Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT).

INTRODUCTION: The most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is a multidisciplinary research team who have conducted research on the risk factors associated with CP respiratory disease, a systematic review on management and a Delphi study on the development of a consensus for the prevention and management of respiratory disease in CP. These strategies have not been investigated; therefore, it is not known if implementation is feasible, if they improve patient outcomes or if they are acceptable for families. METHODS AND ANALYSIS: Mixed-method feasibility pilot randomised controlled trial with economic analysis. Twenty children with CP aged 0-12 years who are at risk of respiratory disease will be followed up for 1 year. All children will receive baseline assessments for comparison. The control group will receive usual care from their treating teams. The intervention group will receive comprehensive assessments from physiotherapy, speech pathology and respiratory medicine. An individualised investigation and treatment plan will then be made. Participants in both groups will complete fortnightly patient-reported outcome surveys to assess symptoms and health service use. Analysis will include assessments of acceptability through qualitative interviews, implementation by ability to recruit, randomise and retain, practicality including costs of intervention and hospitalisation, and explore efficacy through quality-of-life surveys and decreased health service use for respiratory-related symptoms. ETHICS AND DISSEMINATION: Ethics and governance approvals have been obtained through Child and Adolescent Health Service Human Research Ethics Committee. At completion, this study will lead to the design of the definitive protocol to test intervention efficacy that maximises recruitment, retention and adherence to interventions. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620000114943).

The cost of respiratory hospitalizations in children with cerebral palsy.

AIM: To establish the burden of respiratory illness in cerebral palsy (CP) on the Western Australian health care system by quantifying the costs of respiratory hospitalizations in children with CP, compared with non-respiratory hospitalizations. METHOD: A 2-year (2014-2015) retrospective study using linked hospital data (excluding emergency department visits), in a population of children with CP in Western Australia aged 18 years and under (median age at hospitalization 7 years; interquartile range 5-12 years). RESULTS: In 671 individuals (57% male) there were 726 emergency hospitalizations, and 1631 elective hospitalizations. Although there were more elective hospitalizations, emergency hospitalizations were associated with longer stays in hospital, and more days in an intensive care unit, resulting in a higher total cost of emergency hospitalizations than elective hospitalizations (total costs: emergency AU$7 748 718 vs elective AU$6 738 187). 'Respiratory' was the leading cause of emergency hospitalizations, contributing to 36% of all emergency admission costs. For a group of high-cost inpatient users (top 5% of individuals with the highest total inpatient costs) the most common reason for hospitalization was 'respiratory'. Where non-respiratory admissions were complicated by an additional respiratory diagnosis, length of stay was greater. INTERPRETATION: Respiratory hospitalizations in CP are a significant driver of health care costs. In the paediatric group, they are a burden for a subgroup of children with CP. WHAT THIS PAPER ADDS: Respiratory illness is the most costly area for unplanned, emergency hospitalizations for children and young people with cerebral palsy. The top 5% of individuals with the highest total inpatient costs account for a disproportionate amount of health care costs.

Influenza vaccination in Western Australian children: Exploring the health benefits and cost savings of increased vaccine coverage in children.

Introduction: To assess potential benefits and direct healthcare cost savings with expansion of an existing childhood influenza immunisation program, we developed a dynamic transmission model for the state of Western Australia, evaluating increasing coverage in children < 5 years and routinely immunising school-aged children. Methods: A deterministic compartmental Susceptible-Exposed-Infectious-Recovered age-stratified transmission model was developed and calibrated using laboratory-notification and hospitalisation data. Base case vaccine coverage estimates were derived from 2019 data and tested under moderate, low and high vaccine effectiveness settings. The impact of increased coverage on the burden of influenza, influenza-associated presentations and net costs were assessed using the transmission model and estimated health utilisation costs. Results: Under base case vaccine coverage and moderate vaccine effectiveness settings, 225,460 influenza cases are expected annually across all ages. Direct healthcare costs of influenza were estimated to be A$27,608,286 per annum, dominated by hospital costs. Net cost savings of >$A1.5 million dollars were observed for every 10 % increase in vaccine coverage in children < 5 years. Additional benefits were observed by including primary school age children (5-11 years) in the funded influenza vaccination program - a reduction in cases, presentations, hospitalisations and approximately $A4 million net costs savings were observed for every 10 % increase in coverage. The further addition of older children (12-17 years) resulted in only moderate additional net cost savings figures, compared with a 5-11year-old program alone. Net costs savings were predominantly derived by a reduction in influenza-associated hospitalisation in adults. Conclusions: Any increase in influenza vaccine coverage in children < 5 years, above a base case of 50 % coverage resulted in a substantive reduction in influenza cases, presentations, hospitalisations and net costs when applied to the West Australian population. However, the most impactful pediatric program, from both a disease prevention and costs perspective, would be one that increased vaccination coverage among primary-school aged children.

