ForWhen Australian perinatal and infant mental health navigation programme: evaluation protocol.

INTRODUCTION: Many parents and carers experience mental health challenges during pregnancy and early postpartum years, and there are cumulative shortfalls in the identification, follow-up, and treatment of those experiencing perinatal and infant mental health (PIMH) challenges. ForWhen is a new national navigation programme in Australia that aims to improve outcomes for families by supporting parents and carers to access PIMH services that best meet their needs. This paper presents the protocol of an evaluation of the ForWhen programme, to be conducted over the first 3 years of its implementation. The specific objectives of the evaluation include examining the characteristics of navigation service delivery, its implementation and clinical impact, and identifying potential moderators of change. METHODS AND ANALYSIS: Utilising a mixed-methods design, this evaluation will incorporate three phases that reflect the stages of the programme life-cycle: (1) programme description, (2) implementation evaluation and (3) outcomes evaluation. The evaluation will use a mix of quantitative and qualitative data including deidentified routinely collected service data, participant observations, semistructured interviews, surveys and questionnaires, and a resource audit. DISCUSSION: Evaluation findings will be used to inform the development of a refined clinical navigation model, identify barriers and facilitators to successful navigation programme implementation, examine the impact of the ForWhen programme on client clinical outcomes and health service utilisation, understand how the programme is/can be best embedded in the evolving service system, and assess the cost-effectiveness and sustainability of a national navigation programme in improving health outcomes for PIMH in Australia. ETHICS AND DISSEMINATION: This research was approved by South Western Sydney Local Health District Human Research Ethics Committee (2021/ETH11611). This study was registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622001443785). Results will be disseminated at conferences, in scientific journals, and in a final evaluation report.

Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).

BACKGROUND: Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy. METHODS: The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring. DISCUSSION: Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).

Guidance on the use of complex systems models for economic evaluations of public health interventions.

To help health economic modelers respond to demands for greater use of complex systems models in public health. To propose identifiable features of such models and support researchers to plan public health modeling projects using these models. A working group of experts in complex systems modeling and economic evaluation was brought together to develop and jointly write guidance for the use of complex systems models for health economic analysis. The content of workshops was informed by a scoping review. A public health complex systems model for economic evaluation is defined as a quantitative, dynamic, non-linear model that incorporates feedback and interactions among model elements, in order to capture emergent outcomes and estimate health, economic and potentially other consequences to inform public policies. The guidance covers: when complex systems modeling is needed; principles for designing a complex systems model; and how to choose an appropriate modeling technique. This paper provides a definition to identify and characterize complex systems models for economic evaluations and proposes guidance on key aspects of the process for health economics analysis. This document will support the development of complex systems models, with impact on public health systems policy and decision making.

A randomised trial of intracavitary electrocardiography versus surface landmark measurement for central venous access device placement.

BACKGROUND: Malpositioned central venous access devices (CVADs) can lead to significant patient injury including central vein thrombosis and dysrhythmias. Intra-cavitary electrocardiography (IC ECG) has been recommended by peak professional bodies as an accurate alternative for bedside CVAD insertion, to reduce risk of malposition and allowing immediate use of the device. Our objective was to compare the effect of IC ECG on CVAD malposition compared to traditional institutional practice for CVAD placement. METHODS: Randomised controlled trial of IC ECG CVAD insertion verses traditional CVAD insertion (surface landmark measurement with post insertion x ray). Patient recruitment was from December 2016 to July 2018. The setting was a 900-bed tertiary referral hospital based in South Western Sydney, Australia. Three hundred and forty-four adult patients requiring CVAD insertion for intravenous therapy, were enrolled and randomly allocated (1:1 ratio) to either IC-ECG (n = 172) or traditional (n = 172) CVAD insertion. Our primary outcome of interest was the rate of catheters not requiring repositioning after insertion (ready for use). Secondary outcomes were comparison of procedure time and cost. RESULTS: Of the 172 patients allocated to the IC ECG method, 170 (99%) were ready for use immediately compared to 139 of the 172 (81%) in the traditional insertion group (difference, 95% confidence interval (CI): 18%, 11.9-24.1%). The total procedure time was mean 15 min (SD 8 min) for IC ECG and mean 36 min (SD 17 min) for traditional CVAD insertion (difference-19.9 min (95% CI-14.6 to -34.4). IC ECG guided CVAD insertion had a cost reduction of AUD $62.00 per procedure. CONCLUSIONS: Using IC-ECG resulted in nearly no requirement for post-insertion repositioning of CVADs resulting in savings in time and cost and virtually eliminating the need for radiographic confirmation. TRIAL REGISTRATION: This trial is registered at the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au). The registration number is ACTRN12620000919910.

