CIMI Modelling Taskforce Report

1. CIMI Modelling Taskforce Report Dr Linda Bird 14th May 2012

2. Agenda • Members • Mission & TOR • Overview of work • Call For Models • Modelling Approach • Background • Foundations • Summary of Approach

3. Taskforce Members • Technical Resources: • Peter Hendler • Galen Mulrooney • Grahame Grieve • Dipak Kalra • Daniel Karlsson • Cecil Lynch • David Moner • Clinical Modelling Resource: • William Goossen • Jay Lyle • Ian McNicoll • AnnekeGoossen • Heather Leslie • Marcelo Rodrigues dos Santos • Sarah Ryan • Hendry Wijaya • Harold Solbrig Core Members: • Linda Bird • Tom Beale • Dave Carlson • Stephen Chu • Stan Huff • Mike Lincoln • Rahil Qamar Siddiqui • Gerard Freriks • Josh Mandel • Mark Shafarman • Michael van der Zel

4. Mission To develop a CIMI modelling methodology, style guide and a set of models, which together demonstrate and test the approach to CIMI clinical modelling.

5. Terms of Reference This taskforce has been established to: • Further develop and document CIMI's modelling methodology, including modelling patterns and modelling style guides; • Create an initial set of CIMI clinical models to demonstrate the approach and test the technical artefacts; • Further test and develop CIMI technical models and documentation, including the CIMI reference model, the Archetype Object Model 1.5, and CIMI terminology.

6. Planned Deliverables D1 CIMI Reference Model One or more computable representations (UML & BMM) D2 CIMI RM Documentation One or more artefacts documenting the CIMI RM (Word) D3 CIMI Modelling Patterns A set of modelling patterns (UML & ADL) D4 CIMI Clinical Models Based on call for models (UML & ADL) • Heart rate, BMI, Apgar score, Glucose tolerance, Adverse Reaction, Medication Order, Problem List, Nausea, Wound Culture • Example instance data D5 CIMI Modelling Methodology Modelling Style Guide / Best Practices Guidelines Document • Iterative approach to methodology development D6 CIMI Terminology CIMI value sets, semantic concepts, and CIMI SNOMED CT extension • Documentation of approach to terminology binding D7 Updates to AOM Computable representation of AOM to meet CIMI requirements D8 CIMI Taskforce Report A report describing the activities of the modelling taskforce, including: • Mission, Terms of Reference, Planned Deliverables • Outcomes of work item and summary of results • Gap analysis and evaluation between UML & AOM approaches • Methodology for transforming CIMI models into other artefacts, and the degree of semantic interoperability that is supported by these transformations • A methodology for subsumption testing of models • A methodology for providing multiple visualisations of clinical models for different audiences (both clinical and technical) • Recommendations D9 Meeting Minutes A summary of taskforce meetings

7. Planned Deliverables D1 CIMI Reference Model One or more computable representations (UML & BMM) D2 CIMI RM Documentation One or more artefacts documenting the CIMI RM (Word) D3 CIMI Modelling Patterns A set of modelling patterns (UML & ADL) D4 CIMI Clinical Models Based on call for models (UML & ADL) • Heart rate,BMI, Apgar score,Glucose tolerance, Adverse Reaction, Medication Order, Problem List, Nausea, Wound Culture • Example instance data D5 CIMI Modelling Methodology Modelling Style Guide / Best Practices Guidelines Document • Iterative approach to methodology development D6 CIMI Terminology CIMI value sets, semantic concepts, and CIMI SNOMED CT extension • Documentation of approach to terminology binding D7 Updates to AOM Computable representation of AOM to meet CIMI requirements D8 CIMI Taskforce Report A report describing the activities of the modelling taskforce, including: • Mission, Terms of Reference, Planned Deliverables • Outcomes of work item and summary of results • Gap analysis and evaluation between UML & AOM approaches • Methodology for transforming CIMI models into other artefacts, and the degree of semantic interoperability that is supported by these transformations • A methodology for subsumption testing of models • A methodology for providing multiple visualisations of clinical models for different audiences (both clinical and technical) • Recommendations D9 Meeting Minutes A summary of taskforce meetings

