Query Health Concept-to-Codes (C2C) SWG Meeting #5 January 10, 2012

Today’s Agenda Topic Time Allotted Quick Review of Updated Timeline and Future Meeting Times 2:30 – 2:35 Presentation by Subject Matter Experts Victor Beraja - Ibeza 2:35 - 3:15 Rhonda Fascile – CDISC SHARE 3:15 – 4:00

Meeting times extended from 2:30-4:00pm Proposed Timeline Meeting times extended from 2:30-4:00pm TODAY Meeting 1 – Dec 6 Meeting 2 – Dec 13 Meeting 3 – Dec 20 Meeting 4 – Jan 03 Meeting 5 – Jan 10 Meeting 6 – Jan 17 Meeting 7 – Jan 24 Meeting 8 – Jan 31 Meeting 9 – Feb 7 Meeting 10 – Feb 14 Tasks Introductions Scope Proposed Approach Identify SME and presentation timeline for next few meetings Presentation hQuery i2b2 Presentation I2b2 (Cont.) Intermountain Health DOQS (Data Warehousing / Mapping) Presentation DOQS (Data Warehousing / Mapping) Cont. PopMedNet NLM Presentation Ibeza CDISC SHARE Presentation 3M NY Presbyterian Hospital Vocab Team RELMA (LOINC) Tasks NQF AHIMA LexEVS and CTS2 Tasks Preliminary review of presentation summaries and Draft Deliverable Tasks Review of presented concept mapping frameworks to select a proposed approach Begin Consensus Voting process Tasks Consensus Voting Finalized Coordinate offline activities to summarize approaches and develop draft deliverable from presentations

concept to code mapping importance of Context queries Victor Beraja, M.D. Ibeza LLC, 2550 S Douglas Rd., Coral Gables, FL 33134 victor@ibeza.net | Tel.: 305-357-1711 | www.ibeza.net Copyright 2012 concept to code mapping importance of Context queries

Ibeza Mission Simplify healthcare through concept coding and a medical concept glossary. Run medical rules to inform patients and doctors at the point of care about clinical guidelines and insurance benefits so that both can have a frank discussion about what's best for the patient and what is covered by insurance.

Clinical Data Architecture Today Doctors capture clinical data according to well defined History and Physical Exam Sections and Subsections. CMS - E&M Guidelines of 1997 are used by private and public programs. Current EHR’s store Clinical Data using E&M Guidelines to determine level of care. Queries using this architecture will make it simple to find accurate information.

Concepts to Codes Each clinical data concept is mapped to SNOMED and/or LOINC as available within a structure that provides context

Problem #1 w Present Queries Was a dilated fundus exam of the macula done in these patients groups with diabetes Type II? All had CPT 99204 (office visit) and ICD 366.12 (cataract) Group 1: Retina Exam: DME positive Group 2: Retina Exam: DME negative Group 3: Retina Exam: Not done Would miss 66% of positive exams

Solution for Problem #1 Context Search Result 100% accurate result Search for the concepts in the context of Retina Exam of the Office Visit. “Dilated fundus exam” “Macula edema present” or “Macula edema not present” Result 100% accurate result

Problem #2 w Present Queries Both patient groups billed with ICD 362.07 (Diabetic Macular Edema) Do they have edema? Answer: Maybe. The Justification for the test was macular edema. Group 1: No edema Group 2: Edema.

Solution for Problem #2 Context Search Result 100% accurate result Search for the concepts in the context of Fluorescein Angiogram Findings. “Macula edema present” or “Macula edema not present” Result 100% accurate result

CMS vs. HITSP CDA

Clinical Data Today CMS Evaluation and Management Guidelines of 1997 Patient encounter Procedures and Tests Review of Systems ROS Past Family/Soc. History Chief Complaint Physical Exam Eyes, Head & Neck, etc..

