印度结构化半互动脑卒中预防方案二级预防的统计分析计划(SPRINT INDIA):一项随机对照试验

Himani Khatter, J. Pandian, M. Kate, S. Sarma, P. Sylaja, D. Khurana, P. Vijaya, B. Ray, V. Nambiar, S. Aaron, T. George, Gaurav Mittal, I. Sebastian, N. Sundarachary, A. Pai, S. Gorthi, K. Somasundaram, Meenakshi Sharma, R. Dhaliwal, Y. Reddy, S. Narayan, NC Borah, Rupjyoti Das, G. Kulkarni, V. Huded, T. Mathew, P. Srivastava, R. Bhatia, Pawan K. Ojha, J. Roy, Sherly Abraham, Jemin Webster, A. Vaishnav, Arvind K Sharma, S. Jabeen, A. Pathak, S. Bhoi, Sudheer Sharma, S. Sulena, A. Saroja, N. Ramrakhiani, M. Kempegowda, Deepti Arora, S. Verma, R. Huilgol, Aneesh Dasan, V. Renjith
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引用次数: 1

摘要

背景:脑卒中复发是脑卒中患者死亡的主要原因之一。引入卒中预防教育包,改善生活方式行为因素,可减少脑血管事件的发生。印度的结构化半互动式卒中预防一揽子计划(SPRINT)研究旨在评估卒中预防教育一揽子计划在减少卒中患者复发性卒中、心肌梗死和死亡方面的作用。目标是在试验开盲之前为SPRINT印度公司制定详细的统计分析计划。方法:该计划由试验统计人员在SPRINT研究的主要研究者和管理团队的帮助下制定。选择的主要和次要结局测量指标以及对关键基线数据的了解用于构建统计分析计划。所有收集的数据将被彻底审查。患者的基线特征将用相关的描述性统计进行总结。这些发现是为了在两组之间进行最适当的统计比较而计划和解释的。结果:最终的统计分析计划符合既定标准,并将允许透明和有效的报告。结论:SPRINT试验统计分析计划的制定是为了避免由于研究结果的先验知识而产生的分析偏差,并明确地总结预先指定的分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Statistical Analysis Plan for the Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA): A Randomized Controlled Trial
Background: Recurrent stroke is one of the major causes of death in stroke patients. Introducing stroke prevention education package to improve the lifestyle behavioral factors could reduce the vascular events. The Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package (SPRINT) study in India aims to assess the role of a stroke prevention education package to reduce recurrent strokes, myocardial infarction, and death in patients with stroke. The objective is to formulate the detailed statistical analysis plan for the SPRINT India prior to trial unblinding. Methods: The plan was developed by trial statisticians with the help of principal investigator and management team of the SPRINT study. The chosen primary and secondary outcome measures and knowledge of critical baseline data were used to construct the statistical analysis plan. All collected data will be thoroughly reviewed. Patient baseline characteristics will be summarized with relevant descriptive statistics. The findings are planned and explained for the most appropriate statistical comparison between the groups. Results: The final statistical analysis plan corresponds to established criteria and will allow for transparent and efficient reporting. Conclusions: The SPRINT trial statistical analysis plan is developed in order to avoid analysis bias arising from prior knowledge of findings and to explicitly summarize prespecified analyses.
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