BASELINE OBSERVATION CARRY FORWARD: REASONING, PROPERTIES, AND PRACTICAL ISSUES
BASELINE OBSERVATION CARRY FORWARD: REASONING, PROPERTIES, AND PRACTICAL ISSUES
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DOI：
10.1080/10543400902964118
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发表时间：
2009-01-01
影响因子：
1.1
通讯作者：
Pritchett, Yili L.
中科院分区：
文献类型：
--
作者：
Shao, Jun;Jordan, David C.;Pritchett, Yili L.
在一些纵向药物研究中，监管机构建议将基线观察结转（BOCF）作为处理患者脱落的方法，尽管对BOCF存在许多批评。使用BOCF的原因对于许多用户来说并不清楚，他们要么将BOCF视为插补方法，要么认为BOCF是“保守的”，因为它允许在严重惩罚脱落的情况下评估治疗效果。在这篇文章中，我们将解决以下问题：使用BOCF的原因是什么？BOCF是否是评估药物疗效的保守方法？BOCF合理吗？如果没有，有什么替代办法？我们的讨论是基于理论和实践的观点。
In some longitudinal drug studies, regulatory agencies suggest baseline observation carry forward (BOCF) as a method of handling patient dropout, despite the existence of many criticisms to BOCF. The reason for using BOCF is not clear to many users who either treat BOCF as an imputation method or consider BOCF to be "conservative" in the sense that it allows treatment effect to be evaluated with a severe penalty for dropouts. In this article we address the following questions and issues: What is the reason for using BOCF? Is BOCF a conservative approach to assessing drug efficacy? Is BOCF reasonable? If not, what are the alternatives? Our discussions are based on both theoretical and practical viewpoints.