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Clinical LOINC Tutorial




               LOINC®
Panels, Forms, and Patient Assessment Instruments

                          08.13.2009
      Daniel J. Vreeman, PT, DPT, MSc
Assistant Research Professor | Indiana University School of Medicine
            Research Scientist | Regenstrief Institute, Inc




                                                                Copyright © 2009
Overview
• Background
• Standard Panels in LOINC
• Enhanced Panel Model for Patient
  Assessment Instruments
• Current Projects
• Challenges Along the Way
Brief Timeline
• 2000 – First panels in LOINC
• 2000 – Original Model Extension for Standardized Assessment
  Measures (Braden, etc)
   –   Bakken, S, Cimino, JJ, Haskell, R, Kukafka, R, Matsumoto, C, Chan, GK, and Huff, SM (2000).
       Evaluation of the clinical LOINC (Logical Observation Identifiers, Names, and Codes) semantic structure as a terminology model for standard
        J Am Med Inform Assoc 7(6):529-38.


• 2000 – Initial surveys stored in LOINC (HIV, HHC, etc)
• 2002 – Proposed extension for Assessment Instruments
   –   White, TM and Hauan, MJ (2002). Extending the LOINC conceptual schema to support standardized assessment instruments. J Am Med
       Inform Assoc 9(6):586-99.


• 2005 – Dissection of OASIS in LOINC
   –   Choi, J, Jenkins, ML, Cimino, JJ, White, TM, and Bakken, S (2005).
       Toward semantic interoperability in home health care: formally representing OASIS items for integration into a concept-oriented terminolo
       J Am Med Inform Assoc 12(4):410-7.


• 2006 – Initial work with MDS/OASIS (LOINC v2.17)
• 2006 – More discussions about data model, APSE/CHI interest
• 2006 – CHI/NCVHS Endorsement of LOINC as standard for
  federally-required assessment instruments (quest/ans)
Standard Panels in
     LOINC
Panels (Batteries) in LOINC
• Panel term linked to enumerated child elements
   – Child elements can be panels themselves (nesting)
• Panel term names (under discussion)
   –   Component      often have “panel”, include authoritative source
   –   Property       typically “-” because child elements will vary
   –   Scale          typically “-” because child elements will vary
   –   Class          PANEL.*
• Child elements linked and identified as:
   – Required (R)      Element always reported with panel
   – Optional (O)      Element may not be reported depending on
              institutional policies or capabilities
   – Conditional (C) Element is a key finding and thus should be
              assumed to be negative, absent, or not present if
      panel result does not include data for this element.
Example Panel
Example Panel with Nesting
Clinical Panels
Patient Assessment
      Instruments
Iterative Enhancement of the Panel Model
Introduction
• Initial modeling (circa 2000) required modest
  extensions to the LOINC axes
  – E.g. for System to include aggregate units like “family”, and Method
    to distinguish among reported and observed findings
• Survey instruments have psychometric properties
• Question meaning tightly coupled with answers
• With experience in modeling instruments from
  various domains, we uncovered additional
  relevant attributes to store

       General Aim: LOINC could serve as the
        “master question file” in this domain
What’s in the Master Question File?
• Question (item) name/text
     – Exact question text, form-specific display name
•   Data type
•   Description and/or help text
•   For numeric values: units of measure, range checks
•   For categorical results: answers in an answer list
•   Required item (Y/N)
•   Cardinality (more than one answer allowed)
•   Copyright and terms-of-use notices
•   Skip logic
•   Consistency/data integrity logic
•   … and more
Advantages of the Master Catalog
• Single database (LOINC) contains the details about
  individual observations and sets
   – In the database, all forms (sets) look the same
   – Automatic standardization
• Separates the form structure, question details, the
  rendered version (paper or screen), and the
  program that manages it
• Can easily reuse observations (and attributes) in
  different forms/sets
Panels/Forms Available as
   Separate Download
     http://loinc.org/downloads
Rules for Display of Items
1.   SURVEY_QUEST_TEXT (if populated). Used when item is asked as a
     question. Sometimes the item has a label and a question, so we
     store both as [label].[question text]

     Pain Presence. Ask resident: “Have you had pain or hurting at
     any time in the last 7 days?”

