2023 Australian guideline for assessing and managing cardiovascular disease risk.

INTRODUCTION: The 2023 Australian guideline for assessing and managing cardiovascular disease risk provides updated evidence-based recommendations for the clinical assessment and management of cardiovascular disease (CVD) risk for primary prevention. It includes the new Australian CVD risk calculator (Aus CVD Risk Calculator), based on an equation developed from a large New Zealand cohort study, customised and recalibrated for the Australian population. The new guideline replaces the 2012 guideline that recommended CVD risk assessment using the Framingham risk equation. MAIN RECOMMENDATIONS: The new guideline recommends CVD risk assessment in people without known CVD: all people aged 45-79 years, people with diabetes from 35 years, and First Nations people from 30 years. The new Aus CVD Risk Calculator should be used to estimate and categorise CVD risk into low (< 5% risk over five years), intermediate (5% to < 10% risk over five years) or high risk (≥ 10% over five years). The following reclassification factors may be applied to recategorise calculated risk to improve accuracy of risk prediction, particularly in individuals close to a risk threshold: Indigenous status/ethnicity, estimated glomerular filtration rate, urine albumin to creatinine ratio measurements, severe mental illness, coronary artery calcium score and family history of premature CVD. A variety of communication formats is available to communicate CVD risk to help enable shared decision making. Healthy lifestyle modification, including smoking cessation, nutrition, physical activity and limiting alcohol, is encouraged for all individuals. Blood pressure-lowering and lipid-modifying pharmacotherapies should be prescribed for high risk and considered for intermediate risk individuals, unless contraindicated or clinically inappropriate. Reassessment of CVD risk should be considered within five years for individuals at low risk and within two years for those with intermediate risk. Reassessment of CVD risk is not recommended for individuals at high risk. CHANGES IN ASSESSMENT AND MANAGEMENT AS A RESULT OF THE GUIDELINE: The updated guideline recommends assessment over a broader age range and uses the Aus CVD Risk Calculator, which replaces the previous Framingham-based equation. It incorporates new variables: social disadvantage, diabetes-specific risk markers, diagnosis of atrial fibrillation and use of blood pressure-lowering and lipid-modifying therapies. Reclassification factors are also a new addition. Updated risk categories and thresholds are based on the new Aus CVD Risk Calculator. The proportion of the population in the high risk category (≥ 10% over five years) is likely to be broadly comparable to more than 15% risk from the Framingham-based equation. The full guideline and Aus CVD Risk Calculator can be accessed at www.cvdcheck.org.au.

Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol.

BACKGROUND: Despite high blood pressure being the leading preventable risk factor for death, only 1 in 3 patients achieve target blood pressure control. Key contributors to this problem are clinical inertia and uncertainties in relying on clinic blood pressure measurements to make treatment decisions. METHODS: The NEXTGEN-BP open-label, multicenter, randomized controlled trial will investigate the efficacy, safety, acceptability and cost-effectiveness of a wearable blood pressure monitor-based care strategy for the treatment of hypertension, compared to usual care, in lowering clinic blood pressure over 12 months. NEXTGEN-BP will enroll 600 adults with high blood pressure, treated with 0 to 2 antihypertensive medications. Participants attending primary care practices in Australia will be randomized 1:1 to the intervention of a wearable-based remote care strategy or to usual care. Participants in the intervention arm will undergo continuous blood pressure monitoring using a wrist-wearable cuffless device (Aktiia, Switzerland) and participate in 2 telehealth consultations with their primary care practitioner (general practitioner [GP]) at months 1 and 2. Antihypertensive medication will be up-titrated by the primary care practitioner at the time of telehealth consults should the percentage of daytime blood pressure at target over the past week be <90%, if clinically tolerated. Participants in the usual care arm will have primary care consultations according to usual practice. The primary outcome is the difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. Secondary outcomes will be assessed at month 3 and month 12, and include acceptability to patients and practitioners, cost-effectiveness, safety, medication adherence and patient engagement. CONCLUSIONS: NEXTGEN-BP will provide evidence for the effectiveness and safety of a new paradigm of wearable cuffless monitoring in the management of high blood pressure in primary care. TRIAL REGISTRATION: ACTRN12622001583730.

Changes in antidepressant use in Australia: A nationwide analysis (2015-2021).

