ICHOM Patient Centered Outcomes Measure Set for Breast Cancer
1.0.0 - trial-use International flag

ICHOM Patient Centered Outcomes Measure Set for Breast Cancer, published by HL7 International - Clinical Interoperability Council Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-ichom-breast-cancer-ig/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Questionnaires

These define forms used by systems conforming to this implementation guide to capture or expose data to end users.

ClinicalResponseAnnualUpdate

Clinical response questionnaire at annual post-treatment follow-up

ClinicalResponseBaseline

Clinical response questionnaire at baseline (first doctors’ visit)

ClinicalResponseSixMonths

Clinical response questionnaire at 6 months post-treatment follow-up

PatientReportedBaseline

Patient-reported response at baseline (first doctors’ visit)

PatientReportedFollowUp

Patient-reported response at every 6 months for first 2 years post-treatment, after 2 years tracked annually for up to 10 years

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Axilla surgery

Represents if the breast cancer patient received surgery to the axilla during the last year.

Axillary clearance

Represents if the breast cancer patient received axillary clearance during the last year. Axilla clearance could be due to lymph node involvement after sentinel lymph node biopsy.

Best supportive care

Represents if breast cancer patient received best supportive care during the last year.

Body height

Represents the height of a person diagnosed with breast cancer

Body weight

Represents the weight of a person diagnosed with breastcancer

Breast cancer patient

A patient who has been diagnosed with or is receiving medical treatment for breast cancer. This profile includes the ICHOM patient characteristics and demographic factors.

Breast cancer surgery

Represents if the breast cancer patient received surgery during the last year.

Cancer Stage Group

A staging system to describe the amount and spread of breast cancer in a patient’s body, using TNM staging (per AJCC 8th Ed.). This profile is in alignment with the mCODE TNM Stage Group Profile.

Chemotherapy

Represents if the patient received chemotherapy during the last year.

Complication

Represents the type and impact of a complication experienced by a patient

Death attributable to breast cancer

Represents if breast cancer was the cause of death

Endopredict score

Represents the endopredict score on a scale of 1.1 to 6.2

Estrogen receptor status

Represents if the estrogen receptor status is positive in a patient with breast cancer

Germline mutation

Represents if the patient carries a germline mutation predisposing breast cancer

HER2 receptor status

Represents if the human epidermal growth factor receptor 2 (HER2) receptor status is positive in a patient with breast cancer

Histological type of the tumor

Represents the histological type of the tumor

Hormonal therapy

Represents if the patient received hormonal therapy during the last year.

Immunotherapy

Represents if the breast cancer patient received immunotherapy during the last year.

Invasion grade

Represents the tumor grade of DCIS component of the breast cancer tumor

Lymph nodes involved

Represents the number of lymph nodes involved

Mammaprint score

Represents the mammaprintscore on a scale of 0.000 to 1.000

Menopausal status

Represents the menopausal status of a patient

Oncotype Score

Represents the oncotype score on a scale of 0 to 100

Primary Breast Cancer Condition

Represent the properties of the primary breast cancer diagnosis

Progesterone receptor status

Represents if the progesterone receptor status is positive in a patient with breast cancer

Radiotherapy

Represents if the breast cancer patient received radiotherapy during the last year.

Re-operation surgery

Represents whether the patient has had a re-operation since their surgery for breast cancer and whether it was due to involved margins.

Real Treatment Plan Followed

Indicate if the patient followed the multidisciplinary recommended treatment plan

Reconstruction surgery

Represents if the breast cancer patient received reconstruction surgery during the last year.

Recurrence Method

The method of confirming recurrence breast cancer

Resected lymph nodes

Represents the number of lymph nodes resected

Secondary Breast Cancer Condition

Represent the properties of the secondary breast cancer diagnosis

Size of invasive tumor

Represents the size of the invasive tumor

TNM Distant Metastases

Represents the extent of a tumor metastasis in remote anatomical locations (per AJCC 8th Ed.). This profile is in alignment with mCODE TNM Distant Metastases Category Profile.

TNM Primary Tumor Stage

Represents the stage of the primary tumor (per AJCC 8th Ed.). This profile is in alignment with mCODE TNM Primary Tumor Category Profile.

TNM Regional Nodal Stage

Represents the presence or absence of metastases in regional lymph nodes (per AJCC 8th Ed.). This profile is in alignment with mCODE TNM Regional Nodes Category Profile.

Targeted therapy

Type and duration of targeted therapy

Treatment Plan Not Followed

Indicate why the multidisciplinary recommended treatment plan was not followed

Treatment recommended by a multidisciplinary team

Represents the treatment that a multidisciplinary team recommended during a multidisciplinary meeting

Tumor grade

Represents the grade of the breast cancer tumor

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Education Level Extension

Represents the level of education of a patient.

