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mCODE Group
mCODE Profile Name
Rel
Data Element Name
Data Element Desc
PCT 0
PCT 1
PCT 2
Reg 0
Reg 1
Reg 2
Rad 0
Rad 1
Rad 2
PAS 0
PAS 1
PAS 2
Path 0
Path 1
Path 2
EHR Endpoints for Clinical Trials
Patient
Cancer Patient
1
Date Of Birth
A date of birth or approximate year or period (year or date range), if estimated
Y
Y

Y*








Required
Patient
Cancer Patient
1
Administrative Gender
A gender classification used for administrative purposes. Administrative gender is not necessarily the same as a biological description or a gender identity. This attribute does not include terms related to clinical gender.












High
Patient
Cancer Patient
1
Birth Sex
The gender the patient was given at birth


Y*








High
Patient
Cancer Patient
1
Address Zip Code

Y
Y

Y*









High
Patient
Cancer Patient
1
Address Line
The street name, number, direction, and P.O. box












High
Patient
Cancer Patient
1
Address City
Name of city, town












High
Patient
Cancer Patient
1
Address State
Sub-unit of country (abbreviations ok)


Y*









High
Patient
Cancer Patient
1
Address Period
Time period when address was/in use












High
Patient
Cancer Patient
1
Identifier
An identifier for the patient, including code system and unique value



Y*


Y







Required
Patient
Cancer Patient
1
Name
The name of the patient, family name and given name(s)












Required
Patient
Cancer Patient
1
Contact Information
Contact information for the patient












High
Patient
Cancer Patient
1
Communication Language
The language the patient communicates in about their health











High
Patient
Cancer Patient
1
Race
Code and text for the patient's race


Y*








High
Patient
Cancer Patient
1
Ethnicity
Code and text for the patient's ethnicity


Y*









High
Patient
Comorbid Condition
1
Clinical Status
A flag indicating whether the condition is active or inactive, recurring, in remission, relapsed, or resolved (as of the last update of the Condition)


Y*








High
Patient
Comorbid Condition
1
Code
The code representing the type of comorbid condition


Y*









High
Patient
ECOG Performance Status
1
Data Value
Value representing the Eastern Cooperative Oncology Group Performance Status score
Y










High
Patient
Karnofsky Performance Status
1
Data Value
Value representing the Karnofsky Performance status score
Y

Y*








High
Disease
Primary Cancer Condition
1
Body Site
Code for the body location, optionally pre-coordinating laterality or direction. When coding with ICD-O-3, the topography code should then be specified here.





Y


Y




High
Disease
Primary Cancer Condition
1
Laterality
Body side of the body location, if needed to distinguish from a similar location on the other side of the body.





Y


Y




High
Disease
Primary Cancer Condition
1
Clinical Status
A flag indicating whether the condition is active or inactive, recurring, in remission, or resolved (as of the last update of the Condition)



Y*


Y


Y




Required
Disease
Primary Cancer Condition
1
Code
A code describing the type of primary malignant neoplastic disease
Y
Y

Y*


Y


Y




Required
Disease
Primary Cancer Condition
1
Date Of Diagnosis
The date the disease was first clinically recognized with sufficient certainty, regardless of whether it was fully characterized at that time





Y


Y




High
Disease
Primary Cancer Condition
1
Histology Morphology Behavior
A description of the morphologic and behavioral characteristics of the cancer
Y
Y




Y


Y




High
Disease
Primary Cancer Condition
1
Verification Status
A flag indicating whether the condition is unconfirmed, provisional, differential, confirmed, refuted, or entered-in-error






Y


Y




High
Disease
Secondary Cancer Condition
1
Body Site
Code for the body location, optionally pre-coordinating laterality or direction. When coding with ICD-O-3, the topography code should then be specified here.





Y






High
Disease
Secondary Cancer Condition
1
Laterality
Body side of the body location, if needed to distinguish from a similar location on the other side of the body.





