Enying Gong1,2, Lijing L Yan1,3, Kara McCormack4, John A Gallis3,4, Janet Prvu Bettger3,5, Elizabeth L Turner3,4. 1. Global Health Research Center, Duke Kunshan University, Jiangsu, China. 2. School of Population and Global Health, The University of Melbourne, Melbourne, Australia. 3. Duke Global Health Institute, Duke University, Durham, NC, USA. 4. Department of Biostatistics & Bioinformatics, Duke University, Durham, NC, USA. 5. Department of Orthopedic Surgery, Duke University, Durham, NC, USA.
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).
RCT Entities:
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).
Authors: Lijing L Yan; Enying Gong; Wanbing Gu; Elizabeth L Turner; John A Gallis; Yun Zhou; Zixiao Li; Kara E McCormack; Li-Qun Xu; Janet P Bettger; Shenglan Tang; Yilong Wang; Brian Oldenburg Journal: PLoS Med Date: 2021-04-28 Impact factor: 11.069