BACKGROUND: Depression and anxiety affect 4-14% of Australians every year; symptoms may have been exacerbated during the COVID-19 pandemic. We examined recent patterns of antidepressant use in Australia in the period 2015-2021, which includes the first year of the pandemic. METHODS: We used national dispensing claims for people aged ⩾10 years to investigate annual trends in prevalent and new antidepressant use (no antidepressants dispensed in the year prior). We conducted stratified analyses by sex, age group and antidepressant class. We report outcomes from 2015 to 2019 and used time series analysis to quantify changes during the first year of the COVID-19 pandemic (March 2020-February 2021). RESULTS: In 2019, the annual prevalence of antidepressant use was 170.4 per 1000 women and 101.8 per 1000 men, an increase of 7.0% and 9.2% from 2015, respectively. New antidepressant use also increased for both sexes (3.0% for women and 4.9% for men) and across most age groups, particularly among adolescents (aged 10-17 years; 46-57%). During the first year of the COVID-19 pandemic, we observed higher than expected prevalent use (+2.2%, 95% CI = [0.3%, 4.2%]) among females, corresponding to a predicted excess of 45,217 (95% CI = [5,819, 84,614]) females dispensed antidepressants. The largest increases during the first year of the pandemic occurred among female adolescents for both prevalent (+11.7%, 95% CI = [4.1%, 20.5%]) and new antidepressant use (+15.6%, 95% CI = [8.5%, 23.7%]). CONCLUSION: Antidepressant use continues to increase in Australia overall and especially among young people. We found a differential impact of the COVID-19 pandemic in treated depression and anxiety, greater among females than males, and greater among young females than other age groups, suggesting an increased mental health burden in populations already on a trajectory of increased use of antidepressants prior to the pandemic. Reasons for these differences require further investigation.

Social networks and skilled health worker migration in Nigeria: An ego network analysis.

BACKGROUND: Nigeria provides a good case study for researchers, activists, and governments seeking to understand how social networks can help mitigate the negative impact of skilled health worker (SHW) migration in low and middle-income countries. This study aimed to map the social networks of SHWs and explore how they influence migration intentions. METHODS: We combined semi-structured qualitative interviews with an ego-network analysis of 22 SHWs living in Nigeria, used R-Studio to display and visualise their networks, and NVivo for thematic analysis of transcribed interviews. RESULTS: The network size and frequency of interaction were smaller among SHWs seeking to remain in Nigeria, however when compared to SHWs seeking to migrate, they had ties with a diverse group of stakeholders interested in improving health services. The influence of social networks on SHW migration intentions was observed within the following themes: access to information on migration opportunities, modelling of migration behaviour, support for decision making, and opportunities for policy engagement. CONCLUSION: The social networks of SHWs can aid the diffusion of norms that are relevant for improving SHW migration governance. Through their social networks, SHWs can improve awareness of the challenges associated with SHW migration among state actors and the public.

Promoting equitable health workforce distribution through improved migration governance: A mixed methods study of African health professionals' perceptions in Australia.

BACKGROUND: This study examined skilled health worker (SHW) migration governance in African countries and Australia, with an emphasis on areas of influence for achieving an equitable global health workforce distribution. METHODS: We used a mixed-methods research design with African SHW migrants in Australia. An institutional and rights-based framing of governance guided thematic analysis of the interviews, which was mapped to survey findings from a Bayesian Exploratory Factor Analysis. RESULTS: The findings imply that Australian state actors enforce laws that attract SHW migrants and promote safe clinical practice, but do not adequately address their integration concerns or role in health system strengthening. Non-state actors in Australia make donations to African health institutions but rarely promote health workforce equity. African state actors respond to increased SHW migration trends by increasing health worker training and limiting migration, but they lack a comprehensive governance framework for involving citizens and engaging foreign governments. There is limited evidence of a shared community definition of SHW migration governance in many African countries. CONCLUSION: When stakeholders in both sending and receiving countries recognise the indivisibility of the rights at stake (for example, SHW rights as migrants and the right to health), support for an equity-focused SHW migration governance system may increase. Promoting these rights can result in policies that enhance health system strengthening in destination and source countries. Similarly, growing adoption of these rights in sending countries should help inspire a coordinated plan for strengthening health system and SHW migration governance.

Addressing the challenges of noncommunicable diseases and injuries in Latin America and Asia-Pacific countries.

Not available.

The environment and kidney health: challenges and opportunities.

