Abstract PS3-18: Differences in the diagnostic performance of breast ultrasound with or without additional patient information: A secondary analysis of an international multicenter trial
Authors: Pfob André , Barr Richard G. , Duda Volker , Buesch Christopher , Heil Joerg , Golatta Michael 
Published: February 2021

Abstract
Background and objectives: The Breast Imaging Reporting and Data System (BI-RADS) has helped to standardize radiologic reports and assessment in breast cancer diagnostics. So far, BI-RADS consists of the sole, standardized description of images. Individual patient characteristics like disease and family history or age are no part of the current BI-RADS classification system but are often subjectively considered to evaluate the risk of breast cancer in the clinical setting. It is however unclear how and to which extent such additional patient information influence the evaluation of risk of malignancy. Thus, we compared the performance in the detection of breast cancer between the sole analysis of ultrasound images by physician experts and a physician actually examining and counseling a patient in the clinical setting.
Methods: This multicenter, prospective trial took place at 11 trial sites in Austria, France, Germany, Japan, Netherlands, Portugal, and the US from February 2016 to March 2019. The trial enrolled 1288 women presenting with a lesion ≥0.5 and ≤5 cm in 2D B-mode ultrasound. In the clinical setting, the examiner conducted a routine 2D B-mode ultrasound examination and had additional standard information about the patients’ disease history and family history. The final ultrasound images made in the clinical routine (annotated with size measurements) but not any other information about the patient was given to three physician experts (&gt;15 years of experience in breast cancer diagnostics). The examiner in the clinical setting and each of the three experts evaluated the ultrasound images according to BI-RADS and gave a likelihood score for malignancy according to ACR (American College of Radiology). Following the BI-RADS definition by ACR, malignancy was assumed for a likelihood of malignancy &gt;2% (BI-RADS 4 or higher). All patients underwent histopathological confirmation which was the gold standard against which the clinical examiner and the three experts were compared. AUC, sensitivity, specificity, negative-predictive value (NPV), and positive-predictive value (PPV) were the performance measures.
Results: Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6%). AUC of the examiner in the clinical setting (AUC=0.94; 95% CI 0.92-0.95) was significantly better as for all three experts evaluating images only: expert one AUC=0.78 (95% CI 0.75-0.81); expert two AUC=0.81 (95% CI 0.78-0.84); expert three AUC=0.83 (95% CI 0.80-0.86). Sensitivity, specificity, NPV, and PPV of the examiner in the clinical setting were better as for all three experts evaluating images only. NPV of the examiner in the clinical setting was 98.6% (425 of 431), for expert one 87.8% (381 of 434), for expert two 91.2% (198 of 217), and for expert 3 84.1% (413 of 491).
Conclusion: Our findings suggest that information about individual patient characteristics (e.g. age, disease and family history) has great influence to accurately evaluate the risk of breast cancer. Future research may look into incorporating not only a standardized description of images into the BI-RADS classification system but also a standardized description of these individual patient characteristics to further standardize and objectify the risk evaluation in breast cancer diagnostics. Trial registration: NCT02638935
Performance of the examiner in the clinical setting and the three experts evaluating images onlyExaminer clinical settingImages only – Expert 1Images only – Expert 2Images only – Expert 3AUC (95% CI)0.94 (0.92-0.95)0.78 (0.75-0.81)0.81 (0.78-0.84)0.83 (0.80-0.86)Sensitivity –% (no.)98.4% (362 of 368)85.6% (315 of 368)94.8% (349 of 368)78.8% (290 of 368)Specificity –% (no.)46.2% (425 of 920)41.4% (381 of 920)21.5% (198 of 920)44.9% (413 of 920)Negative Predictive Value –% (no.)98.6% (425 of 431)87.8% (381 of 434)91.2% (198 of 217)84.1% (413 of 491)Positive Predictive Value –% (no.)42.2% (362 of 857)36.9% (315 of 854)32.6% (349 of 1071)36.4% (290 of 797)
Citation Format: André Pfob, Richard G. Barr, Volker Duda, Christopher Buesch, Joerg Heil, Michael Golatta. Differences in the diagnostic performance of breast ultrasound with or without additional patient information: A secondary analysis of an international multicenter trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS3-18.