Establishing registry-based clinical trials in perioperative medicine

Establishing registry-based clinical trials in perioperative medicine

 

CIA: Associate Professor Stefan Dieleman

Clinical Quality Registries have become an accepted and important aspect of safe and affordable healthcare. 

Project summary

Clinical Quality Registries have become an accepted and important aspect of safe and affordable healthcare. Implementation of clinical registries across all areas is strongly advocated by the Australian Commission on Safety and Quality in Health Care (ACSQHC). Registries can efficiently provide data for monitoring quality of care, benchmarking hospital outcomes, and supporting implementation of ‘best’, evidence-based practice. The ability to provide timely, relevant and reliable information on patient care to individual clinicians has been shown to reduce variations in practice and improve quality of care, health care outcomes and patient satisfaction.  More so, in an era where data are increasingly collected electronically (and often semi-automatically in perioperative and critical care environments) there is now an even greater opportunity for perioperative clinical registries to be implemented in a cost-effective way.

The Perioperative Clinical Outcomes Registry (PCORE) initiative of the Australian and New Zealand College of Anaesthetists (ANZCA) is a national clinical quality registry in perioperative medicine. The target population is adults undergoing inpatient noncardiac surgery in public and private hospitals in Australia. ANZCA PCORE collects a core set of perioperative data including baseline and intraoperative risk factors, process of care data, in- hospital complications and post-discharge mortality. This registry was established in accordance with the Framework for Australian Clinical Quality Registries developed by the ACSQHC.

In this project, the investigators aim to set up an evaluation environment to support establishing a national infrastructure for registry-based clinical trials.  This multicenter registry environment will be based on PCORE and will comprise additional high quality routine perioperative care data and commonly accepted clinical outcomes, from adults undergoing non-cardiac surgery.  This expanded registry (‘PCOREx’) will provide a high-quality and efficient data resource for current and future clinical research projects. It will provide a data collection infrastructure for large-scale registry based randomised clinical trials (RCTs). It is also an efficient way to provide data for ‘classic’ RCTs and cohort studies, and to collect specific population-level pilot data for the design of definitive studies. Furthermore, by providing credible risk adjusted clinical data and patient-centred outcomes, the additional PCORE research components can also be used to monitor variation in perioperative practice against health outcomes and for centre-level benchmarking.

Chief investigators

Associate Professor Stefan Dieleman, Westmead Hospital, NSW;  Dr Jennifer Reilly, Alfred Hospital, Melbourne.
 

Funding

The project was awarded $A90,148 through the ANZCA research grants program for 2022.   

Last updated 14:37 8.03.2022