|
PROJECT DETAILS
|
|
Contact information
|
|
Name
|
Australian Cardiac Procedures Registry
|
|
Acronym
|
ACPR
|
|
Site link
|
https://acpr.org.au/
|
|
Registry head
|
A/ Prof Chris Reid
|
|
Contact person
|
Angela Brennan/ Diem Dinh
Senior Research Fellow
|
|
Registry location
|
CCRE, Monash University, Melbourne
|
|
Phone number
|
03) 9903 0517 / 03) 9903 0572
|
|
Mailing Address
|
Monash University
Level 6, 99 Commercial Road
Melbourne, 3004, VIC
|
|
Email address
|
angela.brennan@monash.edu.au / diem.dinh@monash.edu.au
|
|
|
|
GENERAL ASPECTS
|
|
Date last updated
|
August 2010
|
|
Background information
|
|
|
Reference population
|
|
What is the common circumstance that determines inclusion in the registry
|
All patients who undergo a cardiac surgery, RCI or device procedure at participating hospitals.
|
|
Does the registry trace individuals through more than one episode of care?
|
Registry does not trace individuals through more than one episode of care.
|
|
What geographical area is covered by the registry
|
Australia; NSW, VIC, QLF, SA.
Expansion into other states of Australia is planned, and possibly in New Zealand.
|
|
|
|
TIME PERIOD COVERED BY THE REGISTRY
|
|
Date in which data was first collected
|
Pilot – commenced 1st July 2009.
|
|
End date (if project no longer collects data)
|
30th November 2009. A number of sites are still collecting data. The aim is for data collection to be ongoing once funding has been obtained.
|
|
Does the registry collect continuous or periodic data?
|
We collect continuous data.
|
|
If the registry documents management of patients, for what periods of time are individuals followed up?
|
30 day follow up undertaken during the pilot. 12 month follow up is planned.
|
|
What database/s, if any, are used to assist with follow up?
|
There are plans to link with the National Death Index (NDI) and date based admitted episodes data sets.
|
|
|
|
|
DATA SET
|
|
|
Content
|
|
|
Number of individuals/ episodes of care included in the registry
|
2059 Individuals
|
|
Date in which this was determined
|
23/07/2010
|
|
Example of data collection questionnaire
|
https://acpr.org.au/
|
|
Data dictionary
|
https://acpr.org.au/downloads/ACPROperationsmanual.pdf
|
|
Data linkage
|
|
|
If nationally approved codes are used to identify the subject, clinician or institution, what is link key?
|
Medicare number
|
|
To which other database is linkage routinely undertaken
|
Links to the NDI are planned once the registry is funded and fully operational
|
|
Security
|
|
|
Where are the electronic data held?
|
Computer networked to and internal network: Data help on computer which is networked within the institution and backed up onto a server.
|
|
What happens to the paper forms?
|
Paper questionnaire or forms are destroyed, or paper records are not kept as all data are collected electronically
|
|
Confidentiality
|
|
|
How are records stored on the database?
|
Reversibility anonymised
|
|
Have subjects given consent for data collection?
|
Signed consent not obtained but option to opt out
|
|
What is the level to which subjects have consented?
|
Subjects informed individually of data collection and use to which data will be put
|
|
|
|
OUTPUTS
|
|
Analysis
|
|
|
How frequently are data transferred from the health care providers to the central database?
|
Weekly (Once the web system if fully operational. It is expected that the sites will enter data on a daily/weekly basis)
|
|
Can ad hoc analyses be preformed for health care providers?
|
Locally: Yes (planned feature)
Centrally: Yes (planned feature)
|
|
Audit reports
|
|
|
How frequently are multi-centre audit reports produced?
|
No reports have been produced.
|
|
How frequently are provider-specific audit reports produced?
|
Audits are planned and will be carried out annually
|
|
Publications
|
No publications to date
|
|
|
|
MANAGEMENT
|
|
|
Is the registry approved by any clinical/professional association?
|
No. Discussions have taken place with CSANZ regarding endorsement of ACPR.
|
|
Who is involved in the management database?
|
Doctors, Nurses, Epidemiologist, Statistician, IT specialist
|
|
Governance
|
|
|
Does a Steering Committee overseas the Registry?
|
Yes
|
|
Does a Management Committee overseas the day-to-day activities of the Registry?
|
Yes
|
|
Do terms of reference exist for the Steering Committee?
|
Yes
|
|
There is a clearly documented pathway for escalating issues identified by the registry?
|
Yes. This is a planned feature. See attached draft peer review process.
|
|
How often does the Steering Committee meet?
|
Bi Monthly (planned)
|
|
How often does the Management Committee meet?
|
Monthly (planned)
|
|
Funding
|
|
|
What is the source of funding for the registry?
|
No explicit funds. A range of funding models are currently being explored including public and private sector funding.
|
|
|
|
|
DATA QUALITY
|
|
|
Coverage
|
|
|
Extent to which the eligible population is representative of the country
|
Level 4: Total population of country included.
|
|
Who is represented in the registry?
|
States: NSW, VIC, SA, and QLD participated in the pilot
|
|
Which group/s, if any, should be represented but is/are not?
|
|
|
Completeness of recruitment of eligible population
|
|
The proportion of the eligible population that the registry includes
|
All hospitals performing cardiac procedures in Australia.
|
|
How and when was completeness last determined?
|
Unknown at this point as no checking/audit of the pilot data has been undertaken. Planned to be checked via linkage with admitted episodes data sets.
|
|
Date in which last preformed
|
N/A
|
|
Variables
|
|
|
What variables are included in the registry
|
Identifier, Admin information, Condition, Intervention, Short term outcome, Major unknown confounders, Long term outcomes ( 12 month follow up is planned once the registry is funded and fully operational beyond the pilot.
|
|
Completeness of data
|
|
|
The percentage of variables at least 95% complete
|
Level 4: All or almost all (>97%)
|
|
When was the completeness last determined?
|
The web system has been built to only allow data to be submitted if a valid value is entered of notes support a null value. A formal analysis of the pilot has not been completed to data.
|
|
Continuous data
|
|
|
The percentage of continuous variables collected as rave data
|
Level 4: All or almost all (>97%)
|
|
Use of explicit definitions for variables
|
|
The percentage of variables which have clear definitions laid out in a document such as a data manual
|
Level 4: All or almost all (>97%)
|
|
Use of explicit rules for deciding how variables are recorded
|
|
The percentage of variables which have clear rules on how to code them in the registry laid out in a document such as a data manual
|
Level 4: All or almost all (>97%)
|
|
Reliability of coding
|
|
How standardised is the coding for conditions and interventions?
|
Level 1: Not tested. No intra-rater reliability test conducted.
|
|
How and when last tested
|
N/A
|
|
Independence of observations of primary outcomes
|
|
What outcome/s do/does the registries collect?
|
Primary outcome of interest collected by the registry: Mortality – see attached key performance indicators for each mortality process for the full list of KPI’s/ outcomes.
|
|
Is there any Bias associated with the outcome due to the way in which it was reported?
|
N/A No formal reports have been produced to date.
|
|
Data Validation
|
|
What measures are taken to ensure that the data are valid
|
Level 3: Range and consistency checks. Planned level 4: Range and consistency checks plus external validation using an alternative source.
|
|
Date this was determined
|
Not undertaken to date
|
|
|
|
|
CLASSIFICATION
|
|
|
Classification of registry
|
Cardiac surgery/ cardiology/cardiac intervention
|
