1. All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute Involvement with Data Standards and Semantics (May 6, 2011) Salvatore Mungal Duke Bioinformatics Shared Resources (DBSR) Duke Cancer Institute (DCI)

2. All Rights Reserved, Duke Medicine 2007 Agenda Background: –The Promise of Interoperability –The caBIG Initiative –Interoperability Fundamentals Groups of Standards Standards at Duke caBIG Interoperability Development Benefits of caBIG Interoperability Adoption Building Blocks/Development caBIG Implementation Framework at Duke Benefits of caBIG Adoption with Data Standards Current Pilot Under Development Future Plans

3. All Rights Reserved, Duke Medicine 2007 The Promise of Interoperability Interoperability is based on common data standards and is a pre-requisite for the aggregation and sharing of data Interoperability in Life Sciences research can lead to faster conclusions via analysis of shared/aggregated data In health care, widespread interoperability can lead to better outcomes in many areas ranging from high quality care, individual patient safety during treatment, to population safety from epidemics, to the everyday chronic and acute care of millions of citizens, irrespective of location Currently, vendor systems are not interoperable, institutional systems are not interoperable, and enterprises are not interoperable. Interoperability is the future Published with permission

4. All Rights Reserved, Duke Medicine 2007 Background: The caBIG Initiative In 2003 Dr. Andrew von Eschenbach set the caBIG initiative in motion Sharing and expanding interoperable datasets for analysis - a crucial goal Accelerated research, cures and better outcomes The success of this initiative relies on the incorporation of standard datatypes, semantics, and software systems i.e. the semantic and syntactic - all working in harmony Interoperability is the future and caBIG leads the charge

5. All Rights Reserved, Duke Medicine 2007 Background: Interoperability Fundamentals The fundamental unit of interoperability is the data standard (HL7  BRIDG, LS_DAM etc.) The fundamental unit in caBIG data standards currently is the Common Data Element (CDE) which uses ISO 11179 that incorporates standard semantics (vocabularies, terminologies etc.) and standard value domains/datatypes in it’s metadata (mapping of ISO 11179 to 21090) caBIG uses CDEs in Clinical/Life Sciences research/studies In a Yin/Yang relationship (syntactic/semantic), software encapsulates data and their CDEs (metadata) to facilitate data sharing - automated interoperability could be realized Other groups are creating their own data standards and are willing to use caBIG as a model

6. All Rights Reserved, Duke Medicine 2007 GROUPS OF STANDARDS GENERIC, BROAD USE XML, TCP/IP, Web services, OCL, CCOW, SECURITY, GIS, etc. W3C, IETF, OMG, HL7 others. DATA ELEMENTS RIM, DATA ELEMENTS, DATA TYPES, TERMINOLOGY, TEMPLATES, CDA HL7, CEN, ISO, NCPDP, X12N, IEEE, SNOMED. LOINC, RXNORM, SPL DATA INTERCHANGE Structured and free form documents, images HL7 V2.N AND V3, DICOM, IEEE X73, ASTM, NCPDP, X12n and others KNOWLEDGE REPRESENTATION Guidelines and Protocols, ARDEN SYNTAX, GLIF, GEM, PRODIOGY, PROTIGÉ, vMR, GELLO, others HL7, ASTM, UK, others ELECTRONIC HEALTH RECORD FUNCTIONAL REQUIREMENTS, CONTENT DATA SETS, EHR MODEL, CCR, TRANSFER EHR, other HER HL7, ASTM, CEN, openEHR APPLICATION LEVEL SUPPORT IDENTIFIERS, RESOURCE REGISTRIES, TOOL SETS, CONFORMANCE AND IMPLEMENTATION MANUALS HIPAA, HL7, ASTM, ISO, CEN Published with permission

