INCISIVE Implementation Guide
0.1.1 - draft

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

Prostate Cancer Message Support Guidance

Introduction

This guide aims to explain the process to follow in order to read and understand the message “Prostate-Cancer-Message-Bundle-Example” based on Prostate 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 Prostate 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 prostatepatient01 Patient.identifier.value 004-000001 Optional
Age at diagnosis prostatediagnosticReport01 DiagnosticReport.extension.valueAge.value 56 Mandatory Extension
Ethnicity prostatepatient01 Patient.extension.valueCodeableConcept.coding.code 1 Optional Extension
Patient.extension.valueCodeableConcept.coding.display White Optional
Family history of Pca prostateobservation01 Observation.component.valueBoolean true Optional
Familial Cancer History Father prostateobservation01 Observation.component.valueBoolean true Optional
Familial Cancer History Mother prostateobservation01 Observation.component.valueBoolean true Optional
Medical History prostatecondition01 Condition.code.text MG30.10 Optional
Medication general info prostatemedication01 Medication.code.text Medication therapy Optional
Symptoms general info prostatecondition01 Condition.evidence.code.coding.code 1 Optional CodeSystem
Condition.evidence.code.coding.display Difficulty starting urination Optional
Clinical findings general info prostatecondition02 Condition.note.text Dysuria Mandatory If Clinical findings general info=null delete all prostatecondition02
Current state prostatepatient01 Patient.extension.valueCode 0 Optional Extension
Provider prostateorganization01 Organization.identifier.type.coding.code 1 Optional CodeSystem
Organization.identifier.type.coding.display AUTH Optional
Case - MessageHeader.eventCoding.display Malignant tumor of prostate (disorder) Mandatory
Delivery Time general info - Bundle.timestamp 2023-07-24T12:29:17.239+02:00 Optional

Tab template Baseline

Variable ID resource FHIR message location Example Value Required by FHIR specification INCISVE Profile Condition
Computerized axial tomography (CT) baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated CT baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Positron emission tomography (PET) baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated PET baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Magnetic resonance imaging (MRI) baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated MRI baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
MRI type baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 0 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Prior biopsy Optional
Bone Scintigraphy Scan baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated Bone Scintigraphy Scan baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Histopathology Image baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated Histopathology Image baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Xray baseline prostateobservation02 Observation.component.valueBoolean true Optional
Annotated Xray baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Prostate volume prostateobservation02 Observation.component.valueQuantity.value 2 Optional
Side of tumor prostateobservation02 Observation.component.valueCodeableConcept.coding.code 0 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Right Optional
Maximum PIRADS prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display PIRADS 1 Optional
Localization of PIRADS prostateobservation02 Observation.bodySite.coding.code 3 Optional CodeSystem
Observation.bodySite.coding.display pZp apex Optional
Extraprostatic extention prostateobservation02 Observation.component.valueBoolean true Optional
Seminal vesicle invasion baseline prostateobservation02 Observation.component.valueBoolean true Optional
PSA baseline prostateobservation02 Observation.component.valueQuantity.value 4.48 Optional
cT baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display cT1 Optional
cN baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display N1 Optional
cM baseline prostateobservation02 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display M1 Optional

