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.

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.

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.

Bringing new tools, a regional focus, resource-sensitivity, local engagement and necessary discipline to mental health policy and planning.

BACKGROUND: While reducing the burden of mental and substance use disorders is a global challenge, it is played out locally. Mental disorders have early ages of onset, syndromal complexity and high individual variability in course and response to treatment. As most locally-delivered health systems do not account for this complexity in their design, implementation, scale or evaluation they often result in disappointing impacts. DISCUSSION: In this viewpoint, we contend that the absence of an appropriate predictive planning framework is one critical reason that countries fail to make substantial progress in mental health outcomes. Addressing this missing infrastructure is vital to guide and coordinate national and regional (local) investments, to ensure limited mental health resources are put to best use, and to strengthen health systems to achieve the mental health targets of the 2015 Sustainable Development Goals. Most broad national policies over-emphasize provision of single elements of care (e.g. medicines, individual psychological therapies) and assess their population-level impact through static, linear and program logic-based evaluation. More sophisticated decision analytic approaches that can account for complexity have long been successfully used in non-health sectors and are now emerging in mental health research and practice. We argue that utilization of advanced decision support tools such as systems modelling and simulation, is now required to bring a necessary discipline to new national and local investments in transforming mental health systems. CONCLUSION: Systems modelling and simulation delivers an interactive decision analytic tool to test mental health reform and service planning scenarios in a safe environment before implementing them in the real world. The approach drives better decision-making and can inform the scale up of effective and contextually relevant strategies to reduce the burden of mental disorder and enhance the mental wealth of nations.

Correction to: Study protocol the Continuing Care Project: a randomised controlled trial of a continuing care telephone intervention following residential substance dependence treatment.

It was highlighted that in the original article [1] author Amanda Baker was erroneously omitted from the authorship during the copy editing stage.

Study protocol the Continuing Care Project: a randomised controlled trial of a continuing care telephone intervention following residential substance dependence treatment.

BACKGROUND: A priority area in the field of substance dependence treatment is reducing the rates of relapse. Previous research has demonstrated that telephone delivered continuing care interventions are both clinically and cost effective when delivered as a component of outpatient treatment. This protocol describes a NSW Health funded study that assesses the effectiveness of delivering a telephone delivered continuing care intervention for people leaving residential substance treatment in Australia. METHODS/DESIGN: All participants will be attending residential alcohol and other drug treatment provided by The Salvation Army or We Help Ourselves. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three treatment arms. The treatment arms will be: (i) 12-session continuing care telephone intervention; (ii) 4-session continuing care telephone intervention, or (iii) continuing care plan only. Baseline assessment batteries and development of the participants' continuing care plan will be completed prior to participants being randomised to a treatment condition. Research staff blind to the treatment condition will complete follow-up assessments with participants at 3-months and 6-months after they have been discharged from their residential service. DISCUSSION: This study will provide comprehensive data on the effect of delivering the continuing care intervention for people exiting residential alcohol and other drug treatment. If shown to be effective, this intervention can be disseminated to improve the rates of relapse among people leaving residential alcohol and other drug treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001231235. Registered on 23rd July 2018. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375621&isReview=true.

Patient Centred Medical Home (PCMH) transitions in western Sydney, Australia: a qualitative study.

