• 2500 hospitals • 2500 cardiologists • 35M clinical records
1998
2004
2005
2006
PVI
2007
2008
2009
2010
2012
2014
2015
AF Ablation in 2016
NCDR collaborations
Registry CathPCI (Diag. Cath &PCI)
ICD ACTION Registry-GWTG (STEMI & NSTEMI)
PVI (CAS, CEA, LLE)
IMPACT (Ped & Adult Congenital Intervention)
PINNACLE (All CV Outpatient)
STS/ACC TVT (Transcatheter Valve Therapy)
# Participants
# Patient Records
% Market Share
1,650
17 million
95%
1,715
1.3 million
100%
1010
700,000
40%
210
350,000
15%
85
40,000
45%
2,500
18 million
15%
380
23,000
98% As of 6/4/2014
CathPCI Registry QI Activities • PCI-RAM, RAB and AKI models reported in Outcome Reports
• AUC updated in Outcome Report • Physician Dashboard live via Cardiosource Reporting Collaborations • States – MA, WV, MI, MD, CA, WA • Payers – United, BCBSA, WellPoint • Health Systems – Tenet, HCA, CHW Prospective Research Projects • TRANSLATE • SAFE-PCI – Results at NCDR.14
NCDR Data Acquisition Software Vendors
Benchmark Reporting
Quality Improvement
Home grown systems
NCDR
P
D
A
S
Clinical Research
ACC’s web tool EHR
Data Quality • Training and Clinical Support Team – – – – – –
Orientation webinars Online FAQs Live customer support Email Monthly webinars Annual meeting with case reviews, etc.
• Data Entry Integrity
– Software value checks – Field level range parameters – Parent:Child fields
• Data Completeness
– Completeness monitoring reports
•
Data Accuracy
– Up to 650 records audited annually.
•
Adjudication
NCDR Data Quality Brief • Self reported • Accuracy
JACC 2012;60:1484-88.
Registry Platform Clinical Research Studies Using a National Clinical Registry as a platform for research • Economical
• Reduces data entry burden • Real world population • Consecutive patients
• Larger patient volumes
• Can use central randomization mechanism • Ongoing data capture
An example… SAFE-PCI for Women In a nutshell… • NCRI proof of concept • First multicenter randomized trial comparing radial with femoral access in U.S. • First randomized trial comparing interventional strategies in women • Sponsored by DCRI • Used NCDR CathPCI Registry platform • Estimated 65% per patient workload reduction
Programmatic outcomes… • • • • •
$750 per patient reimbursement ~ $5 million budget Study start up time cut in half Included research naive sites Wider enrollment spread • 90% sites enrolled at least 1 patient • > 70% sites enrolled at least 10 patients
“FDA believes that national and international registries in selected product areas and electronic health information containing unique device identifiers (UDI) should serve as the foundation of our National Medical Device Surveillance System.”
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