Objective.-To characterize Pap test result interpretive bias when the HPV status is known at the microscopic evaluation.Design.-Forty HPV-positive liquid-based Pap test results initially interpreted as negative for squamous intraepithelial lesion or malignancy were selected from a quality assurance program, separated into 2 groups of 20 slides each, and circulated in 2 groups to 22 members of the College of American Pathologists Cytopathology Committee. Each member reviewed each case and indicated whether the result was negative for squamous intraepithelial lesion or malignancy or was an epithelial cell abnormality (ECA). The participants assessed the severity of ECAs using the Bethesda System. The participants were not informed of the HPV status in the initial review round. Each group of 20 slides was then distributed to the opposite group (to avoid slide recall), and the participants were informed that all slides were from patients who were high-risk HPV positive. Differences in the responses between groups were analyzed by v 2 test and Cochran-Mantel-Haenszel test at the .05 significance level.Results.-Without knowledge of the HPV status, slides were more often categorized as negative for squamous intraepithelial lesion or malignancy and less likely identified as an ECA (P , .001). There was an increase across all categories of ECAs in the biased responses compared with the unbiased responses (P ¼ .002).Conclusions.-Knowledge of positive HPV status biases morphologic Pap test result interpretation. If the HPV status is positive, observers are more likely to report a Pap test result as abnormal across all categories of ECAs.
In February 2017, the Morgan Welch Inflammatory Breast Cancer (IBC) Research Program and Clinic hosted a scientific conference in Houston to commemorate the tenth anniversary of the opening of the first IBC-dedicated clinic in the world. Attendees included basic science researchers, clinicians who treat IBC, as well as patients and their caregivers. Several US-based and international IBC-focused nonprofit organizations were also represented. In this third paper from the conference, we report on the breakout session regarding survivorship and advocacy issues related to IBC, sharing an overview of the educational content presented and discussions regarding the future of IBC advocacy. Panelists focused on lymphedema research and clinical solutions, integrative medicine, and social work, with time provided for questions in small groups. IBC nonprofits that are leading advocacy efforts were introduced, and ways to become involved in these initiatives were discussed. Priorities for future advocacy and clinical care needs were also highlighted. In addition to summarizing these topics, we provide a suggested integrated IBC-specific plan of care that could be provided to the patient at the beginning of care and referred to throughout treatment and follow-up.
Background:Pigmented lesion analysis remains a challenging aspect of dermatology. The DermTech Melanoma Test ('the test') is a non-invasive gene-expression test designed to rule-out melanoma. It consists of the pigmented lesion assay, which detects RNA products of Long Intergenic Non-Coding RNA 00518 (LINC00518) and Preferentially Expressed Antigen in Melanoma (PRAME), and an add-on assay for DNA promoter mutations in telomerase reverse transcriptase (TERT). In previous studies, the test was found to have a negative predictive value ≥99%. This registry study examines the real-world correlation of genomically atypical (test-positive) lesions with histopathologic diagnoses. Methods:Between April 2021 and March 2022, multiple geographically diverse sites throughout the US submitted data to a registry to assess real-world use of the test. Approximately 8,000 clinically atypical lesions were tested. After receiving the test result, providers followed their clinical judgement for biopsy decision. Histopathologic diagnoses for biopsied lesions were correlated with test results.Results: Among the approximately 8000 tests performed,1033 (12.9%) were positive. Thirty-six did not have histopathologic diagnoses or confirmed test results available. Of the 997 complete cases, 134 (13.4%) were diagnosed as melanoma; 89 (66.4%) were in situ and 45 (33.6%) were invasive. Only 7 (5.2%) melanomas were beyond stage T1a. In addition, 73 (7.3%) positive lesions exhibited severe cytologic atypia or atypical junctional melanocytic hyperplasia histopathologically. Conclusions:Over 20% of lesions that tested positive were severely dysplastic, melanoma in situ, or invasive melanoma by histopathology. Nearly 87% of clinically atypical lesions tested negative. Almost all lesions diagnosed as melanoma were in situ or pT1a. This study demonstrates that the test guides appropriate biopsy decisions in real-world settings.
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