Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
J Neurotrauma. 2012 Jan 1;29(1):47-52. doi: 10.1089/neu.2010.1482. Epub 2011 Dec 1.
Clinical trials in traumatic brain injury (TBI) have been fraught with failure due in part to heterogeneity in pathology and insensitive outcome measurements. The International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) prognostic model has been purposed as a means of risk adjustment and outcome prediction for use in trial design and analysis. The purpose of this study was to evaluate the performance of the IMPACT model in predicting 6-month functional outcome and mortality using prospectively collected data at a large, Level 1 neurotrauma center. This population-based cohort study included all TBI patients ≥14 years of age admitted with a Glasgow Coma Scale (GCS) score of ≤8 (severe TBI) to the University of Pittsburgh Medical Center between July 1994 and May 2009. Clinical data were prospectively collected and linked to 6-month functional outcome (Glasgow Outcome Scale [GOS]) and mortality. The discriminatory power and calibration of the three iterations of the IMPACT model (core, extended, and lab) were assessed using multiple regression analyses and indicated by the area under the receiver operating characteristic curve (AUC). A sample of 587 patients was available for analysis; the mean age was 37.8±17 years. The median 6-month GOS was 3 (IQR 3); 6-month mortality was 41%. The prognostic models were composed of age, motor score, and pupillary reactivity (core model), Marshall grade on head CT and secondary insults (extended), and laboratory values (lab); all of these displayed good prediction ability for unfavorable outcome and mortality (unfavorable outcome AUC=0.76, 0.79, 0.76; mortality AUC=0.78, 0.83, 0.83, respectively). All model iterations displayed adequate calibration for predicting unfavorable outcome and mortality. Prospective, independent validation supports the IMPACT prognostic model's prediction of patient 6-month functional status and mortality after severe TBI. The IMPACT prognostic model is an effective instrument to assist TBI study design and analysis.
创伤性脑损伤（TBI）的临床试验由于病理学的异质性和不敏感的结果测量而屡屡失败。国际创伤性脑损伤预后和临床试验分析使命（IMPACT）预后模型被提出作为一种用于试验设计和分析的风险调整和结果预测的手段。本研究的目的是使用大型一级神经创伤中心前瞻性收集的数据评估 IMPACT 模型预测 6 个月功能结局和死亡率的性能。这项基于人群的队列研究纳入了 1994 年 7 月至 2009 年 5 月期间，格拉斯哥昏迷量表（GCS）评分≤8（严重 TBI）收入匹兹堡大学医学中心的所有年龄≥14 岁的 TBI 患者。前瞻性收集临床数据，并与 6 个月功能结局（格拉斯哥结局量表[GOS]）和死亡率相关联。使用多元回归分析评估了 IMPACT 模型的三个迭代（核心、扩展和实验室）的判别能力和校准，并通过接受者操作特征曲线下面积（AUC）表示。共有 587 例患者可用于分析；平均年龄为 37.8±17 岁。中位数 6 个月 GOS 为 3（IQR 3）；6 个月死亡率为 41%。预后模型由年龄、运动评分和瞳孔反应（核心模型）、头部 CT 上的马歇尔分级和继发性损伤（扩展）以及实验室值（实验室）组成；所有这些都对不良结局和死亡率有良好的预测能力（不良结局 AUC=0.76、0.79、0.76；死亡率 AUC=0.78、0.83、0.83）。所有模型迭代均显示出良好的预测不良结局和死亡率的校准。前瞻性、独立验证支持 IMPACT 预后模型对严重 TBI 后患者 6 个月功能状态和死亡率的预测。IMPACT 预后模型是协助 TBI 研究设计和分析的有效工具。
