Group

Description

We adapted the Group resource to collect information about the eligibility criteria in a study as well as the actual study population.

To this end, we modelled two profiles:

Title Canonical
NFDI4Health PR MDS Group Intended https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-intended
NFDI4Health PR MDS Group Actual https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-actual

References

Reference direction Title Path
referenced by NFDI4Health PR MDS Study ResearchStudy.extension[recruitment]
referenced by NFDI4Health PR MDS Chronic Diseases Condition.subject
referenced by NFDI4Health PR MDS Registry Library.subjectReference

Group Eligibility

NFDI4Health PR MDS Group Eligibility represents the eligibility criteria and the target study population size (intended group)

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valueCodeableConceptCodeableConcept
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modifierExtensionΣ ?! I0..*Extension
entityI1..1Reference(Patient | Practitioner | PractitionerRole | Device | Medication | Substance | Group)
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entityI1..1Reference(Patient | Practitioner | PractitionerRole | Device | Medication | Substance | Group)
periodI0..1Period
inactive0..1boolean
{
    "resourceType": "StructureDefinition",
    "id": "nfdi4health-pr-mds-group-eligibility",
    "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-intended",
    "version": "0.9",
    "name": "NFDI4Health_PR_MDS_Group_Eligibility",
    "title": "NFDI4Health PR MDS Group Eligibility",
    "status": "draft",
    "publisher": "NFDI4Health",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.nfdi4health.de"
                }
            ]
        }
    ],
    "description": "Information about the eligibility criteria in a study.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "NFDI4Health",
            "name": "NFDI4Health to FHIR Mapping"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "Group",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Group",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Group",
                "path": "Group",
                "short": "Eligibility criteria for [RESOURCE] participants",
                "definition": "Group of items providing information about eligibility criteria for [RESOURCE] participants.",
                "max": "1",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria"
                    }
                ]
            },
            {
                "id": "Group.actual",
                "path": "Group.actual",
                "fixedBoolean": false
            },
            {
                "id": "Group.characteristic",
                "path": "Group.characteristic",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "code"
                        }
                    ],
                    "rules": "open"
                },
                "short": "Eligibility criteria for study participants",
                "definition": "Group of items providing information about eligibility criteria for study participants."
            },
            {
                "id": "Group.characteristic:eligibleMinimumAge",
                "path": "Group.characteristic",
                "sliceName": "eligibleMinimumAge",
                "short": "Eligibility criteria: Minimum age",
                "definition": "Group of items providing information about the minimum eligible age of [RESOURCE] participants.",
                "min": 0,
                "max": "1",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMin"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMinimumAge.code",
                "path": "Group.characteristic.code",
                "fixedCodeableConcept": {
                    "coding":  [
                        {
                            "code": "189",
                            "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts",
                            "display": "Planned Minimum Age of Subjects"
                        }
                    ]
                }
            },
            {
                "id": "Group.characteristic:eligibleMinimumAge.value[x]",
                "path": "Group.characteristic.value[x]",
                "type":  [
                    {
                        "code": "Quantity"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMinimumAge.value[x].value",
                "path": "Group.characteristic.value[x].value",
                "short": "Minimum eligible age",
                "definition": "Numerical value of the minimum age of potential participants eligible to participate in the [RESOURCE].",
                "comment": "Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. | Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMin.number"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMinimumAge.value[x].code",
                "path": "Group.characteristic.value[x].code",
                "short": "Unit of age",
                "definition": "Unit of measurement used to describe the minimum eligible age.",
                "min": 1,
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-loinc"
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMin.timeUnit"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMaximumAge",
                "path": "Group.characteristic",
                "sliceName": "eligibleMaximumAge",
                "short": "Eligibility criteria: Maximum age",
                "definition": "Group of items providing information about the maximum eligible age of [RESOURCE] participants.",
                "min": 0,
                "max": "1",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMax"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMaximumAge.code",
                "path": "Group.characteristic.code",
                "fixedCodeableConcept": {
                    "coding":  [
                        {
                            "code": "190",
                            "system": "https://www.nfdi4health.de/fhir/metadataschema/CodeSystem/nfdi4health-cs-remaining-concepts",
                            "display": "Planned Maximum Age of Subjects"
                        }
                    ]
                }
            },
            {
                "id": "Group.characteristic:eligibleMaximumAge.value[x]",
