Cost-utility analysis of adjunct repetitive transcranial magnetic stimulation for treatment resistant bipolar depression.

OBJECTIVE: To evaluate the cost-effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an adjunct to standard care from an Australian health sector perspective, compared to standard care alone for adults with treatment-resistant bipolar depression (TRBD). METHODS: An economic model was developed to estimate the cost per disability-adjusted life-year (DALY) averted and quality-adjusted life-year (QALY) gained for rTMS added to standard care compared to standard care alone, for adults with TRBD. The model simulated the time in three health states (mania, depression, residual) over one year. Response to rTMS was sourced from a meta-analysis, converted to a relative risk and used to modify the time in the depressed state. Uncertainty and sensitivity tested the robustness of results. RESULTS: Base-case incremental cost-effectiveness ratios (ICERs) were $72,299 per DALY averted (95 % Uncertainty Interval (UI): $60,915 to $86,668) and $46,623 per QALY gained (95 % UI: $39,676 - $55,161). At a willingness to pay (WTP) threshold of $96,000 per DALY averted, the base-case had a 100 % probability of being marginally cost-effective. At a WTP threshold of $64,000 per QALY gained, the base-case had a 100 % probability of being cost-effective. Sensitivity analyses decreasing the number of sessions provided, increasing the disability weight or the time spent in the depression state for standard care improved the ICERs for rTMS. CONCLUSIONS: Dependent on the outcome measure utilised and assumptions, rTMS would be considered a very cost-effective or marginally cost-effective adjunct to standard care for TRBD compared to standard care alone.

Preventive health resource allocation decision-making processes and the use of economic evidence in an Australian state government-A mixed methods study.

CONTEXT: Recommended best practice for resource allocation decisions by governments include a stepwise process guided by economic evidence. However, the use of economic evidence in preventive health decision-making, which often impacts on multiple sectors of government, is under-researched. This study aimed to explore the resource allocation decision-making processes for preventive health interventions in the New South Wales (NSW) Government in Australia, and specifically examined the barriers and facilitators to the use of economic evidence from the perspective of multiple government departments. METHODS: This mixed methods study was conducted using semi-structured interviews with NSW Treasury representatives (n = 4), a focus group of NSW Ministry of Health representatives (n = 9), and a quantitative questionnaire of all participants. The schedule for the interviews and focus group was based on resource allocation guidance documents from Australian government agencies. Deductive content analysis was undertaken, guided by the Multiple Streams Framework. FINDINGS: NSW Treasury participants believed that decision-making processes where economic efficiency was the key guiding principle was the ideal approach. However, the NSW Ministry of Health participants identified that for preventive health decision-making, economic evidence was not used to inform their own choices but was typically only used to convince other agencies of the merits of proposed initiatives when seeking approval. The key barriers to the use of economic evidence were the lack of capacity within the NSW Ministry of Health to understand and undertake economic evaluations; a lack of collaboration between NSW Treasury and preventive health decision-makers within the NSW Ministry of Health; and deficient processes and governance mechanisms that do not facilitate or incentivise effective inter-sectoral decision-making. CONCLUSIONS: Institutional structures for resource allocation decision-making regarding preventive health result in processes that contrast with best practice recommendations. The multiple challenges to collaborative decision-making across agencies require organisational change to promote a whole-of-government approach.

Cost-Benefit and Cost-Utility Analyses to Demonstrate the Potential Value-for-Money of Supermarket Shelf Tags Promoting Healthier Packaged Products in Australia.

