Can we improve the statistical analysis of stroke trials? Statistical reanalysis of functional outcomes in stroke trials
Can we improve the statistical analysis of stroke trials? Statistical reanalysis of functional outcomes in stroke trials
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DOI：
10.1161/strokeaha.106.474080
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发表时间：
2007-06-01
期刊：
影响因子：
8.3
通讯作者：
Bath, Philip M. W.
中科院分区：
文献类型：
--
作者：
Bath, Philip M. W.
背景和目的--大多数大型急性卒中试验都是中性的。功能结果的分析通常使用是或否的答案，例如，死亡或依赖与独立。我们评估了哪些统计学方法在分析卒中试验的结果方面最有效。方法-评估了急性试验、康复试验和卒中单元试验中研究干预措施改变功能结局的效果的个别患者数据。结果包括改良的Rankin量表、Barthel指数和“3个问题”。使用各种方法对数据进行分析，比较两个处理组。结果--获得了55个数据集的数据(47个试验，54173名患者)。检验结果有很大不同，因此使用功能结果数据的有序性质(有序Logistic回归、t检验、稳健等级检验、自举平均等级差异)的方法在统计学上比将数据分成两组的方法更有效(X(2)；ANOVA，P<；0.001)。这些发现在不同类型和规模的试验以及不同的功能结果衡量标准上是一致的。结论--当分析中风试验的功能结果时，使用原始有序数据的统计测试更有效，更有可能产生可靠的结果。适合的方法有有序Logistic回归、t检验和稳健等级检验。
Background and Purpose - Most large acute stroke trials have been neutral. Functional outcome is usually analyzed using a yes or no answer, eg, death or dependency versus independence. We assessed which statistical approaches are most efficient in analyzing outcomes from stroke trials.Methods - Individual patient data from acute, rehabilitation and stroke unit trials studying the effects of interventions which alter functional outcome were assessed. Outcomes included modified Rankin Scale, Barthel Index, and " 3 questions". Data were analyzed using a variety of approaches which compare 2 treatment groups. The results for each statistical test for each trial were then compared.Results - Data from 55 datasets were obtained ( 47 trials, 54 173 patients). The test results differed substantially so that approaches which use the ordered nature of functional outcome data ( ordinal logistic regression, t test, robust ranks test, bootstrapping the difference in mean rank) were more efficient statistically than those which collapse the data into 2 groups ( chi(2); ANOVA, P < 0.001). The findings were consistent across different types and sizes of trial and for the different measures of functional outcome.Conclusions - When analyzing functional outcome from stroke trials, statistical tests which use the original ordered data are more efficient and more likely to yield reliable results. Suitable approaches included ordinal logistic regression, t test, and robust ranks test.