Developing an FHIR-Based Computational Pipeline for Automatic Population of Case Report Forms for Colorectal Cancer Clinical Trials Using Electronic Health Records.

JCO Clinical Cancer Informatics
Nansu ZongGuoqian Jiang

Abstract

The Fast Healthcare Interoperability Resources (FHIR) is emerging as a next-generation standards framework developed by HL7 for exchanging electronic health care data. The modeling capability of FHIR in standardizing cancer data has been gaining increasing attention by the cancer research informatics community. However, few studies have been conducted to examine the capability of FHIR in electronic data capture (EDC) applications for effective cancer clinical trials. The objective of this study was to design, develop, and evaluate an FHIR-based method that enables the automation of the case report forms (CRFs) population for cancer clinical trials using real-world electronic health records (EHRs). We developed an FHIR-based computational pipeline of EDC with a case study for modeling colorectal cancer trials. We first leveraged an existing FHIR-based cancer profile to represent EHR data of patients with colorectal cancer, and then we used the FHIR Questionnaire and QuestionnaireResponse resources to represent the CRFs and their data population. To test the accuracy of and overall quality of the computational pipeline, we used synoptic reports of 287 Mayo Clinic patients with colorectal cancer from 2013 to 2019 with standard mea...Continue Reading

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Citations

Sep 2, 2020·JCO Clinical Cancer Informatics·Jeremy L Warner, Juli D Klemm
Nov 20, 2020·Contemporary Clinical Trials·Carmen RosaAimee N C Campbell
Apr 18, 2021·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·N RibellesA Garcia-Palomo
Jul 9, 2021·JAMA Oncology·Mitchell S von ItzsteinDavid E Gerber

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Software Mentioned

FHIRForm
HAPI
Research Electronic Data Capture
FHIR
SNOMED CT
OpenClinica
Epic Clarity
DeepPhe
MedKAT

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