INFORMATION FOR HEALTH PROFESSIONALS


AIM

The Australasian Pelvic Floor Procedure Registry (APFPR) offers an important clinician-led opportunity for surgeons and healthcare operators to contribute to the safety and quality of pelvic floor device surgery in Australia.

A data collection form or data inputted directly to the database, completed by qualified surgeons, will ultimately create a powerful dataset.  Once the database is mature, the benefits to surgeons contributing to the APFPR will include:

  • the ability to track patients, complications and devices inserted;
  • provision of regular, timely reports regarding pelvic device procedure activity and outcomes to inform clinical practice; and
  • opportunity to compare outcomes of pelvic device procedure with similar international datasets.

WHAT’S INVOLVED

Watch this 15 minute presentation from the recently held Virtual Annual Scientific Meeting 2021 of RANZCOG (February 2021).

 

For all enquiries on how to contribute to the APFPR, please speak to a member of the team on 03 9903 0101 or apfpr@monash.edu

CLINICIANS


The purpose of the APFPR is to monitor safety and quality of care involving stress urinary incontinence (SUI) and pelvic organ prolapse (POP) pelvic floor procedures, with a focus on those involving mesh, including revision and mesh explantation procedures. Clinicians who agree to participate in the APFPR will be required to:

  • display the APFPR Site Poster in their consulting room(s);
  • provide eligible patients with the APFPR Patient Leaflet;
  • register all eligible patients to the APFPR;
  • provide clinical, procedure and outcome data to the registry on all eligible participating patients at the surgery and post-surgical timepoints;
  • be available for contact in the event that operation or outcomes details require clarification;
  • receive periodic reports on procedures they have undertaken and the outcomes;
  • agree that their de-identified data be used in analysis and reporting;
  • be named as a contributing surgeon to the APFPR Annual Report (unless they notify the APFPR); and
  • notify the APFPR if they cease to work at the health service/hospital where data was being collected.

SITE PRINCIPAL INVESTIGATOR


The Site PI is responsible for the oversight of the APFPR at their site with assistance from the APFPR-CC providing document management in line with all ethics and governance requirements, site staff training, as well as ongoing database and general support. The Site Principal Investigator (Site PI) should be ideally part of a speciality that undertakes SUI and/or POP procedures with a significant proportion involving either synthetic slings and/or pelvic mesh/implantable devices. Responsibilities of a PI include:

  • promotion of the registry within your site and encourage participation by other surgeons;
  • ensuring that registry activities are conducted in accordance with the APFPR Protocol, approving HREC, the principles of the National Statement on Ethical Conduct in Research and relevant privacy regulations;
  • ensuring that clinicians and support staff are trained in the responsibilities of registry participation including recruitment procedures, data collection and database use;
  • ensuring integrity of registry data and support of any monitoring/audit activity conducted by the APFPR Coordinating Centre;
  • reviewing and share APFPR health service reports within their unit as part of continuous quality improvement; and
  • responding to local research governance requirements that includes:
    • generation of research governance/SSA application forms and all; study related docs for the site governance research office;
    • declaring any conflict of interest and payments to HREC/RGO;
    • providing annual progress report to HREC;
    • should the registry end, ensuring a final report be submitted to local HREC;
    • ensuring protocol deviations (eg data collected without consent) are documented and sent to the HREC for review; and
    • maintaining ongoing communication with Site RGO.

FREQUENTLY ASKED QUESTIONS (FAQ)


How will data collection for APFPR affect my practice workflow?

APFPR has been designed to minimise your participation overheads and time spent on data entry and once the data set has matured it will deliver valuable tools that your practice can use.

The APFPR does not yet integrate with any electronic health record (EHR) systems but it is a user-friendly, web-based data entry tool designed to reduce the burden of data entry.

For those who prefer, paper data collection forms are also available.

How can APFPR inform me about my patient population?

Surgeons can access information directly from the database about their own patients (identified), including basic reports.

