A Framework for Evaluating Diagnostic Discordance in Pathology Discovered During Research Studies

Feng, Sherry; Weaver, Donald L.; Carney, Patricia A.; Reisch, Lisa M.; Geller, Berta M.; Goodwin, Andrew; Rendi, Mara H.; Onega, Tracy; Allison, Kim H.; Nelson, Heidi D; Longton, Gary; Pepe, Margaret S.; Elmore, Joann G.

doi:10.5858/arpa.2013-0263-oa

Cited by 14 publications

(11 citation statements)

References 18 publications

(12 reference statements)

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“…[24252627] Briefly, 240 breast biopsy specimens were randomly selected from pathology registries. Each case included standardized data on the woman's age at biopsy, breast density, and biopsy type.…”

Section: Methodsmentioning

confidence: 99%

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Elmore

Longton

Pepe

et al. 2017

Journal of Pathology Informatics

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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, n = 240 cases). Accuracy was assessed by comparing interpretations to a consensus reference standard. Intraobserver reproducibility was assessed by comparing the agreement of interpretations on the same cases between two phases. Estimated probabilities of confirmation by a reference panel (i.e., predictive values) were obtained by incorporating data on the population prevalence of diagnoses.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% (P = 0.04); ductal carcinoma in situ (DCIS), 84% versus 79% (P < 0.01); atypia, 48% versus 43% (P = 0.08); and benign without atypia, 87% versus 82% (P < 0.01). There was a small decrease in intraobserver agreement when the format changed compared to when glass slides were used in both phases (P = 0.08). Predictive values for confirmation by a reference panel using glass versus digital were: invasive carcinoma, 98% and 97% (not significant [NS]); DCIS, 70% and 57% (P = 0.007); atypia, 38% and 28% (P = 0.002); and benign without atypia, 97% and 96% (NS).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.

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Section: Methodsmentioning

confidence: 99%

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Elmore

Longton

Pepe

et al. 2017

Journal of Pathology Informatics

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“…20,21 The methods and test sets developed for the B-Path study are described elsewhere. 22,23 In brief, each of four tests sets (A, B, C, and D) of breast biopsy specimens were created after sampling registries in Vermont and New Hampshire associated with the Breast Cancer Surveillance Consortium. 24 Each test set was composed of 60 cases, one glass slide per case, randomized with stratification (N=240) to contain comparable pathological findings.…”

Section: Methodsmentioning

confidence: 99%

Surgical implications and variability in the use of the flat epithelial atypia diagnosis on breast biopsy specimens

et al. 2017

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Objectives Flat epithelial atypia (FEA) is a relatively new diagnostic term with uncertain clinical significance for surgical management. Any implied risk of invasive breast cancer associated with FEA is contingent upon diagnostic reproducibility, yet little is known regarding its use. Materials and Methods Pathologists in the Breast Pathology Study interpreted one of four 60-case test sets, one slide per case, constructed from 240 breast biopsy specimens. An electronic data form with standardized diagnostic categories was used; participants were instructed to indicate all diagnoses present. We assessed participants’ use of FEA as a diagnostic term within: 1) each test set; 2) 72 cases classified by reference as benign without FEA; and 3) six cases classified by reference as FEA. 115 pathologists participated, providing 6,900 total independent assessments. Results Notation of FEA ranged from 0% to 35% of the cases interpreted, with most pathologists noting FEA on 4 or more test cases. At least one participant noted FEA in 34 of the 72 benign non-FEA cases. For the 6 reference FEA cases, participant agreement with the case reference FEA diagnosis ranged from 17% to 52%; diagnoses noted by participating pathologists for these FEA cases included columnar cell hyperplasia, usual ductal hyperplasia, atypical lobular hyperplasia, and atypical ductal hyperplasia. Conclusions We observed wide variation in the diagnosis of FEA among U.S. pathologists. This suggests that perceptions of diagnostic criteria and any implied risk associated with FEA may also vary. Surgical excision following a core biopsy diagnosis of FEA should be reconsidered and studied further.

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“…The breast pathology (B-Path) and digital pathology (digiPATH) study [41][42][43][44] aims are to understand the diagnostic patterns of pathologists and evaluate the accuracy and efficiency of interpretations using glass slides and digital whole slide images. For this purpose, three expert pathologists were invited to interpret a series of 240 breast biopsies on glass or digital media.…”

Section: Datasetmentioning

confidence: 99%

“…Cases included benign without atypia (30 %), atypical ductal hyperplasia (30 %), ductal carcinoma in situ (30 %), and invasive breast cancer (10 %). The methods of case development and data collection from pathologists have been previously described [41][42][43][44] and will be summarized here briefly.…”

Section: Datasetmentioning

confidence: 99%

Localization of Diagnostically Relevant Regions of Interest in Whole Slide Images: a Comparative Study

et al. 2016

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Whole slide digital imaging technology enables researchers to study pathologists' interpretive behavior as they view digital slides and gain new understanding of the diagnostic medical decision-making process. In this study, we propose a simple yet important analysis to extract diagnostically relevant regions of interest (ROIs) from tracking records using only pathologists' actions as they viewed biopsy specimens in the whole slide digital imaging format (zooming, panning, and fixating). We use these extracted regions in a visual bag-ofwords model based on color and texture features to predict diagnostically relevant ROIs on whole slide images. Using a logistic regression classifier in a cross-validation setting on 240 digital breast biopsy slides and viewport tracking logs of three expert pathologists, we produce probability maps that show 74 % overlap with the actual regions at which pathologists looked. We compare different bag-of-words models by changing dictionary size, visual word definition (patches vs. superpixels), and training data (automatically extracted ROIs vs. manually marked ROIs). This study is a first step in understanding the scanning behaviors of pathologists and the underlying reasons for diagnostic errors.

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A Framework for Evaluating Diagnostic Discordance in Pathology Discovered During Research Studies

Cited by 14 publications

References 18 publications

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

A Randomized Study Comparing Digital Imaging to Traditional Glass Slide Microscopy for Breast Biopsy and Cancer Diagnosis

Surgical implications and variability in the use of the flat epithelial atypia diagnosis on breast biopsy specimens

Localization of Diagnostically Relevant Regions of Interest in Whole Slide Images: a Comparative Study

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