mii-studie-test-data-bundle-studie - MII Implementation Guide Medizinisches Forschungsvorhaben v2027.0.0-ballot

MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Beispiel Bundle: mii-studie-test-data-bundle-studie

Language: de

Security Label: test health data (Details: ActReason code HTEST = 'test health data')

Bundle mii-studie-test-data-bundle-studie of type transaction

Entry 1 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Dokument/mii-exa-studie-dokument

Resso}:

German
Generated Narrative: DocumentReference mii-exa-studie-dokument

Profile: MII PR Studie Dokument
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
status: Current
author: Organization Example Organization for Author
custodian: Organization Example Organization for Custodian
content
Attachments
- ContentType Url Size Title
* pdf https://example.com/fhir/Binary/document 2000 Beispiel Dokument
Contexts
- Related
* ResearchStudy LIFE-Adult-Study

Request:

POST MII_PR_Studie_Dokument

Entry 2 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_EinAuschlussKriterium/mii-exa-studie-ein-auschluss-kriterium

Resso}:

German
Generated Narrative: EvidenceVariable mii-exa-studie-ein-auschluss-kriterium

Profile: MII PR Studie EinAuschlussKriterium
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
status: Active
characteristic
MII EX Studie Backport definitionReference: EvidenceVariable: status = active
description: Altersbeschränkung
definition: Altersbeschränkung
characteristic
MII EX Studie Backport definitionCanonical: https://www.medizininformatik-initiative.de/fhir/EvidenceVariable/administrative-gender
description: Geschlecht
definition: Alle
exclude: false
characteristic
MII EX Studie Backport linkId: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2
description: Kognitive Fatigue (WeiMUS kognitive Skala >= 17)
definition: Unknown
exclude: false
characteristic
MII EX Studie Backport linkId: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09
description: Positiver SARS-CoV-2(COVID-19)-Befund; mind. 3 Monate alt
definition: Unknown
exclude: false
characteristic
MII EX Studie Backport DefinitionByCombination
code: any-of
characteristic: aa83ebf3-cfe4-4ed6-aa71-0779c28e85a2
characteristic: 8e8f63ff-65f1-40cd-bf79-da83d7fb4e09
description: Weitere Einschlusskriterien
definition: Unknown
exclude: false
characteristic
description: diagnostizierte Depressionen, Angststörungen, andere psychiatrische Erkrankungen
definition: Unknown
exclude: true
characteristic
description: Einnahme von Antidepressiva, Opioiden, Antikonvulsiva
definition: Unknown
exclude: true
characteristic
description: weitere neurologische Erkrankungen
definition: Unknown
exclude: true
characteristic
MII EX Studie Backport DefinitionByTypeAndValue
type: Current chronological age
value: >=18 year (Details: UCUM codea = 'a')
description: Alter mindestens 18 Jahre
definition: Mindestalter
exclude: false

Request:

POST MII_PR_Studie_EinAuschlussKriterium

Entry 3 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Studie/mii-exa-studie-studie

Resso}:

German
Generated Narrative: ResearchStudy mii-exa-studie-studie

Profile: MII PR Studie Studie
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
MII EX Studie Backport Label
value: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue
type: Scientific title
MII EX Studie Backport Label
value: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue
type: Öffentlicher Titel
MII EX Studie Akronym: tDCS
MII EX Studie Rekrutierung
rekrutierungsstart: 2023-01-12
rekrutierungsziel: 40
rekrutierungsstand: 35
rekrutierungsstand-genauigkeit: good
rekrutierungsstand-datum: 2023-02-17
MII EX Studie Finanzierung: Öffentliche Förderinstitutionen, aus Steuermitteln getragene Institutionen (DFG, BMBF u. a.)
MII EX Studie Ethikvotum
status: Zustimmende Bewertung
kommission: Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.
ethiknummer: Az.: 83/18
identifier: https://example.com/fhir/sid/drks/DRKS00031294
title: Frontale transkranielle Gleichstromstimulation (tDCS) als potentielle Behandlungsmethode von Long-COVID bedingter Fatigue
status: Active
category: interventional, Zufallszuteilung
description:
Diese Studie untersucht den Einfluss repetitiver anodaler Gleichstromstimulation des linken dorsolateralen präfrontalen Kortex (dlPFC ) auf subjektive und objektive Kennwerte und assoziierte EEG-Parameter der Fatigue bei Long-COVID Patient*innen. Die Studie ist sham-kontrolliert und doppelt-verblindet.

arm
name: frontale anodale tDCS (verum condition)
description: vier Stimulationen, jeweils 30 Minuten, 1.5mA über dem linken dlPFC
arm
name: frontale sham tDCS
description: vier Stimulationen, jeweils 30 Minuten

Request:

POST MII_PR_Studie_Studie

Entry 4 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Cohort/mii-exa-studie-cohort

Resso}:

