Del Boca Frances K, Darkes Jack
University of South Florida, FL 33620-8200, USA.
Addiction. 2007 Aug;102(8):1194-203. doi: 10.1111/j.1360-0443.2007.01863.x. Epub 2007 May 18.
This paper is the second in a series that describes strategies for optimizing the validity and utility of randomized clinical trials (RCTs) in addictions treatment research. Whereas the first paper focused on treatment implementation and research design, here we address issues pertaining to participant samples and assessment methods.
With respect to participant samples, sections focus on the definition of study populations; informed consent; sample size and statistical power; recruitment and enrollment; sample retention; and participant tracking systems. Assessment topics include eligibility screening and baseline assessment; treatment-related variables; outcome measures; the frequency of follow-up evaluation; and assessment process. A final section highlights the importance of pilot testing.
Sample recruitment and retention strategies are needed that safeguard both internal and external validity. Daily estimation assessment procedures are recommended because of their versatility for creating a range of outcome measures. Assessment batteries should include measures that permit the investigation of treatment processes and mechanisms of action.
本文是系列文章中的第二篇，该系列文章描述了优化成瘾治疗研究中随机临床试验（RCT）有效性和实用性的策略。第一篇文章聚焦于治疗实施和研究设计，本文则探讨与参与者样本及评估方法相关的问题。
关于参与者样本，各部分聚焦于研究人群的定义；知情同意；样本量和统计功效；招募与入组；样本留存；以及参与者追踪系统。评估主题包括资格筛选和基线评估；治疗相关变量；结局指标；随访评估的频率；以及评估过程。最后一部分强调了预试验的重要性。
需要样本招募和留存策略以保障内部效度和外部效度。推荐每日估计评估程序，因其在创建一系列结局指标方面具有通用性。评估组合应包括能够对治疗过程和作用机制进行调查的指标。
