Weimar C, König I R, Kraywinkel K, Ziegler A, Diener H C
Department of Neurology, University of Essen, Duisberg-Essen, Germany.
Stroke. 2004 Jan;35(1):158-62. doi: 10.1161/01.STR.0000106761.94985.8B. Epub 2003 Dec 18.
To date, no validated, comprehensive, and practicable model exists to predict functional recovery within the first hours of cerebral ischemic symptoms. The purpose of this study was to externally validate 2 prognostic models predicting functional outcome and survival at 100 days within the first 6 hours after onset of acute cerebral ischemia.
On admission to a participating hospital, patients were registered prospectively and included according to defined criteria. Follow-up was performed 100 days after the event. With the use of prospectively collected data, 2 prognostic models were developed and internally calibrated in 1079 patients and externally validated in 1307 patients. By means of age and National Institutes of Health Stroke Scale (NIHSS) score as independent variables, model I predicts incomplete functional recovery (Barthel Index <95) versus complete functional recovery, and model II predicts mortality versus survival.
In the validation data set, model I correctly predicted 62.9% of the patients who were incompletely restituted or had died and 83.2% of the completely restituted patients, and model II correctly predicted 57.9% of the patients who had died and 91.5% of the surviving patients. Both models performed better than the treating physicians' predictions made within 6 hours after admission.
The resulting prognostic models are useful to correctly stratify treatment groups in clinical trials and should guide inclusion criteria in clinical trials, which in turn increases the power to detect clinically relevant differences.
迄今为止,尚无经过验证的、全面且实用的模型可用于预测脑缺血症状出现后最初数小时内的功能恢复情况。本研究的目的是对外验证两种预测急性脑缺血发作后6小时内100天功能转归和生存情况的预后模型。
患者入住参与研究的医院时进行前瞻性登记,并根据既定标准纳入研究。在事件发生100天后进行随访。利用前瞻性收集的数据,在1079例患者中开发并进行内部校准了两种预后模型,并在1307例患者中进行了外部验证。模型I以年龄和美国国立卫生研究院卒中量表(NIHSS)评分作为自变量,预测功能恢复不完全(巴氏指数<95)与功能完全恢复,模型II预测死亡与生存。
在验证数据集中,模型I正确预测了62.9%功能恢复不完全或已死亡的患者以及83.2%功能完全恢复的患者,模型II正确预测了57.9%已死亡的患者以及91.5%存活的患者。两种模型的表现均优于治疗医师在入院后6小时内做出的预测。
所得的预后模型有助于在临床试验中正确分层治疗组,并应指导临床试验的纳入标准,进而提高检测临床相关差异的效能。