Surgeon-level reports that the APFPR will securely provide to each participating surgeon will be a report of aggregate outcomes of their patients, but data in this format will not identify patients.

Participating sites will receive reports of their own aggregate data but no identifiable surgeon or patient data.

As the dataset matures these reports will be risk-adjusted and benchmarked so that surgeons will be able to monitor patient care and evaluate patient outcomes.

What procedures are included in the registry?

The APFPR is initially accepting information involving stress urinary incontinence (SUI) procedures involving mesh and other prostheses.

These are prospective cases of SUI mesh implantation, or procedures that have followed SUI complications requiring revision or explantation (removal).

The APFPR Steering Committee will shortly determine details of the next modules to be included in the registry.

How do I include my patients on the registry?

Please contact the APFPR Project Team to determine what pelvic floor procedures are being accepted.

Once this is determined, hospital ethics and governance approval is required prior to including a patient on the registry.

When this is obtained, patients eligible for participation can be approached, provided with a patient flyer and registered on the database.

At the time of surgery and post-operative visits, information about their clinical history, pelvic floor status, operation and complications can be provided either directly into the registry database, or via paper collection forms.

In the future the APFPR will work with electronic record providers to integrate APFPR data items into electronic medical record systems.

Who can access my data?

Access to the data is strictly controlled by the APFPR Steering Committee.

Protocols are in place to ensure that the highest levels of privacy and safety are maintained.

Surgeons can access information directly from the database about their own patients (identified), including basic reports.

Surgeon-level reports that the APFPR will provide to each participating surgeon will be a report of aggregate outcomes of their patients, but data in this format will not identify patients.

Participating sites will receive reports of their own aggregate data but no identifiable surgeon or patient data.

Patients can apply to the Registry Coordinator to access their own data if required and researchers can apply to the Steering Committee to access data from the database.

However, all requests must be approved by the APFPR and be compliant with the APFPR Data Access and Publication Policy.

How will data be used?

The APFPR will play an important part in future health outcomes of Australians because it aims to record information that will ultimately improve quality of care and increase safety for patients undergoing procedures that involve medical devices such as pelvic surgical mesh.

The surgical and patient reported outcomes of mesh procedures, including initial procedures and those requiring revision or mesh removal, will be used to provide safety and quality of care reports to hospitals, surgeons, the Therapeutic Goods Administration and government.

As more data is collected more information can be analysed to not only inform surgical best practice, but to inform patients who are considering pelvic surgery with mesh to better understand the benefits and potential risks of these procedures.

The APFPR will also produce public annual (aggregate data) reports and patient-facing infographics about the registry data.

How is my data protected?

Monash University has established and managed clinical registries for more than 20 years.

Monash currently operates nearly 40 state and national registries.

Monash University is accredited at the highest levels of data security and governance systems for sensitive data.

The APFPR complies with State, Territory and Commonwealth privacy laws, with your data permanently stored on infrastructure located in Australia.

Data stored on this infrastructure is backed up daily and accessed by trained APFPR personnel only.

All traffic between the data collector’s personal device, the web server(s), the database server(s), and the file server(s) is encrypted.

External access to information from the APFPR must adhere to strict protocols and procedures in line with the APFPR data access policy.

Registry data will be made available to external researchers (upon Steering Committee and ethics approval if applicable) but only after all identifiable patient and surgeon information has been removed.

Additionally, the APFPR Steering Committee will review all publications prior to submission.

How can I access registry data for research purposes?

Surgeons can access information directly from the database about their own patients (identified), including basic reports.

Surgeon-level reports that the APFPR will provide to each participating surgeon will be a report of aggregate outcomes of their patients, but data in this format will not identify patients.

Participating sites will receive reports of their own aggregate data but no identifiable surgeon or patient data.

Any further enquiries regarding data access should be directed to the APFPR Project Team by calling 1800 571 093 (toll free) or emailing apfpr@monash.edu.

How do I obtain additional posters, flyers or data collection forms?

Please contact the APFPR Project Team by calling 1800 571 093 (toll free) or emailing apfpr@monash.edu.