Transcript Slide 1

Implantable
Cardioverter
Defibrillator:
Overview of the NCDR Data Methodology
Christie Lang, RN, MSN
Associate Director, ICD Registry
American College of Cardiology
Heart Rhythm Society Conference
San Francisco, California
May 15, 2008
Objectives
• Review the development process of an NCDR
Registry Product
• Understand NCDR committee structures
• Provide update regarding V2.0 Leads and Peds.
National Cardiovascular Data Registry
• NCDR is initiative of the American College of
Cardiology with partnerning support from many
societies, for the ICD Registry: Heart Rhythm
Society.
• NCDR mission is to improve the quality of CV
patient care by providing information, knowledge
and tools, implementing quality initiatives; and
supporting research that improves patient care
and outcomes.
Uses of NCDR Data Registries
– Quality Improvement
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Measure/manage individual patient care
Study, develop and monitor care processes
Track outcomes of care.
Assess hospital and provider performance
– Public Reporting
• Quality-base payment
• Certification & privileging, meet regulatory needs
– Post Market Surveillance & Clinical Trials
– Influence Clinical Practice Guidelines
Committee Structure and Project Summary
NCDR Management Board
Scientific Oversight Committee
Committee Structure for
each Registry
Registries
Registry Projects
QI Projects
Steering
Committee
Research &
Publications
Clinical Supp.Team
ACTIO
N
Registr
y
CathPC
I
Registr
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ICD
Registr
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CARE
Registr
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ambulatory
IC3
TAKE ACTION
Steering Committee
Planning Work Group
D2B
longitudinal
ACHIEVE
Steering Committee
Project managed through
ACTION and PCI Steering
committees
longitudinal
ICD Longit.
Steering Committee
Includes 30day
outcomes
Over 130 of our nation’s
CV Outcomes experts involved
Governance: NCDR Management Board
• Each NCDR Registry is governed by NCDR’s Management Board
and a committee structure that provide oversight and direction
dedicated to its mission.
• NCDR Management Board provides oversight and direction for
NCDR activities, which include:
– Accountability for financial performance,
– Accountability for the quality of the Registry products and services.
– Review and approval of Registry policies and strategic and operational
plans,
– Advocate, promote and influence key groups regarding the Registry’s
activities; and
– Set the high level agenda for the NCDR within the ACC community.
Committee Structure for
each Registry
Steering
Committee
The ICD Steering Committee shall provide
scientific and clinical support to the
development of the National ICD Registry.
Research &
Publications
Clinical Supp.Team
• Their tasks include the following:
– Identify and approve list of quality indicators reported to participatin
institutions as well as CMS.
– Identify data elements /definitions needed to calculate selected qua
indicators and enhance the utility of the registry.
– Determine appropriate report content and display format.
– Provide guidance in developing content for training manuals.
– Assist in providing relevant and consistent answers to user questio
on data elements.
Governance: ICD Steering Committee
The Steering Committee consists of a chair and 6-8 members including
2 ACC representatives, 2 HRS representatives, and one biostatistician
specializing in cardiovascular care.
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Stephen Hammill, MD, FHRS
Ralph Brindis, MD, MPH, FACC
Alan Kadish, MD, FACC
Mark Kremers, MD, FACC
Member
Bruce Lindsay, MD, FACC
Member
Michael Mirro, MD, FACC
Member
Martha Radford, MD, FACC
Lynne Warner Stevenson, MD, FACC
Joel Harder, MBA
Christine Lang, RN, MSN
Chair
Member
Member
2007-2010
2007-2010
2007-2010
2007-2010
2007-2010
2007-2010
Member
2007-2010
Member
2007-2010
Liason:HRS
2007-2010
Liason:ACC
2007-2010
It Takes a Team!
How many people are involved prior to an NCDR
Registry product launch?
Staff
CMO
Staff
Working Group
External
Peer reviewers
CSO
α-testers
Β-testers
Registry
Steering Committee
Science oversight
Committee
Vendors
Data Set
Registry Product
Launch
Charter
Development
Each Registry develops a
Charter that provides:
ICD Registry
•Purpose
V1.08
Product
Development
•Business Case
•Project Overview
Launc
•Goals and Objectives
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•Budget
Scientific
Development
•Stakeholder
Identification
Technical
Development
Testing
•Milestone Schedule
Tool Release
Alpha
•Project Assumptions
Pilot
•Project Constraints
•Risks
IT Application Development & Testing
•Source Documents
•Document Version History
Maintenance
Scientific
Development
Scientific Development
During Scientific Development Phase:
• Steering Committee reviews list of key
outcomes measures, clinical questions, etc to be
reported:
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ICD Registry was developed as part of CED by CMS to
determine if patients receiving ICDs in the general
population (“real world”) were comparable to patients
enrolled in the randomized clinical trials of ICD therapy?
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Specifically were the Patients, hospitals, indications,
complications, and outcomes comparable to the
studies
MEASUREMENT IS KEY!
Scientific Development:
Data Elements
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Based on Hypothesis and
Executive Summary Metrics
establish preliminary list of data
elements for registry inclusion
Use existing Clinical Data
Standards. ICD Registry data
elements are derived from
ACC/AHA Electrophysiology Data
Standards.
Review clinical trials, practice
guidelines, performance
measures, existing registries
Include fields for patient, device,
facility and provider information,
disease process.
