Observational Study of Age, Test THreshold and Frequency on English NAtional Mammography Screening Outcomes (ATHENA-M)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10,000,000
- 试验地点
- 1
- 主要终点
- Overdiagnosis
研究概览
简要总结
Breast cancer screening involves taking mammograms (x-rays) of women's breasts to search for signs of cancer. This study investigates the impact of test threshold, screening interval (frequency) and age of eligibility on intermediate outcomes, and health outcomes such as mortality and morbidity. This observational study links breast cancer screening, cancer registry and mortality registration data to answer these questions.
详细描述
Breast cancer screening involves taking mammograms (x-rays) of women's breasts to search for signs of cancer. Different countries give different versions of breast screening, because there is no clear evidence which is best. This study investigates the effect of three variations to breast screening on outcomes for women screened.
Firstly, the test threshold. When radiologists examine the women's mammograms it is often not clear whether cancer is present. The test threshold means the tendency of radiologists to recall more or fewer women for further tests. In England overall 4% of women are recalled for further tests because their mammograms show suspicious signs, but different radiologists vary between 2% and 10%. This study investigates how recalling different proportions of women affects their long term outcomes.
Secondly the interval between screening invitations. In the UK breast screening is every 3 years, which is the longest time between screens in the world. In the US it is every year or 2 years and in Europe every 2 years. This study uses the natural variation in English screening interval to investigate the impact on women's outcomes.
Thirdly the age women are invited for breast screening. The NHS Cancer Plan in England resulted in extension of the upper age limit of eligibility for breast cancer screening from 64 to 70. This study investigates the change on women's outcomes.
The primary outcomes are health outcomes or close approximations, such as mortality, overdiagnosis of cancer which would never have caused harm, stage shift in cancer diagnosis, treatment (to reflect treatment associated morbidity), and false positive recall to assessment (which is known to induce anxiety). Secondary outcomes are intermediate outcomes with known but more proximal links to health outcomes: number of cancers detected at screening and their characteristics, and number of interval cancers detected between screening rounds.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 47 Years 至 73 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women invited for breast cancer screening by the English NHS Breast Screening Programme
排除标准
- •Missing or corrupted data for NHS number, so linkage between databases is not possible
- •For analysis of test threshold and screening interval: women who did not attend routine English NHS Breast screening service within the specified date and age range, even if they attended symptomatic breast cancer services, high risk (family history) breast screening services, or if they were referred for mammograms by their general practitioner
结局指标
主要结局
Overdiagnosis
时间窗: 13 year follow up of particular importance to match breast cancer mortality
Overdiagnosis of breast cancer which would not have been detected symptomatically using compensatory drop method, (difference between cumulative incidence of cancer (screening and symptomatic) between exposure groups
Stage Shift
时间窗: For breast cancers detected at any point during follow-up (up to a maximum 30 years)
Difference in prognostic indicators (DCIS vs invasive, grade, size, nodes involved, cancer type, hormonal status, Nottingham Prognostic Index, distant metastasis) between exposure groups, including both symptomatically and screen detected cancers
Treatment Received
时间窗: Within 1 year of diagnosis
Breast Cancer Treatment received (as a proxy for treatment associated morbidity)
Breast Cancer Specific Mortality
时间窗: 13 year follow up of particular importance to match previous systematic review of results
Breast Cancer Specific Mortality
False positive recall to assessment
时间窗: At point of screening episode
Proportion of women recalled for further tests from their screening mammogram, in whom those further tests did not detect breast cancer
All cause mortality
时间窗: 13 year follow up of particular importance to match breast cancer mortality
All cause mortality
次要结局
- Cancers detected at screening(At screening episode)
- Interval cancers(Up to 3 years after the screening appointment)
- Screen detected cancer characteristics(At screening episode)
研究者
Sian Taylor-Phillips
Professor of Population Health
University of Warwick