German
Generated Narrative: ResearchStudy mii-exa-studie-cohort

Profile: MII PR Studie Studie
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
MII EX Studie Backport Label
value: MII Modul Studie
MII EX Studie Backport AssociatedParty
role: Sponsor
party: Organization Example Organization for Author
MII EX Studie Ethikvotum
status: genehmigt
kommission: Ethik-Kommission der Medizinischen Fakultät der Universität Leipzig
ethiknummer: 159-12-21052012
MII EX Studie Studienregister: DRKS - Deutsches Register Klinischer Studien
MII EX Studie Eligibility: EvidenceVariable: status = active
MII EX Studie Akronym: LIFE ADULT
MII EX Studie Rekrutierung
rekrutierungsstart: 2009-01-01
rekrutierungsziel: 10000
rekrutierungsstand: 10000
rekrutierungsstand-genauigkeit: good
rekrutierungsstand-datum: 2022-05-28
MII EX Studie Finanzierung: Deutsches Bundesministerium für Bildung und Forschung (BMBF)
identifier: https://example.com/fhir/sid/lha/7Q6PJD8NV3-2
title: LIFE-Adult-Study
partOf: ResearchStudy Example Reference Study
status: Active
category: Observational study
focus: Erwachsene der Stadt Leipzig
keyword: Bevölkerung, Leipzig, Erwachsene
description:
Die LIFE Adult-Studie ist eine langfristig angelegte, bevölkerungsbezogene Kohortenstudie. Stichproben aus der Leipziger Erwachsenenbevölkerung werden hinsichtlich vielfältiger Merkmale und Krankheitsrisiken umfassend untersucht. Insbesondere die Häufigkeit von Volkskrankheiten steht im Mittelpunkt der Forschungsarbeiten. Der Einfluss von Lebensstil- und Umweltfaktoren auf diese Erkrankungen wird charakterisiert. Bisher unbekannte Risikofaktoren für die Entstehung von Volkskrankheiten sollen aufgespürt und neue Möglichkeiten der Früherkennung entwickelt werden.

Arms
- Name
* LIFE-Adult-Kohorte

Request:

POST MII_PR_Studie_Cohort

Entry 5 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Proband/mii-exa-studie-proband

Resso}:

German
Generated Narrative: ResearchSubject mii-exa-studie-proband

Profile: MII PR Studie Proband
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
identifier: Anonymous identifier/321123456
status: Candidate
period: 2023-01-01 --> 2023-12-31
study: ResearchStudy LIFE-Adult-Study
individual: Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))
consent: mii-exa-studie-consent

Request:

POST MII_PR_Studie_Proband

Entry 6 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Beteiligte_Person/mii-exa-studie-beteiligte-person

Resso}:

German
Generated Narrative: PractitionerRole mii-exa-studie-beteiligte-person

Profile: MII PR Studie Beteiligte Person
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
practitioner: Practitioner Max Mustermann
organization: Organization Example Organization for Practitioner
code: Doctor
telecom: ph: 0123456789

Request:

POST MII_PR_Studie_Beteiligte_Person

Entry 7 - fullUrl = https://www.medizininformatik-initiative.de/MII_PR_Studie_Register/mii-exa-studie-register

Resso}:

German
Exception parsing generated Narrative (see /tmp/liquid-5a2d0579-448d-44ee-8a2c-6f4b5b9ff49b.html): unexpected non-end of element null::a at line 105 column 50

Request:

POST MII_PR_Studie_Register

Entry 8 - fullUrl = https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-author

Resso}:

German
Generated Narrative: Organization mii-exa-studie-author

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
name: Example Organization for Author

Request:

POST Organization

Entry 9 - fullUrl = https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-custodian

Resso}:

German
Generated Narrative: Organization mii-exa-studie-custodian

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
name: Example Organization for Custodian

Request:

POST Organization

Entry 10 - fullUrl = https://www.medizininformatik-initiative.de/Organization/mii-exa-studie-practitioner-organization

Resso}:

German
Generated Narrative: Organization mii-exa-studie-practitioner-organization

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
name: Example Organization for Practitioner

Request:

POST Organization

Entry 11 - fullUrl = https://www.medizininformatik-initiative.de/Practitioner/mii-exa-studie-practitioner

Resso}:

German
Generated Narrative: Practitioner mii-exa-studie-practitioner

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
name: Max Mustermann

Request:

POST Practitioner

Entry 12 - fullUrl = https://www.medizininformatik-initiative.de/ResearchStudy/mii-exa-studie-reference-study

Resso}:

German
Generated Narrative: ResearchStudy mii-exa-studie-reference-study

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
title: Example Reference Study
status: Completed

Request:

POST ResearchStudy

Entry 13 - fullUrl = https://www.medizininformatik-initiative.de/Patient/mii-exa-studie-patient

Resso}:

German
Generated Narrative: Patient mii-exa-studie-patient

Profile: http://fhir.de/ConsentManagement/StructureDefinition/Patient
Security Label: test health data (Details: ActReason code HTEST = 'test health data')
Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))
Deceased: false

Request:

POST Patient

Entry 14 - fullUrl = https://www.medizininformatik-initiative.de/Consent/mii-exa-studie-consent

Resso}:

German
Generated Narrative: Consent mii-exa-studie-consent

Security Label: test health data (Details: ActReason code HTEST = 'test health data')
Participants
Role Details
Patient Jane Doe Female, DoB: 1980-11-12 ( Krankenversichertennummer (use: official, ))
This consent is made under the policy urn:oid:2.16.840.1.113883.3.1937.777.24.2.1791 .
The subject has given their consent.

Request:

POST Consent

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