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首页> 外文期刊>Journal of the American Academy of Child and Adolescent Psychiatry >Parent-defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials.
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Parent-defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials.

机译：RUPP自闭症研究中父母定义的目标症状对利培酮有反应：客户进行临床试验的方法。

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OBJECTIVE: A consumer-oriented efficacy assessment in clinical trials should measure changes in chief complaint and consumer request (symptoms of most concern to patient/caregiver), which may be diluted in change scores of multisymptom scales. METHOD: In the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network 8-week double-blind trial of risperidone versus placebo, the chief concerns of parents were collected at 0, 4, and 8 weeks (endpoint), in addition to standardized primary measures. Blinded clinical judges rated change from baseline to 4 and 8 weeks on a 9-point scale (1 = normalized, 5 = unchanged, 9 = disastrous); 94 participants had usable data. RESULTS: The most common symptoms identified by parents were tantrums, aggression, and hyperactivity. Interrater reliability was excellent. Mean ratings at endpoint were 2.8 +/- 1.2 on risperidone and 4.5 +/- 1.3 on placebo (p <.001). Ratings were collinear with Clinical Global Impression-Improvement and Aberrant Behavior Checklist Irritability subscale (primary dimensional measure). Effect size d was 1.4, compared to 1.2 on the Aberrant Behavior Checklist Irritability subscale. Effect sizes varied twofold by symptom category, largest for self-injury (2.11) and tantrums (1.95). CONCLUSIONS: Risperidone was superior to placebo in reducing symptoms of most concern to parents of autistic children with irritable behavior. Rating individualized participant-chosen target symptoms seems a reliable, sensitive, efficient, and consumer-friendly way to assess treatment effect and might have clinical application.
机译：目的：在临床试验中，以消费者为导向的功效评估应衡量主要诉求和消费者要求（患者/护理人员最关注的症状）的变化，这些变化可能会被稀释为多症状量表的变化评分。方法：在儿童心理药理学（RUPP）自闭症研究小组的8周利培酮与安慰剂双盲试验中，除了标准化的主要研究对象外，还分别在0、4和8周（终点）收集了父母的主要担忧。措施。盲人临床法官以9分制对从基线到4周和8周的变化进行评分（1 =标准化，5 =不变，9 =灾难性）; 94位参与者有可用数据。结果：父母发现的最常见症状是发脾气，攻击性和活动过度。评估者间的可靠性非常好。利培酮的终点平均评分为2.8 +/- 1.2，安慰剂为4.5 +/- 1.3（p <.001）。评分与临床总体印象改善和异常行为清单易怒子量表（一级维度）共线。效果大小d为1.4，而异常行为清单易怒子量表为1.2。症状大小因症状类别而异，最大的是自伤（2.11）和发脾气（1.95）。结论：利培酮在减轻烦躁行为自闭症儿童父母最关注的症状方面优于安慰剂。评估个性化参与者选择的目标症状似乎是一种可靠，灵敏，有效且对消费者友好的方法，可以评估治疗效果，并且可能具有临床应用价值。

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