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临床试验中重复测量数据的分析。

Analysis of repeated measurement data in the clinical trials.

作者信息

Singh Vineeta, Rana Rakesh Kumar, Singhal Richa

机构信息

Department of Statistics, Institute of Social Sciences, Dr. BR Ambedkar University, Agra, Uttar Pradesh, India.

出版信息

J Ayurveda Integr Med. 2013 Apr;4(2):77-81. doi: 10.4103/0975-9476.113872.

Abstract

Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15(th) day, 30(th) day, and 45(th) day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha.

摘要

统计学是临床试验不可或缺的一部分。统计学内容涵盖临床试验设计、数据监测、分析和报告。临床医生对统计概念有扎实的理解,有助于提高对临床试验的理解以及最终的试验质量。在生物医学研究中,人们发现研究人员经常使用t检验和方差分析来比较感兴趣的组之间的均值,而不考虑数据的性质。在临床试验中,我们会对患者的数据进行不止两次的记录。在这种情况下,使用标准的方差分析程序并不合适,因为它在分析中没有考虑受试者内观察值之间的相关性。为处理这类研究数据,应使用重复测量方差分析。在本文中,通过使用社会科学统计软件包(SPSS)15.0版,对在多中心临床试验中针对缺铁性贫血(Pandu Roga)使用阿育吠陀配方Dhatrilauha在第0天、第15天、第30天和第45天这四个时间点收集的数据进行分析,展示了单向重复测量方差分析的应用。

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