Tab template Timepoints

Variable ID resource FHIR message location Example Value Required by FHIR specification INCISVE Profile Condition
Label timepoints prostateobservation08 Observation.code.coding.code 1 Mandatory CodeSystem
Observation.code.coding.display After 1st Treatment Mandatory
Define other if selected timepoints prostateobservation08 Observation.category.text Between 1st and 2nd dose of CT Optional
Date timepoints prostateobservation08 Observation.valueInteger 2 Optional
PSA 1 prostateobservation03 Observation.component.valueQuantity.value 4.26 Optional
Date - PSA 1 prostateobservation03 Observation.valueInteger 2 Optional
PSA 2 prostateobservation04 Observation.component.valueQuantity.value 3.5 Optional
Date - PSA 2 prostateobservation04 Observation.valueInteger 3 Optional
PSA 3 prostateobservation05 Observation.component.valueQuantity.value 4.1 Optional
Date - PSA 3 prostateobservation05 Observation.valueInteger 4 Optional
PSA 4 prostateobservation06 Observation.component.valueQuantity.value 2.7 Optional
Date - PSA 4 prostateobservation06 Observation.valueInteger 5 Optional
PSA 5 prostateobservation07 Observation.component.valueQuantity.value 5.8 Optional
Date - PSA 5 prostateobservation07 Observation.valueInteger 6 Optional
Biochemical recurrence prostateobservation08 Observation.component.valueBoolean true Optional
Date of biochemical recurrence prostateobservation08 Observation.component.valueInteger 2 Optional If Biochemical recurrence=true, else delete component Date of biochemical recurrence
Free period of BR prostateobservation08 Observation.component.valueInteger 4 Optional If Biochemical recurrence=true, else delete component Free period of BR
Magnetic resonance imaging (MRI) timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated MRI timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Computerized axial tomography (CT) timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated CT timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Bone Scintigraphy Scan timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated Bone Scintigraphy Scan timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Positron emission tomography (PET-choline) timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated PET-choline timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Histopathology Image timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated Histopathology Image timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Xray timepoints prostateobservation08 Observation.component.valueBoolean true Optional
Annotated Xray timepoints prostateobservation08 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display Positive annotation Optional
Salvage therapy with radiotherapy prostateobservation08 Observation.component.valueBoolean true Optional
PSA nadir post-RDT prostateobservation08 Observation.component.valueQuantity.value 4.26 Optional
Salvage therapy with ADT prostateobservation08 Observation.component.valueBoolean true Optional
Distance recurrence prostateobservation08 Observation.component.valueBoolean true Optional

Tab template Treatment

Variable ID resource FHIR message location Example Value Required by FHIR specification INCISVE Profile Condition
Label treatment prostateobservation09 Observation.code.coding.code 1 Mandatory CodeSystem
Observation.code.coding.display After 1st Treatment-1st FollowUp Mandatory
Define other if selected treatment prostateobservation09 Observation.category.text Between 1st and 2nd dose of CT Optional
Treatment prostateprocedure01 Procedure.code.coding.code 1 Optional CodeSystem
Procedure.code.coding.display Active surveillance Optional
Date of treatment prostateprocedure01 Procedure.performedString 2 Optional
Type of therapy prostateprocedure01 Procedure.category.coding.code 0 Optional CodeSystem
Procedure.category.coding.display EBRT = External Beam Radiotherapy Optional
Lymph node dissection prostateobservation09 Observation.component.valueBoolean true Optional
Response to treatment prostateobservation09 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display CR Optional