The supermarket environment impacts the healthiness of food purchased and consumed. Shelf tags that alert customers to healthier packaged products can improve the healthiness of overall purchases. This study assessed the potential value-for-money of implementing a three-year shelf tag intervention across all major supermarket chains in Australia. Cost-benefit analyses (CBA) and cost-utility analyses (CUA) were conducted based on results of a 12-week non-randomised controlled trial of a shelf tag intervention in seven Australian supermarkets. The change in energy density of all packaged foods purchased during the trial was used to estimate population-level changes in mean daily energy intake. A multi-state, multiple-cohort Markov model estimated the subsequent obesity-related health and healthcare cost outcomes over the lifetime of the 2019 Australian population. The CBA and CUA took societal and healthcare sector perspectives, respectively. The intervention was estimated to produce a mean reduction in population body weight of 1.09 kg. The net present value of the intervention was approximately AUD 17 billion (B). Over 98% of the intervention costs were borne by supermarkets. CUA findings were consistent with the CBA-the intervention was dominant, producing both health benefits and cost-savings. Shelf tags are likely to offer excellent value-for-money from societal and healthcare sector perspectives.

A cost-benefit analysis framework for preventive health interventions to aid decision-making in Australian governments.

BACKGROUND: Australian governments are increasingly mandating the use of cost-benefit analysis (CBA) to inform the efficient allocation of government resources. CBA is likely to be useful when evaluating preventive health interventions that are often cross-sectoral in nature and require Cabinet approval prior to implementation. This study outlines a CBA framework for the evaluation of preventive health interventions that balances the need for consistency with other agency guidelines whilst adhering to guidelines and conventions for health economic evaluations. METHODS: We analysed CBA and other evaluation guidance documents published by Australian federal and New South Wales (NSW) government departments. Data extraction compared the recommendations made by different agencies and the impact on the analysis of preventive health interventions. The framework specifies a reference case and sensitivity analyses based on the following considerations: (1) applied economic evaluation theory; (2) consistency between CBA across different government departments; (3) the ease of moving from a CBA to a more conventional cost-effectiveness/cost-utility analysis framework often used for health interventions; (4) the practicalities of application; and (5) the needs of end users being both Cabinet decision-makers and health policy-makers. RESULTS: Nine documents provided CBA or relevant economic evaluation guidance. There were differences in terminology and areas of agreement and disagreement between the guidelines. Disagreement between guidelines involved (1) the community included in the societal perspective; (2) the number of options that should be appraised in ex ante analyses; (3) the appropriate time horizon for interventions with longer economic lives; (4) the theoretical basis and value of the discount rate; (5) parameter values for variables such as the value of a statistical life; and (6) the summary measure for decision-making. CONCLUSIONS: This paper addresses some of the methodological challenges that have hindered the use of CBA in prevention by outlining a framework that is consistent with treasury department guidelines whilst considering the unique features of prevention policies. The effective use and implementation of a preventive health CBA framework is likely to require considerable investment of time and resources from state and federal government departments of health and treasury but has the potential to improve decision-making related to preventive health policies and programmes.

Systematic Review to Update 'Value of a Statistical Life' Estimates for Australia.

The value of a statistical life (VSL) estimates individuals' willingness to trade wealth for mortality risk reduction. This economic parameter is often a major component of the quantified benefits estimated in the evaluation of government policies related to health and safety. This study reviewed the literature to update the VSL recommended for Australian policy appraisals. A systematic literature review was conducted to capture Australian primary studies and international review papers reporting VSL estimates published from 2007 to January 2019. International estimates were adjusted for income differences and the median VSL estimate was extracted from each review study. VSL estimates were used to calculate the value of a statistical life year. Of the 18 studies that met the inclusion criteria, two studies were primary Australian studies with a weighted mean VSL of A$7.0 million in 2017 values. The median VSL in the review studies was A$7.3 million. For Australian public policy appraisals, we recommend the consideration of a base case VSL for people of all ages and across all risk contexts of A$7.0 million. Sensitivity analyses could use a high value of A$7.3 million and a low value that reflects the value (A$4.3 million) currently recommended by the Australian government.

Correction: Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis.

[This corrects the article DOI: 10.1371/journal.pmed.1002326.].

Priority-setting for obesity prevention-The Assessing Cost-Effectiveness of obesity prevention policies in Australia (ACE-Obesity Policy) study.

