Brian McCourt1, James Tcheng, MD2, David Kong, MD1, Bron Kisler3

1Duke Clinical Research Institute, 2Duke Translational Medicine Institute, 3Clinical Data Interchange Standards Consortium

The Semantic Foundation to Interoperable Clinical and Research Information Systems in Cardiology

Robert M. Califf, Robert A. Harrington, Leanne K. Madre, Eric D. Peterson, Deborah Roth and Kevin A. Schulman. Curbing The Cardiovascular Disease Epidemic: Aligning Industry, Government, Payers, And Academics. Health Affairs, 26, no.1 (2007):62-74.

htt // t t h lth ff i / i/ i t/26/1/62

Collect Once, Repurpose Many Times

Clinical Data

Research

Clinical

Decision

Support Public & Population

Health

Quality

Measurement & Patient

Safety

Business,

Operations/

Administration

Don Mon, AHIMA

Groundbreaking Advances

“The adoption of standards and common data elements across diseases is

groundbreaking, promotes cross-disease analysis, and provides a rich source of information to be mined by researchers

around the world.”

Barbara M. Alving, M.D., Acting Director, NCRR

NIH Launches Clinical Studies Nationwide to Investigate Rare Diseases $71 Million Effort to Address Neglected Conditions (Friday, May 5, 2006)

Barbara M. Alving, M.D., Acting Director, NCRR

NIH Launches Clinical Studies Nationwide to Investigate Rare Diseases $71 Million Effort to Address Neglected Conditions (Friday, May 5, 2006)

President’s Council of Advisors on Science and Technology (Dec 2010)

Atomic data elements as the unit of exchange2 use cases related to these projects

CV Standards Background

Long history of data standards work by Duke and cardiovascular professional societies, lead by ACC.2006-2008: Under NIH Roadmap contract, Duke partnered with CDISC and HL7 to develop data standards for Tuberculosis & Cardiology (ACS specifically)

Focus on methodology. 1st time for clinical content as “Data Standard”May 2008 approved as joint CDISC (Clinical Research) & HL7 (Healthcare) standards

2008-2010: Multiple emerging initiatives2010: Opportunity to expand the content of these standards and align to meet needs of broader stakeholder community

Mission

Develop and maintain a consensus set of cardiology data standards as a single collaborative set of work

products serving stakeholders across the healthcare industry

Topics

Cardiology Data Standards ProgramBroad multi-stakeholder project to develop cardiology data standards across healthcare

Project stakeholders, objectives and deliverablesCardiology Domain Analysis Model, R2HL7 & the healthcare pathwayCDISC & the research pathway

Project OverviewCardiovascular Data

Car

diov

erte

rdef

ibpr

oced

ures

(ICD

Reg

istry

)C

onge

nita

l Hea

rt C

ondi

tions

(IMPA

CT)

Con

com

itant

Med

icat

ions

Dem

ogra

phic

s

Vita

l Sig

ns

Adv

erse

Eve

nts

STE

MI/N

STE

MI

(AC

TIO

N)

Top

100

EH

R d

ata

elem

ents

Car

diac

Cat

han

d P

CI

(Cat

hPC

I

Cor

otid

Arte

ry S

tent

ing

and

End

arte

rect

omy

(CA

RE

)

Non-specialty data Common cardiovascular clinical observations - Sub-specialty domains

18 to

tal d

omai

ns a

nd g

row

ing

Cardiac ImagingACC/AHA

/STS

NCRI Grant*

ACC/AHA/STS RegistriesCDISC

Exe

rcis

e E

lect

roca

rdio

grap

hy

SPEC

T M

PI

Ech

ocar

diog

raph

y

Cor

onar

y C

TA

AC

S H

isto

ry &

Sym

ptom

s

CTN

BP

Wom

ens’

Pre

sent

atio

n S

x

FDA

CV Clinical- Data Elements- Event definitions- Clinical terminology anddata definitions

CDISC- SDTM standard for FDA submission- Controlled Terminology alignment- CRF templates- Stds adoption by researchers