Ethnicity Extension

Represents the ethnicity of a patient. This extension is aligned with USCore

Race Extension

Represents the race of a patient. This extension is aligned with USCore.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Agreement response ValueSet

Valueset used in a Patient Reported Outcomes Instrument to express the degree of agreement

Axilla surgery ValueSet

Valueset of surgery types of the axilla

Education level of patient ValueSet

Valueset of the education level of a patient

Estrogen receptor status ValueSet

Valueset of the Estrogen receptor status

Germline Mutation ValueSet

Valueset of the genetic mutation predisposing breast cancer

Grading of tumor ValueSet

Valueset of the grade of the tumor

HER2 receptor status ValueSet

Valueset of the HER2 receptor status

Histological type of the tumor ValueSet

Valueset of the histological types of tumors

Impact of complication ValueSet

ValueSet of the impact of a complication experienced by the breast cancer patient

Intent of therapy ValueSet

Valueset of intent of therapy

Laterality of breast cancer ValueSet

Valueset of the laterality of breast cancer

Laterality of new cancer ValueSet

Valueset of the laterality of new breast cancer

Location of the implant ValueSet

Valueset of the location of the implant during reconstruction surgery

Menopausal status of patient ValueSet

Valueset of the menopausal status of a patient

Molecular profiling

Valueset indicating if a molecular profiling tool was used

Observation identifiers for treatment plan non-compliance reason ValueSet

Valueset of reason for why the treatment plan was not followed

Patient Treatment Education ValueSet

Valueset covering if the patient received sufficient information about the treatment options

Patient treatment preference ValueSet

Valueset of reason for why the treatment plan was not followed

Progesterone receptor status ValueSet

Valueset of the Progesterone receptor status

Re-operation due to involved margins ValueSet

Kind of re-operation due to involved margins

Real Treatment Plan Followed ValueSet

Valueset of if the patient followed the multidisciplinary recommended treatment plan

Reasoncode of the re-operation

Valueset of the reasons of a re-operation

Recommended treatment types ValueSet

Valueset of the kind of treatment that the multidisciplinary team recommended

Recurrence method ValueSet

Valueset of the methods used to confirm recurrence of breast cancer

Recurrence of neoplasm ValueSet

Valueset about whether there is evidence of local, regional or distant recurrence of neoplasm

Relationship status of patient ValueSet

Valueset of the relationship status of a patient

SACQ Patient's comorbidity history ValueSet

Patient’s documented history of comorbidities

Satisfaction response ValueSet

Valueset used in a Patient Reported Outcomes Instrument to express the statisfation response

Staging Type for Stage Group ValueSet

Valueset indicating the type of staging, clinical or pathological, of breast cancer.

TNM Distant Metastases ValueSet

Valueset of the TNM stage for the M category, according to TNM staging rules

TNM Primary Tumor ValueSet

Valueset of the TNM stage for the T category, according to TNM staging rules

TNM Regional Nodes ValueSet

Valueset of the TNM stage for the N category, according to TNM staging rules

Targeted axilla surgery ValueSet

Valueset of targeted surgery types of the axilla

The location of radiotherapy ValueSet

Valueset of the location of radiotherapy

Treatment Plan Not Followed ValueSet

Valueset of reason for the treatment plan not being followed

Type of chemotherapy ValueSet

Valueset of the types of chemotherapy

Type of complication ValueSet

ValueSet of the type of complication experienced by the breast cancer patient

Type of hormonal therapy ValueSet

Valueset of the types of hormonal therapy

Type of re-operation

Valueset of the types of re-operation

Type of reconstruction surgery ValueSet

Valueset of the type of reconstruction surgery that is performed

Type of targeted therapy ValueSet

Valueset of the types of targeted therapy

Type of treatments ValueSet

Valueset of the kind of treatment a patient with breastcancer underwent

Types of breast surgery ValueSet

Valueset of the types of breast surgery a patient underwent

Units of patient's body weight ValueSet

Valueset of the unit of the patient’s body weight

Yes, No and Unknown Valueset

Valueset with yes, no and unknown answers

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Agreement response CodeSystem

Codes used in a Patient Reported Outcomes Instrument to express the degree of agreement

Breast surgery types CodeSystem

Codes indicating the types of breast surgery a patient underwent

Impact of complication CodeSystem

Codes indicating the impact of a complication experienced by the breast cancer patient

Location of the implant CodeSystem

Codes indicating the location of the implant that was placed during reconstruction surgery

Molecular Profiling CodeSystem

Codes used to describe the different types of molecular profiling scoring

Observation identifiers for treatment plan non-compliance reason CodeSystem

Codes covering observation identifiers for treatment plan non-compliance reaso

Patient Treatment Education Codesystem

Codes covering if the patient received sufficient information about the treatment options

