Frequently Asked Questions for Surgeons

For surgeons

Do I have to be a member of ASPS, ACCS or BreastSurgANZ to contribute to the ABDR?

If you perform breast device surgery, we are keen to include your data in the registry – irrespective of your professional affiliation(s).

Do I have to pay anything to contribute to the ABDR?

No, the Registry is funded by the Australian Government and there is no cost to surgeons or patients to participate. Sites are asked to provide a nominal level of resourcing to oversee the day-to-day operations of the registry; that is, to provide a central contact person to act as point-of-contact for the Registry and to maintain the study folder, ensure a data collection form is completed for every operation and to batch and return the Data Collection Forms (DCFs) to Monash University in a timely manner.

Is it a matter of simply filling out the data collection forms for my patients and sending them to you?

There are three requirements to fulfil prior to submitting data.

  1. Each surgeon must sign a Surgeon Participation Agreement. They can be accessed here. Please return signed forms to Monash University.
  2. Sites must have obtained formal approval of a relevant ethics committee. This approval process is overseen by ABDR registry staff.
  3. Every patient must be informed prior to surgery that their data will be sent to the ABDR. We ask surgeons to discuss this with each patient at their pre-surgery consultation and to include a copy of the Patient Leaflet in their pre-surgery information pack.

Do I have to tell patients that I am submitting their data to the ABDR?

Yes, this is an important part of the process. Patients must be notified at their pre-surgery consultation that their data will be sent to the Registry. We provide you with a poster to display in a prominent location in your consulting room(s) and leaflets to include in each patient’s pre-surgery information pack. Following surgery, ABDR staff will send each patient an Explanatory Statement to inform them about the registry and the option to opt out of participating.

How do I order more posters and/or patient leaflets for my consulting rooms?

Please contact registry staff at abdr@monash.edu or (03) 9903 0205.

Does participation in the Registry contribute to my Continuing Professional Development?

Yes, participation in the Registry has already been approved for Continuing Professional Development (CPD) points by the Royal Australasian College of Surgeons (RACS) and Australasian College of Cosmetic Surgery (ACCS).

How do I stay up to date on progress of the ABDR?

The ABDR e-newsletter, released three times per year, will provide up to date information on progress and developments of the registry.

You can also follow our progress on the news section of this website, and by following us on Twitter @BreastDeviceReg and on Facebook.

 

Data collection

Does the ABDR collect online data or rely on hard copy data collection forms?

The registry currently relies on a paper-based data collection process. The capacity for direct entry directly into the database is under development.

When should data be collected? By whom?

The Data Collection Form (DCF) should be completed in the theatre at the time of each surgery. It is preferred that surgeons complete the DCFs themselves although we accept that some surgeons may choose to nominate a delegate to complete them. In this case, we ask that surgeons review each form for data accuracy and completeness.

Sites are asked to complete one double-sided, “tick and stick” data collection form per patient and returned to Monash on a monthly basis (although this varies depending on the frequency of breast device surgeries). Please contact your ABDR research officer if you need assistance with form completion or returns.

What is the difference between the blue section and the pink section of the data collection form?

The blue section of the form is to be completed for every patient, for every surgery. The pink section of the form is to be completed only when the patient is undergoing revision surgery.

A copy of the form can be found here.

Should I complete a form where there has been no replacement device implanted?

Yes, all breast device operations, explants as well as implants, should be submitted to the ABDR. There is provision to record this in the pink section of the form.

Should I collect retrospective cases?

No, we only collect patient data from and after the date of ethics approval. Please refer to the ethics approval letter in the Site Folder mailed to you from the Registry. This will indicate the date from which data may be collected.

Should I complete the data collection form for all my patients, regardless of which site their surgery takes place?

No, we can only accept data collection forms for patients undergoing surgery at sites with ethics approval. Please do NOT submit data for sites that have not been through an ethics approval process.

For more about Ethics and Governance.

When should I submit the forms? To whom?

Please batch forms and return to us on a monthly basis (at minimum). Please use the self-addressed envelopes provided in the sites folder for this purpose.

What is the estimated length of the data collection?

This is an ongoing project so there is no foreseeable end date for collection of data.

Data security

Who owns the data?

The Registry owns the data and is it housed with the Data Custodian, Monash University.

How is the data protected?

Data is housed within the Monash University “red zone” which is compliant with ISO27001 standards (bank level security).

Who can access the data?

Access to the data is strictly controlled by the Steering Committee. Protocols are in place to ensure that the highest levels of privacy and safety are maintained.
Patients can apply to the Registry Coordinator to access their own data and researchers can apply to the Steering Committee to access the database. However, all requests must be compliant with the ABDR Data Access and Publication Policy.

How will data be reported?

Reports will contain aggregate (unidentifiable) data only. Surgeons will receive reports of their own identifiable patient data. Sites will receive reports of their own aggregate data but no identifiable patient data. Patients can apply to the Registry Coordinator to access their own data and researchers can apply to the Steering Committee to access aggregate data. However, all requests must be compliant with the Data Access and Publication Policy.

How can I access registry data for research purposes?

Researchers wishing to access aggregate (de-identified) data should apply to the Steering Committee. The Registry will be acknowledged as the source of data, but researchers will not list all contributing surgeons.