HL7- Mappings to HL7 RIM & EHR stds- Adoption support for EHR’s- CCHIT EHR Certification (future)

Future

CompletedIn progress

In project scopeFuture

CV

Out

com

es

Stro

ke

*National Cardiovascular Research Infrastructure

CDISC

CDASH Standards

ACC

National Cardiovascular

Data Registries

Collaborating OrganizationsAmerican College of Cardiology Foundation (ACC)Clinical Data Standards Interchange Consortium (CDISC)Duke Clinical Research Institute (DCRI)Duke Translational Medicine Institute (DTMI)US Food and Drug Administration (FDA)Health Level Seven (HL7)National Cancer Institute (NCI)National Cardiovascular Research Infrastructure (NCRI)

Partial funding provided by NHLBI Award 1RC2HL101512-01

ACC: Data, Standards and Informatics

Journal of the American College of Cardiologyhttp://content.onlinejacc.org/cgi/collection/data_standards

CDISC Standards & Therapeutic Area Initiatives

Clinical Data Acquisition Standards Harmonization (CDASH)

Widely adopted data elements for common trial domainsActively developing efficacy domains

Study Data Tabulation Model (SDTM)

Data model for submission of trial data to FDA

Karen Hicks, MD. Standardized Data Collection For Clinical Trials. March 26, 2010https://www.trialstransformation.org/standardized-data-collection-for-cardiovascular-trials-march-26-2010-meeting

Karen Hicks, MD. Standardized Data Collection For Clinical Trials. March 26, 2010https://www.trialstransformation.org/standardized-data-collection-for-cardiovascular-trials-march-26-2010-meeting

FDA Cardiovascular Endpoints

Definition of Cardiovascular DeathDefinition of Non-Cardiovascular DeathDefinition of Myocardial InfarctionCommon Classification Schemes for Myocardial Infarction CategoriesDefinition of Hospitalization for Unstable AnginaDefinition of Transient Ischemic Attack and StrokeDefinition of Heart Failure Requiring HospitalizationInterventional Cardiology DefinitionsDefinition of Peripheral Arterial Revascularization ProcedureDefinition of Stent ThrombosisBleeding Definitions

Work Products

Healthcare ResearchUse cases and patient scenarios

Cardiovascular Domain Analysis Model

Data elements and clinical definitions

Activity diagrams

Information model

Healthcare (HL7 RIM) representation HL7

Sample data collection forms CDISC

CDISC (CDASH, SDTM) representations CDISC

Electronic metadata library publication

HL7 and CDISC

via NCI EVS/caDSR

Domain Analysis Model

Produced by subject matter expertsRepresents the domain of cardiology using our language (not technical speak)Explicitly describes requirementsIs the medium that requirements are communicated to technical experts

Scope & Use Cases

ScopeGeneral cardiovascular care (broad)Ischemic heart disease orientation (deep)

Use CasesDocumentation of cardiovascular patient of interest across providersReporting to a quality improvement registryReporting to a clinical trialSubmission of clinical trial with cardiovascular endpoints to the FDA

Use Cases & Storyboards

RoleExamples of typical real life scenariosText descriptions of the work processes that an information system needs to fit into

ProductWritten use case and storyboard documents

Use Cases & Storyboards

Data Elements

Data Element Name: History of peripheral vascular disease

Clinical Definition: Indicate if the patient has a history of peripheral vascular disease. This can include:

1. Claudication either with exertion or at rest.2. Amputation for arterial vascular insufficiency.3. Aorto-iliac occlusive disease reconstruction, peripheral vascular bypass surgery, angioplasty or stent; or percutaneous intervention to the extremities.4. Documented abdominal aortic aneurysm (AAA) repair or stent.5. Positive non-invasive/invasive test.

This does not include procedures such as vein stripping, carotid disease, or procedures originating above the diaphragm.

