Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, 3004, Australia.
Department of Obstetrics and Gynaecology, Western Health, Melbourne, Victoria, Australia.
Int Urogynecol J. 2023 Aug;34(8):1697-1704. doi: 10.1007/s00192-022-05435-8. Epub 2023 Jan 25.
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.
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.
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.
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.
压力性尿失禁（SUI）和盆腔器官脱垂（POP）是常见的盆底功能障碍（PFD）。由于一部分接受手术治疗的患者存在与网片相关的盆底手术（PFPs）相关的严重不良事件，以及这些事件的收集和报告存在缺陷，澳大利亚政府确定迫切需要建立一个跟踪机制，以提高护理安全性和质量。澳大利亚盆底手术登记处（APFPR）是在 2018 年参议院委员会调查之后成立的，旨在跟踪使用器械和/或假体的 PFPs 的结果，目的是改善接受这些手术的女性的健康结果。本文将描述 APFPR 的目的、开发、实施以及在建立过程中可能面临的挑战。
APFPR 是按照国家临床质量登记处（CQRs）的操作原则开发和实施的。该登记处数据库的最小数据集（MDS）是使用改良 Delphi 法开发的，数据主要由参与手术的外科医生收集。患者招募基于选择退出或放弃同意的方式。将从参与的女性患者中获得患者报告的结果测量（PROMs），以提供额外的健康和结果信息，支持对网片相关不良事件的安全性监测。
截至 2023 年 1 月，澳大利亚各地的 32 个地点已获得相关伦理和治理批准，开始招募患者并收集数据。此外，还有两个地点正在等待治理审查，五个地点正在编写文件提交。17 个地点已开始患者登记并将数据输入数据库。迄今为止，APFPR 数据库已登记了 308 名患者。该登记处还在 2022 年发布了第一份状况报告和一份通俗易懂的公众报告。
该登记处将作为一个系统的跟踪机制，收集 PFPs 的结果，特别是涉及器械和/或假体的结果，以提高安全性和护理质量。
