INCISIVE Implementation Guide - Local Development build (v0.1.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Colorectal Cancer Message Support Guidance

Introduction

This guide aims to explain the process to follow in order to read and understand the message “Colorectal-Cancer-Message-Bundle-Example” based on Colorectal Excel template. More information on FHIR messages can also be found in Simplifier INCISIVE project.

Message description

In this chapter describes the message content in a table containing these columns.

Table Columns description

Column Name	Description
Tab Template	Tab name included in excel file of Colorectal Cancer
Variable	Variable name included in Excel file
ID resource	ID identification inside the assigned resource
FHIR message location	Attribute used to inform the variable inside the bundle
Example value	Example value used to inform the variable assigned
Required by FHIR specification	Inform the variable is mandatory/optional in XML, based on compliance with the FHIR specification
INCISIVE profile	URL of profiles created by INCISIVE
Condition	Description term condition

Table with Message description

Tab template General Info

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Patient Number	colorectalpatient01	Patient.identifier.value	004-000001	Optional
Gender	colorectalpatient01	Patient.gender	female	Optional
Age at diagnosis	colorectaldiagnosticReport01	DiagnosticReport.extension.valueAge.value	56	Mandatory	Extension
Ethnicity	colorectalpatient01	Patient.extension.valueCodeableConcept.coding.code	1	Optional	Extension
		Patient.extension.valueCodeableConcept.coding.display	White	Optional
Familial Cancer History Father	colorectalobservation01	Observation.component.valueBoolean	true	Optional
Familial Cancer History Mother	colorectalobservation01	Observation.component.valueBoolean	true	Optional
Medical History	colorectalcondition01	Condition.code.text	N39.8	Optional
Medication general info	colorectalmedication01	Medication.code.text	Medication therapy	Optional
Syndromes	colorectalcondition01	Condition.evidence.code.coding.code	2	Optional	CodeSystem
		Condition.evidence.code.coding.display	Hereditary non-polyposis colon cancer syndrome (HNPCC)	Optional
CEA general info	colorectalobservation01	Observation.component.valueQuantity.value	11.9	Optional
CA19-9	colorectalobservation01	Observation.component.valueQuantity.value	37	Optional
Current state	colorectalpatient01	Patient.extension.valueCode	0	Optional	Extension
Note general info	colorectalobservation01	Observation.note.text	Observation note	Mandatory
Provider	colorectalorganization01	Organization.identifier.type.coding.code	1	Optional	CodeSystem
		Organization.identifier.type.coding.display	AUTH	Optional
Case	-	MessageHeader.eventCoding.display	Malignant neoplasm of colon and/or rectum (disorder)	Mandatory
Delivery Time general info	-	Bundle.timestamp	2023-07-25T12:29:17.239+02:00	Optional

Tab template Baseline

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Altered bowel habit baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Iron-deficiency anemia baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Bowel obstruction baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Weight Loss baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Other symptoms baseline	colorectalcondition02	Condition.evidence.code.text	Other symptoms	Optional
Existence of Laboratory data baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Computerized axial tomography (CT) baseline	colorectalobservation03	Observation.component.valueBoolean	true	Optional
Annotated CT baseline	colorectalobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Magnetic resonance imaging (MRI) baseline	colorectalobservation03	Observation.component.valueBoolean	true	Optional
Annotated MRI baseline	colorectalobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Positron emission tomography (PET/CT) baseline	colorectalobservation03	Observation.component.valueBoolean	true	Optional
Annotated PET/CT baseline	colorectalobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Histopathology Image baseline	colorectalobservation03	Observation.component.valueBoolean	true	Optional
Annotated Histopathology Image baseline	colorectalobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Xray baseline	colorectalobservation03	Observation.component.valueBoolean	true	Optional
Annotated Xray baseline	colorectalobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Location baseline	colorectalobservation03	Observation.bodySite.coding.code	6	Optional	CodeSystem
		Observation.bodySite.coding.display	Rectal	Optional
Location for rectal cancer	colorectalobservation03	Observation.bodySite.coding.code	3	Optional	CodeSystem	If Location baseline=6 or Rectal, else delete coding Location for rectal cancer
		Observation.bodySite.coding.display	High rectal	Optional
Max tumor diameter baseline	colorectalobservation02	Observation.component.valueQuantity.value	4.8	Optional
Lymph nodes baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Lymph node stations baseline	colorectalobservation02	Observation.component.valueInteger	13	Optional
Lymph nodes max short axis diameter baseline	colorectalobservation02	Observation.component.valueQuantity.value	9	Optional
Distant metastasis baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
Distant metastasis location baseline	colorectalobservation02	Observation.bodySite.coding.code	3	Optional	CodeSystem
		Observation.bodySite.coding.display	Ovary	Optional
Ti baseline	colorectalobservation02	Observation.component.valueString	Tis	Optional
Ni baseline	colorectalobservation02	Observation.component.valueString	N0	Optional
Mi baseline	colorectalobservation02	Observation.component.valueString	M0	Optional
Stage	colorectalobservation02	Observation.component.valueString	IIA	Optional
Rectal cancer baseline	colorectalobservation02	Observation.component.valueBoolean	true	Optional
MRF involvement	colorectalobservation02	Observation.component.valueBoolean	true	Optional
EMVI	colorectalobservation02	Observation.component.valueBoolean	true	Optional