The aim of the ACE-Obesity Policy study was to assess the economic credentials of a suite of obesity prevention policies across multiple sectors and areas of governance for the Australian setting. The study aimed to place the cost-effectiveness results within a broad decision-making context by providing an assessment of the key considerations for policy implementation. The Assessing Cost-Effectiveness (ACE) approach to priority-setting was used. Systematic literature reviews were undertaken to assess the evidence of intervention effectiveness on body mass index and/or physical activity for selected interventions. A standardised evaluation framework was used to assess the cost-effectiveness of each intervention compared to a 'no intervention' comparator, from a limited societal perspective. A multi-state life table Markov cohort model was used to estimate the long-term health impacts (quantified as health adjusted life years (HALYs)) and health care cost-savings resulting from each intervention. In addition to the technical cost-effectiveness results, qualitative assessments of implementation considerations were undertaken. All 16 interventions evaluated were found to be cost-effective (using a willingness-to-pay threshold of AUD50,000 per HALY gained). Eleven interventions were dominant (health promoting and cost-saving). The incremental cost-effectiveness ratio for the non-dominant interventions ranged from AUD1,728 to 28,703 per HALY gained. Regulatory interventions tended to rank higher on their cost-effectiveness results, driven by lower implementation costs. However, the program-based policy interventions were generally based on higher quality evidence of intervention effectiveness. This comparative analysis of the economic credentials of obesity prevention policies for Australia indicates that there are a broad range of policies that are likely to be cost-effective, although policy options vary in strength of evidence for effectiveness, affordability, feasibility, acceptability to stakeholders, equity impact and sustainability. Implementation of these policies will require sustained co-ordination across jurisdictions and multiple government sectors in order to generate the predicted health benefits for the Australian population.

Health-related quality of life and upper-limb impairment in children with cerebral palsy: developing a mapping algorithm.

AIM: To: (1) investigate the relationship between upper-limb impairment and health-related quality of life (HRQoL) for children with cerebral palsy and (2) develop a mapping algorithm from the Cerebral Palsy Quality of Life Questionnaire for Children (CPQoL-Child) onto the Child Health Utility 9D (CHU9D) measure. METHOD: The associations between physical and upper-limb classifications and HRQoL of 76 children (40 females, 36 males) aged 6 to 15 years (mean age 9 years 7 months [SD 3y]) were assessed. Five statistical techniques were developed and tested, which predicted the CHU9D scores from the CPQoL-Child total/domain scores, age, and sex. RESULTS: Most participants had mild impairments. The Manual Ability Classification System (MACS) level was significantly negatively correlated with CHU9D and CPQoL-Child (r=-0.388 and r=-0.464 respectively). There was a negative correlation between the Neurological Hand Deformity Classification (NHDC) and CPQoL-Child (r=-0.476, p<0.05). The generalized linear model with participation, pain domain, and age had the highest predictive accuracy. INTERPRETATION: The weak negative correlations between classification levels and HRQoL measures may be explained by the restricted range of impairment levels of the participants. The MACS and NHDC explained the impact of upper-limb impairment on HRQoL better than the other classifications. The generalized linear model with participation, pain, and age is the suggested mapping algorithm. The suggested mapping algorithm will facilitate the use of CPQoL-Child for economic evaluation and can be used to conduct cost-utility analyses. WHAT THIS PAPER ADDS: The Manual Ability Classification System and Neurological Hand Deformity Classification were the best predictors of health-related quality of life measures. Age and Cerebral Palsy Quality of Life Questionnaire for Children participation and pain domain scores can predict Child Health Utility 9D scores.

The economic cost of preventable disease in Australia: a systematic review of estimates and methods.

