临床试验的公平试验:一种治疗实施模式

Kenneth L Lichstein, Brant W Riedel, Rick Grieve
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引用次数: 232

摘要

我们提出了一种心理治疗实施模式,在这种模式中,独立治疗成分(递送、接收和实施)的适当水平是断言是否进行了有效临床试验的先决条件。交付部分是指治疗呈现的准确性,接收部分是指病人对治疗理解的准确性,制定部分是指由病人发起的场外应用的程度。根据我们报告的一项调查,临床科学家经常解决其中的一个或两个问题,但很少解决所有三个问题。讨论了模型缺陷的来源和影响,即治疗成分水平不足,以及成分评估和归纳的方法。我们的结论是,任何一个组成部分的缺陷都与缺陷的程度成正比,并且临床试验经常被错误地认为是公平的测试,导致有偏见的疗效判断。
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Fair tests of clinical trials: A treatment implementation model

We propose a psychotherapy treatment implementation model whereby adequate levels of independent treatment components (delivery, receipt, and enactment) are prerequisite to asserting whether a valid clinical trial has been conducted. The delivery component refers to the accuracy of treatment presentation, receipt refers to the accuracy of the client's comprehension of treatment, and enactment refers to the extent of out of session application initiated by the client. Clinical scientists regularly address one or two of these components, but rarely all three, according to a survey we report. Sources and effects of model deficits, i.e., inadequate levels of treatment components, as well as methods of component assessment and induction, are discussed. We conclude that faults in any one of the components drain validity proportional to the degree of deficit, and that clinical trials have often incorrectly been considered fair tests, resulting in biased efficacy judgments.

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