Tab template Timepoints

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Label timepoints	colorectalobservation04	Observation.code.coding.code	1	Mandatory	CodeSystem
		Observation.code.coding.display	After 1st Treatment	Mandatory
Define other if selected timepoints	colorectalobservation04	Observation.category.text	Between 1st and 2nd dose of CT	Optional
Date timepoints	colorectalobservation04	Observation.valueInteger	2	Optional
Altered bowel habit timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Iron-deficiency anemia timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Bowel obstruction timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Weight Loss timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Other symptoms timepoints	colorectalcondition03	Condition.evidence.code.text	Other symptoms	Optional
Performance status	colorectalobservation04	Observation.component.valueInteger	5	Optional
Existence of Laboratory data timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Computerized axial tomography (CT) timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Annotated CT timepoints	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Magnetic resonance imaging (MRI) timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Annotated MRI timepoints	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Positron emission tomography (PET/CT) timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Annotated PET/CT timepoints	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Histopathology Image timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Annotated Histopathology Image timepoints	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Xray timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Annotated Xray timepoints	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional
Max tumor diameter timepoints	colorectalobservation04	Observation.component.valueQuantity.value	4.8	Optional
Lymph nodes timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Lymph node stations timepoints	colorectalobservation04	Observation.component.valueInteger	13	Optional
Lymph nodes max short axis diameter timepoints	colorectalobservation04	Observation.component.valueQuantitiy.value	9	Optional
Distant metastasis timepoints	colorectalobservation04	Observation.component.valueBoolean	true	Optional
Distant metastasis location timepoints	colorectalobservation04	Observation.bodySite.coding.code	3	Optional	CodeSystem
		Observation.bodySite.coding.display	Ovary	Optional
Response to treatment	colorectalobservation04	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	CR	Optional
Ti timepoints	colorectalobservation04	Observation.component.valueString	Tis	Optional
Ni timepoints	colorectalobservation04	Observation.component.valueString	N0	Optional
Mi timepoints	colorectalobservation04	Observation.component.valueString	M0	Optional

Tab template Treatment

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Label treatment	colorectalobservation05	Observation.code.coding.code	1	Mandatory	CodeSystem
		Observation.code.coding.display	After 1st Treatment-1st FollowUp	Mandatory
Define other if selected treatment	colorectalobservation05	Observation.category.text	Between 1st and 2nd dose of CT	Optional
Surgery treatment	If = true
Type of surgery	colorectalprocedure01	Procedure.category.text	Segmentomy	Optional		If Surgery treatment=true, else delete all colorectalprocedure01
Date of surgery	colorectalprocedure01	Procedure.performedString	2	Optional
Chemotherapy (CTX)	If = true
Type of CTX	colorectalprocedure02	Procedure.code.text	Capecitabine	Optional		If CTX=true, else delete all colorectalprocedure02
Date of last CTX	colorectalprocedure02	Procedure.performedString	2	Optional
Chemoradiotherapy (CRT)	If = true
Type of CRT	colorectalprocedure03	Procedure.code.text	Nitrosoureas	Optional		If CRT=true, else delete all colorectalprocedure03
Date of last CRT	colorectalprocedure03	Procedure.performedString	2	Optional
Chemoimmunotherapy (CIT)	If = true
Type of CIT	colorectalprocedure04	Procedure.code.text	Tamoxifen	Optional		If CIT=true, else delete all colorectalprocedure04
Date of last CIT	colorectalprocedure04	Procedure.performedString	2	Optional
Radiation therapy (RT)	If = true
Date of last RT	colorectalprocedure05	Procedure.performedString	2	Optional		If RT=true, else delete all colorectalprocedure05
Location of RT	colorectalprocedure05	Procedure.bodySite.coding.code	1	Optional	CodeSystem
		Procedure.bodySite.coding.display	Rectum	Optional
Delivered dose Rectum [Gy]	colorectalmedicationAdministration01	MedicationAdministration.dosage.dose.value	40.4	Optional
Delivered dose LN [Gy]	colorectalmedicationAdministration02	MedicationAdministration.dosage.dose.value	50.4	Optional
Number of fractions	colorectalmedicationAdministration02	MedicationAdministration.dosage.rateQuantity.value	28	Optional
Neoadjuvant treatment	colorectalobservation05	Observation.component.valueBoolean	true	Optional
Post-treatment surgery	If = true
Type of post-treatment surgery	colorectalprocedure06	Procedure.category.text	Segmentomy	Optional		If Post-treatment surgery=true, else delete all colorectalprocedure06
Date of post-treatment surgery	colorectalprocedure06	Procedure.performedString	2	Optional

