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Australian Rheumatology Association Database (ARAD)

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