Measures of Completeness and Accuracy of Clinical Information in Skin Biopsy Requisition Forms

Romano, Ryan C.; Novotny, Paul J.; Sloan, Jeff A.; Comfere, Nneka I.

doi:10.1093/ajcp/aqw186

Cited by 13 publications

(16 citation statements)

References 20 publications

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“…Real-world limitations for testing between community prescribers and diagnostic service providers have been documented. Romano et al showed that clinical impression/diagnosis was absent from nearly a quarter of biopsy requisition forms (n=249) 31. The lack of information from the requesting physician afforded to the biomarker testing facility in the current study reflects a similar trend.…”

Section: Discussionmentioning

confidence: 49%

“…Test requesters should be encouraged to complete IHC requisition forms with additional patient and disease information. This will allow the pathologist testing the sample to provide a more accurate assessment that will determine treatment strategy 31. Consistent with real-world data and reference lab testing/processing practices, limitations in the available data set preclude us from confirming whether concordance analyses were performed on serial samples from singular blocks.…”

Section: Discussionmentioning

confidence: 94%

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A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies

et al. 2018

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AimsAt the time of analysis, two widely used, drug-specific, tumour-cell programmed death ligand 1 (PD-L1) assays were approved by the US Food and Drug Administration for anti-PD-1 therapies: the Dako PD-L1 immunohistochemistry (IHC) 28-8 pharmDx assay and the Dako PD-L1 IHC 22C3 pharmDx assay. Given that the majority of current PD-L1 testing in US clinical practice is performed at commercial reference laboratories, we aimed to evaluate the concordance of the 28-8 and 22C3 assays in a real-world setting.MethodsMatched PD-L1 IHC 28-8 and 22C3 results from routine assessment were obtained from 1930 patients, including 412 confirmed to have lung cancer, submitted from hospitals in over 38 US states/territories. Biopsies were stained, reviewed and scored by trained/certified pathologists at a single cancer reference laboratory between 2015 and 2017. Rate of concordance between assay findings was assessed by Bland-Altman analysis; overall per cent agreement (OPA), positive per cent agreement and negative per cent agreement; and Cohen’s kappa.ResultsPD-L1 IHC 28-8 and 22C3 displayed strong correlation across all samples and in samples with a confirmed lung cancer diagnosis irrespective of biopsy site. The OPA was 97%–98% for all samples, depending on the expression level defining PD-L1 positivity. In the Bland-Altman analysis, the mean difference in percentage of tumour cells positively stained for PD-L1 between the paired assay findings was –0.80% for all samples and –0.93% in samples with a confirmed lung cancer diagnosis.ConclusionsThese data, in conjunction with recent findings, support the analytical concordance of the PD-L1 IHC 28-8 and 22C3 assays for assessing per cent tumour-cell membrane PD-L1 expression.

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Section: Discussionmentioning

confidence: 49%

Section: Discussionmentioning

confidence: 94%

A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies

et al. 2018

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“…8,9 Insufficient clinical information on the skin biopsy requisition form is a common finding and is considered an important challenge for accurate histopathological diagnosis. 10-13 Nevertheless, the clinicopathological concordance of biopsies referred by dermatologists is probably better than those referred by physicians in other medical disciplines. 7,14,15…”

Section: Introductionmentioning

confidence: 99%

Clinicopathological concordance in the diagnosis of skin diseases: a retrospective analysis of 5000 histopathology reports