Y






High
Disease
Secondary Cancer Condition
1
Clinical Status
A flag indicating whether the condition is active or inactive, recurring, in remission, or resolved (as of the last update of the Condition)



Y*


Y






Required
Disease
Secondary Cancer Condition
1
Code
A code describing the type of secondary malignant neoplastic disease
Y
Y

Y*


Y






Required
Disease
Secondary Cancer Condition
1
Date Of Diagnosis
The date the disease was first clinically recognized with sufficient certainty, regardless of whether it was fully characterized at that time


Y*


Y






High
Disease
Secondary Cancer Condition
1
Histology Morphology Behavior
A description of the morphologic and behavioral characteristics of the cancer





Y






High
Disease
Secondary Cancer Condition
1
Verification Status
A flag indicating whether the condition is unconfirmed, provisional, diferential, confirmed, refuted, or entered-in-error



Y*


Y






High
Disease
TNM Clinical Stage Group
1
Data Value
The category describing the extent of the disease, according to the TNM staging rules, typically taking into account several anatomic and prognostic elements
Y
Y










Medium
Disease
TNM Clinical Stage Group
1
Staging System
Method or staging system used to stage the cancer












Medium
Disease
TNM Clinical Primary Tumor Category
1
Data Value
Category of the primary tumor according to TNM staging rules











Medium
Disease
TNM Clinical Primary Tumor Category
1
Staging System
Method or staging system used to stage the cancer











Medium
Disease
TNM Clinical Regional Nodes Category
1
Data Value
Category of regional lymph nodes according to TNM staging rules











Low
Disease
TNM Clinical Regional Nodes Category
1
Staging System
Method or staging system used to stage the cancer











Low
Disease
TNM Clinical Distant Metastases Category
1
Data Value
Category of distant metastases according to TNM staging rules











Low
Disease
TNM Clinical Distant Metastases Category
1
Staging System
Method or staging system used to stage the cancer











Low
Disease
TNM Pathological Stage Group
1
Data Value
The category describing the extent of the disease, according to the TNM staging rules, typically taking into account several anatomic and prognostic elements
Y
Y






Y




Low
Disease
TNM Pathological Stage Group
1
Staging System
Method or staging system used to stage the cancer








Y




Low
Disease
TNM Pathological Primary Tumor Category
1
Data Value
Category of the primary tumor according to TNM staging rules







Y




Low
Disease
TNM Pathological Primary Tumor Category
1
Staging System
Method or staging system used to stage the cancer







Y




Low
Disease
TNM Pathological Regional Nodes Category
1
Data Value
Category of regional lymph nodes according to TNM staging rules







Y




Low
Disease
TNM Pathological Regional Nodes Category
1
Staging System
Method or staging system used to stage the cancer







Y




Low
Disease
TNM Pathological Distant Metastases Category
1
Data Value
Category of distant metastases according to TNM staging rules.







Y




Low
Disease
TNM Pathological Distant Metastases Category
1
Staging System
Method or staging system used to stage the cancer







Y




Low
Genomics
Genomic Region Studied
1
DNA Ranges Examined
The range(s) of the DNA sequence examined











Low
Genomics
Genomic Region Studied
1
DNA Region Description
The description for the DNA region studied in the genomics report











Low
Genomics
Genomic Region Studied
1
Gene Mutation
The gene mutations tested for in blood or tissue by molecular genetics methods











Low
Genomics
Genomic Region Studied
1
Gene Studied
The ID for the gene studied











Low
Genomics
Genomic Region Studied
1
Genomic Reference Sequence ID
Range(s) of DNA sequence examined. The genomic reference sequence is a contiguous stretch of chromosome DNA that spans all of the exons of the gene and includes transcribed and non transcribed stretches. For this ID use either the NCBI genomic nucleotide RefSeq IDs with their version number (see: NCBI.NLM.NIH.Gov/RefSeq) or use the LRG identifiers, without transcript (t or p) extensions -- when they become available. (source: LOINC)











Low
Genomics
Genomic Region Studied
1
Genomic Region Coordinate System
The method of counting along the genome, for example, 0-based interval counting or 0-based character counting











Low
Genomics
Cancer Genomics Report
1
Code
A code identifying the laboratory test. If there is a coded identifier for the test from the Genetic Testing Registry (GTR), LOINC, or other source, it should be included into the code sub-field of the code structure. The report name should be put into text sub-field of the code structure.












Medium
Genomics
Cancer Genomics Report
1
Performing Organization Name
The name of the organization producing the report












Medium
Genomics
Cancer Genomics Report
1
Issued
The date/time this report wnoChangesued











Medium
Genomics
Cancer Genomics Report
1
Genetic Specimen
A small sample of blood, hair, skin, amniotic fluid (the fluid that surrounds a fetus during pregnancy), or other tissue which is excised from a subject for the purposes of genomics testing or analysis











Medium
Genomics
Cancer Genomics Report
1
Genetic Variant
A test for a specific mutation on a particular gene. This profile is used to record whether a single discrete variant tested is present or absent (denoted as positive or negative respectively).













