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.

Pressure injury prevalence in intensive care versus non-intensive care patients: A state-wide comparison.

BACKGROUND: Hospital-acquired pressure injury is associated with increased morbidity and mortality and considered to be largely preventable. Pressure injury prevalence is regarded as a marker of health care quality. OBJECTIVE: To compare the state-wide prevalence, severity and location of pressure injuries of intensive care unit patients compared to patients in non-intensive care wards. METHOD: The study employed a secondary data analysis design to extract and analyse de-identified pressure injury data from all Queensland Health hospitals with level I-III intensive care facilities that participated in Queensland Bedside Audits between 2012-2014. The sample included all adult ICU and non-ICU patients that provided consent for the Queensland Bedside Audits, excluding those in mental health units. RESULTS: Excluding Stage I, overall hospital-acquired pressure injury prevalence from 2012 to 2014 was 11% for intensive care patients and 3% for non-intensive care patients. Intensive care patients were 3.8 times more likely (RR 2.7-5.4, 95% CI) than non-intensive care patients to develop a pressure injury whilst in hospital. The sacrum/coccyx was the most common site of hospital-acquired pressure injury in all patients (intensive care patients 22%; non-intensive care patients 35%) however, mucosal pressure injury proportion was significantly higher in intensive care patients (22%) than in non-intensive care patients (2%). Stage II HAPI prevalence was the most common stage reported, 53% for intensive care patients compared to 63% for non-intensive care patients. CONCLUSION: There are significant differences in hospital-acquired pressure injury prevalence by stage and location between intensive care and non-intensive care patients reflecting the possible impact of critical illness on the development of skin injury. This has implications for resource funding for pressure injury prevention and the imposition of government initiated financial penalties for hospital-acquired pressure injury. For future comparisons to be effective between intensive care units, benchmarking partners should share similar characteristics and relevant targets.

Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study.

INTRODUCTION: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm ('adverse events'). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.This study aims to develop consistent, informed and robust best practice guidance, at state and national levels, that will improve the response, learning and health system improvements arising from adverse events. METHODS AND ANALYSIS: The setting will be healthcare organisations in Australian public health systems in the states of New South Wales, Queensland, Victoria and the Australian Capital Territory. We will apply a multistage mixed-methods research design with evaluation and in-situ feasibility testing. This will include literature reviews (stage 1), an assessment of the quality of 300 adverse event investigation reports from participating hospitals (stage 2), and a policy/procedure document review from participating hospitals (stage 3) as well as focus groups and interviews on perspectives and experiences of investigations with healthcare staff and consumers (stage 4). After triangulating results from stages 1-4, we will then codesign tools and guidance for the conduct of investigations with staff and consumers (stage 5) and conduct feasibility testing on the guidance (stage 6). Participants will include healthcare safety systems policymakers and staff (n=120-255) who commission, undertake or review investigations and consumers (n=20-32) who have been impacted by adverse events. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Northern Sydney Local Health District Human Research Ethics Committee (2023/ETH02007 and 2023/ETH02341).The research findings will be incorporated into best practice guidance, published in international and national journals and disseminated through conferences.

Safer Baby Bundle: study protocol for the economic evaluation of a quality improvement initiative to reduce stillbirths.

INTRODUCTION: Stillbirth continues to be a public health concern in high-income countries, and with mixed results from several stillbirth prevention interventions worldwide the need for an effective prevention method is ever present. The Safer Baby Bundle (SBB) proposes five evidence-based care packages shown to reduce stillbirth when implemented individually, and therefore are anticipated to produce significantly better outcomes if grouped together. This protocol describes the planned economic evaluation of the SBB quality improvement initiative in Australia. METHODS AND ANALYSIS: The implementation of the SBB will occur over three state-based health jurisdictions in Australia-New South Wales, Queensland and Victoria, from July 2019 onwards. The intervention is being applied at the state level, with sites opting to participate or not, and no individual woman recruitment. The economic evaluation will be based on a whole-of-population linked administrative dataset, which will include the data of all mothers, and their resultant children, who gave birth between 1 January 2016 and 31 December 2023 in these states, covering the preimplementation and postimplementation time period. The primary health outcome for this economic evaluation is late gestation stillbirths, with the secondary outcomes including but not limited to neonatal death, gestation at birth, mode of birth, admission to special care nursery and neonatal intensive care unit, and physical and mental health conditions for mother and child. Costs associated with all healthcare use from birth to 5 years post partum will be included for all women and children. A cost-effectiveness analysis will be undertaken using a difference-in-difference analysis approach to compare the primary outcome (late gestation stillbirth) and total costs for women before and after the implementation of the bundle. ETHICS AND DISSEMINATION: Ethics approval for the SBB project was provided by the Royal Brisbane & Women's Hospital Human Research Ethics Committee (approval number: HREC/2019/QRBW/47709). Approval for the extraction of data to be used for the economic evaluation was granted by the New South Wales Population and Health Services Research Ethics Committee (approval number: 2020/ETH00684/2020.11), Australian Institute of Health and Welfare Human Research Ethics Committee (approval number: EO2020/4/1167), and Public Health Approval (approval number: PHA 20.00684) was also granted. Dissemination will occur via publication in peer reviewed journals, presentation at clinical and policy-focused conferences and meetings, and through the authors' clinical and policy networks.This study will provide evidence around the cost effectiveness of a quality improvement initiative to prevent stillbirth, identifying the impact on health service use during pregnancy and long-term health service use of children.