Fracture liaison service utilising an emergency department information system to identify patients effectively reduce re-fracture rate is cost-effective and cost saving in Western Australia.

OBJECTIVES: To assess the benefits of the Emergency Department Information System (EDIS)-linked fracture liaison service (FLS). METHODS: Patients identified through EDIS were invited to attend an FLS at the intervention hospital, the Sir Charles Gairdner Hospital (SCGS-FLS). The intervention group was compared to usual care. Retrospective control (RC) at this hospital determined historical fracture risk (SCGH-RC). Prospective control (PC) was from a comparator, Fremantle Hospital (FH-PC). The main outcome measures were cost-effectiveness from a health system perspective and quality of life by EuroQOL (EQ-5D). Bottom-up cost of medical care, against the cost of managing recurrent fracture (weighted basket), was determined from the literature and 2013/14 Australian Refined Diagnosis Related Groups (AR-DRG) prices. Mean incremental cost-effectiveness ratios were simulated from 5000 bootstrap iterations. Cost-effectiveness acceptability curves were generated. RESULTS: The SCGH-FLS program reduced absolute re-fracture rates versus control cohorts (9.2-10.2%), producing an estimated cost saving of AUD$750,168-AUD$810,400 per 1000 patient-years in the first year. Between-groups QALYs differed with worse outcomes in both control groups (p < 0.001). The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $8721 (95% CI -$1218, $35,044) and $8974 (95% CI -$26,701, $69,929), respectively, per 1% reduction in 12-month recurrent fracture risk. The SCGH-FLS compared with SCGH-RC and FH-PC had a mean incremental cost of $292 (95% CI -$3588, $3380) and -$261 (95% CI -$1521, $471) per EQ-5D QALY gained at 12 months respectively. With societal willingness to pay of $16,000, recurrent fracture is reduced by 1% in >80% of patients. CONCLUSIONS: This simple and easy model of identification and intervention demonstrated efficacy in reducing rates of recurrent fracture and was cost-effective and potentially cost saving.

Realist evaluation of the impact of the research translation process on health system sustainability: a study protocol.

INTRODUCTION: Sustainability at a system level relates to the capacity of the system to be able to service the ongoing health needs of the population. It is a multifaceted concept encompassing both the affordability and efficiency of a system and the system's ability to adapt and change.To address issues that currently threaten health system sustainability, healthcare leaders, policy makers, clinicians and researchers are searching for solutions to ensure the delivery of safe, value-based care into the future. The timely translation of research evidence into sustainable interventions that can be adopted into the health system is one way of bolstering the sustainability of the system as a whole. We present a protocol for the realist evaluation of a research translation funding programme to understand how the research translation process contributes to health system sustainability and value-based healthcare. METHODS AND ANALYSIS: Underpinned by the realist evaluation framework, we will: (1) Develop the Initial Program Theory (IPT) of the research translation process; (2) Test the program theory through case study analysis; and (3) Refine and consolidate the theory through stakeholder consultation. The evaluation uses a case example of a research translation programme, chosen for its representation of a microcosm of the broader health system and the heterogeneity of service improvement activities taking place within it. Across the three phases, analysis of data from documents about the research translation program and interviews and focus groups with stakeholders and program users will draw on the context (C), mechanism (M), outcome (O) formula that is core to realist evaluation. In addition, system dynamic methods will capture the feedback loops and complex relationships among the IPT and context-mechanism-outcome configurations. This approach to evaluation of a research translation funding programme may be adapted to similar programmes operating in other settings. ETHICS AND DISSEMINATION: Curtin University Human Research Ethics Committee, Western Australia, approved this study (approval number: HRE2020-0464). Results will be published in scientific journals, and communicated to respondents and relevant partners.

An impact review of a Western Australian research translation program.

