An exploration of site effects in a multisite trial of OROS-methylphenidate for smokers with attention deficit/hyperactivity disorder.
An exploration of site effects in a multisite trial of OROS-methylphenidate for smokers with attention deficit/hyperactivity disorder.
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DOI：
10.3109/00952990.2011.596979
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发表时间：
2011-09
期刊：
影响因子：
--
通讯作者：
Winhusen T
中科院分区：
文献类型：
--
作者：
Covey LS;Hu MC;Green CA;Brigham G;Hurt RD;Adler L;Winhusen T
多站点试验是在社区环境中进行研究的黄金标准，它可以掩盖不同站点之间的差异，从而导致对特定站点影响的歪曲陈述。在一项安慰剂对照试验中，根据吸烟者的临床研究特点(ADHD、戒烟和一般精神健康)，选择了三种类型的站点，以渗透释放口服系统(OROS-MPH)作为ADHD的强化治疗。进行分析以确定临床结果，即ADHD症状和戒烟率的减少，以及治疗对这些结果的影响是否会因地点类型而不同。255名被诊断为ADHD的成年吸烟者被纳入三种临床类型：ADHD 72例，烟草依赖79例，精神卫生诊所104例。这三个地点类型在人口统计特征、吸烟史、ADHD症状的基线水平和精神病史方面相似。治疗交互作用的地点类型，而不是地点类型，可以预测长期戒烟。地点类型、治疗和时间的显著三向交互作用预测ADHD症状的改善。相对于安慰剂，OROS-MPH对精神健康和ADHD诊所有中等到强烈的影响；在烟草依赖诊所观察到较弱的影响。Oros-mph在减少ADHD症状方面的益处因地点而异，但对改善戒烟没有影响。对场地类型效应的评估可以表明多场地试验结果的概括性，应该常规地纳入多场地试验的设计。
Multi-site trials, the gold standard for conducting studies in community-based settings, can mask variability across sites resulting in misrepresentation of effects in specific sites. In a placebo-controlled trial of osmotic-release oral system methylphenidate (OROS-MPH) as augmentation treatment for smokers with ADHD, three types of sites were selected according to their clinical research specialty (ADHD, smoking cessation, and general mental health). Analysis was conducted to determine if clinical outcomes, i.e., reduction in ADHD symptoms and smoking cessation rates, and the effect of treatment on these outcomes would differ by type of site. 255 adult smokers diagnosed with ADHD were enrolled in three clinic types: 72 in ADHD, 79 in tobacco dependence, 104 in the mental health clinics. The three site-types were similar in demographic characteristics, smoking history, baseline level of ADHD symptoms, and history of psychiatric illness. Site-type but not a site-type by treatment interaction predicted prolonged smoking abstinence. A significant three-way interaction of site-type, treatment, and time predicted improvement in ADHD symptoms. Moderate to strong effects of OROS-MPH relative to placebo were observed in the mental health and the ADHD clinics; a weak effect was observed in the tobacco dependence clinics. OROS-MPH benefit varied by site for reducing ADHD symptoms but not for improving smoking abstinence. Assessment of site-type effects can indicate the generalizability of findings from multisite trials and should be routinely incorporated in the design of multisite trials.
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影响因子：
1.7
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