Stillbirth in Australia 2: Working together to reduce stillbirth in Australia: The Safer Baby Bundle initiative.

The rate of late gestation stillbirth in Australia is unacceptably high. Up to one third of stillbirths are preventable, particularly beyond 28 weeks' gestation. The aim of this second paper in the Stillbirth in Australia series is to highlight one key national initiative, the Safer Baby Bundle (SBB), which has been led by the Centre of Research Excellence in Stillbirth in partnership with state health departments. Addressing commonly identified evidence practice gaps, the SBB contains five elements that, when implemented together, should result in better outcomes than if performed individually. This paper describes the development of the SBB, what the initiative aims to achieve, and progress to date. By collaborating with Departments of Health and other partners to amplify uptake of the SBB, we anticipate a reduction of at least 20% in Australia's stillbirth rate after 28 weeks' gestation is achievable.

Using the quality improvement cycle on clinical indicators--improve or remove?

The variable life-adjusted display is a graphical, statistical methodology used in Queensland to monitor patient outcomes of clinical indicators. The quality improvement cycle is a systematic approach employed by patient safety and quality programs worldwide to improve patient care. The quality improvement cycle is beneficial to the review and refinement of indicator definitions. Indicators with definitional issues that are not subject to the quality improvement cycle may initially prompt quality improvement opportunities, but are more likely to potentially lead to unnecessary chart and clinical reviews, which will disengage coders and clinicians. Queensland recently used the quality improvement cycle to refine the laparoscopic cholecystectomy complications of surgery indicator definition and several maternity definitions.

Using control charts to monitor quality of hospital care with administrative data.

OBJECTIVE: Nearly all hospital-specific comparative analyses, based on administrative data, are presented using cross-sectional displays. In this paper, we compare cross-sectional analyses with sequential monitoring using control charts. ANALYSIS: of administrative data to compare cross-sectional funnel plots with one type of control chart: the risk-adjusted, expected-minus-observed plot. SETTING: Eighteen tertiary and base hospitals in Queensland, Australia, for the two financial years 2003-04 and 2004-05. PARTICIPANTS: Patients admitted with acute myocardial infarction. MAIN OUTCOME MEASURE: Risk-adjusted, 30-day, in-hospital, mortality rates. RESULTS: There were no outliers on the cross-sectional funnel plots for either of the 2 years using three-sigma limits and three low-outliers and one high-outlier using two-sigma limits. One reasonable interpretation of these plots is that most of the variations are due to statistical noise and there is little to be learnt by seeking to understand the reasons for variation across hospitals. In contrast, for the control charts, 28% of hospitals signalled for a relative increase of 75% above that for all hospitals combined. CONCLUSION: If the aim of clinical indicators based on administrative data is to provide a starting point for learning, then control charting provides potentially more useful information than the more commonly used cross-sectional analyses. Control charts provide an understandable and up-to-date overview that allows early detection of runs of good or bad outcomes that can help hospitals identify areas for more in-depth self-monitoring and learning.

Identifying variations in quality of care in Queensland hospitals.

Identifying and acting on variations from good practice is one of the critical tasks of clinical governance. We describe one aspect of Queensland's post-Bundaberg clinical governance arrangements: the use of variable life-adjusted displays (VLADs) to monitor outcomes of care in the 87 largest public and private hospitals in Queensland, which together account for 83% of all hospital activity. VLAD control charts were created for 31 clinical indicators using routinely collected data, and are disseminated monthly. About a third of hospitals had a run of cases in the 3-year period that flagged at the 30% level (local level investigation). For three indicators, about one in five hospitals had sufficiently cumulatively more deaths than statistically expected that the hospital was highlighted for state-wide review. VLADs do not provide definitive answers about the quality of care. They are used to develop ideas about why variations in reported outcomes occur and suggest possible solutions, be they ways of improving data quality, improving casemix adjustment, or implementing system changes to improve quality of care. Critical to the approach is that there is not just monitoring - the monitoring is tied in with systems that ensure that investigation, learning and action occur as a result of a flag.