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. 2015 Mar 17;313(11):1122-32.
doi: 10.1001/jama.2015.1405.

Diagnostic concordance among pathologists interpreting breast biopsy specimens

Joann G Elmore  1 , Gary M Longton  2 , Patricia A Carney  3 , Berta M Geller  4 , Tracy Onega  5 , Anna N A Tosteson  6 , Heidi D Nelson  7 , Margaret S Pepe  2 , Kimberly H Allison  8 , Stuart J Schnitt  9 , Frances P O'Malley  10 , Donald L Weaver  11
Affiliations

Diagnostic concordance among pathologists interpreting breast biopsy specimens

Joann G Elmore et al. JAMA. .

Abstract

Importance: A breast pathology diagnosis provides the basis for clinical treatment and management decisions; however, its accuracy is inadequately understood.

Objectives: To quantify the magnitude of diagnostic disagreement among pathologists compared with a consensus panel reference diagnosis and to evaluate associated patient and pathologist characteristics.

Design, setting, and participants: Study of pathologists who interpret breast biopsies in clinical practices in 8 US states.

Exposures: Participants independently interpreted slides between November 2011 and May 2014 from test sets of 60 breast biopsies (240 total cases, 1 slide per case), including 23 cases of invasive breast cancer, 73 ductal carcinoma in situ (DCIS), 72 with atypical hyperplasia (atypia), and 72 benign cases without atypia. Participants were blinded to the interpretations of other study pathologists and consensus panel members. Among the 3 consensus panel members, unanimous agreement of their independent diagnoses was 75%, and concordance with the consensus-derived reference diagnoses was 90.3%.

Main outcomes and measures: The proportions of diagnoses overinterpreted and underinterpreted relative to the consensus-derived reference diagnoses were assessed.

Results: Sixty-five percent of invited, responding pathologists were eligible and consented to participate. Of these, 91% (N = 115) completed the study, providing 6900 individual case diagnoses. Compared with the consensus-derived reference diagnosis, the overall concordance rate of diagnostic interpretations of participating pathologists was 75.3% (95% CI, 73.4%-77.0%; 5194 of 6900 interpretations). Among invasive carcinoma cases (663 interpretations), 96% (95% CI, 94%-97%) were concordant, and 4% (95% CI, 3%-6%) were underinterpreted; among DCIS cases (2097 interpretations), 84% (95% CI, 82%-86%) were concordant, 3% (95% CI, 2%-4%) were overinterpreted, and 13% (95% CI, 12%-15%) were underinterpreted; among atypia cases (2070 interpretations), 48% (95% CI, 44%-52%) were concordant, 17% (95% CI, 15%-21%) were overinterpreted, and 35% (95% CI, 31%-39%) were underinterpreted; and among benign cases without atypia (2070 interpretations), 87% (95% CI, 85%-89%) were concordant and 13% (95% CI, 11%-15%) were overinterpreted. Disagreement with the reference diagnosis was statistically significantly higher among biopsies from women with higher (n = 122) vs lower (n = 118) breast density on prior mammograms (overall concordance rate, 73% [95% CI, 71%-75%] for higher vs 77% [95% CI, 75%-80%] for lower, P < .001), and among pathologists who interpreted lower weekly case volumes (P < .001) or worked in smaller practices (P = .034) or nonacademic settings (P = .007).

Conclusions and relevance: In this study of pathologists, in which diagnostic interpretation was based on a single breast biopsy slide, overall agreement between the individual pathologists' interpretations and the expert consensus-derived reference diagnoses was 75.3%, with the highest level of concordance for invasive carcinoma and lower levels of concordance for DCIS and atypia. Further research is needed to understand the relationship of these findings with patient management.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Elmore reports serving as a medical editor for the nonprofit Informed Medical Decisions Foundation. Dr Allison reports personal fees from Genentech. No other authors had potential conflicts of interest to report.

Figures

Figure 1
Figure 1
Comparison of the 3 Reference Panel Members’ Independent Preconsensus Diagnoses vs the Consensus-Derived Reference Diagnosis for 240 Breast Biopsy Casesa
Figure 2
Figure 2
Pathologist Recruitment and Randomization into Test Sets
Figure 3
Figure 3
Comparison of 115 Participating Pathologists’ Interpretations vs the Consensus-Derived Reference Diagnosis for 6900 Total Case Interpretationsa
Figure 4
Figure 4
Participating Pathologists’ Interpretations of Each of the 240 Breast Biopsy Test Cases
Figure 5
Figure 5
Slide Example for Each Diagnostic Category
See this image and copyright information in PMC

Comment in

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