CDA the Primacy of Information by nikeborome


									 HL7’s Clinical Document

           Liora Alschuler
Dallas, Texas         February, 2005
About me
 Liora Alschuler
      alschuler.spinosa, consultants
      Co-chair HL7 Structured Documents TC
      Co-editor, CDA
      Member, 2005, HL7 Board of Directors
      Project manager for Operation Jumpstart, (initial
       design of CDA)
      past Chair, XML SIG

 Also contributing: Bob Dolin, MD, Kaiser-Permanente;
  John Madden, MD, Duke University Medical Center
Clinical Document Architecture: CDA

 What is it?
 How does it allow you to:
     Do simple things simply
     Invest in information (doing complex things
What is CDA?
 ANSI/HL7 CDA r1-2000 (Release one)
    On CD, includes prose spec, RMIM, DTDs
 December 2004 ballot (Release two)
    Structured Documents Tech Cmte, zip file on – PASSED, will be published shortly
 A specification for document exchange using
    XML,
    the HL7 Reference Information Model (RIM)
    Version 3 methodology
    and vocabulary (SNOMED, ICD, local,…)
CDA: A Document Exchange Specification

 This is a CDA
 and this
 and this
 and this
 and this
 and this
 and this
CDA: A Document Exchange Specification

 A CDA can be a
     Discharge Summary
     Referral (CCR is one such)
     Progress Note
     H&P
     Public health report
 … any content that carries a signature

 XML is Extensible Markup Language
 In XML, structure & format are conveyed by
  markup which is embedded into the
Sample CDA
CDA = header + body
 CDA Header
    Metadata required for document discovery,
     management, retrieval
 CDA Body
    Clinical report
          Discharge Summary
          Referral
          Progress Note
          H&P
          Public health report
     … any content that carries a signature
CDA Header

 The header describes:
     The document itself (unique ID, document
      type classification, version)
     Participants (providers, authors, patients…)
     Document relationships (to orders, other
 Metadata sufficient for document
CDA Body: two types of markup
 Human-readable “narrative block”, all that
  is required to reproduce the legal, clinical
 Optional machine-readable CDA Entries,
  which drive automated processes
CDA Body: Human-readable
    paragraph
    list
    table
    caption
    link                                                 required
    content
    revise (delete/insert)
    subscript/superscript
    special characters (e.g., symbols, Greek letters) in
    emphasis
    line break
    renderMultiMedia (non-XML graphics, video…)
CDA Body: Machine Processible
    Clinical statement
         Observation
         Procedure
         Organizer
         Supply
         Encounter
         Substance Administration
         Observation Media
         Region Of Interest
         Act
CDA Body: Why isn’t XML + SNOMED enough?

                   “hives”: SNOMED CT 247472004

                   “Dr. Dolin asserts that Henry Levin
                   manifests hives as a previously-diagnosed
                    allergic reaction to penicillin”
First: human readable
                  Allergy to penicillin

Next: series of   Observation:      RIM-defined
                           Prior dx: SNOMED

related           Hives
                           Allergy to penicillin: SNOMED

statements                 Prior dx: SNOMED
                           Hives: SNOMED
                  Hives is a manifestation of a reaction
                  to penicillin
                  Relationship:    RIM-defined
Then: supply context

                Who is the subject?
                Target:         RIM-defined
                Id:             local
How are these concepts, relationships

                 CDA Body,                       Extl
 CDA Header                        CDA Entries
                 Section, and                    Refs
                 Narrative Block
Investing in Information
 CDA XML can be simple
 CDA XML can be complex
 Simple encoding relatively inexpensive
 Complex encoding costs more
 You get what you pay for:
     like charging a battery,
     the more detailed the encoding
     the greater the potential for reuse
CDA: Return on Investment
    Low end: Access to documents
         “please send referral letter to…”
         “please get me the discharge summary…”
         “what imaging reports are available from the
          last episode?”
    High end: Reuse
         Send synopsis to tumor board
         Attach to claim for automated adjudication of
         Extract data for clinical research
Low End Applications for CDA
 Persistant, accessible, human-readable
 Document requirements:
     CDA header
     Release One or Two body
          Narrative block
          Non-semantic markup (HTML-like)
 Document options:
    More complex markup can be inserted, to be
     used or ignored
Low End Investment in CDA
 Many forms of document creation technology
     Voice (dictation, transcription)
     eForm
     EHR (CDA is output as “report”)
        What is the simplest way to create a
        CDA document?


