Project Summary for Minimal Common Oncology Data Elements (mCODE) (PSS in Confluence)
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Project Details
Number | 1509 View Ballot Items List (with NIBs) |
---|---|
Name | Minimal Common Oncology Data Elements (mCODE) (PSS in Confluence) |
Sponsor(s) | Clinical Interoperability Council Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | This project will develop a common set of standardized data elements relevant to many types of cancer. It is intended to facilitate collection of "real world data" from clinical encounters with higher uniformity and quality, independent of the provider or EHR vendor. Data structures accurately capturing patient characteristics, disease characteristics, treatments, and outcomes that matter to patients and clinicians would rapidly accelerate progress toward using current therapies optimally and potentially, new clinical guidelines. The resulting Minimal Common Oncology Data Elements (mCODE)-based data sets, with data from the clinical care settings, will not require extensive curation, and will be shareable with other mCODE-based data sets without reformatting. A core team of oncologists will guide the selection and prioritization of content, and the results (subject to HL7 approval) will be delivered as FHIR profiles in an Implementation Guide (IG). The results will be US Realm-specific, but the lessons learned, and many of the actual profiles, could have universal applicability. The intent is to base mCODE on a common base logical model determined and approved by CIMI. |
Project Facilitator | Mark Kramer |
Status | STU - Test Period/Accepting Comments |
SD Approval Date | Mar 11, 2019 |
TSC Approval Date | Apr 1, 2019 |
Type | Ballot - STU to Normative |
Objectives / Deliverables | Submit for STU Ballot (First Ballot Cycle) - Target: 2019 Sep Ballot Complete STU Reconciliation - Target: 2020 Jan WGM Submit for Normative Ballot - Target: 2020 Sep Ballot Complete Normative Reconciliation - Target: 2021 Jan WGM Submit Publication Request - Target: 2021 Feb Receive ANSI Approval - Target: 2021 April Project End Date (all objectives have been met) - Target: 2021 April |
Next Milestone Date | 2026 January WGM |
Project End Date | 2026 January WGM |
Project Intent | Supplement to a Current Standard, Implementation Guide |
Project Need | Tremendous progress could be made if oncology data gathered in clinical encounters could be captured in standard form. Currently, only 3-5% of cancer patients participate in randomized clinical trials (RCTs), and very little medical knowledge is gained from the other 95-97%. A significant part of the problem with real-world data is caused by the variability in the ways that EHRs capture clinical data, with much information going into clinical notes. Attempts to extract structured information clinical notes using natural language processing (NLP) have not been able to deliver high quality, computable data at scale. The only effective method of involves human data curation, which is expensive and unscalable. Although large repositories of cancer data already exist, the usefulness of this data is hindered by the variability and lack of structure in the data. The interested parties, led by American Society of Clinical Oncologists (ASCO), believes the best starting point to begin to address this problem is to identify a small set of data elements that should be collected for all cancer cases, an effort they have named "mCODE", for Minimal Common Oncology Data Elements. Of course, mCODE will not be effective unless clinicians are willing to routinely apply it during patient care. Data collection is therefore an essential feature of mCODE use cases, for which the design goal is to minimize disruption of normal workflow and maximize incentives for adoption by the clinicians. MITRE and ASCO have teamed up to develop an mCODE-based Fast Healthcare Interoperability Resources (FHIR) implementation and Substitutable Medical Applications and Reusable Technologies (SMART)-on-FHIR application to extract mCODE data in computable formats. Intermountain Healthcare, as a participating CancerLinQ data repository and leader in quality cancer care, will operate test sites for capturing the required mCODE data and for utilizing the tailored reports during clinical care. The incentive driving initial mCODE adoption is its use in therapeutic decision-making and comparative effectiveness analysis, by providing cancer patients and oncologists with a cohort of (anonymized) similar patients, with their treatments an outcomes, in real-time. The ultimate goal is to use real world data to accelerate progress toward using current therapies optimally and potentially developing new clinical guidelines, particularly for patients currently underserved by RCTs, such as elderly and disadvantaged patients, patients with multiple comorbidities, for rare tumors, and to assess outcomes in patients who receive multiple lines of treatment. |
Implementers | 1) Intermountain Healthcare 2) Partners Healthcare |
Security Risks | No |
External Drivers | None |
Common Names / Keywords/ Aliases | mCODE (aka Minimal Common Oncology Data Elements) |
Lineage | N/A |
Dependancies | |
Project Document Repository |
https://confluence.hl7.org/display/CIC/Minimal+Common+Oncology+Data+Elements (this page is proposed - has not been created yet) |
Backwards Compatibility | N/A |
External Vocabularies | Yes |
Products | FHIR Implementation Guide; FHIR Profile |
Joint Copyright? | No |
External Pjt Collaborators | Was the content externally developed ? : No Is this a hosted (externally funded) project? (not asking for amount, just whether or not it is funded) No |
Realm | Realm Specific - Enter "U.S." or name of HL7 Affiliate below |
HL7 Affiliate | U.S. |
Stakeholders | Clinical and Public Health Laboratories, Quality Reporting Agencies, Standards Development Organizations (SDOs) |
Vendors | EHR, PHR; Health Care IT; Clinical Decision Support Systems; Lab; HIS |
Providers | Clinical and Public Health Laboratories; Local and State Departments of Health; Medical Imaging Service; Healthcare Institutions (hospitals, long term care, home care, mental health) |
Ballot Cycle Info | 2021 May Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 18 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Minimal Common Oncology Data Elements (mCODE), Release 1 - US Realm 2019 Sept Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 16 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Minimal Common Oncology Data Elements (mCODE), Release 1 - US Realm |
Misc Notes | 2024 January: RLeftwich: The mCode project plans to ballot an updated FHIR IG in May 2024 for a new version of the IG updated for pediatric cancer concepts. There is also consideration of updating this as a universal realm project in the interest of HL7’s globalization initiative. 2023 October: TSC approved STU Publication Request for HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Edition 3 - US Realm for 2 years 2023 January: TSC approved Unballoted STU Update Publication Request for minimal Common Oncology Data Elements (mCODE) Implementation Guide 2.1.0 - STU 2.1 2021 December: TSC approved STU Publication Request for HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm - STU2 2020 March: TSC approved STU Publication Request for Minimal Oncology Data Elements (mCODE) through April 7, 2022 External vocabularies: SNOMED CT, LOINC, RxNorm, HGNC (Hugo Genetics Nomeclature Committee), UCUM, GTR (Genetics Test Registry) For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? DSTU 2 Other Stakeholders: Patients |
U.S. Govt Interest? | No |
USRSC Approval | Received |
FMG Approval | All Received |
ARB Approval | Not Needed |
Start Date | Feb 7, 2019 |
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