Medium
Genomics
Cancer Genomics Report
1
Genomic Region Studied
The area of the genome region referenced in testing for variants











Medium
Genomics
Genetic Specimen
1
Specimen Type
The kind of material that forms the specimen











Low
Genomics
Genetic Specimen
1
Collection Body Site
The anatomical collection site











Low
Genomics
Genetic Specimen
1
Laterality
Body side of the collection site, if needed to distinguish from a similar location on the other side of the body.











Low
Genomics
Cancer Genetic Variant
1
Data Value
The overall result of the genetic test; specifically, whether a variant is present, absent, no call, or indeterminant
Y
Y










Low
Genomics
Cancer Genetic Variant
1
Method
The method used to perform the genetic test.  Examples include Fluorescent in situ hybridization (FISH), polymerase chain reaction-based assays (PCR), and next-generation sequencing (NGS).











Low
Genomics
Cancer Genetic Variant
1
Amino Acid Change
The symbolic representation of an amino acid variant reported using HGVS nomenclature (pHGVS)











Low
Genomics
Cancer Genetic Variant
1
Amino Acid Change Type
The type of change related to the amino acid variant











Low
Genomics
Cancer Genetic Variant
1
Cytogenetic Location
The cytogenetic (chromosome) location











Low
Genomics
Cancer Genetic Variant
1
Cytogenetic Nomenclature
The cytogenetic (chromosome) location, represented using the International System for Human Cytogenetic Nomenclature (ISCN)











Low
Genomics
Cancer Genetic Variant
1
Gene Studied
A gene targeted for mutation analysis, identified in HUGO Gene Nomenclature Committee (HGNC) notation. The required code is HGNC gene ID. Gene IDs are of the format HGNC:n, where n is a unique number. Only the number, n, should be given as the code. For example, the HGNC identifier for the EGFR gene is 3236. The display text associated with the code should be the HGNC official gene symbol. For example, the official gene symbol for epidermal growth factor receptor is EGFR.
Y
Y










Low
Genomics
Cancer Genetic Variant
1
Genomic DNA Change
The symbolic representation of a genetic structural variant reported using HGVS nomenclature (gHGVS)











Low
Genomics
Cancer Genetic Variant
1
Genomic Source Class
The genomic class of the specimen being analyzed, for example, germline for inherited genome, somatic for cancer genome, and prenatal for fetal genome











Low
Genomics
Cancer Genetic Variant
1
Variation Code
The variation ID assigned by ClinVar, for example, 360448 is the identifier which includes the HGVS nomenclature NM_005228.4(EGFR):c.-237A>G (single nucleotide variant in EGFR). Other acceptable variant standards include the Catalogue Of Somatic Mutations In Cancer (COSMIC) and the International System for Human Cytogenetic Nomenclature (ISCN).











Low
Labs/Vitals
Tumor Marker
1
Code
A code identifying the type of tumor marker test
Y
Y






Y




High
Labs/Vitals
Tumor Marker
1
Data Value
The result of a tumor marker test, whose data type depends on the specific type of test. The data value element is 'required if known' because, for quantitative tests that are indeterminate, no data value will be reported, and the reason for the null value should be reported in the DataAbsentReason field.
Y
Y

Y




Y




High
Treatment
Cancer Related Medication Statement
1
medication[x]
Codefor the medication taken or reference to a Medication
Y
Y

Y*








High
Treatment
Cancer Related Medication Statement
1
Termination Reason
A code explaining unplanned or premature termination of a course of medication


Y*








High
Treatment
Cancer Related Medication Statement
1
Treatment Intent
The purpose of the medication


Y*








High
Treatment
Cancer Related Radiation Procedure
1
Code
Code for the radiation therapy procedure performed
Y
Y

Y*


Y


Y




Medium
Treatment
Cancer Related Radiation Procedure
1
Body Site
The body location(s) where the procedure was performed


Y*


Y


Y




Medium
Treatment
Cancer Related Radiation Procedure
1
Laterality
Body side of the body location, if needed to distinguish from a similar location on the other side of the body.


Y*


Y


Y




Medium
Treatment
Cancer Related Radiation Procedure
1
Treatment Intent
The purpose of the treatment


Y*


Y


Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Code
Code for the surgical procedure performed
Y
Y







Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Body Site
The body location(s) where the procedure was performed








Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Laterality
Body side of the body location, if needed to distinguish from a similar location on the other side of the body.








Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Treatment Intent
The purpose of the treatment








Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Reason Code
The explanation or justification for why the surgical procedure was performed








Y




Medium
Treatment
Cancer Related Surgical Procedure
1
Reason Reference
Reference to a primary or secondary cancer condition








Y




Medium
Outcome
Cancer Patient
1
Date of Death
An indication that the patient is no longer living, given by a date of death or boolean


Y*










High
Outcome
Cancer Disease Status
1
Data Value
A clinician's qualitative judgment on the current trend of the cancer, e.g., whether it is stable, worsening (progressing), or improving (responding). The judgment may be based a single type or multiple kinds of evidence, such as imaging data, assessment of symptoms, tumor markers, laboratory data, etc.


