Abstract
BackgroundIn England, a national breast screening programme (NHSBSP) has been in place since 1988, and assessment of its impact on breast cancer incidence and mortality is essential to ensure that the programme is indeed doing more good than harm. This article describes large observation studies designed to estimate the effects of the current programme in terms of the benefits on breast cancer incidence and mortality and detrimental effect in terms of overdiagnosis. The case-control design of the cervical screening programme evaluation was highly effective in informing policy on screening intervals and age ranges. We propose innovative selection of cases and controls and gathering of additional variables to address new outcomes of interest and develop new methodologies to control for potential sources of bias.Methods/DesignTraditional case-control evaluation of breast screening uses women who have died from breast cancer as cases, and women known to be alive at the time of case death as controls. Breast screening histories prior to the cases’ date of first diagnosis are compared. If breast screening is preventing mortality from breast cancer, cases will be characterised by a lesser screening history than controls. All deaths and incident cases of primary breast cancer in England within each 2-year study period will be included in this ongoing evaluation. Cases will be age- and area-matched to controls and variables related to cancer treatment and breast tumour pathology will be obtained to investigate the interplay between screening and treatment, and the effect of screening on incidence of advanced stage disease. Screening attendance at other national screening programmes will also be collected to derive superior adjustment for self-selection bias.The study is registered and has received full ethics approval.
Highlights
In England, a national breast screening programme (NHSBSP) has been in place since 1988, and assessment of its impact on breast cancer incidence and mortality is essential to ensure that the programme is doing more good than harm
A major issue to be addressed by the Department of Health’s (England) Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis (PRU), is to evaluate the policy of mammography screening as delivered in the current National health service breast screening programme (NHSBSP) in terms of benefits on mortality from and on incidence of invasive primary breast cancer, and harms from the most adverse outcome of breast screening
In view of the above, there is a need for a large case– control study to (1) evaluate the effect of the NHSBSP on primary breast cancer mortality, with improvements to design and analysis methodology for coping with bias, notably self-selection bias: we propose to do this by developing a procedure using data from different cancer screening programmes
Summary
In England, a national breast screening programme (NHSBSP) has been in place since 1988, and assessment of its impact on breast cancer incidence and mortality is essential to ensure that the programme is doing more good than harm. This article describes large observation studies designed to estimate the effects of the current programme in terms of the benefits on breast cancer incidence and mortality and detrimental effect in terms of overdiagnosis. A major issue to be addressed by the Department of Health’s (England) Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis (PRU), is to evaluate the policy of mammography screening as delivered in the current NHSBSP in terms of benefits on mortality from and on incidence of invasive primary breast cancer, and harms from the most adverse outcome of breast screening. In the post-RCT epoch, analytical observational studies are the design of choice
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