et al. 2019

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BACKGROUND: The accuracy of clinical diagnoses of skin diseases has not been researched in Saudi Arabia.OBJECTIVES: Assess concordance between the histopathological and clinical diagnosis in skin diseases.DESIGN: Retrospective.SETTING: Academic tertiary care center.METHODS: Demographic, clinical and pathological data were collected from the medical record for the period 1997-2013.MAIN OUTCOME MEASURES: Concordance between the pathological and clinical diagnosis.SAMPLE SIZE: 4268 cases.RESULTS: Of 4268 biopsies, 2440 (58.1%) were females. The mean age (SD) of patients was 36.9 (17.8) years. The three most common locations from which skin biopsies were retrieved in descending order were the lower extremity (1123; 29.1%), head, neck, scalp and hair (1033; 26.7%) and trunk (853; 22.1%). Overall concordance was 75.9% (partial concordance 47.6%, full concordance 28.3%). Biopsies from the oral mucosa and lips had the lowest concordance (overall 58.5%, full 26.4%) at P=.004. Overall concordance was highest for the following three diagnoses: malignant neoplasms, 88%; vesiculobullous diseases 87%; urticarias, erythemas, and purpuras 87%.CONCLUSION: There is considerable variability in concordance among different histopathological diagnoses. The full concordance between the clinical diagnosis and the pathological diagnosis is low. This is a reflection of the fact that the biopsies were obtained only in cases where the clinical diagnosis was a dilemma.LIMITATIONS: Single center, retrospective, incomplete medical records, low percentage of biopsies were assessed by dermatopathologists.CONFLICT OF INTEREST: None.

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“…The next generation of CPOE needs to address the design, workflow integration, and usability of customized user interfaces that can efficiently search for, retrieve, and present clinical data that are necessary for pathologic interpretation to the pathologist at the point of care. [ 7 ] Troude et al . showed that standardization and computerization of radiology requisitions resulted in a significant drop in missing data, leading to improved quality of information reported on radiology requisitions.…”

Section: Discussionmentioning

confidence: 99%

“…When these elements are absent or difficult to find within the RF or EVN, this may lead to diagnostic delays, unnecessary pathology stains and studies, or surgical procedures with potentially adverse impact on the quality of dermatologic care. [ 7 ] Ultimately, provision of the necessary clinical elements and clear communication between the clinician and dermatopathologist is vital to quality and safety of patient care. [ 8 ] The objective of this study was to determine the rates of provision of critical clinical elements in the RF and EVN in a tertiary dermatology practice.…”

Section: Introductionmentioning

confidence: 99%

Rates of provision of clinical information in the skin biopsy requisition form and corresponding encounter visit note

Olson

Lohse

Comfere

2016

Journal of Pathology Informatics

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Background:The skin biopsy requisition form (RF) serves as a key communication tool for transfer of relevant information related to skin biopsy between clinicians and pathologists. Clinical information in the skin biopsy RF is frequently missing or incomplete.Objective:To determine the rates of provision of critical clinical information necessary for histopathologic interpretation in the skin biopsy RF and encounter visit note (EVN).Methods:A retrospective review of 300 RFs and corresponding EVNs from May 1 to 7, 2012, in a tertiary care dermatology practice.Results:Age (100%), lesion location (100%), and clinical impression (93%) were the most commonly supplied elements in the RF and EVN. Clinical elements that were commonly not provided in the RF but present in the EVN included sampling method – partial versus complete (46%), duration of lesion (54%), morphology of lesion (97%), clinical symptoms (63%), clinical photos (63%), previous clinical (97%), and dermatopathologic diagnoses (82%).Limitations:Retrospective study design.Conclusions:These data suggest that while missing critical clinical information in the RF is often present in the EVN, some information is still not present in either source.

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Measures of Completeness and Accuracy of Clinical Information in Skin Biopsy Requisition Forms

Abstract: In inflammatory dermatoses, providing high-quality clinical information on the RF promotes optimal histopathologic diagnostic performance and appropriate pathology service utilization.

Cited by 13 publications

References 20 publications

A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies

A real-world, comparative study of FDA-approved diagnostic assays PD-L1 IHC 28-8 and 22C3 in lung cancer and other malignancies

Clinicopathological concordance in the diagnosis of skin diseases: a retrospective analysis of 5000 histopathology reports

Rates of provision of clinical information in the skin biopsy requisition form and corresponding encounter visit note

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