                                                      Point to document body

See NLM Project: freely available application (by 3/1)
 What you can do with simple CDA
 documents: the registry hub
                                                              4. Retrieve

                                           “what imaging
                                           reports are available
                                           from the last
1. Create documents     2. Register        episode?”         3. Discover

  Ubiquitous access to distributed information
        By class of document, patient, provider, encounter (CDA
         header metadata)
        Documents remain under local control
        Document creation technology evolves under local control
        Registry (hub) for access control, identifier xRef
A tip of the hat to…
 40% of Finnish population covered including Helsinki
Investing in Information
 Simple documents
     retrieval, display
     metadata registry
 Two examples of higher-level investment:
     HIMSS 2004, Dr. John Madden, Duke
      University Medical Center, created a CDA
      pathology note that doubles as a tumor board
     Also at Duke, the Starbrite “Single Source”
      Proof of Concept for clinical trials
        A single
   facilitates multiple
       standards !
 Pathologist view:
CAP/ACoS standards
compliant, template-
  driven data entry
      Repository view:
HL7-CDA standard XML with
XQuery-ready, context-linked
    SNOMED encodings
South Hospital

            Clinician view:
         Traditional format,
       print/electronic delivery
        South Hospital

 Tumor registrar view:
Irrelevant items filtered,
     stage computed
One CDA, many applications:

                 Display or print
                 (referring physician’s

Source CDA
                                   Archival CDA
(pathologist,                      XML
author’s view)

                 Tumor Board,
                 synopsis, meets
                 CAP reporting
Investing in Information
 “Single Source”
     Create once
     Use many
     Reuse clinical data in clinical trials
 Duke Clinical Research Institute
     Proof of Concept
     Principals:
          Landen Bain, Rebecca Kush, Liora Alschuler
          Microsoft, primary technology partner
    The Challenge: Integrate Patient Care
    and Clinical Research Data

Patient Care World                 Clinical Research World

            Medical Record

                             The Void
Single Source vs Previous Solutions
 eSource & electronic data capture
     redundant with creation of clinic note
     require information reside in EMR/EHR
     proprietary data formats
 CDA & CDISC in “single-source”
     capture trial data, merge it into clinic note
     work with current technology, workflow
     open, non-proprietary data formats
CDA in Starbrite Trial
                       Manual creation and re-entry of CRF


     lab, ADT,
     meds,       LIS
                          display    manual               re-key CRF
                                     entry to
                                    CRF

                                    CLINIC           CRO

     lab, ADT,
                         display    dictate

                                    chart note

                       Redundant creation of chart note
CDA in Starbrite Trial

                    Merged workflow: electronic CRF
                    re-used in chart note
             HIS                    validation

 lab, ADT,
             LIS                                 db
 meds,                                  ODM
 source            display   eCRF
 documents                                             Proposed
                                                      processes
                             chart note                source)

                             CLINIC              ARO
One CDA, many applications: clinical

                 Clinic note inserted
                 into patient chart             See demo here,
                                                Microsoft pod!

Source CDA
                                 Archival CDA
(principal                       XML
author’s view)
                 Case report form
                 submission to
                 research database
Investing in Information
                           Disecting the curve
                           What is easy:
                              Header
                              Human-readable body
                              Low degree of coding
                           What is hard:
                              Concensus on semantic
                               content requirements
                              Model/vocabulary
Investing in Information
 Example of what is hard
     TermInfo 2004 conference
          NASA August 1-4, 2004, Houston, TX
          Notes posted to the summit’s web page:
          New project within HL7
     Looked at issues raised by David Markwell
      (and previously identified by others)
Investing in information: what is hard?

 Issue 1: Code/value dichotomy
     abdominal tenderness is observed
          examination (code) / abdomen tender (value);
           abdominal examination / abdomen tender;
          abdominal palpitation / abdomen tender;
          abdominal tenderness / present, etc.
Investing in information: what is hard?

 Strong collaborative effort established to
  address issues
 Most syntatic issues addressed, full
  concentration on semantic interoperability
 Issues will be resolved, but will take time
  and experience
  Investing in Information: phased
 Lay groundwork
    CDA header metadata
    XML R1 or R2 CDA body

 Build
    Concensus on requirements
    Understanding of modeling process
    Vocabulary glossary

 Understand
    Relationship of vocabulary to model

 Introduce interoperable semantic content as
  requirements and business drivers dictate
CDA: doing simple things simply, &
more complex things slowly
 What can be done now
   Basic (Level One) CDA (R1 or R2) can be created with
    any degree of technical sophistication
      Document scanner+web form

      Transcription

      Electronic health record

 What can be done later
   Increase coding sophistication as business
    requirements dictate (return on investment and
Thank you!

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