印度阿育吠陀治疗缺血性脑卒中患者康复的统计分析计划(SAP):一项随机对照试验(RESTORE)

P. Sarma, Himani Khatter, Aneesh Dhasan, V. Nambiar, S. Narayan, Deepti Arora, S. Verma, Meenakshi Sharma, M. Kate, J. Pandian, P. Sylaja
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引用次数: 0

摘要

中风通常会导致功能丧失。中风后的恢复评估对治疗和研究都至关重要。印度阿育吠陀治疗缺血性卒中患者的康复:一项随机对照试验(RESTORE)旨在生成循证数据,以创建统一的康复方案,并启动交叉转诊实践,以支持综合治疗方法。目的是在数据分析之前为RESTORE试验制定详细的统计分析计划。方法由试验统计人员在RESTORE试验主要研究者和试验管理团队的协助下制定统计分析方案。统计分析计划是使用指定的主要和次要结果测量,以及重要基线数据的知识来建立的。所有收集的数据将被彻底审查。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。结论建立RESTORE试验统计分析计划是为了减少对结果的先验知识造成的分析偏差,并明确地概述预先指定的分析。
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Statistical Analysis Plan (SAP) for AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A Randomized Controlled Trial (RESTORE)
Background Stroke often results in a loss of functional ability. The evaluation of recovery after a stroke is crucial for both treatment and research. The AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A randomized controlled trial (RESTORE) aims to generate evidence-based data for creating a uniform rehabilitation protocol and initiating a cross-referral practice to support an integrative treatment approach. The objective is to develop a detailed statistical analysis plan for the RESTORE trial prior to data analysis. Methods The statistical analysis plan was developed by the trial statistician with the assistance of the RESTORE trial principal investigator and the trial management team. The statistical analysis plan was built using the specified primary and secondary outcome measures, as well as knowledge of important baseline data. All data collected will be thoroughly examined. Results The final statistical analysis plan corresponds to established criteria and will allow for transparent and efficient reporting. Conclusions The RESTORE trial statistical analysis plan is created to reduce analysis bias caused by prior knowledge of results and to explicitly outline prespecified analysis.
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