Tuberculosis & Cardiology Projects Anita Walden & Brian McCourt RCRIM Presentation HL7 WGM January 2007 (San Diego)

Tuberculosis & Cardiology ProjectsTuberculosis & Cardiology Projects

Anita Walden & Brian McCourt

RCRIM Presentation

HL7 WGM January 2007 (San Diego)

TopicsTopics

■ Background, Objectives, Methodology

■ Project specific details

■ Tuberculosis Project

■ Cardiology Project

■ Questions & Discussion

Background & Project ObjectivesBackground & Project Objectives

■ Funded by two independent NIH Roadmap Funded by two independent NIH Roadmap contractscontracts

■ Focus on methodology for developing Focus on methodology for developing therapeutic area data standardstherapeutic area data standards

■ Produce real, useful products along the wayProduce real, useful products along the way

■ Report on experience, process, best practices Report on experience, process, best practices back to the larger communityback to the larger community

ProductsProducts

■ Develop and/or contribute to data exchange Develop and/or contribute to data exchange standards within SDOs (HL7, CDISC…)standards within SDOs (HL7, CDISC…)

■ Implementation GuideImplementation Guide

■ Publish consensus set of Common Data Publish consensus set of Common Data Elements (CDE’s)Elements (CDE’s)

■ Generate a Domain Analysis ModelGenerate a Domain Analysis Model

■ including storyboards, use cases and activity including storyboards, use cases and activity diagram artifactsdiagram artifacts

AssumptionsAssumptions

■ Data collected for patient care must support Data collected for patient care must support multiple re-uses, including researchmultiple re-uses, including research

■ Clinical data for patient care and research are Clinical data for patient care and research are the same.the same.

■ Stakeholders need to represent as many of Stakeholders need to represent as many of the uses of the data as possiblethe uses of the data as possible

■ Clinicians, researchers, standards Clinicians, researchers, standards organizations, industry, international…organizations, industry, international…

MethodologyMethodology

■ Engage stakeholders in objectivesEngage stakeholders in objectives

■ Select a use case from stakeholder Select a use case from stakeholder contributions to define specific project scope contributions to define specific project scope and objectivesand objectives

■ Develop a consensus set of CDE’s used in use Develop a consensus set of CDE’s used in use casecase

■ Use case and CDE’s guide DAM developmentUse case and CDE’s guide DAM development

■ Incorporate interchange standards under the Incorporate interchange standards under the DAMDAM

CDE ProcessCDE Process

■ Collect & aggregate data elements from Collect & aggregate data elements from stakeholders current databasesstakeholders current databases

■ Convene expert group to select ‘Package 1’ Convene expert group to select ‘Package 1’ and focus on terminology, definitions, value and focus on terminology, definitions, value listslists

■ Clinical leadership at core of group, supported Clinical leadership at core of group, supported by experts from CDISC, NCI, HL7…by experts from CDISC, NCI, HL7…

■ Biweekly conference callsBiweekly conference calls

■ Release for public commentRelease for public comment

■ Publish via NCI EVS/caDSRPublish via NCI EVS/caDSR

DAM ProcessDAM Process

■ Start with pretty good understanding of Start with pretty good understanding of storyboards, activity diagrams, use cases and storyboards, activity diagrams, use cases and CDE’s to set scopeCDE’s to set scope

■ Work with experienced modelerWork with experienced modeler

■ Vetted by stakeholdersVetted by stakeholders

■ A use of DAM, provide context (associations) A use of DAM, provide context (associations) for Data Elements that will be provided to for Data Elements that will be provided to NCI’s caDSR.NCI’s caDSR.

