|
PROJECT DETAILS
|
|
Contact information
|
|
Name
|
Australian Rheumatology Association Database
|
|
Acronym
|
ARAD
|
|
Site link
|
http://www.rheumatology.org.au/rheumatologists/aradatabase.asp
|
|
Registry head
|
Prof Rachelle Buchbinder
|
|
Contact person
|
Maree Williams
ARAD Project Co-coordinator
|
|
Registry location
|
Department of Epidemiology and Preventive Medicine
Monash University
Alfred Hospital
89 Commercial Road
Prahran VIC 3004
|
|
Phone number
|
03 95081856
|
|
Mailing Address
|
Monash Department of Clinical Epidemiology
Suite 41, Cabrini Medical Centre
183 Wattle tree Rd
Malvern VIC 3144
|
|
Email address
|
Maree.Williams@monash.edu
|
|
|
|
GENERAL ASPECTS
|
|
Date last updated
|
August 2010
|
|
Background information
|
Is a national Australian database which collects important health information from individuals with inflammatory arthritis including: Rheumatoid arthritis, Ankylosing spondylitis, Juvenile arthritis, Psoriatic arthritis.
The aim of ARAD is to determine the short and long term effectiveness and safety of new biological drugs, such as Enbrel, Remicade, Humira, Kineret, MabThera and Orencia, used to treat inflammatory arthritis conditions.
ARAD collects information from patients every 6 months via questionnaires. Questions about medical history, medication history, responses to medication, physical functioning and quality of life are asked.
Patients and rheumatologists across Australia contribute to ARAD.
|
|
Reference population
|
|
What is the common circumstance that determines inclusion in the registry
|
Participants with inflammatory arthritis are recruited to join ARAD by their rheumatologist. Most participants have been recruited as they have started or are in the process of starting biologic therapy. However some patients who have not started biologics have been recruited as controls.
|
|
Does the registry trace individuals through more than one episode of care?
|
Registry follows patient up over more than one episode of care.
|
|
What geographical area is covered by the registry
|
Participants have been recruited throughout Australia.
|
|
|
|
TIME PERIOD COVERED BY THE REGISTRY
|
|
Date in which data was first collected
|
23/04/2001
|
|
End date (if project no longer collects data)
|
N/A
|
|
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?
|
Follow up is ongoing for the life of the registry.
|
|
What database/s, if any, are used to assist with follow up?
|
National Death Index, Australian State and Territory Cancer Registries and Medicare Australia.
|
|
|
|
|
DATA SET
|
|
|
Content
|
|
|
Number of individuals/ episodes of care included in the registry
|
Number of Individuals answering questionnaires:3098
Number of Individuals available for follow up tracking only: 1055
|
|
Date in which this was determined
|
1/8/2010
|
|
Example of data collection questionnaire and data dictionary
|
Please see attached
|
|
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
|
National Death Index, Australian State and Territory Cancer Registries and Medicare Australia
|
|
Security
|
|
|
Where are the electronic data held?
|
Computer connected to an external network.
|
|
What happens to the paper forms?
|
Paper questionnaires or forms containing information on individuals are kept and stored.
|
|
Confidentiality
|
|
|
How are records stored on the database?
|
Identifiable
|
|
Have subjects given consent for data collection?
|
Signed consent obtained only on first contact with service.
|
|
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?
|
N/A
|
|
Can ad hoc analyses be preformed for health care providers?
|
Locally: No
Centrally: Yes
|
|
Audit reports
|
|
|
How frequently are multi-centre audit reports produced?
|
Other (6 monthly to Rheumatologists)
|
|
How frequently are provider-specific audit reports produced?
|
Other (6 monthly to Rheumatologists)
|
|
Publications
|
http://www.rheumatology.org.au/rheumatologists/arad-publications.asp
|
|
|
|
MANAGEMENT
|
|
|
Is the registry approved by any clinical/professional association?
|
Yes. The Australia Rheumatology Association supports the database.
|
|
Who is involved in the management database?
|
Doctors, nurses, Allied Health professionals, Epidemiologist, Statistician, IT specialist, Lay people
|
|
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?
|
No
|
|
How often does the Steering Committee meet?
|
Four times a year
|
|
How often does the Management Committee meet?
|
Weekly
|
|
Funding
|
|
|
What is the source of funding for the registry?
|
Public sector funding body, Private sector, Research grant.
|
|
|
|
|
DATA QUALITY
|
|
|
Coverage
|
|
|
Extent to which the eligible population is representative of the country
|
Level 3: Good evidence the eligible population is representative.
|
|
Who is represented in the registry?
|
Australia
|
|
Which group/s, if any, should be represented but is/are not?
|
All states represented and rural and urban rheumatologists participating.
|
|
Completeness of recruitment of eligible population
|
|
The proportion of the eligible population that the registry includes
|
Level 1: Unknown or few (<80%)
|
|
How and when was completeness last determined?
|
An estimate of the ARAD population with the population of Australia taking biologics is currently underway
|
|
Date in which last preformed
|
2010
|
|
Variables
|
|
|
What variables are included in the registry
|
Identifier, Admin information, Condition, Intervention, Short term outcome: Major known confounders, Long term outcome.
|
|
Completeness of data
|
|
|
The percentage of variables at least 95% complete
|
Level 4: All or almost all (>97%)
|
|
When was the completeness last determined?
|
Estimated September 2010
|
|
Continuous data
|
|
|
The percentage of continuous variables collected as rave data
|
Level 2: Many (70-89%)
|
|
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 1: None
|
|
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 1: None
|
|
Reliability of coding
|
|
How standardised is the coding for conditions and interventions?
|
Level 1: Not tested. No inter or intra-rater reliability tests conducted.
|
|
How and when last tested
|
Not tested
|
|
Independence of observations of primary outcomes
|
|
What outcome/s do/does the registries collect?
|
Primary outcome of interest collected by the registry: Safety of biologic treatment collected by symptoms, side effects, infections, hospitalizations.
Other outcomes collected by the registry: Efficacy collected by biologic medication start and stop dates, reasons for stopping biologic medications, symptoms, joint surgery, hospitalizations and the quality of life questionnaires include EQ-5D, SF-36, AQOL, HAQ and PEDs-QL.
|
|
Is there any Bias associated with the outcome due to the way in which it was reported?
|
Level 2: Observer neither independent nor blinded to the intervention.
|
|
Data Validation
|
|
What measures are taken to ensure that the data are valid
|
Level 4: Range and consistency checks plus external validation using an alternative source.
|
|
How this was determined
|
Range and consistency checks are done as the data is collected and at analysis. External validation is done on a regular basis.
|
|
Date this was determined
|
2010
|
|
|
|
|
CLASSIFICATION
|
|
|
Classification of registry
|
Rheumatology
|
