Roze S, Liens D, Palmer A, Berger W, Tucker D, Renaudin C
Center for Outcomes Research, A Unit of IMS, Basel, Switzerland.
Curr Med Res Opin. 2006 Dec;22(12):2549-56. doi: 10.1185/030079906X148490.
The aim of this study was to describe a health economic model developed to project lifetime clinical and cost outcomes of lipid-modifying interventions in patients not reaching target lipid levels and to assess the validity of the model.
The internet-based, computer simulation model is made up of two decision analytic sub-models, the first utilizing Monte Carlo simulation, and the second applying Markov modeling techniques. Monte Carlo simulation generates a baseline cohort for long-term simulation by assigning an individual lipid profile to each patient, and applying the treatment effects of interventions under investigation. The Markov model then estimates the long-term clinical (coronary heart disease events, life expectancy, and quality-adjusted life expectancy) and cost outcomes up to a lifetime horizon, based on risk equations from the Framingham study. Internal and external validation analyses were performed.
The results of the model validation analyses, plotted against corresponding real-life values from Framingham, 4S, AFCAPS/TexCAPS, and a meta-analysis by Gordon et al., showed that the majority of values were close to the y = x line, which indicates a perfect fit. The R2 value was 0.9575 and the gradient of the regression line was 0.9329, both very close to the perfect fit (= 1).
Validation analyses of the computer simulation model suggest the model is able to recreate the outcomes from published clinical studies and would be a valuable tool for the evaluation of new and existing therapy options for patients with persistent dyslipidemia.
本研究旨在描述一种健康经济模型,该模型用于预测未达到血脂目标水平的患者进行降脂干预后的终生临床和成本结果,并评估该模型的有效性。
基于网络的计算机模拟模型由两个决策分析子模型组成,第一个子模型采用蒙特卡罗模拟,第二个子模型应用马尔可夫建模技术。蒙特卡罗模拟通过为每位患者分配个体血脂谱,并应用所研究干预措施的治疗效果,生成一个用于长期模拟的基线队列。然后,马尔可夫模型根据弗雷明汉研究的风险方程,估计直至终生的长期临床(冠心病事件、预期寿命和质量调整预期寿命)和成本结果。进行了内部和外部验证分析。
将模型验证分析的结果与来自弗雷明汉、4S、AFCAPS/TexCAPS以及戈登等人的一项荟萃分析的相应实际值进行对比绘制,结果显示大多数值接近y = x线,这表明拟合良好。R2值为0.9575,回归线的斜率为0.9329,两者都非常接近完美拟合(= 1)。
计算机模拟模型的验证分析表明,该模型能够重现已发表临床研究的结果,并且对于评估持续性血脂异常患者的新治疗方案和现有治疗方案将是一个有价值的工具。