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
{"title":"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","authors":"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","doi":"10.1177/25166085221098928","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":93323,"journal":{"name":"Journal of stroke medicine","volume":"441 1","pages":"14 - 20"},"PeriodicalIF":0.0000,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Statistical Analysis Plan for the Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA): A Randomized Controlled Trial\",\"authors\":\"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\",\"doi\":\"10.1177/25166085221098928\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":93323,\"journal\":{\"name\":\"Journal of stroke medicine\",\"volume\":\"441 1\",\"pages\":\"14 - 20\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of stroke medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/25166085221098928\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of stroke medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/25166085221098928","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.