Department of Psychiatry and Behavioral Sciences, Stanford University, School of Medicine, Stanford, CA 94305, USA.
Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.
To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN).
The original aim was to enter 240 participants with AN to one of four cells: Behavioral family therapy (BFT) plus fluoxetine; BFT plus placebo; systems family therapy (SFT) plus fluoxetine; SFT plus placebo.
Recruitment was delayed pending a satisfactory resolution concerning participant safety. After 6 months of recruitment it became clear that the medication was associated with poor recruitment leading to a study redesign resulting in a comparison of two types of family therapy with a projected sample size of 160. One site was unable to recruit and was replaced.
Problems with the delineation of safety procedures, recruitment, re-design of the study, and replacement of a site, were the main elements resulting in a 1-year delay. Suggestions are made for overcoming such problems in future AN trials.
描述青少年厌食症（AN）的控制治疗试验实施中的障碍。
最初的目标是将 240 名 AN 参与者分为四个细胞之一：行为家庭治疗（BFT）加氟西汀；BFT 加安慰剂；系统家庭治疗（SFT）加氟西汀；SFT 加安慰剂。
由于参与者安全性的令人满意的解决方案而推迟了招募。招募 6 个月后，很明显，药物治疗与招募不佳有关，导致研究重新设计，比较两种类型的家庭治疗，预计样本量为 160。一个站点无法招募并被替换。
安全程序、招募、研究重新设计以及站点替换等方面的问题是导致延迟 1 年的主要因素。为未来的 AN 试验提出了克服这些问题的建议。