The translation gap between knowledge production and implementation into clinical practice and policy is an ongoing challenge facing researchers, funders, clinicians and policy makers globally. Research generated close to practice and in collaboration with end users is an approach that is recognised as an effective strategy to facilitate an improvement in the relevance and use of health research as well as building research capacity amongst end users. The Research Translation Projects (RTP) program funded by the Western Australian (WA) Department of Health facilitates clinical and academic collaboration through competitive funding of short-term research projects. Its aim is to improve healthcare practice while also finding efficiencies that can be delivered to the WA health system. A mixed methods approach was adopted to evaluate the research impact of the RTP program, at completion of the two-year funding period, across a range of impact domains through the adaptation and application of the Canadian Academy of Health Sciences' (CAHS) framework for research impact. In addition, further analysis was undertaken to address specific objectives of the RTP program more closely, in particular research capacity building and collaboration and health system Inefficiencies targeted by the program. Social network analysis was applied to assess the extent and growth of collaboration across WA health organisations over time. Results indicated that the 'bottom up' approach to research translation has triggered modest, yet positive outcomes across impact domains including advancing knowledge, collaboration and capacity building as well as contributing to changes in policy and practice. Additionally, the projects identified opportunities by which inefficiencies in the health system can be addressed. Further work is required to better understand the pathways by which short-term outcomes can be translated into more long-term impacts and the mechanisms that trigger this process.

Cost-effectiveness of early placement of vena cava filters to prevent symptomatic pulmonary embolism in patients with contraindications to prophylactic anticoagulant.

INTRODUCTION: Vena cava filters have been used as a primary means to prevent symptomatic pulmonary embolism (PE) in trauma patients who cannot be anticoagulated after severe injury, but the economic implications for this practice remain unclear. METHODS: Using a healthcare system perspective to analyze the a priori primary outcome of the da Vinci trial, we report the cost-effectiveness of using vena cava filters as a primary means to prevent PE in patients who have contraindications to prophylactic anticoagulation after major trauma. RESULTS: Of the 240 patients enrolled, complete, prospectively collected, hospital cost data during the entire hospital stay - including costs for the filter, medical/nursing/allied health staff, medical supplies, pathology tests, and radiological imaging - were available in 223 patients (93%). Patients allocated to the filter group (n = 114) were associated with a reduced risk of PE (0.9%) compared to those in the control group (n = 109, 5.5%; p = 0.048); and the filter's benefit was more pronounced among those who could not be anticoagulated within 7 days (filter: 0% vs control: 16%, Bonferroni-corrected p = 0.02). Overall, the cost needed to prevent one PE was high (AUD $379,760), but among those who could not be anticoagulated within 7 days, the costs to prevent one PE (AUD $36,156; ~ USD $26,032) and gain one quality-adjusted life-year (AUD $30,903; ~ USD $22,250) were substantially lower. CONCLUSION: The cost of using a vena cava filter to prevent PE for those who have contraindications to prophylactic anticoagulation within 3 days of injury is prohibitive, unless such contraindications remain for longer than 7 days. (Australian New Zealand Clinical Trials Registry no.: ACTRN12614000963628).

Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants.

INTRODUCTION: The current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life. METHOD AND ANALYSIS: Early Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies' GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739). TRIAL REGISTRATION NUMBER: ACTRN12619001422112.

The economic and health burdens of diseases caused by group A Streptococcus in New Zealand.

OBJECTIVES: In preparation for the future arrival of a group A Streptococcus (GAS) vaccine, this study estimated the economic and health burdens of GAS diseases in New Zealand (NZ). METHODS: The annual incidence of GAS diseases was based on extrapolation of the average number of primary healthcare episodes managed each year in general practices (2014-2016) and on the average number of hospitalizations occurring each year (2005-2014). Disease incidence was multiplied by the average cost of diagnosing and managing an episode of disease at each level of care to estimate the annual economic burden. RESULTS: GAS affected 1.5% of the population each year, resulting in an economic burden of 29.2 million NZ dollars (2015 prices) and inflicting a health burden of 2373 disability-adjusted life years (DALYs). Children <5 years of age were the most likely age group to present for GAS-related healthcare. Presentations for superficial throat and skin infections (predominantly pharyngitis and impetigo) were more common than other GAS diseases. Cellulitis contributed the most to the total economic and health burdens. Invasive and immune-mediated diseases disproportionately contributed to the total economic and health burdens relative to their frequency of occurrence. CONCLUSION: Preventing GAS diseases would have substantial economic and health benefits in NZ and globally.

