Welcome to the CodeX May newsletter! CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications. Check out some of our exciting updates below.
Reminder: Dig into genomics data challenges in the May Community of Practice call this Friday. Register for the May 28, 12-1 ET call.
Recent CodeX Use Case Achievements
CodeX initiatives aim to collect patient data once and then use it for multiple reasons, employing mCODE standards, which are expected to have a growing impact in collecting and sharing cancer data. The standard can create efficiencies in routine data sharing, such as that required by prior authorization, enabling patients to access their information, or sharing data to multiple registries for research or enabling connections to clinical trials.
Recent updates on the progress across the eight CodeX active use case follow. Four are in the Execution Phase – mCODE++ Extraction, ICAREdata, Trial Matching, Registry Reporting. Radiation Therapy is in the Planning Phase, with Members preparing for Execution. Oncology Clinical Pathways, Prior Authorization, and Genomics Data Sharing are in Discovery.
ICAREdata or EHR Endpoints for Clinical Trials is making great progress. Nine health systems are implementing tools to capture and/or extract mCODE data in their electronic health record systems, with collection underway at three institutions.
Thanks to strong partnership with health systems and Epic, implementation of the ICAREdata collection and extraction tools continues to become simpler over time. The University of Chicago (UChicago) and MITRE teams are close to completing validation of queries to generate comma-separated values (CSV) files to support mCODE extraction. In collaboration with Epic, these queries will be made available to other Epic sites in the community to accelerate implementation. Furthermore, the form to capture mCODE Cancer Disease Status is available as Epic-released development to all Epic customers as of the November 2020 release. Data modeling work is underway for a new ICAREdata pilot for mCODE-enabled adverse event reporting.
With the Trial Matching use case, efforts have reached the point where real patient data is being used, and about half a dozen patients have been onboarded. Trial match results are being returned in a FHIR bundle. Further analysis will show whether initial data elements being collected and shared via the standard are sufficient to narrow down the trials that patients may qualify for.
Last week, members of the Trial Matching team—Cancer Insights, MITRE, and PatientLink—participated in the HL7 Connectathon, demonstrating the ability of patient data elements to be sent to mCODE-enabled matching services trials through a patient data management application. Please see the “Connectathon” section for links to the materials presented and learn how to engage in the use case.
Trial Matching use case champion American Cancer Society Cancer Action Network recently published a press release detailing the important work underway and partners involved to improve technology and use of data standards to integrate matching capability into existing medical record systems and patient data management applications to reach more patients and care providers.
The use case for cancer Registry Reporting also is achieving progress, with support from the Centers for Disease Control and Prevention (CDC) and Center for International Blood and Marrow Transplant Research (CIBMTR) and additional organizations working on identifying data elements required for reporting information to cancer registries. Team members are continuing pilot planning for a proof of concept with the University of California San Francisco and the California Cancer Registry leveraging the CDC’s MedMorph Reference Architecture. The registry reporting team has also been meeting with the College of American Pathologists (CAP), exploring ways that mCODE can be bundled with pathology data elements to provide a more robust patient summary to state registries.
The Radiation Therapy use case team expects to move into the Execution stage after the CodeX Steering Committee meeting on June 2nd, with champions American Society for Radiation Oncology (ASTRO) and the American Association of Physicists in Medicine (AAPM) playing a lead role in solidifying terminology and architecture. Along with ASTRO and AAPM, CodeX Members Canadian Organization of Medical Physicists (COMP), MITRE, Society for Imaging Informatics in Medicine (SIIM), Varian, and Wemedoo are collaborating with others to develop, test and deploy open data standards that enable interoperable, multi-purpose exchange of radiation therapy treatment summary data for care coordination and data reuse. This team contributed to the definition of new radiation therapy concepts in mCODE and were submitted as part of mCODE STU 2.
The Prior Authorization in Oncology team is hosting a multi-stakeholder discovery session on June 3, 1-2:30 ET to learn more about current state problems being faced in provider-payer data exchange and where FHIR standardization can add the most value within the oncology ecosystem. CodeX Members United Healthcare/Optum, MITRE, Mettle Solutions, and Pfizer will be joined by CodeX program management support organization Point-of-Care Partners and interested community members representing payers, health systems, electronic health record system vendors, clinical pathway vendors, government agencies and patient advocacy organizations. Click on the following link to register: http://bit.ly/CodeXListeningSession
HL7 FHIR CONNECTATHON Synopsis
From May 17th to 19th, CodeX Members and program management staff participated in the Virtual HL7 FHIR CONNECTATHON to demonstrate prototypes, test backend application development progress, and take in feedback from the larger HL7 community.
The Trial Matching team led a track at the Connectathon with two scenarios. The first scenario could be completed by any FHIR developer and showed how patients using an mCODE record could request and receive potential clinical trial matches. The second scenario detailed how a clinical trial matching service could mCODE-enable their matching service by creating a matching service wrapper. The team also put together two demos, showing how a patient can send data to clinical trial matching services and view the results, all through a patient data manager application. Full track details can be found here.