2.   DISPLAY_NAME_FOR_FORM (if populated). Provides an override
     display linked to the instance of the LOINC in a particular form.
     Allows for presentation variation that doesn’t affect meaning and
     for where the LOINC naming conventions require some difference
     b/w the item and the LOINC Component.
     Item label = “Body Mass Index (BMI)”
     LOINC Component = “Body mass index”


3.   COMPONENT. This is the default display
Rules for Display of Items
• LOINC is developing/evolving other display
  names
  – Short Name
  – Long Common Name
  – Consumer Name
• May be useful in some contexts, but our
  current practice is to capture the exact form
  display with previous rules
• Some of the original surveys in LOINC may
  not yet follow the model
Structured Answer Lists
• Many items in surveys have highly specialized, fixed
  answer lists
   – Often the answer lists define the meaning of the question
   – Few are represented by existing codes in reference terminologies
• LOINC has created answer codes where needed
   – Have “LA” prefix and a mod-10 check digit
   – Are unique by lexical string (ignoring capitalization)
   – Intentionally do NOT distinguish based on context-specific meaning
• In some cases, the answer list is identified with a
  Regenstrief-assigned OID (for HL7 CDA use)
• Answer list shows sequence, but not bound by it
• Store local codes for items and have place to store
  universal code (e.g. SNOMED) – not yet populated
Current Projects and
     Directions
ASPE as Key Supporter
• ASPE (Jennie Harvell) has championed use
  of HIT standards for assessment
  instruments in many venues
• Initial Reports
  – Making the "Minimum Data Set" Compliant with Health Information Tech
  – Standardizing the MDS with LOINC® and Vocabulary Matches
Consolidated Health Informatics Initiative

• CHI Goal:
  – Adopts a portfolio of existing health information
    interoperability standards (health vocabulary and
    messaging) enabling all agencies in the federal
    health enterprise to “speak the same language”
• In 2006, adopted LOINC as standard:
  – Laboratory test order names
  – Medications: Structured Product Labeling Sections
Consolidated Health Informatics Initiative

• In 2007, CHI adopted LOINC as standard
  for federally-required assessments:
  – questions and answers
  – assessment forms that include functioning
    and disability content
• Jennie Harvell (ASPE) Co-chaired
Currently in LOINC
• US Government Forms
    – CARE, MDSv2, MDSv3, OASIS, RFC
    – US Surgeon General’s Family Health Portrait
•   Geriatric Depression Scale
•   HIV Signs and Symptoms Checklist
•   Home Health Care Classification
•   howRU
•   OMAHA
•   PHQ (9 and 2)
Find them in RELMA
Current RI/LOINC Efforts
• ASPE-funded effort to create LOINC®
  representation of new instrument versions
  – MDSv3 (done)
  – OASIS-C (this fall)
• CMS-funded effort to create LOINC®
  representation of new CARE instrument
  – Make recommendations on legacy instruments
  – Interoperability recommendations
HL7 CDA Implementation Guide
Many Other Potential Opportunities
• Mental health instruments
• Lots of other commonly-used
  instruments (SF-36, etc)
• AHRQ Common Framework forms
• CDC case report forms
• PhenX protocols for clinical research
  trials
Challenges
Corralling the Creativity
Intellectual Property Issues
• Must negotiate separate agreements with each
  copyright/IP holder
• Many instruments are fiercely protected
  – Protection against change and attribution are
    understandable
  – Some want royalties
  – Commercial use in LOINC’s context is tricky
• Even more complicated when several
  instruments included in larger CMS ones (MDS,
  CARE, etc)
Modeling
• Despite many instruments now in LOINC,
  reuse of items has been minimal
  – E.g. extremely few of same items b/w MDSv2
    and MDSv3
  – MDSv3 has greater similarity to CARE, but the
    lookback period is different (7D vs 2D)
• Lament the seemingly trivial differences
  between the CMS-required instruments
Original PHQ-9




    CARE




   MDSv3
MDSv2




MDSv3




OASIS



CARE
Incongruity with HL7 Information Model
 • Items for things that could go in PID, etc
 • Flat data model vs stacked
    – Every ‘Check all that apply’ stored as separate yes/no item




