학술논문
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.
Document Type
Article
Author
Billot, Laurent; Lindley, Richard I.; Harvey, Lisa A.; Maulik, Pallab K.; Hackett, Maree L.; Murthy, Gudlavalleti V. S.; Anderson, Craig S.; Shamanna, Bindiganavale R.; Jan, Stephen; Walker, Marion; Forster, Anne; Langhorne, Peter; Verma, Shweta J.; Felix, Cynthia; Alim, Mohammed; Gandhi, Dorcas B. C.; Pandian, Jeyaraj Durai
Source
Subject
*MEDICAL rehabilitation
*STROKE treatment
*STROKE patients
*RANDOMIZED controlled trials
*MULTI-centre shell model
*CAREGIVERS
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Language
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. [ABSTRACT FROM AUTHOR]