Development, validation, and application of a microsimulation model to predict stroke and mortality in medically managed asymptomatic patients with significant carotid artery stenosis.
Development, validation, and application of a microsimulation model to predict stroke and mortality in medically managed asymptomatic patients with significant carotid artery stenosis.
复制标题
开发、验证和应用微观模拟模型来预测患有严重颈动脉狭窄的无症状患者的中风和死亡率。
DOI：
10.1111/j.1524-4733.2007.00204.x
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发表时间：
2007
期刊：
影响因子：
--
通讯作者：
Lorell,BeverlyH
中科院分区：
文献类型：
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作者：
Smolen,HarryJ;Cohen,DavidJ;Samsa,GregoryP;Toole,JamesF;Klein,RobertW;Furiak,NicolasM;Lorell,BeverlyH
目的：建立一种模型来预测经医学治疗的颈动脉明显狭窄的无症状患者在多年时间框架内的无卒中生存率和死亡率。方法：我们校准，验证和应用蒙特卡罗微模拟模型。为了校准，我们调整了一般人群死亡率和卒中风险，以捕获无症状颈动脉狭窄患者特有的这些风险。为了验证，我们比较了来自可比患者群体的模型预测和实际无卒中生存曲线和卒中计数。在最近的一项单臂颈动脉血管重建术试验中，经过验证的模型预测了假设的医学管理臂的无卒中生存期。结果：在60个月的时间框架内，每个月，模型预测和实际校准试验无脑卒中生存曲线无统计学差异（P < 0.62）。在验证中，校准模型的无卒中生存曲线与独立人群的实际曲线相匹配；24个月后，模型预测曲线与实际曲线无统计学差异（P < 0.32）。我们还比较了独立试验的模型预测和实际中风数。该模型预测了187.25次中风（95%置信区间为161.49-213.01），而实际数字为171.6次，与模拟平均值的标准差相差在1.22以内。结论：考虑到最近的颈动脉狭窄试验中缺乏医学管理的人群，我们的模型可以估计这些患者的无卒中生存和死亡率数据。该模型还可以估计预防中风的新型医学和程序性治疗的有效性。当只有单臂试验数据存在时，这些有效性估计可以为政策、指南或成本-效果分析的制定提供信息。
Objective:To develop a model to predict stroke‐free survival and mortality over a multiyear time frame for a trial‐excluded population of medically managed asymptomatic patients with significant carotid artery stenosis.Methods:We calibrated, validated, and applied a Monte Carlo microsimulation model. For calibration we adjusted general‐population mortality and stroke risks to capture these risks specific to asymptomatic carotid stenosis patients. For validation, we compared model‐predicted and actual stroke‐free survival curves and stroke counts from a population of comparable patients. For application, the validated model predicted stroke‐free survival for a hypothetical medically managed arm of a recent single‐arm carotid revascularization trial.Results:For each month in the 60‐month time frame, the model‐predicted and actual calibration trial stroke‐free survival curves were not statistically different (P> 0.62). In validation, the calibrated model's stroke‐free survival curvematched the actual curve from an independent population; beyond 24 months, the model‐predicted and actual curves were not statistically different (P> 0.32). We also compared model‐predicted and actual number of strokes from the independent trial. The model predicted 187.25 strokes (95% confidence interval 161.49–213.01), while the actual number was 171.6, within 1.22 standard deviations of the simulated mean.Conclusions:Given the absence of medically managed populations in recent carotid stenosis trials, our model can estimate stroke‐free survival and mortality data for these patients. The model may also estimate the effectiveness of novel medical and procedural therapies for stroke prevention. These effectiveness estimates can inform the development of policies, guidelines, or cost‐effectiveness analyses when only single‐arm trial data exist.