Hedden Sarra L, Woolson Robert F, Carter Rickey E, Palesch Yuko, Upadhyaya Himanshu P, Malcolm Robert J
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC 29425, USA.
J Subst Abuse Treat. 2009 Jul;37(1):54-63. doi: 10.1016/j.jsat.2008.09.011. Epub 2008 Nov 13.
"Loss to follow-up" can be substantial in substance abuse clinical trials. When extensive losses to follow-up occur, one must cautiously analyze and interpret the findings of a research study. Aims of this project were to introduce the types of missing data mechanisms and describe several methods for analyzing data with loss to follow-up. Furthermore, a simulation study compared Type I error and power of several methods when missing data amount and mechanism varies. Methods compared were the following: Last observation carried forward (LOCF), multiple imputation (MI), modified stratified summary statistics (SSS), and mixed effects models. Results demonstrated nominal Type I error for all methods; power was high for all methods except LOCF. Mixed effect model, modified SSS, and MI are generally recommended for use; however, many methods require that the data are missing at random or missing completely at random (i.e., "ignorable"). If the missing data are presumed to be nonignorable, a sensitivity analysis is recommended.
在药物滥用临床试验中,“失访”情况可能相当严重。当出现大量失访情况时,必须谨慎分析和解读研究结果。本项目的目的是介绍缺失数据机制的类型,并描述几种用于分析存在失访情况的数据的方法。此外,一项模拟研究比较了在缺失数据量和机制不同时,几种方法的I型错误率和检验效能。所比较的方法如下:末次观察值结转(LOCF)、多重填补(MI)、修正分层汇总统计量(SSS)和混合效应模型。结果表明,所有方法的I型错误率均为名义水平;除LOCF外,所有方法的检验效能都很高。一般建议使用混合效应模型、修正SSS和MI;然而,许多方法要求数据是随机缺失或完全随机缺失(即“可忽略”)。如果假定缺失数据是不可忽略的,则建议进行敏感性分析。