Scientific
Development
Scientific
Development
ICD Registry Key Outcomes
Measures:
Incidence of Lead Dislodgement
Scientific
Development
Scientific Development
• Dataset review, recommendations and approval:
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Alpha testers
Steering Committee
Science Oversite Committee
Chief Medical Officer
Chief Science Officer
Charter
Development
ICD Registry V1.08
Product Development
Timeline
Launc
h
Scientific
Development
Technical
Development
Testing
Tool Release
Alpha
Pilot
IT Application Development & Testing
Maintenance
Technical Development: Data Collection Tool
• Map dataset against current
NCDR registries for consistency
of key core data elements
• Format data elements in
consistent sections
– Patient demographic
– History/risk factors
– ICD Procedural information
– Medications
– Device
– Adverse Events
– Discharge
• Technical Specifications created
Technical
Development
Technical Development – data dictionary
Technical
Development
Online data collection
tool features include:
• Access from any web browser
• Submit data to the NCDR™
• Data completeness reminders
Data Collection
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Flo
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1. Hospital
collects,
harvests, and
submits data
5. Participant
Hospital's
Outcome Report
3. NCDR Data Analysis
Computer
Outcome Report
generated and posted
on Hospital’s website
Data Flow
Data combined for
Hospital, Comparison
Group, and National
Data Flow
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ta
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Data that “Passed”
checks sent for
analysis
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2. NCDR Data
Quality
Computer
Submitted data is
checked and Hospital
resubmits (if needed)
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Hospital collects and
submits to DQR
Successfully
submitted data is
analyzed
Data is pooled for
many uses
Algorithms are used to
combine data for
participants’ reports
and other uses
Data is returned to
Hospital as an
Outcome Report
Data Flow
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Hospital data
aggregated,
algorithms applied
and stored
4. National Data
Pool
Charter
Development
ICD Registry V1.08
Product Development
Timeline
Launc
h
Scientific
Development
Technical
Development
Testing
Tool Release
Alpha
Pilot
IT Application Development & Testing
Maintenance
Testing
Testing
Feasibility Check
• Alpha Testing
• Pilot testing of the form
• Assessing flow of form in practice
Usability Check
• Feasibility of data collection
• Comprehension of data elements and definitions in
practice
• Beta Testing
• Vendor certification
Consistency Check
Charter
Development
ICD Registry V1.08
Product Development
Timeline
Launc
h
Scientific
Development
Technical
Development
Testing
Tool Release
Alpha
Pilot
IT Application Development & Testing
Maintenance
Release
Tool Release
• Training and Roll out needed: Webinars,
Training Manuals, FAQ’s developed.
• Client and Contract support for Participants.
• Software Vendors go thru intensive
certification process.
• Medications and devices tables are up to
date and subject for review as needed
Charter
Development
ICD Registry V1.08 Development
Timeline
Launc
h
Scientific
Development
Technical
Development
Testing
Tool Release
Alpha
Pilot
IT Application Development & Testing
Maintenance
Maintenance
Maintenance Phase- Evaluation
• Quarterly Outcome Reports
• Participant FAQ’s for clarification
• Feedback from Committees
– Steering Committee
– Research and Publications Committee
• Metric change
• Literature Review
• Guideline Recommendations
Is it Time for a Revision?
Enhancements needed for V 1.08
• Specific data element oversights
– Long QT, HCM etc
• Pulse generator focused
– No lead information except CS lead placement
• Medicare primary prevention focus
– Secondary prevention, non-Medicare
– Pediatric
Coming Soon!
Version 2.0: Peds and Leads
• The ICD Registry Working Group met biweekly for the past year to revise the data
collection form.
• May 07: Working Group met with the FDA to
begin discussion to incorporate Leads.
• November 07 at AHA ICD Registry Working
group met with PACES (Pediatric and
Congenital Electrophysiology Society ) and the
FDA to incorporate Pediatrics and Leads in to
the ICD Registry.
• Version 2.0 launch scheduled mid 2009.
Coming Soon!
Version 2.0: Peds and Leads
• Includes pediatric
patients receiving ICDs
• Data will provide insight
on pediatric SCD and
ICD impact
• Adding Leads will clarify
the benefits, risks and
performance of this
technology in adults and
pediatric patients.
Version 2.0: Leads and Pediatrics
Data to be collected will include:
• Atrial, ventricular, defibrillator, and
left ventricular leads at the time of
implantation, revison, replacement
and removal.
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This will improve lead surveillance
following implantation.
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Lead ID
Lead Data
Lead Location
Lead Placement Issues
Lead Function Issues
Lead Integrity Issues
Maintenance
Maintenance Phase- Audit
• The purpose of the Data Quality Program is to ensure
that data submitted to the NCDR are complete,
consistent, and accurate ultimately to improve the overall
quality of the Registry.
• For a participant’s data submission to be included in
national and peer group benchmarks, the submission
must pass all composite category inclusion thresholds of
completeness established in the threshold reports.
• This report presents the threshold results for all core
elements, as well as the number of unique records, %
valid and invalid values, as well as missing values.
• Inclusion threshold criteria were chosen for their clinical
and structural pertinence.
Maintenance
Maintenance Phase- Audit
• Onsite Auditing will begin 2008.
• 10% Hospitals will be randomly selected for the audit to
compare the data entered into the Registry with the
original patient data in the hospital record system.
• Also, auditing will include selected hospitals where the
data is inconsistent.
• Examples of inconsistent data will include hospitals
reporting no complications or reporting an MD as board
certified in EP who is not listed with the ABIM
• Each hospital will receive a confidential audit report
which displays their audit score and individual accuracy
for each element.
Take Home Message
• Process is long, thorough, but 100% guided by
science.
• Incredible teamwork needed for ultimate
success.
• Your feedback and involvement is the key to its
success!
THANK
YOU