leaps, bounds, and fhir accelerators · hl7® fhir® accelerator is a trademark owned by hl7...
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mCODE™ is a trademark of the American Society of Clinical OncologyHL7® FHIR® Accelerator is a trademark owned by HL7 International.
Approved for Public Release; Distribution Unlimited. Case Number #19-03297-11
Greg ShemancikDeputy Lead, CodeX FHIR Accelerator
Senior Healthcare Analyst, MITRE
Leaps, Bounds, and FHIR AcceleratorsHow CodeX is Empowering the Future of Cancer Data Interoperability
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EHR data challenges:• Significant variation• Unstructured data• High Burden
Most of the nearly15 million individuals living
with cancer in the U.S. have
Electronic Health Records (EHRs)
Only 3% of adult cancer patients participate in clinical trials that gather high-quality data
45% increase in cancer drugs in development over
the past ten years with87% as targeted therapies
By the numbers
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mCode Divider slide
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Minimal set of critical data elements
Standardized for collection and sharing
Recommended by top oncologists
Supports multiple cancer use cases
Improves cancer care and research
A standard health record for oncology
mCODE , or Minimal Common Oncology Data Elements, is a data standard that can be widely adopted. It holds promise to greatly increase high-quality data for all cancer types.
mCode background
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Initial Collaborators
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1st Cancer Data Summit October 2-3, 2019 McLean, VA
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mCode v1.0
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CodeX
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FHIR establishes the high-level syntax and interfaces for exchange
Argonaut / US Core / USCDI standardize foundational patient data
Da Vinci and Carin formalize targeted exchange frameworks
Discipline focused modeling provide the detail needed for semantic interoperability
The Path to Meaningful Interoperability
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Prioritize use cases around interest and impact
Create new data models and FHIR IGs, augment mCODE
Build Reference Implementations
Execute pilots to demonstrate feasibility and value
Develop open standards and open source
A community and platform to accelerate interoperable data modeling and implementation around mCODE, leading to step-change improvements in cancer careand research
HL7 FHIR Accelerator
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Registry Reporting
Payment Models
Patient Data Management
Evidence-Based Care
Real World Data Trials
Basic mCODE Extraction
New Use Cases Domains of Interest
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Ask questions and learn from the experience of other community
members
Develop and share best practices for clinical workflows, data
modeling, and exchange
Latest developments on mCODE, CodeX, and cancer data exchange
A group of health systems and supporting organizations, working together within the CodeX HL7 FHIR Accelerator.
Goal: Develop and share best practices for implementing mCODE and extensions into production EHRs and other systems.
Community of Practice
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Use Cases Targeted to Improve Cancer Care and Research
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Drug Value Based Agreements8
EHR Endpoints for Clinical Trials1
Empowering Patients to Find Clinical Trials2
Registry Reporting3
Oncology Clinical Pathways Navigation4
Radiation Therapy Data for Care Coordination5
Clinical Cancer Data Exchange (Providers/Payers)6
Alternative Payment Model Data Reporting7
New Use-Case-Based Projects in DiscoveryAround Which to Grow the Community Further and Faster
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Empowering Patients to Find Clinical Trials
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mCODE++: leveraging mCODE with possible extensions
Existing and Future Patient – Clinical Trial
Matching Services
Patient Information
Eligibility CriteriamCODE++
Note: This use case focuses on the patient looking for clinical trials. Healthcare providers looking for trials on behalf of their patients and/or investigators trying to enroll patients in a trial will be addressed in separate use cases.
Patients want to identify clinical trials for which they are eligible.
Investigators want patients to enroll in clinical trials.
EHR-Based Data
Patient-Accessible
Data
Clinical Trial Information
Providers want to find clinical trials suitable for their patients.
