Clinical Registries
in Cardiac Surgery
Peter S. Greene, MD
CMIO, Johns Hopkins Medicine
Diane Alejo
Information Systems Manager
Division of Cardiac Surgery
September 15, 2010
ICTR Clinical Registry Workshop
Cardiac Surgery Data Management
Cardiac Surgery Database spans 1944 - 2010
• Clinical and administrative data tracking
• Supports IRB approved clinical research activities
• Allows longitudinal outcome follow-up
STS Adult Cardiac Surgery Data / STS Congenital Data
Heart and Heart- Lung Transplant Database
UNOS Registry
ISHLT / INTERMACS VAD Registry
Collaborative Transplant Research Database
History of Cardiac Surgery Database
933
1944-1950
Blalock-Taussig Registry
15,010
1950-1982
Cardiac Registry - Medical Archive’s Operative Logs
7,738
1983-1994
Cardiac Surgery Database & Cardiac Transplant Database
18,934
1996-2010
Expanded Data Collection - Point of Care / Work Flow Integration
42, 615
Total
Operations recorded in the Databases
STS Adult Cardiac Surgery Database Participation
> 13,000 Johns Hopkins Adult Cardiac Operations submitted to STS from 1997- 2010
Patient
Care
STS
Research
NQF
PQRI
Clinical
Documentation
Leap
Frog
DATA
Performance
Improvement
Payers
Billing
Resident
Education
Maintenance
of
Certification
Admin
Reports
UNOS
ICD 9
codes
STS Participation
Clinical
Data
Performance Improvement
Score Cards
Maintenance of Certification
Surgeon / Resident Portfolios
LeapFrog / PQRI
National Quality Forum
DRG
Codes
Cardiac
Database
REPORTS
Payers , RFI / RFP’s
APRDRG
codes
Clinical Registries
CPT
codes
Administrative Reporting
Billing / Resource Utilization
Research
Data
Consumers & Marketing
Sources of Data and Reporting For Outcome
Measurement & Research in Cardiac Surgery
Some Lessons Learned
1. Must have strong clinical leadership and pervasive buy-in
2. Must integrate with clinical workflow
3. Must provide net benefit to clinicians
4. Must stay within scope of readily known data
5. Must have a stable and capable clinical team
6. Must have a stable and capable data team
7. Must audit for completeness
8. Must give regular feedback
9. Must pre-stage submissions
Outcome Data
STS National Database
Standardized information on cardiac & thoracic surgical procedures
Data analyzed by separate, independent, objective data analysis center (DCRI)
Opportunities to improve patient care
# Participants
Adult Cardiac
General Thoracic
Congenital
992
# Records
2.7+ million
Harvest
4 times / year
81
185,508 operations
2 times / year
142
96,628 operations
2 times / year
STS National Database
STS Pilot Pay For Performance (P4P) Program
Incentive payments for achievement of thresholds in performance measures
A model of quality improvement with 3 types of measures:
Structureal: IT, database participation, volume
Process:
IMA use, discharge beta blockers
Outcomes:
Mortality, Morbidity: CVA, renal failure
Blended STS NCD and financial (UB-92) database
NQF performance measures
2007 PQRI Initiative – CMS
New 2007 STS Composite Scoring System
STS National Database
DCRI – Data Warehouse and Analysis Center
Data transmitted electronically
National, Regional and “Like Institution” benchmarking
Reports include site specific, risk adjusted, regional and national
aggregate date including morbidity, mortality and LOS for CABG,
Valves and CABG/Valve surgery
Statistical Analysis – Risk Modeling- Logistic Regression,
Hierarchical regression modeling
STS National Database
STS Auditing
Risk factor model variables
NQF measures
Op log procedures
Operative deaths and morbidity
STS National Database
Participation
STS Adult Database
STS Congenital Database
992
81
STS Thoracic Database
142
Total
1215
STS Composite Quality Score
Distribution of Participant Site Ratings
100
77
Percent
75
50
25
12
11
0
March 2008
STS Composite Quality Ratings
Jan – Dec 2009
JHH
STS
Overall
95.3 %
95.3 %
Avoidance of
Mortality
97.3 %
97.9 %
Avoidance of
Morbidity
82.6 %
84.5 %
Use of IMA
98.5 %
94.5 %
Medications
80.2 %
76.0 %
Rating
* Participant is significantly lower than the STS mean
* * Participant is not significantly different than the STS mean
* * * Participant is significantly higher than the STS mean
Research Informatics
Department of Surgery
PREMISES OF THIS PROPOSAL
FOR A SURGERY DATA CENTER
• Almost every faculty member and research trainee has a
need for accessing clinical data for research purposes
• There is insufficient revenue to support a centralized
research database
– There is a modest amount of research database activity in the
department
• There is an extensive amount of clinical information
within JHMI in an electronic format, but these exist in
multiple sources
• There is an extensive amount of surgical patient data
being collected and analyzed for non-research activities
(e.g.: safety, accreditation, payers, training)
Departmental Prototype
ORMIS
Lung Cancer Database (M. Brock)
STS Thoracic Database
Clinical
Data
Maryland Trauma Registry
EPR
IDX
SALAR
Surgery
Anesthesia
ADR
POE
Core
Transplant Information Systems
Teleresults
UNOS / CTRD
Specialty Surgical
Research Databases
NSQIP
Clinical Trial Databases
Tumor
Registry
Casemix
CVIEW
Research
Data
Cardiac Surgery Database
STS Adult Cardiac / Congenital
ISHLT VAD Registry
Internal Data Sources and Internal Database Initiatives
Idea – Explore Influence of Randomness
Idea – Quality Collaborative
Idea – Patient Registries
From Dr. Adrian Puttgen
Dept. Neurology, Critical Care
http://www.youtube.com/watch?
v=WQ2PFoHptK8
Clinical Registry Opportunities
1. Unique patient population
2. Unique patient tracking capability
3. Unique patient detail or comprehensiveness
4. Unique patient data integration
5. Regional quality programs
6. National quality programs