TAMOXIFEN & BREAST CANCER--ACCEPTANCE/COST EFFECTIVENESS

他莫昔芬

• 批准号: 6494994
• 负责人: JOY MELNIKOW
• 金额: $ 2.09万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6494994
• 关键词: behavioral /social science research tag; breast neoplasms; cancer prevention; chemoprevention; clinical research; cost effectiveness; female; human subject; preference; tamoxifen; women's health

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.

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。 采取或推荐他莫昔芬的决定提出了一系列潜在的结果和相关的成本，必须在个人和临床决策中加以考虑。 目的：本三年计划的主要目标是：（1）评估妇女对他莫昔芬预防乳腺癌的接受程度和效用，（2）评估自我感知的乳腺癌风险与他莫昔芬预防偏好的相关性，并与使用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相关性进行比较;（3）通过临床乳腺检查和乳房X线摄影确定他莫昔芬预防性治疗与每年筛查相比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截面数据，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，将从300名可能符合他莫昔芬预防条件的女性的访谈中收集效用和患者偏好。由于低收入的少数民族妇女在很大程度上被排除在检查他莫昔芬预防的临床试验之外，因此将特别努力招募参加加州乳腺癌早期检测计划的非洲裔美国人和拉丁美洲妇女，以评估这些参数。 费用将来自医疗保险的平均允许费用和门诊药物的平均批发价格。 在可能的情况下，将通过文献的系统性综述确定模型概率，主要依赖于随机试验的最新发表结果和他莫昔芬相关结局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，将使用改良的德尔菲程序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。 成本效益分析将以修改以前开发的马尔可夫过程模型为基础。将进行单向和双向敏感性分析和蒙特卡罗分析。 预期成果：该项目的研究结果将提高对妇女的决策他莫昔芬预防的理解，确定影响他莫昔芬预防的成本效益的关键参数，并提供他莫昔芬与其他预防性干预措施相比的边际成本效益的观点，在随机对照试验的背景下。