Long-term economic outcomes for interventions in early childhood: protocol for a systematic review.

INTRODUCTION: Investment in early childhood produces positive returns: for the child, the family and the community. Benefits have been shown to be significant within certain parameters, but a systematic review of the economic evidence across multiple sectors including health, education and social welfare will have the capacity to inform policy relative to the full range of social determinants. This review will take a broad approach, encompassing a range of costs and benefits to enable the identification of the most beneficial investments in early childhood and to highlight gaps in current research. METHODS AND ANALYSIS: Economic evaluations incorporating both costs and long-term outcomes of early childhood interventions and programmes will be included. Outcomes may be valued in monetary units or quantified non-monetary units (eg, quality-adjusted life years (QALY), disability-adjusted life years (DALY)). Results will be expressed as a ratio according to the outcome; with monetary outcomes expressed as cost-benefit ratios or return on investment, and non-monetary outcomes expressed as cost per QALY or DALY. The target population is children aged 0-5 years.Extensive database searches across sectors will be undertaken. The review will involve five phases: defining the research question, identifying relevant studies, selecting studies, extracting and collating data, and summarising and reporting results. The search commenced in 2019 and the expected end date is December 2020. ETHICS AND DISSEMINATION: The findings of this review will inform policymakers and practitioners in public health, education, social welfare and primary care settings. The publication plan includes a series of academic publications, and policy papers prepared and disseminated through Telethon Kids Institute networks. Exemption from ethics approval was granted by the University of Western Australia Human Ethics Office (RA/4/20/5677). PROSPERO REGISTRATION NUMBER: CRD42020145901.

Step-up, step-down mental health care service: evidence from Western Australia's first - a mixed-method cohort study.

BACKGROUND: Mental health Step-up, Step-down services (SUSD), also known as subacute services or Prevention and Recovery Services, have emerged to fill an identified gap between hospital-based inpatient care and clinical community-based mental health support. Evidence for the effectiveness of the SUSD service model is limited but growing. Accordingly, this study looked to add to the extant body of knowledge, by (i) assessing change outcomes in mental health and wellbeing, and predictors of these changes, for patients who accessed Western Australia's first SUSD service; and (ii) evaluating patients' satisfaction with service, and what patients value from their stay. METHODS: This was a mixed-method retrospective cohort study. Participants comprised 382 patients who accessed a 22-bed Mental Health SUSD facility and incurred 551 episodes of care during the 01/07/2014-30/06/2016 period. Patients' change outcomes in psychological distress, general self-efficacy, and work and social adjustment from service entry to service exit were analyzed using generalized linear modeling. Simple Pearson's correlation coefficients were calculated for preliminary assessment of the associations between patients' service satisfaction and their change outcomes. Qualitative outcomes that patients valued from their stay were analyzed thematically according to a semi-grounded theoretical approach. RESULTS: Significant improvements were observed in patients' self-reported psychological distress, self-efficacy, and work and social adjustment (all p < 0.0001). A strong and persistent baseline effect existed across the three measures. Older age, female gender, and having a dependent child in the same household were protective/enhancing factors for the patients' recovery. Satisfaction with service was high. Patients valued having the time and space to recuperate, gain insight, focus, and create changes in their lives. CONCLUSION: The encouraging findings, regarding both patients' change outcomes and satisfaction with service, support the value of the SUSD service model for patients with mental illnesses. Strengths and limitations were discussed; ensued recommendations were offered to both service providers and researchers to enhance the robustness of future research findings, to help inform more effective policy and funding decisions related to mental health care.

Maintaining quality of life in patients with chronic obstructive pulmonary disease (COPD) by extending the maintenance phase of community-based pulmonary rehabilitation: protocol for a randomised controlled trial (ComEx3 Study).

INTRODUCTION: Pulmonary rehabilitation is a core component of the treatment of people with chronic obstructive pulmonary disease (COPD); however, the benefits gained diminish in the ensuing months. The optimal strategy for maintaining the benefits is unclear with weekly supervised maintenance exercise programmes proposed as one strategy. However, the long-term future of maintenance programs is dependent on quality evidence. METHODS AND ANALYSIS: The ComEx3 randomised controlled trial will investigate the efficacy of extending a weekly supervised maintenance programme for an additional 6 months following an initial 10-week maintenance programme (intervention) by comparing with a control group who receive the same 10-week maintenance programme followed by 6 months of usual care. 120 participants with COPD will be recruited. Primary objective is to determine health-related quality of life over 12 months. Secondary objectives are to determine functional exercise capacity trajectory and to perform an economic evaluation of the intervention to the health system. Outcomes will be analysed for superiority according to intention-to-treat and per-protocol approaches. ETHICS AND DISSEMINATION: Approval has been received from the relevant ethics committees. Findings will be disseminated in peer-reviewed journals and conferences, targeting those involved in managing people with COPD as well as those who develop policies and guidelines. CLINICAL TRIAL REGISTRATION: ANZCTR 12618000933257.

