Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Jayasinghe, Randi T., Ruseckaite, Rasa, Dean, Joanne, Kartik, Aruna, Wickremasinghe, Anagi C., Daly, Oliver, O’Connell, Helen E., Craig, Amanda, Duggan, Anne, Vasiliadis, Dora, Karantanis, Emmanuel, Gallagher, Elizabeth, Holme, Gwili, Keck, James, Williams, Jarrod, King, Jennifer, Yin, Jessica, Short, John, Sketcher-Baker, Kirstine, Brennan, Pip, Rayner, Sally, Ahern, Susannah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10415488/
https://www.ncbi.nlm.nih.gov/pubmed/36695860
http://dx.doi.org/10.1007/s00192-022-05435-8
_version_ 1785087551394021376
author Jayasinghe, Randi T.
Ruseckaite, Rasa
Dean, Joanne
Kartik, Aruna
Wickremasinghe, Anagi C.
Daly, Oliver
O’Connell, Helen E.
Craig, Amanda
Duggan, Anne
Vasiliadis, Dora
Karantanis, Emmanuel
Gallagher, Elizabeth
Holme, Gwili
Keck, James
Williams, Jarrod
King, Jennifer
Yin, Jessica
Short, John
Sketcher-Baker, Kirstine
Brennan, Pip
Rayner, Sally
Ahern, Susannah
author_facet Jayasinghe, Randi T.
Ruseckaite, Rasa
Dean, Joanne
Kartik, Aruna
Wickremasinghe, Anagi C.
Daly, Oliver
O’Connell, Helen E.
Craig, Amanda
Duggan, Anne
Vasiliadis, Dora
Karantanis, Emmanuel
Gallagher, Elizabeth
Holme, Gwili
Keck, James
Williams, Jarrod
King, Jennifer
Yin, Jessica
Short, John
Sketcher-Baker, Kirstine
Brennan, Pip
Rayner, Sally
Ahern, Susannah
author_sort Jayasinghe, Randi T.
collection PubMed
description 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.
format Online
Article
Text
id pubmed-10415488
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-104154882023-08-12 Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry Jayasinghe, Randi T. Ruseckaite, Rasa Dean, Joanne Kartik, Aruna Wickremasinghe, Anagi C. Daly, Oliver O’Connell, Helen E. Craig, Amanda Duggan, Anne Vasiliadis, Dora Karantanis, Emmanuel Gallagher, Elizabeth Holme, Gwili Keck, James Williams, Jarrod King, Jennifer Yin, Jessica Short, John Sketcher-Baker, Kirstine Brennan, Pip Rayner, Sally Ahern, Susannah Int Urogynecol J Original Article 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. Springer International Publishing 2023-01-25 2023 /pmc/articles/PMC10415488/ /pubmed/36695860 http://dx.doi.org/10.1007/s00192-022-05435-8 Text en © The Author(s) 2023, corrected publication 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Jayasinghe, Randi T.
Ruseckaite, Rasa
Dean, Joanne
Kartik, Aruna
Wickremasinghe, Anagi C.
Daly, Oliver
O’Connell, Helen E.
Craig, Amanda
Duggan, Anne
Vasiliadis, Dora
Karantanis, Emmanuel
Gallagher, Elizabeth
Holme, Gwili
Keck, James
Williams, Jarrod
King, Jennifer
Yin, Jessica
Short, John
Sketcher-Baker, Kirstine
Brennan, Pip
Rayner, Sally
Ahern, Susannah
Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title_full Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title_fullStr Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title_full_unstemmed Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title_short Establishment and initial implementation of the Australasian Pelvic Floor Procedure Registry
title_sort establishment and initial implementation of the australasian pelvic floor procedure registry
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10415488/
https://www.ncbi.nlm.nih.gov/pubmed/36695860
http://dx.doi.org/10.1007/s00192-022-05435-8
work_keys_str_mv AT jayasingherandit establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT ruseckaiterasa establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT deanjoanne establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT kartikaruna establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT wickremasingheanagic establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT dalyoliver establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT oconnellhelene establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT craigamanda establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT duggananne establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT vasiliadisdora establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT karantanisemmanuel establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT gallagherelizabeth establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT holmegwili establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT keckjames establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT williamsjarrod establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT kingjennifer establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT yinjessica establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT shortjohn establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT sketcherbakerkirstine establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT brennanpip establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT raynersally establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry
AT ahernsusannah establishmentandinitialimplementationoftheaustralasianpelvicfloorprocedureregistry