Reference standard
carcinoma, ductal carcinoma
PATHOLOGY
The reference standard used to verify the positive or negative status of additional lesions were pathology findings (at needle biopsy or excision) or follow-up imaging. As per standard of care (in absence of bilateral mastectomy), all participants underwent mammographic follow-up at 12 months. A 6- or 12-month post-surgical CEM or MRI exam was allowed for follow-up of additional lesions graded NBCC 3 and above that had been downgraded following work-up.The study pathologist was given a diagram for each patient (see The presence or absence of a pathological correlate for each image-detected lesion was recorded. Retrospective review of each patient’s pathology and imaging findings by the first author and a study pathologist for lesion concordance was also undertaken.Lesions shown to be invasive carcinoma, ductal carcinoma True positive lesions were those called positive on imaging that had positive pathology correlate. False-positive lesions were those called positive on CEM or MRI with a concordant negative reference standard. False-negative lesions were those that were positive on pathology without suspicious findings on CEM or MRI. As outlined by Moskowitz et al. [