7. All Rights Reserved, Duke Medicine 2007 Standards at Duke Duke is facilitating several projects in HL7 –Cardiovascular DAM –Anesthesiology DAM –InfoButton Standard –Tuberculosis DAM The caBIG Standards –ISO 21090/11179, –HL7 –Semantics - Vocabularies, Terminologies and Ontologies (LOINC etc.) Several applications with standards (listed later)

8. All Rights Reserved, Duke Medicine 2007 DATA KNOWLEDGE PROCESS STANDARDS Low cost Accessible Patient Safety Quality Analysis Statistics Research Clinical Trials EBM Analysis Statistics Research Clinical Trials EBM Analysis Statistics Research Clinical Trials EBM Analysis Statistics Research Clinical Trials Surveillance Analysis Public/Private Partnership Vendor/Provider Partnership Published with permission Privacy, Security, Trust, Integrity

9. All Rights Reserved, Duke Medicine 2007 Preventive Care Acute CareChronic Care Data Decision Support NormalConcernAbnormal Outpatient Specialty Emergency Hospital Intensive Control Treatment Performance Symptoms DiagnosesTreatment Outcomes Genomic Medicine Nursing Homes, etc. Home Care Published with permission A view of the healthcare world

10. All Rights Reserved, Duke Medicine 2007 Where do standards start? With the smallest element – the data element If we define a structured set of any and all data elements that might be contained within an electronic health record, and if we include precise and unambiguous definitions, data types, units, roles and use, and many other attributes, and if we define unique value sets for these data elements (single, integrated terminology) then we can achieve interoperability independently of how these data elements might be packaged for interchange. Published with permission

11. All Rights Reserved, Duke Medicine 2007 EHR Interoperability Diagram Patient Encounter Provider EHR Database Personal EHR Population EHR Profile Research Database Enterprise Data Warehouse Personal EHR Profile Disease Registry Profile Billing/Claims Institution EHR Database Research Database Disease Registry Derived from master data element registry Published with permission

12. All Rights Reserved, Duke Medicine 2007 caBIG Interoperability Development at Duke Cancer Central Participant Registry (C3PR) caTRIP –Many elements are part of other caBIG applications RProteomics Duke Cancer Proteome Characterization Center (proposal) VCDE/Architecture Mentorship

13. All Rights Reserved, Duke Medicine 2007 caBIG Adoption at Duke Flagship C3D implementation –Many trials in production, many more in development (all CDE based) caAERS (CALGB and Duke) (in progress) C3PR multi-center pilot caGRID RProteomics (soon to be in development) caArray

14. All Rights Reserved, Duke Medicine 2007 Data Entity Overview

15. All Rights Reserved, Duke Medicine 2007 CDE BASED Data Entity Overview CDE Based

16. All Rights Reserved, Duke Medicine 2007 Program Project (P01) Proposal

17. All Rights Reserved, Duke Medicine 2007 Program Project (P01) Proposal CDE Based CDE BASED

18. All Rights Reserved, Duke Medicine 2007 Duke Proteome Characterization Center (PCC) (Proposed) Key: Red arrows indicate semantic involvement

19. All Rights Reserved, Duke Medicine 2007 Duke Proteome Characterization Characterization Center (PCC) (Proposed) CDE Based CDE BASED

20. All Rights Reserved, Duke Medicine 2007 Benefits of caBIG Interoperability Adoption C3D –Top-shelf CDMS (with CBIIT tech. support) –Regulatory compliant (21 CFR Part 11) –Shared Global Library (parent-child) –caDSR-Direct (local curation ability) –Thousands of Common Data Elements –Development curve Less steep now, new trials up much faster More cluster (brain, breast, etc) replication

21. All Rights Reserved, Duke Medicine 2007 Supported Projects on caBIG Platforms Goal: All Investigator-initiated Clinical Trials (all CDE based) Currently ~40 trials in production or development –Single and multi-center –Both IND/IDE and Registry International –Launching first trial with Beijing Cancer Hospital …more to come Funding Mix –Gov’t – NIH (NCI, NINDS, etc) and DoD –Foundation (Komen, etc.) –Industry/Pharma