The accelerating environmental degradation as a result of modernisation and climate change is an urgent threat to human health. Environment change can impact kidney health in a variety of ways such as water scarcity, global heating and changing biodiversity. Ever increasing industrialization of health care has a large carbon footprint, with dialysis being a major contributor. There have been calls for all stakeholders to adopt a 'one health approach' and develop mitigation and adaptation strategies to combat this challenge. Because of its exquisite sensitivity to various elements of environment change, kidney health can be a risk marker and a therapeutic target for such interventions. In this narrative review, we discuss the various mechanisms through which environmental change is linked to kidney health and the ways that the global kidney health communities can respond to environmental change.

Going digital: opportunities and barriers in the use of technology for health research.

Digital health refers to the use of novel information com-munication technologies in healthcare. The use of these technologies could positively impact public health and health outcomes of populations by generating timely data, and facili-tating the process of data collection, analysis, and knowledge translation. Using selected case studies, we aim to describe the opportunities and barriers in the use of technology applied to health-related research. We focus on three areas: strategies to generate new data using novel data collection methods, strategies to use and analyze existing data, and using digital health for health-related interventions. Exemplars from seven countries are provided to illustrate activity across these areas. Although the use of health-related technologies is increasing, challenges remain to support their adoption and scale-up -especially for under-served populations. Research using digital health approaches should take a user-centered design, actively working with the population of interest to maximize their uptake and effectiveness.

Cardiovascular disease risk profile and management practices in 45 low-income and middle-income countries: A cross-sectional study of nationally representative individual-level survey data.

BACKGROUND: Global cardiovascular disease (CVD) burden is high and rising, especially in low-income and middle-income countries (LMICs). Focussing on 45 LMICs, we aimed to determine (1) the adult population's median 10-year predicted CVD risk, including its variation within countries by socio-demographic characteristics, and (2) the prevalence of self-reported blood pressure (BP) medication use among those with and without an indication for such medication as per World Health Organization (WHO) guidelines. METHODS AND FINDINGS: We conducted a cross-sectional analysis of nationally representative household surveys from 45 LMICs carried out between 2005 and 2017, with 32 surveys being WHO Stepwise Approach to Surveillance (STEPS) surveys. Country-specific median 10-year CVD risk was calculated using the 2019 WHO CVD Risk Chart Working Group non-laboratory-based equations. BP medication indications were based on the WHO Package of Essential Noncommunicable Disease Interventions guidelines. Regression models examined associations between CVD risk, BP medication use, and socio-demographic characteristics. Our complete case analysis included 600,484 adults from 45 countries. Median 10-year CVD risk (interquartile range [IQR]) for males and females was 2.7% (2.3%-4.2%) and 1.6% (1.3%-2.1%), respectively, with estimates indicating the lowest risk in sub-Saharan Africa and highest in Europe and the Eastern Mediterranean. Higher educational attainment and current employment were associated with lower CVD risk in most countries. Of those indicated for BP medication, the median (IQR) percentage taking medication was 24.2% (15.4%-37.2%) for males and 41.6% (23.9%-53.8%) for females. Conversely, a median (IQR) 47.1% (36.1%-58.6%) of all people taking a BP medication were not indicated for such based on CVD risk status. There was no association between BP medication use and socio-demographic characteristics in most of the 45 study countries. Study limitations include variation in country survey methods, most notably the sample age range and year of data collection, insufficient data to use the laboratory-based CVD risk equations, and an inability to determine past history of a CVD diagnosis. CONCLUSIONS: This study found underuse of guideline-indicated BP medication in people with elevated CVD risk and overuse by people with lower CVD risk. Country-specific targeted policies are needed to help improve the identification and management of those at highest CVD risk.

An electronic decision support-based complex intervention to improve management of cardiovascular risk in primary health care: a cluster randomised trial (INTEGRATE).

OBJECTIVES: To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. DESIGN, SETTING: Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 - 13 September 2019. PARTICIPANTS: General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. INTERVENTION: Electronic point-of-care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy-based medication adherence program. MAIN OUTCOME MEASURES: Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low-density lipoprotein (LDL) cholesterol goals at study end. RESULTS: After a median 15 months' follow-up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85-1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). CONCLUSIONS: Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement.