Connecting Healthcare with Income Maximisation Services: A Systematic Review on the Health, Wellbeing and Financial Impacts for Families with Young Children.

Financial counselling and income-maximisation services have the potential to reduce financial hardship and its associated burdens on health and wellbeing in High Income Countries. However, referrals to financial counselling services are not systematically integrated into existing health service platforms, thus limiting our ability to identify and link families who might be experiencing financial hardship. Review evidence on this is scarce. The purpose of this study is to review "healthcare-income maximisation" models of care in high-income countries for families of children aged between 0 and 5 years experiencing financial difficulties, and their impacts on family finances and the health and wellbeing of parent(s)/caregiver(s) or children. A systematic review of the MEDLINE, EMBase, PsycInfo, CINAHL, ProQuest, Family & Society Studies Worldwide, Cochrane Library, and Informit Online databases was conducted according to the Preferred Reporting Items for Systemic Reviews and Meta-Analyses (PRISMA) statement. A total of six studies (five unique samples) met inclusion criteria, which reported a total of 11,603 families exposed to a healthcare-income maximisation model. An average annual gain per person of £1661 and £1919 was reported in two studies reporting one Scottish before-after study, whereby health visitors/midwives referred 4805 clients to money advice services. In another UK before-after study, financial counsellors were attached to urban primary healthcare centres and reported an average annual gain per person of £1058. The randomized controlled trial included in the review reported no evidence of impacts on financial or non-financial outcomes, or maternal health outcomes, but did observe small to moderate effects on child health and well-being. Small to moderate benefits were seen in areas relating to child health, preschool education, parenting, child abuse, and early behavioral adjustment. There was a high level of bias in most studies, and insufficient evidence to evaluate the effectiveness of healthcare-income maximisation models of care. Rigorous (RCT-level) studies with clear evaluations are needed to assess efficacy and effectiveness.

A Dynamic Approach to Economic Priority Setting to Invest in Youth Mental Health and Guide Local Implementation: Economic Protocol for Eight System Dynamics Policy Models.

Background: Mental illness costs the world economy over US2.5 Bn each year, including premature mortality, morbidity, and productivity losses. Multisector approaches are required to address the systemic drivers of mental health and ensure adequate service provision. There is an important role for economics to support priority setting, identify best value investments and inform optimal implementation. Mental health can be defined as a complex dynamic system where decision makers are challenged to prospectively manage the system over time. This protocol describes the approach to equip eight system dynamics (SD) models across Australia to support priority setting and guide portfolio investment decisions, tailored to local implementation context. Methods: As part of a multidisciplinary team, three interlinked protocols are developed; (i) the participatory process to codesign the models with local stakeholders and identify interventions for implementation, (ii) the technical protocol to develop the SD models to simulate the dynamics of the local population, drivers of mental health, the service system and clinical outcomes, and (iii) the economic protocol to detail how the SD models will be equipped to undertake a suite of economic analysis, incorporating health and societal perspectives. Models will estimate the cost of mental illness, inclusive of service costs (health and other sectors, where necessary), quality-adjusted life years (QALYs) lost, productivity costs and carer costs. To assess the value of investing (disinvesting) in interventions, economic analysis will include return-on-investment, cost-utility, cost benefit, and budget impact to inform affordability. Economic metrics are expected to be dynamic, conditional upon changing population demographics, service system capacities and the mix of interventions when synergetic or antagonistic interactions. To support priority setting, a portfolio approach will identify best value combinations of interventions, relative to a defined budget(s). User friendly dashboards will guide decision makers to use the SD models to inform resource allocation and generate business cases for funding. Discussion: Equipping SD models to undertake economic analysis is intended to support local priority setting and help optimise implementation regarding the best value mix of investments, timing and scale. The objectives are to improve allocative efficiency, increase mental health and economic productivity.