                "path": "Group.characteristic.value[x]",
                "type":  [
                    {
                        "code": "Quantity"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMaximumAge.value[x].value",
                "path": "Group.characteristic.value[x].value",
                "short": "Maximum eligible age",
                "definition": "Numerical value of the maximum age of potential participants eligible to participate in the [RESOURCE].",
                "comment": "Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'. | Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMax.number"
                    }
                ]
            },
            {
                "id": "Group.characteristic:eligibleMaximumAge.value[x].code",
                "path": "Group.characteristic.value[x].code",
                "short": "Unit of time",
                "definition": "Unit of measurement used to describe the maximum eligible age.",
                "min": 1,
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-time-units-ucum-loinc"
                },
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.ageMax.timeUnit"
                    }
                ]
            },
            {
                "id": "Group.characteristic:gender",
                "path": "Group.characteristic",
                "sliceName": "gender",
                "short": "Eligible gender",
                "definition": "Gender of potential participants eligible to participate in the [RESOURCE].",
                "comment": "Short input help: Select all that apply. If no gender was explicitly excluded in the [RESOURCE], 'Male', 'Female', and 'Diverse' should be selected.",
                "min": 0,
                "max": "*",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.genders"
                    }
                ]
            },
            {
                "id": "Group.characteristic:gender.code",
                "path": "Group.characteristic.code",
                "fixedCodeableConcept": {
                    "coding":  [
                        {
                            "code": "263495000",
                            "system": "http://snomed.info/sct",
                            "display": "Gender (observable entity)"
                        }
                    ]
                }
            },
            {
                "id": "Group.characteristic:gender.value[x]",
                "path": "Group.characteristic.value[x]",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ]
            },
            {
                "id": "Group.characteristic:gender.value[x].coding",
                "path": "Group.characteristic.value[x].coding",
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-eligibility-gender-snomedct-local",
                    "description": "The gender of potential participants eligible to participate in the study."
                }
            },
            {
                "id": "Group.characteristic:inclusionCriteria",
                "path": "Group.characteristic",
                "sliceName": "inclusionCriteria",
                "short": "Inclusion criteria",
                "definition": "Inclusion criteria for participation in the [RESOURCE].",
                "comment": "Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.",
                "min": 0,
                "max": "1"
            },
            {
                "id": "Group.characteristic:inclusionCriteria.code",
                "path": "Group.characteristic.code",
                "fixedCodeableConcept": {
                    "coding":  [
                        {
                            "code": "55919000",
                            "system": "http://snomed.info/sct",
                            "display": "Including (qualifier value)"
                        }
                    ]
                }
            },
            {
                "id": "Group.characteristic:inclusionCriteria.value[x]",
                "path": "Group.characteristic.value[x]",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ]
            },
            {
                "id": "Group.characteristic:inclusionCriteria.value[x].text",
                "path": "Group.characteristic.value[x].text",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.inclusionCriteria"
                    }
                ]
            },
            {
                "id": "Group.characteristic:inclusionCriteria.exclude",
                "path": "Group.characteristic.exclude",
                "patternBoolean": false
            },
            {
                "id": "Group.characteristic:exclusionCriteria",
                "path": "Group.characteristic",
                "sliceName": "exclusionCriteria",
                "short": "Exclusion criteria",
                "definition": "Exclusion criteria for participation in the [RESOURCE].",
                "comment": "Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.",
                "min": 0,
                "max": "1"
            },
            {
                "id": "Group.characteristic:exclusionCriteria.code",
                "path": "Group.characteristic.code",
                "fixedCodeableConcept": {
                    "coding":  [
                        {
                            "code": "77765009",
                            "system": "http://snomed.info/sct",
                            "display": "Exclude (qualifier value)"
                        }
                    ]
                }
            },
            {
                "id": "Group.characteristic:exclusionCriteria.value[x]",
                "path": "Group.characteristic.value[x]",
                "type":  [
                    {
                        "code": "CodeableConcept"
                    }
                ]
            },
            {
                "id": "Group.characteristic:exclusionCriteria.value[x].text",
                "path": "Group.characteristic.value[x].text",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.eligibilityCriteria.exclusionCriteria"
                    }
                ]
            },
            {
                "id": "Group.characteristic:exclusionCriteria.exclude",
                "path": "Group.characteristic.exclude",
                "patternBoolean": true
            }
        ]
    }
}

