1. Ekagra caDSR Forms Interchange Feasibility of using ODM & CDA Nov 13, 2008 Ashwin Mathur (mathura2@mail.nih.gov)

2. Ekagra Background

3. Ekagra The need To be able to represent Forms templates in a consistent ‘standards’ based format for sharing with other systems

4. Ekagra Forms Domain Model

5. Ekagra Requirements Information to be captured - Form metadata Questions Question Text CDE IDs Header info Long Name, Definition, Context, etc. Form Structure Modules Name Order Form Behavior Skip Patterns (if any)

6. Ekagra Clinical Document Architecture (CDA) HL7 standard for exchanging clinical documents For transmission of actual clinical data Uses HL7 v3.0 complex datatypes Levels of compliance (Level 1, Level2, Level3) in increasing order of conformity

7. Ekagra CDA Header

8. Ekagra CDA body mappings

9. Ekagra CDA Example Link

10. Ekagra Requirements  Information to be captured – CDA approach  Forms meta-data ◦ Questions  Question Text  CDE IDs ◦ Header info  Long Name, Definition, Context, etc.  Forms structure ◦ Modules  Name  Order  Forms Behavior  Skip Patterns (if any)  Additional CDA requirements ◦ Header fields data (recordTarget, author, etc.) ◦ Responses to each question ◦ Code system mappings to each response X X X X X

11. Ekagra CDA Summary Advantages Strongly typed Different levels of conformity Human-readable & machine computable (for Level 3 conformant documents) Disadvantages (Forms Perspective)  Needs actual data for compliance  Header elements like recordTarget, author & custodian are mandatory  Elements cannot be referenced - no re-use  No support for data validation  No explicit ordering of sections  No support for skip-patterns

12. Ekagra Operational Data Model (ODM) CDISC Standard for ‘interchange and archive of clinical trials data’ Includes clinical data along with its associated metadata, administrative data & reference data

13. Ekagra ODM Mappings

14. Ekagra ODM Meta-data Mappings

15. Ekagra ODM Example Link

16. Ekagra Requirements  Information to be captured – ODM approach  Forms meta-data ◦ Questions  Question Text  CDE IDs ◦ Header info  Long Name, Definition, Context, etc.  Forms structure ◦ Modules  Name  Order  Forms Behavior  Skip Patterns (if any)

17. Ekagra ODM Summary Advantages Elements loosely coupled – promotes re-use Supports data validation Supports skip-patterns Supports module & question ordering Supports data and metadata in one document Disadvantages Not strongly typed Not easily human- readable

18. Ekagra ODM for CDA Clinical Global Improvement Patient is suicide risk? Patient in remission 1)Record Target details 1)Patient information 1)Patient Name ______ 2)Patient Address 1)Home Number ______ 2)City ______ 3)State ______ 4)Country ______ 5)Zip ______ 2)Author details 1)Author Name ______ 2)Author Address 1)Home Number ______ 2)City ______ 3)State ______ 4)Country ______ 5)Zip ______ 3)Custodian details 1)Custodian Name ______ 2)Custodian Address 1)Home Number ______ 2)City ______ 3)State ______ 4)Country ______ 5)Zip ______ 4)Patient Health Info 1)Clinical Global Improvement 1 2 3 4 5 2)Patient is suicide risk? Yes No 3)Patient in remission Yes No C D A

19. Ekagra The proposed approach Use ODM to capture form meta-data form data CDA meta-data CDA data Produce CDA from captured data ODM Container CDA Form Data CDA Data Form Metadata CDA Metadata

20. Ekagra Issues 1. Datatypes - CDA has complex HL7 datatypes while ODM has simple datatypes Workaround: The CDA complex datatypes can be broken down into multiple parts with simple datatypes in a ODM element Further restrictions on the data can be applied using the ‘RangeCheck’ element in ODM

21. Ekagra Example Clinical Global Improvement Patient’s suicide risk Patient in remission House Number City State PatientName Author Name What is the Clinical Global Improvement Patient’s suicide risk Patient in remission C D AO D M Form > xslt C D A John Doe 21 North Ave Burlington MA 01803 USA 21 North Ave Burlington MA 01803 USA SELF Good Health Clinic 21 North Ave Burlington MA 01803 USA Clinical Global Improvement 2 > Patient is suicide risk? Yes Patient in remission Yes

22. Ekagra ODM-CDA Requirements  Forms requirements  Forms meta-data ◦ Questions  Question Text  CDE IDs ◦ Header info  Long Name, Definition, Context, etc.  Forms structure ◦ Modules  Name  Order  Forms Behavior  Skip Patterns (if any)  Additional CDA requirements ◦ Header fields data (recordTarget, author, etc.) ◦ Answers to each question ◦ Code system mappings to each answer (for enumerated value domains)

23. Ekagra Summary CDAODM Forms meta-data Questions Question Text CDE IDs Header infoLong Name, Definition, Context, etc. Forms structure Modules Name Order Forms Behavior Skip Patterns (if any) CDA requirements Header fields data (recordTarget, author, etc.) Answers to each question Code system mappings to each answer X X X X X

24. Ekagra Conclusion CDA is instance-specific and needs actual data to be generated ODM provides good support for capturing meta-data and data Data needed to generate CDA can be captured in an ODM ODM -> xslt -> CDA

25. Ekagra Questions?