it infrastructure components to support clinical care and ...€¦ · sap is-h (mpi, billing)...

Prof. Dr. H.U. Prokosch CCC Erlangen-Nuremberg

Chair of Medical Informatics, University of Erlangen-Nuremberg CIO University Hospital Erlangen

IT Infrastructure Components

to support clinical care

and translational research projects

in a comprehensive cancer center

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Chair of Medical Informatics / CCC Erlangen-Nuremberg H.U. Prokosch / MIE 2011

IT Infrastructure Components in a Comprehensive Cancer Center ::

Cancer Documentation in Germany

. . . was for many years driven by

n  Clinical Cancer Registries

§  Organized within the ADT (= Arbeitsgemeinschaft Deutscher Tumorzentren = Consortium of the German Clinical Cancer Registries)

n  Epidemiological Cancer Registries

§  Organized within the GEKID (=Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. = Association of the German Epidemiological Cancer Registries)

n  the joint definition of the ADT minimal oncological (basis) documentation data set

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Traditional Sources for Cancer Data Registration (Situation at the Erlangen Clinical Cancer Registry in 2008)

Cancer Registry

tumor center Erlangen-Nuremberg

TUREK 2

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Comprehensive Cancer Centers in Germany funded by the German Cancer Aid since 2007

. . . have been established

n  to provide centers of excellence for interdisciplinary cancer care,

n  medical education, as well as

n  clinical and translational cancer research

. . . in a rapidly changing environment:

n  massive growth in data, especially requiring linkage of molecular, genomic and clinical data

n  need for faster processes from „bench to bedside“ (translational research)

n  dramatically increasing documentation requirements in the clinical care context (billing, quality insurance, benchmarking, certification, . . .)

K. Beckmann, S. Jud, K. Heusinger, M. Schwenk, C. Bayer, L. Häberle, et al. Dokumentation in der gynäkologischen Onkologie, Der Gynäkologe 43 (2010), 400–410.

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What are the IT Infrastructure Components required to support Clinical Cancer Documentation

and Clinical Research in Oncology?

How can those be implemented without putting additional burden

on physician´s workload?

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Similar work in US projects

n  D. Fenstermacher, C. Street, T. McSherry, V. Nayak, C. Overby, M. Feldman. The Cancer Biomedical Informatics Grid (caBIG). Conf Proc IEEE Eng Med Biol Soc 1 (2005), 743-746.

n  M.F. Ochs, J.T. Casagrande. Information systems for cancer research, Cancer Invest 26 (2008), 1060-1067.

n  P. McConnell, R.C. Dash, R. Chilukuri, R. Pietrobon, K. Johnson, R. Annechiarico R, A.J. Cuticchia. The cancer translational research informatics platform, BMC Med Inform Decis Mak 8, 60 (2008), doi:10.1186/1472-6947-8-60.

n  S.N. Murphy, G. Weber, M. Mendis, V. Gainer, H.C. Chueh, S. Churchill, et al. Serving the enterprise and beyond with informatics for integrating biology and the bedside (i2b2). J Am Med InformAssoc 17,2 (2010), 124-130.

n  . . . . .

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Erlangen University Hospital IT Infrastructure in 2008

SAP IS-H (MPI, Billing)

Soarian (EHR)

Cognos DataManager, Talend OpenStudio (ETL)

WebRIS, SyngoVIA (RIS, PACS)

Meierhofer, QIMS (Surgery)

Amondis, ZENZY (Pharmacy)

Paschmann (Patho)

Swisslab (Lab, ...)

TransDB (Finding

Repository)

DWH Cognos ReportNet (Routine reporting)

Central EHR

eGate (Comm. Server)

Communication Ancillary Systems Cancer Registration

Turek-2 (Cancer Registry)

...

only patient demographics; no clinical data

Planning and freetext documentation of tumorboard conferences

No webbased interface for external communication

Only freetext documentation

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Soarian (EHR)





Paschmann (Patho)

Swisslab (Lab, ...)

TransDB (Finding

Repository)


Central EHR




...

Erlangen University Hospital IT Infrastructure in 2008

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Problems:

n  no tool web-based communication with external partners for direct acquisition of follow-up data

n  no comprehensive cancer documentation yet in clinical care

n  only unstructured documentation of pathology findings

n  only project specific (typically homegrown) developments of study database systems (Excel, MS Access, SPSS)

n  no IT support for chemotherapy planning

n  no user-friendly clinical data warehouse for explorative research

n  no professional IT support for biobanking (only freezers and Excel-Files)

No data reuse for multiple purposes

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stakeholder decisions in 2008 . . .

n  migrate to a new cancer registry system with a web-based interface to communicate with external partners (GTDS® )

n  stepwise establish a comprehensive cancer documentation in clinical care, starting with a structured documentation of cancer conference decisions (within the Soarian® electronic health record system)

n  establish a faculty wide GCP-certified database system for clinical trials (secuTrial®)

n  establish an integration platform/clinical data warehouse for explorative research (i2b2®)

n  establish a commercial biobanking management system (Starlims®)

apply the single source concept as much as possible

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Soarian (EHR)





. . . . .