BACKGROUND: Growing evidence supports the benefits of eHealth interventions to increase patient engagement and improve outcomes for a range of conditions. However, ineffective program delivery and usage attrition limit exposure to these interventions and may reduce their effectiveness. OBJECTIVE: This study aims to evaluate the delivery fidelity of an eHealth intervention, describe use patterns, compare outcomes between low and high users, and identify mediating factors on intervention delivery and receipt. METHODS: This is a mixed methods study of an internet-based intervention being evaluated for effectiveness in a randomized controlled trial (RCT). The intervention comprised medication and cardiovascular disease (CVD) risk data uploaded from the primary care electronic health record (EHR); interactive, personalized CVD risk score estimation; goal setting and self-monitoring; an interactive social forum; and optional receipt of heart health messages. Fidelity was assessed over 12 months. Trial outcomes were compared between low and high users. Data sources included program delivery records, web log data, trial data, and thematic analysis of communication records. RESULTS: Most participants in the intervention group (451/486, 93%) had an initial training session conducted by telephone (413/447, 92.4% of participants trained), with a mean duration of 44 minutes (range 10-90 minutes). Staff conducted 98.45% (1776/1804) of the expected follow-ups, mostly by telephone or email. Of the 451 participants who commenced log-ins, 46.8% (211) were categorized as low users (defined as at least one log-in in 3 or fewer months of follow-up), 40.4% (182) were categorized as high users (at least one log-in in more than 3 months of follow-up), and 12.8% (58) were nonadopters (no log-ins after their training session). The mean log-in frequency was 3-4 per month in ongoing users. There was no significant difference between the groups in the primary trial outcome of adherence to guideline-recommended medications (P=.44). In unadjusted analyses, high users had significantly greater eHealth literacy scores (P=.003) and were more likely to meet recommended weekly targets for fruit (P=.03) and fish (P=.004) servings; however, the adjusted findings were not significant. Interactive screen use was highest for goal tracking and lowest for the chat forum. Screens with EHR-derived data held only an early interest for most users. Fidelity measures (reach, content, dose delivered, and dose received) were influenced by the facilitation strategies used by staff, invisible qualities of staff-participant communication, and participants' responsiveness to intervention attributes. CONCLUSIONS: A multifeature internet-based intervention was delivered with high fidelity to the RCT protocol and was regularly used by 40.4% (182/451) of users over 12 months. Higher log-in frequency as an indicator of greater intervention exposure was not associated with statistically significant improvements in eHealth literacy scores, lifestyle changes, or clinical outcomes. Attributes of the intervention and individualized support influenced initial and ongoing use.

A computer-guided quality improvement tool for primary health care: cost-effectiveness analysis based on TORPEDO trial data.

OBJECTIVE: To assess the cost-effectiveness of a computer-guided quality improvement intervention for primary health care management of cardiovascular disease (CVD) in people at high risk. DESIGN: Modelled cost-effectiveness analysis of the HealthTracker intervention and usual care for people with high CVD risk, based on TORPEDO trial data on prescribing patterns, changes in intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores. PARTICIPANTS: Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size. INTERVENTION: HealthTracker, integrated into health care provider electronic health record systems, provides real time decision support, risk communication, a clinical audit tool, and a web portal for performance feedback. MAIN OUTCOME MEASURES: Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker. RESULTS: The estimated numbers of major CVD events over five years per 1000 patients at high CVD risk were lower in PHNs using HealthTracker, both for patients with prior CVD events (secondary prevention; 259 v 267 with usual care) and for those without prior events (primary prevention; 168 v 176). Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention. The estimated ICER for one averted CVD event was $7406 for primary prevention and $17 988 for secondary prevention. CONCLUSION: Modelled cost-effectiveness analyses provide information that can assist decisions about investing in health care quality improvement interventions. We estimate that HealthTracker could prevent major CVD events for less than $20 000 per event averted. TRIAL REGISTRATION (TORPEDO): Australian New Zealand Clinical Trials Registry, ACTRN 12611000478910.

Cardiovascular disease risk assessment for Aboriginal and Torres Strait Islander adults aged under 35 years: a consensus statement.

