Young Brennan J, Beidel Deborah C, Turner Samuel M, Ammerman Robert T, McGraw Kelly, Coaston Susannah C
Maryland Center for Anxiety Disorders, Department of Psychology, University of Maryland, College Park, MD, USA.
J Anxiety Disord. 2006;20(8):1133-47. doi: 10.1016/j.janxdis.2006.03.007. Epub 2006 Apr 25.
Pretreatment attrition, the systematic self-exclusion of potential participants during the recruitment phase of a study, poses a significant threat to the external validity of randomized clinical trials. Very little is known about the factors that contribute to pretreatment attrition, especially among families seeking treatment for a child. The current study assessed pretreatment attrition in a randomized clinical trial of behavior therapy, fluoxetine, and placebo for child and adolescent social phobia. Reluctance toward medication treatment accounted for 44.7% of study refusals and was disproportionately common among ethnic minority families. Parents were particularly worried about the potential for side effects or physical/psychological dependency upon the medication. Results are discussed in terms of the implications for external validity in future psychopharmacological clinical trials.
预处理损耗,即在研究招募阶段潜在参与者的系统性自我排除,对随机临床试验的外部效度构成了重大威胁。对于导致预处理损耗的因素,我们知之甚少,尤其是在为孩子寻求治疗的家庭中。本研究评估了行为疗法、氟西汀和安慰剂治疗儿童及青少年社交恐惧症的随机临床试验中的预处理损耗情况。对药物治疗的抵触占研究拒绝的44.7%,在少数族裔家庭中尤为常见。家长们特别担心药物的副作用或身体/心理依赖的可能性。本文将根据这些结果对未来精神药理学临床试验外部效度的影响进行讨论。