LinkId Text Cardinality Type Description & Constraints ClinicalResponseSixMonths Clinical response questionnaire at 6 months post-treatment follow-up Questionnaire http://hl7.org/fhir/uv/ichom-breast-cancer/Questionnaire/ClinicalResponseSixMonths#1.0.0 General-Information-Clinical General information 1..1 group NA-Clinical What is the patient's medical record number? 1..1 string LastName-Clinical What is the patient's last name? 1..1 string Tumor-Factors Tumor factors 1..1 group received_surgery Has the patient received surgery? 1..1 boolean TNMPT_BREAST Indicate the pathological tumor stage (per AJCC 8th Ed.) 1..1 choice Enable When: received_surgery = true Value Set: TNM Primary Tumor ValueSet TNMPN_BREAST Indicate the pathological nodal stage (per AJCC 8th Ed.) 1..1 choice Enable When: received_surgery = true Value Set: TNM Regional Nodes ValueSet TNMPM_BREAST Indicate the pathological distant metastasis (per AJCC 8th Ed.) 1..1 choice Enable When: received_surgery = true Value Set: TNM Distant Metastases ValueSet SIZEINV Indicate size of invasive component of tumor (in mm) 1..1 integer Enable When: received_surgery = true NumLymphNodesResect Indicate the number of lymph nodes resected 1..1 integer Enable When: received_surgery = true LYMPHINV_BREAST Indicate the number of lymph nodes involved according to the TNM stage AJCC 8th Ed. 1..1 integer Enable When: received_surgery = true Treatment-Variables Treatment Variables 1..1 group TREATMENT_BREAST Indicate whether the patient received one of the following treatment during the last year (select all that apply) 1..* choice Value Set: Type of treatments ValueSet SURGERY_BREAST Indicate whether the patient received surgery during the last year 1..1 choice Enable When: TREATMENT_BREAST = Surgical procedure (procedure) (SNOMED CT#387713003) Value Set: Types of breast surgery ValueSet SurgeryDateKnown Is the date of surgery known? 1..1 boolean Enable When: TREATMENT_BREAST = Surgical procedure (procedure) (SNOMED CT#387713003) SurgeryDate Please provide the date of surgery 1..1 date Enable When: SurgeryDateKnown = true SURGERYAX Indicate whether the patient received surgery to the axilla 1..1 choice Enable When: TREATMENT_BREAST = Operative procedure on axilla (SNOMED CT#699455008) Value Set: Axilla surgery ValueSet SURGERYAXDATE-Known Is the date of surgery to the axilla known? 1..1 boolean Enable When: TREATMENT_BREAST = Operative procedure on axilla (SNOMED CT#699455008) SURGERYAXDATE Please provide the date of surgery to the axilla 1..1 date Enable When: SURGERYAXDATE-Known = true SURGERYAX2 Indicate whether the patient received axillary clearance due to lymph node involvement after sentinel lymph node biopsy during the last year 1..1 choice Enable When: SURGERYAX = Sentinel lymph node biopsy (SNOMED CT#396487001) SURGERYAX = Excision of axillary lymph node (SNOMED CT#234262008) Value Set: Yes, No and Unknown Valueset SURGERYAX2DATE-Known Is the date of axillary clearance known? 1..1 boolean Enable When: SURGERYAX2 = Yes (expandedYes-NoIndicator#Y) SURGERYAX2DATE Please provide the date of axillary clearance 1..1 date Enable When: SURGERYAX2DATE-Known = true RECONSTRUCTION_DELAY Indicate whether the patient received a delayed reconstruction 1..1 choice Enable When: SURGERY_BREAST = Mastectomy without immediate reconstruction (Breast surgery types CodeSystem#mastectomy-without-immediate-reconstruction) Value Set: Yes, No and Unknown Valueset SURGERY_RECONSTRUCTION Indicate what type of reconstruction the patient received 1..1 choice Enable When: SURGERY_BREAST = Mastectomy without immediate reconstruction (Breast surgery types CodeSystem#mastectomy-without-immediate-reconstruction) SURGERY_BREAST = Mastectomy with immediate reconstruction (Breast surgery types CodeSystem#mastectomy-with-immediate-reconstruction) Value Set: Type of reconstruction surgery ValueSet ImplantReconstruction Indicate the location of the implant 1..1 choice Enable When: SURGERY_RECONSTRUCTION != Autologous (Type of reconstruction surgery CodeSystem#autologous) SURGERY_RECONSTRUCTION != unknown (NullFlavor#UNK) Value Set: Location of the implant ValueSet RECONSTRUCTDATE-Known Is the date of the delayed reconstruction known? 1..1 boolean Enable When: RECONSTRUCTION_DELAY = Yes (expandedYes-NoIndicator#Y) RECONSTRUCTDATE Please provide the date of delayed reconstruction 1..1 date Enable When: RECONSTRUCTDATE-Known = true RADIOTX_BREAST What was the intent of radiotherapy 1..