Cardiovascular disease (CVD) is a leading cause of preventable morbidity and mortality in Aboriginal and Torres Strait Islander peoples. This statement from the Australian Chronic Disease Prevention Alliance, the Royal Australian College of General Practitioners, the National Aboriginal Community Controlled Health Organisation and the Editorial Committee for Remote Primary Health Care Manuals communicates the latest consensus advice of guideline developers, aligning recommendations on the age to commence Aboriginal and Torres Strait Islander CVD risk assessment across three guidelines. MAIN RECOMMENDATIONS: In Aboriginal and Torres Strait Islander peoples without existing CVD: CVD risk factor screening should commence from the age of 18 years at the latest, including for blood glucose level or glycated haemoglobin, estimated glomerular filtration rate, serum lipids, urine albumin to creatinine ratio, and other risk factors such as blood pressure, history of familial hypercholesterolaemia, and smoking status. Individuals aged 18-29 years with the following clinical conditions are automatically conferred high CVD risk: ▶type 2 diabetes and microalbuminuria; ▶moderate to severe chronic kidney disease; ▶systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg; ▶familial hypercholesterolaemia; or ▶serum total cholesterol > 7.5 mmol/L. Assessment using the National Vascular Disease Prevention Alliance absolute CVD risk algorithm should commence from the age of 30 years at the latest - consider upward adjustment of calculated CVD risk score, accounting for local guideline use, risk factor and CVD epidemiology, and clinical discretion. Assessment should occur as part of an annual health check or opportunistically. Subsequent review should be conducted according to level of risk. CHANGES IN MANAGEMENT AS A RESULT OF THIS STATEMENT: From age 18 years (at the latest), Aboriginal and Torres Strait Islander adults should undergo CVD risk factor screening, and from age 30 years (at the latest), they should undergo absolute CVD risk assessment using the NVDPA risk algorithm.

A realist evaluation approach to explaining the role of context in the impact of a complex eHealth intervention for improving prevention of cardiovascular disease.

BACKGROUND: Reduction of cardiovascular disease (CVD) is a worldwide health priority and innovative uses of technology-based interventions may assist patients with improving prevention behaviours. Targeting these interventions to recipients most likely to benefit requires understanding how contexts of use influence responsiveness to the intervention, and how this interaction favours or discourages health behaviour. Using a realist evaluation approach, the aim of this study was to examine the contextual factors influencing behaviour change within a multi-feature eHealth intervention with personalised data integration from the primary care electronic health record (EHR). METHODS: Realist evaluation of qualitative data from the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised trial (N = 934). Thirty-six participants from the intervention group (N = 486) who had completed 12 months of study follow-up were interviewed. Coding of transcripts was structured around configurations of contexts, mechanisms, and outcomes of intervention use. Contextual narratives were derived from thematic analysis of the interviews. RESULTS: Mechanisms favouring positive health behaviour occurred when participants responded to four interactive features of the intervention. Facilitating mechanisms included greater cognitive engagement whereby participants perceived value and benefit, and felt motivated, confident and incentivised. Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention. Increased personalisation occurred when modifiable CVD risk factors became relatable to lifestyle behaviour; and experiences of feeling greater agency/self-efficacy emerged. Use and non-use of the intervention were influenced by four overarching narratives within the individual's micro-level and meso-level environments: illness experiences; receptiveness to risk and prevention information; history of the doctor-patient relationship; and relationship with technology. CONCLUSIONS: Intervention-context interactions are central to understanding how change mechanisms activate within complex interventions to exert their impact on recipients. Intervention use and non-use were context-dependent, underscoring the need for further research to target eHealth innovations to those most likely to benefit.

The Systematic Medical Appraisal Referral and Treatment Mental Health Project: Quasi-Experimental Study to Evaluate a Technology-Enabled Mental Health Services Delivery Model Implemented in Rural India.

BACKGROUND: Although around 10% of Indians experience depression, anxiety, or alcohol use disorders, very few receive adequate mental health care, especially in rural communities. Stigma and limited availability of mental health services contribute to this treatment gap. The Systematic Medical Appraisal Referral and Treatment Mental Health project aimed to address this gap. OBJECTIVE: This study aimed to evaluate the effectiveness of an intervention in increasing the use of mental health services and reducing depression and anxiety scores among individuals at high risk of common mental disorders. METHODS: A before-after study was conducted from 2014 to 2019 in 12 villages in Andhra Pradesh, India. The intervention comprised a community antistigma campaign, with the training of lay village health workers and primary care doctors to identify and manage individuals with stress, depression, and suicide risk using an electronic clinical decision support system. RESULTS: In total, 900 of 22,046 (4.08%) adults screened by health workers had increased stress, depression, or suicide risk and were referred to a primary care doctor. At follow-up, 731 out of 900 (81.2%) reported visiting the doctor for their mental health symptoms, compared with 3.3% (30/900) at baseline (odds ratio 133.3, 95% CI 89.0 to 199.7; P<.001). Mean depression and anxiety scores were significantly lower postintervention compared with baseline from 13.4 to 3.1 (P<.001) and from 12.9 to 1.9 (P<.001), respectively. CONCLUSIONS: The intervention was associated with a marked increase in service uptake and clinically important reductions in depression and anxiety symptom scores. This will be further evaluated in a large-scale cluster randomized controlled trial.

