New insights on the relation between untreated and treated outcomes for a given therapy effect model is not necessarily linear
New insights on the relation between untreated and treated outcomes for a given therapy effect model is not necessarily linear
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DOI：
10.1016/j.jclinepi.2007.07.007
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发表时间：
2008-03-01
影响因子：
7.2
通讯作者：
Leizorovicz, Alain
中科院分区：
文献类型：
--
作者：
Boissel, Jean-Pierre;Cucherat, Michel;Leizorovicz, Alain
背景和目标：已经假设治疗效果的大小与疾病的严重程度之间的关系，并且观察到对于一些治疗是线性的。我们把这种关系称为效应模型。我们的目标是证明这种关系是一般的，不一定是线性的。研究设计和设置：我们扩展了观察效应模型的数量。然后，我们建立了三个数值模型的治疗活动对应的三种模式，我们已经确定。结果：实证结果证实了该效应模型，并表明该效应在短的事件频率范围内可能是线性的。然而，由于随机临床试验数据的不可避免的局限性，它提供了对这一现象的不完整理解。数值建模和仿真表明，真实的效应模型可能更为复杂。它可能只是在极少数情况下是线性的。效应模型是通用的。结论：与一般假设不同，由于效应模型往往是曲线型的，相对危险度不能假定为常数。在发现和开发新疗法、制定医疗保健政策决策或根据患者风险状况调整临床决策时，应考虑效应模型。(C)2008年爱思唯尔公司All rights reserved.
Background and Objectives: A relation between the size of treatment efficacy and severity of the disease has been postulated and observed as linear for a few therapies. We have called this relation the effect model. Our objectives were to demonstrate that the relation is general and not necessarily linear.Study Design and Setting: We extend the number of observed effect model. Then we established three numerical models of treatment activity corresponding to the three modes of action we have identified. Using these models, we simulated the relation.Results: Empirical evidence confirms the effect model and suggests that it may be linear over a short range of event frequency. However, it provides an incomplete understanding of the phenomenon because of the inescapable limitations of data from randomized clinical trials. Numerical modeling and simulation show that the real effect model is likely to be more complicated. It is probably linear only in rare instances. The effect model is general. It depends on factors related to the individual, disease and outcome.Conclusion: Contrarily to common, assumption, since the effect model is often curvilinear, the relative risk cannot be granted as constant. The effect model should be taken into account when discovering and developing new therapies, when making, health care policy decisions or adjusting clinical decisions to the patient risk profile. (C) 2008 Elsevier Inc. All rights reserved.