Ekagra caDSR Forms Interchange Feasibility of using ODM & CDA Nov 13, 2008 Ashwin Mathur ([email protected])

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caDSR Forms Interchange

Feasibility of using ODM & CDA

Nov 13, 2008Ashwin Mathur

([email protected])

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Background

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The need

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

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Forms Domain Model

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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)

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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

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CDA Header

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CDA body mappings

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CDA Example

Link

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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

XXX

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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

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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

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ODM Mappings

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ODM Meta-data Mappings

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ODM Example

Link

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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)

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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

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ODM for CDA

<ClinicalDocument> <recordTarget/> <author/> <custodian/><component> <structuredBody> <section> <title>Clinical Global Improvement</title> <code code=“2004848v3.0” codeSystem=“caDSR”/> <text/> <entry/> </section> <section> <title>Patient is suicide risk?</title> <code code=“2004849v2.0” codeSystem=“caDSR”/> <text/> <entry/> </section> <section> <title>Patient in remission</title> <code code=“2004847v2.0” codeSystem=“caDSR”/> <text/> <entry/> </section></structuredBody></component></ClinicalDocument>

1) Record Target details1) Patient information

1) Patient Name ______2) Patient Address

1) Home Number ______2) City ______3) State ______4) Country ______5) Zip ______

2) Author details1) Author Name ______2) Author Address

1) Home Number ______2) City ______3) State ______4) Country ______5) Zip ______

3) Custodian details1) Custodian Name ______2) Custodian Address

1) Home Number ______2) City ______3) State ______4) Country ______5) Zip ______

4) Patient Health Info1) Clinical Global Improvement

1 2 3 4 52) Patient is suicide risk?

Yes No3) Patient in remission

Yes No

C D A

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The proposed approach

Use ODM to capture form meta-data form data CDA meta-data CDA data

Produce CDA from captured data

ODM Container

CDACDAForm Data

CDA Data

Form Metadata

Form Metadata

CDA Metadata

CDA Metadata

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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 <ItemDef> element

Further restrictions on the data can be applied using the ‘RangeCheck’ element in ODM

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Example

<ClinicalDocument> <recordTarget/> <author/> <custodian/> <component> <structuredBody> <section> <title>Clinical Global Improvement</title> <code code=“2004848v3.0” codeSystem=“caDSR”/> <text/> <entry/> </section> <section> <title>Patient’s suicide risk</title> <code code=“2004849v2.0” codeSystem=“caDSR”/> <text/> <entry/> </section> <section> <title>Patient in remission</title> <code code=“2004847v2.0” codeSystem=“caDSR”/> <text/> <entry/> </section></structuredBody></component></ClinicalDocument>

<ODM><ItemGroupDef OID="CDA001" Name="recordTarget"> <ItemRef ItemOID="ID004" OrderNumber="1" Mandatory="Yes" /> <ItemRef ItemOID="ID001" OrderNumber="2" Mandatory="Yes" /> <ItemRef ItemOID="ID002" OrderNumber="3" Mandatory="Yes" /> <ItemRef ItemOID="ID003" OrderNumber="4" Mandatory="Yes" /></ItemGroupDef><ItemGroupDef OID="CDA002" Name="author"> <ItemRef ItemOID="ID005" OrderNumber="1" Mandatory="Yes" /> <ItemRef ItemOID="ID001" OrderNumber="2" Mandatory="Yes" /> <ItemRef ItemOID="ID002" OrderNumber="3" Mandatory="Yes" /> <ItemRef ItemOID="ID003" OrderNumber="4" Mandatory="Yes" /></ItemGroupDef><ItemGroupDef OID="MOD001" Name="Obs"> <ItemRef ItemOID="ID006" OrderNumber="1" Mandatory="Yes" /> <ItemRef ItemOID="ID007" OrderNumber="2" Mandatory="Yes" /> <ItemRef ItemOID="ID008" OrderNumber="3" Mandatory="Yes" /></ItemGroupDef>

