National arrangements for clinical quality registries
Clinical quality registries are organisations that monitor the quality (appropriateness and effectiveness) of health care, within specific clinical domains, by routinely collecting, analysing and reporting health-related information, for a self-improving health system.
Role of clinical quality registries
Clinical quality registries use clinical data to identify benchmarks and variation in clinical outcomes and feed-back essential risk-adjusted clinical information, to clinicians, patients, consumers, health service administrators and government to inform clinical practice and health service decision making.
This clinical outcome feedback loop is shown in the graphic below.
Registries may also provide reports to jurisdictions, healthcare providers, funders, clinical colleges, researchers and patients and consumers.
Reporting processes of care through clinical quality registries are fundamental for continuous quality improvement and inform:
- Patient outcomes
- Compliance with evidence-based guidelines and standards
- Development of new guidelines and standards.
The Framework for Australian clinical quality registries
The Commission developed the Framework for Australian clinical quality registries (the Framework) to facilitate efficiencies in the development of national clinical quality registry infrastructure and to promote best practice in design, development, operation and security. The Framework was endorsed by Health Ministers in 2014 and contains:
- Strategic principles
- National health information arrangements
- A national infrastructure model
- Operating principles
- Technical guidelines
- Prioritisation criteria.
Use of the Framework
The Framework details national guidance on the development and implementation of clinical quality registries in Australia. The application of the Framework to clinical quality registries provides assurances that registry data, and the systems that hold those data, have satisfied minimum security, technical and operating standards.
The Framework was developed in collaboration with Australian states & territories and expert registry groups, and involved public consultation and piloting.
Since releasing the Framework, the Commission has received feedback from registry stakeholders, indicating that the Framework is well accepted, however stakeholders have identified further guidance on governance to maximise the operational efficiency of CQRs, is needed.
The Commission is now revising the Framework to strengthen guidance on CQR governance arrangements, to better support organisational oversight, management and CQR operations. The development of a corresponding CQR quality Standard will further strengthen the guidance provided by the Framework, to support successful implementation.
Clinical quality registry business case template
It is important that clinical quality registries are developed and maintained in alignment with the Framework for Australian clinical quality registries (the Framework). To assist stakeholders, the Commission has developed a clinical quality registry business case template (CQR business case template). The CQR business case template provides the structure for stakeholders to consider the alignment of their registry operations (or proposed operations) with the principles provided in the Framework. The CQR business case template also details the components of a CQR that should be considered and addressed when seeking funding. The Commission is currently reviewing the Framework to provide guidance on governance arrangements for CQRs and to update other components of the Framework.
Please note: The Commission does not fund clinical registries. The CQR business case template details the components of a CQR, as provided in the Framework that should be considered and addressed when seeking contributions from relevant industry groups, networks, academic or collegial organisations.
Legislation and regulation relating to clinical quality registries
As part of the Commission's work to revise the Framework for Australian clinical quality registries (the Framework), the Commission engaged MinterEllison to undertake a review of the Commonwealth, state and territory privacy laws and other relevant legislation that relate to the operation of clinical quality registries (CQRs) including how health data are stored, managed and shared for reporting on clinical outcomes. The review process and findings are provided in the report, Legislation and regulation relating to clinical quality registries.
The report, prepared by MinterEllison:
- Summarises the privacy legislation and regulatory considerations for CQR custodians in each Australian jurisdiction
- Identifies the role and function of data custodians; how health data is stored and shared; in what formats health data should be stored and the length of time data collected for the purpose of research should be held for
- Describes the requirements for establishing a CQR as a quality assurance activity or within a research framework.
Economic evaluation of clinical quality registries
The Commission engaged Monash University and Health Outcomes Australia to evaluate the economic impact of five Australian clinical quality registries. Using a conservative methodology the evaluation study showed that Australian clinical quality registries have delivered significant value for money, when correctly implemented and sufficiently mature.
Substantial benefits were measured, including:
- Greater survival for patients
- Improvements in quality of life after treatment
- Avoided costs of treatment or hospital stay.
The study found that:
- Benefit to cost ratios ranged from 2:1 to 7:1 – meaning that for every dollar spent, the return on that investment ranged from $2 to as much as $7
- The return on investment could range from $4 if national coverage were achieved by all five clinical quality registries
- Not every clinical quality registry will be cost-effective. Problems such as low coverage, inadequate reporting and inadequate collection of information about patient outcomes will limit the effect of clinical quality registries, and their value to the health system.
Prioritised list of clinical domains project
This project aimed to implement and document a process applying the prioritisation criteria (and other elements) in the framework, to create a prioritised list of clinical domains for potential development of national clinical quality registries.
The process used and combined the available data with the collective judgement of experts. Key steps included:
- Shortlisting to identify a manageable list of diseases, conditions and interventions based on cost to the health system, burden of disease and stakeholder priorities
- Identifying prioritisation criteria in the Framework that are essential to the successful functioning of a clinical quality registry (threshold criteria)
- Applying threshold criteria to remove diseases, conditions and interventions that are not suitable for clinical quality registry development
- Grouping remaining diseases, conditions and interventions into clinical domains
- Prioritising clinical domains against the remaining prioritisation criteria.
Australian Register of Clinical Registries
Clinical quality registries (CQRs) have the potential to report on retrospective, current and prospectively collected data to a wide range of stakeholders including clinicians, patients, hospital administrators, government, funders and insurers. The collected data includes: processes of care, health outcomes, patient reported outcome measures (PROMs), patient reported experience measures (PREMs) and health system costs. Each component of the collected data contributes to our understanding of the benefit and cost-effectiveness of treatment and care from the perspectives of the patient, clinician, health service provider, health insurer and government. There is enormous potential for CQRs to inform care delivery at the patient, clinician, local, national and international levels.
The Commission has developed the Australian Register of Clinical Registries to facilitate collaboration and awareness of registry activity among key stakeholders. Once a clinical registry is registered via the online form, Commission staff will contact the registrant to confirm the information provided. A brief summary of the registry, web link and registry contact details will be published on the Commission’s website.
How to register a clinical register
Visit the Australian Register of Clinical Registries to either, register and provide details on your clinical registry or to update previously provided information.
Searching for a clinical registry?
The list of clinical registries, includes summary information about each clinical registry that has registered with the Australian Register of Clinical Registries. Clinical registries will be added to this list as the content of each registered clinical registry is curated and prepared for publishing.
The search function allows you to conduct a basic search of the clinical registries for information such as clinical condition, registry name and participating sites. The ‘prioritised clinical domain’ field included in the list is in line with the Prioritised list of clinical domains for clinical quality registry development: Final report.
Once you find a relevant clinical registry, you will be able to contact the person listed as the ‘Registry contact’ for more information.
Once developed, the Commission will be conducting national consultations to gather feedback on the revised Framework. This is planned to occur later in 2020. Key organisations and individuals with an interest, or experience in managing or developing clinical quality registries are invited to participate. Information about the consultation will be available on the Commission’s website in the coming months.
If you have any questions or would like to be kept up-to-date on the project and associated consultation please contact Dr Bernadette Aliprandi-Costa and the project team via email at CQR@safetyandquality.gov.au or phone 02 9126 3600.