Cancer Biomarkers: The Role of Structured Data Reporting

Simpson, Ross W.; Berman, Michael A.; Foulis, Philip; Divaris, Dimitrios X. G.; Birdsong, George G.; Mirza, Jaleh; Moldwin, Richard; Spencer, Samantha; Srigley, John R.; Fitzgibbons, Patrick L.

doi:10.5858/arpa.2014-0082-ra

Cited by 20 publications

(18 citation statements)

References 21 publications

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“…The importance and challenges of reporting cancer genetic testing was highlighted recently by the College of American Pathology, which proposed an XML-based electronic cancer checklist that could be implemented with a system similar to the one we described here. 6 However, the XML document that was developed would not necessarily be extensible to other third-party laboratories or clinical sites. One potential solution would be to use the interoperable Fast Healthcare Interoperability Resources (FHIR) standard from Health Level Seven International, which uses the SMART platform (SMART on FHIR Genomics).…”

Section: Discussionmentioning

confidence: 99%

“…This disconnect can create challenges in reporting important genetic information from the laboratory to the treating oncologist. 6 Oncologists at Vanderbilt University Medical Center (VUMC) have partnered with Foundation Medicine Incorporated (FMI, Cambridge, MA), a provider of tumor exome sequencing, to analyze patients' tumors for genetic variants that may inform clinical decision making. 7 This collaboration, like most with third-party laboratories, has relied on the use of faxed documents to report test results.…”

Section: Introductionmentioning

confidence: 99%

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Implementing and Improving Automated Electronic Tumor Molecular Profiling

Rioth

Staggs

Hackett

et al. 2016

JOP

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Oncology practice increasingly requires the use of molecular profiling of tumors to inform the use of targeted therapeutics. However, many oncologists use third-party laboratories to perform tumor genomic testing, and these laboratories may not have electronic interfaces with the provider's electronic medical record (EMR) system. The resultant reporting mechanisms, such as plain-paper faxing, can reduce report fidelity, slow down reporting procedures for a physician's practice, and make reports less accessible. Vanderbilt University Medical Center and its genomic laboratory testing partner have collaborated to create an automated electronic reporting system that incorporates genetic testing results directly into the clinical EMR. This system was iteratively tested, and causes of failure were discovered and addressed. Most errors were attributable to data entry or typographical errors that made reports unable to be linked to the correct patient in the EMR. By providing direct feedback to providers, we were able to significantly decrease the rate of transmission errors (from 6.29% to 3.84%; P , .001). The results and lessons of 1 year of using the system and transmitting 832 tumor genomic testing reports are reported.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Implementing and Improving Automated Electronic Tumor Molecular Profiling

Rioth

Staggs

Hackett

et al. 2016

JOP

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“…Searchable formats are recommended to facilitate audit of institutional or pathologist-specific prevalence. 131,[143][144][145][146][147] No Explanatory note.…”

Section: Reporting Of Predictive Pd-l1 Assaysmentioning

confidence: 99%

Fit-For-Purpose PD-L1 Biomarker Testing For Patient Selection in Immuno-Oncology: Guidelines For Clinical Laboratories From the Canadian Association of Pathologists-Association Canadienne Des Pathologistes (CAP-ACP)

Cheung

Barnes

Bigras

et al. 2019

Applied Immunohistochemistry &Amp; Molecular Morphology

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Since 2014, programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/ complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immunooncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.

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“…Anatomic pathology (AP) observations assess physical and morphologic alterations of tissue, and molecular pathology (MP) observations address subcellular changes in the genetic or protein structure of the cells. 21 , 22 Synoptic questions semantically conform to the “Observable” entity hierarchy of the SNOMED CT concept model, as well as to the intended semantics of LOINC. LOINC 23 is specified for representing laboratory test order questions, and SNOMED CT 24 is mandated for populating categorical answer value sets within Meaningful Use guidelines as issued by the Office of the National Coordinator.…”

Section: Introductionmentioning

confidence: 98%