OBJECTIVE: The aim of this literature review was to establish the economic burden of preventable disease in Australia in terms of attributable health care costs, other costs to government and reduced productivity. METHODS: A systematic review was conducted to establish the economic cost of preventable disease in Australia and ascertain the methods used to derive these estimates. Nine databases and the grey literature were searched, limited to the past 10 years, and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were followed to identify, screen and report on eligible studies. RESULTS: Eighteen studies were included. There were at least three studies examining the attributable costs and economic impact for each risk factor. The greatest costs were related to the productivity impacts of preventable risk factors. Estimates of the annual productivity loss that could be attributed to individual risk factors were between $840 million and $14.9 billion for obesity; up to $10.5 billion due to tobacco; between $1.1 billion and $6.8 billion for excess alcohol consumption; up to $15.6 billion due to physical inactivity and $561 million for individual dietary risk factors. Productivity impacts were included in 15 studies and the human capital approach was the method most often employed (14 studies) to calculate this. CONCLUSIONS: Substantial economic burden is caused by lifestyle-related risk factors. Implications for public health: The significant economic burden associated with preventable disease provides an economic rationale for action to reduce the prevalence of lifestyle-related risk factors. New analysis of the economic burden of multiple risk factors concurrently is needed.

A Systematic Review and Meta-Analysis of Prostate Cancer Utility Values of Patients and Partners Between 2007 and 2016.

Background. There is widespread agreement that both the length and quality of life matter when assessing new technologies and/or models of care in the treatment for cancer patients. Quality of life for partners/carers also matters, particularly for prostate cancer. Purpose. This systematic review aims to provide up-to-date utility values along the prostate cancer care continuum (i.e., from prescreening through to palliative care) for use where future trial-based or modelled economic evaluations cannot collect primary data from men and/or partners. Data Sources. A protocol was developed and registered on the international register of systematic reviews-PROSPERO. Databases searched included EBSCO Information Services (CINAHL, EconLit, Global Health, HEED, MEDLINE Complete, PsycINFO), Cochrane Database of Systematic Reviews, Web of Science, and Embase. Study Selection. Study selection terms included health-related quality of life, prostate cancer, and partners or carers. Data Extraction. The authors identified articles published between 2007 and 2016 that provided health state utility values, with statistical uncertainty, for men with or at risk of prostate cancer and/or their partner/carers. Data Synthesis and Results. Study quality and generalizability of utilities was evaluated and meta-analysis conducted against prespecified criteria. From 906 original articles, 29 recent primary studies met the inclusion/exclusion criteria. We tabulate all the utility values with uncertainty, along with considerable methodological detail and patient population characteristics. Limitations. Utility values pertaining to carers/partners were limited to one study. Conclusions. Studies varied in design, measurement instruments utilized, quality, and generalizability. There is sufficient qualitative and quantitative detail for the reported utility values to be readily incorporated into economic evaluations. More research is needed with carers/partners and with newly developing prostate cancer-specific quality of life tools.

The health burden of preventable disease in Australia: a systematic review.

OBJECTIVE: A systematic review was conducted to determine the health burden of preventable disease in Australia. METHODS: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement guidelines were followed to identify, screen and describe the protocols used in the systematic review. RESULTS: Eleven studies were included in the review. Data on the health burden associated with lifestyle-related risk factors were extracted by disease with outcomes reported in attributable number and proportion of deaths, years of life lost, years lived with disability and disability-adjusted life years (DALYs). Around one-third of DALYs was attributed to all modifiable risk factors. The range of estimates of DALYs attributable to each prioritised risk factor was: combined dietary risk factors, 7.2% to 9.7%; tobacco, 7.9% to 9.0%; alcohol, 5.1% to 12.2%; high body mass, 5.5% to 8.3%; and physical inactivity, 1.2% to 5.5%. CONCLUSIONS: Although the methods used to estimate preventable health burden varied greatly between studies, all found that a substantial amount of death and disability was attributable to lifestyle-related risk factors. Implications for public health: There is a large health burden in Australia caused by modifiable risk factors and further action is warranted to address this burden.

Equity Weights for Socioeconomic Position: Two Methods-Survey of Stated Preferences and Epidemiological Data.