8. Overview of Work

9. Meeting Summary July 5 Mission, TOR, Deliverables, Call for Models, Secretary July 12 Tasks & Activities Planning, Secretary July 19 Model Submissions, Storage/Github, Modelling Process July 26 Modelling Patterns: openEHR, NHS LRA August 2 Modelling Patterns: ADL workbench, SNOMED August 9 Modelling Patterns: VA, MOHH, R4C, EN13606 Assoc Heart Rate model submissions: comparative analysis August 16 HL7 v3, Modelling Pattern Review, CIMI Entry patterns August 23 CIMI Entry patterns, Heart Rate Model & Style Guide August 30 Terminology: NHS, Extensions to AOM, Binding Syntax September 6 Model granularity, Time Series, Heart Rate Terminology Planning for Rockville

10. Overview of Work • Infrastructure • Call For Models • Model Submissions - Review • CIMI Modelling Patterns • CIMI Style Guide • CIMI Models

11. Infrastructure • Issue tracking (github) • https://github.com/clinicalmodels/cimi/ • Google doc repository • Documents, clinical models, reference model, modelling patterns, model submissions • http://content.clinicalmodels.org • Google groups email list • cimi-modelling-taskforce • http://groups.google.com/group/cimi-modelling-taskforce?hl=en-GB • CIMI website • CIMI models tab, Quick links, Links to the Doc repository

12. CIMI Modelling • CIMI Reference Model • Published draft • Outstanding issues discussed on github • CIMI Style Guide & Patterns • Early draft includes draft quality criteria and modelling principles • CIMI Modelling Patterns • ENTRY types (e.g. Observation) • Isosemantic patterns • Time series • CIMI Models • First draft of CIMI Heart Rate model, based on: • Comparative analysis of CIMI model submissions • Proposed OBSERVATION design pattern

13. Call For Models

14. Call For Models • Modelling Patterns plus: • Heart Rate • Body Mass Index • Apgar Score • Glucose Tolerance Test Result • Adverse Reaction • Medication order • Problem list • Nausea • Wound Culture Result

15. Model Submissions • CIHI/Infoway– Allergy/Intolerance, Medication Order • EN13606 Association – Blood Pressure, Investigation, Observation, Description of others • Intermountain Healthcare – All requested models • Kaiser Permanente – HealthConcern • MOHHoldings– All models (some generalisations) • NEHTA – Adverse Reaction, Problem/Diagnosis, Med Order • NHS – Allergies/Adverse Reaction, Problem&Issue, Diagnosis, Medication Activity • openEHR – All models • Results4Care – Heart rate, BMI, Apgar Score • Tolven– All models (except Apgar score & wound culture) • VA – Problem List

16. Modelling Approach

17. CIMI Architectural Overview

18. CIMI Modelling Layers COMPOSITION CLUSTER ENTRY SECTION Dispensed Medications GUI Discharge Summary Doc or Message Add Implementation Purpose Context Neonatal Blood Pressure in EHR Current Medication List in EHR G.P. Dispensed Medication Item Inpatient Discharge Summary Add Care Setting Context Home Blood Pressure Outpatient Clinic Current Medication List Paediatric Medication Item Cardiology Discharge Summary Add Specialty Context Neonatal Blood Pressure Nephrologist Medication List Dispensed Medication Item Medication Reconciliation Report Add Use Case Context Standing Blood Pressure Current Medication List Medication Item Discharge Summary Clinical Models Blood Pressure Medication List Schedule, Address, Material Event Summary, Assessment Modelling Patterns Observation, Action Clinical List Reference Model