Impact of this XML Schema HQuery results have 100% accuracy The context gives source of information EHR vendors can then communicate Clinical Data among each other and with HIE with the same ease with which they currently communicate labs in real time Size of eRx in the US healthcare market Size of APA in the US healthcare market .

Why is this So Important? Public Health use is to identify “Hot Spots” We run rules in real time to Detect individual cases prevent them from becoming a “Hot Spot” statistic. Improve quality of care Reduce fraud, waste, abuse, and Maintain proper medical care

Summary Context Searches can be accomplished by incorporating Sections and Subsections into HL7-CDA Context Searches yield accurate queries with primary source information

Standards Overview and Current Status • How do your standards relate to concept mapping? Each clinical data concept is mapped to SNOMED and/or LOINC • Are you able to maintain the integrity of the original data in its native form (i.e. data as collected and not modified)? The integrity of the original data is preserved by creating a dictionary of clinical terms offered to the public so everyone can use the same terms in their clinical forms. New terminology submitted is then revised by a team of experts. These determine if the “new” term is added as “new” or as an “alternate wording” of an existing clinical term.

Standards Integration and Infrastructure • How do you see your standard integrating with the QH Reference Implementation solution? Our standards allow Context Queries of specific Clinical Data. For example you will be able to query number of patients who had a dilated fundus exam with an exam of the macula for diabetic maculopathy.  Standards Alignment to Query Health • Where does the mapping occur? Is it at the Data Source level? Or at the Information Requestor level? Or Both? Both. At the creation of the glossary of concepts mapped to SNOMED and LOINC. • Can it be easily implemented elsewhere? Yes  Standards Maintenance • Who maintains the development of standards? A dedicated group of medical experts and engineers oversees the integrity and development of the standard. • Who maintains the mappings and how often are they released? A dedicated group of medical experts on a quarterly basis

The End

Query Health Concept to Codes Teleconference January 10, 2012 CDISC SHARE Project Overview Rhonda Facile, CDISC

CDISC SHARE Background Vision and Goals Project Plan Acknowledgements Where we are today Next Steps Acknowledgements

Harmonized through BRIDG Model** Controlled Terminology (NCI-EVS) Global Content Standards for Clinical Research (Protocol-driven Research; Protocol Reporting) Harmonized through BRIDG Model** Controlled Terminology (NCI-EVS) Glossary FDA eSubmissions Analysis and Reporting FDA Critical Path Initiative Protocol Study Design Eligibility Registration Schedule (PR Model) Case Report Forms (CRF) (CDASH) Study Data Lab Data (LAB and PGx) Tabulated CRF data (SDTM) Study Data Lab Data Study Design Analysis Datasets (ADaM) * *Transport: CDISC ODM, SASXPT and/or HL7 CDISC has standards that span the entire dd process. Going forward, we need to link up the standards and create more electronic readable formats to make full spectrum ** CDISC, ISO, HL7 Standard

CDISC SHARE CDISC Standards now encompass the entire drug development process. The focus of CDISC SHARE is on integrating the CDISC standards family into an aligned, linked, machine readable, easily accessible, metadata repository. 2D to 3D world

The Need for Better Metadata To enhance Data Quality and Compliance To decrease the time needed to aggregate and review results Machine readable standards to improve “compliance” Illustrate inherent relationships between metadata Speed up standards development

Compliance Issues – 1 example Slide By: Ellen Pinnow, MS Health Programs Coordinator FDA, Office of Women’s Health, Slide from 2006 CDISC US Interchange This one simple slide illustrates how some of the first users of SDTM didn’t follow the SDTMIG even for something as simple as using the prescribed codes for male and female, thus making data aggregation difficult for answering even such a simple question as the proportion of women being included in clinical trials. It shows how creative implementation can be….

