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Posted by / 06-Feb-2020 00:06

Before randomisation, the women who volunteered to participate signed an informed consent form approved by the University of Toronto’s Human Experimentation Committee.

The study was conducted in 15 screening centres in six Canadian provinces (Nova Scotia, Quebec, Ontario, Manitoba, Alberta, and British Columbia).

Overall, 22% (106/484) of screen detected invasive breast cancers were over-diagnosed, representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial.

Regular mammography screening is done to reduce mortality from breast cancer.

Study surgeon could order diagnostic mammography or consult with the study radiologist if necessary before sending recommendations to family doctors.

Bracketed interventions indicate protocol at subsequent screens Fig 1 Process of randomisation and initial screening (screen 1).

Participants were recruited to the study by a general publicity campaign, by reviewing population lists and sending personal invitation letters, by group mailings, and through family doctors.4 Women were eligible if they were aged 40-59, had had no mammography in the previous 12 months, had no history of breast cancer, and were not pregnant.

We have now followed the study participants for a mean of 22 years.

Randomisation was individual and stratified by centre and five year age group.5 Irrespective of the findings on physical examination, women aged 40-49 were independently and blindly assigned randomly to receive mammography or no mammography.

Those allocated to mammography were offered another four rounds of annual mammography and physical examination, those allocated to no mammography were told to remain under the care of their family doctor, thus receiving usual care in the community, although they were asked to complete four annual follow-up questionnaires.

Breast examination was carried out by nurses unless stated otherwise ( ve indicates abnormality found by examiner, -ve no abnormality found).

MA=mammography ( ve indicates abnormality found by radiologist, -ve no abnormality found).

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