Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system: comparison of two independent examiners
PurposeBreast ultrasound could be a valuable tool complementary to mammography in breast cancer screening. Automated 3D breast ultrasound (ABUS) addresses challenges of hand-held ultrasound and could allow double reading analysis of ultrasound images. This trial assesses the inter-rater reliability...
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| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
26 July 2017
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| In: |
Archives of gynecology and obstetrics
Year: 2017, Volume: 296, Issue: 3, Pages: 571-582 |
| ISSN: | 1432-0711 |
| DOI: | 10.1007/s00404-017-4473-y |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s00404-017-4473-y Verlag, Volltext: https://link.springer.com/article/10.1007/s00404-017-4473-y 
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| Author Notes: | Anna Maier, Joerg Heil, Anna Lauer, Aba Harcos, Benedikt Schaefgen, Alexandra von Au, Julia Spratte, Fabian Riedel, Geraldine Rauch, André Hennigs, Christoph Domschke, Sarah Schott, Joachim Rom, Florian Schuetz, Christof Sohn, Michael Golatta |
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| 245 | 1 | 0 | |a Inter-rater reliability and double reading analysis of an automated three-dimensional breast ultrasound system |b comparison of two independent examiners |c Anna Maier, Joerg Heil, Anna Lauer, Aba Harcos, Benedikt Schaefgen, Alexandra von Au, Julia Spratte, Fabian Riedel, Geraldine Rauch, André Hennigs, Christoph Domschke, Sarah Schott, Joachim Rom, Florian Schuetz, Christof Sohn, Michael Golatta |
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| 520 | |a PurposeBreast ultrasound could be a valuable tool complementary to mammography in breast cancer screening. Automated 3D breast ultrasound (ABUS) addresses challenges of hand-held ultrasound and could allow double reading analysis of ultrasound images. This trial assesses the inter-rater reliability and double reading analysis of an ABUS system.MethodsTo assess the reproducibility and diagnostic validity of the ABUS system, SomoV™, a blinded double reading analysis, was performed in 1019 patients (2038 breasts) by two examiners (examiner A/B) and compared to single reading results, as well as to the reference standard regarding its diagnostic validity. Cohen’s kappa coefficients were calculated to measure the inter-rater reliability and agreement of the different diagnostic modalities. Patient comfort and time consumption for image acquisition and reading were analyzed descriptively as secondary objectives.ResultsAnalysis of inter-rater reliability yielded agreement in 81.6% (κ = 0.37; p < 0.0001) showing fair agreement. Single reading analysis of SomoV™ exams (examiner A/examiner B) compared to reference standard showed good specificity (examiner A: 88.3%/examiner B: 84.5%), fair inter-rater agreement (examiner A: κ = 0.31/examiner B: κ = 0.31), and adequate sensitivity (examiner A: 53.1%/examiner B: 64.2%). Double reading analysis yielded good sensitivity and specificity (73.7 and 77.7%). Mammography (n = 1911) alone detected 160 of 176 carcinomas (sensitivity 90.1%). Adding SomoV™ to mammography would have detected 12 additional carcinomas, resulting in a higher sensitivity of 97.7%.ConclusionSomoV™ is a promising technique with good sensitivity, high patient comfort, and fair inter-examiner reliability. It allows double reading analysis that, in combination with mammography, could increase detection rates in breast cancer screening. | ||
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