Tab template Histology - Mutations

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Biopsy	If = true
Biopsy label	colorectalprocedure07	Procedure.statusReason.coding.code	1	Optional	CodeSystem	If Biopsy=true, else delete all colorectalprocedure07
		Procedure.statusReason.coding.display	After 1st Treatment	Optional
Define other if selected histology-mutations	colorectalprocedure07	Procedure.category.text	Between 1st and 2nd dose of CT	Optional
Date of Biopsy	colorectalprocedure07	Procedure.performedString	2	Optional
Surgery histology-mutations	If = true
Surgery date	colorectalprocedure08	Procedure.performedString	2	Optional
Colon Cancer Type	colorectalobservation08	Observation.category.coding.code	1	Optional	CodeSystem
	colorectalobservation08	Observation.category.coding.display	Adenocarcinoma	Optional
Colon Cancer Grade	colorectalobservation08	Observation.component.valueInteger	1	Optional
K-Ras	colorectalobservation06	Observation.component.valueBoolean	true	Optional
APC	colorectalobservation06	Observation.component.valueBoolean	true	Optional
TP53	colorectalobservation06	Observation.component.valueBoolean	true	Optional
18q LOH	colorectalobservation06	Observation.component.valueBoolean	true	Optional
TGFBR	colorectalobservation06	Observation.component.valueBoolean	true	Optional
PIK3CA	colorectalobservation06	Observation.component.valueBoolean	true	Optional
MSI	colorectalobservation06	Observation.component.valueBoolean	true	Optional
MMR	colorectalobservation06	Observation.component.valueBoolean	true	Optional
Sampling	colorectalobservation07	Observation.component.valueString	Light microscopy	Optional
Staining/type of assay performed	colorectalobservation07	Observation.component.valueString	Hematoxylin	Optional
Magnification	colorectalobservation07	Observation.component.valueString	x10	Optional
Other sample-related information	colorectalobservation07	Observation.component.valueString	example	Optional