 • “Unknown” or “unable to determine” as answer
   choices vs flavors of null
 • In general, CMS has not been thinking in terms of
   interoperable data exchange
    – Resistant to getting involved in SDO processes like
      balloting
Many Yes/No Diseases
Always New Challenges
• How to label/store definitional text vs text
  giving examples
  – Rashes – e.g. intertrigo, eczema, drug rash, heat rash…
• Answer list sequences
  – Same answers across instruments but different order
• Skip logic shown at level of answer
  – Current strategy is to aggregate up to question level

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Clinical LOINC Tutorial: Standardizing Patient Assessment Instruments

  • 1. Clinical LOINC Tutorial LOINC® Panels, Forms, and Patient Assessment Instruments 08.13.2009 Daniel J. Vreeman, PT, DPT, MSc Assistant Research Professor | Indiana University School of Medicine Research Scientist | Regenstrief Institute, Inc Copyright © 2009
  • 2. Overview • Background • Standard Panels in LOINC • Enhanced Panel Model for Patient Assessment Instruments • Current Projects • Challenges Along the Way
  • 3. Brief Timeline • 2000 – First panels in LOINC • 2000 – Original Model Extension for Standardized Assessment Measures (Braden, etc) – Bakken, S, Cimino, JJ, Haskell, R, Kukafka, R, Matsumoto, C, Chan, GK, and Huff, SM (2000). Evaluation of the clinical LOINC (Logical Observation Identifiers, Names, and Codes) semantic structure as a terminology model for standard J Am Med Inform Assoc 7(6):529-38. • 2000 – Initial surveys stored in LOINC (HIV, HHC, etc) • 2002 – Proposed extension for Assessment Instruments – White, TM and Hauan, MJ (2002). Extending the LOINC conceptual schema to support standardized assessment instruments. J Am Med Inform Assoc 9(6):586-99. • 2005 – Dissection of OASIS in LOINC – Choi, J, Jenkins, ML, Cimino, JJ, White, TM, and Bakken, S (2005). Toward semantic interoperability in home health care: formally representing OASIS items for integration into a concept-oriented terminolo J Am Med Inform Assoc 12(4):410-7. • 2006 – Initial work with MDS/OASIS (LOINC v2.17) • 2006 – More discussions about data model, APSE/CHI interest • 2006 – CHI/NCVHS Endorsement of LOINC as standard for federally-required assessment instruments (quest/ans)
  • 5. Panels (Batteries) in LOINC • Panel term linked to enumerated child elements – Child elements can be panels themselves (nesting) • Panel term names (under discussion) – Component often have “panel”, include authoritative source – Property typically “-” because child elements will vary – Scale typically “-” because child elements will vary – Class PANEL.* • Child elements linked and identified as: – Required (R) Element always reported with panel – Optional (O) Element may not be reported depending on institutional policies or capabilities – Conditional (C) Element is a key finding and thus should be assumed to be negative, absent, or not present if panel result does not include data for this element.
  • 9. Patient Assessment Instruments Iterative Enhancement of the Panel Model
  • 10. Introduction • Initial modeling (circa 2000) required modest extensions to the LOINC axes – E.g. for System to include aggregate units like “family”, and Method to distinguish among reported and observed findings • Survey instruments have psychometric properties • Question meaning tightly coupled with answers • With experience in modeling instruments from various domains, we uncovered additional relevant attributes to store General Aim: LOINC could serve as the “master question file” in this domain
  • 11. What’s in the Master Question File? • Question (item) name/text – Exact question text, form-specific display name • Data type • Description and/or help text • For numeric values: units of measure, range checks • For categorical results: answers in an answer list • Required item (Y/N) • Cardinality (more than one answer allowed) • Copyright and terms-of-use notices • Skip logic • Consistency/data integrity logic • … and more
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  • 16. Advantages of the Master Catalog • Single database (LOINC) contains the details about individual observations and sets – In the database, all forms (sets) look the same – Automatic standardization • Separates the form structure, question details, the rendered version (paper or screen), and the program that manages it • Can easily reuse observations (and attributes) in different forms/sets
  • 17.
  • 18. Panels/Forms Available as Separate Download http://loinc.org/downloads
