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

Autor: Jayasinghe RT; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia. randi.jayasinghe@monash.edu., Ruseckaite R; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia., Dean J; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia., Kartik A; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia., Wickremasinghe AC; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia., Daly O; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia.; Department of Obstetrics and Gynaecology, Western Health, Melbourne, Victoria, Australia., O'Connell HE; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia.; Department of Surgery, University of Melbourne, Parkville, Australia., Craig A; Department of Health and Aged Care, Therapeutic Goods Administration, Canberra, Australia., Duggan A; Australian Commission on Safety and Quality in Health Care, Sydney, Australia., Vasiliadis D; Consumer Representative, Australasian Pelvic Floor Procedure Registry, Melbourne, Australia., Karantanis E; St George Hospital, Kogarah, Australia., Gallagher E; Calvary John James, Canberra Private and Canberra Hospital, Canberra, Australia., Holme G; Commonwealth of Australia, Canberra, Australia., Keck J; St Vincent's Private Hospital Melbourne, Melbourne, Australia., Williams J; Ministry of Health New Zealand, Wellington, New Zealand., King J; Westmead Hospital, Westmead, Australia., Yin J; Holywood Medical Centre (WA), Nedlands, Australia., Short J; Christchurch Women's Hospital & Southern Cross Hospital - Invercargill, Christchurch, New Zealand., Sketcher-Baker K; Clinical Excellence Queensland, Queensland Health, Herston, Australia., Brennan P; Consumer Representative, Australasian Pelvic Floor Procedure Registry, Melbourne, Australia., Rayner S; Commonwealth of Australia, Canberra, Australia., Ahern S; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia.
Jazyk: angličtina
Zdroj: International urogynecology journal [Int Urogynecol J] 2023 Aug; Vol. 34 (8), pp. 1697-1704. Date of Electronic Publication: 2023 Jan 25.
DOI: 10.1007/s00192-022-05435-8
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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