Modelling treatment-effect heterogeneity in randomized controlled trials of complex interventions (psychological treatments)
Modelling treatment-effect heterogeneity in randomized controlled trials of complex interventions (psychological treatments)
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DOI：
10.1002/sim.2891
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发表时间：
2007-11-20
影响因子：
2
通讯作者：
Bentall, Richard
中科院分区：
文献类型：
--
作者：
Dunn, Graham;Bentall, Richard
我们描述了工具变量（IV）的方法，用于估计随机对照试验中的心理干预的“剂量”-反应效应，在这些试验中，患者对分配的治疗的依从性存在变异性（即，实际治疗次数的变异性），患者与其治疗师之间的治疗联盟强度也存在变异性。假设治疗对结局的影响是参加会议的次数和治疗联盟的强度的函数，在没有参加任何会议的情况下没有干预效果（排除限制），并且联盟强度的影响由治疗效果模型中的乘法项（相互作用）表示。所描述的IV方法考虑到：（a）会话、联盟和结果之间的隐藏混杂;（B）联盟中的测量误差;以及（c）该联盟仅在接受治疗的患者中测量。三个两阶段的估计程序进行说明，并证明其等效性，通过蒙特卡罗模拟和实际试验的结果分析。版权所有（C）2007约翰威利父子有限公司
We describe instrumental variable (IV) methods for the estimation of the 'dose'-response effects of psychological interventions in randomized controlled trials in which there is variability in the patients' adherence to the allocated therapy (that is, variability in the actual number of sessions of therapy attended) and also variability in the strength of the therapeutic alliance between patients and their therapists. The effect of the therapy on outcome is assumed to be a function of both the number of sessions attended and the strength of the therapeutic alliance, with no intervention effects in the absence of any sessions attended (an exclusion restriction) and the effect of the strength of the alliance being represented by a multiplicative term (interaction) in the treatment-effect model. The IV methods that are described allow for: (a) hidden confounding between sessions, alliance and outcome; (b) measurement errors in the alliance; and (c) that alliance is only measured in those receiving treatment. Three two-stage estimation procedures are illustrated, and their equivalence demonstrated, through Monte Carlo simulation and analysis of the results of an actual trial. Copyright (C) 2007 John Wiley & Sons, Ltd.