19. IsoSemantic Models – Example of Problem e.g. “Suspected Lung Cancer”

20. IsoSemantic Models – Example Instances e.g. “Suspected Lung Cancer”

21. IsoSemantic Models – Graph-based Model

22. IsoSemantic Models – Compositional Grammar • Problem Diagnosis = $ProblemDiagnosisName: • 246090004 |associated finding| = (404684003|Clinical Finding|: • 363698007 | finding site | = ($BodySite: • 272741003|laterality| = $Laterality), • 246112005 | severity| = $Severity), • 408729009 | finding context | = $FindingContext • GP Problem Diagnosis= 86049000|Cancer| : • 246090004 |associated finding| = (404684003|Clinical Finding|: • 363698007 | finding site | = 39607008|Lung|), • 408729009 | finding context | = 415684004|Suspected| • Polyclinic Problem Diagnosis= 162572001 |Suspected cancer|: • 246090004 |associated finding| = (404684003|Clinical Finding|: • 363698007 | finding site | = 39607008|Lung|) • RH Problem Diagnosis= 86049000|Suspected lung cancer|

23. Overview • Foundations • CIMI Reference Model • Archetype Object Model • CIMI Modelling Patterns • CIMI Style Guide • Modelling Approach • Analyse clinical models submitted (with value sets) • Identify maximal set of data elements • Remove ‘out of scope’ data elements (Style Guide) • Select appropriate CIMI Modelling Patterns(Style Guide) • Define CIMI model (Mindmap, ADL, UML) • Add Terminology bindings • Meaning (nodes, node relationships) • Value sets (maximal set from submitted models) • Add Example Model Data Instances • Technical Validation • ADL, UML • Clinical Validation / Review • Confirm mappings from submitted models

24. F1. Define CIMI Reference Model

25. F1. Define CIMI Reference Model

26. F1. Define CIMI Reference Model • Updated documentation • Discussion on GitHub regarding issues raised in reviews • Create BMM file to load CIMI Reference Model in ADL Workbench • Automated EA UML to BMM file generation

27. F2. Archetype Object Model • Extend to support relationship meaning • Terminology binding syntax • Review to identify other gaps • Test through use

28. F2. Archetype Object Model Relationship_id[0..1]:String

29. F2. Archetype Object Model

30. F2. Archetype Object Model Terminology Binding Syntax • Semantics/meaning (node and relationships) • Value sets • Options • CTS2 • FHIR • IHTSDO: URI Specification (Draft) • E.g. http://snomed.info/sct/{sctid}/version/{timestamp} • MOHH: URI Specification (Generic binding) • terminology : <code system id>[:version] ? <query type>= <query expression> [& <extension key> = extensionvalue]* • query_type: concept, conceptlist, refset / refsetlist, escg, ocl • E.g. terminology:2.16.840.1.113883.6.96:20110123?refset=284296007 &scope=CIMI

31. F3. CIMI Modelling Patterns Modelling Patterns Reviewed: • openEHR • NHS LRA • SNOMED CT • results4Care DCMs • IMH CEMs • MOHH LIM • VA’s Discernables • EN13606 Association • HL7 v3 RIM • Tolven

32. F3. CIMI Modelling Patterns • Modelling Patterns Considered • Clinical Statement/Entry Types • Observation, Evaluation/Finding, Instruction, Action • Isosemantic Patterns • Name (focal concept), Details • Event History/ Time Series • E.g. Heart rate time series, Apgar score (1, 2, 5, 8, 10 mins) • Clinical process links • E.g. interprets, caused by, evidence for, derived from • Review: ISO13606, LRA, SNOMED CT • Other Patterns & Reusable Model Components • E.g. Event summary, Reference Range, Schedule, Material, Score/Assessment Scale • State machine / Careflow • E.g. Medication activity state transitions, Contsys

33. Clinical Investigator Record (CIR) Ontology

34. Clinical Statement Types (Observation) • openEHR • Observation, Evaluation, Instruction, Action, Admin Entry • MOHH • Observation, Finding, Activity (Medication, Laboratory), Administration • NHS LRA • ELEMENTs: Property Observation, Finding Observation, Activity (Investigation, Material, General), Material Entity • ENTRYs: GenericFinding, GenericProcedure, GenericProblemAndIssue, .... • Intermountain/GE • Observed, StandardLabObs, Procedure, Order, Intolerance, Allergy, Adverse Reaction Summary, Admit/AdminDiagnosis, ... • SNOMED CT • Observable Entity, Clinical Finding, Procedure, ... • EN13606 Association • Observation, Evaluation, Instruction, Action • HL7 v3 • Act (Observation, Procedure, Exposure, Patient Encounter, Financial Contract, Financial Transaction, Account, Invoice Element, Context Structure, Device, Task, Supply)