Presenting a comprehensive multi-scale evaluation framework for participatory modelling programs: A scoping review.

INTRODUCTION: Systems modelling and simulation can improve understanding of complex systems to support decision making, better managing system challenges. Advances in technology have facilitated accessibility of modelling by diverse stakeholders, allowing them to engage with and contribute to the development of systems models (participatory modelling). However, despite its increasing applications across a range of disciplines, there is a growing need to improve evaluation efforts to effectively report on the quality, importance, and value of participatory modelling. This paper aims to identify and assess evaluation frameworks, criteria, and/or processes, as well as to synthesize the findings into a comprehensive multi-scale framework for participatory modelling programs. MATERIALS AND METHODS: A scoping review approach was utilized, which involved a systematic literature search via Scopus in consultation with experts to identify and appraise records that described an evaluation framework, criteria, and/or process in the context of participatory modelling. This scoping review is registered with the Open Science Framework. RESULTS: The review identified 11 studies, which varied in evaluation purposes, terminologies, levels of examination, and time points. The review of studies highlighted areas of overlap and opportunities for further development, which prompted the development of a comprehensive multi-scale evaluation framework to assess participatory modelling programs across disciplines and systems modelling methods. The framework consists of four categories (Feasibility, Value, Change/Action, Sustainability) with 30 evaluation criteria, broken down across project-, individual-, group- and system-level impacts. DISCUSSION & CONCLUSION: The presented novel framework brings together a significant knowledge base into a flexible, cross-sectoral evaluation effort that considers the whole participatory modelling process. Developed through the rigorous synthesis of multidisciplinary expertise from existing studies, the application of the framework can provide the opportunity to understand practical future implications such as which aspects are particularly important for policy decisions, community learning, and the ongoing improvement of participatory modelling methods.

Participatory Systems Modelling for Youth Mental Health: An Evaluation Study Applying a Comprehensive Multi-Scale Framework.

The youth mental health sector is persistently challenged by issues such as service fragmentation and inefficient resource allocation. Systems modelling and simulation, particularly utilizing participatory approaches, is offering promise in supporting evidence-informed decision making with limited resources by testing alternative strategies in safe virtual environments before implementing them in the real world. However, improved evaluation efforts are needed to understand the critical elements involved in and to improve methods for implementing participatory modelling for youth mental health system and service delivery. An evaluation protocol is described to evaluate the feasibility, value, impact, and sustainability of participatory systems modelling in delivering advanced decision support capabilities for youth mental health. This study applies a comprehensive multi-scale evaluation framework, drawing on participatory action research principles as well as formative, summative, process, and outcome evaluation techniques. Novel data collection procedures are presented, including online surveys that incorporate gamification to enable social network analysis and patient journey mapping. The evaluation approach also explores the experiences of diverse stakeholders, including young people with lived (or living) experience of mental illness. Social and technical opportunities will be uncovered, as well as challenges implementing these interdisciplinary methods in complex settings to improve youth mental health policy, planning, and outcomes. This study protocol can also be adapted for broader international applications, disciplines, and contexts.

Participatory Methods for Systems Modeling of Youth Mental Health: Implementation Protocol.