* choice Enable When: TREATMENT_BREAST = Radiation oncology AND/OR radiotherapy (SNOMED CT#108290001) Value Set: Intent of therapy ValueSet RADIOTXTYPE_BREAST Indicate location/type of radiotherapy 1..1 choice Enable When: TREATMENT_BREAST = Radiation oncology AND/OR radiotherapy (SNOMED CT#108290001) Value Set: The location of radiotherapy ValueSet RadioTxStartDate-Known Is the start date of radiotherapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Radiation oncology AND/OR radiotherapy (SNOMED CT#108290001) RadioTxStartDate Please provide the start date of radiotherapy 1..1 date Enable When: RadioTxStartDate-Known = true RadioTxStopDate-Known Is the stop date of radiotherapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Radiation oncology AND/OR radiotherapy (SNOMED CT#108290001) RadioTxStopDate Please provide the stop date of radiotherapy 1..1 date Enable When: RadioTxStopDate-Known = true CHEMOTXINTENT Indicate the intent of chemotherapy 1..1 choice Enable When: TREATMENT_BREAST = Adjuvant chemotherapy (Treatment variables CodeSytem#adjuvant-chemotherapy) TREATMENT_BREAST = Neoadjuvant chemotherapy (Treatment variables CodeSytem#neoadjuvant-chemotherapy) Value Set: Intent of therapy ValueSet CHEMOTXTYPE_BREAST Indicate the type of chemotherapy (select all that apply) 1..* choice Enable When: TREATMENT_BREAST = Adjuvant chemotherapy (Treatment variables CodeSytem#adjuvant-chemotherapy) TREATMENT_BREAST = Neoadjuvant chemotherapy (Treatment variables CodeSytem#neoadjuvant-chemotherapy) Value Set: Type of chemotherapy ValueSet ChemoTxStartDate-Known Is the start date of chemotherapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Adjuvant chemotherapy (Treatment variables CodeSytem#adjuvant-chemotherapy) TREATMENT_BREAST = Neoadjuvant chemotherapy (Treatment variables CodeSytem#neoadjuvant-chemotherapy) ChemoTxStartDate Please provide the start date of chemotherapy 1..1 date Enable When: ChemoTxStartDate-Known = true ChemoTxStopdate-Known Is the stop date of chemotherapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Adjuvant chemotherapy (Treatment variables CodeSytem#adjuvant-chemotherapy) TREATMENT_BREAST = Neoadjuvant chemotherapy (Treatment variables CodeSytem#neoadjuvant-chemotherapy) ChemoTxStopdate Please provide the stop date of chemotherapy 1..1 date Enable When: ChemoTxStopdate-Known = true HORMONTX_BREAST Indicate the intent of hormonal therapy 1..1 choice Enable When: TREATMENT_BREAST = Hormone therapy (SNOMED CT#169413002) Value Set: Intent of therapy ValueSet HORMONTXTYPE Indicate the type of hormonal therapy (select all that apply) 1..* choice Enable When: TREATMENT_BREAST = Hormone therapy (SNOMED CT#169413002) Value Set: Type of hormonal therapy ValueSet HORMONTXSTARTDATE-Known Is the start date of hormonal therapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Hormone therapy (SNOMED CT#169413002) HORMONTXSTARTDATE Please provide the start date of hormonal therapy 1..1 date Enable When: HORMONTXSTARTDATE-Known = true HORMONTXSTOPDATE-Known Is the stop date of hormonal therapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Hormone therapy (SNOMED CT#169413002) HORMONTXSTOPDATE Please provide the stop date of hormonal therapy, if applicable 1..1 date Enable When: HORMONTXSTOPDATE-Known = true TARGETTX_BREAST Indicate the type of targeted therapy 1..1 choice Enable When: TREATMENT_BREAST = Targeted therapy (Treatment variables CodeSytem#targeted-therapy) Value Set: Type of targeted therapy ValueSet TargetTxStartDate-Known Is the start date of targeted therapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Targeted therapy (Treatment variables CodeSytem#targeted-therapy) TargetTxStartDate Please provide the start date of targeted therapy 1..1 date Enable When: TargetTxStartDate-Known = true TargetTxStopDate-Known Is the stop date of targeted therapy known? 1..1 boolean Enable When: TREATMENT_BREAST = Targeted therapy (Treatment variables CodeSytem#targeted-therapy) TargetTxStopDate Please provide the stop date of targeted therapy 1..1 date Enable When: TargetTxStopDate-Known = true SURGERYPATIENT Indicate if the patient has had one of the following re-operations since their surgery for breast cancer (select all that apply) 1..* choice Value Set: Type of re-operation SURGERYDATEPATIENT-Known Is the date of the reoperation known? 