35. Observation (Existing Definitions) • openEHR • Observation: the observation of any phenomenon or state of interest to do with the patient. • NHS LRA • Property Observation: Used to represent the results of investigations undertaken to find out more information about a patient's state of health or wellbeing and device or procedure related parameter settings. (Meaning-value pairs)  • SNOMED CT • Observable Entity: represents a question or procedure which can produce an answer or a result. Used to code elements on a checklist or any element where a value • EN13606 Association • Observation/Inspection: Used to define all that can be documented about a specific state of a process in the Patient System at a point in time using the faculties of seeing, hearing, tasting, touching, smelling, or directly via a medical device or service. • HL7 RIM • Observation: An Act of recognizing and noting information about the subject, and whose immediate and primary outcome (post-condition) is new data about a subject. Observations often involve measurement or other elaborate methods of investigation, but may also be simply assertive statements.

36. Observation (Suggested CIMI Definition) Used to represent the resultsof investigations undertaken to find out more information about a patient’s state of health or wellbeing, and related settings. Comments: • E.g. Heart rate, Blood glucose • Represented using the common name-value or question-answer pattern • Supports isosemantic representation of Observation Names that may include method, patient_state, device, body location and other related information in pre or post-coordinated form.

37. F3. CIMI Modelling Patterns • (Clinical Entry) Who When Where What/How/Why

38. F3. CIMI Modelling Patterns • (Observation) When Who What/Why/How Where What

39. F4. CIMI Style Guide To describe and demonstrate the approach to CIMI clinical modelling Goal: Consistency and reproducibility of CIMI models Table of Contents: • Background & Architectural Framework • Reference Model • Modelling Layers • Modelling Patterns • Modelling Principles • Quality Criteria • Scope of Clinical Models • Granularity of Clinical Models • Consistency and Reuse • Isosemantic Models • Terminology Binding • Additional Principles • Modelling Methodology • Appendix: Example models and instance data

40. F4. CIMI Style Guide (Quality Criteria – 6.1) CIMI models will be: • Able to satisfy the URU principles – that is they will be • Understandable (cohesive and coherently expressed) • Reliable and reusable (consistency) • Useful (fit for purpose) • Uptodate (currency) • Clinically accurate • Clinically valid • Evidence based • Adequate to express required clinical statements • Able to maintain contextual integrity (when transformed into isosemantic models) • Able to maintain semantic fidelity (when transformed into isosemantic models) • Clear and precise, minimizing the potential for: • Misinterpretation and • Misuse or inconsistency in use • With low complexity (suitable for easy implementation and avoid cognitive overload of users)

41. F4. CIMI Style Guide (Scope – 6.2) The following information will be included in CIMI clinical models: • Information that is considered to be directly relevant to the clinical concept being modelled. • Information that describes the who, what, when, where, how and why of the clinical concept being modelled. • Information that may either be represented using pre-coordination or post-coordinated in the structure – for example, the body location of a diagnosis. • Information that is not described in the exclusion list. • To be decided: Information that provides a classification for other items in the model

42. F4. CIMI Style Guide • (Scope – 6.2) The following information will be excluded from CIMI clinical models: • Information that is specific to an implementation use-case- for example, recordkeeping metadata (unless the model is specifically designed for this purpose). • Information that is specific to a care-setting- for example, hospital ward details (unless the model is specifically designed for this purpose). • Information that is specific to a clinical specialty – for example, neonatal care information (unless the model is specifically designed for this purpose). • Information that is used for administrative purposes only – e.g. financial details (unless the model is specifically designed to include this) • Information that is specific to a local environment (e.g. to satisfy local legislation requirements). • Information that is included in the pattern on which the model is based • Information that is considered not to be directly related to the clinical concept being modelled.

