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格拉斯哥结局量表扩展数据的集中管理:从 TRACK-TBI 中获得的经验教训。

Central Curation of Glasgow Outcome Scale-Extended Data: Lessons Learned from TRACK-TBI.

机构信息

Department of Neurological Surgery, Harborview Medical Center, University of Washington, Seattle, Washington, USA.

Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, United Kingdom.

出版信息

J Neurotrauma. 2021 Sep 1;38(17):2419-2434. doi: 10.1089/neu.2020.7528. Epub 2021 Apr 28.

Abstract

The Glasgow Outcome Scale (GOS) in its original or extended (GOSE) form is the most widely used assessment of global disability in traumatic brain injury (TBI) research. Several publications have reported concerns about assessor scoring inconsistencies, but without documentation of contributing factors. We reviewed 6801 GOSE assessments collected longitudinally, across 18 sites in the 5-year, observational ransforming esearch and linical nowledge in (TRACK-TBI) study. We recorded error rates (i.e., corrections to a section or an overall rating) based on site assessor documentation and categorized scoring issues, which then informed further training. In cohort 1 ( = 1261; February 2014 to May 2016), 24% of GOSEs had errors identified by central review. In cohort 2 ( = 1130; June 2016 to July 2018), acquired after curation of cohort 1 data, feedback, and further training of site assessors, the error rate was reduced to 10%. GOSE sections associated with the most frequent interpretation and scoring difficulties included whether current functioning represented a change from pre-injury (466 corrected ratings in cohort 1; 62 in cohort 2), defining dependency in the home and community (163 corrections in cohort 1; three in cohort 2) and return to work/school (72 corrections in cohort 1; 35 in cohort 2). These results highlight the importance of central review in improving consistency across sites and over time. Establishing clear scoring criteria, coupled with ongoing guidance and feedback to data collectors, is essential to avoid scoring errors and resultant misclassification, which carry potential to result in "failure" of clinical trials that rely on the GOSE as their primary outcome measure.

摘要

格拉斯哥结局量表(GOS)及其扩展形式(GOSE)是颅脑创伤(TBI)研究中最广泛用于评估总体残疾的方法。有几项研究报告了评估者评分不一致的问题,但没有记录导致这种情况的因素。我们对 TRACK-TBI 研究中 18 个地点的 5 年纵向收集的 6801 份 GOSE 评估进行了回顾,记录了基于现场评估者记录的错误率(即对某一部分或总体评分的更正),并对评分问题进行了分类,然后提供了进一步的培训。在队列 1(n=1261;2014 年 2 月至 2016 年 5 月)中,有 24%的 GOSE 由中心审查发现错误。在队列 2(n=1130;2016 年 6 月至 2018 年 7 月)中,在对队列 1 数据进行管理、反馈和进一步培训现场评估者之后,错误率降低到 10%。与最频繁的解释和评分困难相关的 GOSE 部分包括当前功能是否代表与受伤前相比的变化(队列 1 中有 466 次更正评分;队列 2 中有 62 次)、定义家庭和社区中的依赖(队列 1 中有 163 次更正;队列 2 中有 3 次)以及重返工作/学校(队列 1 中有 72 次更正;队列 2 中有 35 次)。这些结果强调了中心审查在提高不同地点和随时间推移的一致性方面的重要性。建立明确的评分标准,并为数据收集者提供持续的指导和反馈,对于避免评分错误和由此导致的错误分类至关重要,这可能导致依赖 GOSE 作为主要结局指标的临床试验“失败”。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/440d/8390785/091298294977/neu.2020.7528_figure1.jpg

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