The Cancer Registry Reporting team attended the two-day MedMorph Track of the May Connectathon, testing and evaluating the MedMorph reference architecture that underpins the registry reporting use case. The MITRE team developed a Backend Services App which was successfully tested on Day 2 and operates as the core component of the MedMorph reference architecture, submitting data from a test EHR to a test state registry. Full MedMorph track details can be found here.
On behalf of the Prior Authorization in Oncology team, CodeX Members Mettle Solutions and MITRE demonstrated a colorectal cancer and breast cancer chemotherapy regimen prior authorization workflow that leverages existing standards in the oncology context as part of Da Vinci Project Burden Reduction Track. The workflow outlines a way for payers and providers to efficiently communicate and exchange information—bundling multiple services—to execute prior authorizations in oncology. More information can be found on the Connectathon Confluence site: breast cancer chemotherapy example and colorectal cancer example.
mCODE Community of Practice Recap
The April Community of Practice presentation (slides and recordings part 1, part 2, part 3) focused on the realities of clinical trials data—how crucial it is to ensure data quality—with multiple manual steps required to verify the accuracy of information and then gather it so it can be disseminated.
But mCODE offers the potential to facilitate data collection and exchange, said Vivek Upadhyay, a fellow in hematology and oncology at Dana-Farber Cancer Institute and a joint fellow in Clinical Informatics at Mass General Brigham. He described current efforts at his organization to implement mCODE data collection tools developed through and supported by the ICAREdata use case.
The value of automating the clinical trial data process became painfully obvious during the COVID-19 pandemic, because remote monitoring of patients added extra expense and work to the process of verifying clinical trial information. Data verification, typically called monitoring “is very expensive — it accounts for one third of all costs in clinical trials. For example, a 100-patient Phase 2 clinical trial may cost a total of $20 million to conduct, but $7 million to $8 million of that cost likely would be directed to monitoring,” he said.
The pandemic sparked interest in electronic initiatives, such as eSource and a FHIR-based approach, which is expected to achieve more efficiency. “FHIR allows more efficiency,” Upadhyay said. In particular, FHIR offers more potential in effectively gathering and sharing unstructured data, such as in the information contained in SOAP notes. “That’s where mCODE-based solutions offer a profound solution — it enables the information that is unstructured to be formatted in a way that is structured.”
At Mass General Brigham, two tests of mCODE are underway to measure the results of treatment. One of the tests involves patients with solid tumors and measuring the effects of high doses of vitamin D in conjunction with standard chemotherapy, while the other is studying the effect of genomics-guided treatments for patients with brain metastasis.
The effort to gather clinical data on these patients is challenging because it involves multiple patients being treated at several institutions; however, because it involved organizations all using the same instance of the Epic records system, patient data could be collected more easily by using a SmartForm within the Epic record.
Much work lies ahead, but automated, standardized data collection in these trials could greatly reduce the manpower needed now in data-gathering, particularly for initiatives that feed data into cancer registries, he said.
HL7 ballot comments (based on CodeX experience and other stakeholder input) for mCODE STU2 closed May 17th. Follow progress on mCODE by reviewing the continuous integration (CI) build. Also, review differences between STU1 and STU2 via this change log.
Look for the 2.0 release in September.
- Join the May CodeX/mCODE Community of Practice call this Friday with Dr. James Chen of Ohio State University, who will be discussing challenges to standardizing and structuring genomics data, how mCODE is working to improve these challenges, and an early introduction to the CodeX genomics work group . Register for the May 28, 12-1 ET call. Participation is open to all.
- AHIP will have its Institute and Expo virtually, June 22 to 24. Hear from Steve Bratt, CodeX Program Manager, June 23, 12:30 p.m. - 1:15 p.m. EST, in a panel titled Creating Scalable Data Solutions with Multistakeholder Collaboratives along with a HL7 FHIR Accelerator colleagues, Lenel James (Blue Cross Blue Shield Association), Jocelyn Keegan (Point-of-Care Partners) and Patrick Murta (Humana).
- More information, including registration links, can be found at https://www.ahip.org/events/institute-expo-online/#d=all. Steve Bratt, CodeX Program Manager, will participate in a panel titled Creating Scalable Data Solutions with Multi-stakeholder Collaboratives.
- American Cancer Society Cancer Action Network. (2021. May 18). ACS CAN and CodeX Lead Project to Expand Cancer Clinical Trial Enrollment Through Improved Technology [Press release]
- Informonster Podcast Steve Bratt, CodeX Program Manager, and Carmela Couderc, Clinical Informaticist at MITRE, to discus mCODE and CodeX and accelerating healthcare innovation. Part One. Part Two.
- Structured Data Capture for Oncology; Alexander K. Goel, Walter Scott Campbell, and Richard Moldwin; JCO Clinical Cancer Informatics 2021 :5, 194-201
- HL7 News February 2021 Edition - CodeX Community Accelerates Smarter Data for the Fight Against Cancer (p.16)
- HL7 News October 2020 Edition - CodeX Community Stress-Tests the Value of a Common Language for Cancer Data
- "The Dish on Health IT" Podcast - Episode 11: HL7 CodeX: Transforming Cancer Care and Research