TAMOXIFEN & BREAST CANCER--ACCEPTANCE/COST EFFECTIVENESS

用他莫昔芬降低或预防乳腺癌的风险是一个有争议的干预措施。服用或推荐他莫昔芬的决定会带来一系列潜在的结果和相关的成本，这些都必须在个人和临床决策中加以考虑。目标：这项为期三年的建议的主要目标是：(1)评估女性对他莫昔芬预防乳腺癌效果的接受程度和效用；(2)评估自我感知的乳腺癌风险与他莫昔芬预防偏好的关系，与使用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的关系；(3)与通过临床乳房检查和乳房x光检查进行年度筛查相比，确定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，并对已有数据进行二次分析。通过使用NCI Gail乳腺癌风险筛查工具，将对300名可能适合他莫昔芬预防的女性进行访谈，收集效用和患者偏好。由于低收入的少数族裔妇女在很大程度上被排除在检查他莫昔芬预防作用的临床试验之外，因此将特别努力招募参加加州乳腺癌早期检测项目的非裔美国人和拉丁裔妇女，对这些参数进行评估。费用将来自医疗保险平均允许收费和门诊药物的平均批发价格。在可能的情况下，将通过对文献的系统回顾来确定模型概率，主要依靠最近发表的随机试验结果和他莫昔芬相关结果相对风险的大型荟萃分析，以及基于人群的数据或大型队列研究来估计基线风险。当从医学文献中无法获得概率时，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、中风、髋部骨折、白内障和令人烦恼的副作用。成本效益分析将基于先前开发的马尔可夫过程模型的修改。将进行单向和双向、敏感性分析和蒙特卡罗分析。预期结果：该项目的研究结果将增进对妇女关于他莫昔芬预防的决策的理解，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.