J Pathol Inform
Breast cancer; diagnostic accuracy; digital whole-slide imaging; intraobserver reproducibility
BACKGROUND: Digital whole slide imaging may be useful for obtaining second opinions and is used in many countries. However, the U.S. Food and Drug Administration requires verification studies.
METHODS: Pathologists were randomized to interpret one of four sets of breast biopsy cases during two phases, separated by ≥9 months, using glass slides or digital format (sixty cases per set, one slide per case,
RESULTS: Sixty-five percent of responding pathologists were eligible, and 252 consented to randomization; 208 completed Phase I (115 glass, 93 digital); and 172 completed Phase II (86 glass, 86 digital). Accuracy was slightly higher using glass compared to digital format and varied by category: invasive carcinoma, 96% versus 93% (
CONCLUSIONS: In this large randomized study, digital format interpretations were similar to glass slide interpretations of benign and invasive cancer cases. However, cases in the middle of the spectrum, where more inherent variability exists, may be more problematic in digital format. Future studies evaluating the effect these findings exert on clinical practice and patient outcomes are required.
Women & Children
Elmore, Joann G; Longton, Gary M; Pepe, Margaret S; Carney, Patricia A; Nelson, Heidi D; Allison, Kimberly H; Geller, Berta M; Onega, Tracy; Tosteson, Anna N A; Mercan, Ezgi; Shapiro, Linda G; Brunyé, Tad T; Morgan, Thomas R; and Weaver, Donald L, "A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis." (2017). Articles, Abstracts, and Reports. 1599.