ANALYSIS OF DATA FROM MULTICLINIC TRIALS
ANALYSIS OF DATA FROM MULTICLINIC TRIALS
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DOI：
10.1016/0197-2456(86)90034-6
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发表时间：
1986-12-01
期刊：
影响因子：
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通讯作者：
FLEISS, JL
中科院分区：
文献类型：
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作者：
FLEISS, JL
由于多临床随机临床试验中的诊所既不代表固定分层效应，也不代表随机分类效应，因此对此类试验数据的适当分析一直是争议和辩论的主题。以下是讨论的一些争议因素，并提出了一些解决的基础。在分析中忽略诊所的影响是有效的吗？从分析中删除诊所是否有效？多诊所临床试验在结构上是否与根据分类因素对患者进行分层的单诊所试验相似？假设在分析中将考虑诊所，那么诊所内治疗差异的加权平均值还是未加权平均值应被视为治疗间总体差异的最佳估计值？如果存在治疗与临床相互作用的证据，应如何分析数据？
Because the clinics in a multiclinic randomized clinical trial represent neither fixed stratification effects nor random classificatory effects, the appropriate analysis of data from such a trial has been the subject of controversy and debate. The following are some of the elements of controversy that are discussed and for which some bases for resolution are proposed. It is ever valid to ignore the effects of clinics in the analysis ? Is it ever valid to drop clinics from the analysis? Is a multiclinic clinical trial similar in structure or not to a single-clinic trial in which patients have been stratified on a classificatory factor? Assuming tht clinics will be taken account of in the analysis, should it be the weighted or the unweighted average of within-clinic treatment differences that is to be taken as the best estimate of the overall difference between the treatments? How should the data be analyzed if there is evidence of treatment-by-clinic interaction?