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Sliding Scoring of the Glasgow Outcome Scale-Extended as Primary Outcome in Traumatic Brain Injury Trials.
Journal of Neurotrauma ( IF 4.2 ) Pub Date : 2020-12-03 , DOI: 10.1089/neu.2019.6969
Sharon D Yeatts 1 , Reneé H Martin 1 , William Meurer 2, 3 , Robert Silbergleit 2 , Gaylan L Rockswold 4 , William G Barsan 2 , Frederick K Korley 2 , David W Wright 5 , Byron J Gajewski 6
Affiliation  

The Glasgow Outcome Scale-Extended (GOS-E), an ordinal scale measuring global outcome, is used commonly as the primary outcome measure in clinical trials of traumatic brain injury. Analysis is often based on a dichotomization and thus has inherent statistical limitations, including loss of information related to the collapse of adjacent categories. A fixed dichotomization defines favorable outcome consistently for all subjects, whereas a sliding dichotomy tailors the definition of favorable outcome according to baseline prognosis/severity. Literature indicates that the sliding dichotomy is more statistically efficient than the fixed dichotomy; however, the sliding dichotomy still collapses categories and therefore discards information. We propose an alternative, a sliding scoring system for the GOS-E, intended to address the limitations of the sliding dichotomy. The score is assigned based on the number of levels between the achieved score and the favorable cut-point. The proposed scoring system reflects the magnitude of change, where change is defined according to each subject's baseline prognosis. Because the score is approximately continuous, statistical methods can rely on the normal distribution, both for analysis and study design. Two examples show the corresponding potential for improved power. A sliding score approach allows for quantification of the magnitude of change while still accounting for prognosis. Scientific advantages include increased power and an intuitive interpretation.

中文翻译:

格拉斯哥结果量表的滑动评分 - 扩展为创伤性脑损伤试验中的主要结果。

Glasgow Outcome Scale-Extended (GOS-E) 是一种衡量总体结果的有序量表,通常用作外伤性脑损伤临床试验的主要结果衡量标准。分析通常基于二分法,因此具有固有的统计局限性,包括与相邻类别崩溃相关的信息丢失。固定二分法对所有受试者一致地定义有利结果,而滑动二分法根据基线预后/严重程度定制有利结果的定义。文献表明滑动二分法比固定二分法在统计上更有效;然而,滑动二分法仍然折叠类别并因此丢弃信息。我们提出了一个替代方案,一个 GOS-E 的滑动评分系统,旨在解决滑动二分法的局限性。分数是根据达到的分数和有利的分界点之间的级别数分配的。建议的评分系统反映了变化的幅度,其中变化是根据每个受试者的基线预后定义的。由于分数近似连续,统计方法可以依赖正态分布,用于分析和研究设计。两个例子显示了提高功率的相应潜力。滑动评分方法允许量化变化的幅度,同时仍考虑预后。科学优势包括增强的力量和直观的解释。建议的评分系统反映了变化的幅度,其中变化是根据每个受试者的基线预后定义的。由于分数近似连续,统计方法可以依赖正态分布,用于分析和研究设计。两个例子显示了提高功率的相应潜力。滑动评分方法允许量化变化的幅度,同时仍考虑预后。科学优势包括增强的力量和直观的解释。建议的评分系统反映了变化的幅度,其中变化是根据每个受试者的基线预后定义的。由于分数近似连续,统计方法可以依赖正态分布,用于分析和研究设计。两个例子显示了提高功率的相应潜力。滑动评分方法允许量化变化的幅度,同时仍考虑预后。科学优势包括增强的力量和直观的解释。滑动评分方法允许量化变化的幅度,同时仍考虑预后。科学优势包括增强的力量和直观的解释。滑动评分方法允许量化变化的幅度,同时仍考虑预后。科学优势包括增强的力量和直观的解释。
更新日期:2020-12-15
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