BACKGROUND: Patient Centred Medical Homes (PCMHs), increasingly evidenced to provide high quality primary care, are new to Australia. To learn how this promising new healthcare model works in an Australian setting we explored experiences of healthcare providers in outer urban Sydney, where a number of practices are transitioning from traditional Australian general practice models to incorporate elements of PCMH approaches. METHODS: We collected qualitative data from semi-structured interviews with healthcare providers working in a range of transitioning practices and thematically analysed the data. We interviewed 35 participants including general practitioners, practice managers and practice nurses from 25 purposively sampled general practices in western Sydney, Australia, seeking maximal variation in practice size, patient demographics and type of engagement in practice transformation. RESULTS: Interviewees described PCMH transformation highlighting the importance of whole of practice engagement with a shared vision; key strategies for transformation to PCMH models of care including leadership, training and supportive information technology; structures and processes required to provide team-based, data-driven care; and constraints such as lack of space and the current Australian fee-for-service general practice funding model. They also reported their perceptions of early outcomes of the PCMH model of care, describing enhanced patient and staff satisfaction and also noting fewer hospital admissions, as likely to reduce costs of care. CONCLUSIONS: Our study exploring the experience of early adopters of PCMH models of care in Australia, informs the international movement towards PCMH models of care. Our findings provide guidance for practices considering similar transitions and describe the challenges of such transitions within a fee-for-service payment system.

The economic burden of physical inactivity: a global analysis of major non-communicable diseases.

BACKGROUND: The pandemic of physical inactivity is associated with a range of chronic diseases and early deaths. Despite the well documented disease burden, the economic burden of physical inactivity remains unquantified at the global level. A better understanding of the economic burden could help to inform resource prioritisation and motivate efforts to increase levels of physical activity worldwide. METHODS: Direct health-care costs, productivity losses, and disability-adjusted life-years (DALYs) attributable to physical inactivity were estimated with standardised methods and the best data available for 142 countries, representing 93·2% of the world's population. Direct health-care costs and DALYs were estimated for coronary heart disease, stroke, type 2 diabetes, breast cancer, and colon cancer attributable to physical inactivity. Productivity losses were estimated with a friction cost approach for physical inactivity related mortality. Analyses were based on national physical inactivity prevalence from available countries, and adjusted population attributable fractions (PAFs) associated with physical inactivity for each disease outcome and all-cause mortality. FINDINGS: Conservatively estimated, physical inactivity cost health-care systems international $ (INT$) 53·8 billion worldwide in 2013, of which $31·2 billion was paid by the public sector, $12·9 billion by the private sector, and $9·7 billion by households. In addition, physical inactivity related deaths contribute to $13·7 billion in productivity losses, and physical inactivity was responsible for 13·4 million DALYs worldwide. High-income countries bear a larger proportion of economic burden (80·8% of health-care costs and 60·4% of indirect costs), whereas low-income and middle-income countries have a larger proportion of the disease burden (75·0% of DALYs). Sensitivity analyses based on less conservative assumptions led to much higher estimates. INTERPRETATION: In addition to morbidity and premature mortality, physical inactivity is responsible for a substantial economic burden. This paper provides further justification to prioritise promotion of regular physical activity worldwide as part of a comprehensive strategy to reduce non-communicable diseases. FUNDING: None.

Are cardiovascular disease risk assessment and management programmes cost effective? A systematic review of the evidence.

The World Health Organization recommends that countries implement population-wide cardiovascular disease (CVD) risk assessment and management programmes. The aim of this study was to conduct a systematic review to evaluate whether this recommendation is supported by cost-effectiveness evidence. Published economic evaluations were identified via electronic medical and social science databases (including Medline, Web of Science, and the NHS Economic Evaluation Database) from inception to March 2016. Study quality was evaluated using a modified version of the Consolidated Health Economic Evaluation Reporting Standards. Fourteen economic evaluations were included: five studies based on randomised controlled trials, seven studies based on observational studies and two studies using hypothetical modelling synthesizing secondary data. Trial based studies measured CVD risk factor changes over 1 to 3years, with modelled projections of longer term events. Programmes were either not, or only, cost-effective under non-verified assumptions such as sustained risk factor changes. Most observational and hypothetical studies suggested programmes were likely to be cost-effective; however, study deigns are subject to bias and subsequent empirical evidence has contradicted key assumptions. No studies assessed impacts on inequalities. In conclusion, recommendations for population-wide risk assessment and management programmes lack a robust, real world, evidence basis. Given implementation is resource intensive there is a need for robust economic evaluation, ideally conducted alongside trials, to assess cost effectiveness. Further, the efficiency and equity impact of different delivery models should be investigated, and also the combination of targeted screening with whole population interventions recognising that there multiple approaches to prevention.