Using developmental evaluation to enhance continuous reflection, learning and adaptation of an innovation platform in Australian Indigenous primary healthcare.

Effective efforts to strengthen health systems need diverse, multi-stakeholder networks working together on complex or 'wicked' problems such as prevention and control of chronic diseases, solutions to which go beyond the role and capability of one organisation. The contextual complexities inherent in 'wicked' problems mean that solutions warrant a systems approach that encompasses innovation and new ways of thinking about, facilitating and implementing collective decision-making processes and change practices.Innovation platforms are a mechanism for facilitating communication and collaboration among diverse stakeholders, promoting joint action and stimulating innovation. Developmental evaluation is an approach that is increasingly being used to evaluate innovative and emergent programmes and projects, as it enables evaluators to provide real-time feedback so that evaluation findings can be used to guide development and adaptations. Developmental evaluation emphasises learning and adaptation, and aligns well with the implementation of innovation platforms that have continuous reflection, learning and adaptation as a specific design principle.Here, we outline our rationale for applying a developmental evaluation to enhance the formation, functioning and outcomes of an innovation platform aimed at accelerating and strengthening large-scale quality improvement efforts in Australian Aboriginal and Torres Strait Islander primary healthcare. We provide examples to explain how the developmental evaluation findings were used for adaptation of the innovation platform and assess to what extent our application of developmental evaluation was consistent with, and reflective of, its essential principles.Our evaluation aligned strongly with the principles of developmental evaluation, and the approach we took was well suited to situations with a developmental purpose, innovation niche and complexity such as innovation platforms. As a result, along with the increasing interest in multi-stakeholder platforms (e.g. innovation platforms) and the inherent challenges with evaluating these complex networks, we anticipate our use of this approach being of interest globally.

The NASSS framework for ex post theorisation of technology-supported change in healthcare: worked example of the TORPEDO programme.

BACKGROUND: Evaluation of health technology programmes should be theoretically informed, interdisciplinary, and generate in-depth explanations. The NASSS (non-adoption, abandonment, scale-up, spread, sustainability) framework was developed to study unfolding technology programmes in real time-and in particular to identify and manage their emergent uncertainties and interdependencies. In this paper, we offer a worked example of how NASSS can also inform ex post (i.e. retrospective) evaluation. METHODS: We studied the TORPEDO (Treatment of Cardiovascular Risk in Primary Care using Electronic Decision Support) research programme, a multi-faceted computerised quality improvement intervention for cardiovascular disease prevention in Australian general practice. The technology (HealthTracker) had shown promise in a cluster randomised controlled trial (RCT), but its uptake and sustainability in a real-world implementation phase was patchy. To explain this variation, we used NASSS to undertake secondary analysis of the multi-modal TORPEDO dataset (results and process evaluation of the RCT, survey responses, in-depth professional interviews, videotaped consultations) as well as a sample of new, in-depth narrative interviews with TORPEDO researchers. RESULTS: Ex post analysis revealed multiple areas of complexity whose influence and interdependencies helped explain the wide variation in uptake and sustained use of the HealthTracker technology: the nature of cardiovascular risk in different populations, the material properties and functionality of the technology, how value (financial and non-financial) was distributed across stakeholders in the system, clinicians' experiences and concerns, organisational preconditions and challenges, extra-organisational influences (e.g. policy incentives), and how interactions between all these influences unfolded over time. CONCLUSION: The NASSS framework can be applied retrospectively to generate a rich, contextualised narrative of technology-supported change efforts and the numerous interacting influences that help explain its successes, failures, and unexpected events. A NASSS-informed ex post analysis can supplement earlier, contemporaneous evaluations to uncover factors that were not apparent or predictable at the time but dynamic and emergent.

Strengthening and measuring research impact in global health: lessons from applying the FAIT framework.