22. All Rights Reserved, Duke Medicine 2007 Supported Projects on caBIG Platforms CDE Based Goal: All Investigator-initiated Clinical Trials (all CDE based) Currently ~40 trials in production or development –Single and multi-center –Both IND/IDE and Registry International –Launching first trial with Beijing Cancer Hospital …more to come Funding Mix –Gov’t – NIH (NCI, NINDS, etc) and DoD –Foundation (Komen, etc.) –Industry/Pharma CDE BASED

23. All Rights Reserved, Duke Medicine 2007 Duke-Beijing Abraxane Trial CDE Based First CT collaboration caTissue-based tumor registry Future network in China CDE BASED

24. All Rights Reserved, Duke Medicine 2007 C3PR Multi-center Pilot (Completed) CDE Based PANVAC multi-center vaccine study –Grid-enabled –Secure –Accessible –CDE based Dorian GT S CDS webSSO caXchange Key Id P Study Service Registration Service XYZ Cancer Center CDE BASED

25. All Rights Reserved, Duke Medicine 2007 Under Development caTissue (works with annotated samples) –Pilot implementation underway –Potential for broad institutional adoption caArray –Installed (annotation tool is very useful) –caGrid enabled Laboratory Information System (GE – in use) –Uses LOINC Data warehouse –Implements a text analytic tool using Radlex

26. All Rights Reserved, Duke Medicine 2007 Under Development (con’t) DISCERN (in use) –HL7 is part of the eBrowser (DSR) –Potential for broad institutional adoption (available to all Duke Researchers) caArray –Installed (annotation tool is very useful) –caGrid enabled Laboratory Information System (GE – in use) –Uses LOINC Data warehouse (in use) –Implements a text analytic tool using RadLex

27. All Rights Reserved, Duke Medicine 2007 Under Development (con’t) Cardiovascular Data Standards (DCRI) –DAM has ~ 1285 CDEs (HL7 conversion next) –Country wide adoption expected Bioconductor (off site caBIG compatible app.) –Genomic analysis (heavy use) GenePattern (off site caBIG compatible app.) –Genomic analysis (heavy use)

28. All Rights Reserved, Duke Medicine 2007 Future Plans C3D (all CDE based) –Streamline trial start-up with eCRF Harmonization –Exchange data with caAERS –Complete integration with Velos eResearch Expanded use of caARRAY by DBSR –Annotations China (all CDE/Forms based) –Set-up local Suite environment in Beijing –Build-out multi-center Chinese network

29. All Rights Reserved, Duke Medicine 2007 Future Plans (con’t) Proteomic Center (proposed) –Streamline all data collection and analysis with annotation engine, Tranche –Integration of RProteomics for analysis Duke will continue their involvement with HL7 standards Continued expansion of CRF creation (CDE based) by other groups –caDSR-Direct (local curation ability)

30. All Rights Reserved, Duke Medicine 2007 Summary Duke is very involved with data standards Interoperability is the future Currently, vendor systems are not interoperable, institutional systems are not interoperable, and enterprises are not interoperable The fundamental unit of interoperability is the data standard (HL7  BRIDG, LS_DAM etc.) The fundamental unit in caBIG data standards currently is the Common Data Element (CDE) which uses ISO 11179 that incorporates standard semantics (vocabularies, terminologies etc.) and standard value domains/datatypes in it’s metadata For data standards, start with the smallest element – the data element

31. All Rights Reserved, Duke Medicine 2007 Acknowledgements DBSR William Barry, Director Pankaj Agarwal DTMI W. Ed Hammond, Director Anita Walden CCIS Bob Annecharico, Director Mohammad Farid DCRI Brian McCourt, Assoc. Director Rebecca Wilgus

32. All Rights Reserved, Duke Medicine 2007 Questions? Q & A