Clinical and Economic Evaluation of Breast MRI for High-Risk Screening

描述（由申请人提供）：项目概述：我的职业目标是成为一名独立的临床研究者，致力于优化成像在乳腺癌早期检测中的应用，最终目的是提高乳腺癌筛查的有效性。迄今为止，我在临床乳腺成像、决策分析方法和卫生服务研究方面的经验非常适合开展拟议的研究。这项研究的目的是评估乳腺癌遗传风险增加的女性（>20%的终身风险，包括BRCA基因突变携带者）进行乳腺癌MRI筛查的临床和经济后果。拟议的研究将：1）开发和完善一个复杂的计算机模拟模型，该模型将整合当前可用的数据和替代终点，2）应用该模型预测乳腺X线摄影和MRI单独或联合筛查的长期健康和经济结果，以及3）评估患者对将MRI添加到当前筛查方案中所涉及的权衡的偏好。本提案中描述的研究将实现以下三个具体目标：1）完善乳腺癌自然史和结局的马尔可夫蒙特卡罗疾病模型。2)比较乳腺X线摄影和MRI筛查策略的临床有效性和成本效益。3)确定患者对假阳性检测结果的偏好，以改善临床有效性和成本效益的模型估计。相关性：这项拟议中的研究将使用计算机模拟模型来估计使用乳腺MRI筛查乳腺癌遗传风险增加的妇女的益处和成本。这项研究的结果将为制定标准化指南提供必要的数据，以优化MRI在乳腺癌筛查中的作用。

DESCRIPTION (provided by applicant): Project Summary: My career goal is to become an independent clinical investigator dedicated to optimizing the application of imaging in the early detection of breast cancer, with the ultimate aim of increasing the effectiveness of breast cancer screening. My experiences to date in clinical breast imaging, decision analytic methodologies, and health services research are uniquely suited to carry out the proposed research. The goal of the proposed research is to evaluate the clinical and economic consequences of MRI screening for breast cancer in women with increased genetic risk of breast cancer (>20% lifetime risk, including BRCA gene mutation carriers). The proposed research will: 1) develop and refine a complex computer simulation model, which will integrate currently available data and surrogate endpoints, 2) apply the model to predict long-term health and economic outcomes of screening with mammography and MRI, alone or in combination, and 3) evaluate patient preferences regarding trade-offs involved in adding MRI to current screening regimens. The research described in this proposal will carry out the following three specific aims: 1) Refine a Markov Monte Carlo disease model of breast cancer natural history and outcomes. 2) Compare the clinical effectiveness and cost-effectiveness of screening strategies utilizing mammography and MRI. 3) Determine patient preferences regarding false-positive test results to improve model estimates of clinical effectiveness and cost-effectiveness. Relevance: The proposed research will use computer simulation modeling to estimate the benefits and costs of using breast MRI for screening women at increased genetic risk of breast cancer. The results of the proposed research will provide data essential for developing standardized guidelines for optimizing the role of MRI in breast cancer screening.