BACKGROUND: Despite significant investment, mental health issues remain a leading cause of death among young people globally. Sophisticated decision analysis methods are needed to better understand the dynamic and multisector drivers of youth mental health. System modeling can help explore complex issues such as youth mental health and inform strategies to effectively respond to local needs and achieve lasting improvements. The advantages of engaging stakeholders in model development processes have long been recognized; however, the methods for doing so are often not well-described. OBJECTIVE: This paper aims to describe the participatory procedures that will be used to support systems modeling for national multisite implementation. The Right Care, First Time, Where You Live research program will focus on regional youth mental health applications of systems modeling in 8 different sites across Australia. METHODS: The participatory model development approach involves an iterative process of engaging with a range of participants, including people with lived experience of mental health issues. Their knowledge of the local systems, pathways, and drivers is combined with the academic literature and data to populate the models and validate their structure. The process centers around 3 workshops where participants interact and actively engage in group model-building activities to define, refine, and validate the systems models. This paper provides a detailed blueprint for the implementation of this process for mental health applications. RESULTS: The participatory modeling methods described in this paper will be implemented at 2 sites per year from 2022 to 2025. The 8 selected sites have been chosen to capture variations in important factors, including determinants of mental health issues and access to services. Site engagement commenced in August 2021, and the first modeling workshops are scheduled to commence in February 2022. CONCLUSIONS: Mental health system decision makers require tools to help navigate complex environments and leverage interdisciplinary problem-solving. Systems modeling can mobilize data from diverse sources to explore a range of scenarios, including the impact of interventions in different combinations and contexts. Involving stakeholders in the model development process ensures that the model findings are context-relevant and fit-for-purpose to inform decision-making. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/32988.

From Spreadsheets to Script: Experiences From Converting a Scottish Cardiovascular Disease Policy Model into R.

Given the advantages in transparency, reproducibility, adaptability and computational efficiency in R, there is a growing interest in converting existing spreadsheet-based models into an R script for model re-use and upskilling training among health economic modellers. The objective of this exercise was to convert the Scottish Cardiovascular Disease (CVD) Policy Model from Excel to R and discuss the lessons learnt throughout this process. The CVD model is a competing risk state transition cohort model. Four health economists, with varied experience of R, attempted to replicate an identical model structure in R based on the model in Excel and reproduce the intermediate and final results. Replications varied in their use of specialist health economics packages in addition to standard data management packages. Two versions of the CVD model were created in R along with a Shiny app. Version 1 was developed without health economics specialist packages and produced identical results to the Excel version. Version 2 used the heemod package and did not achieve the same results, possibly due to the non-standard elements of the model and limited time to adapt the functions. The R model requires less than half the computational time than the Excel model. Conversion of the spreadsheet models to script models is feasible for health economists. A step-by-step guide for the conversion process is provided and modellers' experience is discussed. Coding without specialist packages allows full flexibility, while specialist packages may add convenience if the model structure is suitable. Whichever approach is taken, transparency and replicability remain the key criteria in model programming. Model conversions must maintain standards in these areas regardless of the choice of software.

Which Social, Economic, and Health Sector Strategies Will Deliver the Greatest Impacts for Youth Mental Health and Suicide Prevention? Protocol for an Advanced, Systems Modelling Approach.

Background: Current global challenges are generating extensive social disruption and uncertainty that have the potential to undermine the mental health, wellbeing, and futures of young people. The scale and complexity of challenges call for engagement with systems science-based decision analytic tools that can capture the dynamics and interrelationships between physical, social, economic, and health systems, and support effective national and regional responses. At the outset of the pandemic mental health-related systems models were developed for the Australian context, however, the extent to which findings are generalisable across diverse regions remains unknown. This study aims to explore the context dependency of systems modelling insights. Methods: This study will employ a comparative case study design, applying participatory system dynamics modelling across eight diverse regions of Australia to answer three primary research questions: (i) Will current regional differences in key youth mental health outcomes be exacerbated in forward projections due to the social and economic impacts of COVID-19?; (ii) What combination of social policies and health system strengthening initiatives will deliver the greatest impacts within each region?; (iii) To what extent are optimal strategic responses consistent across the diverse regions? We provide a detailed technical blueprint as a potential springboard for more timely construction and deployment of systems models in international contexts to facilitate a broader examination of the question of generalisability and inform investments in the mental health and wellbeing of young people in the post COVID-19 recovery. Discussion: Computer simulation is known as the third pillar of science (after theory and experiment). Simulation allows researchers and decision makers to move beyond what can be manipulated within the scale, time, and ethical limits of the experimental approach. Such learning when achieved collectively, has the potential to enhance regional self-determination, help move beyond incremental adjustments to the status quo, and catalyze transformational change. This research seeks to advance efforts to establish regional decision support infrastructure and empower communities to effectively respond. In addition, this research seeks to move towards an understanding of the extent to which systems modelling insights may be relevant to the global mental health response by encouraging researchers to use, challenge, and advance the existing work for scientific and societal progress.

Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in SMART Recovery Mutual Support Groups: Stage 1 Mixed Methods Pilot Study.

BACKGROUND: Mutual support groups are an important source of long-term help for people impacted by addictive behaviors. Routine outcome monitoring (ROM) and feedback are yet to be implemented in these settings. SMART Recovery mutual support groups focus on self-empowerment and use evidence-based techniques (eg, motivational and behavioral strategies). Trained facilitators lead all SMART Recovery groups, providing an opportunity to implement ROM. OBJECTIVE: The aim of this stage 1 pilot study is to explore the feasibility, acceptability, and preliminary outcomes of a novel, purpose-built mobile health ROM and feedback app (SMART Track) in mutual support groups coordinated by SMART Recovery Australia (SRAU) over 8 weeks. METHODS: SMART Track was developed during phase 1 of this study using participatory design methods and an iterative development process. During phase 2, 72 SRAU group participants were recruited to a nonrandomized, prospective, single-arm trial of the SMART Track app. Four modes of data collection were used: ROM data directly entered by participants into the app; app data analytics captured by Amplitude Analytics (number of visits, number of unique users, visit duration, time of visit, and user retention); baseline, 2-, and 8-week follow-up assessments conducted through telephone; and qualitative telephone interviews with a convenience sample of study participants (20/72, 28%) and facilitators (n=8). RESULTS: Of the 72 study participants, 68 (94%) created a SMART Track account, 64 (88%) used SMART Track at least once, and 42 (58%) used the app for more than 5 weeks. During week 1, 83% (60/72) of participants entered ROM data for one or more outcomes, decreasing to 31% (22/72) by the end of 8 weeks. The two main screens designed to provide personal feedback data (Urges screen and Overall Progress screen) were the most frequently visited sections of the app. Qualitative feedback from participants and facilitators supported the acceptability of SMART Track and the need for improved integration into the SRAU groups. Participants reported significant reductions between the baseline and 8- week scores on the Severity of Dependence Scale (mean difference 1.93, SD 3.02; 95% CI 1.12-2.73) and the Kessler Psychological Distress Scale-10 (mean difference 3.96, SD 8.31; 95% CI 1.75-6.17), but no change on the Substance Use Recovery Evaluator (mean difference 0.11, SD 7.97; 95% CI -2.02 to 2.24) was reported. CONCLUSIONS: Findings support the feasibility, acceptability, and utility of SMART Track. Given that sustained engagement with mobile health apps is notoriously difficult to achieve, our findings are promising. SMART Track offers a potential solution for ROM and personal feedback, particularly for people with substance use disorders who attend mutual support groups. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15113.

Gazing through time and beyond the health sector: Insights from a system dynamics model of cardiovascular disease in Australia.