The End Rheumatic Heart Disease in Australia Study of Epidemiology (ERASE) Project: data sources, case ascertainment and cohort profile.

PURPOSE: Acute rheumatic fever (ARF) and rheumatic heart disease (RHD) persist as public health issues in developing countries and among disadvantaged communities in high-income countries, with rates in Aboriginal and Torres Strait Islander peoples in Australia among the highest recorded globally. A robust evidence base is critical to support policy recommendations for eliminating RHD, but available data are fragmented and incomplete. The End RHD in Australia: Study of Epidemiology (ERASE) Project aims to provide a comprehensive database of ARF and RHD cases in Australia as a basis for improved monitoring and to assess prevention and treatment strategies. The objective of this paper is to describe the process for case ascertainment and profile of the study cohort. PATIENTS AND METHODS: The ERASE database has been built using linked administrative data from RHD registers, inpatient hospitalizations, and death registry data from 2001 to 2017 (mid-year). Additional linked datasets are available. The longitudinal nature of the data is harnessed to estimate onset and assess the progression of the disease. To accommodate systematic limitations in diagnostic coding for RHD, hospital-only identified RHD has been determined using a purposefully developed prediction model. RESULTS: Of 132,053 patients for whom data were received, 42,064 are considered true cases of ARF or RHD in the study period. The patient population under 60 years in the compiled dataset is more than double the number of patients identified in ARF/RHD registers (12,907 versus 5049). Non-registered patients were more likely to be older, non-Indigenous, and at a later disease stage. CONCLUSION: The ERASE Project has created an unprecedented linked administrative database on ARF and RHD in Australia. These data provide a critical baseline for efforts to end ARF/RHD in Australia. The methodological work conducted to compile this database resulted in significant improvements in the robustness of epidemiological estimates and entails valuable lessons for ARF/RHD research globally.

A Multicenter Trial of Vena Cava Filters in Severely Injured Patients.

BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).

Direct cost of alcohol-related presentations to Royal Perth Hospital emergency department.

OBJECTIVE: To quantify the direct cost of alcohol-related presentations to Royal Perth Hospital ED, as part of the binational Alcohol Harm in Emergency Departments study. METHODS: Secondary analysis of a prospective observational study of all ED presentations over a 168-h period in December 2014. Direct costs for health service usage were based on activity-based costing methodologies from the Royal Perth Hospital Business Intelligence Unit. Patients were classified as either alcohol positive or alcohol negative (using predetermined criteria) to determine the direct cost of these presentations. RESULTS: Of the 213 alcohol-positive presentations in the original study, 206 had costing data available. Direct cost of care in the ED for alcohol-positive patients was $121 619 across all age groups during the study week (annual estimate $6.3 million). This cost was largely driven by injuries. On average, the direct cost of care in the ED was $590 per alcohol-positive and $575 per alcohol-negative patient. Costs of care provided in the ED were largely attributable to ED (72%) and radiology (17%) services. Extrapolation using mean costs for the patients without costing data, the study week cost was $144 629, with the annual estimate $7.5 million. CONCLUSIONS: Alcohol-related presentations to the ED are a significant public health burden. If the study week is representative, the annual cost is substantial. Although the direct mean cost of presentations to the ED is similar between alcohol-positive and alcohol-negative patients, these presentations would not have occurred without the influence of alcohol.

Comparison between gallium-68 citrate positron emission tomography-computed tomography and gallium-67 citrate scintigraphy for infection imaging.