1..1 boolean Enable When: SURGERYPATIENT != unknown (NullFlavor#UNK) SURGERYPATIENT != Clinical finding absent (SNOMED CT#373572006) SURGERYDATEPATIENT Please provide the date of the reoperation 1..1 date Enable When: SURGERYDATEPATIENT-Known = true DisutilityofCare Disutility of care 1..1 group REOP_BREAST Indicate if the patient has undergone a reoperation due to involved margins after primary surgery 1..1 choice Enable When: SURGERY_BREAST != unknown (NullFlavor#UNK) Value Set: Re-operation due to involved margins ValueSet REOP_RECONSTRUCTION What type of reconstruction did the patient receive during reoperation? 1..1 choice Enable When: REOP_BREAST = Mastectomy with immediate reconstruction (Breast surgery types CodeSystem#mastectomy-with-immediate-reconstruction) Value Set: Type of reconstruction surgery ValueSet REOPDATE_BREAST-Known Is the date of the reoperation due to positive margins known? 1..1 boolean Enable When: REOP_BREAST != unknown (NullFlavor#UNK) REOPDATE_BREAST Provide the date of the reoperation due to positive margins 1..1 date Enable When: REOPDATE_BREAST-Known = true ComplicationImpact What was the impact of the complication experienced by the patient 1..* choice Enable When: TREATMENT_BREAST != No treatment (Treatment variables CodeSytem#no-treatment) TREATMENT_BREAST != unknown (NullFlavor#UNK) Value Set: Impact of complication ValueSet ComplicationAttrTreatment Indicate whether the complication is attributable to treatment 1..1 choice Enable When: ComplicationImpact != No complication (Impact of complication CodeSystem#no-complication) ComplicationImpact != unknown (NullFlavor#UNK) Value Set: Yes, No and Unknown Valueset COMPL_BREAST Indicate the type of complication 1..1 choice Enable When: ComplicationAttrTreatment = Yes (expandedYes-NoIndicator#Y) Value Set: Type of complication ValueSet Documentation for this format
Clinical response at 6 months post-treatment follow-up
HL7 International - Clinical Interoperability Council Group
Clinical response questionnaire at 6 months post-treatment follow-up
What is the patient's medical record number?
Indicate the pathological tumor stage (per AJCC 8th Ed.)
Indicate the pathological nodal stage (per AJCC 8th Ed.)
Indicate the pathological distant metastasis (per AJCC 8th Ed.)
Indicate size of invasive component of tumor (in mm)
Indicate the number of lymph nodes resected
Indicate the number of lymph nodes involved according to the TNM stage AJCC 8th Ed.
Indicate whether the patient received one of the following treatment during the last year (select all that apply)
Indicate whether the patient received surgery during the last year
Indicate whether the patient received surgery to the axilla
Is the date of surgery to the axilla known?
Please provide the date of surgery to the axilla
Indicate whether the patient received axillary clearance due to lymph node involvement after sentinel lymph node biopsy during the last year
Is the date of axillary clearance known?
Please provide the date of axillary clearance
Indicate whether the patient received a delayed reconstruction
Indicate what type of reconstruction the patient received
Is the date of the delayed reconstruction known?
Please provide the date of delayed reconstruction
Is the start date of radiotherapy known?
Please provide the start date of radiotherapy
Please provide the stop date of radiotherapy
Indicate the type of chemotherapy (select all that apply)
Is the start date of chemotherapy known?
Please provide the start date of chemotherapy
Please provide the stop date of chemotherapy
Indicate the type of hormonal therapy (select all that apply)
Is the start date of hormonal therapy known?
Please provide the start date of hormonal therapy
Is the stop date of hormonal therapy known?
Please provide the stop date of hormonal therapy, if applicable
Is the start date of targeted therapy known?
Please provide the start date of targeted therapy
Is the stop date of targeted therapy known?
Please provide the stop date of targeted therapy
Indicate if the patient has had one of the following re-operations since their surgery for breast cancer (select all that apply)
Please provide the date of the reoperation
Indicate if the patient has undergone a reoperation due to involved margins after primary surgery
What type of reconstruction did the patient receive during reoperation?
Is the date of the reoperation due to positive margins known?
Provide the date of the reoperation due to positive margins
What was the impact of the complication experienced by the patient
Indicate whether the complication is attributable to treatment