TimelinesTimelines

Engage StakeholdersEngage Stakeholders Summer ‘05Summer ‘05

‘‘Call for Data Elements’Call for Data Elements’ Fall ‘05Fall ‘05

Aggregate CDE’sAggregate CDE’s January ’06January ’06

Convene expert groupConvene expert group May-Aug ‘06May-Aug ‘06

DAM initiatedDAM initiated December ’06December ’06

Package 1 CDE’s out for Package 1 CDE’s out for public commentpublic comment

February ’07February ’07

Start Package 2Start Package 2 February ‘07February ‘07

DAM v1DAM v1 Summer ’07Summer ’07

CDE’s Pkg 1 publishedCDE’s Pkg 1 published Aug/Sept ’07Aug/Sept ’07

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Data Element Contributors

– World Health OrganizationStop TB Partnership• DOT• DOT Plus

– Center for Disease Control and Prevention (CDC) • TIMS – Meta data• NEDSS – Meta data• RVCT - forms

– MOXI Brazil CRF forms– TB Alliance

• TBESC - forms• TBTC Study 26 – Meta data• TBTC Study 27 – forms

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Scope

• Clinical focus

– Pulmonary Tuberculosis

• Use Case

– Use data from EHR and public health reporting to trigger notification to researcher of potential study candidate

– Development of standard CRF modules for tuberculosis research projects

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Single Source for Data Reuse and InteroperabilityPatient Enrollment/Aggregated Data Research

Treatment/SurveillanceTreatment/Surveillance Treatment/SurveillanceTreatment/Surveillance EnrollmentEnrollment Data Data AggregationAggregation

EnrollmentEnrollment Data Data AggregationAggregation

PatientPatientPatientPatient

Hosp.EHR

State Health Dept

Federal Health Dept

Researcher

Query (message V 2.5)

Query

(m

essa

ge

V 2.5)

Local Health Dept

Local Health Dept

Query (message V2.5)

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Expert GroupRepresented Organizations

• Aereas Global TB Vaccine Foundation

• Center for Disease Control and Prevention (CDC)

• Clinical Data Interchange Standards Consortium (CDISC)

• Clinical research experts• Duke University Medical

Center • Foundation for Innovative

New Diagnostics (FIND)

•Global Alliance for TB Drug Development•KNCV•Health Level 7 (HL7)•National Cancer Institute•National Heart, Lung & Blood Institute (NHLBI)•National Institutes of Health (NIH)•National TB Controllers Association•WHO’s Stop TB Partnership•Pharmaceutical Companies

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TB Specifics

• Draft of CRF modules using current TB package #1 data elements.

• WHO is aware of the initiative• TBTN needs to engage pharmaceutical companies in the

process• Continue to engage the global communities • Challenges

– Languages– Time Zones– Country Resources– TB not high priority in US– Much of the work is International– Technology is limited in many countries– Additional Funding to continue

Creating, Implementing, and Creating, Implementing, and Sharing Best Practices for Sharing Best Practices for

Clinical Trials NetworksClinical Trials Networks

This project has been funded in whole or in part with federal funds from the National Institutes of Health, under contract No.

HHSN268200425212C, "Re-Engineering the Clinical Research Enterprise."

Data Element ContributorsData Element Contributors

■ American Heart Association American Heart Association Get With the GuidelinesGet With the Guidelines

■ Society of Thoracic SurgeonsSociety of Thoracic Surgeons

■ NIH (NHLBI)NIH (NHLBI)

■ GlaxoSmithKlineGlaxoSmithKline

■ Merck Merck

■ American College of American College of Cardiology National Cardiology National Cardiovascular Data Registry Cardiovascular Data Registry (NCDR)(NCDR)

■ CRUSADECRUSADE

■ Duke DatabankDuke Databank

■ Eli LillyEli Lilly

■ European Society of European Society of Cardiology Cardiac Registry Cardiology Cardiac Registry and Registration Standards and Registration Standards (CARDS)(CARDS)

Expert Group - Expert Group - Represented OrganizationsRepresented Organizations■ Professional Societies & Clinical Professional Societies & Clinical

OrganizationsOrganizations

■ Am. College of Cardiology (ACC)Am. College of Cardiology (ACC)

■ Am. Heart Assoc.Am. Heart Assoc.

