English Mammography Screening Outcomes by Age, Frequency and Test Threshold
NCT ID: NCT05247463
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10000000 participants
OBSERVATIONAL
2021-01-01
2024-12-30
Brief Summary
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Detailed Description
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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.
This is an observational study linking women's screening records to cancer registry and mortality records from 1988 to 2018.
This observational study began on 1st January 2021, building on the POSTBOx study (NCT04365114). POSTBOx evaluates the impact of one or two readers on women's outcomes, POSTBOx primary outcomes 4 and 5 and secondary outcome 1 were dependent on obtaining follow up funding, which was achieved in this ATHENA-M project. The ATHENA-M funding also adds two additional exposures (screening interval and age of eligibility), and expands analysis of the test threshold exposure. Both projects were significantly delayed in data linkage and transfer, the investigators expect complete data transfer to the analysis team at Warwick between February and April 2022.
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Women invited to Breast Cancer Screening in England
Women invited to Breast Cancer Screening in England up to 31st March 2018
Increase in upper age of eligibility for breast cancer screening from 64 to 70
The upper age limit of eligibility for Breast Cancer Screening increased in England from 64 to 70 as a result of the NHS Cancer Plan, so women were offered an additional 2 rounds of screening.
Women attending Breast Cancer Screening in England
Women attending mammography screening to examine the effect of screening test threshold on outcomes, up to 31st March 2018
Screening round length
The target round length (frequency) of breast cancer screening in England is every 3 years. However in practice there is variability in this due to local centre capacity. The exposures are round lengths of approximately 2 years and approximately 3 years
Screening test threshold
Radiologists and equivalent health professionals examine women's screening mammograms for potential signs of cancer, and recall some women for further diagnostic tests. Each has a different test threshold for recall, characterised by the proportion of previous cases that they have recalled.
Interventions
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Increase in upper age of eligibility for breast cancer screening from 64 to 70
The upper age limit of eligibility for Breast Cancer Screening increased in England from 64 to 70 as a result of the NHS Cancer Plan, so women were offered an additional 2 rounds of screening.
Screening round length
The target round length (frequency) of breast cancer screening in England is every 3 years. However in practice there is variability in this due to local centre capacity. The exposures are round lengths of approximately 2 years and approximately 3 years
Screening test threshold
Radiologists and equivalent health professionals examine women's screening mammograms for potential signs of cancer, and recall some women for further diagnostic tests. Each has a different test threshold for recall, characterised by the proportion of previous cases that they have recalled.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
47 Years
73 Years
FEMALE
No
Sponsors
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University of Birmingham
OTHER
University of Bristol
OTHER
University of Warwick
OTHER
Responsible Party
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Sian Taylor-Phillips
Professor of Population Health
Locations
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University of Warwick
Coventry, Warwickshire, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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SOC.03/20-21
Identifier Type: -
Identifier Source: org_study_id