BACKGROUND: There is an implicit equity approach in cost-effectiveness analysis that values health gains of socioeconomic position groups equally. An alternative approach is to integrate equity by weighting quality-adjusted life-years according to the socioeconomic position group. OBJECTIVES: To use two approaches to derive equity weights for use in cost-effectiveness analysis in Australia, in contexts in which the use of the traditional nonweighted quality-adjusted life-years could increase health inequalities between already disadvantaged groups. METHODS: Equity weights derived using epidemiological data used burden of disease and mortality data by Socio-Economic Indexes for Areas quintiles from the Australian Institute of Health and Welfare. Two ratios were calculated comparing quintile 1 (lowest) to the total Australian population, and comparing quintile 1 to quintile 5 (highest). Preference-based weights were derived using a discrete choice experiment survey (n = 710). Respondents chose between two programs, with varying gains in life expectancy going to a low- or a high-income group. A probit model incorporating nominal values of the difference in life expectancy was estimated to calculate the equity weights. RESULTS: The epidemiological weights ranged from 1.2 to 1.5, with larger weights when quintile 5 was the denominator. The preference-based weights ranged from 1.3 (95% confidence interval 1.2-1.4) to 1.8 (95% confidence interval 1.6-2.0), with a tendency for increasing weights as the gains to the low-income group increased. CONCLUSIONS: Both methods derived plausible and consistent weights. Using weights of different magnitudes in sensitivity analysis would allow the appropriate weight to be considered by decision makers and stakeholders to reflect policy objectives.

Economic evaluation of simulated and traditional clinical placements in occupational therapy education.

INTRODUCTION: This economic evaluation complements results of the randomised controlled trial that established non-inferiority of the learning outcomes of a one-week simulated clinical placement (SCP) in occupational therapy qualifying degrees in comparison to an equivalent traditional clinical placement (TCP). This companion study presents detailed cost analyses of two placement alternatives and a cost-benefit study to assess the value for money of SCP. An economic evaluation of simulated versus traditional placements has not previously been conducted in Australia. METHODS: Nine SCP/TCP rounds were conducted by six Australian universities. Costs were collected using study-specific instruments. Public health sector costs were sourced from available literature. Willingness-to-pay for SCP/TCP was estimated using both a Discrete Choice Experiment and a Contingent Valuation method. These methods were employed to assess a comparative 'value' of SCP/TCP from the perspective of heads of occupational therapy departments (N = 28), who were asked to put a monetary value on the broader range of benefits associated with SCP/TCP. RESULTS: From the universities' perspective the average cost per student ranged from AUD$460 to AUD$1511 for simulated and AUD$144 to AUD$1112 for traditional placement. From the health care sector perspective, the difference in costs favoured simulated placements for four implementations and traditional placements for five. In the Discrete Choice Experiment respondents preferred traditional rather than simulated placement and would pay additional AUD$533. The estimated monetary value of simulated placements from a contingent valuation ranged from AUD$200 to AUD$1600. CONCLUSIONS: For universities that procure TCPs predominately at public health care facilities and sustain high administrative overheads, the SCP program could be a cost-saving alternative. From a broader value-for-money perspective, respondents favoured TCP over SCP, yet placed importance on placement availability and opportunity to demonstrate competence for students during the placement. Results should be interpreted with caution and further research with larger sample sizes is required.

A systematic review of utility values in children with cerebral palsy.