■ ACC/AHA Task Force on Data ACC/AHA Task Force on Data StandardsStandards

■ Assoc. of Italian Hospital Assoc. of Italian Hospital CardiologistsCardiologists

■ European Soc. CardiologyEuropean Soc. Cardiology

■ Soc. Cardiovascular Soc. Cardiovascular Angiography & InterventionAngiography & Intervention

■ Society of Thoracic SurgeonsSociety of Thoracic Surgeons

■ GovernmentGovernment

■ FDAFDA

■ NIH (NIH (NCINCI, NCRR, , NCRR, NHLBINHLBI))

■ VHAVHA

■ Standards OrganizationsStandards Organizations

■ HL7HL7 & HL7 Cardiology SIG & HL7 Cardiology SIG

■ CDISCCDISC (incl. pharma) (incl. pharma)

■ Integrating the Healthcare Integrating the Healthcare EnterpriseEnterprise

■ Industry & AcademiaIndustry & Academia

■ AstraZenecaAstraZeneca

■ GEGE

■ Leuven Coordinating CentreLeuven Coordinating Centre

■ MortaraMortara

■ UCLAUCLA

ScopeScope

■ Clinical focusClinical focus

■ Acute ischemic heart disease/Acute Coronary Acute ischemic heart disease/Acute Coronary Syndromes (ACS)Syndromes (ACS)

■ Use CasesUse Cases

■ A clinical site reporting data to a quality improvement A clinical site reporting data to a quality improvement registry (also IHE RFD use case)registry (also IHE RFD use case)— HL7 CDA HL7 CDA

■ A research study sending data to another organization A research study sending data to another organization or for regulatory submissionor for regulatory submission— CDISC SDTMCDISC SDTM

Status of related standards workStatus of related standards work

■ HL7 CDAHL7 CDA

■ 11stst draft mapping of ACC NCDR to HL7 CDA draft mapping of ACC NCDR to HL7 CDA completedcompleted

■ To do – 1To do – 1stst draft Implementation Guide draft Implementation Guide

■ Get feedback on work from HL7 groupsGet feedback on work from HL7 groups

■ CDISC SDTMCDISC SDTM

■ 11stst draft in development mapping of ACC NCDR to draft in development mapping of ACC NCDR to SDTMSDTM

■ Need to understand relationship to BRIDG and HL7 Need to understand relationship to BRIDG and HL7 effortsefforts

PilotsPilots

■ ‘‘Multiple data re-use’ pilot for futureMultiple data re-use’ pilot for future

■ Implement the draft HL7 CV CDA for reporting Implement the draft HL7 CV CDA for reporting data to the ACC’s NCDR registry and to SDTM data to the ACC’s NCDR registry and to SDTM model model

■ ‘‘Single Source’ clinical trialSingle Source’ clinical trial

■ Use existing HL7 messaging to report data Use existing HL7 messaging to report data directly to a large international phase III trial directly to a large international phase III trial electronic data capture system.electronic data capture system.

DiscussionDiscussion

■ All feedback & comments welcomeAll feedback & comments welcome

■ Domain Analysis Model: How should a clinical domain DAM Domain Analysis Model: How should a clinical domain DAM relate to other models (i.e. BRIDG, Detailed Clinical Models relate to other models (i.e. BRIDG, Detailed Clinical Models (DCM)?(DCM)?

■ eDCI Message: What should we know in relation to these eDCI Message: What should we know in relation to these projects?projects?

■ SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece SDTM & HL7 v3: Work related to the cardiology SDTM-CDA piece to know about?to know about?

■ CDE’s & EVS/caDSR: Work related to TB standard CRFs to know CDE’s & EVS/caDSR: Work related to TB standard CRFs to know about?about?

■ Other?Other?