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REGIONAL CARDIOVASCULAR REGISTRIES – Improving Care and facilitating RCTs Professor Christopher Reid, Co-Director CCRE Therapeutics School of Public Health & Preventive Medicine, Monas

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

15 th Vietnam National Congress of Cardiology

Hanoi, October 2016

the US National Institutes of Health

NIL related to this presentation

3

 Explosion of cardiac registries over the past decades

 Majority have been led by clinical societies and

stakeholders / governments

 Focus on quality of care

4 Cardiac registries development in Australia – a trigger for action!

5

Cardiac registries – Australian Initiatives

ANZSCTS

Registry

6

Cardiac registries – Regional Initiatives

Thai Acute Coronary

Syndrome Registry

(TACS) group

• Quality Assurance function

– Benchmarking of national standards

– Morbidity / Mortality / Treatment / Guidelines

– Appropriate risk modelling

Improving Patient Outcomes

The purpose of registries?

8

Minimal core data

Registries are a data spine: additional data may be sought from limited samples over limited time for

specific additional studies to answer specific questions

Standardized Data Collection

9

Forms based manual entry

On-line, web based ECR Highly secure ISO standard environment

0 units are out of control

Mortality 30day 2008/10 - Surgeon ID=xxxx AllProcScore, N=214

0

1 2 3 4 5

6

9

10 11 1213

14 15

16

17 18 1920

21

22 2324

25

26

27

28 29 30

33 34 0 20 40 60

Registries – Observational Findings

Surgical Units

Registries – Observational Findings

NEJM, 1 st September 2013

Registries facilitating RCTs

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

Transforms existing standards, procedures and cost structure Registries facilitating RCTs

Prophylactic INtra-aortic BALLoon Counterpulsation in High-Risk

Cardiac Surgery: A Pilot Randomised Controlled Trial

– Identification of Participants who may satisfy

inclusion / exclusion criteria for trials through

Randomisation

Cost Effective Clinical Trials Registries facilitating RCTs

Effectiveness)

Systematic reviews

Clinical guidelines

Regulatory approval Clinical

practice

Various methods

Health policy

Effectiveness)

Clinical trials

Clinical guidelines

Regulatory approval

Clinical practice

Health policy

Epidemiology, Registries

Comparative effectiveness research

Costing Studies

Systematic reviews

Summary

RCT Clinical Trials remain as gold standard

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