BACKGROUND: Preliminary studies have reported promising results for the utility of gallium-68 (Ga-68) citrate positron emission tomography-computed tomography (PET-CT) for infection imaging. This technique offers reduced radiation dose to patients, shorter time between injection and imaging and reduced time for image acquisition compared to the 'gold standard' nuclear imaging technique: gallium-67 (Ga-67) citrate scintigraphy. AIMS: To compare the two imaging modalities to ascertain whether Ga-68 citrate PET-CT is of equivalent diagnostic efficacy for bone and joint infection or pyrexia of unknown origin (PUO) and to assess image quality and reporter confidence. METHODS: Patients with PUO and suspected bone or joint infection underwent Ga-67 citrate scintigraphy and Ga-68 citrate PET-CT. Participants were followed up for 3 months to record subsequent treatment, investigations and outcome. RESULTS: 60 patients were recruited to this multicentre prospective study: 32 for bone and joint infection, 28 for PUO. The results show a sensitivity of 81% for Ga-67 citrate scintigraphy and 69% for Ga-68 citrate PET-CT, a specificity of 79% for Ga-67 citrate and 67% for Ga-68 citrate and were concordant for 76% of the participants. The reporting physician confidence was significantly lower for Ga-68 citrate (P < 0.05), frequently due to prominent physiologic blood pool activity adjacent to the site of infection. CONCLUSION: The sensitivity and specificity of Ga-68 citrate PET-CT were found to be consistently lower than Ga-67 citrate scintigraphy. Additionally, due to the insufficient level of confidence of the reporting physicians for the Ga-68 citrate PET-CT, this modality could not currently be recommended to replace Ga-67 citrate scintigraphy for routine clinical use.

Cost analysis of a brief intervention for the prevention of falls after discharge from an emergency department.

RATIONALE, AIMS AND OBJECTIVES: There is considerable uncertainty around the cost-effectiveness of interventions for preventing secondary falls in older people presenting to emergency departments (ED). The objective was to complete an economic evaluation of a brief educational ED intervention aimed at preventing falls in older people post discharge. METHODS: A net cost analysis was completed from the health system perspective, using data from a controlled clinical trial, where an education intervention was compared to standard care. Patients aged 65 and older presenting to the ED with any diagnosis were enrolled. The costs, using Australian dollars (A$) at 2015 values, included resources required for the intervention and any health care cost incurred in the 6-month follow-up period (time horizon). Cost data were sourced through institutional billing records and liaison with the patient and their general practitioner. Mean costs and differences were analysed through nonparametric bootstrapping. RESULTS: The total costs in the control group (n = 201) were A$1 576 496 compared to A$1 292 130 in the intervention group (n = 211). The mean net cost per patient was A$7749 and A$6187 (P = 0.68) respectively resulting in a mean difference of A$1580 per patient in the intervention group (95% CI: A$-2806 to A$6150). Patients who presented to the ED with a fall diagnosis were reviewed through subgroup analysis. Total costs for patients who presented with a fall in the control group (n = 69) were A$708 995 compared to A$512 874 in the intervention group (n = 97). The mean net cost per patient was A$10 326 and A$5343 respectively (P = 0.33) with an overall saving of A$4624 per patient in the intervention group (95% CI: A$-2868 to A$15 426). CONCLUSIONS: A brief intervention had no net cost benefit across the whole study population, but is more cost effective in older people presenting to the ED with a fall.

An economic case for a vaccine to prevent group A streptococcus skin infections.

BACKGROUND: Group A streptococcus (GAS) causes an exceptionally diverse range of diseases, raising questions about the optimal product characteristics of a commercially viable vaccine. The objectives of this study were to (1) estimate the current health and economic burdens caused by 24 diseases attributable to GAS each year in Australia and (2) use these estimates to explore the value of a GAS vaccine for different clinical indications, age schedules, and population groups. METHODS: For objective 1, we estimated the population heath and economic burdens by synthesising data from administrative databases, nationally representative surveys, literature reviews, public reimbursement schedules, and expert opinion. For objective 2, we modelled the prospective lifetime burden of GAS for all infants from birth, for children from 5 years of age, and for adults from 65 years of age. A vaccine was assumed to reduce each GAS disease by 70% for a period of 10 years, and the difference in outcomes between vaccinated and non-vaccinated cohorts were used to calculate the cost-effective value of vaccination. RESULTS: The annual health and economic burdens of GAS diseases totalled 23,528 disability-adjusted life years and AU$185.1 million in healthcare costs respectively; approximately half of each measure was due to cellulitis, followed by other skin infections and throat infections. Reducing the incidence of throat infections, skin infections, and cellulitis in non-Indigenous cohorts resulted in 30%, 33%, and 28% of the total vaccine value for an infant schedule (cost-effective vaccine price AU$260 per course); 47%, 26%, and 22% of the value for a child schedule (AU$289); and 2%, 15% and 74% for an adult schedule (AU$489). CONCLUSIONS: A vaccine that prevents GAS cellulitis and other skin infections, in addition to throat infections, would maximise its value and commercial viability, with a cost-effective price in line with other recently-licensed and funded vaccines in Australia.

