Open Source System Debuts for EHR Data Sharing

Monica M. Bertagnolli, MD, FACS, FASCO

A consortium of cancer care institutions released details on a prototype system designed to link electronic health record (EHR) systems to provide a source of real-world patient information to guide research and improve cancer treatment.

Minimal Common Oncology Data Elements (mCODE) is an open source system allowing for the interflow of common clinical data amassed on patients within institutional EHR systems. mCODE collects data on 6 core domains: patient characteristics and demographics; lab tests and vital signs; specific details regarding the cancer; genomics such as molecular characteristics; treatments including surgical, radiation, drug and other treatments; and outcomes, such as current cancer status and survival. These elements of the patient journey are subdivided into 27 types of profiles and encompass 73 distinct data elements that can provide critical information for clinical inquiry.

The initial set of standards and specifications for mCODE was released at the 2019 American Society of Clinical Oncology Annual Meeting by a collaboration including ASCO, its nonprofit subsidiary CancerLinQ, the MITRE Corporation, and the Alliance for Clinical Trials in Oncology Foundation (The Alliance Foundation).

The lack of interoperability and inability to share information among EHR systems smoothly has long been a concern among oncologists and an impediment to large-scale research efforts that depend on agglomerations of data that, when mined, filtered, and analyzed, yield insights into drug performance and patient experiences under treatment.

As many as 15 million individuals in the United States are living with cancer and much of the information about them is stored in EHRs of one kind or another. These systems have their own standards for classifying data and priorities for what kinds of data should be collected. This adds to the incompatibility between EHR systems, interferes with care coordination, and adds to administrative work and the costs of healthcare.

Through its common elements structure, mCODE can bypass many of the communication barriers posed by multiple different EHR systems and protocols used by the healthcare community.

This is partly accomplished by incorporation of Fast Healthcare Interoperability Resources (FHIR), a draft standard that establishes formats for data reporting and applies coding that facilitates the exchange of EHR information across systems. Investigators said when using mCODE, clinicians would be able to plug common clinical terms into a search engine and draw the data they need from institutional EHRs hooked into the system.

In fact, one of the core principles that will drive the success of mCODE is its adherence to standard, widely available medical terminologies, investigators said. Additionally, the system will be available free of charge. It is available for download at mCODEinitiative.org.

Investigators also said mCODE will be capable of capturing increasingly complex genomic data that is produced by new discoveries in molecular diagnostics and treatment.

"Progress and quality care for patients with cancer can hinge on our ability to seamlessly share patient data among doctors, hospitals, and researchers. But data sharing is much more difficult, if not impossible, when EHR systems contain incompatible information," said ASCO President Monica M. Bertagnolli, MD, FACS, FASCO. "With mCODE, we're bringing the oncology community together around common data standards that will bring us one step closer to our goal of learning from every patient with cancer."

The Alliance Foundation is initiating a research effort that will integrate patient data collected via EHRs with clinical trial information broadening the amount of information on treatment and patient population available for drawing conclusions about efficacy and treatment strategies.

"This work will validate the use of mCODE as a tool for clinical research and will also establish a platform for conducting research that includes many patients not currently represented in conventional prospective clinical trials," said Steven Piantadosi, MD, PhD, scientific director of the Alliance Foundation ICAREdata Project.

Jay J. Schnitzer, MD, PhD, noted that the huge base of information mCODE will make available will contribute enormously to advances in oncology. "Publishing mCODE is an important step towards realizing incredible insights into treatment that the 97% of cancer patients not participating in clinical trials could generate,” said Schnitzer, who serves as MITRE's chief technology officer. "Through wide adoption and integration of cancer data standards, and the application of technologies like FHIR, shared treatment experiences could be turned into information that patients and clinicians can use to better navigate care options."

mCODE is currently being piloted at Partner's Healthcare in Boston and Intermountain Healthcare headquartered in Salt Lake City, among other cancer centers across the country. The results of these pilots will be used to improve the functioning of mCODE.

Bertagnolli MM. mCODE: Minimal Common Oncology Data Elements. Presented at: The American Society of Clinical Oncology Annual Meeting; June 1-4, 2019; Chicago, IL.

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