IT Infrastructure Components to support clinical care and translational research projects in a comprehensive cancer center Prof. Dr. H.U. Prokosch CCC Erlangen-Nuremberg Chair of Medical Informatics, University of Erlangen-Nuremberg CIO University Hospital Erlangen
Cancer Documentation in Germany Seite 2... 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
Traditional Sources for Cancer Data Registration (Situation at the Erlangen Clinical Cancer Registry in 2008) Seite 3 tumor center Erlangen-Nuremberg TUREK 2 Cancer Registry
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) Seite 4 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.
Seite 5 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?
Seite 6 Similar work in US projects n 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. 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.....
Seite 7 Erlangen University Hospital IT Infrastructure in 2008 Central EHR Communication Ancillary Systems Cancer Registration SAP IS-H (MPI, Billing) Soarian (EHR) Planning and freetext documentation of tumorboard conferences egate (Comm. Server) Only freetext documentation TransDB (Finding Repository) Swisslab (Lab,...) WebRIS, SyngoVIA (RIS, PACS) Meierhofer, QIMS (Surgery) Amondis, ZENZY (Pharmacy) Paschmann (Patho)... only patient demographics; no clinical data No webbased interface for external communication Turek-2 (Cancer Registry) Cognos DataManager, Talend OpenStudio (ETL) Cognos ReportNet (Routine reporting) DWH
Seite 8 Erlangen University Hospital IT Infrastructure in 2008 Central EHR Communication Ancillary Systems Cancer Registration SAP IS-H (MPI, Billing) Soarian (EHR) egate (Comm. Server) Swisslab (Lab,...) WebRIS, SyngoVIA (RIS, PACS) Meierhofer, QIMS (Surgery) Amondis, ZENZY (Pharmacy) TransDB (Finding Repository) Paschmann (Patho)... Turek-2 (Cancer Registry) Cognos DataManager, Talend OpenStudio (ETL) Cognos ReportNet (Routine reporting) DWH
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 Seite 9 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
Seite 10 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) apply the n establish a faculty wide GCP-certified database single system source concept for clinical trials (secutrial ) as much as possible n establish an integration platform/clinical data warehouse for explorative research (i2b2 ) n establish a commercial biobanking management system (Starlims )
Seite 11 Results: Erlangen University Hospital IT Infrastructure in 2011 Central EHR Communication Ancillary Systems Cancer Registration SAP IS-H (MPI, Billing) Soarian (EHR) egate (Comm. Server) Swisslab (Lab, Patho...) WebRIS, SyngoVIA (RIS, PACS) Meierhofer, QIMS (Surgery) GTDS (Cancer Registry) TransDB (Finding Repository) Amondis, ZENZY (Pharmacy)..... OnkoDat (Chemotherapy) Turek-2 (Cancer Registry) patient demographics and clinical data Cognos DataManager, Talend OpenStudio (ETL) Cognos ReportNet (Routine reporting) DWH
Seite 12 Results: Erlangen University Hospital IT Infrastructure in 2011 Central EHR Communication Ancillary Systems Cancer Registration SAP IS-H (MPI, Billing) Soarian (EHR) comprehensive & structured documentation of cancer data egate (Comm. Server) structured documentation TransDB (Finding Repository) Swisslab (Lab, Patho,...) WebRIS, SyngoVIA (RIS, PACS) Meierhofer, QIMS (Surgery) Amondis, ZENZY (Pharmacy)..... OnkoDat (Chemotherapy) GTDS (Cancer Registry) Cognos DataManager, Talend OpenStudio (ETL) Cognos ReportNet (Routine reporting) DWH to be stepwise established for all chemotherapy planning units
Seite 13 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
Results: Erlangen Research IT Infrastructure in 2011 Seite 14 multi center clinical trials Central EHR Communication Ancillary Systems Research Platform SAP IS-H (MPI, Billing) Soarian (EHR) egate (Comm. Server) Swisslab (Lab, Patho,...) WebRIS, SyngoVIA (RIS, PACS) SecuTrial (Trial Data Capture) StarLIMS (Biobank) Meierhofer, QIMS (Surgery) GTDS (Cancer Registry) Amondis, ZENZY (Pharmacy) EHR data reuse TransDB (Finding Repository)..... OnkoDat (Chemotherapy) Cognos DataManager, Talend OpenStudio (ETL) multi center research data integration Cognos ReportNet (Routine reporting) DWH i2b2 (Scientific reporting, explorative analysis)
Results: Usage of the GCP certified database for clinical trials Seite 15 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
Seite 16 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)
Results: Web-based Query Interface for Patient Populations Seite 17 Select all prostate cancer patients who had a digital rectal examination and have undergone nerve-preserving surgery? 27 patients found
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 Seite 18 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
Seite 19 IT Infrastructure components of the CCC Erlangen-Nuremberg in 2011 Central EHR Communication Ancillary Systems Research Platform SAP IS-H (MPI, Billing) Soarian (EHR) egate (Comm. Server) Swisslab (Lab, Patho,...) WebRIS, SyngoVIA (RIS, PACS) SecuTrial (Trial Data Capture) StarLIMS (Biobank) Meierhofer, QIMS (Surgery) GTDS (Cancer Registry) Amondis, ZENZY (Pharmacy) TransDB (Finding Repository)..... OnkoDat (Chemotherapy) Cognos DataManager, Talend OpenStudio (ETL) multi center research data integration Cognos ReportNet (Routine reporting) DWH i2b2 (research database, explorative analysis)
Seite 20 ulli.prokosch@uk-erlangen.de 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. H.U. Prokosch