Patient DatamCODE++
extraction
Treatment Data
Clinical Trial Matches
Target Outcome: Develop open data standards and open APIs that enable interoperable, scalable, and accessible trial matching services. Open data standards and open APIs that support clinical trial matching will organize and improve existing and future trial matching services. Comparing a patient’s mCODE++ data to mCODE++ descriptions of trials would enable more automated matching.
Problem: Existing patient-facing tools for trial matching typically require a challenging amount of manual clinical data entry to provide matches.
Empowering Patients to Find Clinical Trials
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Reimagining CAR-T Registry Reporting
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Researchers have an improved base of CAR-T
patient data
Proposed Process:
• Define the necessary structured data elements by comparing registry forms for CAR-T patient reporting with the mCODE set
• Utilize existing FHIR endpoints in the registry and cancer center to build an application, questionnaire, etc.
• Collect and structure necessary elements from cancer center using solution at pilot site, reporting back to registry in low burden standardized way
Registries and clinical sites leverage extended mCODE elements to more easily package and report necessary CAR-T patient data
Reimagining CAR-T Registry Reporting
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Final Thoughts
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Source: Greene, S. M., R. J. Reid, and E. B. Larson. 2012. Implementing the learning health system: From concept to action. Annals of Internal Medicine 157(3):207-210.
Every patient’s journey can improve
all future care
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Brian Anderson [email protected] Quina [email protected] Bratt [email protected] Shemancik [email protected]
Please contact us if interested in learning more about mCODE and CodeX
Become an mCODE Pilot SiteJoin CodeX and the Community of PracticeVisit our booth for mCODE demosHIMSS20 Interoperability Showcase, Kiosk #15
For more info
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Questions
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Appendix
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Oncology Clinical Pathways are evidence-based treatment protocols for delivering cancer care. This initiative uses mCODE elements in producing computable pathways, which provide key decision support in the selection of treatment options.
CaminoClinicalCare
Demonstrate the use of mCODE elements to allow providers and patients to make informed, shared, data-driven decisions and provide data back to generate new knowledge.
CompassClinicalCare
EHR-based clinical trials endpoints collection:
Develop and validate data elements that define clinical utility (treatment response, toxicity, change in treatment, deviation from clinical pathway).
ICAREdataTMClinicalResearch
Initial Use-Case-Based Projects Currently Underway Today
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Building a Trusted Network of Health SystemsProviding requirements and Testing Solutions
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ICAREdata
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• Partner with clinical trials to demonstrate prospective collection of RWD can support clinical oncology research
• Use ICAREdata method to collect key outcome data not yet well represented in EHRs
• Serve as mCODE pilot for clinical oncology research
ICAREdata Approach Increase oncology research data pool Improve clinical trial efficiency Reduce clinical trial costs Inform therapeutics development Inform regulatory decision-making Inform data-driven patient care
Support the collection of high-quality real-world data (RWD), based on mCODE, to enable clinical oncology researchGoal
Clinical ResearchEHR-based clinical trials endpoints collectionICAREdata® Study
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Data-driven patient
care
RWD-based clinical
oncology research
Clinician Patient
Clinician Patient
PATIENTS
CLINICAL TRIAL
AllCare Events
Clinical TrialCare Events
Clinical Trial Data
Research QualityReal-World Data (RWD)
Learning Health System
Every patient’s journey
improves all future care
Standard data elements
Data collected only on patients in clinical trials (97% cancer patients not represented)
Data collected on all patients as part of routine cancer care
Support the collection of high-quality real-world data, based on mCODE to enable clinical oncology research
ICAREdata®Integrating Clinical Trials And Real-world Endpoints data
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1. Create a guiding coalition of health systems, specialty societies, and leaders
2. Work with clinicians and patients to develop the requirements
3. Identify data elements through use cases that demonstrate tangible impact
4. Focus on core data elements that are cross cutting to use cases
5. Execute targeted implementation pilots at the point of care
6. Enable early adoption and scale by engaging industry and health systems
An agile and iterative approach grounded by implementation
A Repeatable process for disciplines beyond oncology