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.
The Commission is conducting a national public consultation on the revised Framework for Australian clinical quality registries Second Edition (the Framework 2nd edition). Please access the Framework 2nd edition consultation version below.
Australia’s Framework for clinical quality registries
The Framework for Australian clinical quality registries Second Edition (Framework 2nd edition) provides future-focussed guidance to jurisdictional health departments and CQR custodians to support well-designed CQRs operating under, or moving towards national arrangements to meet their core purpose. That is, work towards achieving national reporting and the return of information to patients, clinicians, health service providers, health insurers, governments and the community on the appropriateness of health care in high-priority clinical conditions, medical devices, therapies and interventions.
The Framework 2nd edition provides national best practice principles and detailed guidance for establishing and operating Australian national clinical quality registries. These include guidance on governance, infrastructure, security and privacy compliance, technical standards and reporting.
The Commission is seeking your feedback on the Framework 2nd edition, logical design and infrastructure, and security compliance guidelines.
You are invited to provide feedback to the Commission on the Framework 2nd edition in whole, or on specific sections that are important to you. Consultation is open to anyone who wishes to participate.
Have your say
Access the draft Framework 2nd edition and associated guidelines below and provide your feedback by:
- Responding to a short online survey
(Word document of the survey questions)
- Providing a written submission and emailing it to CQR@safetyandquality.gov.au
Consultation will close on 31 March 2023.
Role of clinical quality registries
Clinical Quality Registries (CQRs) are unique safety and quality clinical data collections that report on retrospective, current and prospectively collected health data. The purpose of CQRs is to systematically monitor the quality of health care within specific clinical domains so that the information generated can be used to improve care. CQRs do this by routinely collecting and analysing processes of care, health outcomes, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) for an eligible population and generating risk-adjusted reports that are in a format that can be used for quality improvement activities.
This clinical outcome feedback loop is shown in the graphic below.
The Framework for Australian clinical quality registries - background
In 2014, Australian Health Ministers endorsed the Framework for Australian clinical quality registries (incorporating the Operating principles and technical standards for clinical quality registries (endorsed by Health Ministers in 2010)). In 2016, the Commission developed the Prioritised list of clinical domains for clinical quality registry development. In 2019, in line with the Commission’s Work Plan, the Commission convened the Clinical Quality Registry Framework Review Advisory Group to advise on the revision of the Framework for Australian clinical quality registries (2014 version).
Since releasing the Framework (2014), the Commission received feedback from registry stakeholders, indicating that the Framework is well accepted, however stakeholders identified further guidance on governance and updated guidance on national infrastructure and security compliance to maximise operational efficiency of CQRs, was needed.
The Framework 2nd edition, which is led by the Commission, provides best practice strategic and operating principles and guidance for national CQR regarding governance arrangements, current registry logical design and infrastructure, reporting capability, approach to outlier management and data security arrangements.
In 2020, the Australian Government Department of Health and Aged Care (the Department) released the National Clinical Quality Registry and Virtual Registry Strategy 2022-2030 (the Strategy), endorsed by all jurisdictions. The National Strategy, which is led by the Department, provides a series of actions for governments, registries, and other stakeholders to build capacity and efficiency in line with the Framework 2nd edition, and support adoption of broader digital health and other key health reforms.
The Commission has now revised the Framework to strengthen guidance that better supports organisational oversight, CQR design, management and operations. The development of a corresponding CQR quality Standard will further strengthen the guidance provided by the Framework, to support successful implementation.
Please access the Framework 2nd edition December 2022 consultation version above.
Governance, accreditation, and quality assurance of clinical quality registries review
The Commission engaged the Rosemary Bryant AO Research Centre to undertake a review of the processes that exist or are recommended for clinical quality registry (CQR) governance, accreditation and quality assurance internationally and in Australia. The findings will help inform the Commission’s work underway to revise the Framework for Australian clinical quality registries, and the development of a national accreditation scheme for CQRs.
The Evidence Check included 26 studies and a review of country approaches to CQRs. The key findings include:
- Complete, high quality CQR data capture at a health system level is best achieved when data collection fits within existing reporting structures and is facilitated by national digital hosting capability. This includes contemporary database technology and quality assurance processes and national accreditation of CQRs.
- Successful national CQRs have organisational governance arrangements; receive some government funding and are coordinated between national, state and territory governments and stakeholder groups.
- Internationally, there is evidence of central CQR organisation(s) that: collect and analyse data for numerous databases; provide expertise and a skilled and reliable workforce; establish linkage with other national datasets and have established auditing and quality assurance systems.
- In general, national CQRs, irrespective of the ownership model (government led and funded; stakeholder led and government funded and stakeholder led and funded) ensure peak bodies and/or expert clinicians: advise on clinical indicators; include consumer participation in oversight committees; report benchmarks to health services and monitor outcomes; include public reporting of clinical outcomes and hospital performance; facilitate continual access to, or ownership of data by health services to facilitate continuous quality improvement; provide access to data for clinicians and patients; provide access to product information for implant manufacturers and allow data to be accessed with permission for research.
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 (the Register) to facilitate collaboration and awareness of registry activity among key stakeholders.
The Register is voluntary and contains a list of clinical registries that have self-nominated to be published on the Register. 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.
For clarification, the registration process does not include approval or endorsement by the Commission that the clinical registry is a clinical quality registry.
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.
If you have any questions 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.
If you would like to be kept up-to-date on the clinical quality registries, register your interest to receive updates.