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15th Vietnam National Congress of Cardiology
Hanoi, October 2016
REGIONAL CARDIOVASCULAR
REGISTRIES – Improving Care and
facilitating RCTs
Professor Christopher Reid,
Co-Director CCRE Therapeutics
School of Public Health & Preventive Medicine, Monash University
Director, Curtin Centre of Clinical Research & Education
School of Public Health, Curtin University
Faculty Disclosures
• No Disclosures
CM Reid has received research support from Astra Zeneca, AMRAD, Bayer, BMS, Boehringer-Ingelheim, Sanofi Aventis, Servier,
National Heart Foundation, National Health and Medical Research Council of Australia (Research Fellowship, Project and Program grants), and
the US National Institutes of Health.
NIL related to this presentation
2
Cardiac registries development
Global Initiatives
Explosion of cardiac registries over the past decades
Majority have been led by clinical societies and
stakeholders / governments
Focus on quality of care
3
Cardiac registries development in Australia – a trigger for action!
4
Cardiac registries – Australian Initiatives
ANZSCTS
Registry
5
Cardiac registries – Regional Initiatives
Thai Acute Coronary
Syndrome Registry
(TACS) group
6
The purpose of registries?
• Quality Assurance function
– Benchmarking of national standards
– International comparisons
– High quality and poor performance
• Monitor trends
– Patient characteristics
– Procedure details
• Monitoring outcomes
– Morbidity / Mortality / Treatment / Guidelines
– Appropriate risk modelling
Improving
Patient
Outcomes
Cardiac registries development
registries
Data
Standardized Data Collection
Minimal core data
are
‘Epidemiologically sound’
a
Objective Data collection
Relevant Outcomes
data
spine
‘All or none’ i.e. no cherry-picking
Linkable & identifiable if follow-up required*
* When needed for determination of delayed outcomes
Registries are a data spine: additional data may be sought from limited samples over limited time for
specific additional studies to answer specific questions
8
Cardiac registries development
Data
Forms based manual entry
On-line, web based ECR
Highly secure ISO standard environment
9
Cardiac registries development
Reporting
10
60
40
.02
.0186587
0
-5
20
-10
0
34
28
3
9
26
50
150
200
20 6
2 1 14 100
811 32
16
22
12
23
10
19
18 27
731
5
4 25
29
17
1
3
5
6
risk21
increase
50% risk 4
increase
75% risk increase
33 3015 30% 224
13
0
HID
30% risk decrease
50% risk decrease
75% risk decrease
control
00 units are out of 100
200
300
400
500
Mortality 30day 2008/10Total
- Surgeon
ID=xxxx
AllProcScore,performed
N=214
number
of procedures
0
0
• Can we avoid league
tables?
.03
5
Fraction defective
• Public Availability?
.04
• Peer review process
.01
Cumulative Expected - Observed Mortality
.05
• Identification of Outliers
– What method?
– Control charts, Cumulative sum plots, VLADs, Funnel Plots
Registries – Observational Findings
Registries – Observational Findings
Surgical Units
Registries facilitating RCTs
• Registries are becoming well established in
the region
• Can we utilize the registries to inform clinical
practice on comparative effectiveness of
clinical interventions and care?
NEJM, 1st September 2013
Registries facilitating RCTs
NEJM, 1st September 2013
Registries facilitating RCTs
Results
0 – lost to follow-up
2.8% v 3.0% - P=0.63
RTA – no effect on mortality
TARGET was completed at a fraction
of the cost of a conventional RCT as
the recruitment, most data collection and
follow-up was done by the registry in the
provision of usual care
NEJM, Sept 1st 2013
Registries facilitating RCTs
Transforms existing standards, procedures and cost structure
Prophylactic INtra-aortic BALLoon Counterpulsation in High-Risk
Cardiac Surgery: A Pilot Randomised Controlled Trial
Registries facilitating RCTs
– Identification of Participants who may satisfy
inclusion / exclusion criteria for trials through
ANZSCTS registry
– Outcome ascertainment
ANZSCTS
Registry
Data
Specific trial
related data
Randomisation
Cost
Effective
Clinical
Trials
Registries facilitating RCTs
Can it work?
(Efficacy)
Evidence
generation
Evidence
synthesis
Does it work?
(Effectiveness)
Is it worth it?
(CostEffectiveness)
Clinical
trials
Systematic
reviews
Various
methods
Clinical
guidelines
Decisionmaking
Regulatory
approval
Clinical
practice
Health
policy
Registries facilitating RCTs
Can it work?
(Efficacy)
Evidence
generation
Evidence
synthesis
Does it work?
(Effectiveness)
Is it worth it?
(CostEffectiveness)
Clinical
trials
Epidemiology,
Registries
Costing
Studies
Systematic
reviews
Comparative
effectiveness
research
Health
Technology
assessment
Clinical
guidelines
Decisionmaking
Regulatory
approval
Clinical
practice
Health
policy
Summary
RCT Clinical Trials remain as gold standard
Registries provide “real life” experience and
are expanding in the region
Registries play a role in safety and quality and
understanding CVD management in the region
RCT’s + Registries can play a key
role in comparative effectiveness research
A Bright future for Registries and Trials
Thank You
