Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening

University of Warwick13,094,122 enrolled

Overview

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)

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.

Study Type

OBSERVATIONAL

Enrollment

13,094,122

Conditions

Breast Cancer Ductal Carcinoma in Situ

Interventions

Breast Screening Mammography with single readerDIAGNOSTIC_TEST

One clinician examined each woman's mammograms for signs of cancer

Breast screening mammography with two readersDIAGNOSTIC_TEST

Two clinicians seperately examined each woman's mammograms for signs of cancer

Test thresholdDIAGNOSTIC_TEST

Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled

Eligibility

Sex: FEMALEMin age: 47 YearsMax age: 73 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Locations (1)

Univesity of Warwick

Coventry, Warwickshire, United Kingdom

Outcomes

Primary Outcomes

Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method

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)

Time frame: 13 years, and up to 30 years

Cancers detected at screening

Biopsy proven cancers detected at screening

Time frame: 1 day screening episode

False positive recalls

Recall of women for further tests after screening which did not result in detection of cancer

Time frame: 1 day screening episode

Breast cancer mortality

Mortality due to breast cancer (dependent on securing follow-on funding)

Time frame: 13 years, and up to 30 years

All cause mortality

Mortality due to any cause (dependent on securing follow on funding)

Time frame: 13 years, and up to 30 years

Characteristics of cancer detected

Size, grade and stage (reported overall, screen detected, and symptomatic detected).

Time frame: 1 day screening episode, 3year, 13 year and up to 30 year follow up

Secondary Outcomes

Breast cancer morbidity

Treatment received as a proxy for treatment associated morbidity (reported overall, screen detected and symptomatically detected, if follow on funding obtained)

Data from ClinicalTrials.gov

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