Nationwide real-world implementation of AI for cancer detection in population-based mammography screening.

Journal: Nature medicine
PMID:

Abstract

Artificial intelligence (AI) in mammography screening has shown promise in retrospective evaluations, but few prospective studies exist. PRAIM is an observational, multicenter, real-world, noninferiority, implementation study comparing the performance of AI-supported double reading to standard double reading (without AI) among women (50-69 years old) undergoing organized mammography screening at 12 sites in Germany. Radiologists in this study voluntarily chose whether to use the AI system. From July 2021 to February 2023, a total of 463,094 women were screened (260,739 with AI support) by 119 radiologists. Radiologists in the AI-supported screening group achieved a breast cancer detection rate of 6.7 per 1,000, which was 17.6% (95% confidence interval: +5.7%, +30.8%) higher than and statistically superior to the rate (5.7 per 1,000) achieved in the control group. The recall rate in the AI group was 37.4 per 1,000, which was lower than and noninferior to that (38.3 per 1,000) in the control group (percentage difference: -2.5% (-6.5%, +1.7%)). The positive predictive value (PPV) of recall was 17.9% in the AI group compared to 14.9% in the control group. The PPV of biopsy was 64.5% in the AI group versus 59.2% in the control group. Compared to standard double reading, AI-supported double reading was associated with a higher breast cancer detection rate without negatively affecting the recall rate, strongly indicating that AI can improve mammography screening metrics.

Authors

  • Nora Eisemann
    Institute for Social Medicine and Epidemiology, University of Lübeck, Lubeck, Germany.
  • Stefan Bunk
    Vara, Berlin, Germany. Electronic address: stefan.bunk@vara.ai.
  • Trasias Mukama
    Vara, Berlin, Germany. Electronic address: trasias.mukama@vara.ai.
  • Hannah Baltus
    Institute for Social Medicine and Epidemiology, University of Lübeck, Lubeck, Germany.
  • Susanne A Elsner
    Institute for Social Medicine and Epidemiology, University of Lübeck, Lubeck, Germany.
  • Timo Gomille
    Diagnosticum Visiorad, Pinneberg, Germany.
  • Gerold Hecht
    Reference Center Mammography North, German Breast Cancer Screening Program, Oldenburg, Germany.
  • Sylvia Heywang-Köbrunner
    Referenzzentrum Mammographie Munich, Brustdiagnostik München and FFB gGmbH, Munich, Germany.
  • Regine Rathmann
    Radiology Center Schwarzer Bär, Hannover, Germany.
  • Katja Siegmann-Luz
    Reference Center Mammography Berlin, German Breast Cancer Screening Program, Berlin, Germany.
  • Thilo Töllner
    Clinic Dr. Hancken, Stade, Germany.
  • Toni Werner Vomweg
    Radiological Institute Dr. von Essen, Koblenz, Germany.
  • Christian Leibig
    Neurochip Research Group, Natural and Medical Sciences Institute, Reutlingen, Germany; International Max Planck Research School of Cognitive and Systems Neuroscience, University of Tübingen, Tübingen, Germany; Bernstein Center for Computational Neuroscience Munich and Department of Biology II, Ludwig-Maximilians-Universität München, Planegg-Martinsried, Germany; ZEISS Vision Science Lab, Institute for Ophthalmic Research, University of Tübingen, Tübingen, Germany. Electronic address: christian.leibig@uni-tuebingen.de.
  • Alexander Katalinic
    Institute for Cancer Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23562 Lübeck, Germany; Institute for Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, 23562 Lübeck, Germany.