Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration

• Published in: European radiology 2013-08, Vol.23 (8), p.2061-2071
• Main Authors: Skaane, Per, Bandos, Andriy I., Gullien, Randi, Eben, Ellen B., Ekseth, Ulrika, Haakenaasen, Unni, Izadi, Mina, Jebsen, Ingvild N., Jahr, Gunnar, Krager, Mona, Hofvind, Solveig
• Format: Article
• Language: English
• Subjects: Aged; Arbitration; Breast; Breast cancer; Breast Neoplasms - diagnosis; Diagnostic Radiology; Early Detection of Cancer - methods; False Positive Reactions; Female; Humans; Image Processing, Computer-Assisted; Imaging; Imaging, Three-Dimensional - methods; Internal Medicine; Interventional Radiology; Mammography; Mammography - methods; Management decisions; Medical screening; Medicine; Medicine & Public Health; Middle Aged; Neuroradiology; Observer Variation; Prospective Studies; Radiographic Image Interpretation, Computer-Assisted - methods; Radiology; Reproducibility of Results; Ultrasound
• ISSN: 0938-7994; 1432-1084
• DOI: 10.1007/s00330-013-2820-3

Objectives To compare double readings when interpreting full field digital mammography (2D) and tomosynthesis (3D) during mammographic screening. Methods A prospective, Ethical Committee approved screening study is underway. During the first year 12,621 consenting women underwent both 2D and 3D imaging. Each examination was independently interpreted by four radiologists under four reading modes: Arm A—2D; Arm B—2D + CAD; Arm C—2D + 3D; Arm D—synthesised 2D + 3D. Examinations with a positive score by at least one reader were discussed at an arbitration meeting before a final management decision. Paired double reading of 2D (Arm A + B) and 2D + 3D (Arm C + D) were analysed. Performance measures were compared using generalised linear mixed models, accounting for inter-reader performance heterogeneity ( P