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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 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 Cardiac registries development in Australia – a trigger for action! Cardiac registries – Australian Initiatives ANZSCTS Registry Cardiac registries – Regional Initiatives Thai Acute Coronary Syndrome Registry (TACS) group 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 Cardiac registries development Data Forms based manual entry On-line, web based ECR Highly secure ISO standard environment Cardiac registries development Reporting 10 60 40 02 0186587 -5 20 -10 34 28 26 50 150 200 20 14 100 811 32 16 22 12 23 10 19 18 27 731 25 29 17 risk21 increase 50% risk increase 75% risk increase 33 3015 30% 224 13 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 • Can we avoid league tables? 03 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 – 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 ... 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 Cardiac registries development