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Leveraging Clinical Data for Research: The MIRACUM Consortium in the German Medical Informatics Initiative
04.12.2019 Heidelberg University Office Kyoto Joint Lecture (Kyoto, Japan)
Prof. Dr. Thomas GanslandtHeinrich-Lanz-Center for Digital Health (HLZ)
Hot Topic: Digital Health
Goal: Learning Health System
Dissemination
Data generation
Knowledgegeneration
Research
Diagnostics
Therapy
Outcomes
Clinical CareTranslation
Translation
DataEvidence
Secundary use
Data quality
Governance & Data protection
Digital participation
Machine learning
Secondary Use of Routine Clinical Data
ResearchLifecycle
Hypothesisgeneration
Feasibilityanalysis
Recruitment
Datacapture
Dataanalysis
Longtermarchiving
Clinical IT
Collaborating Hospitals
The German Medical Informatics Initiative (MII)
Foster re-use ofroutine clinical data
Demonstrate utilitythrough clinical use cases
Strengthen MedicalInformatics as a discipline
160 M€ fundingby BMBF
Long-term perspective
MII Consortia & Coverage of the MIRACUM Consortium
Image source: http://www.medizininformatik-initiative.de/en/node/5
Greifswald
Dresden
Medical Informaticsin Research And Care in University Medicine
Competition vs. Collaboration in the MII
Competitive grant application
◼ 4 distinct consortia
◼ individual IT architectures anddata models
◼ individual clinical use cases
Funder expects an overall solution
◼ data sharing needs to work acrosssite & consortium boundaries
◼ rollout to nonacademic sites
Challenges to address together
◼ how can we implement harmonizeddata structures & encodings?
◼ how can we achieve broad consentby patients?
◼ how can we align governancepolicies and data use contracts?
◼ how can we securely implementshared health data analyses?
Cross-Consortial Governance & Collaboration Structures of the MII
Task forces
MII Modular Core Dataset
Oncology Pathology findings
Imaging findings
PDMS/Biosignals
Biomaterial
Genetic tests Structure data
Billing codes
Cost data
Exte
nsi
on
mo
du
les
Diagnoses
Procedures
Lab findings
Medication
PersonDemographics Case data
Bas
ic m
od
ule
s
…… …
…… …
Data structuresbased onHL7 FHIR Standard
Semanticannotationbased on
internationalterminologies
Collaborativetools for
requirementsspecification
and datamodelling
Open governanceprocesses
and balloting
How to implement the MII Core Dataset (shown for lab findings)
Diagnoses Demographics
Case dataProcedures
E.g. project to determinecomparability of lab findings
In MII
HL7 FHIR
Data structure
LISDorneri/med
PDMSPhilips
ICCA
Laboratory results
Terminology
Collaborative Solutions for Data Protection & Governance
Clinical IT
Data usecontract
Anonymous orpseudonymous
dataset
Pseudonymization
Identifyingdata
Medicaldata
Data protectionofficer
Patient consent
Data usepolicy
MIRACUM Use Cases
Patient Recruitmentfor Clinical Trials
Predictive Toolfor Asthma/COPD
and Neurooncology
MolecularTumor Board
MIRACUM Use Case 1:Patient recruitment for clinical trials
Recruitment
Exclusion
Screening ofCandidates
Research
Clinical care
MIRACUM Use Case 2:Predictive tools for asthma/COPD & neurooncology
Application ofML-models
Endotyping
Use case
PredictionInfrastructure
MIRACUM Use Case 3:Molecular Tumorboard
Treatment
Bio-informatics
Visualization
MIRACUM Open Source Data Integration Center Architecture
Consent-Manage-
ment
Local ID-Manage-
ment
ID-/Consent-Management
Sourcesystem 1
Comm-Server
Sourcesystem 2
Clinicaldata
repository
Routinebusiness
intelligence
Clinical Module
ClinicalDecisionSupport
Enrichment
Researchqueries
Research data
longtermarchive
Research Module
Researchdata
repository
Harmoni-zation
Federation
MII Demonstrator Study: Harvesting Low-hanging Fruit
Long-term development vs. Needto show short-term results
◼ 4 years planned to implement DICs
◼ funder and general public should getcontinuous updates
Achieve "quick win" with Demonstrator
◼ choose reproductive questions
◼ restrict to easily available data
◼ re-use established software
Implementation Strategy
◼ goal: analysis of comorbidities and rare disease geovisualization
◼ data: diagnoses, demographics, case-related data
◼ datasource: "§21" billing dataset
◼ platform: i2b2, SQL queries
◼ privacy: only aggregated localanalyses, raw data stays at sites
Demonstrator Study: Iterative approach, harvesting low-hanging fruit
20Locations
19Approvals
1,8Mill. patients
3,2Mill. cases
(09/2018 - 03/2019)
MII Demonstrator Study - Results:Charlson Comorbidity Index vs. Discharge Reason
MII Demonstrator Study - Results:Charlson Comorbidity Categories vs. Principal Diagnosis
Fraction of caseswith the comorbidity16. Certain conditions originating
in the perinatal period
15. Pregnancy, childbirth and the puerperium
09. Diseases of the circulatory system
Conclusions & Outlook
Collaborative approaches towardssecondary use of clinical data work
◼ MIRACUM is sucessfully implementingbased on int'l terminologies, opensource and iterative approach
◼ successful cross-consortial worktowards interoperable structures
◼ alignment with international initiatives(e.g. OMOP/OHDSI, EHDEN, SPHN)
Decisive phase for the MII
◼ in the second half of the fundingperiod, DIC infrastructure needsto be put to visible use
Intensified cross-consortial efforts
◼ new shared Use cases⚫ CORD: on Rare Disases
⚫ POLAR: on Polypharmacy
◼ bid for grant in National researchdata infrastructure (NFDI)