Patient treatment preference CodeSystem

Codes covering for why the treatment plan was not followed

Real Treatment Plan Followed CodeSystem

Codes covering if the patient followed the multidisciplinary recommended treatment plan

Real Treatment Plan Not Followed CodeSystem

Codes covering if the patient has not followed the multidisciplinary recommended treatment plan

Recurrence method CodeSystem

Additional code covering combination of radiological and histological diagnosis method

Recurrence of neoplasm CodeSystem

Additional code covering whether there is evidence of local, regional or distant recurrence of neoplasm

Satisfaction response CodeSystem

Codes used in a Patient Reported Outcomes Instrument to express the statisfation response

Treatment variables CodeSytem

Codes defining types of treatment a breast cancer patient could receive

Type of complication CodeSystem

Codes indicating the type of a complication experienced by the breast cancer patient

Type of reconstruction surgery CodeSystem

Codes indicating the type of reconstruction surgery that is performed

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

AxillaSurgeryPatient147

Example of a breast cancer patient who underwent surgery to the axilla

AxillaryClearancePatient147

Example of a breast cancer patient who received axilla clearance

BestSupportiveCarePatient147

Example of a breast cancer patient who received best supportive care

BodyHeightPatient147

Example of the height of a patient diagnosed with breast cancer

BodyWeightPatient147

Example of the weight of a patient diagnosed with breast cancer

BreastCancerSurgeryPatient147

Example of the surgical procedure the breast cancer patient underwent

ChemotherapyPatient147

Example of a breast cancer patient who received chemotherapy

ClinicalMetastasesPatient147

Extended example: example showing clinical TNM staging (M)

ClinicalNodalStagePatient147

Extended example: example showing clinical TNM staging (N)

ClinicalTNMStagePatient147

Example showing TNM staging in patient with breast cancer

ClinicalTumorStagePatient147

Extended example: example showing clinical TNM staging (T)

ComplicationPatient147

Example of a complication in patient with breast cancer

DeathAttributableBCPatient147

Example of death attributable to breast cancer

ERStatusPatient147

Example of the estrogen receptor status in a patient with breast cancer

EndopredictonPatient147

Example of the endopredict score

Example Real Treatment Plan Followed

Example of how the real treatment plan was followed

Example Treatment Plan Not Followed

Example of why the treatment plan was not followed

Example of Breast Cancer Patient Cornetet

The characteristics and demographic factors of an example patient.

Example of Breast Cancer Patient Letsche

The characteristics and demographic factors of an example patient.

Example of Breast Cancer Patient Mortera

The characteristics and demographic factors of an example patient.

Example of Targeted therapy

Example of the targeted therapy for this patient.

Example of menopausal status

Example of the menopausal status of a patient

GermlineMutationPatient147

Example of whether a patient carries a germline mutation predisposing breast cancer

HERStatusPatient147

Example of the human epidermal growth factor receptor 2 (HER2) status in a patient with breast cancer

HistotypePatient147

Example of the histological type of the breast cancer tumor

HormonaltherapyPatient147

Example of a breast cancer patient who received hormonal therapy

ImmunotherapyPatient147

Example of a breast cancer patient who received immunotherapy

InvasionGradePatient147

Example of the tumor grade of DCIS component of the breast cancer tumor

LymphNodesInvolvedPatient147

Example of the number of involved lymph nodes in a patient with breast cancer

LymphNodesResectedPatient147

Example of the number of resected lymph nodes in a patient with breast cancer

MammaprintPatient147

Example of the mammaprint score

OncotypePatient147

Example of the oncotype score

PRStatusPatient147

Example of the progesterone receptor status in a patient with breast cancer

PathologicalMetastasesPatient147

Extended example: example showing patholgical TNM staging (M)

PathologicalNodalStagePatient147

Extended example: example showing patholgical TNM staging (N)

PathologicalTNMStagePatient147

Example showing TNM staging in patient with breast cancer

PathologicalTumorStagePatient147

Extended example: example showing patholgical TNM staging (T)

PrimaryBreastCancerPatient147

Example of the primary breast cancer diagnosis of a patient

RadiotherapyPatient147

Example of a breast cancer patient who received radiotherapy

ReconstructionSurgeryPatient147

Example of a breast cancer patient who underwent reconstruction surgery

RecurrenceMethodPatient147

Example of method of confirming recurrence breast cancer

ReoperationSurgeryPatient147

Example of a reoperation due to involved margins after primary surgery

SecondaryBreastCancerPatient147

Example of the secondary condition breast cancer diagnosed in a patient

TreatmentPlanPatient147

Example of the treatment that a multidisciplinary team recommended during a multidisciplinary meeting

TumorGradePatient147

Example of the grade of a breast cancer tumor

TumorSizePatient147

Example of the size of the invasive tumor of a patient with breast cancer