The economic burden of physical inactivity: a systematic review and critical appraisal.

OBJECTIVE: To summarise the literature on the economic burden of physical inactivity in populations, with emphases on appraising the methodologies and providing recommendations for future studies. DESIGN: Systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO registration number CRD42016047705). DATA SOURCES: Electronic databases for peer-reviewed and grey literature were systematically searched, followed by reference searching and consultation with experts. ELIGIBILITY CRITERIA: Studies that examined the economic consequences of physical inactivity in a population/population-based sample, with clearly stated methodologies and at least an abstract/summary written in English. RESULTS: Of the 40 eligible studies, 27 focused on direct healthcare costs only, 13 also estimated indirect costs and one study additionally estimated household costs. For direct costs, 23 studies used a population attributable fraction (PAF) approach with estimated healthcare costs attributable to physical inactivity ranging from 0.3% to 4.6% of national healthcare expenditure; 17 studies used an econometric approach, which tended to yield higher estimates than those using a PAF approach. For indirect costs, 10 studies used a human capital approach, two used a friction cost approach and one used a value of a statistical life approach. Overall, estimates varied substantially, even within the same country, depending on analytical approaches, time frame and other methodological considerations. CONCLUSION: Estimating the economic burden of physical inactivity is an area of increasing importance that requires further development. There is a marked lack of consistency in methodological approaches and transparency of reporting. Future studies could benefit from cross-disciplinary collaborations involving economists and physical activity experts, taking a societal perspective and following best practices in conducting and reporting analysis, including accounting for potential confounding, reverse causality and comorbidity, applying discounting and sensitivity analysis, and reporting assumptions, limitations and justifications for approaches taken. We have adapted the Consolidated Health Economic Evaluation Reporting Standards checklist as a guide for future estimates of the economic burden of physical inactivity and other risk factors.

Doing it hard in the bush: Aligning what gets measured with what matters.

What gets measured gets managed. Funding of health services is substantially determined by operational activity and specific outcome indicators. In day-to-day clinical decision-making, surrogate markers, such as glycosylated haemoglobin and blood pressure, are commonly used to modify risks of 'hard' outcomes that include kidney failure, ischaemic cardiac events, stroke and all-cause mortality. In many settings, surrogates are all we have to go on. As a consequence, current health funding models heavily rely on surrogate-based key performance indicators [KPIs]. While surrogates are convenient and provide immediate information, there is an obligation to ensure that they are appropriate, reliable and validated in context. In contrast, hard outcomes, the real consequences of illness, are usually realised over an extended timeframe. Additionally, and for a host of reasons, hard endpoints have the greatest social, emotional and economic impact for people at the far end of the health system; those in rural and remote settings - 'in the bush' - especially Indigenous Australians. We propose a health service assessment approach that aligns short-term decision-making with patient-centred and longer term hard outcomes, one that takes into account community, cultural and environmental factors, especially remoteness. Communities should have a major say in determining what health indicators are measured and managed.

The CARE Plus study - a whole-system intervention to improve quality of life of primary care patients with multimorbidity in areas of high socioeconomic deprivation: exploratory cluster randomised controlled trial and cost-utility analysis.

