Clinical impact and frequency of anatomic pathology errors in cancer diagnoses

Abstract

BACKGROUND.To the authors' knowledge, the frequency and clinical impact of errors in the anatomic pathology diagnosis of cancer have been poorly characterized to date. METHODS.The authors examined errors in patients who underwent anatomic pathology tests to determine the presence or absence of cancer or precancerous lesions in four hospitals. They analyzed 1 year of retrospective errors detected through a standardized cytologic-histologic correlation process (in which patient same-site cytologic and histologic specimens were compared). Medical record reviews were performed to determine patient outcomes. The authors also measured the institutional frequency, cause (i.e., pathologist interpretation or sampling), and clinical impact of diagnostic cancer errors. RESULTS.The frequency of errors in cancer diagnosis was found to be dependent on the institution (P Ͻ 0.001) and ranged from 1.79 -9.42% and from 4.87-11.8% of all correlated gynecologic and nongynecologic cases, respectively. A statistically significant association was found between institution and error cause (P Ͻ 0.001); the cause of errors resulting from pathologic misinterpretation ranged from 5.0 -50.7% (the remainder were due to clinical sampling). A statistically significant association was found between institution and assignment of the clinical impact of error (P Ͻ 0.001); the aggregated data demonstrated that for gynecologic and nongynecologic errors, 45% and 39%, respectively, were associated with harm. The pairwise kappa statistic for interobserver agreement on cause of error ranged from 0.118 -0.737. CONCLUSIONS. Errors in cancer diagnosis

Verification and classification bias interactions in diagnostic test accuracy studies for fine‐needle aspiration biopsy

“…7 Major disagreement rates show wide variability, ranging from 0.3% to 10%, depending on many factors such as the tissue type, the type of referral (physician requested or routine transfer), and the institution. [8][9][10][11][12][13][14][15][16][17] We are not aware of any studies that have explored the interactions between these 2 types of bias in FNAB DTA studies. In addition and importantly, verification bias and classification bias may interact in unpredictable ways so that it is difficult to estimate the total bias based on the estimated bias due to each component.…”

Intersection of biobanking and clinical care: should discrepant diagnoses and pathological findings be returned to research participants?

“…6 Another study has shown that the frequency of errors in cancer diagnosis are institution-dependent and may occur in up to 11.8% of all cytologic-histologic specimen pairs. 7 In addition to diagnostic discrepancies, standard pathological review at the biobank may also yield incidental findings previously unobserved at the collection site. In the context of biobanking, a "pathological incidental finding" is considered to be any clinically relevant information about a biospecimen discovered during review by the biobank that was not noted at the biospecimen collection site.…”

Original research in pathology: judgment, or evidence-based medicine?

“…Recent examples abound, 34,[46][47][48][49][50][51][52][53][54][55][56] regardless of whether the operative terms are 'interobserver variation' or outright 'error'. [57][58][59] We thus encounter a fundamental challenge in the use of morphological data in EBM.…”