Del Boca Frances K, Darkes Jack
Department of Psychology, University of South Florida, Tampa, FL 33620-8200, USA.
Addiction. 2007 Jul;102(7):1047-56. doi: 10.1111/j.1360-0443.2007.01862.x.
This paper is the first in a series that examines methods for improving the validity and utility of randomized clinical trials (RCTs) in addictions treatment research. The specific foci of this article are treatment implementation and research design.
We begin by considering the conditions under which the RCT provides an appropriate design choice. Sections that follow discuss methodological issues with respect to RCT structure and collaborative arrangements; treatment specification, delivery and cost; experimental design; and randomization/blinding procedures. We emphasize the importance of advance planning; treatment integrity and discriminability; treatment standardization; staff training and supervision; client compliance; maintenance of between-group equivalence across study conditions; and inclusion of appropriate comparison groups in study designs.
Investigators are encouraged to maximize the internal validity of RCTs, but also to consider methods for enhancing external validity. The utility of addictions RCTs for advancing theory and improving clinical practice can be enhanced by investigating underlying mechanisms of action.
本文是系列文章中的第一篇，探讨改善成瘾治疗研究中随机临床试验（RCT）有效性和实用性的方法。本文的具体重点是治疗实施和研究设计。
我们首先考虑RCT提供适当设计选择的条件。接下来的章节讨论了与RCT结构和合作安排、治疗规范、提供和成本、实验设计以及随机化/盲法程序相关的方法学问题。我们强调预先规划、治疗完整性和可区分性、治疗标准化、工作人员培训和监督以及服务对象依从性的重要性；在研究条件下保持组间等效性；以及在研究设计中纳入适当的对照组。
鼓励研究人员最大限度地提高RCT的内部有效性，但也要考虑提高外部有效性的方法。通过研究潜在的作用机制，可以增强成瘾RCT在推进理论和改善临床实践方面的效用。