Group Actual

NFDI4Health PR MDS Group Actual represents the actual study population including the obtained study population size

idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
populationDescriptionI0..1Extension(string)
populationLocationI1..1Extension(Complex)
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
activeΣ0..1boolean
typeΣ1..1codeBinding
actualΣ I1..1booleanFixed Value
codeΣ0..1CodeableConcept
nameΣ0..1string
quantityΣ0..1unsignedInt
managingEntityΣ I0..1Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
code1..1CodeableConcept
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueQuantityQuantity
valueRangeRange
valueReferenceReference()
exclude1..1boolean
periodI0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
entityI1..1Reference(Patient | Practitioner | PractitionerRole | Device | Medication | Substance | Group)
periodI0..1Period
inactive0..1boolean
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
populationDescriptionI0..1Extension(string)
populationLocationI1..1Extension(Complex)
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
activeΣ0..1boolean
typeΣ1..1codeBinding
actualΣ I1..1booleanFixed Value
codeΣ0..1CodeableConcept
nameΣ0..1string
quantityΣ0..1unsignedInt
managingEntityΣ I0..1Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
code1..1CodeableConcept
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueQuantityQuantity
valueRangeRange
valueReferenceReference()
exclude1..1boolean
periodI0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
entityI1..1Reference(Patient | Practitioner | PractitionerRole | Device | Medication | Substance | Group)
periodI0..1Period
inactive0..1boolean
idΣ0..1string
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
populationDescriptionI0..1Extension(string)
populationLocationI1..1Extension(Complex)
modifierExtension?! I0..*Extension
identifierΣ0..*Identifier
activeΣ0..1boolean
typeΣ1..1codeBinding
actualΣ I1..1booleanFixed Value
codeΣ0..1CodeableConcept
nameΣ0..1string
quantityΣ0..1unsignedInt
managingEntityΣ I0..1Reference(Organization | RelatedPerson | Practitioner | PractitionerRole)
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
code1..1CodeableConcept
valueCodeableConceptCodeableConcept
valueBooleanboolean
valueQuantityQuantity
valueRangeRange
valueReferenceReference()
exclude1..1boolean
periodI0..1Period
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
entityI1..1Reference(Patient | Practitioner | PractitionerRole | Device | Medication | Substance | Group)
periodI0..1Period
inactive0..1boolean
{
    "resourceType": "StructureDefinition",
    "id": "nfdi4health-pr-mds-group-actual",
    "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-actual",
    "version": "0.9",
    "name": "NFDI4Health_PR_MDS_Group_Actual",
    "title": "NFDI4Health PR MDS Group Actual",
    "status": "draft",
    "publisher": "NFDI4Health",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.nfdi4health.de"
                }
            ]
        }
    ],
    "description": "Information about the actual study population.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "NFDI4Health",
            "name": "NFDI4Health to FHIR Mapping"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "Group",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Group",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Group",
                "path": "Group",
                "max": "1"
            },
            {
                "id": "Group.extension",
                "path": "Group.extension",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "url"
                        }
                    ],
                    "ordered": false,
                    "rules": "open"
                },
                "min": 1
            },
            {
                "id": "Group.extension:populationDescription",
                "path": "Group.extension",
                "sliceName": "populationDescription",
                "min": 0,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-population-description"
                        ]
                    }
                ]
            },
            {
                "id": "Group.extension:populationLocation",
                "path": "Group.extension",
                "sliceName": "populationLocation",
                "min": 1,
                "max": "1",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-population-location"
                        ]
                    }
                ]
            },
            {
                "id": "Group.actual",
                "path": "Group.actual",
                "fixedBoolean": true
            },
            {
                "id": "Group.quantity",
                "path": "Group.quantity",
                "mapping":  [
                    {
                        "identity": "NFDI4Health",
                        "map": "Design.population.obtainedSampleSize"
                    }
                ]
            }
        ]
    }
}

Examples

Example data for NFDI4Health PR MDS Group Intended and NFDI4Health PR MDS Group Actual used to represent the eligibility criteria and the actual study population in the SHIP Trend study.


Example of NFDI4Health PR MDS Group Eligibility representing the eligibility criteria in the SHIP Trend study.

InstanceOfGroupActualSHIP


Example of NFDI4Health PR MDS Group Actual representing the actual study population and size in the SHIP Trend study.

InstanceOfGroupActualSHIP


Example data for NFDI4Health PR MDS Group Eligibility used to represent the eligibility criteria in the SPOVID study.

InstanceOfGroupEligibilitySPOVID

Example data for NFDI4Health PR MDS Group Eligibility used to represent the actual criteria in the SPOVID study.

InstanceOfGroupActualSPOVID