PURPOSE: Project aims include the following: (i) to identify reported utility values associated with CP in children aged ≤ 18 years; (ii) to explore utility value elicitation techniques in published studies; and (iii) to examine performance of the measures and/or elicitation approaches. METHODS: Peer-reviewed studies published prior to March 2017 were identified from six electronic databases. Construct validity, convergent validity, responsiveness, and reliability of instruments were assessed. RESULTS: Five studies met the inclusion criteria. Utility values of hypothetical general CP states obtained from a general population of parents ranged from 0.55 to 0.88 using time trade off (TTO) and 0.60-0.87 using standard gamble (SG) techniques. Utility values reported by clinicians of three hypothetical spastic quadriplegic CP states, using the Health Utility Index Mark 2 (HUI-2), ranged from 0.40 to 0.13. Other sources of utilities identified were based on both proxy and child ratings using Health Utility Index Mark 3 (HUI-3) (values ranged from - 0.013 to 0.84 depending on the valuation source) and the Assessment of Quality of Life 4 Dimension instrument, with values ranging from 0.01 to 0.58. Construct validity of the HUI-3 varied from moderate to strong, whereas mixed results were found for convergent validity. Responsiveness and reliability were not reported. CONCLUSION: There was substantial variation in reported utilities. Indirect techniques (i.e. via multi-attribute utility instruments) were more frequently used than direct techniques (e.g. TTO, SG). Further research is required to improve the robustness of utility valuation of health-related quality of life in children with CP for use in economic evaluation.

Extending the paradigm: a policy framework for healthy and equitable eating (HE2).

OBJECTIVE: The current short communication aimed to provide a new conceptualisation of the policy drivers of inequities in healthy eating and to make a call to action to begin populating this framework with evidence of actions that can be taken to reduce the inequities in healthy eating. DESIGN: The Healthy and Equitable Eating (HE2) Framework derives from a systems-based analytical approach involving expert workshops. SETTING: Australia. SUBJECTS: Academics, government officials and non-government organisations in Australia. RESULTS: The HE2 Framework extends previous conceptualisations of policy responses to healthy eating to include the social determinants of healthy eating and its social distribution, encompassing policy areas including housing, social protection, employment, education, transport, urban planning, plus the food system and environment. CONCLUSIONS: As the burden of non-communicable diseases continues to grow globally, it is important that governments, practitioners and researchers focus attention on the development and implementation of policies beyond the food system and environment that can address the social determinants of inequities in healthy eating.

Systematic review of the economic impact of cerebral palsy.

BACKGROUND: Cerebral palsy (CP) and its associated conditions can pose a significant economic burden on families, the health care system and the general economy. The boundary for inclusion of costs in research can vary substantially across studies. AIMS: To summarize the evidence for burden of disease for CP including the impacts on the health system, the community and carers. METHODS: Literature was identified from Ovid Medline, Embase, CINHAL, PsyInfo, Econlit, Health Economic Evaluation Database (HEED) and NHS Economic Evaluation Database (NHS EED) in the Cochrane Library. The search was restricted to articles published in English between 1970 and April 2016. All costs were converted to $USD 2016 price. RESULTS: Twenty-two articles were included. Studies varied from snapshot cost descriptions to more complex lifetime estimates, from prevalence-based to incidence-based studies, and from inclusion to exclusion of non-medical costs. There was a strong positive relationship between CP severity and expenditure. Significant costs were incurred by families and the welfare system to facilitate school and community engagement. CONCLUSION: Facilitating participation for people with CP involves substantial expense. The size, nature and distribution of the economic burden emphasises the importance of finding effective strategies to reduce the risk and severity of CP, together with how it is financed.

Economic evaluation and cost of interventions for cerebral palsy: a systematic review.

AIM: Economic appraisal can help guide policy-making for purchasing decisions, and treatment and management algorithms for health interventions. We conducted a systematic review of economic studies in cerebral palsy (CP) to inform future research. METHOD: Economic studies published since 1970 were identified from seven databases. Two reviewers independently screened abstracts and extracted data following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Any discrepancies were resolved by discussion. RESULTS: Of 980 identified references, 115 were included for full-text assessment. Thirteen articles met standard criteria for a full economic evaluation, two as partial economic evaluations, and 18 as cost studies. Six were full economic evaluations alongside clinical studies or randomized controlled trials, whereas seven involved modelling simulations. The economic case for administration of magnesium sulfate for imminent preterm birth is compelling, achieving both health gain and cost savings. Current literature suggests intrathecal baclofen therapy and botulinum toxin injection are cost-effective, but stronger evidence for long-term effects is needed. Lifestyle and web-based interventions are inexpensive, but broader measurement of outcomes is required. INTERPRETATION: Prevention of CP would avoid significant economic burden. Some treatments and interventions have been shown to be cost-effective, although stronger evidence of clinical effectiveness is needed. What this paper adds Cost-effectiveness evidence shows prevention is the most significant strategy. Some treatments are cost-effective, but stronger evidence for long-term effectiveness is required. Comparison of treatment costs is challenging owing to variations in methodologies and varying clinical indications.

