Preparing to contribute to the ABDR consists of a few steps:
- Surgeon/clinician agreement
- Ethics and Institutional Agreements by the site
- Implementation
- Preparing for data collection
If you undertake breast device procedures, please complete this form and return a signed copy to the ABDR via email to abdr@monash.edu or posted to the ABDR, Monash University, 553 St. Kilda Road, Melbourne, 3004. Upon receipt of the surgeon’s agreement, a representative of the ABDR will be in contact to commence data collection.
The ABDR currently has formal agreements (governance) with more than 300 participating sites in Australia. ABDR project officers will work with contributing surgeons to gain ethics and governance approval to conduct this research at your operating sites.
If you operate at a site that currently does not have ethics or governance approval to contribute data to the ABDR, please contact the registry on 03 99030205, abdr@monash.edu.
Ethics and Institutional Agreements (Governance)
Members of the ABDR team will assist surgeons/clinicians with ethics and institutional agreements.
Ethics
With most registries it is impracticable to seek individual consent from every participant to allow their clinical data to be included in a registry. So the large majority of Australian ethics committees now allow bona fide registries to adopt an opt-out approach to consent. When asked to approve opt-out consent, the ethics committee will typically weigh up the degree to which the public interest in having the registry outweighs any impingement on individual privacy, the degree to which the information collected by the registry is sensitive, and the security of the data collection system.
Institutional Agreements (Governance)
Formal agreements are put in place between the registry custodian (Monash University) and the institutions and providers supplying data to the ABDR. The agreement commits Monash to maintaining the security of data provided and to providing regular reporting within specified time-frames. The institution agrees to provide the data required in a timely and accurate manner, and participate in specified auditing activities.
Formal Implementation and Ongoing Data Capture
Once surgeon/clinician and institutional agreements are in place, we will contact staff at the consulting room and/or theatre to arrange a visit to formally implement the registry. You will be provided with a study folder with relevant documentation and instruction.
Preparing for data collection/Informing the patient prior to surgery
- To maintain HREC requirements, patients must be informed of the ABDR prior to their surgery. This is achieved by:
- Displaying a Patient Poster in the consult rooms
- Ensuring each patient receives the Patient Leaflet prior to surgery
- Posters, leaflets and Data Collection Forms (DCFs) are provided by the ABDR. To order more, please email abdr@monash.edu.
Completing Data Collection Forms
Data is captured via the ABDR Data Collection Form (DCF). This is a one page, double-sided paper form, based on a short “tick and stick” process. The form is easy to complete and captures the minimum data required by the registry. It has been reviewed by relevant craft groups and has been piloted. In future, there will be capacity for hospital personnel to enter patient data directly into the ABDR database (if that is their preference).
- The ABDR Data Collection Form (DCF) is completed in THEATRE
- This is a collaborative effort from the theatre staff and surgeons/clinicians
- Site contact batches DCFs to Monash University in the envelopes provided or via secured transfer protocol
To learn more about the ABDR DCF click here.
