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Background

According to the National Cancer Institute, 38.5 percent of men and women will be diagnosed with cancer at some point during their lifetimes. In 2014, an estimated 14.7M people were living with cancer in the United States. While these numbers are staggering, the silver lining in the wide prevalence of cancer is the potential to learn from treatment of millions of patients. If we had research-quality data from all cancer patients, it would enable higher quality health outcomes. Today, we lack the data models, technologies, and methods to capture that data.

mCODE™ (short for Minimal Common Oncology Data Elements) is an initiative intended to assemble a core set of structured data elements for oncology electronic health records (EHRs). mCODE is a step towards capturing research-quality data from the treatment of all cancer patients. This would enable the treatment of every cancer patient to contribute to comparative effectiveness analysis (CEA) of cancer treatments by allowing for easier methods of data exchange between health systems. mCODE has been created and is being supported by the American Society of Clinical Oncology (ASCO®)in collaboration with the MITRE Corporation.

In late 2018, ASCO convened committee of twenty leading clinical experts in oncology, radiology, surgery, and public health developed two use cases that drove the initial clinical data requirements for mCODE:

While mCODE ultimately is meant to be applicable across all types of cancer, the initial focus (and both use cases) has been on solid tumors.

After initial development, in early 2019, an open survey was conducted to validate and prioritize the data elements from these use cases. Further down-scoping was done based on whether the data would be stored or capture in an electronic health record (EHR), and if it would place undue documentation burden on clinicians.

Currently, there are two defined mCODE roles involving the exchange of mCODE data. However, this may change in the future. The first role is the “mCODE Data Sender”. This participant provides mCODE data in response to a data query or autonomously pushes mCODE data to an mCODE receiver. The data sender does not have to be the originator of the data it possesses. The second mCODE data exchange role is the “mCODE Data Receiver”. This participant accepts mCODE data from an mCODE Data Sender.

There are multiple actors recognized in the IG including:

  • Provider - the oncologist, or their representatives, who works to treat cancer patients.
  • Patient - the patient who is suspected to have, or is diagnosed with, cancer.
  • Application - EHR systems or lab systems.