Study enrolment due to Covid-19


Parameter Case Report Form and Response Options

Study enrolment due to Covid-19 Yes No Unknown
Confirmed Covid-19 diagnosis as main reason for enrolment in the study

This profile of a FHIR Observation captures if a confirmed Covid-19 diagnosis is the main reason for enrolment in the study.


Profile - Study Inclusion due to Covid-19

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19

Snapshot

identifierΣ0..*Identifier
basedOnΣ I0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)
partOfΣ I0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)
statusΣ ?!1..1codeBinding
systemΣ1..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
systemΣ1..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
subjectS Σ I1..1Reference(Patient | Group)
focusΣ I0..*Reference(Resource)
encounterΣ I0..1Reference(Encounter)
effectiveDateTimedateTime
effectivePeriodPeriod
effectiveTimingTiming
effectiveInstantinstant
issuedΣ0..1instant
performerΣ I0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)
systemΣ1..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
note0..*Annotation
bodySite0..0CodeableConcept
method0..1CodeableConcept
specimenI0..0Reference(Specimen)
deviceI0..1Reference(Device | DeviceMetric)
lowI0..1SimpleQuantity
highI0..1SimpleQuantity
type0..1CodeableConceptBinding
appliesTo0..*CodeableConcept
ageI0..1Range
text0..1string
hasMemberΣ I0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)
derivedFromΣ I0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)
codeΣ1..1CodeableConcept
valueQuantityQuantity
valueCodeableConceptCodeableConcept
valueStringstring
valueBooleanboolean
valueIntegerinteger
valueRangeRange
valueRatioRatio
valueSampledDataSampledData
valueTimetime
valueDateTimedateTime
valuePeriodPeriod
dataAbsentReasonI0..1CodeableConceptBinding
interpretation0..*CodeableConceptBinding
referenceRange0..*see (referenceRange)


ValueSets

Valuesets are provided with SNOMED-CT codes.

Canonical: https://www.netzwerk-universitaetsmedizin.de/fhir/ValueSet/yes-no-unknown-other-na

ValueSet 'YesNoUnknownOtherNa'

Version1.0.6
Published byBerlin Institute of Health at Charité (BIH)
StatusActive
ExperimentalFalse

Yes/No/Unknown/Other/Na response options

Contact Information

Website: https://www.bihealth.org/en/re...

This value set includes codes from the following code systems:


Examples

Covid-19 as primary reason for study inclusion

{
    "resourceType": "Observation",
    "id": "study-inclusion-covid-19-yes",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
        ]
    },
    "category":  [
        {
            "coding":  [
                {
                    "code": "survey",
                    "system": "http://terminology.hl7.org/CodeSystem/observation-category"
                }
            ]
        }
    ],
    "code": {
        "coding":  [
            {
                "code": "02",
                "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                "display": "Study inclusion due to Covid-19"
            }
        ],
        "text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
    },
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373066001",
                "display": "Yes (qualifier value)"
            }
        ],
        "text": "Covid-19 as primary reason for study inclusion"
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "code": "OBI",
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_02_StudyInclusionCovid19",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "subject": {
        "reference": "Patient/gecco-patient"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00"
}


Covid-19 not the primary reason for study inclusion

{
    "resourceType": "Observation",
    "id": "study-inclusion-covid-19-no",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
        ]
    },
    "category":  [
        {
            "coding":  [
                {
                    "code": "survey",
                    "system": "http://terminology.hl7.org/CodeSystem/observation-category"
                }
            ]
        }
    ],
    "code": {
        "coding":  [
            {
                "code": "02",
                "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                "display": "Study inclusion due to Covid-19"
            }
        ],
        "text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
    },
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "373067005",
                "display": "No (qualifier value)"
            }
        ],
        "text": "Covid-19 not the primary reason for study inclusion"
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "code": "OBI",
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_02_StudyInclusionCovid19",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "subject": {
        "reference": "Patient/gecco-patient"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00"
}


Unknown if Covid-19 is primary reason for study inclusion

{
    "resourceType": "Observation",
    "id": "study-inclusion-covid-19-unknown",
    "meta": {
        "profile":  [
            "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/study-inclusion-covid-19"
        ]
    },
    "category":  [
        {
            "coding":  [
                {
                    "code": "survey",
                    "system": "http://terminology.hl7.org/CodeSystem/observation-category"
                }
            ]
        }
    ],
    "code": {
        "coding":  [
            {
                "code": "02",
                "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes",
                "display": "Study inclusion due to Covid-19"
            }
        ],
        "text": "Confirmed Covid-19 diagnosis as main reason for enrolment in the study"
    },
    "valueCodeableConcept": {
        "coding":  [
            {
                "system": "http://snomed.info/sct",
                "code": "261665006",
                "display": "Unknown (qualifier value)"
            }
        ],
        "text": "Unknown if Covid-19 is primary reason for study inclusion"
    },
    "identifier":  [
        {
            "type": {
                "coding":  [
                    {
                        "code": "OBI",
                        "system": "http://terminology.hl7.org/CodeSystem/v2-0203"
                    }
                ]
            },
            "system": "https://www.charite.de/fhir/CodeSystem/observation-identifiers",
            "value": "ecrf_02_StudyInclusionCovid19",
            "assigner": {
                "reference": "Organization/Charité"
            }
        }
    ],
    "status": "final",
    "subject": {
        "reference": "Patient/gecco-patient"
    },
    "effectiveDateTime": "2020-10-16T08:49:21+02:00"
}