Y*









Required
Outcome
Cancer Disease Status

Evidence Type
A description of the evidence used to support the clinician’s evaluation.  The values here would be constrained to general categories of information such as imagining, physical exam, pathology, and would not contain the actual evidence (e.g., lab results) used to make the determination.















Required
Outcome
Cancer Disease Status

Effective Date
Not part of mCODE, but available in the Observation resource which Cancer Disease Status is based. It is required for ICAREdata as the assessment date















Required

Extensions to mCODE ELEMENTS Under Consideration
See status on Extend_mCode_DataElement


















Observation
2
Tumor Size










Y





Cancer Related Radiation Procedure
TBD
Radiation Modality
The modality (i.e., type) of radiation therapy 






Y










Cancer Related Radiation Procedure
TBD
Radiation Therapy Technique
The method by which the modality is applied






Y










Cancer Related Radiation Procedure
TBD
Total Fractions Delivered
Total # of fractions delivered during a course of RT




Y

Y










Cancer Related Radiation Procedure
TBD
Total Dose Delivered
Total dose of radiation delivered during a course of RT




Y

Y










Cancer Related Radiation Procedure
TBD
Total Dose Planned
Total dose of radiation planned during a course of RT






Y










Cancer Related Radiation Procedure
TBD
Number of fractions planned
Total number of fractions planned during a course of RT






Y










Cancer Related Radiation Procedure
TBD
Treatment Start Date
The date of the first radiation therapy event in a course of treatment






Y










Cancer Related Radiation Procedure
TBD
Treatment End Date
The date of the last radiation therapy event in a course of treatment




Y

Y









Cancer Treatment Plan Change
Care Plan with Review

Change in Treatment Plan
A flag indicating whether a change was made to the Care Plan at the time of the review















Required
Cancer Treatment Plan Change
Care Plan with Review

Care Plan Change Reason
If treatment plan changed and if so, why: no, yes-not responding, yes-AE/toxicity, yes-planned therapy transition, yes-other.















Required
Cancer Treatment Plan Change
Care Plan with Review

Reviewed Date
Date treatment plan was reviewed















Required
Cancer Medication Request
Medication Request












Y







Domain
Introduced by
Organization
Status  (proposed, adopted as mCODE core, adopted as mCODE core ++, Not added - parked, Not added - already in mCODE, Not added - not in scope, not fit for purpose)
Status Reason
Use Case
Element Name
Element Definition
Element notes
Data type (numeric, coded, free text?)
mCODE gap analysis evaluation results (related, similar, gap explanation)
Is this or something similar implemented elsewhere? If yes, where, in what context? (other than mCODE)
Is there a Code System that may manage this element?  
If Yes, which one or ones?
Is there an existing concept that aligns?
Code System (e.g. LOINC, SNOMED CT)
Concept Code
Consider for submission?
Concept Name
Is there a set of values that are expected to populate the element?
FHIR Map?
General Notes
Outcomes
ICAREdata
MITRE
Accepted

Clinical Trials Endpoint Collection
TreatmentChangeReason
Rationale for clinician and/or patient decision to change patient's treatment plan.
This is the answer to the question: Based on your evaluation, are you making a change in treatment?






SNOMED CT



266721009 |Absent response to treatment (situation)| 399119000 |Toxicity due to radiotherapy (disorder)| 399213007 |Toxicity due to chemotherapy (disorder)| 182890002 |Patient requests alternative treatment (finding)|
CarePlan.activity.detail.reasonCode or CarePlan.reasonCondition
Binding activity.detail.reasonCode = example (binding strength), SNOMEDCTClinicalFindings 
Outcomes
ICAREdata
MITRE
Accepted

Clinical Trials Endpoint Collection
TreatmentChangeIndicator
Record of clinician and/or patient decision to change or not change patient's treatment plan.
This is the data item used to manage encounter specific recording of whether the clinician modified the treatment plan.



Y
LOINC
No



Based on your evaluation, are you making a change in treatment?
True False
CarePlan.extension:review
Boolean Reason Code required when value in this extension = True
Outcomes
Jim O'Connor/Rob Dingwell
MITRE
Accepted
See Column V - this has been proposed for mCODE 2.0 as experimental
Oncology Clinical Pathways
TumorSize InvasiveComponentTumorSize TumorInvasiveComponentSize
Working Definition: Maximal measurement of a  tumor.  