OBJECTIVE: To construct a whole-of-system model to inform strategies that reduce the burden of cardiovascular disease (CVD) in Australia. METHODS: A system dynamics model was developed with a multidisciplinary modelling consortium. The model population comprised Australians aged 40 years and over, and the scope encompassed acute and chronic CVD as well as primary and secondary prevention. Health outcomes were CVD-related deaths and hospitalisations, and economic outcomes were the net benefit from both the healthcare system and societal perspectives. The eight strategies broadly included creating social and physical environments supportive of a healthy lifestyle, increasing the use of preventive treatments, and improving systems response to acute CVD events. The effects of strategies were estimated as relative differences to the business-as-usual between 2019-2039. Probabilistic sensitivity analysis produced uncertainty intervals of interquartile ranges (IQR). FINDINGS: The greatest reduction in CVD-related deaths was seen in strategies that improve systems response to acute CVD events (8.9%, IQR: 7.7-10.2%), yet they resulted in an increase in CVD-related hospitalisations due to future recurrent admissions (1.6%, IQR: 0.1-2.3%). This flow-on effect highlighted the importance of addressing underlying CVD risks. On the other hand, strategies targeting the broad environment that supports a healthy lifestyle were effective in reducing both hospitalisations (7.1%; IQR: 5.0-9.5%) and deaths (8.1% reduction; IQR: 7.1-8.9%). They also produced an economic net benefit of AU$43.3 billion (IQR: 37.7-48.7) using a societal perspective, largely driven by productivity gains. Overall, strategic planning to reduce the burden of CVD should consider the varying effects of strategies over time and beyond the health sector.

Federal and state cooperation necessary but not sufficient for effective regional mental health systems: insights from systems modelling and simulation.

For more than a decade, suicide rates in Australia have shown no improvement despite significant investment in reforms to support regionally driven initiatives. Further recommended reforms by the Productivity Commission call for Federal and State and Territory Government funding for mental health to be pooled and new Regional Commissioning Authorities established to take responsibility for efficient and effective allocation of 'taxpayer money.' This study explores the sufficiency of this recommendation in preventing ongoing policy resistance. A system dynamics model of pathways between psychological distress, the mental health care system, suicidal behaviour and their drivers was developed, tested, and validated for a large, geographically diverse region of New South Wales; the Hunter New England and Central Coast Primary Health Network (PHN). Multi-objective optimisation was used to explore potential discordance in the best-performing programs and initiatives (simulated from 2021 to 2031) across mental health outcomes between the two state-governed Local Health Districts (LHDs) and the federally governed PHN. Impacts on suicide deaths, mental health-related emergency department presentations, and service disengagement were explored. A combination of family psychoeducation, post-attempt aftercare, and safety planning, and social connectedness programs minimises the number of suicides across the PHN and in the Hunter New England LHD (13.5% reduction; 95% interval, 12.3-14.9%), and performs well in the Central Coast LHD (14.8% reduction, 13.5-16.3%), suggesting that aligned strategic decision making between the PHN and LHDs would deliver substantial impacts on suicide. Results also highlighted a marked trade-off between minimising suicide deaths versus minimising service disengagement. This is explained in part by the additional demand placed on services of intensive suicide prevention programs leading to increases in service disengagement as wait times for specialist community based mental health services and dissatisfaction with quality of care increases. Competing priorities between the PHN and LHDs (each seeking to optimise the different outcomes they are responsible for) can undermine the optimal impact of investments for suicide prevention. Systems modelling provides essential regional decision analysis infrastructure to facilitate coordinated federal and state investments for optimal impacts.

Study protocol for the Healthier Wealthier Families (HWF) pilot randomised controlled trial: testing the feasibility of delivering financial counselling to families with young children who are identified as experiencing financial hardship by community-based nurses.