BACKGROUND: Multimorbidity is common in deprived communities and reduces quality of life. Our aim was to evaluate a whole-system primary care-based complex intervention, called CARE Plus, to improve quality of life in multimorbid patients living in areas of very high deprivation. METHODS: We used a phase 2 exploratory cluster randomised controlled trial with eight general practices in Glasgow in very deprived areas that involved multimorbid patients aged 30-65 years. The intervention comprised structured longer consultations, relationship continuity, practitioner support, and self-management support. Control practices continued treatment as usual. Primary outcomes were quality of life (EQ-5D-5L utility scores) and well-being (W-BQ12; 3 domains). Cost-effectiveness from a health service perspective, engagement, and retention were assessed. Recruitment and baseline measurements occurred prior to randomisation. Blinding post-randomisation was not possible but outcome measurement and analysis were masked. Analyses were by intention to treat. RESULTS: Of 76 eligible practices contacted, 12 accepted, and eight were selected, randomised and participated for the duration of the trial. Of 225 eligible patients, 152 (68 %) participated and 67/76 (88 %) in each arm completed the 12-month assessment. Two patients died in the control group. CARE Plus significantly improved one domain of well-being (negative well-being), with an effect size of 0.33 (95 % confidence interval [CI] 0.11-0.55) at 12 months (p = 0.0036). Positive well-being, energy, and general well-being (the combined score of the three components) were not significantly influenced by the intervention at 12 months. EQ-5D-5L area under the curve over the 12 months was higher in the CARE Plus group (p = 0.002). The incremental cost in the CARE Plus group was £929 (95 % CI: £86-£1788) per participant with a gain in quality-adjusted life years of 0.076 (95 % CI: 0.028-0.124) over the 12 months of the trial, resulting in a cost-effectiveness ratio of £12,224 per quality-adjusted life year gained. Modelling suggested that cost-effectiveness would continue. CONCLUSIONS: It is feasible to conduct a high-quality cluster randomised control trial of a complex intervention with multimorbid patients in primary care in areas of very high deprivation. Enhancing primary care through a whole-system approach may be a cost-effective way to protect quality of life for multimorbid patients in deprived areas. TRIAL REGISTRATION: ISRCTN 34092919 , assigned 14/1/2013.

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial.

BACKGROUND: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. METHODS: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. DISCUSSION: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. TRIAL REGISTRATION: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014.

Relationships of multimorbidity and income with hospital admissions in 3 health care systems.

Associations of multimorbidity and income with hospital admission were investigated in population samples from 3 widely differing health care systems: Scotland (n = 36,921), China (n = 162,464), and Hong Kong (n = 29,187). Multimorbidity increased odds of admissions in all 3 settings. In Scotland, poorer people were more likely to be admitted (adjusted odds ratio [aOR] = 1.62; 95% CI, 1.41-1.86 for the lowest income group vs the highest), whereas China showed the opposite (aOR = 0.58; 95% CI, 0.56-0.60). In Hong Kong, poorer people were more likely to be admitted to public hospitals (aOR = 1.68; 95% CI, 1.36-2.07), but less likely to be admitted to private ones (aOR = 0.18; 95% CI, 0.13-0.25). Strategies to improve equitable health care should consider the impact of socioeconomic deprivation on the use of health care resources, particularly among populations with prevalent multimorbidity.

No one's discussing the elephant in the room: contemplating questions of research impact and benefit in Aboriginal and Torres Strait Islander Australian health research.