43. F4. CIMI Style Guide • (Granularity of Models – 6.3) More than one piece of atomic data can be included in the same clinical model when the following conditions hold: • The atomic pieces of data are all directly related to the concept being modelled • It is considered to be good clinical practice for instances of these data items to be observed, evaluated or performed together, using the same who, what, when, where and how information. For example: • Systolic and diastolic blood pressures will be included together within a single ‘Blood Pressure’ observation model.

44. F4. CIMI Style Guide (Isosemantic Models – 6.5) CIMI clinical models will support isosemantic models in terms are both: • The ability to transform CIMI models to/from isosemantic representations in other languages/ standards (e.g. CDA, openEHR, ISO13606, DCM, CEM), and • The ability to transform CIMI models between isosemantic representations that use a different split between terminology pre-coordination and structure. The first category of isosemantic models (alternative language representations) will be supported by defining mappings to other languages. It is not anticipated that CIMI will provide these mappings, although some exemplars may be provided to demonstrate the capability. The second category of isosemantic models (terminology pre-coordination versus structure) will be supported by: • Identifying where in the model intensional description logic applies • Including the structural representation, for any information which may be represented using a separate attribute in some clinical contexts; • Defining the semantics of each of these structural attributes using terminology bindings; • Defining the semantics of the relationships between these structural attributes using terminology bindings; • Identifying the focus attribute of the isosemantic pattern (i.e. the attribute which may be represented using a precoordination of the other attributes) • Providing an expression formalism to show the relationship between different isosemantic forms (e.g. compositional grammar)

45. F4. CIMI Style Guide (Terminology Binding) All finalised CIMI Clinical Models will: • Include a terminology semantic binding from each node in the model to a terminology concept (or expression), which represents the meaning of the node. • Include a terminology semantic binding from each node relationship in all isosemantic patterns to a terminology concept that represents the meaning of the relationship. All finalised CIMI Clinical Models may (where appropriate): • Include a terminology semantic binding from other node relationships to a terminology concept that represents the meaning of the relationship. • Include a terminology value binding from a node of type Codeable Text to a terminology reference set, containing concepts which represent the set of valid values for the node.

46. Overview • Foundations • CIMI Reference Model • Archetype Object Model • CIMI Modelling Patterns • CIMI Style Guide • Modelling Approach • Analyse clinical models submitted (with value sets) • Identify maximal set of data elements • Remove ‘out of scope’ data elements (Style Guide) • Select appropriate CIMI Modelling Patterns(Style Guide) • Define CIMI model structure (Mindmap, ADL, UML) • Add Terminology bindings • Meaning (nodes, node relationships) • Value sets (maximal set from submitted models) • Add Example Model Data Instances • Technical Validation • ADL, UML • Clinical Validation / Review • Confirm mappings from submitted models

47. M1. Analyse clinical models submitted (with value sets) • Heart Rate • Linda and Marcello • Body Mass Index • Gerard and Rahil • Apgar Score • William and Michael • Problem list • Mike and Galen • Adverse Reaction • Stan and Stephen • Glucose Tolerance Test Result • Medication order • Care Giver Reported Nausea • Wound Culture Result

48. M1. Analyse clinical models submitted (Heart Rate) • openEHR • openEHR-EHR.OBSERVATION.heart_rate.v1 – Rev 5 • MOHHoldings • Observation • IMH • HeartRateMeas • Results4Care • HeartRate • EN13606 Association • Heart Rate ACTION • Heart Rate OBSERVATION • NEHTA • openEHR.EHR.OBSERVATION.heart_rate.v1 – Rev 5 • TOLVEN • Pulse Rate

49. M1. Analyse clinical models submitted (Heart Rate – openEHR/NEHTA)

50. M1. Analyse clinical models submitted (Heart Rate – openEHR/NEHTA)