INTRODUCTION: Poverty and deprivation can harm children's future health, learning, economic productivity and societal participation. The Australian Healthier Wealthier Families project seeks to reduce the childhood inequities caused by poverty and deprivation by creating a systematic referral pathway between two free, community-based services: universal, well-child nursing services, which provide health and development support to families with children from birth to school entry, and financial counselling. By adapting the successful Scottish 'Healthier Wealthier Children' model, the objectives of this Australian pilot are to test the (1) feasibility of systematising the referral pathway, and (2) short-term impacts on household finances, caregiver health, parenting efficacy and financial service use. METHODS AND ANALYSIS: This pilot randomised controlled trial will run in three sites across two Australian states (Victoria and New South Wales), recruiting a total of 180 participants. Nurses identify eligible caregivers with a 6-item, study-designed screening survey for financial hardship. Caregivers who report one or more risk factors and consent are randomised. The intervention is financial counselling. The comparator is usual care plus information from a government money advice website. Feasibility will be evaluated using the number/proportion of caregivers who complete screening, consent and research measures, and access financial counselling. Though powered to assess feasibility, impacts will be measured 6 months post-enrolment with qualitative interviews and questionnaires about caregiver-reported income, loans and costs (adapted from national surveys, for example, the Household, Income and Labour Dynamics in Australia Survey); health (General Health Questionnaire 1, EuroQol five-dimensional questionnaire, Depression, Anxiety, Stress Scale short-form); efficacy (from the Longitudinal Study of Australian Children); and financial service use (study-designed) compared between arms. ETHICS AND DISSEMINATION: Ethics committees of the Royal Children's Hospital (HREC/57372/RCHM-2019) and South West Sydney Local Health District (2019/ETH13455) have approved the study. Participants and stakeholders will receive results through regular communication channels comprising meetings, presentations and publications. TRIAL REGISTRATION NUMBER: ACTRN12620000154909; prospectively registered. Pre-results.

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial.

BACKGROUND: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores. METHODS: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear's active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months' worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD. DISCUSSION: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered on 3 June 2019.

Reducing youth suicide: systems modelling and simulation to guide targeted investments across the determinants.

BACKGROUND: Reducing suicidal behaviour (SB) is a critical public health issue globally. The complex interplay of social determinants, service system factors, population demographics, and behavioural dynamics makes it extraordinarily difficult for decision makers to determine the nature and balance of investments required to have the greatest impacts on SB. Real-world experimentation to establish the optimal targeting, timing, scale, frequency, and intensity of investments required across the determinants is unfeasible. Therefore, this study harnesses systems modelling and simulation to guide population-level decision making that represent best strategic allocation of limited resources. METHODS: Using a participatory approach, and informed by a range of national, state, and local datasets, a system dynamics model was developed, tested, and validated for a regional population catchment. The model incorporated defined pathways from social determinants of mental health to psychological distress, mental health care, and SB. Intervention scenarios were investigated to forecast their impact on SB over a 20-year period. RESULTS: A combination of social connectedness programs, technology-enabled coordinated care, post-attempt assertive aftercare, reductions in childhood adversity, and increasing youth employment projected the greatest impacts on SB, particularly in a youth population, reducing self-harm hospitalisations (suicide attempts) by 28.5% (95% interval 26.3-30.8%) and suicide deaths by 29.3% (95% interval 27.1-31.5%). Introducing additional interventions beyond the best performing suite of interventions produced only marginal improvement in population level impacts, highlighting that 'more is not necessarily better.' CONCLUSION: Results indicate that targeted investments in addressing the social determinants and in mental health services provides the best opportunity to reduce SB and suicide. Systems modelling and simulation offers a robust approach to leveraging best available research, data, and expert knowledge in a way that helps decision makers respond to the unique characteristics and drivers of SB in their catchments and more effectively focus limited health resources.

Embedding an economist in regional and rural health services to add value and reduce waste by improving local-level decision-making: protocol for the 'embedded Economist' program and evaluation.