Swisslab (Lab, Patho...)

TransDB (Finding

Repository)


Central EHR




OnkoDat (Chemotherapy)

GTDS (Cancer Registry)

patient demographics and clinical data

Results: Erlangen University Hospital IT Infrastructure in 2011

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Soarian (EHR)





. . . . .

Swisslab (Lab, Patho, . . .)

TransDB (Finding

Repository)


Central EHR





comprehensive & structured documentation of cancer data

structured documentation

to be stepwise established for all chemotherapy planning units

Results: Erlangen University Hospital IT Infrastructure in 2011

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Results: new documentation modules within our EHR system n  planning and standardized structured documentation of 10

tumorboard conferences (incl. automatic tumorboard letter creation)

n  complete ADT-based interdisciplinary cancer documentation extended with study-specific documentation for prostate and colon cancer

n  documentation forms for melanoma outpatient followups

n  documentation of psycho-oncological and psycho-social care

n  generation of „cancer patient diary“ for quality assurance purposes

n  documentation of informed consent (for cancer registry & biobanking) in the electronic medical record

n  study participation documentation within the EHR

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SecuTrial (Trial Data Capture)

Results: Erlangen Research IT Infrastructure in 2011


Soarian (EHR)





. . . . .

Swisslab (Lab, Patho, ...)

TransDB (Finding

Repository)


Central EHR


Communication Ancillary Systems Research Platform


StarLIMS (Biobank)


i2b2 (Scientific reporting, explorative analysis)

multi center research data integration

multi center clinical trials

EHR data reuse

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n  four oncological multicenter clinical trials (phase II – IV), in §  gynecology

§  radiotherapy

§  surgery

are currently running based on SecuTrial

n  pseudonomized documentation of patient/relatives counseling sessions

Results: Usage of the GCP certified database for clinical trials

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Results: Reuse of EHR data for cancer research

Single Source for

n  Colon Cancer Documentation §  with data transfer into GCP-certified clinical trials database (SecuTrial)

§  with data transfer into research data warehouse for explorative analysis (i2b2)

§  (linked to biospecimen documentation of the biobank mgmt. system)

n  Prostate Cancer Documentation §  with workflow support and „reminders“ for missing documentation §  generating reports for prostata cancer center audits §  local research database (pseudonymized) for explorative data analysis

(i2b2) §  anonymized data transfer into the

nationwide prostate cancer research database (i2b2)

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Results: Web-based Query Interface for Patient Populations

27 patients found

Select all prostate cancer patients who had a digital rectal examination and

have undergone nerve-preserving surgery?

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Results: Integration Platform for the two hospitals cooperating within the CCC

n  The Comprehensive Cancer Center Erlangen – Nuremberg comprises §  University Hospital Erlangen

§  1.302 beds

§  65.660 inpatients and 356.611 outpatients in 2008

§  Hospital Nuremberg §  2.184 beds

§  90.411 inpatients and 93.300 outpatients in 2008

n  I2b2 as integration platform for cancer data from §  more than 5.000 cancer patients from University Hospital Erlangen

§  about 6.000 cancer patients from Hospital Nuremberg

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SecuTrial (Trial Data Capture)

IT Infrastructure components of the CCC Erlangen-Nuremberg in 2011


Soarian (EHR)





. . . . .

Swisslab (Lab, Patho, ...)

TransDB (Finding

Repository)


Central EHR


Communication Ancillary Systems Research Platform


StarLIMS (Biobank)


i2b2 (research database, explorative analysis)

multi center research data integration

Seite 20 IT Infrastructure Components in a Comprehensive Cancer Center ::

Chair of Medical Informatics / CCC Erlangen-Nuremberg H.U. Prokosch

Thank you very much . . .

Thanks to my team: Markus Ries, Alexander Beyer, Martin Schwenk, Christof Seggwies, Felix Köpcke, Sebastian Mate, Marcus Martin, Barbara Bärthlein, Thomas Bürkle and the cooperating clinicians: Matthias W. Beckmann, Michael Stürzl, Roland Croner, Bernd Wullich parts of the described projects have been funded by the German Federal Ministry of Education and Research and by the German Cancer Aid.

[email protected]

it infrastructure components to support clinical care and ...€¦ · sap is-h (mpi, billing)...

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