BACKGROUND: There remains a concern that Indigenous Australians have been over-researched without corresponding improvements in their health; this trend is applicable to most Indigenous populations globally. This debate article has a dual purpose: 1) to open a frank conversation about the value of research to Indigenous Australian populations; and 2) to stimulate ways of thinking about potential resolutions to the lack of progress made in the Indigenous research benefit debate. DISCUSSION: Capturing the meaning of research benefit takes the form of ethical value-oriented methodological considerations in the decision-making processes of Indigenous research endeavours. Because research practices come from Western knowledge bases, attaining such positions in research means reconciling both Indigenous and Western knowledge systems to produce new methodologies that guide planning, evaluating and monitoring of research practices as necessary. Increasingly, more sophisticated performance measures have been implemented to ensure academic impact and benefits are captured. Assessing societal and other non-academic impacts and benefits however, has not been accorded corresponding attention. Research reform has only focussed on research translation in more recent years. The research impact debate must take account of the various standards of accountability (to whom), impact priorities (for whom), positive and negative impacts, and biases that operate in describing impact and measuring benefit. SUMMARY: A perennial question in Indigenous research discourse is whether the abundance of research conducted; purportedly to improve health, is justified and benefits Indigenous people in ways that are meaningful and valued by them. Different research stakeholders have different conceptions of the value and nature of research, its conduct, what it should achieve and the kinds of benefits expected. We need to work collaboratively and listen more closely to the voice of Indigenous Australians to better understand, demonstrate and measure health research benefits. The authors conclude that as an imperative, a systematic benefit assessment strategy that includes identification of research priorities and planning, monitoring and evaluation components needs to be developed and implemented across research projects. In Indigenous health research, this will often mean adopting a benefit-led approach by changing the way research is done and preferencing alternative research methodologies. As a point of departure to improving impact and reaching mutually beneficial outcomes for researchers and partners in Indigenous health research, we need to routinise the assessment of benefit from outset of research as one of the standards toward which we work.

Double trouble: the impact of multimorbidity and deprivation on preference-weighted health related quality of life a cross sectional analysis of the Scottish Health Survey.

OBJECTIVE: To investigate the association between multimorbidity and Preference_Weighted Health Related Quality of Life (PW_HRQoL), a score that combines physical and mental functioning, and how this varies by socioeconomic deprivation and age. DESIGN: The Scottish Health Survey (SHeS) is a cross-sectional representative survey of the general population which included the SF-12, a survey of HRQoL, for individuals 20 years and over. METHODS: For 7,054 participants we generated PW_HRQoL scores by running SF-12 responses through the SF-6D algorithm. The resulting scores ranged from 0.29 (worst health) to 1 (perfect health). Using ordinary least squares, we first investigated associations between scores and increasing counts of longstanding conditions, and then repeated for multimorbidity (2+ conditions). Estimates were made for the general population and quintiles of socioeconomic deprivation. For multimorbidity, the analyses were repeated stratifying the population by age group (20-44, 45-64, 65+). RESULTS: 45% of participants reported a longstanding condition and 18% reported multimorbidity. The presence of 1, 2, or 3+ longstanding conditions were associated with average reductions in PW_HRQoL scores of 0.081, 0.151 and 0.212 respectively. Reduction in scores associated with multimorbidity was 33% greater in the most deprived quintile compared to the least deprived quintile, with the biggest difference (80%) in the 20-44 age groups. There were no significant gender differences. CONCLUSIONS: PW_HRQoL decreases markedly with multimorbidity, and is exacerbated by higher deprivation and younger age. There is a need to prioritise interventions to improve the HRQoL for (especially younger) adults with multimorbidity in deprived areas. BOX 1: What Is Known?Prevalence and premature onset of multimorbidity increases as socioeconomic position worsens. Previous studies have investigated the effect of multimorbidity on Health Related Quality of Life (HRQoL) on separate physical and mental health states. There is limited data on how HRQoL falls as the number of conditions increase, and how estimates vary across the general population.Leaving physical and mental health as separate categories can inhibit assessment of overall HRQoL. The use of a Preference_Weighted Health Related Quality of Life (PW_HRQoL) score provides a single summary measure of overall health, by weighting mental and physical states by their perceived importance as part of overall HRQoL. The use of a single score enables a simple and consistent assessment of the impact of conditions and how this varies across the population. Economists term PW_HRQoL scores health utilities.What this study adds?This is the first study to estimate how the impact of multimorbidity on PW_HRQoL scores varies by age group and socioeconomic deprivation. Multimorbidity has a substantial negative impact on HRQoL which is most severe in areas of deprivation, especially in younger adults.Measuring the burden of multimorbidity using PW_HRQoL provides consistency with how economists measure HRQoL; changes in which can be used in economic evaluation to assess the cost effectiveness of interventions.

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).

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.