Department of Neurosurgery, Virginia Commonwealth University, Richmond, Virginia 23298-0508, USA.
J Neurotrauma. 2010 May;27(5):843-52. doi: 10.1089/neu.2010.1293.
The eight-point extended Glasgow Outcome Scale (GOSE) is commonly used as the primary outcome measure in traumatic brain injury (TBI) clinical trials. The outcome is conventionally collected through a structured interview with the patient alone or together with a caretaker. Despite the fact that using the structured interview questionnaires helps reach agreement in GOSE assessment between raters, significant variation remains among different raters. We introduce an alternate GOSE rating system as an aid in determining GOSE scores, with the objective of reducing inter-rater variation in the primary outcome assessment in TBI trials. Forty-five trauma centers were randomly assigned to three groups to assess GOSE scores on sample cases, using the alternative GOSE rating system coupled with central quality control (Group 1), the alternative system alone (Group 2), or conventional structured interviews (Group 3). The inter-rater variation between an expert and untrained raters was assessed for each group and reported through raw agreement and with weighted kappa (kappa) statistics. Groups 2 and 3 without central review yielded inter-rater agreements of 83% (weighted kappa = 0.81; 95% CI 0.69, 0.92) and 83% (weighted kappa = 0.76, 95% CI 0.63, 0.89), respectively, in GOS scores. In GOSE, the groups had an agreement of 76% (weighted kappa = 0.79; 95% CI 0.69, 0.89), and 63% (weighted kappa = 0.70; 95% CI 0.60, 0.81), respectively. The group using the alternative rating system coupled with central monitoring yielded the highest inter-rater agreement among the three groups in rating GOS (97%; weighted kappa = 0.95; 95% CI 0.89, 1.00), and GOSE (97%; weighted kappa = 0.97; 95% CI 0.91, 1.00). The alternate system is an improved GOSE rating method that reduces inter-rater variations and provides for the first time, source documentation and structured narratives that allow a thorough central review of information. The data suggest that a collective effort can be made to minimize inter-rater variation.
八点扩展格拉斯哥结局量表（GOSE）常用于创伤性脑损伤（TBI）临床试验的主要结局指标。结果通常通过与患者单独或与护理人员一起进行结构化访谈来收集。尽管使用结构化访谈问卷有助于在 GOSE 评估中达成评估者之间的一致意见，但不同评估者之间仍然存在显著差异。我们引入了一种替代的 GOSE 评分系统，作为确定 GOSE 评分的辅助手段，目的是减少 TBI 试验中主要结局评估的评估者间变异性。45 个创伤中心被随机分配到三组，使用替代 GOSE 评分系统结合中心质量控制（第 1 组）、单独使用替代系统（第 2 组）或常规结构化访谈（第 3 组）评估样本病例的 GOSE 评分。评估了每个组中专家和非训练评估者之间的组内变异性，并通过原始一致性和加权 Kappa（kappa）统计报告。没有中心审查的第 2 组和第 3 组的组内一致性分别为 83%（加权 Kappa=0.81；95%CI 0.69，0.92）和 83%（加权 Kappa=0.76，95%CI 0.63，0.89），GOS 评分。在 GOSE 中，这三组的一致性分别为 76%（加权 Kappa=0.79；95%CI 0.69，0.89）和 63%（加权 Kappa=0.70；95%CI 0.60，0.81）。在使用替代评分系统结合中心监测的组中，三个组中 GOS 的组内一致性最高（97%；加权 Kappa=0.95；95%CI 0.89，1.00）和 GOSE（97%；加权 Kappa=0.97；95%CI 0.91，1.00）。替代系统是一种改进的 GOSE 评分方法，可降低评估者间的变异性，并首次提供源文档和结构化叙述，允许对信息进行彻底的中心审查。数据表明，可以共同努力最大限度地减少评估者间的变异性。