Effect of 6 months hybrid closed-loop insulin delivery in young people with type 1 diabetes: a randomised controlled trial protocol.

INTRODUCTION: Automated insulin delivery (also known as closed loop, or artificial pancreas) has shown potential to improve glycaemic control and quality of life in people with type 1 diabetes (T1D). Automated insulin delivery devices incorporate an insulin pump with continuous glucose monitoring(CGM) and an algorithm, and adjust insulin in real time. This study aims to establish the safety and efficacy of a hybrid closed-loop (HCL) system in a long-term outpatient trial in people with T1D aged 12 -<25 years of age, and compare outcomes with standard therapy for T1D as used in the contemporary community. METHODS AND ANALYSIS: This is an open-label, multicentre, 6-month, randomised controlled home trial to test the MiniMed Medtronic 670G system (HCL) in people with T1D aged 12 -<25 years, and compare it to standard care (multiple daily injections or continuous subcutaneous insulin infusion (CSII), with or without CGM). Following a run-in period including diabetes and carbohydrate counting education, dosage optimisation and baseline glucose control data collection, participants are randomised to either HCL or to continue on their current treatment regimen. The primary aim of the study is to compare the proportion of time spent in target sensor glucose range (3.9-10.0 mmol/L) on HCL versus standard therapy. Secondary aims include a range of glucose control parameters, psychosocial measures, health economic measures, biomarker status, user/technology interactions and healthcare professional expectations. Analysis will be intention to treat. A study in adults with an aligned design is being conducted in parallel to this trial. ETHICS AND DISSEMINATION: Ethics committee permissions were gained from respective institutional review boards. The findings of the study will provide high-quality evidence on the role of HCL in clinical practice.

Patterns of Medicare-funded primary health and specialist consultations in Aboriginal and non-Aboriginal Australians in the two years before hospitalisation for ischaemic heart disease.

BACKGROUND: Ischaemic heart disease (IHD) remains the leading cause of morbidity and mortality for both Aboriginal and non-Aboriginal Australians. Patterns of primary and specialist care in patients leading up to the first hospitalisation for IHD potentially impact on prevention and subsequent outcomes. We investigated the differences in general practice (GP), specialist and emergency department (ED) consultations, and associated resource use in Aboriginal and non-Aboriginal people in the two years preceding hospitalisation for IHD. METHODS: Linked-data were used to identify first IHD admissions for Western Australians aged 25-74 years in 2002-2007. Person-linked GP, specialist and ED consultations were obtained from the Medicare Benefits Schedule (MBS) and ED records to assess health care access and costs for the preceding 2 years. RESULTS: Aboriginal people constituted 4.7% of 27,230 IHD patients, 3.5% of 1,348,238 MBS records, and 14% of 33,170 ED presentations. Aboriginal (vs. non-Aboriginal) people were younger (mean 50.2 vs 60.5 years), more commonly women (45.2% vs 28.4%), had more comorbidities [Charlson index≥1, 35.2% vs 26.3%], were more likely to have had GP visits (adjusted rate-ratio 1.07, 95% CI 1.02-1.12), long/prolonged (16.0% vs 11.9%) consults and non-vocationally registered GP consults (17.1% vs 3.2%), but less likely to received specialist consults (mean 1.0 vs 4.1). Mean number of urgent/semi-urgent ED presentations in the year preceding the IHD admission was higher in Aboriginal people (2.9 vs 1.9). Aboriginal people incurred 2.7% of total associated MBS expenditure (estimated at $59.7 million). Mean total cost per person was 43.3% lower in Aboriginal patients, with cost differentials being greatest in diabetic and chronic kidney disease patients. CONCLUSIONS: Despite being over-represented in urgent/semi-urgent ED presentations and admissions for IHD, Aboriginal people were under-resourced compared with the rest of the population, particularly in terms of specialist care prior to first IHD hospitalisation. The findings underscore the need for better primary and specialist shared care delivery models particularly for Aboriginal people.