Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are common pelvic floor disorders (PFDs). Owing to significant adverse events associated with mesh-related pelvic floor procedures (PFPs) in a proportion of the surgically treated population, and deficits in collection and reporting of these events, the Australian Government identified an urgent need for a tracking mechanism to improve safety and quality of care. The Australasian Pelvic Floor Procedure Registry (APFPR) was recently established following the 2018 Senate Committee Inquiry with the aim of tracking outcomes of PFP involving the use of devices and/or prostheses, with the objective of improving the health outcomes of women who undergo these procedures. This paper will describe the APFPR's aims, development, implementation and possible challenges on the way to its establishment. METHODS: The APFPR has been developed and implemented in accordance with the national operating principles of clinical quality registries (CQRs). The minimum datasets (MDS) for the registry's database have been developed using a modified Delphi process, and data are primarily being collected from participating surgeons. Patient recruitment is based on an opt-out approach or a waiver of consent. Patient-reported outcome measures (PROMs) providing additional health and outcome information will be obtained from participating women to support safety monitoring of mesh-related adverse events. RESULTS: Currently in the Australasian Pelvic Floor Procedure Registry (APFPR) there are 32 sites from various jurisdictions across Australia, that have obtained relevant ethics and governance approvals to start patient recruitment and data collection as of January 2023. Additionally, there are two sites that are awaiting governance review and five sites that are having documentation compiled for submission. Seventeen sites have commenced patient registration and have entered data into the database. Thus far, we have 308 patients registered in the APFPR database. The registry also published its first status report and a consumer-friendly public report in 2022. CONCLUSIONS: The registry will act as a systematic tracking mechanism by collecting outcomes on PFP, especially those involving devices and/or prostheses to improve safety and quality of care.

Evaluation of the acceptability of patient-reported outcome measures in women following pelvic floor procedures.

PURPOSE: Patient-reported outcome measures (PROMs) are valuable tools in evaluating the outcomes of surgical treatment health-related quality of life (HRQoL) of women with stress urinary incontinence (SUI) and may be incorporated into related clinical quality registries. The aim of this study was to assess the feasibility and acceptability of incorporating PROMs into the Australian Pelvic Floor Procedure Registry (APFPR). METHODS: Semi-structured qualitative interviews were conducted with women with SUI (N = 12) and their managing clinicians (N = 11) in Victoria, Australia. Interview topics covered content and face validity, appropriateness, and acceptability of three incontinence-specific, two pain, one anxiety and depression, one sexual function and one patient global impression of improvement instruments identified through the literature to determine their suitability and acceptability for the APFPR. We analysed interview data into topics using conventional content analysis. RESULTS: Study participants agreed that PROMs were needed for the APFPR. Both participant groups suggested that some of the instruments were ambiguous, therefore only three instruments (one incontinence-specific, sexual function and patient global impression of improvement) will be included in the APFPR. Both clinicians and women agreed it would be appropriate to answer PROMs at baseline and then at 6- and 12-month postsurgically. Email, phone call and mail-out of the instruments were the preferred options for administration. CONCLUSION: Most women and clinicians supported the feasibility of incorporating PROMs in the APFPR. Participants believed the PROMs would demonstrate useful aggregate HRQoL data and have potential for use in individual care.