  • 19. Rules for Display of Items 1. SURVEY_QUEST_TEXT (if populated). Used when item is asked as a question. Sometimes the item has a label and a question, so we store both as [label].[question text] Pain Presence. Ask resident: “Have you had pain or hurting at any time in the last 7 days?” 2. DISPLAY_NAME_FOR_FORM (if populated). Provides an override display linked to the instance of the LOINC in a particular form. Allows for presentation variation that doesn’t affect meaning and for where the LOINC naming conventions require some difference b/w the item and the LOINC Component. Item label = “Body Mass Index (BMI)” LOINC Component = “Body mass index” 3. COMPONENT. This is the default display
  • 20. Rules for Display of Items • LOINC is developing/evolving other display names – Short Name – Long Common Name – Consumer Name • May be useful in some contexts, but our current practice is to capture the exact form display with previous rules • Some of the original surveys in LOINC may not yet follow the model
  • 21. Structured Answer Lists • Many items in surveys have highly specialized, fixed answer lists – Often the answer lists define the meaning of the question – Few are represented by existing codes in reference terminologies • LOINC has created answer codes where needed – Have “LA” prefix and a mod-10 check digit – Are unique by lexical string (ignoring capitalization) – Intentionally do NOT distinguish based on context-specific meaning • In some cases, the answer list is identified with a Regenstrief-assigned OID (for HL7 CDA use) • Answer list shows sequence, but not bound by it • Store local codes for items and have place to store universal code (e.g. SNOMED) – not yet populated
  • 22. Current Projects and Directions
  • 23. ASPE as Key Supporter • ASPE (Jennie Harvell) has championed use of HIT standards for assessment instruments in many venues • Initial Reports – Making the "Minimum Data Set" Compliant with Health Information Tech – Standardizing the MDS with LOINC® and Vocabulary Matches
  • 24. Consolidated Health Informatics Initiative • CHI Goal: – Adopts a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to “speak the same language” • In 2006, adopted LOINC as standard: – Laboratory test order names – Medications: Structured Product Labeling Sections
  • 25. Consolidated Health Informatics Initiative • In 2007, CHI adopted LOINC as standard for federally-required assessments: – questions and answers – assessment forms that include functioning and disability content • Jennie Harvell (ASPE) Co-chaired
  • 26. Currently in LOINC • US Government Forms – CARE, MDSv2, MDSv3, OASIS, RFC – US Surgeon General’s Family Health Portrait • Geriatric Depression Scale • HIV Signs and Symptoms Checklist • Home Health Care Classification • howRU • OMAHA • PHQ (9 and 2)
  • 27. Find them in RELMA
  • 28. Current RI/LOINC Efforts • ASPE-funded effort to create LOINC® representation of new instrument versions – MDSv3 (done) – OASIS-C (this fall) • CMS-funded effort to create LOINC® representation of new CARE instrument – Make recommendations on legacy instruments – Interoperability recommendations
  • 30. Many Other Potential Opportunities • Mental health instruments • Lots of other commonly-used instruments (SF-36, etc) • AHRQ Common Framework forms • CDC case report forms • PhenX protocols for clinical research trials
  • 32. Intellectual Property Issues • Must negotiate separate agreements with each copyright/IP holder • Many instruments are fiercely protected – Protection against change and attribution are understandable – Some want royalties – Commercial use in LOINC’s context is tricky • Even more complicated when several instruments included in larger CMS ones (MDS, CARE, etc)
  • 33. Modeling • Despite many instruments now in LOINC, reuse of items has been minimal – E.g. extremely few of same items b/w MDSv2 and MDSv3 – MDSv3 has greater similarity to CARE, but the lookback period is different (7D vs 2D) • Lament the seemingly trivial differences between the CMS-required instruments
  • 34. Original PHQ-9 CARE MDSv3
  • 36. Incongruity with HL7 Information Model • Items for things that could go in PID, etc • Flat data model vs stacked – Every ‘Check all that apply’ stored as separate yes/no item • “Unknown” or “unable to determine” as answer choices vs flavors of null • In general, CMS has not been thinking in terms of interoperable data exchange – Resistant to getting involved in SDO processes like balloting
  • 38. Always New Challenges • How to label/store definitional text vs text giving examples – Rashes – e.g. intertrigo, eczema, drug rash, heat rash… • Answer list sequences – Same answers across instruments but different order • Skip logic shown at level of answer – Current strategy is to aggregate up to question level