Current 2D World Relationship Relationship Relationship “Consider a very simple example from the SDTM Vital Signs domain (see Figure 1 and 2). We as humans look at this tabulation and from the layout and positional relationships, from the column headings and from the actual content immediately build a number of relationships between data items in our heads. We understand that there is a relationship between the result value and unit variables. These are intrinsically linked in that one is not useful without the other. The relationship between systolic and diastolic is less clear, and is suggested only by the juxtaposition of the two rows. The fact that blood pressure is comprised of systolic and diastolic is not represented at all. While we can manipulate the data by writing some code, we have failed to tell the computer, the machine, about all of these relationships. Because these relationships are not explicitly represented, we need to do significant manual work. If we can build metadata to describe the internal relationships in our data, then manipulation engines can be built to undertake this work in a more automated fashion.” Relationship Slide By: Dave Iberson-Hurst

CDISC SHARE VISION A global, accessible electronic library, which through advanced technology, enables precise and standardized data element definitions and richer metadata that can be used in applications and studies to improve biomedical research and its link with healthcare. http://www.cdisc.org/cdisc-share SHARE metadata is envisioned to help find, understand and use clinical data efficiently.

CDISC SHARE Library Contents Metadata (SDTM and CDASH) Trial Design Metadata Definitions Datatypes Links to controlled terminology (CT) dictionaries via the NCIt (which links to CDISC CT, SNOMED, ICD9, ICD10, UMLS, etc.) Implementation instructions CDASH CRF metadata and instructions CDISC Metadata standards, extensions to those in the future

CDISC SHARE Goals (1) Create an environment where existing content is consistently and easily maintained Provide a consistent approach to standard definition Speed up new clinical research content development Improve access to standards Encourage the widest possible participation in new clinical research content development (asynchronous contribution - 24/7)

CDISC SHARE Goals (2) Facilitate data reuse - Data Aggregation and Mining can use legacy data to answer new questions, sometimes saving the cost of a new trial. Decrease costs - Downloadable metadata could reduce standards maintenance costs and enable process improvement Deliver all of CDISC’s existing and all new content in both human and machine-readable forms Enable better automated handling of clinical research data through the use of machine-readable content Facilitate alignment of Clinical Research and Healthcare Standards

How do we achieve this? Semantic Interoperability - Focus on developing rigorous and unambiguous definitions. BRIDG the Foundation of CDISC SHARE, ensure the link to healthcare CDISC SHARE Model – link all CDISC Standards ISO 21090 Standard – detailed data types to facilitate machine readability and transport.

Semantic Interoperability CDASH Same? SDTM Ensure semantic interoperability across existing standards. This includes providing clear, unambiguous metadata definitions - “Rigorous and unambiguous definitions in SHARE would act as target standard to which disparate data could be mapped” Slide – Dave Iberson-Hurst 34

A domain analysis information model representing protocol-driven biomedical/clinical research Provides a basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare. ISO 21090 compliant, HL7 alignment, RIM alignment http://www.cdisc.org/bridg

Which Metadata Model? SDTM Intermountain Open eHR There is no recognized industry standard for modeling metadata and showing the relationships between data and metadata. Share seeks to provide a consistent and standardized mechanism by which data and metadata can be modeled to ensure that metadata across separate organizations is standardized and data is of the highest quality to facilitate optimum compliance. Slide – Dave Iberson-Hurst

Controlled Terminology The CDISC SHARE MODEL CDISC SHARE MODEL SDTM Variables CDASH Variables Controlled Terminology BRIDG Classes 21090 Data types Here’s a view the show the model would be applied to show the relationships of metadata around the concept of blood pressure. We have chosen to follow BRIDG model

Research Concept in Template Spreadsheet The model template spreadsheets like this.

