Assessment of the integrity of study blindness in a pediatric clinical trial of risperidone.
Assessment of the integrity of study blindness in a pediatric clinical trial of risperidone.
复制标题
利培酮儿科临床试验中研究盲性完整性的评估。
DOI：
10.1097/01.jcp.0000185426.08268.92
复制
发表时间：
2005
影响因子：
2.9
通讯作者：
Koenig,Kathleen
中科院分区：
文献类型：
--
作者：
Vitiello,Benedetto;Davies,Mark;Arnold,LEugene;McDougle,ChristopherJ;Aman,Michael;McCracken,JamesT;Scahill,Lawrence;Tierney,Elaine;Posey,DavidJ;Swiezy,NaomiB;Koenig,Kathleen
目的：儿科精神药理学的对照临床试验依赖于设盲的父母和临床评估人员获取结果数据，但人们对掩蔽程序的成功知之甚少。临床评价者和家长的盲目性进行了检查，在利培酮在autosit.Methods：临床评价者和家长被要求猜测个人治疗分配结束时，为期8周的安慰剂对照试验利培酮在儿童（5-17岁）与自闭症。结果：无论是临床评估者还是家长，正确猜测个体治疗分配（利培酮或安慰剂）的比率均显著高于偶然性（P< 0.001）。在利培酮和安慰剂治疗组中，临床评估者将改善归因于利培酮，而将缺乏改善归因于安慰剂。父母与改善归因于利培酮只在安慰剂treatment arm. Parents报告说，不良事件影响了他们的猜测，但存在的不良事件是不相关的guess.Conclusion的正确性：改善与归因于积极的治疗，无论实际的治疗分配，不良事件并没有出现是一个威胁到研究盲。
Objective:Controlled clinical trials in pediatric psychopharmacology rely on blinded parents and clinical evaluators for outcome data, but little is known about the success of the masking procedures. The blindness of clinical evaluators and parents was examined in a clinical trial of risperidone in autism.Methods:Clinical evaluators and parents were asked to guess individual treatment assignments at the end of an 8-week placebo-controlled trial of risperidone in children (aged 5-17 years) with autism. Clinical evaluators did not have access to adverse event data.Results:The rates of correctly guessing individual treatment assignment (risperidone or placebo) were significantly greater than chance for both clinical evaluators and parents (P< 0.001). Clinical evaluators associated improvement with attribution to risperidone, and lack of improvement with attribution to placebo, in both the risperidone and placebo treatment arms. Parents associated improvement with attribution to risperidone only in the placebo treatment arm. Parents reported that adverse events influenced their guesses, but presence of adverse events was not associated with correctness of guess.Conclusion:Improvement was associated with attribution to active treatment regardless of actual treatment assignment, and adverse events did not appear to be a threat to study blindness.