CASE-CONTROL STUDY OF MAMMOGRAPHY

乳房X线照相术病例对照研究

• 批准号: 2767474
• 负责人: JOE Vandiver SELBY
• 金额: $ 22.22万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-05-01 至 2000-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2767474
• 关键词: breast neoplasm /cancer diagnosis; cancer prevention; cancer risk; case history; clinical research; diagnosis design /evaluation; female; health surveys; human data; human middle age (35-64); human mortality; human old age (65+); human population study; mammography; mass screening; prognosis; public health; women's health

The effectiveness of screening mammography for women aged 40-49 and >70 has not been demonstrated in randomized controlled trials and remains a controversial issue despite its high degree of public health importance. No new RCTs, which is the best way to evaluate this question, are currently planned and case-control studies present an option for obtaining new information on the efficacy of screening mammography in a timely manner. We propose to perform such a study among women aged 40-87 in a large pre-paid health plan in Northern California. Far larger than any published to date, this study will include an estimated 1500 women with fatal breast cancer, diagnosed from 1980-1994, who were members of the health plan and potentially exposed to mammography for at least 3 years before their diagnosis. Exposure to screening mammography, as opposed to diagnostic mammography, will be determined by medical audits and compared between cases and controls for specified periods up to the diagnosis. Screening will be evaluated among women 40-49, 50-69, and 70-87 years of age taking into account the detectable preclinical phase of breast cancer. In addition we will evaluate the efficacy of mammography among approximately 300 black and 118 Asian women. The important problems of confounding and healthy screening biases will be addressed by comparing data on risk factors obtained from the medical records before diagnosis and by controlling for the number of previous health checkups and for the number of screening mammograms done prior to an interval being assessed. The estimated relative risk (OR) of breast cancer mortality will be determined by multiple logistic regression for matched sets and efficacy will equal 1 - OR. The research team is experienced in conducting these types of studies and the setting offers a defined and accessible population, a high level of exposure to mammography, an ability to link computer-stored datasets, and the centralized availability of medical records.

筛查乳房X线摄影对40-49岁和> 70的女性的有效性 在随机对照试验中尚未证明，并且仍然是 尽管公共卫生的重要性很高，但有争议的问题。 没有新的RCT，这是评估这个问题的最佳方法，是 目前计划的和案例对照研究提出了一种选择的选择 及时筛查乳房X线摄影的功效的新信息 方式。 我们建议在40-87岁的女性中进行此类研究 北加州的大型预付健康计划。 远大于任何 迄今为止已发表的这项研究将包括大约1500名女性 致命的乳腺癌，从1980 - 1994年诊断为 健康计划，并可能暴露于乳房X线摄影至少3年 在诊断之前。 暴露于乳房X线摄影，而不是 诊断乳房X线摄影将由医学审核确定，并比较 在诊断之前的指定期间和对照之间。 筛查将在40 - 49年，50 - 69年和70 - 87年的女性中进行评估 考虑到乳腺癌可检测到的临床前阶段的年龄。 此外，我们将评估乳房X线摄影的功效 大约300名黑人和118名亚洲妇女。 重要的问题 通过比较将解决混杂和健康的筛查偏见 诊断前从病历中获得的风险因素的数据 并控制以前的健康检查数量和 在评估间隔之前进行的乳房X线照片的数量。 乳腺癌死亡率的估计相对风险（OR）将是 由匹配集和功效的多个逻辑回归确定 将等于1-或。 研究小组在执行这些方面经验丰富 研究类型和设置提供了定义且可访问的 人口，高水平的乳腺X线摄影，能够连接的能力 计算机存储的数据集以及医疗的集中式可用性 记录。