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临床研究中缺失数据的预防

Prevention of missing data in clinical research studies.

作者信息

Wisniewski Stephen R, Leon Andrew C, Otto Michael W, Trivedi Madhukar H

机构信息

Epidemiology Data Center, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA.

出版信息

Biol Psychiatry. 2006 Jun 1;59(11):997-1000. doi: 10.1016/j.biopsych.2006.01.017. Epub 2006 Mar 29.

Abstract

Missing data is a problem that is ubiquitous to all clinical studies and a source of multiple problems from an analytic point of view (reduced statistical power, increased the type I error, bias) Statistical approaches have been developed to analyze data collected from trials with missing data. Understanding and implementing the appropriate statistical technique is essential but should be differentiated from preventive approaches that are designed to reduce rates of missing data In this article, we draw attention to these preventive efforts. Seven steps to minimizing the amount of missing data are defined as documentation, training, monitoring reports, patient contact, data entry and management, pilot studies, and communication. Although the implementation of these approaches is time consuming and costly, the overall quality of the study is increased. Despite efforts devoted to areas, no study is without missing data. Once the study is completed, it is essential to assess the pattern of missing data and apply the appropriate statistical analysis.

摘要

缺失数据是所有临床研究中普遍存在的问题,从分析角度来看,也是多种问题的根源(统计效能降低、I型错误增加、偏差)。已经开发出统计方法来分析从存在缺失数据的试验中收集的数据。理解并应用适当的统计技术至关重要,但这应与旨在降低缺失数据率的预防方法区分开来。在本文中,我们提请关注这些预防措施。将减少缺失数据量的七个步骤定义为记录、培训、监测报告、患者联系、数据录入与管理、预试验和沟通。尽管实施这些方法既耗时又成本高昂,但研究的整体质量会提高。尽管在这些方面付出了努力,但没有一项研究不存在缺失数据。一旦研究完成,评估缺失数据的模式并应用适当的统计分析至关重要。

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