Rebecca Wilgus - NCRI Year One Progress Report

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National Cardiovascular Research Infrastructure (NCRI): Year One Progress Report

Rebecca Wilgus, RN MSNDuke Clinical Research Institute

AMIA TBI/CRI Summit

National Cardiovascular Research Infrastructure (NCRI): Year One Progress Report

Rebecca Wilgus, RN MSNDuke Clinical Research Institute

AMIA TBI/CRI SummitMarch 10, 2011March 10, 2011

Clinical Research in CrisisClinical Research in Crisis

Most clinical guideline recommendations founded only upon “expert consensus”.

Repetitive creation and disassembly of operational infrastructure for individual trials.

Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials.

15% of sites obtaining IRB approvals never enroll anyone.

Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers.

Most clinical guideline recommendations founded only upon “expert consensus”.

Repetitive creation and disassembly of operational infrastructure for individual trials.

Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials.

15% of sites obtaining IRB approvals never enroll anyone.

Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers.

Patient

Clinician

Healthcare Data

SystemsPatient care

Quality Improvement

Research

Reimbursement

Post Marketing Safety

Decision Support

Administration & Mgt.

Public Health Reporting

Single Source Multiple Uses

Applied Data Standards

Common VisionCommon Vision

Fully integrated platforms between electronic health records, quality reporting and clinical researchFully integrated platforms between electronic health records, quality reporting and clinical research

Secondary Reporting

Clinical Research

Key OrganizationsKey Organizations

National Cardiovascular Research Infrastructure (NCRI) American College of Cardiology Foundation (ACCF) Duke Clinical Research Institute (DCRI) Duke Translational Medicine Institute (DTMI)

NCRI Funding SourceNCRI Funding Source

NHLBI Award 1RC2HL101512-01 American Recovery & Reinvestment Act of 2009

(ARRA) NIH Research and Research Infrastructure “Grand

Opportunities” (GO) initiative

NHLBI Award 1RC2HL101512-01 American Recovery & Reinvestment Act of 2009

(ARRA) NIH Research and Research Infrastructure “Grand

Opportunities” (GO) initiative

NCRI: Specific AimsNCRI: Specific Aims

Aim 1: Expanding NCDR Site Capability for Research

Aim 2: Facilitate standards and interoperability for cardiovascular clinical research founded on NCDR and CDISC.

Aim 3: A large simple randomized clinical trials platform to solicit and advance research questions that fill critical evidence gaps.

Aim 4: An integrated electronic repository of tools and programs to assist clinical research site activities accessible by a web-based informatics infrastructure

Aim 1: Expanding NCDR Site Capability for Research

Aim 2: Facilitate standards and interoperability for cardiovascular clinical research founded on NCDR and CDISC.

Aim 3: A large simple randomized clinical trials platform to solicit and advance research questions that fill critical evidence gaps.

Aim 4: An integrated electronic repository of tools and programs to assist clinical research site activities accessible by a web-based informatics infrastructure

NCDR RegistriesNCDR Registries

Rumsfeld et al, US Cardiology, 2009;6(2):11-15

NCRI Data Standards Governance WorkgroupNCRI Data Standards Governance Workgroup

Subject matter experts who oversee the clinical content of consensus data standards

Formally chartered, volunteers from multiple cardiology sub-specialities

Representatives from ACC Steering committee of each registry

Serve on the ACC Data Standards committee and/or ACC Informatics committee

Subject matter experts who oversee the clinical content of consensus data standards

Formally chartered, volunteers from multiple cardiology sub-specialities

Representatives from ACC Steering committee of each registry

Serve on the ACC Data Standards committee and/or ACC Informatics committee

NCRI Data Standards Governance WorkgroupNCRI Data Standards Governance Workgroup

H. Vernon Anderson, MD, FACC University of Texas

Mark Kremers, MD, FACC Mid Carolina Cardiology

Martha Radford, MD, FACC New York University Medical Center

Matthew Roe, MD, FACC Duke University Medical Center

Richard Shaw, MD, FACC California Pacific Medical Center

James Tcheng, MD, FACC Duke University Medical Center

William Weintraub, MD, FACC Christiana Care Health System

Cardiovascular Data

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

Cardiac ImagingACC/AHA/STS

NCRI Grant*ACC/AHA/STS RegistriesCDISC

ens’

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

data 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

*National Cardiovascular Research Infrastructure

Data element: chest x-ray result

Funding &Development

PartnersCV/TB ResearchSurveillance

Patient Care Regulatory

= = = =

Data Mapping

Data element: chest x-ray result

Funding &Development

PartnersCV/TB ResearchSurveillance

Patient Care Regulatory

Global CV Data Standards:an agreed upon set of common data elements,

how they are defined, how they “look” electronically

Data Element HarmonizationData Element Harmonization

NCRI Goal: To standardize and harmonize cardiovascular data elements for efficient data entry, transfer and analysis throughout the country. Accomplished through several harmonization efforts :

