Yue John K, Lee Young M, Sun Xiaoying, van Essen Thomas A, Elguindy Mahmoud M, Belton Patrick J, Pisică Dana, Mikolic Ana, Deng Hansen, Kanter John H, McCrea Michael A, Bodien Yelena G, Satris Gabriela G, Wong Justin C, Ambati Vardhaan S, Grandhi Ramesh, Puccio Ava M, Mukherjee Pratik, Valadka Alex B, Tarapore Phiroz E, Huang Michael C, DiGiorgio Anthony M, Markowitz Amy J, Yuh Esther L, Okonkwo David O, Steyerberg Ewout W, Lingsma Hester F, Menon David K, Maas Andrew I R, Jain Sonia, Manley Geoffrey T
1Department of Neurological Surgery, University of California, San Francisco, California.
2Brain and Spinal Injury Center, Zuckerberg San Francisco General Hospital, San Francisco, California.
J Neurosurg. 2024 Mar 15;141(2):417-429. doi: 10.3171/2023.11.JNS231425. Print 2024 Aug 1.
The International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) and Corticosteroid Randomization After Significant Head Injury (CRASH) prognostic models for mortality and outcome after traumatic brain injury (TBI) were developed using data from 1984 to 2004. This study examined IMPACT and CRASH model performances in a contemporary cohort of US patients.
The prospective 18-center Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study (enrollment years 2014-2018) enrolled subjects aged ≥ 17 years who presented to level I trauma centers and received head CT within 24 hours of TBI. Data were extracted from the subjects who met the model criteria (for IMPACT, Glasgow Coma Scale [GCS] score 3-12 with 6-month Glasgow Outcome Scale-Extended [GOSE] data [n = 441]; for CRASH, GCS score 3-14 with 2-week mortality data and 6-month GOSE data [n = 831]). Analyses were conducted in the overall cohort and stratified on the basis of TBI severity (severe/moderate/mild TBI defined as GCS score 3-8/9-12/13-14), age (17-64 years or ≥ 65 years), and the 5 top enrolling sites. Unfavorable outcome was defined as GOSE score 1-4. Original IMPACT and CRASH model coefficients were applied, and model performances were assessed by calibration (intercept [< 0 indicated overprediction; > 0 indicated underprediction] and slope) and discrimination (c-statistic).
Overall, the IMPACT models overpredicted mortality (intercept -0.79 [95% CI -1.05 to -0.53], slope 1.37 [1.05-1.69]) and acceptably predicted unfavorable outcome (intercept 0.07 [-0.14 to 0.29], slope 1.19 [0.96-1.42]), with good discrimination (c-statistics 0.84 and 0.83, respectively). The CRASH models overpredicted mortality (intercept -1.06 [-1.36 to -0.75], slope 0.96 [0.79-1.14]) and unfavorable outcome (intercept -0.60 [-0.78 to -0.41], slope 1.20 [1.03-1.37]), with good discrimination (c-statistics 0.92 and 0.88, respectively). IMPACT overpredicted mortality and acceptably predicted unfavorable outcome in the severe and moderate TBI subgroups, with good discrimination (c-statistic ≥ 0.81). CRASH overpredicted mortality in the severe and moderate TBI subgroups and acceptably predicted mortality in the mild TBI subgroup, with good discrimination (c-statistic ≥ 0.86); unfavorable outcome was overpredicted in the severe and mild TBI subgroups with adequate discrimination (c-statistic ≥ 0.78), whereas calibration was nonlinear in the moderate TBI subgroup. In subjects ≥ 65 years of age, the models performed variably (IMPACT-mortality, intercept 0.28, slope 0.68, and c-statistic 0.68; CRASH-unfavorable outcome, intercept -0.97, slope 1.32, and c-statistic 0.88; nonlinear calibration for IMPACT-unfavorable outcome and CRASH-mortality). Model performance differences were observed across the top enrolling sites for mortality and unfavorable outcome.
The IMPACT and CRASH models adequately discriminated mortality and unfavorable outcome. Observed overestimations of mortality and unfavorable outcome underscore the need to update prognostic models to incorporate contemporary changes in TBI management and case-mix. Investigations to elucidate the relationships between increased survival, outcome, treatment intensity, and site-specific practices will be relevant to improve models in specific TBI subpopulations (e.g., older adults), which may benefit from the inclusion of blood-based biomarkers, neuroimaging features, and treatment data.
利用1984年至2004年的数据,开发了创伤性脑损伤(TBI)后死亡率和预后的国际创伤性脑损伤临床试验预后与分析任务组(IMPACT)和重型颅脑损伤后皮质类固醇随机化(CRASH)预后模型。本研究在美国当代患者队列中检验了IMPACT和CRASH模型的性能。
前瞻性的18中心创伤性脑损伤转化研究与临床知识(TRACK-TBI)研究(入组年份2014 - 2018年)纳入年龄≥17岁、就诊于I级创伤中心且在TBI后24小时内接受头部CT检查的受试者。从符合模型标准的受试者中提取数据(对于IMPACT,格拉斯哥昏迷量表[GCS]评分为3 - 12分且有6个月格拉斯哥预后量表扩展版[GOSE]数据[n = 441];对于CRASH,GCS评分为3 - 14分且有2周死亡率数据和6个月GOSE数据[n = 831])。在整个队列中进行分析,并根据TBI严重程度(重度/中度/轻度TBI定义为GCS评分3 - 8/9 - 12/13 - 14)、年龄(17 - 64岁或≥65岁)以及5个入组人数最多的研究地点进行分层。不良预后定义为GOSE评分为1 - 4分。应用原始的IMPACT和CRASH模型系数,并通过校准(截距[<0表示预测过高;>0表示预测过低]和斜率)和区分度(c统计量)评估模型性能。
总体而言,IMPACT模型对死亡率预测过高(截距 -0.79 [95%CI -1.05至 -0.53],斜率1.37 [1.05 - 1.69]),对不良预后预测可接受(截距0.07 [-0.14至0.29],斜率1.19 [0.96 - 1.42]),区分度良好(c统计量分别为0.84和0.83)。CRASH模型对死亡率预测过高(截距 -1.06 [-1.36至 -0.75],斜率0.96 [0.79 - 1.14]),对不良预后预测过高(截距 -0.60 [-0.78至 -0.41],斜率1.20 [1.03 - 1.37]),区分度良好(c统计量分别为0.92和0.88)。IMPACT在重度和中度TBI亚组中对死亡率预测过高,对不良预后预测可接受,区分度良好(c统计量≥0.81)。CRASH在重度和中度TBI亚组中对死亡率预测过高,在轻度TBI亚组中对死亡率预测可接受,区分度良好(c统计量≥0.86);在重度和轻度TBI亚组中对不良预后预测过高,区分度足够(c统计量≥0.78),而在中度TBI亚组中校准呈非线性。在年龄≥65岁的受试者中,模型表现各异(IMPACT - 死亡率,截距0.28,斜率0.68,c统计量0.68;CRASH - 不良预后,截距 -0.97,斜率1.32,c统计量0.88;IMPACT - 不良预后和CRASH - 死亡率校准呈非线性)。在入组人数最多的研究地点中,观察到模型在死亡率和不良预后方面的性能差异。
IMPACT和CRASH模型能充分区分死亡率和不良预后。观察到的死亡率和不良预后的高估强调了更新预后模型以纳入TBI管理和病例组合的当代变化的必要性。阐明生存率提高、预后、治疗强度和特定地点实践之间关系的研究,对于改进特定TBI亚人群(如老年人)的模型将是相关的,这可能受益于纳入基于血液的生物标志物、神经影像学特征和治疗数据。