The mCODE initiative, pioneered by ASCO, is reshaping cancer research by addressing the longstanding challenge of limited EHR interoperability. By assembling a concise yet comprehensive dataset, mCODE facilitates the exchange of research-quality cancer data, unlocking valuable insights from patient treatment journeys. Leveraging existing standards like FHIR, mCODE has achieved widespread adoption, with over 70 implementations, including major EHR vendors. The initiative’s impact extends beyond cancer research, optimizing data exchange in areas like radiation oncology. With a responsive closed-loop feedback system and ongoing refinement, mCODE is positioned as a transformative force, advancing not only oncology but also influencing the broader landscape of healthcare data exchange.
In the realm of cancer research, the Minimal Common Oncology Data Elements (mCODE) initiative, spearheaded by the American Society of Clinical Oncology (ASCO), is paving the way for a significant transformation. By assembling a comprehensive set of structured data elements, mCODE aims to overcome the historical challenges of restricted Electronic Health Record (EHR) interoperability. This initiative addresses the critical need to harness big data in cancer research and promises to revolutionize the way treatment data is accessed and analyzed across health systems.
Historical Challenges in Cancer Research:
Historically, the lack of EHR interoperability has been a major impediment to unlocking the full potential of cancer research. The majority of clinical trials, which form the backbone of cancer research, encompass only 6.3 percent of cancer patients nationwide. This limitation stems from the siloed nature of data across the healthcare continuum, hindering the ability of researchers to study vast amounts of treatment data.
Travis Osterman, a key figure in the initiative and Associate Vice President for Research Informatics at Vanderbilt University Medical Center, highlighted the difficulty in accessing data: “We’re not learning everything we can from the patients that are being treated, and if you ask my colleagues why, it’s because the data are hard to get to.”
mCODE Initiative’s Genesis and Goals:
To address these challenges, ASCO established the mCODE initiative in 2018, bringing together a diverse group of experts, including oncologists, informaticians, and researchers. The primary goal of mCODE is to facilitate the interoperability of research-quality cancer data, ensuring that valuable insights are gained from every patient’s treatment journey.
Osterman emphasized the unique approach of mCODE, aiming for a broad yet concise standard. Unlike many existing data standards that delve deep into specific areas, mCODE sought to create the smallest dataset that effectively describes a cancer patient’s journey. The initiative identified six high-level domains, including disease, genomics, outcome, treatment, patient, and assessment, each accompanied by a set of data elements.
Leveraging Existing Standards for Adoption:
Recognizing the importance of adoption, mCODE leveraged existing data standards, such as HL7 Fast Healthcare Interoperability Resources (FHIR). Osterman highlighted the pragmatic approach: “FHIR provides the abstraction, and then mCODE provides the data elements that get bundled together.” This collaborative effort aimed to avoid reinventing the wheel and streamline the integration of mCODE into existing systems.
mCODE Adoption and Success:
Since its introduction at the ASCO 2019 annual meeting, mCODE has witnessed significant adoption, with over 70 implementations, including major Electronic Health Record vendors like Epic. Osterman, who serves as the chair of the mCODE executive committee, expressed satisfaction with the widespread success of the project within a relatively short timeframe.
Key Use Cases and Impact:
mCODE’s impact extends beyond the realm of cancer research. One notable use case involves supporting the exchange of electronic consent forms and case report forms for clinical trials. By providing a standard language that abstracts above EHR systems, mCODE enables seamless communication across different EHR platforms, fostering collaboration between researchers and clinical trial sponsors.
The initiative has also played a pivotal role in optimizing data exchange in radiation oncology. Osterman noted challenges in interoperability for radiation oncology providers using systems from smaller EHR vendors. However, mCODE has significantly addressed this issue, with upwards of 90 percent of radiation oncology health record systems supporting mCODE natively. This accomplishment simplifies the exchange of data between different health record systems, fostering a more cohesive and interconnected healthcare landscape.
Closed-Loop Feedback Ecosystem:
A key contributor to mCODE’s success is its closed-loop feedback ecosystem. The CodeX initiative, an HL7 FHIR accelerator, operates as a member-driven platform supporting mCODE implementers. This collaborative approach allows implementers to provide feedback on gaps or challenges they encounter, fostering continuous improvement.
Ongoing Refinement and Specialized Implementation Guides:
As with any innovative project, ongoing refinement is crucial. Osterman highlighted the responsiveness of mCODE to feedback from implementers, citing an example where radiation oncologists sought more granularity in data elements. The mCODE executive committee, in collaboration with the technical review group and HL7, updated the standard to address these specific needs. This iterative process ensures that mCODE evolves to meet the dynamic requirements of diverse healthcare domains.
Expanding Horizons: CC Direct and Pediatric Malignancies:
mCODE’s reach extends to initiatives beyond the standard cancer research landscape. CC Direct, a White House initiative focused on pediatric malignancies, is implementing mCODE. Osterman emphasized the collaboration with governmental agencies to understand specific needs in the pediatric malignancy space. This collaborative approach exemplifies mCODE’s adaptability and its potential to extend its impact to diverse healthcare domains.
Overall, the mCODE initiative emerges as a transformative force, poised to redefine the landscape of cancer research and healthcare data exchange. Its success, evident in over 70 implementations within a five-year span, highlights its effectiveness in overcoming historical barriers. The collaborative closed-loop feedback ecosystem ensures continual refinement, adapting to the evolving needs of healthcare domains. As mCODE extends its reach to initiatives beyond standard cancer research, such as pediatric malignancies, its impact becomes increasingly far-reaching. By fostering interoperability, mCODE stands at the forefront of advancing cancer care and is set to influence broader healthcare practices, exemplifying a remarkable achievement in data standardization and collaborative innovation.