Within the NCDR registries

Across other published cardiology standards (AHA, STS, etc)

Across CDISC - Clinical Data Standards Acquisition Harmonization (CDASH) elements

With FDA Cardiovascular Endpoint Data Elements

With ACC Top 100 EHR Data Elements

NCRI Goal: To standardize and harmonize cardiovascular data elements for efficient data entry, transfer and analysis throughout the country. Accomplished through several harmonization efforts :

Within the NCDR registries

Across other published cardiology standards (AHA, STS, etc)

Across CDISC - Clinical Data Standards Acquisition Harmonization (CDASH) elements

With FDA Cardiovascular Endpoint Data Elements

With ACC Top 100 EHR Data Elements

Data Element HarmonizationData Element Harmonization

Data Element Harmonization PrioritiesData Element Harmonization Priorities

1) ACC Top 1002) NCDR-STS Harmonized Data Elements3) ACC-AHA Data Standards4) NCDR Harmonized Data Elements5) Other Sources (e.g. GWTG, EVS/caDSR)

Harmonized Data ElementsHarmonized Data Elements

Governance Workgroup Approved Medical History (90) Family History (2) Adverse Events (12) Procedures (92) Medications

CDASH with 34 meds +26 medication classes

Lab ResultsCDASH with 19 lab tests

Discharge (16) Physical Exam (4)

Governance Workgroup Approved Medical History (90) Family History (2) Adverse Events (12) Procedures (92) Medications

CDASH with 34 meds +26 medication classes

Lab ResultsCDASH with 19 lab tests

Discharge (16) Physical Exam (4)

Pending FDA Endpoints

Out of scope Insufficient value/use

Demographics Administrative

Insurance Of CV value, but not within

CV specialty domain Stroke details

Out of scope Insufficient value/use

Demographics Administrative

Insurance Of CV value, but not within

CV specialty domain Stroke details

350 + expected…350 + expected…

Harmonized Data ElementsHarmonized Data Elements

Data Elements Description Definition Data Structure Permissible values Relationships

Information Model Use Cases Story Boards Activity Diagrams

NCRI Infrastructure ComponentsNCRI Infrastructure Components

Internal Randomization (w/in EDC system) Integrated EMR->NCDR->EDC data collection EDC data collection for supplemental research

data (e.g. study drug admin, efficacy details) Consistent application of data validation rules

(improves quality of data) 21CFR11 Compliant Data output using CDISC SDTM

Infrastructure ImplementationData Reporting ProcessInfrastructure ImplementationData Reporting Process

Infrastructure ImplementationReality CheckInfrastructure ImplementationReality Check

Registry Coordinator Focus Group+ Positive effects the infrastructure

and workflow could have on patient care/outcomes

+ Organization and structure imposed by the process

- Lack of detail available to explain new workflow

- Doubt that infrastructure design could really be implemented

Registry Coordinator Focus Group+ Positive effects the infrastructure

and workflow could have on patient care/outcomes

+ Organization and structure imposed by the process

- Lack of detail available to explain new workflow

- Doubt that infrastructure design could really be implemented

Study Coordinator Focus Group+ Very positive about combining

registry and trial workflow

+ Comfortable with re-use of data for two different reporting purposes

- Coordination and timeliness of data should be clearly defined

- Challenges w/ respect to re-use/ownership of data

Study Coordinator Focus Group+ Very positive about combining

registry and trial workflow

+ Comfortable with re-use of data for two different reporting purposes

- Coordination and timeliness of data should be clearly defined

- Challenges w/ respect to re-use/ownership of data

Infrastructure Implementation:Proof of Concept

SAFE PCI for Women Randomized, open-label trial of women undergoing PCI

Enrollment begins May, 2011

Assess the impact of trans-radial and trans-femoral device technique on safety of anticoagulant and antiplatelet medications.

Hypothesis: Compared with femoral, the radial approach is: Superior with respect to bleeding and vascular complications Non-inferior with respect to procedural failure

Part of the FDA Critical Path initiative and the Cardiac Safety Research Consortium public-private partnership (CSRC, www.cardiac-safety.org).

SAFE PCI for Women Randomized, open-label trial of women undergoing PCI

Enrollment begins May, 2011

Assess the impact of trans-radial and trans-femoral device technique on safety of anticoagulant and antiplatelet medications.

Hypothesis: Compared with femoral, the radial approach is: Superior with respect to bleeding and vascular complications Non-inferior with respect to procedural failure

Part of the FDA Critical Path initiative and the Cardiac Safety Research Consortium public-private partnership (CSRC, www.cardiac-safety.org).

