Abstract
Background
The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China.
Objective
To present the detailed statistical analysis plan for the trial prior to database locking and data analysis.
Methods
The detailed analysis plan outlines primary and secondary outcome measures, describes the over-arching data analysis principles to be adopted as well as more detailed descriptions of specific analytical approaches for effectiveness analyses, as well strategies to handle missing outcome data.
Discussion
Publication of the statistical analysis plan increases the transparency of the data analysis procedure and reduces potential bias in trial reporting.
Trial registration
The trial was registered with clinicaltrials.gov (NCT03185858).
Get full access to this article
View all access options for this article.
References
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