Tab template Histology - Mutations

Variable ID resource FHIR message location Example Value Required by FHIR specification INCISVE Profile Condition
Biopsy label prostateprocedure02 Procedure.statusReason.coding.code 1 Optional CodeSystem
Procedure.statusReason.coding.display After 1st Treatment Optional
Date of Biopsy prostateprocedure02 Procedure.performedString 3 Optional
Type of Biopsy prostateprocedure02 Procedure.category.coding.code 1 Optional CodeSystem
Procedure.category.coding.display Randomized biopsy Optional
Define other if selected histology-mutations prostateprocedure02 Procedure.category.text Between 1st and 2nd dose of CT Optional
Max Gleason prostateobservation10 Observation.component.valueInteger 7 Optional
ISUP group prostateobservation10 Observation.component.valueInteger 4 Optional
% of affected cores in the right lobe prostateobservation10 Observation.component.valueQuantity.value 95 Optional
% of affected cores in the left lobe prostateobservation10 Observation.component.valueQuantity.value 60 Optional
Intraductal prostateobservation10 Observation.component.valueBoolean true Optional
Cribriform features prostateobservation10 Observation.component.valueBoolean true Optional
pT histology-mutations prostateobservation10 Observation.component.valueCodeableConcept.coding.code 1 Optional ​CodeSystem
Observation.component.valueCodeableConcept.coding.display pT1 Optional
Gleason Total PR prostateobservation10 Observation.component.valueInteger 6 Optional
Seminal vesicle invasion histology-mutations prostateobservation10 Observation.component.valueBoolean true Optional
Extraprostatic extension prostateobservation10 Observation.component.valueBoolean true Optional
pN histology-mutations prostateobservation10 Observation.component.valueCodeableConcept.coding.code 1 Optional CodeSystem
Observation.component.valueCodeableConcept.coding.display N1 Optional
Sampling prostateobservation11 Observation.component.valueString Light microscopy Optional
Staining/type of assay performed prostateobservation11 Observation.component.valueString Hematoxylin Optional
Magnification prostateobservation11 Observation.component.valueString x10 Optional
Other sample-related information prostateobservation11 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 prostateobservation12 Observation.code.coding.code 1 Mandatory CodeSystem
Observation.code.coding.display After 1st Treatment Mandatory
Define other if selected lab results prostateobservation12 Observation.category.text Between 1st and 2nd dose of CT Optional
Date Laboratory prostateobservation12 Observation.valueInteger 2 Optional
Leukocytes prostateobservation12 Observation.component.valueQuantity.value 15.8 Optional
Hemoglobin (Hb) prostateobservation12 Observation.component.valueQuantity.value 16.7 Optional
Hematocrit (HCT) prostateobservation12 Observation.component.valueQuantity.value 47.4 Optional
Platelets (PLT) prostateobservation12 Observation.component.valueQuantity.value 287 Optional
Blood sugar level prostateobservation12 Observation.component.valueQuantity.value 87 Optional
Insulin prostateobservation12 Observation.component.valueQuantity.value 4 Optional
Urea prostateobservation12 Observation.component.valueQuantity.value 36 Optional
Creatinine prostateobservation12 Observation.component.valueQuantity.value 0.72 Optional
Uric acid prostateobservation12 Observation.component.valueQuantity.value 3.5 Optional
Potassium prostateobservation12 Observation.component.valueQuantity.value 4.8 Optional
Sodium prostateobservation12 Observation.component.valueQuantity.value 142 Optional
Calcium prostateobservation12 Observation.component.valueQuantity.value 9.31 Optional
Cholesterol prostateobservation12 Observation.component.valueQuantity.value 197 Optional
Triglycerides prostateobservation12 Observation.component.valueQuantity.value 59 Optional
HDL prostateobservation12 Observation.component.valueQuantity.value 60 Optional
Low density lipoprotein (LDL) prostateobservation12 Observation.component.valueQuantity.value 120 Optional
SGOT prostateobservation12 Observation.component.valueQuantity.value 19 Optional
SGPT prostateobservation12 Observation.component.valueQuantity.value 33 Optional
y-GT prostateobservation12 Observation.component.valueQuantity.value 14 Optional
ALP prostateobservation12 Observation.component.valueQuantity.value 227 Optional
LDH prostateobservation12 Observation.component.valueQuantity.value 270 Optional
TSH prostateobservation12 Observation.component.valueQuantity.value 0.73 Optional
Cortisol prostateobservation12 Observation.component.valueQuantity.value 22 Optional
CRP prostateobservation12 Observation.component.valueQuantity.value 0.5 Optional
BNP prostateobservation12 Observation.component.valueQuantity.value 120 Optional
HbA1c prostateobservation12 Observation.component.valueQuantity.value 5.1 Optional
Total protein in urine prostateobservation12 Observation.component.valueQuantity.value 80 Optional
Creatinine urine prostateobservation12 Observation.component.valueQuantity.value 100 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
Label timepoints prostateobservation08 Observation.code.coding.code 1 Mandatory CodeSystem
Observation.code.coding.display After 1st Treatment 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.
Variable ID resource FHIR message location Example Value Required by FHIR specification INCISVE Profile Condition
Clinical findings general info prostatecondition02 Condition.note.text Dysuria Mandatory If Clinical findings general info=null delete all prostatecondition02
  • 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
Current state prostatepatient01 Patient.extension.valueCode 0 Optional Extension
  • 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 prostateobservation02 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 biochemical recurrence prostateobservation08 Observation.component.valueInteger 2 Optional If Biochemical recurrence=true, else delete component Date of biochemical recurrence

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