FLUTE Cross-border Prostate Cancer Data Standard Guide
0.1.0 - ci-build
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
Logical models representing the prostate cancer study variables
| Inclusion Criteria for Prostate Cancer Cohorts |
Criteria for including men in cohorts based on clinical suspicion of prostate cancer. |
| Prostate Cancer study Variables |
Study variables for a study on prostate cancer. |
Model Mapping from the StudyVariables Logical models and this guide
| Concept Map for Inclusion Criteria to FHIR |
Concept map defining the inclusion criteria for prostate cancer cohorts, mapping study variables to FHIR resources. |
| Requirements to Study variables Model Map |
Requirements to Study variables Model Map |
| Study variables Model to FHIR R4 Map |
Study variables Model to this guide Map |
HL7 FHIR Profiles representing Prostate Cancer Study variables
| FamilyMemberHistory: prostate cancer family history |
A record detailing a patient's family history of prostate cancer. |
| Observation: PI-RADS |
A risk assessment based on the PI-RADS (Prostate Imaging-Reporting and Data System) scoring system. |
| Observation: prostate specific antigen |
Observation for the measurement of prostate specific antigen (PSA) levels in the blood. |
| Observation: prostate volume |
Observation for measuring the volume of the prostate. |
| Procedure: biopsy |
This profile represents the biopsy procedure performed on a patient. |
| Procedure: DRE |
This profile represents the digital rectal examination (DRE) procedure performed on a patient. |
HL7 FHIR Profiles implementing outcome variable for Prostate Cancer study
| Observation: Outcome BCN-RC 2 |
This profile represents the outcome for BCN-RC 2 ISUP-GG. |
These define logic, asset collections and other libraries as part of content in this implementation guide.
| Prostate Cancer Inclusion Criteria |
Defines criteria for including patients in prostate cancer cohorts. |
| Prostate Cancer Research Variables |
Retrieves key research variables for prostate cancer studies. |
These define forms used by systems conforming to this implementation guide to capture or expose data to end users.
| Study variable Extraction |
Study variable extractable questionnaire |
These define constraints on FHIR resources for systems conforming to this implementation guide.
| DocumentReference: link with variables |
This profile described how to link an Image (or other kinds of 'documents' with the associated FLUTE variables. |
| ImagingStudy: link with variables |
This profile described how to link an Imaging Study with the associated FLUTE variables. |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| Resource supporting information |
This extension provides a means to link the source resource to any target related information. This extension shall not be used when other more specific elements or standard extensions apply. E.g. Observation.hasMember. |
These define sets of codes used by systems conforming to this implementation guide.
| DRE Observation Interpretation Codes |
This ValueSet includes codes for interpreting the results of a digital rectal examination (DRE) in the context of prostate assessment. |
| Gleason Grade |
Gleason Grade for Prostate Cancer |
| Malignant tumor of prostate Value Set |
Malignant tumor of prostate. |
| Prostate Imaging – Reporting and Data System |
Prostate Imaging – Reporting andData System (R) |
| Type of Biopsy |
ValueSet for categorizing types of biopsy as initial or repeated |
These test plans are available to verify test coverage for this implementation guide
| TestPlan for the populate of a questionnaire and extract of a questionnaireResponse |
TestPlan for the populate of a questionnaire and extract of a questionnaireResponse for the study variable |
These test definitions are available to FHIR test engines to verify systems are conforming to this implementation guide
| Study Inclusion Criteria - Scenario 01 |
This TestScript evaluates the inclusion criteria for patients participating in the study. |
| Study Inclusion Criteria - Scenario 02 |
This TestScript evaluates the inclusion criteria for patients participating in the study. |
| This TestScript is designed to validate the cql library ResearchVariables2 |
This TestScript is designed to validate the cql library ResearchVariables2 with an extract of a questionnaire response |
| This TestScript is designed to validate the extract of a questionnaire response |
This TestScript is designed to validate the extract of a questionnaire response |
| This TestScript is designed to validate the populate of a questionnaire |
This TestScript is designed to validate the populate of a questionnaire |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| EXP-S1-IncludedPatient |
This bundle includes all the resources for a patient who has been included in the study. |
| EXP-S1-Patient |
The Patient included in the study S1. |
| EXP-S2-ExcludedPatient |
This bundle includes all the resources for a patient who has been excluded from the study. |
| EXP-S2-Patient |
The Patient excluded in the study S2. |
| Questionnaire-StudyVariable-S1 |
The Questionnaire response for the Patient included S1. |
| Questionnaire-StudyVariable-S2 |
The Questionnaire response for the Patient excluded S2. |