More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk
More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk
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DOI：
10.1002/sim.1837
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发表时间：
2005-01-15
影响因子：
2
通讯作者：
Conley, RR
中科院分区：
文献类型：
--
作者：
McMahon, RP;Arndt, S;Conley, RR
精神病学试验中常见的不良反应指标通常使用重复测量方差分析，尽管其分布违反了该方法的关键假设；此外，一些不良影响可能集中在参与者的脆弱亚群中。为了测试不良反应的治疗差异，我们建议使用Kendall的tau(B)作为参与者内部不良事件趋势的综合衡量标准，并结合Conover和Salsburg提出的加权修改等级检验。在难治性精神分裂症患者中进行的一项对照临床试验的锥体外系副作用数据被用来将拟议的分析与使用混合模型和交替测试的重复测量方差分析进行比较，以确定tau(B)趋势分数的治疗差异。版权所有2004年John Wiley Sons，Ltd.
Common adverse effect measures in psychiatric trials are typically analysed with repeated measures ANOVA, despite having distributions which violate key assumptions of that method; moreover, some adverse effects may be concentrated in vulnerable subgroups of participants. For testing treatment differences in adverse effects, we propose use of Kendall's tau(b) as a summary measure of within-participant trends in adverse events, in conjunction with a weighted modification of a rank test proposed by Conover and Salsburg. Data on extrapyramidal side effects from a controlled clinical trial conducted in persons with treatment resistant schizophrenia was used to compare the proposed analysis to repeated measures ANOVA using mixed models and alternate tests for treatment differences in tau(b) trend scores. Copyright 2004 John Wiley Sons, Ltd.