Valid Values: Yes, No

Merging Killip Class across multiple databases

Variable Name Type / Values Description / Derivation

KILLIPB Numeric1=Killip class I2=Killip class II3=Killip class III4=Killip class IV

Baseline Killip ClassGUSTO IIb

GUSTO2B.KILLIPB (3=I, 4=II, 5=III, 6=IV) **at randomizationOtherwise missingPURSUIT

****IMPUTED KILLIP CLASS****

QSRAND.RALES (3=None, 4=<= 1/3 up, 5=>1/3 up) DEMO.DSYSBPB

Killip 1 = RALES=3 AND DSYSBPB>=80Killip 2 = RALES=4 AND DSYSBPB>=80Killip 3 = RALES=5 AND DSYSBPB>=80Killip 4 = DSYSBPB<80

**rales and SBP at randomizationPARAGON A

BASELINE.KILLIPB (1=I, 2=II, 3=III, 4=IV) **at randomizationPARAGON B

DEMOG.KILLIP (1=I, 2=II, 3=III, 4=IV) **at time of index event.GUSTO IV ACS

N/ASYNERGY

HISTBASE.KILLIP * at time of randomization

Example courtesy of Karen Pieper

Definitions are recommended by expert panel and formally vetted via CDISC & HL7 public processes to produce

consensus version. ACC serves as stewarding

organization of resulting standards.

Aggregation & Harmonization Process

3. Elements needed to support FDA Endpoint definitions

1. EHR Top 100

2. Select NCDR elements for harmonization and inclusion in standard

NCRI Data Standards Workgroup

4. CDISC & HL7 StandardsDevelopment Processes

5. Maintenance

Harmonization is hard work!

Many sources, inconsistent definitions. Often for a good reason.

Sample Data Collection Forms

Case Report Form (CRF) mockupCRF’s are familiar to many stakeholders

Highlights metadata and relationship issues across domainsHighlights requirement to align data elements and clinical workflows

Data Elements

Activity Diagram

RoleRepresent patient care processesRecognize the data in context of the workflow

ProductCV Activity diagrams based on care guidelines and common practices

Activity Diagram

Information Model

RoleRepresent scope of the data used in the domainRepresent the relationship among data elementsMechanism to load the content into a metadata repository (EVS/caDSR, CDISC SHARE)

ProductInformation model for cardiovascular disease including diagram, classes, attributes, descriptions

Information Model

Cardiology (Acute Coronary Syndrome) Domain Analysis Model, Release 1Cardiology (Acute Coronary Syndrome) Domain Analysis Model, Release 1

Information Model: Design Notes

Using Enterprise Architect as UML modeling toolIncludes annotations of NCI EVS Vocab, HL7 Reference Information Model, CDISC SDTM and use casesFollowing NCI modeling conventions to support the metadata publication process

Semantic Integration Workbench (SIW) process for loading model into the Enterprise Vocabulary Server/cancer Data Standards Repository (EVS/caDSR)

Add-on tooling: build a back-end EA reporting function to generate clinician friendly data element reports (to replace Excel data element curation spreadsheets)

NCI EVS\caDSR Data Element Representation

HL7

Clinical Interoperability CouncilForum and portal for domain experts to contribute clinical knowledge to using HL7 Development Framework (HDF)Drafting a DAM Modeling GuideContributing requirements, and typically information models, to NCI’s EVS/caDSR

Detailed Clinical ModelsHighly specific, free of context

Schedule

Spring/Summer: CDISC Public CommentCardiology CDASH domains with SDTM mapping

August 1 – September 5: HL7 Ballot OpenCardiology DAM, R2

October: Terminology/Metadata PublicationVia UML semantic integration

Healthcare & Research Pathways

CV Domain Analysis Model, R2

HL7 RIM Representation

Cardiovascular EHR Functional Profile CCHIT Certification

RIM-derived messages

NCI EVS/caDSR Terminology/

Metadata Publication

CDISC CDASH Representation SDTM Mappings

FDA Cardiovascular Trials Data Warehouse

BRIDG Model

Future

Brian McCourtbrian.mccourt@duke.edu

Thank You!