C50
Conditions
Interventions
Group 1: In gynaecological practices with such AI systems installed: Initial diagnosis with aid of AI, possibly followed by human second opinion
Group 2: In gynaecological practices without such AI sy
Sponsors
Kassenärztliche Vereinigung Schleswig-Holstein
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Participation in QuaMaDi • Performing a mammogram as part of QuaMaDi
Exclusion criteria
Exclusion criteria: • Waiver of mammography in favour of other imaging procedures (e.g. sonography) within the framework of QuaMaDi • Age under 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Breast Cancer Detection Rate, calculated using the number of positive, histologically confirmed biopsy results within QuaMaDi divided by the number of women examined • Recall Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of other diagnosis tests prior to a biopsy (overall and in categories (ultrasound, MRI, further mammography, other if specified) for women getting a recall • Number of biopsies among all women getting recalled • The number of histologically positive biopsies among all women getting recalled (PPV I) • The number of histologically positive biopsies among all biopsies (PPV II) • If possible: The amount of time needed for diagnosis of i) Mammograms without a following histologically positive biopsy ii) Mammograms with AI information „not suspicious/normal“ and iii) Mammograms with a following histologically positive biopsy | — |
Countries
Germany
Contacts
Public ContactHannah Baltus
Universität zu Lübeck; Institut für Sozialmedizin und Epidemiologie
Outcome results
None listed