Numeric
Considered in initial breast cancer modeling, previous to mCODE. It was not included in mCODE 1.0.   https://github.com/standardhealth/shr-spec/blob/master/spec/ns-onco-core/oncocore.txt  (find "tumor") 1. Profile on AbnormalBodyStructure 2. with isPrimaryTumor Profile on LabObservation: TumorDimensions, FocalSubject constrained to Tumor and components of TumorDimension2 and 3 (SCT) and SizeofGrossTumorBed, TumorLongestDimension (LNC33728-8) and TumorInvolvementAtSurgicalMargin SCT#371488000
Y - NAACR ( CS TUMOR SIZE, CS TUMOR SIZE/EXT EVAL, EOD--TUMOR SIZE, TUMOR SIZE CLINICAL**, TUMOR SIZE PATHOLOGIC**, TUMOR SIZE SUMMARY )
Y
SNOMED CT and possibly LOINC
Yes  SNOMED No LOINC
SNOMED CT LOINC
263605001 |Tumor size (observable entity)| which has specific descendants. Or - depending on definition:  399734001 |Primary tumor size (observable entity)| 384631001 |Tumor size, invasive component, greatest dimension (observable entity)|
Element under consideration as "experimental" for mCODE 2.0. JIRA entered and sample profile created in GitHub. https://jira.hl7.org/browse/FHIR-28549

N/A
Observation.code
https://loinc.org/44635-1/ This LOINC code is Invasive component size.maximum dimension [Length] in Breast tumor. No LOINC code exists for invasive component maximum size that is not specific to breast.  https://loinc.org/33728-7/   Size.maximum dimension in Tumor is not specific to the invasive component Qualify data element name? Baseline vs: post treatment?  JO: PATHWAYS NEED SOME CONCEPT OF TUMOR SIZE. Invasive component not known until surgery FHIR: Observation based on ImagingStudy with reference to Specimen?  NCCN strongly believes tumor size is a valuable data point. Oncologists regularly make decisions based on "tumor size"   (Bob Miller, ASCO might be a good source, Margaret VanMeter IMH, Amy Lin UCSF, Larry Shulman and Peter Gabriel at UPENN) Met with Dr. VanMeter 5/27/2020 - documented results. Clarification required:  Tumor size pre or post removal? Maximum measurement - are qualifing elements required to describe method of measurement, whether the measurement represents height, length, width (orientation assumed?) Tumor depth into body site might be a companion element.
Outcomes
Jim O'Connor/Rob Dingwell
MITRE
Not Added
See here for minutes with documenting how existing mCODE element treatmentResponse with evidence qualification may support this requirement. https://confluence.hl7.org/pages/viewpage.action?pageId=86973022&;preview=/86973022/97463465/202011_CodeX_DataElementStatus.pptx
Oncology Clinical Pathways
Pathologic Treatment Response (Consider Objective Treatment Response to make it clear that this element is intended to record the result of one or more measurements vs: subjective evaluation - TreatmentResponse with method = Pathology)
Pathologic response definition reference:  https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response.  Option: Cancer treatment response as a result of pathologic examination. 
This is a specific measurement of treatment response:  based solely on surgical and pathology findings.  The more general concept, Treatment Response might be needed for another use case.  It is used both in cancer research and clinical care.
Coded
TBD
Allowable values are expected to be closely aligned with RECIST criteria.







Complete, Partial, Stable, and Progressive disease   399056007 |Complete therapeutic response (finding)| 399204005 |Partial therapeutic response (finding)| 399178002 |Static therapeutic response (finding)| 84190002 |Minimal therapeutic response (finding)| 102471002 |Absence of therapeutic response (finding)| In this hierarchy:  118208006 |Finding related to therapeutic response (finding)| 442754001 |Inconclusive evaluation finding (finding)|

Element notes indicate this is a specific measurement, however the suggested values are reflective of a measurement having taken place.  Note: RECIST mentions there are separate guidelines for malignant brain tumors. The RECIST guidelines mention that this assessment encompasses all "target" tumors. Not one specific lesion/tumor.  (FROM RECIST)  (inevaluable missing from the list) 4.3.1. Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease: neither sufficient decrease to qualify fo rcomplete/partial response nor sufficient increase to qualify for progressive disease. Are non-target lesions in scope? Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcomes
Jim O'Connor/Rob Dingwell
MITRE
Not added - parked
Not cancer specific

menopauseStatus
Evaluation of where a patient is in the menopause life cycle.
This may be a coded list to represent pre-menopause, peri-menopause, menopause, post-menopause.  Trials reference this element - at times to make sure a patient is not pregnant.
Coded
not covered by mCODE











Outcomes
Jim O'Connor/Rob Dingwell
MITRE
Not added - parked
TBD

residualDisease
Cancer remaining after treatment.
NCI dictionary: Cancer cells that remain after attempts to remove the cancer have been made. Not clear how this would be recorded - observation related to treatment?













Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
radiotherapyModality
Type of radiation used to deliver the therapy. This DE has two distinct VSs (BrachytherapyModalityVS and TeleradiotherapyModalityVS)

Coded

ASTRO's MDEs paper includes a comprehensive list of modalities on Table 2. Commission on Cancer (CoC) includes this data element in their RT Summary Template
Yes, for the most part. We have applied for the required SNOMED CT codes
SNOMED CT







Subset of http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_29.html 360037004 |Imaging - action (qualifier value)| and all descendants 
Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
radiotherapyTechnique
Method by which the radiation modality is applied (e.g., intensity modulated RT, intraoperabive RT). This DE has two distinct VSs (BrachytherapyTechniqueVS and TeleradiotherapyTechniqueVS)

Coded

ASTRO's MDEs paper includes a comprehensive list of techniques on Table 2.
Not so much. We have applied for the required SNOMED CT codes
SNOMED CT








Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
radiotherapyFractionsDelivered
The number of fractions delivered during a distinct phase.

Numeric

N/A










Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
radiotherapyDoseDeliveredToVolume
Dose parameters for one radiotherapy volume.
*Note: Perhaps this DE is not required, since it is comprised by the extensions below (volumen and totalDoseDelivered)












Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
volume
A BodyStructure resource representing the body structure treated, for example, Chest Wall Lymph Nodes.













Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
totalDoseDelivered
The total amount of radiation delivered to this volume within the scope of this dose delivery.

Quantity (numeric)












Treatment
Sharon Sebastian
MITRE
Accepted (this was an existing DE, and we contributed to the update)

Radiation Therapy Treatment Data
treatmentIntent
The purpose of a treatment.

Code












Treatment
Sharon Sebastian
MITRE
Accepted (this was an existing DE, and we contributed to the update)

Radiation Therapy Treatment Data
terminationReason
A code explaining an unplanned or premature termination of a plan of treatment, course of medication, or research study.

Coded












Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
radiotherapySessions
The number of sessions in a course of radiotherapy.

Numeric












Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
bodyStructure.location
Body location of the RT

Coded












Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
bodyStructure.morphology
Type of radiotherapy volume

Coded












Treatment
Sharon Sebastian
MITRE
Accepted

Radiation Therapy Treatment Data
bodyStructure.locationQualifier
Body site modifier

Coded












Condition
Caroline Potteiger
MITRE
Proposed
This is option #2 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
Patient Clinical Trial Matching
Extension - cancer type
The broad cancer type of the primary cancer condition.
This records a broad cancer type associated with the specific primary cancer condition
Coded
mCODE has very specific cancer types in the PrimaryOrUncertainBehaviorCancerDisorderVS and there is a need to assign a broader cancer type.

Yes
OncoTree

OncoTree



The OncoTree IDs

This is option #2. In this option, the PrimaryCancerCondition profile would stay the same with the addition of an extension - Cancer Type that has a value set associated with it containing the OncoTree ID codes. Con - requires a new extension
November 18, 2020 update: this is a future item, initial implementation involves matching services mapping their cancer type to mCODE.

