Breast cancer Cancer
Conditions
Interventions
EDITH is a multi-centre, pragmatic, cluster, randomised controlled trial (RCT). Cluster will be at the clinic day level including 660,000 women across approximately 30 screening centres with opt-out c
Sponsors
University of Warwick
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women routinely invited for NHSBSP breast screening at participating centres during the trial recruitment period, typically screening target age 50-70 years but pragmatically include all screened women even if outside target age range (for example older women are allowed to self-refer every 3 years). 2. Women whose mammograms cannot be read by AI (for instance due to cosmetic breast implants, or not having standard 2D digital four-view mammograms acquired) will be included in the main trial intention to treat analysis comparing the trial arms. In practice they are effectively a test failure and will receive standard care (two human readers) regardless of trial arm. This analysis will deliver comparison of the AI pathway as it would actually be implemented for all women in comparison to current standard practice.
Exclusion criteria
Exclusion criteria: 1. Women being screened in the moderate and high-risk screening service (separate to NHSBSP) 2. Women being screened following the very high-risk protocol (separate protocol to population risk women: annual mammography/MRI) 3. Women who have opted out from participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cancer detection rate (CDR) measured as cancers detected out of all women screened 2. Recall rate measured as women recalled out of all women screened Primary analysis will be at the end of the 4-year trial before interval cancers have been captured. The final analysis will be when all women have undergone a second round of screening or more than 3 years follow up to capture interval cancer rates. The nested test accuracy study will take place towards the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Arbitration rate measured as women requiring additional read by third person out of all women screened 2. Interval cancer rate measured as the number of interval cancers within 3 years out of all women screened and the next screen CDR measured using as the number of cancers detected out of all women screened at 3 years 3. Characteristics of cancers detected measured using size, type and grade 4. Outcomes by population group to explore inequalities and by breast density, measured using age, ethnicity, socioeconomic status [SES] 5. AI failure rates 6. Atypia detection (incidental findings) 7. Workload measured using e.g. reading volume, arbitration volume, recall to assessment volume 8. Reader behaviour and performance measured using e.g. AI vendor, AI threshold, batch length, time on task, reader experience and reading volume 9. Opt-out rates and reasons for opting out as a measure of acceptability in screening-eligible women (where provided by women) 10. Cost to the NHS of the three pathways 11. Cost-effectiveness by technology and population subgroup, and impact on NHS capacity 12. Test accuracy of AI from a nested test accuracy study overall and by population subgroup (e.g. age, ethnicity, breast density, socioeconomic status) Primary analysis will be at the end of the 4-year trial before interval cancers have been captured. The final analysis will be when all women have undergone a second round of screening or more than 3 years follow up to capture interval cancer rates. The nested test accuracy study will take place towards the end of the trial. | — |
Countries
England, United Kingdom
Contacts
Public ContactAmy Hopkins
Outcome results
None listed