Step 1: Assess your registry against criteria for being identified as a clinical quality registry
- Collects Individually identifiable patient level data;
- Collects data from multiple sites;
- Collects treatment or care details of individuals; and
- Collects outcome data as a core function of the registry.
Step 2: Determine whether your registry has the characteristics and properties of a clinical quality registries.
My registry applies the operating principles described for Australian Clinical Quality Registries. That is:
Attributes of Australian Clinical Quality Registries
- Australian Clinical Quality Registries should be developed with clear and precisely defined purposes.
- For Australian Clinical Quality Registries to provide the maximum value to the health system they should focus their core data collection on the essential elements required to serve their main purposes.
- Data collected by Australian Clinical Quality Registries should be confined to items which are epidemiologically sound, i.e. simple, objective, and reproducible;
- Methods used to collect data in Australian Clinical Quality Registries should be systematic, with identical approaches used at the different institutions contributing information.
- Outcome determination should be undertaken at a time when the clinical condition has stabilised and the outcome can therefore be reasonably ascertained.
- In determining the time to outcome assessment, Australian Clinical Quality Registries must consider the burden and cost of data collection together with the likelihood of loss to follow-up.
- Australian Clinical Quality Registries must ensure that complete registry data are collected from the eligible population.
- The collection of data for an Australian Clinical Quality Registry must not impact on the provision of health care and should not be a burden or incur a cost to consumers.
- Data capture should be performed as close as possible to the time and place of care by appropriately trained data collectors;
- Data should be uniformly and easily accessible from the primary data source.
- Standard definitions, terminology and specifications should be used in Australian Clinical Quality Registries wherever possible to enable meaningful comparisons to be made and to allow maximum benefit to be gained from linkage to other registers and other databases (if approved by relevant ethics committees, etc.).
- Australian Clinical Quality Registries must use data dictionaries when they are established to ensure that a systematic and identical approach is taken to data collection and data entry. They need to publish eligibility criteria, metadata, data dictionaries, etc.;
- To avoid duplicating data capture, Australian Clinical Quality Registries use data from existing data sources, including administrative data, where they are of a satisfactory quality;
- Australian Clinical Quality Registries should have the capacity to enhance their value through linkage to other disease and procedure registers or other databases.
- Australian Clinical Quality Registries should collect individually identifiable patient or subject information.
- Where patterns or processes of care have an established link to outcomes and process measures are simple, reliable and reproducible, they should be considered for collection by Australian Clinical Quality Registries.
- Where possible, outcomes should be assessed using objective measures. Where this is not possible, outcome should be assessed by an independent person and undertaken using standardised and validated tools.
- Australian Clinical Quality Registries should collect objective, reliable co-variates for risk adjustment to enable factors outside the control of clinicians to be taken into account by using appropriate statistical adjustments.
- To protect register data, Australian Clinical Quality Registries must utilise secure access controls and secure electronic transfer and electronic messaging systems.
- The collection, storage and transmission of clinical registry data must be in line with relevant legislation and guidelines.
- Institutional policy principles set out in Part B: Technical standards should be met.
Ensuring data quality
- Australian Clinical Quality Registries should report as a quality measure the percentage of eligible patients recruited to the registry.
- Australian Clinical Quality Registries should have a robust quality control plan which allows ongoing monitoring of the completeness and accuracy of the data collected.
- Australian Clinical Quality Registry data should be checked in a sample of cases. This usually involves audit against source records. The sample size needs to be sufficient to produce reliable measures of data completeness and accuracy. The frequency of audits needs to be sufficient for data quality lapses to be identified promptly. Incomplete or inaccurate data should be identified by the data centre and remedied as soon as possible.
- Australian Clinical Quality Registries should incorporate in-built data management processes such as data range and validity checks.
- Australian Clinical Quality Registry reports should be produced according to a strict timeline and should be appropriately funded to enable this to occur.
Organisation and governance
- Australian Clinical Quality Registries must formalise governance structures to ensure accountability, oversee resource application, provide focus and optimise output from the registry.
- Australian Clinical Quality Registries must establish policies to manage a range of contingencies arising from the analysis of data from the registry, which includes a formal plan ratified by the Steering Committee to address outliers or unexplained variance, to ensure that quality of care issues are effectively addressed and escalated appropriately.
- Custodianship of clinical register data needs to be made explicit in Contracts and/or Funding Agreements.
- Data access and reporting policies for Australian Clinical Quality Registries should be made available to persons wishing to use register data.
- Third parties wishing to access data and publish findings must seek approval from the Steering Committee and obtain relevant Institutional Ethics Committee endorsement where identified or re-identifiable data or contact with patients is sought.
Ethics and privacy
- With the exception of instances where data collection has been mandated through legislation or enabled through regulation or legislation:
- Institutional Ethics Committee (IEC) approval must be obtained to establish the Australian Clinical Quality Registry.
- Registry personnel should be familiar with and abide by the requirements set out in relevant privacy legislation, the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research.
- Participants or their next of kin should be made aware of the collection of register data. They should be provided with information about the Australian Clinical Quality Registry, the purpose to which their data will be put and provided with the option to not participate. This should be at no cost to the registry participant.
- Where projects are undertaken using register data, IEC approval must be sought unless the project falls within the scope of an institution's quality assurance activity.
- Data from Australian Clinical Quality Registries should be used to evaluate quality of care by identifying gaps in best practice and benchmarking performance.
- Australian Clinical Quality Registries must report without delay on risk-adjusted outcome analyses to institutions and clinicians.
- Australian Clinical Quality Registries should verify data collected using a formalised peer review process prior to publishing findings.
- Local clinical register database managers should have the capacity to undertake ad hoc analyses of their data to enable monitoring of clinical care.
- Australian Clinical Quality Registries must produce a publicly-accessible aggregated annual report detailing clinical and corporate findings.
- Australian Clinical Quality Registries must have documented procedures for reporting on quality of care, including addressing outliers or unexplained variance.
Resources and funds
- Australian Clinical Quality Registries should be appropriately funded to allow data collection, reporting and the institution of strong quality control procedures.
Step 3: Let us know about your Registry
- Contact the Registry delegate at the NHMRC Centre of Research Excellence in Patient Safety on 03 9903 0891
Please click here to download the Registry attributes survey