Lewis Steff C, Sandercock Peter A G, Dennis Martin S
J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):397-400. doi: 10.1136/jnnp.2007.126045. Epub 2007 Aug 31.
Models are used to adjust for case mix and to stratify treatment allocation in clinical trials and can, if accurate enough, be used to aid decision-making in individual patients. We aimed to validate, in patients assessed within 6 hours of onset, a previously described six simple variable (SSV) model that was developed in stroke patients who were assessed sub-acutely. The explanatory variables in the model are age, living alone, independent pre-stroke, Glasgow Coma Scale verbal score, ability to lift arms and ability to walk.
The six variables were collected at randomisation in the Third International Stroke Trial (IST3) trial of recombinant tissue plasminogen activator in ischaemic stroke. We assessed survival to 30 days and functional status at 6 months using the Oxford Handicap Scale. We constructed receiver operator characteristic (ROC) curves to establish the model's discriminatory performance and tested its calibration by charting predicted versus actual outcomes.
537 patients (mean age, 74 years) were included, of whom 422 (79%) survived 30 days and 179 (33%) were alive and independent at 6 months. The SSV model had an area under the ROC curve of 0.73 for 30-day survival and 0.82 for independent survival at 6 months. Calibration was satisfactory.
This study confirms the external validity of the SSV model in an ischaemic stroke population assessed within 6 hours of symptom onset. The SSV model comprising easily collected variables can therefore be used to stratify patients in hyper-acute stroke trials, but probably is not accurate enough for decision-making in individual patients.
模型用于调整病例组合,并在临床试验中对治疗分配进行分层。如果足够准确,模型还可用于辅助个体患者的决策制定。我们旨在对先前描述的一个六变量简易模型(SSV)进行验证,该模型是在亚急性期接受评估的卒中患者中开发的,此次验证针对发病6小时内接受评估的患者。该模型中的解释变量包括年龄、独居、卒中前独立生活能力、格拉斯哥昏迷量表语言评分、抬臂能力和行走能力。
在缺血性卒中重组组织型纤溶酶原激活剂的第三次国际卒中试验(IST3)中,随机收集这六个变量。我们使用牛津残疾量表评估30天生存率和6个月时的功能状态。我们构建了受试者工作特征(ROC)曲线以确定模型的辨别性能,并通过绘制预测结果与实际结果来检验其校准情况。
纳入537例患者(平均年龄74岁),其中422例(79%)存活30天,179例(33%)在6个月时存活且独立生活。SSV模型在预测30天生存率时ROC曲线下面积为0.73,预测6个月独立生存率时为0.82。校准情况良好。
本研究证实了SSV模型在症状发作6小时内接受评估的缺血性卒中人群中的外部有效性。因此,包含易于收集变量的SSV模型可用于超急性卒中试验中对患者进行分层,但可能不够准确,无法用于个体患者的决策制定。