In a Swedish randomized, single-blinded, population-based non-inferiority trial (NCT04838756) of 105,915 women, AI-supported mammography screening was noninferior to standard double reading for interval cancers: 1.55 vs 1.76 per 1,000 (proportion ratio 0.88; 95% CI 0.65–1.18; p=0.41). Sensitivity was higher with AI (80.5% vs 73.8%; p=0.031) with identical specificity (98.5% in both), while reducing radiologist reading workload.
Why It Matters To Your Practice
Interval cancers are a key safety metric in screening; this trial suggests AI triage can be deployed without increasing interval cancer rates (1.55 vs 1.76/1,000).
Higher sensitivity with unchanged specificity implies potential for better detection without more false positives—important for patient anxiety, downstream testing, and clinic throughput.
AI was used both to triage exams to single vs double reading and as detection support—closer to real-world workflow redesign than “AI as a second opinion” alone.
Clinical Implications
Consider AI-supported triage models as an option to maintain safety while reducing double-reading burden, particularly where radiologist capacity is constrained.
Expect sensitivity gains to be most evident for invasive cancers (reported as consistent across age and breast density), not for in-situ disease.
Plan implementation with governance: define triage thresholds, escalation rules (single→double read), QA monitoring, and pathways for discordant reads.
Insights
Noninferiority margin was 20%; observed proportion ratio favored AI (0.88) but with CI crossing 1.0—so interpret as “not worse,” not definitively better, for interval cancers.
Interval cancer characteristics were descriptively less unfavorable with AI support (e.g., fewer invasive: 75 vs 89; fewer T2+: 38 vs 48; fewer non-luminal A: 43 vs 59), suggesting possible stage/biology shift.
Specificity held steady at 98.5% in both arms (p=0.88), countering a common concern that AI-driven detection increases recalls.
The Bottom Line
In this large Swedish Breast Cancer screening trial, AI-supported triage was noninferior for interval cancers (1.55 vs 1.76/1,000) with higher sensitivity and unchanged specificity—supporting real-world adoption where workload relief is needed.