Update to HL7

1. Update to HL7 “A collaborative project to develop a universal framework for encoding and disseminating electronic clinical guidelines” HL7 Working Group Meeting April-May 2003 Guy Mansfield, Ph.D. Health Informatics, IDX Systems

2. Apelon UNMC Mayo SMI IHC Project Overview • An R&D consortium to develop the technology infrastructure to enable computable clinical guidelines, that will be shareable and interoperable across multiple clinical information system platforms • Scope: 3 year, $18 M, multi-site, collaborative project • Partners in the project are: • IDX Systems Inc. • Apelon, Inc. • Intermountain Healthcare (IHC) • Mayo Clinic • Stanford Medical Informatics (SMI) • University of Nebraska Medical Center (UNMC) • Funded in part by: NIST Advanced Technology Program IDX Health Informatics

3. Project Approach “Jim Campbell’s Taxonomy of Guidelines” SAGE Level 1: Original text guideline Level 2: Structured markup Level 3: Scrubbed “markup” (disambiguated) Level 4: Codified “markup” (vocabulary standards) Level 5: Knowledge “markup” (structured knowledge) Level 6: Context “markup” (specify clinical setting) Level 7: Executable form (deployable knowledge)

4. Project Approach Standards-based Sharable Active Guideline Environment • Ultimate goal: An infrastructure that will allow execution of standards-based clinical practice guidelines across heterogeneous CIS platforms. • Focus is on the goal of active deployment of guideline knowledge within the workflow of clinical information systems. • Employ (and extend where necessary), best available informatics standards and controlled terminologies. • Build on an invaluable foundation of earlier research and effort. • Close collaboration with leading Standard Development Organizations: HL7, SNOMED, LOINC, others.

5. SAGE Main deliverables • An interoperable guideline model – A computable knowledge representation “format” for encoding the content and logic of executable clinical practice guidelines. • A guideline workbench – A software tool for authoring, encoding, and maintaining guidelines in the format of the SAGE guideline model. • A guideline deployment system – Software that “decodes” the content of electronic guidelines and surfaces that content via functions of the local clinical information system. • Controlled resources -- Specification of a common layer of information models and terminologies to mediate guideline content.

6. Imagine if SAGE technology were in place today . . . Author Disambiguation, encoding, testing Consolidated feedback Research, meta analysis, “crafting the guideline” Feedback Encode • Guidelines would be routinely encoded in a standard, computable format, and would be widely available for downloading. • Healthcare organizations would be able to import proven guidelines, and execute them via their local clinical information systems. Guidelines.net? Guidelines-R-Us.com? Evaluate Publish Outcomes research In Practice Import Guidelines active in local CIS Download to local care delivery organization Install Clinical editing, guideline set up

7. SAGE Guideline Model Concepts Guideline Recommendation Sets Guideline Recommendation Sets Guideline Recommendation Sets Metadata Context Decisions Actions Route Decisions Actions Conceptual Overview of SAGE Architecture Guideline content encoded using standard terminologies and information models Data queries and decision logic represented using standard expression language Expression Language Common Layer of Terminologies and Information Models Care Workflow Model Medical Ontologies Patient Data Model (Virtual Medical Record) Health Care Organization Model Binding SAGE Guideline Execution Engine Local EMR concepts mapped to standard models for execution Clinical Information System Applications EMR Standards-based API

8. SAGE Challenges: Guideline Deployment Concepts “SAGE” Engine CIS Rule Execution System Guideline Execution Services CIS Patient EMR Guideline File(s) Events EMR data Queries CIS Actions Local Clinical Information System • Guideline goals • Guideline context • Guideline actions • Guideline decisions CIS Order Entry Local CIS Resources

9. Imagine if . . .

10. SAGE Project Plan Overview 2002 2003 2004 Aug 03 Jan 04 Jun 04 Nov 04 (timeline approximate) • Use Case Prototyping • Guideline scenario “storyboarding” • Usability evaluation; use case analysis Use Case Prototyping Guideline Model Requirements Iterative Guideline Model Specification Continuing Model Refinement End-to-end SAGE Integrated Testing Guideline Workbench Requirements Iterative Workbench Design and Development Deployment System Architecture Design Iterative Deployment Architecture Development Deployment System Requirements Controlled Resources (Phase 1) Controlled Resources (Phase 2)

11. Requirements AnalysisWork Cycle • Select initial “generic” guideline • Define/storyboard specific scenarios • Model and evaluate user interactions (Mayo Usability Laboratory) • Document use cases • Perform UML Modeling

12. Selecting Exemplar Guidelines Exemplar Guideline Diabetes Management (DBM) Immunizations (IMM) Community Acquired Pneumonia (CAP) Total Joint Replacement (TJR) Clinical Domain Chronic disease monitoring and treatment. Acute exacerbation of chronic disease. Chronic disease as a comorbidity. Routine health maintenance, in both outpatient and inpatient settings. Emergency room evaluation and diagnosis. Outpatient treatment of acute disease. Inpatient and ICU treatment of acute disease. Follow-up of acute disease. Surgical guideline. Comprehensive pre-op workup, inpatient plan of care, and post-op outpatient management.

13. What is our Coverage of Universe of Guideline Content ??? N scenarios for each guideline DBM IMM IMM DBM CAP CAP TJR TJR ??? ??? Wide Coverage: Comprehensive Guideline Model Narrow Coverage: Limited Guideline Model

14. Requirements AnalysisWork Cycle • Select initial “generic” guideline • Define/storyboard specific scenarios (clinical setting, roles, context) 3. Model and evaluate user interactions (Mayo Usability Laboratory) 4. Document use cases 5. Perform UML Modeling Apply HDF 101?

15. Guideline File(s) Making Guideline Content Specific Enough to Encode and Execute “Generic” Immunization Guideline Scenario: Outpatient Visit Scenario: Pediatric Inpatient • Text-based • Ambiguous • Encoded • Executable • Text-based • Specificity Added: • Clinical context • Care setting • Care roles • Care work flow • Decision logic • Actions defined

16. Completed with Clinician input. Modeled initially using PowerPoint slides Specify Guideline Scenarios

17. Screens developed using VISIO/HTML Model CIS User Interfaces • Guideline recommendations integrated into a nurse care flowsheet • View suggested orders • Submit suggested orders Real time access to information – potentially via “infobutton” functionality Next Step: On to the Usability Lab

18. Usability Lab Evaluation Done using scenarios and prototypes Performed at Mayo Usability Laboratory

19. Usability Lab Evaluation Done using scenarios and prototypes Performed at Mayo Usability Laboratory

20. Use Case Documentation

21. Sequence diagrams UML Modeling

22. SAGE: Frequently Asked Questions Is the SAGE project developing guideline content ? No. While we are fully characterizing and encoding a small set of guidelines to be used in our R&D work, the main objective of the SAGE project is to enable a technology infrastructure for encoding and wide-spread dissemination of active guideline content. Is the SAGE project developing an IDX-specific solution ? No. We are using IDX Carecast as our prototyping CIS environment during the project; however, our goal is a universal infrastructure that will allow activation of guideline content in multiple HIS vendor systems. Where can I get more information on the SAGE project ? Our project web site www.sageproject.net/ is just coming online and will provide increasing detailed project updates in the near future.

23. Thank You ~ www.sageproject.net