A case study in comparing therapies involving informative drop-out, non-ignorable non-compliance and repeated measurements
A case study in comparing therapies involving informative drop-out, non-ignorable non-compliance and repeated measurements
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DOI：
10.1002/sim.2409
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发表时间：
2005-12-30
影响因子：
2
通讯作者：
Lindfors, O
中科院分区：
文献类型：
--
作者：
Härkänen, T;Knekt, P;Lindfors, O
到目前为止，几乎没有对不同的心理疗法进行长期随访的比较。赫尔辛基心理治疗研究是一项随机临床试验，在研究治疗开始后对患者进行12个月的监测，每个治疗持续约6个月。在随访期间，在预先确定的五个时间点测量患者的精神状态。一般来说，在对给定治疗的依从性不完全或从随访中退出是不可忽视的情况下，试验的分析是复杂的。在本研究中，部分患者的治疗质量偏离了方案，部分患者在研究治疗或随访期间接受了与研究治疗效果相似的辅助治疗。这可能导致标准的意向治疗分析提供了过度保守或自由的结论。在某些情况下，不遵守行为可能是不可忽视的，因此特定于受试者的潜在因素可能通过遵守行为直接或间接地影响结果。最健康和最不健康的患者最有可能先验地退出随访，因此缺失的数据过程具有信息性。缺失的数据可以在一定程度上通过与退出的患者访谈中收集的替代信息来补充。利用基于随机效应的选择模型来解释不可忽略的缺失数据和不合规的贝叶斯分层处理模型与不同的混合效应模型进行了比较。版权所有(c) 2005 John Wiley & Sons, Ltd。
Virtually no comparisons of different psychotherapies with long follow-up times have been carried out until now. The Helsinki Psychotherapy Study is a randomized clinical trial, where patients were monitored for 12 months after the onset of study treatments, of which each lasted approximately 6 months. The patients' psychiatric status was measured at five pre-determined time points during the follow-up period. In general, the analyses of trials are complicated in cases where compliance with the given treatment is incomplete or the drop-out from the follow-up is non-ignorable. In the present study, the quality of the treatment deviated from the protocol for some patients and some patients took auxiliary treatments which had similar effects to the study treatment during the study treatment or follow-up period. This might have resulted in standard intention-to-treat analyses providing excessively conservative or liberal conclusions. Non-compliance may have been non-ignorable in some cases, so subjectspecific latent factors may have influenced the outcome both directly and indirectly via compliance behaviour. The most and least healthy patients are the most likely to dropout from the follow-up a priori, so the missing data process is informative. The missing data can partly be augmented with surrogate information collected during interviews with patients who dropped out. A Bayesian hierarchical as-treated model, which uses random-effects-based selection models to account for non-ignorable missing data and non-compliance, was compared with different mixed effects models. Copyright (c) 2005 John Wiley & Sons, Ltd.