Inclusion of equity in economic analyses of public health policies: systematic review and future directions.

OBJECTIVES: To assess current approaches to inclusion of equity in economic analysis of public health interventions and to recommend best approaches and future directions. METHODS: We conducted a systematic review of studies that have used socioeconomic position (SEP) in cost-effectiveness analyses. Studies were identified using MedLine, EconLit and HEED and were evaluated based on their SEP specific inputs and methods of quantification of the health and financial inequalities. RESULTS: Twenty-nine relevant studies were identified. The majority of studies comparing two or more interventions left interpretation of the size of the health and financial inequality differences to the reader. Newer approaches include: i) use of health inequality measures to quantify health inequalities; ii) inclusion of financial impacts, such as out-of-pocket expenditures; and iii) use of equity weights. The challenge with these approaches is presenting results that policy makers can easily interpret. CONCLUSIONS: Using CEA techniques to generate new information about the health equity implications of alternative policy options has not been widely used, but should be considered to inform future decision making. Implications for public health: Inclusion of equity in economic analysis would facilitate a more nuanced comparison of interventions in relation to efficiency, equity and financial impact.

Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy.

INTRODUCTION: With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population. METHODS AND ANALYSIS: The Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective. ETHICS AND DISSEMINATION: The protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12616001240437; Pre-results.

Effectiveness and cost-effectiveness of embedded simulation in occupational therapy clinical practice education: study protocol for a randomised controlled trial.

BACKGROUND: Clinical placements are a critical component of the training for health professionals such as occupational therapists. However, with growing student enrolments in professional education courses and workload pressures on practitioners, it is increasingly difficult to find sufficient, suitable placements that satisfy program accreditation requirements. The professional accrediting body for occupational therapy in Australia allows up to 200 of the mandatory 1000 clinical placement hours to be completed via simulation activities, but evidence of effectiveness and efficiency for student learning outcomes is lacking. Increasingly placement providers charge a fee to host students, leading educators to consider whether providing an internal program might be a feasible alternative for a portion of placement hours. Economic analysis of the incremental costs and benefits of providing a traditional versus simulated placement is required to inform decision-making. METHODS/DESIGN: This study is a pragmatic, non-inferiority, single-blind, multicentre, two-group randomised controlled trial (RCT) with an embedded economic analysis. The RCT will compare a block of 40 hours of simulated placement (intervention) with a 40-hour block of traditional placement (comparator), with a focus on student learning outcomes and delivery costs. Six universities will instigate the educational intervention within their respective occupational therapy courses, randomly assigning their cohort of students (1:1 allocation) to the simulated or traditional clinical placements. The primary outcome is achievement of professional behaviours (e.g. communication, clinical reasoning) as assessed by a post-placement written examination. Secondary outcomes include proportions passing the placement assessed using the Student Practice Evaluation Form-Revised, changes in student confidence pre-/post-placement, student and educator evaluation of the placement experience and cost-effectiveness of simulated versus traditional clinical placements. Comprehensive cost data will be collected for both the simulated and traditional placement programs at each site for economic evaluation. DISCUSSION: Use of simulation in health-related fields like occupational therapy is common, but these activities usually relate to brief opportunities for isolated skill development. The simulated clinical placement evaluated in this trial is less common because it encapsulates a 5-day block of integrated activities, designed and delivered in a manner intended to emulate best-practice placement experiences. The planned study is rare due to inclusion of an economic analysis that aims to provide valuable information about the relationship between costs and outcomes across participating sites. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001339448 . Registered 26 September 2016.