (Online):1747-4949
Published Online:22 October 2016

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