如何利用REDCap实现临床试验的随机化操作
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摘要
随机化是一种偶然(而不是选择)将参与者/受试者分配到特定组的过程,是临床试验应遵循的基本原则之一。随机对照试验是评价干预措施疗效的金标准,其实施往往需要随机分组。REDCap系统中,也置入了随机化模块,有利于随机对照研究的数据管理的规范化。本研究主要介绍REDCap实现随机化的具体操作。
Randomization is the process of accidentally(rather than selectively) assigning participants/subjects to a specific group. It is also one of the basic principles that clinical trials should follow. Randomized controlled trials are the gold standard for evaluating the efficacy of interventions, and their implementation often requires randomization. In the REDCap system, a randomization module is also put in place, which facilitates the standardization of data management in randomized controlled studies. This study mainly introduces the specific operation of randomization using REDCap.
Randomization is the process of accidentally(rather than selectively) assigning participants/subjects to a specific group. It is also one of the basic principles that clinical trials should follow. Randomized controlled trials are the gold standard for evaluating the efficacy of interventions, and their implementation often requires randomization. In the REDCap system, a randomization module is also put in place, which facilitates the standardization of data management in randomized controlled studies. This study mainly introduces the specific operation of randomization using REDCap.
引文
[1]Higham R,Tharmanathan P,Birks Y. Use and reporting of restricted randomization:a review[J]. J Eval Clin Pract,2015,21(6):1205-11.
[2]曾宪涛,李宾,吕军,等.全球临床研究的现状分析及趋势展望[J].中国循证心血管医学杂志,2017(12):1409-14.
[3]Clark L,Schmidt U,Tharmanathan P,et al. Allocation concealment:a methodological review[J]. J Eval Clin Pract,2013,19(4):708-12.
[4]Berger V W,Odia I. Characterizing permuted block randomization as a big stick procedure[J]. Contemp Clin Trials Commun,2016,2:80-4.
[5]贺海蓉,郑婕,耿辉,等.如何利用REDCap数据采集系统实现病例报告表的设计[J].中国循证心血管医学杂志,2018,10(2):133-7.
[6]高凡,田国祥,贺海蓉,等. REDCap实现多中心研究数据管理的方法[J].中国循证心血管医学杂志,2018(4):392-5.
[7]耿辉,贺海蓉,郑婕,等.多中心临床数据采集系统REDCap权限设置与管理[J].中国循证心血管医学杂志,2018,10(1):11-3.
[8]Kenneth F. Schulz,Douglas GAltman,David Moher,等. CONSORT2010声明:报告平行对照随机临床试验指南的更新[J].中西医结合学报,2010(7):604-12.
[9]Sedgwick P. Controlled trials:allocation concealment,random allocation,and blinding[J]. BMJ,2015,350:2633.
[2]曾宪涛,李宾,吕军,等.全球临床研究的现状分析及趋势展望[J].中国循证心血管医学杂志,2017(12):1409-14.
[3]Clark L,Schmidt U,Tharmanathan P,et al. Allocation concealment:a methodological review[J]. J Eval Clin Pract,2013,19(4):708-12.
[4]Berger V W,Odia I. Characterizing permuted block randomization as a big stick procedure[J]. Contemp Clin Trials Commun,2016,2:80-4.
[5]贺海蓉,郑婕,耿辉,等.如何利用REDCap数据采集系统实现病例报告表的设计[J].中国循证心血管医学杂志,2018,10(2):133-7.
[6]高凡,田国祥,贺海蓉,等. REDCap实现多中心研究数据管理的方法[J].中国循证心血管医学杂志,2018(4):392-5.
[7]耿辉,贺海蓉,郑婕,等.多中心临床数据采集系统REDCap权限设置与管理[J].中国循证心血管医学杂志,2018,10(1):11-3.
[8]Kenneth F. Schulz,Douglas GAltman,David Moher,等. CONSORT2010声明:报告平行对照随机临床试验指南的更新[J].中西医结合学报,2010(7):604-12.
[9]Sedgwick P. Controlled trials:allocation concealment,random allocation,and blinding[J]. BMJ,2015,350:2633.