Infrastructure Implementation: Proof of conceptInfrastructure Implementation: Proof of concept

Potential efficiencies gained with Data Standards-based Infrastructure: • Make possible re-use of data transfer processes, data

collection forms, data validation checks

• Reduces development time

• Reduces operational costs related to trial start-up

• Improves data quality for Registries and Research studies

• Facilitates acceptance of study results among stakeholders

• Increases credibility of trial data

Potential efficiencies gained with Data Standards-based Infrastructure: • Make possible re-use of data transfer processes, data

collection forms, data validation checks

• Reduces development time

• Reduces operational costs related to trial start-up

• Improves data quality for Registries and Research studies

• Facilitates acceptance of study results among stakeholders

• Increases credibility of trial data

Key ChallengesKey Challenges

Parallel Workflows Patient Care Clinical Research QI Registry

Systems Integration Lack of persistent ID’s in the

registry tools Question Structure Transformation of data from

one format to another Lack of meta-data required to

restructure into SDTM format Validation requirements

Year 1 AccomplishmentsYear 1 Accomplishments

Established the NCRI Data Standards Governance Workgroup

Harmonized over 350 cardiology data elements

Represented the elements in a CV information model, domain analysis model artifacts & the CDISC SDTM model

Established the NCRI Data Standards Governance Workgroup

Harmonized over 350 cardiology data elements

Represented the elements in a CV information model, domain analysis model artifacts & the CDISC SDTM model

Year 1 Accomplishments, continuedYear 1 Accomplishments, continued

Enhanced robust data modeling tools to facilitate the development and maintenance of these complex, multi-dimensional data models

Created standardized EDC forms, queries and data transfer processes

Created a randomization module within the electronic data capture system

Enhanced robust data modeling tools to facilitate the development and maintenance of these complex, multi-dimensional data models

Created standardized EDC forms, queries and data transfer processes

Created a randomization module within the electronic data capture system

And for patient care, this meansimproved….And for patient care, this meansimproved….

Efficiency of and Capacity for Evidence Synthesis

Efficiency for Hypothesis Generation

Efficient development and conduct of Clinical Research Initiatives

Findings Dissemination

Care Delivery Guideline Development

Quality Monitoring

Efficiency of and Capacity for Evidence Synthesis

Efficiency for Hypothesis Generation

Efficient development and conduct of Clinical Research Initiatives

Findings Dissemination

Care Delivery Guideline Development

Quality Monitoring

On the horizonOn the horizon

Data definitions derived from use case and context

Tap additional existing data sources

ACC administrative infrastructure may facilitate opportunities for informative sub-studies and evolution of clinical practice guidelines

Integration with EHR initiatives will evaporate the distinction between source documents and CRFs

Data definitions derived from use case and context

Tap additional existing data sources

ACC administrative infrastructure may facilitate opportunities for informative sub-studies and evolution of clinical practice guidelines

Integration with EHR initiatives will evaporate the distinction between source documents and CRFs

Thank YouThank YouNCRI Principal Investigators

Robert Harrington, MD, FACC DukeEric Peterson, MD, FACC DukeJohn Rumsfeld, MD, FACC ACCF

NCRI Principal InvestigatorsRobert Harrington, MD, FACC DukeEric Peterson, MD, FACC DukeJohn Rumsfeld, MD, FACC ACCF

NCRI Duke - ACC Joint Informatics CommitteeDavid Kong, MD, Duke Dana Pinchotti, ACCF Cindy Kluchar, Duke

Brian McCourt , Duke Arsalan Khalid, ACCF Jacqueline Huvane, Duke

Britt Barham, Duke Ganesean Srinivasan, ACCF Salvatore Mungal , Duke

Chris Tolk, CDISC

NCRI Duke - ACC Joint Informatics CommitteeDavid Kong, MD, Duke Dana Pinchotti, ACCF Cindy Kluchar, Duke

Brian McCourt , Duke Arsalan Khalid, ACCF Jacqueline Huvane, Duke

Britt Barham, Duke Ganesean Srinivasan, ACCF Salvatore Mungal , Duke

Chris Tolk, CDISC

Questions?Questions?

Rebecca Wilgus: rebecca.warlick@duke.edu

Brian McCourt: brian.mccourt@duke.edu

Dana Pinchotti: dpinchotti@acc.org

Rebecca Wilgus: rebecca.warlick@duke.edu

Brian McCourt: brian.mccourt@duke.edu

Dana Pinchotti: dpinchotti@acc.org

www.ncrinetwork.orgwww.ncrinetwork.org

Rebecca Wilgus - NCRI Year One Progress Report

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