Introduced by
Use Case
Status
Status Reason
New Profile Name
Base Profile/Resource
Element
New or Existing
Cardinality
MS Flag (only option is to add)
Terminology Binding (new value set, modify existing VS, no change)
Terminology Binding Strength (N/A, example, extensible, preferred, required)
Notes
Caroline Potteiger
P-CT Matching
Proposed
This is option #1 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
PrimaryCancerConditionType *name might be too similar to PrimaryCancerCondition,
PrimaryCancerCondition
code
existing
1..1
NewVS OncoTreeSCTVS = a translation of the OncoTree cancer types into SNOMED
Extensible
This is option #1 (out of 3) of a way to constrain the PrimaryCancerCondition codes into broad cancer types. This includes creating a new profile of "PrimaryCancerConditionType" that uses the new OncoTreeSCTVS. This VS contains the translation of the OncoTree cancer types into SNOMED terms. (Option 2 = new element documented on Extend_mCODE_DataElement tab)
Caroline Potteiger
P-CT Matching
Proposed
This is option #3 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
BreastCancerType
PrimaryCancerCondition
code
existing
1..1
NewVS BreastCancerVS = the PrimaryOrUncertainBehaviorCancerDisorder codes that deal with breast cancer.
Extensible
This is option #3 (out of 3) of a way to constrain the PrimaryCancerCondition codes into broad cancer types. This includes creating profiles for each of the different cancer types and then created value sets that constrain the PrimaryOrUncertainBehaviorCancerDisorder codes for that specific cancer type. Con - includes creating many new profiles and value sets
Carmela Couderc
Radiation Therapy
Proposed
Support proposed data elements
CancerRadiationTherapyProcedure (to be represented by three VSs: Cancer Related Radiation Procedure/ RadiotherapySummary/ BrachytherapyPrescriptionDelivery/ TeleradiotherapyPrescriptionDelivery)
Procedure
code
new
1..1
RadiationTherapyProcedureVS
Extensible
New category.code: SNOMED-CT 108290001
Carmela Couderc
Oncology Clinical Pathways Prior Authorization
Proposed
Support workflow
CancerRelatedMedication Request; CancerRelatedServiceRequest; CancerRelatedMedicationDispense
MedicationRequest, MedicationDispense, ServiceRequest

new






Introduced by
Use Case
Status
Status Reason
mCODE Artifact
Profile Impact (new profile, change to existing profile
Element
Cardinality
MS Flag (add, no change, new element)
Terminology Binding (new value set, modify existing VS, no change)
Terminology Binding Strength (N/A, example, extensible, preferred, required)
Explanation of the change
Rute Martins
Radiation Therapy Treatment Data
Draft
Need to analyze ASTRO terminology against mCODE VS
Cancer Related Radiation Procedure
change existing profile
Code
unchanged
add
new
unchanged

Rute Martins
Radiation Therapy Treatment Data
Draft
Need to analyze ASTRO terminology against mCODE VS
Cancer Related Radiation Procedure
change existing profile
Body Site
unchanged
add
new
unchanged

Caroline Potteiger
Patient Clinical Trials
Draft
Still in the process of determining which cancer type to start with and how to group medications.
Cancer Related Medication Statement
change existing profile
Medication[x]
unchanged
unchanged
New value set
extensible
Requires a new ImmunotherapyVS that constrains the existing codes in RxNorm.
Caroline Potteiger
Patient Clinical Trials
Draft
This is option #2 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
Primary Cancer Condition
change existing profile
Extension - cancer type
1.1
MS
New data element
Required
This is option #2. In this option, the PrimaryCancerCondition profile would stay the same with the addition of a extension - Cancer Type that has a value set associated with it containing the OncoTree ID codes. Con - requires a new extension

Element 
mCODE 1.0 or new element
If Column B = mCODE 1.0, profile name
Status  (proposed, in review, accepted, ready for definition)
Status Reason

mCODE 1.0 Value Set Name
Updated/New Name
Updated/New Value Set Scope
Updated/New Inclusion/Exclusion
Code System
Updated / New Value Set Content Logical Definition - intensional or extensional/enumeration
Is this or something similar implemented elsewhere? If yes, where, in what context?
Binding Strength Preferred, extensional, example
General Notes
RadiationTherapyModality
new

Proposed
Required for the RTTD use case
New

RadiationTherapyModalityVS
Retrieve data retrospectively, and constrain data entry values for radiation procedure modality.

SNOMED CT
Extensional
RadiationProcedureValueSet (mCODE 1.0)  http://hl7.org/fhir/us/mcode/ValueSet-mcode-radiation-procedure-vs.html   Ultimately, there may be two distinct VSs: one that expresses a radiation procedure and a second that expresses the modality (type of radiation applied to the patient)
Extensional
"Radiation Procedure Value Set from mCODE 1.0 has 5 concepts - that could be considered modality values rather than specific procedures. Many more concepts need to be added once SNOMED CT codes are assigned to each concept.
Type or modality?
RadiationTherapyTechnique
new

Proposed
Required for the RTTD use case
New

RadiationTherapyTechniqueVS
Retrieve data retrospectively, and constrain data entry values for radiation procedure modality.