BACKGROUND: To date, efforts to measure impact have largely focused on health research in high-income countries, reflecting where the majority of health research funding is spent. Nevertheless, there is a growing body of health and medical research being undertaken in low- and middle-income countries (LMICs), supported by both development aid and established research funders. The Framework to Assess the Impact of Translational health research (FAIT) combines three approaches to measuring research impact (Payback, economic assessment and case study narrative). Its aim is to strengthen the focus on translation and impact measurement in health research. FAIT has been used by several Australian research initiatives; however, it has not been used in LMICs. Our aim was to apply FAIT in an LMIC context and evaluate its utility. METHODS: We retrospectively applied all three FAIT methods to two LMIC studies using available data, supplemented with group discussion and further economic analyses. Results were presented in a scorecard format. RESULTS: FAIT helped clarify pathways of impact for the projects and provided new knowledge on areas of impact in several domains, including capacity-building for research, policy development and economic impact. However, there were constraints, particularly associated with calculating the return on investment in the LMIC context. The case study narrative provided a layperson's summary of the research that helped to explain outcomes and succinctly communicate lessons learnt. CONCLUSION: Use of FAIT to assess the impact of LMIC research was both feasible and useful. We make recommendations related to prospective use, identification of metrics to support use of the Payback framework, and simplification of the economic assessment, which may facilitate further application in LMIC environments.

Developing cardiovascular disease risk programs in India-Why location and wealth matter.

In a Perspective, David Peiris and Dorairaj Prabhakaran discuss implications and challenges of cardiovascular disease risk assessments in the population of India.

Quarter-dose quadruple combination therapy for initial treatment of hypertension: placebo-controlled, crossover, randomised trial and systematic review.

BACKGROUND: Globally, most patients with hypertension are treated with monotherapy, and control rates are poor because monotherapy only reduces blood pressure by around 9/5 mm Hg on average. There is a pressing need for blood pressure-control strategies with improved efficacy and tolerability. We aimed to assess whether ultra-low-dose combination therapy could meet these needs. METHODS: We did a randomised, placebo-controlled, double-blind, crossover trial of a quadpill-a single capsule containing four blood pressure-lowering drugs each at quarter-dose (irbesartan 37·5 mg, amlodipine 1·25 mg, hydrochlorothiazide 6·25 mg, and atenolol 12·5 mg). Participants with untreated hypertension were enrolled from four centres in the community of western Sydney, NSW, Australia, mainly by general practitioners. Participants were randomly allocated by computer to either the quadpill or matching placebo for 4 weeks; this treatment was followed by a 2-week washout, then the other study treatment was administered for 4 weeks. Study staff and participants were unaware of treatment allocations, and masking was achieved by use of identical opaque capsules. The primary outcome was placebo-corrected 24-h systolic ambulatory blood pressure reduction after 4 weeks and analysis was by intention to treat. We also did a systematic review of trials evaluating the efficacy and safety of quarter-standard-dose blood pressure-lowering therapy against placebo. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614001057673. The trial ended after 1 year and this report presents the final analysis. FINDINGS: Between November, 2014, and December, 2015, 55 patients were screened for our randomised trial, of whom 21 underwent randomisation. Mean age of participants was 58 years (SD 11) and mean baseline office and 24-h systolic and diastolic blood pressure levels were 154 (14)/90 (11) mm Hg and 140 (9)/87 (8) mm Hg, respectively. One individual declined participation after randomisation and two patients dropped out for administrative reasons. The placebo-corrected reduction in systolic 24-h blood pressure with the quadpill was 19 mm Hg (95% CI 14-23), and office blood pressure was reduced by 22/13 mm Hg (p<0·0001). During quadpill treatment, 18 (100%) of 18 participants achieved office blood pressure less than 140/90 mm Hg, compared with six (33%) of 18 during placebo treatment (p=0·0013). There were no serious adverse events and all patients reported that the quadpill was easy to swallow. Our systematic review identified 36 trials (n=4721 participants) of one drug at quarter-dose and six trials (n=312) of two drugs at quarter-dose, against placebo. The pooled placebo-corrected blood pressure-lowering effects were 5/2 mm Hg and 7/5 mm Hg, respectively (both p<0·0001), and there were no side-effects from either regimen. INTERPRETATION: The findings of our small trial in the context of previous randomised evidence suggest that the benefits of quarter-dose therapy could be additive across classes and might confer a clinically important reduction in blood pressure. Further examination of the quadpill concept is needed to investigate effectiveness against usual treatment options and longer term tolerability. FUNDING: National Heart Foundation, Australia; University of Sydney; and National Health and Medical Research Council of Australia.