FLUTE Cross-border Prostate Cancer Data Standard Guide
0.1.0 - ci-build
Funded by the European Union

FLUTE Cross-border Prostate Cancer Data Standard Guide, published by Flute Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/flute/ and changes regularly. See the Directory of published versions

Logical Model: StudyVariables - Detailed Descriptions

Draft as of 2024-09-25

Definitions for the StudyVariables logical model.

Guidance on how to interpret the contents of this table can be found here

0. StudyVariables
Definition

Study variables for a study on prostate cancer.

ShortProstate Cancer study Variables
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. StudyVariables.patient
Definition

Patient

ShortPatient
Control1..1
TypeReference(Patient)
4. StudyVariables.ageAtBiopsy
Definition

Age at the time of biopsy. Represents the patient's age when the biopsy was performed.

ShortAge at the time of biopsy. Represents the patient's age when the biopsy was performed.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. StudyVariables.pcaFamilyHistory
Definition

Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).

ShortFamily history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. StudyVariables.typeOfBiopsy
Definition

Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).

ShortType of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. StudyVariables.psa
Definition

Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.

ShortLevel of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.
Control1..1
TypeQuantity
12. StudyVariables.dre
Definition

Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).

ShortResults of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
14. StudyVariables.prostateVolume
Definition

Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).

ShortProstate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).
Control1..1
TypeQuantity
16. StudyVariables.pirads
Definition

PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.

ShortPI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

Guidance on how to interpret the contents of this table can be found here

0. StudyVariables
Definition

Study variables for a study on prostate cancer.

ShortProstate Cancer study Variables
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. StudyVariables.patient
Definition

Patient

ShortPatient
Control1..1
TypeReference(Patient)
4. StudyVariables.ageAtBiopsy
Definition

Age at the time of biopsy. Represents the patient's age when the biopsy was performed.

ShortAge at the time of biopsy. Represents the patient's age when the biopsy was performed.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. StudyVariables.pcaFamilyHistory
Definition

Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).

ShortFamily history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. StudyVariables.typeOfBiopsy
Definition

Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).

ShortType of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. StudyVariables.psa
Definition

Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.

ShortLevel of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.
Control1..1
TypeQuantity
12. StudyVariables.dre
Definition

Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).

ShortResults of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
14. StudyVariables.prostateVolume
Definition

Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).

ShortProstate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).
Control1..1
TypeQuantity
16. StudyVariables.pirads
Definition

PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.

ShortPI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

Guidance on how to interpret the contents of this table can be found here

0. StudyVariables
Definition

Study variables for a study on prostate cancer.

ShortProstate Cancer study Variables
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. StudyVariables.patient
Definition

Patient

ShortPatient
Control1..1
TypeReference(Patient)
4. StudyVariables.ageAtBiopsy
Definition

Age at the time of biopsy. Represents the patient's age when the biopsy was performed.

ShortAge at the time of biopsy. Represents the patient's age when the biopsy was performed.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
6. StudyVariables.pcaFamilyHistory
Definition

Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).

ShortFamily history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
8. StudyVariables.typeOfBiopsy
Definition

Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).

ShortType of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
10. StudyVariables.psa
Definition

Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.

ShortLevel of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml.
Control1..1
TypeQuantity
12. StudyVariables.dre
Definition

Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).

ShortResults of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious).
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
14. StudyVariables.prostateVolume
Definition

Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).

ShortProstate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc).
Control1..1
TypeQuantity
16. StudyVariables.pirads
Definition

PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.

ShortPI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI.
Control1..1
Typeinteger
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension