Incorporating patient-reported outcome measures (PROMs) into a clinical quality registry (CQR) for ovarian cancer: considerations and challenges.

As medical treatment increasingly focuses on improving health-related quality of life, patient-reported outcome measures (PROMs) are an essential component of clinical research. The National Gynae-Oncology Registry (NGOR) is an Australian clinical quality registry. A suitable PROM was required for the NGOR ovarian cancer module to complement clinical outcomes and provide insights into outcomes important to patients. Our narrative review aimed to identify existing ovarian cancer-specific PROMs and ascertain which tool would be most appropriate for implementation into the NGOR ovarian cancer module.A literature review of Cochrane Library, Embase, MEDLINE and PubMed databases was performed to identify existing ovarian cancer-specific PROM tools. A steering committee was convened to (1) determine the purpose of, and criteria for our required PROM; and (2) to review the available tools against the criteria and recommend the most appropriate one for implementation within the NGOR.The literature review yielded five tools: MOST, EORTC QLQ-OV28, FACIT-O, NFOSI-18 and QOL-OVCA. All were developed and validated for use in clinical trials, but none had been validated for use in clinical quality registry. Our expert steering committee pre-determined purpose of a PROM tool for use within the NGOR was to enable cross-service comparison and benchmarking to drive quality improvements. They identified that while there was no ideal, pre-existing, ovarian cancer-specific PROM tool for implementation into the NGOR, on the basis of its psychometric properties, its available translations, its length and its ability to be adapted, the EORTC tool is most fit-for-purpose for integration into the NGOR.This process enabled identification of the tool most appropriate to provide insights into how ovarian cancer treatments impact patients' quality of life and permit benchmarking across health services.

Correction: Identifying areas of Australia with high out-of-hospital cardiac arrest incidence and low bystander cardiopulmonary resuscitation rates: A retrospective, observational study.

[This corrects the article DOI: 10.1371/journal.pone.0301176.].

Identifying areas of Australia with high out-of-hospital cardiac arrest incidence and low bystander cardiopulmonary resuscitation rates: A retrospective, observational study.

AIM: This study aims to explore regional variation and identify regions within Australia with high incidence of out-of-hospital cardiac arrest (OHCA) and low rates of bystander cardiopulmonary resuscitation (CPR). METHOD: Adult OHCAs of presumed medical aetiology occurring across Australia between 2017 and 2019 were mapped onto local government areas (LGA) using the location of arrest coordinates. Bayesian spatial models were applied to provide "smoothed" estimates of OHCA incidence and bystander CPR rates (for bystander-witnessed OHCAs) for each LGA. For each state and territory, high-risk LGAs were defined as those with an incidence rate greater than the state or territory's 75th percentile and a bystander CPR rate less than the state or territory's 25th percentile. RESULTS: A total of 62,579 OHCA cases attended by emergency medical services across 543 LGAs nationwide were included in the study. Nationally, the OHCA incidence rate across LGA ranged from 58.5 to 198.3 persons per 100,000, while bystander CPR rates ranged from 45% to 75%. We identified 60 high-risk LGAs, which were predominantly located in the state of New South Wales. Within each region, high-risk LGAs were typically located in regional and remote areas of the country, except for four metropolitan areas-two in Adelaide and two in Perth. CONCLUSIONS: We have identified high-risk LGAs, characterised by high incidence and low bystander CPR rates, which are predominantly in regional and remote areas of Australia. Strategies for reducing OHCA and improving bystander response may be best targeted at these regions.

Sex disparities in bystander defibrillation for out-of-hospital cardiac arrest.

Background: Previous studies have suggested that females experiencing out-of-hospital cardiac arrest (OHCA) receive lower rates of both bystander cardiopulmonary resuscitation (CPR) and defibrillation compared to males. Whether this disparity has improved over time is unknown. Methods: A state-wide OHCA registry in Victoria, Australia collected data over twenty years (2002-2021) regarding rates of bystander interventions in OHCA. Characteristics and outcomes of each OHCA were compared with logistic regression according to sex and time (defined in two-year periods). Results: 32,502 OHCAs were included (69.7% male). Both bystander CPR and defibrillation rates increased for females over time (p < 0.0001). There was no sex disparity in receipt of bystander CPR after adjustment for baseline differences. Females were less likely than males to receive bystander defibrillation, with sex disparity increasing from 2010 onwards (adjOR 0.26 (95%CI 0.09-0.80) in 2020-21 for females compared to males). Conclusion: Initiatives to increase bystander CPR and defibrillation have resulted in higher overall rates of bystander interventions in the last two decades and no significant sex differences in provision of bystander CPR. However, females receive less bystander defibrillation than males, and sex disparity is increasing. Strategies to promote bystander defibrillation in females experiencing OHCA with a shockable rhythm should be a priority.

A two-point strategy to clarify prognosis in >80 year olds experiencing out of hospital cardiac arrest.

BACKGROUND: The global population is aging, with the number of ≥80-year-olds projected to triple over the next 30 years. Rates of out-of-hospital cardiac arrest (OHCA) are also increasing within this age group. METHODS: The Victorian Ambulance Cardiac Arrest Registry was utilised to identify OHCAs in patients aged ≥80 years between 2002-2021. Predictors of survival to discharge were defined and a prognostic score derived from this cohort. RESULTS: 77,628 patients experienced OHCA of whom 25,269 (32.6%) were ≥80 years (80-90 years = 18,956; 90-100 years = 6,148; >100 years = 209). The number of patients ≥80 years increased over time both absolutely (p = 0.002) and proportionally (p = 0.028). 619 (2.4%) patients survived to discharge without change over time. Older ages had no difference in witnessed OHCA status but were less likely to have shockable rhythm (OR 0.50 (95% CI 0.44-0.57) for 90-100-year-olds, OR 0.28 (95% CI 0.12-0.63) for 90-100-year-olds). If OHCA was witnessed and there was a shockable rhythm then survival was 14%; if one factor was present survival was 5-6% and if neither factor was present, survival was 0.09%. These survival rates enabled derivation of a simplified prognostic assessment score - the '15/5/0' score - highly comparable to a previously-published American cohort. CONCLUSIONS: Elderly OHCA rates have increased to one-third of caseload. The most important factors predicting survival were whether the OHCA was witnessed and there was a shockable rhythm. We present a simple two-point '15/5/0' prognostic score defining which patients will gain most from advanced resuscitative measures.

A study protocol for a cluster-randomised controlled trial of smartphone-activated first responders with ultraportable defibrillators in out-of-hospital cardiac arrest: The First Responder Shock Trial (FIRST).

Objective: To describe the First Responder Shock Trial (FIRST), which aims to determine whether equipping frequently responding, smartphone-activated (GoodSAM) first responders with an ultraportable AED can increase 30-day survival rates in OHCA. Methods: The FIRST trial is an investigator-initiated, bi-national (Victoria, Australia and New Zealand), registry-nested cluster-randomised controlled trial where the unit of randomisation is the smartphone-activated (GoodSAM) first responder. High-frequency GoodSAM responders are randomised 1:1 to receive an ultraportable, single-use AED or standard alert procedures using the GoodSAM app.The primary outcome is survival to 30 days. The secondary outcome measures (shockable rhythm, return of spontaneous circulation, event survival, and time to first shock delivery) are routinely collected by OHCA registries in both regions. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) (Registration: ACTRN12622000448741) on 22 March 2022. Results: The trial started in November 2022 and the last patient is expected to be enrolled in November 2024. We aim to detect a 7% increase in the proportion of 30-day survivors, from 9% in patients attended by control responders to 16% in patients attended by responders randomised to the ultraportable AED intervention arm. With 80% power, an alpha of 0.05, a cluster size of 1.5 and a coefficient of variation for cluster sizes of 1, the sample size required to detect this difference is 714 (357 per arm). Conclusion: The FIRST study will increase our understanding of the potential role of portable AED use by smartphone-activated community responders and their impact on survival outcomes.

Opportunities and barriers for the use of Australian cancer registries as platforms for randomized clinical trials.

It is well recognized that randomized controlled trials (RCTs) are a powerful tool to investigate causal relationships, and are considered the gold standard level of research evidence. However, RCTs can be expensive and time-consuming, and when they employ strict eligibility criteria, it results in an unrepresentative population and limited external validity. Recently, the registry-based randomized clinical trial (RRCT) has emerged as an alternative trial design. Utilizing registries to underpin such studies, RRCTs can have advantages including rapid recruitment, and enhanced generalizability. In Australia, legislated mandatory reporting of cancer diagnoses means that jurisdictional cancer registries are a rich source of systematically collected patient details, representing sound platforms for comprehensive data capture that can serve as a key tool for further research. We review the roles of cancer registries in Australia, discuss important considerations relevant to the design of RRCTs, and outline the opportunities provided by cancer registries to strengthen cancer research.

Factors involved in treatment decision making for women diagnosed with ductal carcinoma in situ: A qualitative study.

Whilst some of the diversity in management of women with ductal carcinoma in situ (DCIS) may be explained by tumour characteristics, the role of patient preference and the factors underlying those preferences have been less frequently examined. We have used a descriptive qualitative study to explore treatment decisions for a group of Australian women diagnosed with DCIS through mammographic screening. Semi-structured telephone interviews were performed with 16 women diagnosed with DCIS between January 2012 and December 2018, recruited through the LifePool dataset (a subset of BreastScreen participants who have agreed to participate in research). Content analysis using deductive coding identified three themes: participants did not have a clear understanding of their diagnosis or prognosis; reported involvement in decision making about management varied; specific factors including the psychosexual impact of mastectomy and perceptions of radiotherapy, could act as barriers or facilitators to specific decisions about treatment. The treatment the women received was not simply determined by the characteristics of their disease. Interaction with the managing clinician was pivotal, however many other factors played a part in individual decisions. Recognising that decisions are not purely a function of disease characteristics is important for both women with DCIS and the clinicians who care for them.

Developing an Australian multi-module clinical quality registry for gynaecological cancers: a protocol paper.

INTRODUCTION: Gynaecological cancers collectively account for almost 10% of cancer diagnoses made in Australian women. The extent of variation in gynaecological cancer survival rates and treatment outcomes across Australia is not well documented. The purpose of the clinical quality registry described in this paper is to systematically monitor and improve quality of care provided to these women, and facilitate clinical process improvements to ensure better patient outcomes and greater adherence to best practice care. The registry infrastructure has been developed in conjunction alongside the inaugural ovarian, tubal and peritoneal (OTP) module, allowing for concurrent piloting of the methodology and one module. Additional tumour modules will be developed in time to cover the other gynaecological tumour types. METHOD AND ANALYSIS: The National Gynae-Oncology Registry (NGOR) aims to capture clinical data on all newly diagnosed cancers of the uterus, ovary, fallopian tubes, peritoneum, cervix, vulva and vagina in Australia with a view to using these data to support improved clinical care and increased adherence to 'best practice'. Data are sourced from existing clinical databases maintained by clinicians and/or hospital gynaecological cancer units. A pilot phase incorporating only OTP cancers has recently been conducted to assess the feasibility of the registry methodology and assess the support of a quality initiative of this nature among clinicians and other key stakeholders. ETHICS AND DISSEMINATION: The NGOR has received National Mutual Acceptance (NMA) ethics approval from Monash Health Human Research Ethics Committee (HREC), NMA HREC Reference Number: HREC/17/MonH/198. We also have approval from Mercy Health HREC and University of Tasmania HREC. Data will be routinely reported back to participating sites illustrating their performance against measures of agreed best practice. It is through this feedback system that the registry will support changes to quality of care and improved patient outcomes.

Electronic health records and online medical records: an asset or a liability under current conditions?

Objective The aim of the present study was to audit the current use of medical records to determine completeness and concordance with other sources of medical information. Methods Medical records for 40 patients from each of five Melbourne major metropolitan hospitals were randomly selected (n=200). A quantitative audit was performed for detailed patient information and medical record keeping, as well as data collection, storage and utilisation. Using each hospital's current online clinical database, scanned files and paperwork available for each patient audited, the reviewers sourced as much relevant information as possible within a 30-min time allocation from both the record and the discharge summary. Results Of all medical records audited, 82% contained medical and surgical history, allergy information and patient demographics. All audited discharge summaries lacked at least one of the following: demographics, medication allergies, medical and surgical history, medications and adverse drug event information. Only 49% of records audited showed evidence the discharge summary was sent outside the institution. Conclusions The quality of medical data captured and information management is variable across hospitals. It is recommended that medical history documentation guidelines and standardised discharge summaries be implemented in Australian healthcare services. What is known about this topic? Australia has a complex health system, the government has approved funding to develop a universal online electronic medical record system and is currently trialling this in an opt-out style in the Napean Blue Mountains (NSW) and in Northern Queensland. The system was originally named the personally controlled electronic health record but has since been changed to MyHealth Record (2016). In Victoria, there exists a wide range of electronic health records used to varying degrees, with some hospitals still relying on paper-based records and many using scanned medical records. This causes inefficiencies in the recall of patient information and can potentially lead to incidences of adverse drug events. What does this paper add? This paper supports the concept of a shared medical record system using 200 audited patient records across five Victorian metropolitan hospitals, comparing the current information systems in place for healthcare practitioners to retrieve data. This research identifies the degree of concordance between these sources of information and in doing so, areas for improvement. What are the implications for practitioners? Implications of this research are the improvements in the quality, storage and accessibility of medical data in Australian healthcare systems. This is a relevant issue in the current Australian environment where no guidelines exist across the board in medical history documentation or in the distribution of discharge summaries to other healthcare providers (general practitioners, etc).

Diagnosing delirium in very elderly intensive care patients.

OBJECTIVE: To determine the incidence of delirium in elderly intensive care patients and to compare incidence using two retrospective chart-based diagnostic methods and a hospital reporting measure (ICD-10). DESIGN: Retrospective study. SETTING: An ICU in a large metropolitan private hospital in Melbourne, Australia. PATIENTS: English-speaking participants (n=348) 80+ years, admitted to ICU for >24 hours. MEASUREMENTS AND MAIN RESULTS: Medical files of ICU patients admitted October 2009-October 2012 were retrospectively assessed for delirium using the Inouye chart review method, DSM-IV diagnostic criteria and ICD-10 coding data. General patient characteristics, first onset of delirium symptoms, source of delirium information, administration of delirium medication, hospital and ICU length of stay, 90 day mortality were documented. Delirium was found in 11-29% of patients, the highest incidence identified by chart review. Patients diagnosed with delirium had higher 90 day mortality, and those meeting criteria for all three methods had longer hospital and ICU length of stay. CONCLUSIONS: ICU delirium in the elderly is often under-reported and strategies are needed to improve staff education and diagnosis.