Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,094,122
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
Analysis of women's medical records to understand the impact of previous changes to breast cancer screening (increase from one to two clinicians examining each woman's mammograms, and what proportion of women they recall for further tests)
详细描述
Retrospective observational study examining the records and outcomes of women who attended breast cancer screening between 1988 and 2016. Linkage of records from the breast screening service, the cancer registry, and mortality. Analysis of whether changing the threshold for whether to recall women for further tests or the number of clinicians examining the mammograms for signs of cancer affects outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 是
入选标准
- •Women who attended the English National Health Service (NHS) breast cancer screening service at least once between 1988 and 2016, aged between 47 and 73
- •All eligible episodes of screening for each woman (we expect women to be screened around 7 times each)
排除标准
- •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
All cause mortality
时间窗: 13 years, and up to 30 years
Mortality due to any cause (dependent on securing follow on funding)
Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method
时间窗: 13 years, and up to 30 years
Overdiagnosis of breast cancer (measured as difference in total cancer incidence, screen and symptomatic). Will also report mechanism of action (number of screen detected cancers, number of symptomatically detected cancers at 3,13, and 30 years follow-up)
False positive recalls
时间窗: 1 day screening episode
Recall of women for further tests after screening which did not result in detection of cancer
Characteristics of cancer detected
时间窗: 1 day screening episode, 3year, 13 year and up to 30 year follow up
Size, grade and stage (reported overall, screen detected, and symptomatic detected).
Cancers detected at screening
时间窗: 1 day screening episode
Biopsy proven cancers detected at screening
Breast cancer mortality
时间窗: 13 years, and up to 30 years
Mortality due to breast cancer (dependent on securing follow-on funding)
次要结局
- Breast cancer morbidity(Up to 30 years)
- Breast cancer free survival(Up to 30 years follow-up)
研究者
Sian Taylor-Phillips
Associate Professor of Screening and Test Evaluation
University of Warwick