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.

Published online

Journal Article

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).

Full Text

Duke Authors

Cited Authors

  • Gong, E; Yan, LL; McCormack, K; Gallis, JA; Bettger, JP; Turner, EL

Published Date

  • August 28, 2019

Published In

Start / End Page

  • 1747493019869707 -

PubMed ID

  • 31462178

Pubmed Central ID

  • 31462178

Electronic International Standard Serial Number (EISSN)

  • 1747-4949

Digital Object Identifier (DOI)

  • 10.1177/1747493019869707

Language

  • eng

Conference Location

  • United States