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
EHR
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)
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
Car
diov
erte
rdef
ibpr
oced
ures
(ICD
Reg
istry
)
Con
geni
tal H
eart
Con
ditio
ns(IM
PAC
T)
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
CTNBP
Wom
ens’
Pre
sent
atio
n S
x
FDA
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
CV
End
poin
ts
Stro
ke
*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)
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
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
Data Elements Description Definition Data Structure Permissible values Relationships
Information Model Use Cases Story Boards Activity Diagrams
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
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: [email protected]
Brian McCourt: [email protected]
Dana Pinchotti: [email protected]
Rebecca Wilgus: [email protected]
Brian McCourt: [email protected]
Dana Pinchotti: [email protected]
www.ncrinetwork.orgwww.ncrinetwork.org