BACKGROUND: Systematic approaches to the inclusion of economic evaluation in national healthcare decision-making are usual. It is less common for economic evaluation to be routinely undertaken at the 'local-level' (e.g. in a health service or hospital) despite the largest proportion of health care expenditure being determined at this service level and recognition by local health service decision makers of the need for capacity building in economic evaluation skills. This paper describes a novel program - the embedded Economist (eE) Program. The eE Program aims to increase local health service staff awareness of, and develop their capacity to access and apply, economic evaluation principles in decision making. The eE program evaluation is also described. The aim of the evaluation is to capture the contextual, procedural and relational aspects that assist and detract from the eE program aims; as well as the outcomes and impact from the specific eE projects. METHODS: The eE Program consists of a embedding a health economist in six health services and the provision of supported education in applied economic evaluation, provided via a community of practice and a university course. The embedded approach is grounded in co-production, embedded researchers and 'slow science'. The sites, participants, and program design are described. The program evaluation includes qualitative data collection via surveys, semi-structured interviews, observations and field diaries. In order to share interim findings, data are collected and analysed prior, during and after implementation of the eE program, at each of the six health service sites. The surveys will be analysed by calculating frequencies and descriptive statistics. A thematic analysis will be conducted on interview, observation and filed diary data. The Framework to Assess the Impact from Translational health research (FAIT) is utilised to assess the overall impact of the eE Program. DISCUSSION: This program and evaluation will contribute to knowledge about how best to build capacity and skills in economic evaluation amongst decision-makers working in local-level health services. It will examine the extent to which participants are able to improve their ability to utilise evidence to inform decisions, avoid waste and improve the value of care delivery.

Endometriosis and chronic pelvic pain have similar impact on women, but time to diagnosis is decreasing: an Australian survey.

Chronic pelvic pain (CPP) affects a significant number of women worldwide. Internationally, people with endometriosis report significant negative impact across many areas of their life. We aimed to use an online survey using the EndoCost tool to determine if there was any difference in the impact of CPP in those with vs. those without a confirmed diagnosis of endometriosis, and if there was any change in diagnostic delay since the introduction of clinical guidelines in 2005. 409 responses were received; 340 with a diagnosis of endometriosis and 69 with no diagnosis. People with CPP, regardless of diagnosis, reported moderate to severe dysmenorrhea and non-cyclical pelvic pain. Dyspareunia was also common. Significant negative impact was reported for social, academic, and sexual/romantic relationships in both cohorts. In the endometriosis cohort there was a mean diagnostic delay of eight years, however there was a reduction in both the diagnostic delay (p < 0.001) and number of doctors seen before diagnosis (p < 0.001) in those presenting more recently. Both endometriosis and CPP have significant negative impact. Whilst there is a decrease in the time to diagnosis, there is an urgent need for improved treatment options and support for women with the disease once the diagnosis is made.

Evidence on result-based financing in maternal and child health in low- and middle-income countries: a systematic review.

Introduction: Result-Based Financing (RBF) is an umbrella term for financial mechanisms that link incentives to outputs or outcomes. International development agencies are promoting RBF as a viable financing approach for the realization of universal health coverage, with numerous pilot trials, particularly in low- and middle-income countries (LMICs). There is limited synthesized evidence on the performance of these mechanisms and the reasons for the lack of RBF institutionalization. This study aims to review the evidence of RBF schemes that have been scaled or institutionalized at a national level, focusing on maternal, newborn, and child health (MNCH) programming in LMICs. Methods: A systematic literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors identified and reviewed country-level RBF evaluation reports for the period between January 2000 and June 2019. Data were extracted from both published and gray literature on RBF application in MNCH using a predesigned matrix. The matrix headers included country of application; program setting; coverage and duration; evaluation design and methods; outcome measures; and key findings. A content thematic analysis approach was used to synthesize the evidence and emerging issues. Results: The review identified 13 reports from 11 countries, predominantly from Sub-Saharan Africa. Performance-based financing was the most common form of RBF initiatives. The majority of evaluation designs were randomized trials. The evaluations focused on outputs, such as coverage and service utilization, rather than outcomes. RBF schemes in all 11 countries expanded their scope, either geographically or accordingly in terms of performance indicators. Furthermore, only three studies conducted a cost-effectiveness analysis, and only two included a discussion on RBF's sustainability. Only three countries have institutionalized RBF into their national policy. On the basis of the experience of these three countries, the common enabling factors for institutionalization seem to be political will, domestic fund mobilization, and the incorporation of demand-side RBF tools. Conclusion: RBF evidence is still growing, partial, and inconclusive. This limited evidence may be one of the reasons why many countries are reluctant to institutionalize RBF. Additional research is needed, particularly regarding cost-effectiveness, affordability, and sustainability of RBF programs.