COMPLIANCE AS AN EXPLANATORY VARIABLE IN CLINICAL-TRIALS

COMPLIANCE AS AN EXPLANATORY VARIABLE IN CLINICAL-TRIALS
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DOI:
10.2307/2289707
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发表时间:
1991-03-01
影响因子:
3.7
通讯作者:
FELDMAN, D
FELDMAN, D
中科院分区:
数学1区
文献类型:
--
作者:
EFRON, B;FELDMAN, D

文献摘要

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脂类研究诊所冠状动脉一级预防试验(LRC-CPPT)测量了药物氯苯乙胺降低胆固醇水平的有效性。研究中的患者被测量了依从性(实际服用的预期剂量的比例)和胆固醇的降低。治疗组依从性-反应回归分析显示,随着依从性的增加,药物对胆固醇水平有平稳的升高作用。然而,在控制组中也看到了类似的、尽管不那么戏剧性的遵从性反应回归。本文研究了从治疗和控制顺应性-反应曲线中恢复真实剂量-反应曲线。提出了一个简单的模型,并对LRC-CPPT数据进行了分析和应用。在这个模型下,可以估计真实剂量-反应曲线的一部分,但不是全部。
The Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT) measured the effectiveness of the drug cholestyramine for lowering cholesterol levels. The patients in the study were measured for compliance (the proportion of the intended dose actually taken) and for cholesterol decrease. The compliance-response regression for the Treatment group shows a smooth increasing effect of the drug in cholesterol level with increasing compliance. However, a similar, though less dramatic, compliance-response regression is seen in the Control group. This article investigates the recovery of the true dose-response curve from the Treatment and Control compliance-response curves. A simple model is proposed, analyzed, and applied to the LRC-CPPT data. Under this model, part but not all of the true dose-response curve can be estimated.