<ItemDef OID="ID001" DataType=“int" Name="ID001"> <Question><TranslatedText>House Number</TranslatedText></Question></ItemDef><ItemDef OID="ID002" DataType="string" Name="ID002"> <Question><TranslatedText>City</TranslatedText></Question></ItemDef><ItemDef OID="ID003" DataType="string" Name="ID003"> <Question><TranslatedText>State</TranslatedText></Question></ItemDef><ItemDef OID="ID004" DataType="string" Name="ID004"> <Question><TranslatedText>PatientName</TranslatedText></Question></ItemDef><ItemDef OID="ID005" DataType="string" Name="ID005"> <Question><TranslatedText>Author Name</TranslatedText></Question></ItemDef><ItemDef OID="ID006" DataType="string" Name="ID006"> <Question><TranslatedText>What is the Clinical Global Improvement</TranslatedText></Question> <ExternalQuestion Dictionary="caDSR" Version="3.0" Code="2004848v3.0 "/></ItemDef><ItemDef OID="ID007" DataType="string" Name="ID007"> <Question><TranslatedText>Patient’s suicide risk</TranslatedText></Question> <ExternalQuestion Dictionary="caDSR" Version="3.0" Code="2004849v2.0 "/></ItemDef><ItemDef OID="ID008" DataType="string" Name="ID008"> <Question><TranslatedText>Patient in remission</TranslatedText></Question> <ExternalQuestion Dictionary="caDSR" Version="3.0" Code="2004847v2.0 "/></ItemDef></ODM>

C D AO D MForm<ClinicalDocument> <recordTarget><patientRole><realmCode></realmCode> <patient> <name></name> <addr> <streetAddressLine></streetAddressLine> <city></city><state></state> <postalCode></postalCode><country></country> </addr> </recordTarget> <author><assignedAuthor> <code code=‘' codeSystem=‘' /> <addr> <streetAddressLine></streetAddressLine> <city></city><state></state> <postalCode></postalCode><country></country> </addr> <assignedPerson><name></name></assignedPerson> </assignedAuthor></author> <custodian> <assignedCustodian><representedCustodianOrganization> <name></name> <addr> <streetAddressLine></streetAddressLine> <city></city><state></state> <postalCode></postalCode><country></country> </addr> </representedCustodianOrganization></assignedCustodian> </custodian> <component> <structuredBody> <section> <title></title> <code code=“” codeSystem=“”/> <text></text> <entry/> </section> <section> <title></title> <code code=“” codeSystem=“”/> <text></text> <entry/> </section> <section> <title></title> <code code=“” codeSystem=“”/> <text></text> <entry/> </section></structuredBody></component></ClinicalDocument>

<<maps to>>

<<maps to>>

<<maps to>>

C D A<ClinicalDocument> <recordTarget><patientRole><realmCode></realmCode> <patient> <name>John Doe</name> <addr> <streetAddressLine>21 North Ave</streetAddressLine> <city>Burlington</city><state>MA</state> <postalCode>01803</postalCode><country>USA</country> </addr> </recordTarget> <author><assignedAuthor> <code code='SELF' codeSystem='2.16.840.1.113883.5.111' /> <addr> <streetAddressLine>21 North Ave</streetAddressLine> <city>Burlington</city><state>MA</state> <postalCode>01803</postalCode><country>USA</country> </addr> <assignedPerson><name>SELF</name></assignedPerson> </assignedAuthor></author> <custodian> <assignedCustodian><representedCustodianOrganization> <name>Good Health Clinic</name> <addr> <streetAddressLine>21 North Ave</streetAddressLine> <city>Burlington</city><state>MA</state> <postalCode>01803</postalCode><country>USA</country> </addr> </representedCustodianOrganization></assignedCustodian> </custodian> <component> <structuredBody> <section> <title>Clinical Global Improvement</title> <code code=“2004848v3.0” codeSystem=“caDSR”/> <text>2</text> <entry><observation>><code code=“2004848v3.0”></observation></entry> </section> <section> <title>Patient is suicide risk?</title> <code code=“2004849v2.0” codeSystem=“caDSR”/> <text>Yes</text> <entry><observation><code code=“2004848v3.0”></observation></entry> </section> <section> <title>Patient in remission</title> <code code=“2004847v2.0” codeSystem=“caDSR”/> <text>Yes</text> <entry><observation><code code=“2004848v3.0”></observation></entry> </section></structuredBody></component></ClinicalDocument>

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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)

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Summary

CDA ODM

Forms meta-data

Questions

Question Text

CDE IDs

Header info Long Name, Definition, Context, etc.

Forms structureModules

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

XX

X

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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

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Questions?