System-integrated technology-enabled model of care (SINEMA) to improve the health of stroke patients in rural China: Statistical analysis plan for a cluster-randomized controlled trial.

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).

Duke Scholars

Author Lijing Yan DKU Faculty

Author John Gallis  

Author Janet Prvu Bettger Orthopaedic Surgery

Author Elizabeth Louise Turner Biostatistics & Bioinformatics, Division of Biostatistics