SNOMED CT
Extensional
No, this is a brand new data element. Of note, the RadiationTherapyTechnique is closely associated with RadiationTherapyModality
Extensional
This is a brand new VS that will be associated with a new mCODE extension. It is an important aspect of radiation therapy. Examples of RT techniques include 2D, 2D, IORT, and Sealed.
Code
mCODE 1.0
CancerRelatedRadiationProcedure
Proposed
Replacement
RadiationProcedureVS
RadiationTherapyModalityVS

Radiation therapeutic method.
Updated
SNOMED CT
See Modality
Intensional



Medication[x]
mCODE 1.0
CancerRelatedMedicationStatement
November 2020: on hold, transforming to MedicationRequest
Proposed
Still in the process of determining which cancer type to start with and how to group medications.
Replacement
US Core Medication Codes (RxNorm)
ImmunotherapyVS
Constrain the existing RxNorm codes pertaining to Immunotherapy treatments
Includes all immunotherapy treatments
RxNorm
intensional
The US Core Medication codes contains codes for all medications. The purpose of this value set is to constrain and group the codes for Immunotherapy into a broader Immunotherapy type VS.
Extensional
Note: question sent to VSAC support as to whether an intensional value set could be created using either MED-RT or ATC codes (as a category) with an expansion = RxNorm. Not available as of 4/30/2020. Suggestion was to use ATC to derive the RxNorm codes, and then to select the RxNorm TTYs desired and create an extensional value set.
Code
mCODE 1.0
PrimaryCancerCondition
Proposed
This is option #1 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
New
PrimaryOrUncertainBehaviorCancerDisorderVS
OncoTreeSCTVS
This new value set contains the translation of the OncoTree cancer types into SNOMED terms. All of these SNOMED terms are included in the PrimaryOrUncertainBehaviorCancerDisorderVS.
Includes the OncoTree cancer translated into SNOMED
SNOMED CT
New value set that constrains an existing value set.
OncoTree
Extensional
This is option #1 (out of 3) to constrain the PrimaryCancerCondition codes into broad cancer types. This includes creating a new profile of "PrimaryCancerConditionType" that uses the new OncoTreeSCTVS. This VS contains the translation of the OncoTree cancer types into SNOMED terms.
Code
mCODE 1.0
PrimaryCancerCondition
Proposed
This is option #3 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
New
PrimaryOrUncertainBehaviorCancerDisorderVS
BreastCancerVS
This new value set constrains the existing PrimaryOrUncertainBehaviorVS into codes only relevant for breast cancer.
Includes the breast cancer codes from PrimaryOrUncertainBehaviorVS
SNOMED CT and ICD-10
New value set that constrains an existing value set.

Extensional
This is option #3 (out of 3) of a way to constrain the PrimaryCancerCondition codes into broad cancer types. This includes creating profiles for each of the different cancer types and then created value sets that constrain the PrimaryOrUncertainBehaviorCancerDisorder codes for that specific cancer type. Con - includes creating many new profiles and value sets
Extension - cancer type
new

Proposed
This is option #2 (out of 3) to constrain the existing primary cancer condition codes into broad cancer types.
New

CancerTypeVS
This value set contains the OncoTree IDs for cancer type.
OncoTree IDs only
OncoTree
New value set

Extensional
This is option #2. In this option, the PrimaryCancerCondition profile would stay the same with the addition of an extension - Cancer Type that has a value set associated with it containing the OncoTree ID codes. Con - requires a new extension
mCODE 1.0
CancerRelatedRadiationProcedure
Proposed
The RTTD SMEs feel a concept should be added to express that the treatment was stopped b/c it wasn't working (e.g., the tumor was growing)


TreatmentTerminationReasonVS
Add one code to the VS (i.e., Absent response to treatment [situation], SNOMED-CT: 266721009)

SNOMED CT
Update value set by adding 1 code (266721009)
No
Extensional (required)
The existing VS does not provide a response that reflects that a radiation treatment was not working, therefore it was terminated. There is a "lack of drug action", but nothing r/t a procedure or treatment.

UNDER CONSTRUCTION


Intervention Type

Definition

Assessment
The process of both provider clinical observation and interpretation, and the application of assessment tools. In both activities the aim is to arrive at outcomes that define the status of the patient in order to guide further care.

Assistance
Non-clinical aid with the tasks of care such as applications and setting up appointments.

Coordination
Organizing activities and sharing information.

Counseling
Psychosocial procedure that involves mental/behavioral strategies such as listening, reflecting, etc. to facilitate recognition of course of action/solution.

Education
Procedure that is synonymous with those activities such as teaching, demonstration, instruction, explanation, and advice that aims to increase knowledge and skills, change behaviors, assist coping.

Evaluation of eligibility
Chosen to mark the activities prior to determination of eligibility. (Crucial for federal food assistance programs).

Provision
For the purposes of the project, provision covers any concrete support that is able to be given to the patient directly at the point of service.

Referral
A type of order wherein clinicians/providers request services and/or assessment from other professionals and/or programs.

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