Tab template Lab Results

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Exam label	colorectalobservation09	Observation.code.coding.code	1	Mandatory	CodeSystem
		Observation.code.coding.display	After 1st Treatment	Mandatory
Define other if selected lab results	colorectalobservation09	Observation.category.text	Between 1st and 2nd dose of CT	Optional
Date Laboratory	colorectalobservation09	Observation.valueInteger	2	Optional
Leukocytes	colorectalobservation09	Observation.component.valueQuantity.value	15.8	Optional
Hemoglobin (Hb)	colorectalobservation09	Observation.component.valueQuantity.value	16.7	Optional
Hematocrit (HCT)	colorectalobservation09	Observation.component.valueQuantity.value	47.4	Optional
Platelets (PLT)	colorectalobservation09	Observation.component.valueQuantity.value	287	Optional
Blood sugar level	colorectalobservation09	Observation.component.valueQuantity.value	87	Optional
Insulin	colorectalobservation09	Observation.component.valueQuantity.value	4	Optional
Urea	colorectalobservation09	Observation.component.valueQuantity.value	36	Optional
Creatinine	colorectalobservation09	Observation.component.valueQuantity.value	0.72	Optional
Uric acid	colorectalobservation09	Observation.component.valueQuantity.value	3.5	Optional
Potassium	colorectalobservation09	Observation.component.valueQuantity.value	4.8	Optional
Sodium	colorectalobservation09	Observation.component.valeQuantity.value	142	Optional
Calcium	colorectalobservation09	Observation.component.valueQuantity.value	9.31	Optional
Cholesterol	colorectalobservation09	Observation.component.valueQuantity.value	197	Optional
Triglycerides	colorectalobservation09	Observation.component.valueQuantity.value	59	Optional
HDL	colorectalobservation09	Observation.component.valueQuantity.value	60	Optional
Low density lipoprotein (LDL)	colorectalobservation09	Observation.component.valueQuantity.value	120	Optional
SGOT	colorectalobservation09	Observation.component.valueQuantity.value	19	Optional
SGPT	colorectalobservation09	Observation.component.valueQuantity.value	33	Optional
y-GT	colorectalobservation09	Observation.component.valueQuantity.value	14	Optional
ALP	colorectalobservation09	Observation.component.valueQuantity.value	227	Optional
LDH	colorectalobservation09	Observation.component.valueQuantity.value	270	Optional
TSH	colorectalobservation09	Observation.component.valueQuantity.value	0.73	Optional
Cortisol	colorectalobservation09	Observation.component.valueQuantity.value	22	Optional
CRP	colorectalobservation09	Observation.component.valueQuantity.value	0.5	Optional
BNP	colorectalobservation09	Observation.component.valueQuantity.value	120	Optional
HbA1c	colorectalobservation09	Observation.component.valueQuantity.value	5.1	Optional
Total protein in urine	colorectalobservation09	Observation.component.valueQuantity.value	80	Optional
Creatinine urine	colorectalobservation09	Observation.component.valueQuantity.value	100	Optional
Carcinoembryonic antigen (CEA)	colorectalobservation09	Observation.component.valueQuantity.value	11.9	Optional

In order to build the message for each patient, and to report the variables in the table above, the following steps must be followed:

1. Search inside the message text with the same word that appears in the “Variable” column.
2. Check that the resource to which it redirects us has the same id as in the “ID resource” column.
3. Enter the desired value in the double quoted space of the attribute indicated in the “Fhirmessage location” column.
4. Do not delete any part of the message, the whole structure must be the same, just change the example value, for the value you want to report. Do not change the order.
5. If you don’t have the information of the element, you can delete the node, but validate XML to ensure the structure of the XML FHIR is still correct and has no errors (you can omit the warnings in the validation). The entire message structure is static except for the values given for the attributes in the “Fhir message location” column and the timestamp which is the current datatime.
   

Description mandatory/optional of term

There will be mandatory/optional for different scenarios, according to different scenarios corresponding to different rules. These scenarios are described separately below.

• If the attribute is mandatory, all attribute structure information for this column must be reported. It cannot be deleted.

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Notes general info	colorectalobservation01	Observation.note.text	Observation note	Mandatory

• If the attribute is mandatory with a comment reporting the condition of this variable, all attribute structure information for this column must be reported, unless the variable has not value for report, all resources must be deleted.

• If an optional attribute needs to be deleted, all attribute structures except for the primary resource (e.g., observation, procedure, condition, etc.) must be deleted if that primary resource has another variable. For example, for the variable Gender, you can delete the attribute gender from the resource Patient, while other attributes such as identifier have values and do not have to be deleted.

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Gender	colorectalpatient01	Patient.gender	female	Optional

• If the attribute is optional, this happens in observation.component because Observation.component has two parts inside, Observation.component.code and Observation.component.value (this value can be valueCodeableConcept, ValueBoolean, ValueSrting, valueInteger, valueQuantity, etc.). If the variable has a value that needs to be informed, then code is mandatory, that code is mostly the SNOMED CT code or LOINC code for that variable. This means that if you need to delete variable, then you need to delete all Observation.component and cannot delete the whole Observation resource, unless there are no other elements in the same Observation, then you can delete the whole Observation resource.

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Annotated CT baseline	breastobservation03	Observation.component.valueCodeableConcept.coding.code	1	Optional	CodeSystem
		Observation.component.valueCodeableConcept.coding.display	Positive annotation	Optional

• If the attribute is optional with a comment reporting the condition of this variable, you can delete all resource if the variable has not value for report.

Variable	ID resource	FHIR message location	Example Value	Required by FHIR specification	INCISVE Profile	Condition
Date of surgery	colorectalprocedure01	Procedure.performedString	2	Optional