TAMOXIFEN & BREAST CANCER--ACCEPTANCE/COST EFFECTIVENESS

使用他莫昔芬降低或预防乳腺癌的风险是一种有争议的干预措施。服用或推荐他莫昔芬的决定提出了一系列潜在的结果和相关成本，在个人和临床政策决策中都必须考虑这些因素。目的：这项为期3年的提案的主要目标是：(1)评估妇女对他莫昔芬预防乳腺癌结果的接受度和有效性，(2)评估自我感知的乳腺癌风险与他莫昔芬预防偏好之间的关联，以及(2)比较使用NCI Gail乳腺癌风险筛查工具计算的乳腺癌风险与他莫昔芬预防偏好之间的关联，以及(3)确定与通过临床乳房检查和乳房X光检查进行年度筛查相比，他莫昔芬预防降低乳腺癌死亡率的边际成本-效果。方法：我们将从300名妇女的访谈中收集横断面数据，并对先前存在的数据进行二次分析。公用事业和患者偏好将从对300名有资格接受他莫昔芬预防的妇女的采访中收集，这些妇女是通过使用NCI Gail乳腺癌风险筛查工具确定的。由于低收入少数民族妇女在很大程度上被排除在检查他莫昔芬预防措施的临床试验之外，因此将特别努力招募非洲裔美国人和拉丁裔妇女参加加州的乳腺癌早期检测计划，以评估这些参数。费用将来自联邦医疗保险允许的平均费用和门诊药物的平均批发价。如果可能，模型概率将从系统的文献回顾中确定，主要依赖于最近发表的随机试验的结果和对他莫昔芬相关结果的相对风险的大型荟萃分析，以及用于估计基线风险的基于人群的数据或大型队列研究。当无法从医学文献中获得概率时，将使用改进的德尔菲法向专家组征求专家意见。结果将包括乳腺癌、子宫内膜癌、静脉血栓栓塞症、中风、髋部骨折、白内障和令人讨厌的副作用。成本效益分析将基于对先前开发的马尔可夫过程模型的修改。将进行单向和双向的灵敏度分析和蒙特卡罗分析。预期结果：该项目的研究结果将提高妇女对他莫昔芬预防决策的理解，确定影响他莫昔芬预防成本效益的关键参数，并在随机对照试验的背景下，提供关于他莫昔芬与其他预防干预措施相比的边际成本效益的观点。

Risk reduction or prophylaxis of breast cancer with tamoxifen is a controversial intervention. The decision to take or recommend tamoxifen presents a range of potential outcomes and associated costs which must be considered in both individual and clinical policy decisions. Objectives: The primary objectives of this 3 year proposal are: (1) to evaluate women's acceptance and utilities for the outcomes of tamoxifen prophylaxis of breast cancer, (2) to evaluate the association of self-perceived breast cancer risk with preferences for tamoxifen prophylaxis compared to the association of calculated breast cancer risk using the NCI Gail breast cancer risk screening tool with preferences for tamoxifen prophylaxis and (3) to determine the marginal cost- effectiveness of tamoxifen prophylaxis for reduction of breast cancer mortality compared with annual screening by clinical breast exam and mammography. Methods: We will collect cross- sectional data from interviews with 300 women as well as perform secondary analyses on pre-existing data. Utilities and patient preferences will be collected from interviews with 300 women potentially eligible for tamoxifen prophylaxis, as identified through use of the NCI Gail breast cancer risk screening tool. Because low income minority women have been largely excluded from clinical trials examining tamoxifen prophylaxis, particular efforts will be made to recruit African American and Latina women participating in California's Breast Cancer Early Detection Program for assessment of these parameters. Costs will be derived from Medicare average allowed charges and average wholesale prices for outpatient medications. Model probabilities will be determined when possible from a systematic review of the literature, relying primarily on recent published results from randomized trials and a large meta-analysis for relative risks of tamoxifen related outcomes, and population based data or large cohort studies for estimating baseline risks. When probabilities are not available from the medical literature, expert opinion will be solicited from a panel using a modified Delphi process. Outcomes will include breast cancer, endometrial cancer, venous thromboembolism, stroke, hip fracture, cataracts, and bothersome side effects. The cost-effectiveness analysis will be based on modifications of a previously developed Markov process model. One way and two way, sensitivity analyses and Monte Carlo analysis will be conducted. Expected results: Findings from this project will enhance understanding of women's decisionmaking about tamoxifen prophylaxis, identify key parameters influencing cost effectiveness of tamoxifen prophylaxis, and provide perspective on the marginal cost effectiveness of tamoxifen compared with other preventive interventions, outside the context of randomized controlled trials.