Transport & Protection of the Content SDTM ADaM CDASH View View View View SHARE Scientific Concepts (BRIDG, Terminology, Data Types...) BRIDG The content is the stable part in the middle, which should not be affected by how it is viewed (top part) or how it is transported (bottom part).  XML V3 Message(s) XML Format(s) Tabular Form Slide – Dave Iberson-Hurst

CDISC SHARE Model Benefits Summary Richer content Machine readable Layered / structured One definition used many times Linked together CDISC Standards Structured using BRIDG constructs to reflect the nature of the data

Project Plan

2009 - Present CDASH & SDTM definitions aligned  Implementation rules extracted  Metadata model agreed  CDISC SHARE Model tested  Scientific concepts & attributes mapping (In progress) CDASH & SDTM reviewed and definitions aligned Implementation rules extracted from published standards Metadata model developed and agreed Model tested on SDTM observation classes Scientific concepts and their attributes identified and (mind) mapped for each type of SDTM domain

Content Mapping Current process Transforming SDTM and CDASH into scientific concept structured metadata All SDTM and CDASH domains and variables BRIDG definitions Controlled terminology Data types Also includes all of the SDTM and CDASH ‘rules’ 1 sheet per domain, tests in sub tabs. SDTM domains that have a CDASH component first since these are well defined and recognized, then the remainder of the SDTM. These excel spreadsheets will form the basis for the first batch load into the Share software.

Governance Use Cases Under Development Work Item  A simple addition to a code list Research Concept Code List Code List Item Work Item Addition of a Scientific Concept to a Domain Research Concept Existing Domain Research Concept Research Concept Research Concept Distinction between content objects and work items, both of which have to be managed.  A work item can be of any size, and may involve work on one to very many content objects. Work Item New Domain New Domain Research Concept Research Concept Research Concept Research Concept Slide: Dave Iberson-Hurst

CDISC Share Phase 1 – Functionality Requirements Users should be able to: import & export content manipulate metadata access an electronic equivalent of a subset in PDF of SDTMIG v3.1.2, CDASH v 1.1, Controlled Terminology

High-Level Project Plan MD Model Model Development Model/Technology Team Content Content Team LAB Team to start soon! Study Construction Concepts Lab Team Governance & User Interface Governance Team High Level Project Plan User Interface Team Software Requirements Software R1

Project Plan 6 subteams Content Governance User Interface Study Construction Concepts Model/technology Lab – to start soon One more team to be initiated to evaluate potential software tools soon.

Longer Term CDISC Share Development Plan Continuing SW Releases (do not need to be aligned with Phases) Major Development Phases Continuous smaller increments in content Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 SDTM CDASH Oncology, Devices, TA (current) SEND and new TA ADaM and new TA new TA Slide – Dave Iberson-Hurst

CDISC Share - Conclusion Precise definitions Rich metadata 24/7 access Linked to NCIt Links Clinical Research to Healthcare.

Active Participants Clyde Ulmer - FDA Dave Iberson-Hurst - Assero Erin Muhlbradt - NCI-EVS Rhonda Facile – NCI-EVS Fred Wood - Octagon Chris Tolk - CDISC Gary Walker - Quintiles Dianne Reeves – NCI-CBIIT Hanming Tu - Octagon Julie Evans - CDISC Madhavi Vemuri – J & J Jian Chen – Edetek Melissa Cook - Octagon Carlo Radovsky – Etera Solutions Mike Riben – MD Anderson Geoff Lowe – MEDIDATA Solutions Diane Wold - GSK Frederick Malfait – Roche Simon Bishop - GSK Kerstin Forsberg – Astra Zeneca Terry Hardin - Parexel Kevin Burges – Formedix Tsai Yiying - FDA Michael Morozewicz Barry Cohen - Octagon CDISC acknowledges all volunteers, their affiliated companies and the NCI-EVS for support of the CDISC Share project. Bold = team leaders

Questions about CDISC Share. Interested in joining a team Questions about CDISC Share? Interested in joining a team? Contact rfacile@cdisc.org dave.iberson-hurst@assero.co.uk jevans@cdisc.org Or visit: cdisc.org

Strength through collaboration. ...and sharing As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards.