FLUTE Cross-border Prostate Cancer Data Standard Guide
0.1.0 - ci-build
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
| Draft as of 2025-11-05 |
Definitions for the StudyVariables logical model.
Guidance on how to interpret the contents of this table can be foundhere
| 0. StudyVariables | |
| Definition | Study variables for a study on prostate cancer. |
| Short | Prostate Cancer study Variables |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. StudyVariables.patient | |
| Definition | Patient |
| Short | Patient |
| Control | 1..1 |
| Type | Reference(Patient) |
| 4. StudyVariables.ageAtBiopsy | |
| Definition | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Short | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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. |
| Short | Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml. |
| Control | 1..1 |
| Type | Quantity |
| 12. StudyVariables.dre | |
| Definition | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Short | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc). |
| Control | 1..1 |
| Type | Quantity |
| 16. StudyVariables.pirads | |
| Definition | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Short | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Guidance on how to interpret the contents of this table can be foundhere
| 0. StudyVariables | |
| Definition | Study variables for a study on prostate cancer. |
| Short | Prostate Cancer study Variables |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. StudyVariables.patient | |
| Definition | Patient |
| Short | Patient |
| Control | 1..1 |
| Type | Reference(Patient) |
| 4. StudyVariables.ageAtBiopsy | |
| Definition | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Short | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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. |
| Short | Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml. |
| Control | 1..1 |
| Type | Quantity |
| 12. StudyVariables.dre | |
| Definition | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Short | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc). |
| Control | 1..1 |
| Type | Quantity |
| 16. StudyVariables.pirads | |
| Definition | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Short | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Guidance on how to interpret the contents of this table can be foundhere
| 0. StudyVariables | |
| Definition | Study variables for a study on prostate cancer. |
| Short | Prostate Cancer study Variables |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. StudyVariables.patient | |
| Definition | Patient |
| Short | Patient |
| Control | 1..1 |
| Type | Reference(Patient) |
| 4. StudyVariables.ageAtBiopsy | |
| Definition | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Short | Age at the time of biopsy. Represents the patient's age when the biopsy was performed. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Family history of prostate cancer. Indicates whether the patient has a known family history of prostate cancer (0: No, 1: Yes). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Type of biopsy. Specifies whether the biopsy was an initial biopsy or a repeated one (0: initial, 2: repeated). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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. |
| Short | Level of prostate-specific antigen. The measurement of PSA levels in the blood, typically reported in ng/ml. |
| Control | 1..1 |
| Type | Quantity |
| 12. StudyVariables.dre | |
| Definition | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Short | Results of digital rectal examination. Indicates the findings of the DRE (0: normal, 1: suspicious). |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This 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). |
| Short | Prostate volume as determined by MRI. The measured volume of the prostate, typically reported in cubic centimeters (cc). |
| Control | 1..1 |
| Type | Quantity |
| 16. StudyVariables.pirads | |
| Definition | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Short | PI-RADS score. The Prostate Imaging Reporting and Data System score used to assess prostate cancer risk on MRI. |
| Control | 1..1 |
| Type | integer |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |