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INTRODUCTION: The Dental Caries Utility Index (DCUI) is a new oral health-specific health state classification system for adolescents, consisting of 5 domains: pain/discomfort, difficulty eating food/drinking, worried, ability to participate in activities, and appearance. Each domain has 4 response levels. This study aims to generate an Australian-specific utility algorithm for the DCUI. METHODS: An online survey was conducted using a representative sample of the adult Australian general population. The discrete choice experiment (DCE) was used to elicit the preferences on 5 domains. Then, the latent utilities were anchored onto the full health-dead scale using the visual analogue scale (VAS). DCE data were modeled using conditional logit, and 2 anchoring procedures were considered: anchor based on the worst health state and a mapping approach. The optimal anchoring procedure was selected based on the model parsimony and the mean absolute error (MAE). RESULTS: A total of 995 adults from the Australian general population completed the survey. The conditional logit estimates on 5 dimensions and levels were monotonic and statistically significant, except for the second level of the "worried" and "appearance" domains. The mapping approach was selected based on a smaller MAE between the 2 anchoring procedures. The Australian-specific tariff of DCUI ranges from 0.1681 to 1. CONCLUSION: This study developed a utility algorithm for the DCUI. This value set will facilitate utility value calculations from the participants' responses for DCUI in economic evaluations of dental caries interventions targeted for adolescents. HIGHLIGHTS: Preference-based quality-of-life measures (PBMs), which consist of a health state classification system and a set of utility values (a scoring algorithm), are used to generate utility weights for economic evaluations.This study is the first to develop an Australian utility value set for the Dental Caries Utility Index (DCUI), a new oral health-spe

OBJECTIVE: This study sought whether higher risk patients with coronary heart disease (CHD) benefit more from intensive disease management. DESIGN: Longitudinal cohort study. SETTING: State-wide public hospitals (Queensland, Australia). PARTICIPANTS: This longitudinal study included 20 426 patients hospitalised in 2010 with CHD as the principal diagnosis. Patients were followed-up for 5 years. PRIMARY AND SECONDARY OUTCOMES AND MEASURES: The primary outcome was days alive and out of hospital (DAOH) within 5 years of hospital discharge. Secondary outcomes included all-cause readmission and all-cause mortality. A previously developed and validated risk score (PEGASUS-TIMI54) was used to estimate the risk of secondary events. Data on sociodemography, comorbidity, interventions and medications were also collected. RESULTS: High-risk patients (n=6573, risk score ≥6) had fewer DAOH (∆=-142 days (95% CI: -152 to -131)), and were more likely to readmit or die (all p<0.001) than their low-risk counterparts (n=13 367, risk score <6). Compared with patients who were never prescribed a medication, those who consumed maximal dose of betablockers (∆=39 days (95% CI: 11 to 67)), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (∆=74 days (95% CI: 49 to 99)) or statins (∆=109 days (95% CI: 90 to 128)) had significantly greater DAOH. Patients who received percutaneous coronary intervention (∆=99 days (95% CI: 81 to 116)) or coronary artery bypass grafting (∆=120 days (95% CI: 92 to 148)) also had significantly greater DAOH than those who did not. The effect sizes of these therapies were significantly greater in high-risk patients, compared with low-risk patients (interaction p<0.001). Analysis of secondary outcomes also found significant interaction between both medical and interventional therapies with readmission and death, implicating greater benefits for high-risk patients. CONCLUSIONS: CHD patients can be effectively risk-stratified, and use of this inform

BACKGROUND: Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. METHODS: A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. RESULTS: Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution's mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. CONCLUSION: Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Background: Economic-evaluations of Cerebral palsy (CP) were based on utility estimates of health-related quality of life (HRQoL) from generic multi-attribute utility instruments (MAUIs). However, generic instruments had limited use as they could not capture some of the important aspects of living with CP. The Cerebral palsy 6 Dimension (CP-6D) is a disease specific MAUI. In this study, we compared the results of CP-6D with the Assessment of Quality of Life (AQoL-4D), a generic MAUI, and tested the criterion validity of the CP-6D in the general population.Methods:An online survey of the Australian general population (n = 2002), who completed both the AQoL-4D and CP-6D MAUIs, was conducted. Validity was assessed from the correlations between the domains, items and instruments. ANOVA and t-tests were used to assess the instrument's discrimination in different social demographic categories.Results:There was a moderate correlation between the instruments (0.64). Differences in socio-demographic characteristics showed a medium effect size (p < 0.001) in both instruments and had a similar effect on utility weights in both instruments. Although the CP-6D was more sensitive to changes in income and education.Conclusions: Our results suggest that CP-6D and AQoL-4D were measuring a similar underlying construct. Both instruments responded similarly to socio-demographic differences.

BACKGROUND: New parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents. OBJECTIVE: This study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently. METHODS: The study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks' gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples' randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples. RESULTS: Selection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participant

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OBJECTIVES: Preference-based quality-of-life measures (PBMs) have been developed in many clinical areas to aid estimation of more accurate utility values for economic evaluations. Existing oral health-related quality-of-life (OHRQoL) instruments are non-PBM and hence, cannot be used to generate utility values. The objective of this study was to develop a classification system for a new PBM (dental caries utility index-DCUI) for the most prevalent childhood oral health condition: dental caries. METHODS: Possible domains and items to be included in the classification system were identified based on the reviewing available pediatric non-PBM OHRQoL instruments, studies eliciting utility values for oral health outcomes and clinical dentistry textbooks and based on the findings, a draft classification system was developed. To refine the draft classification system, semi-structured interviews were conducted among a convenience sample of 15 12-17-year-old adolescents who had experience with dental caries. The classification system was further refined and validated by a group of dental experts, using a modified Delphi technique. RESULTS: The classification system comprised five items (pain/discomfort, difficulty in eating food/drinking, worried, ability to participate in activities, and appearance) and each item had a four-level response scale. CONCLUSION: The classification system developed herein is considered an amenable tool for the subsequent development of a new PBM for dental caries. Once the scoring algorithm is completed, the classification system can be used to incorporate economic evaluations of dental caries health interventions.

BACKGROUND AND OBJECTIVE: The CP-6D is a new preference-based measure derived from the CPQOL, a cerebral palsy-specific quality-of-life questionnaire. The CP-6D contains six dimensions, each with five levels. A preference-based value set is required to score the CP-6D on a utility scale and render it suitable for cost-utility analysis. This study aims to estimate the utility value set for the CP-6D for interventions for people with cerebral palsy (CP). METHODS: A discrete choice experiment was designed and administrated to an adult Australian online panel. Each respondent answered 12 choice sets. Each choice was presented as a combination of the health state from the CP-6D and duration spent in that health state before death. Conditional logit and mixed logit regression were used to analyse the data. The utility values were estimated as a ratio of the coefficient of each dimension to the coefficient of the duration. RESULTS: A total of 2002 participants completed the survey and responded to each choice. Generally, the dimension levels were monotonic, meaning the coefficients reflected the ordered nature of the levels in each dimension. The dimensions relating to manual ability, social well-being and acceptance had the greatest effect on choice. The value of the worst 'pits' health state is - 0.582. CONCLUSION: This study provides the first CP-specific utility value set that can potentially be used in cost-utility analyses of interventions for people with CP where the CPQOL has been applied, both prospectively and retrospectively.

OBJECTIVES: In recent years, discrete choice experiments (DCEs) have become frequently used to generate utility values, but there are a diverse range of approaches to do this. The primary focus of this systematic review is to summarise the methods used for the design and analysis of DCEs when estimating utility values in both generic and condition-specific preference-based measures. METHODS: Published literature using DCEs to estimate utility values from preference-based instruments were identified from MEDLINE, Embase, Cochrane Library and CINAHL using PRISMA guidelines. To assess the different DCE methods, standardised information was extracted from the articles including the DCE design method, the number of choice sets, the number of DCE pairs per person, randomisation of questions, analysis method, logical consistency tests and techniques for anchoring utilities. The CREATE checklist was used to assess the quality of the studies. RESULTS: A total of 38 studies with samples from the general population, students and patients were included. Values for health states described using generic multi attribute instruments (MAUIs) (especially the EQ-5D) were the most commonly explored using DCEs. The studies showed considerable methodology and design diversity (number of alternatives, attributes, sample size, choice task presentation and analysis). Despite these differences, the quality of articles reporting the methods used for the DCE was generally high. CONCLUSION: DCEs are an important approach to measure utility values for both generic and condition-specific instruments. However, a gold standard method cannot yet be recommended.

INTRODUCTION: Cerebral palsy (CP) is a lifelong condition. The CP quality of life (CPQOL) instrument is a frequently used disease-specific instrument to assess health-related quality of life (HRQoL) in people with CP, but it cannot be used to generate quality-adjusted life years (QALY) which are the basis of cost utility analysis (CUA). Generic utility instruments (such as the EQ-5D or SF-6D) that are used to value HRQOL may be insensitive to small but important health changes in children with CP. This study aims to generate a preference-based scoring algorithm for the CP six dimensions (CP-6D), a classification system developed from the CPQOL. METHODS AND ANALYSIS: A discrete choice experiment with duration (DCEtto) will be administrated to value health states described by the CP-6D classification system. These health states will be presented to members of Australian general population and parents of children with CP via an online survey. Conditional logit regression will be used to produce the utility algorithm for CP-6D. ETHICS AND DISSEMINATION: The Griffith University Human Research Ethics Committee approved for the study (reference HREC/number 2018/913). The developed algorithm can be applied to previous and future economic evaluation of interventions and treatments targeting people with CP which have used either the CPQOL or CP-6D.

© 2019, Springer Nature Switzerland AG. When making funding decisions, research organisations largely consider the merits (e.g. scientific rigour and feasibility) of submitted research proposals; yet, there is often little or no reference to their value for money. This may be attributed to the challenges of assessing and integrating value of research into existing research prioritisation processes. We propose a framework that considers both the merits of research and its value for money to guide health research funding decisions. A practical framework is developed based on current processes followed by funding organizations for assessing investigator-initiated research proposals, and analytical methods for evaluating the expected value of research. We apply the analytical methods to estimate the expected return on investment of two real-world grant applications. The framework comprises four sequential steps: (1) initial screening of applications for eligibility and completeness; (2) merit assessment of eligible proposals; (3) estimating the expected value of research for the shortlisted proposals that pass the first two steps and ranking of proposals based on return on investment; and (4) selecting research proposals for funding. We demonstrate how the expected value for money can be efficiently estimated using certain information provided in funding applications. The proposed framework integrates value-for-money assessment into the existing research prioritisation processes. Considering value for money to inform research funding decisions is vital to achieve efficient utilisation of research budgets and maximise returns on research investments.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. Introduction Active surveillance is a strategy for managing low-risk, localised prostate cancer, where men are observed with serial prostate-specific antigen assessments to identify signs of disease progression. Currently, there are no strategies to support active surveillance compliance nor are there interventions that can prevent or slow disease progression, ultimately delaying transition to active treatment before it is clinically required. Recently, we proposed that exercise may have a therapeutic potential in delaying the need for active treatment in men on active surveillance. Methods and analysis A single-blinded, two arm, multicentre randomised controlled trial will be undertaken with 168 patients randomly allocated in a ratio of 1:1 to exercise or usual care. Exercise will consist of supervised resistance and aerobic exercise performed three times per week for the first 6 months in an exercise clinical setting, and during months 7-12, a progressive stepped down approach will be used with men transitioning to once a week supervised training. Thereafter, for months 13 to 36, the men will self-manage their exercise programme. The primary endpoint will be the time until the patients begin active therapy. Secondary endpoints include disease progression (prostate specific antigen), body composition and muscle density, quality of life, distress and anxiety and an economic analysis will be performed. Measurements will be undertaken at 6 and 12 months (postintervention) and at 24 and 36 months follow-up. The primary outcome (time to initiation of curative therapy) will be analysed using Cox proportional hazards regression. Outcomes measured repeatedly will be analysed using mixed effects models to examine between-group differences. Data will be analysed using an intention-to-treat

© Author(s) (or their employer(s)) 2018. Objectives Healthcare budgets are limited, and therefore, research funds should be wisely allocated to ensure high-quality, useful and cost-effective research. We aimed to critically review the criteria considered by major Australian organisations in prioritising and selecting health research projects for funding. Methods We reviewed all grant schemes listed on the Australian Competitive Grants Register that were health-related, active in 2017 and with publicly available selection criteria on the funders' websites. Data extracted included scheme name, funding organisation, selection criteria and the relative weight assigned to each criterion. Selection criteria were grouped into five representative domains: Relevance, appropriateness, significance, feasibility (including team quality) and cost-effectiveness (ie, value for money). Results Thirty-six schemes were included from 158 identified. One-half of the schemes were under the National Health and Medical Research Council. The most commonly used criteria were research team quality and capability (94%), research plan clarity (94%), scientific quality (92%) and research impact (92%). Criteria considered less commonly were existing knowledge (22%), fostering collaboration (22%), research environment (19%), value for money (14%), disease burden (8%) and ethical/moral considerations (3%). In terms of representative domains, relevance was considered in 72% of the schemes, appropriateness in 92%, significance in 94%, feasibility in 100% and cost-effectiveness in 17%. The relative weights for the selection criteria varied across schemes with 5%-30% for relevance, 20%-60% for each appropriateness and significance, 20%-75% for feasibility and 15%-33% for cost-effectiveness. Conclusions In selecting research projects for funding, Australian research organisations focus largely on research appropriateness, significance and feasibility; however, value for money is most often overlooked.

© 2018 Journal of Medical Internet Research. All rights reserved. Background: Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed. Objective: The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress. Methods: A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life. Results: Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention. Conclusions: This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial.

AIMS: To determine if an intensified form of heart failure management programme (INT-HF-MP) based on individual profiling is superior to standard management (SM) in reducing health care costs during 12-month follow-up (primary endpoint). METHODS AND RESULTS: A multicentre randomized trial involving 787 patients (full analysis set) discharged from four tertiary hospitals with chronic HF who were randomized to SM (n = 391) or INT-HF-MP (n = 396). Mean age was 74 ± 12 years, 65% had HF with a reduced ejection fraction (31.4 ± 8.9%) and 14% were remote-dwelling. Study groups were well matched. According to Green, Amber, Red Delineation of rIsk And Need in HF (GARDIAN-HF) profiling, regardless of location, patients in the INT-HF-MP received a combination of face-to-face (home visits) and structured telephone support (STS); only 9% (`low risk') were designated to receive the same level of management as the SM group. The median cost in 2017 Australian dollars (A$1 equivalent to ∼EUR €0.7) of applying INT-HF-MP was significantly greater than SM ($152 vs. $121 per patient per month; P < 0.001), However, at 12 months, there was no difference in total health care costs for the INT-HF-MP vs. SM group (median $1579, IQR $644 to $3717 vs. $1450, IQR $564 to $3615 per patient per month, respectively). This reflected minimal differences in all-cause mortality (17.7% vs. 18.4%; P = 0.848) and recurrent hospital stay (18.6 ± 26.5 vs. 16.6 ± 24.8 days; P = 0.199) between the INT-HF-MP and SM groups, respectively. CONCLUSION: During 12-months follow-up, an INT-HF-MP did not reduce healthcare costs or improve health outcomes relative to SM.

INTRODUCTION: Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. METHODS AND ANALYSIS: A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 'best' health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. ETHICS AND DISSEMINATION: Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences.

The aim of this study is to consider the cost-effectiveness of a nurse-led, home-based intervention (HBI) in cardiac patients with private health insurance compared to usual post-discharge care. A within trial analysis of the Young @ Heart multicentre, randomized controlled trial along with a micro-simulation decision analytical model was conducted to estimate the incremental costs and quality adjusted life years associated with the home based intervention compared to usual care. For the micro-simulation model, future costs, from the perspective of the funder, and effects are estimated over a twenty-year time horizon. An Incremental Cost-Effectiveness Ratio, along with Incremental Net Monetary Benefit, is evaluated using a willingness to pay threshold of $50,000 per quality adjusted life year. Sub-group analyses are conducted for men and women across three age groups separately. Costs and benefits that arise in the future are discounted at five percent per annum. Overall, home based intervention for secondary prevention in patients with chronic heart disease identified in the Australian private health care sector is not cost-effective. The estimated within trial incremental net monetary benefit is -$3,116 [95% CI: -11,145, $4,914]; indicating that the costs outweigh the benefits. However, for males and in particular males aged 75 years and above, home based intervention indicated a potential to reduce health care costs when compared to usual care (within trial: -$10,416 [95% CI: -$26,745, $5,913]; modelled analysis: -$1,980 [95% CI: -$22,843, $14,863]). This work provides a crucial impetus for future research to understand for whom disease management programs are likely to benefit most.

BACKGROUND: High levels of childbirth fear impact birth preparation, obstetric outcomes and emotional wellbeing for around one in five women living in developed countries. Higher rates of obstetric intervention and caesarean section (CS) are experienced in fearful women. The efficacy of interventions to reduce childbirth fear is unclear, with no previous randomised controlled trials reporting birth outcomes or postnatal psychological wellbeing following a midwife led intervention. METHOD: Between May 2012 and June 2013 women in their second trimester of pregnancy were recruited. Women with a fear score ≥ 66 on the Wijma Delivery Expectancy / Experience Questionnaire (W-DEQ) were randomised to receive telephone psycho-education by a midwife, or usual maternity care. A two armed non-blinded parallel (1:1) multi-site randomised controlled trial with participants allocated in blocks of ten and stratified by hospital site and parity using an electronic centralised computer service. The outcomes of the RCT on obstetric outcomes, maternal psychological well-being, parenting confidence, birth satisfaction, and future birth preference were analysed by intention to treat and reported here. RESULTS: 1410 women were screened for high childbirth fear (W-DEQ ≥66). Three hundred and thirty-nine (n = 339) women were randomised (intervention n = 170; controls n = 169). One hundred and eighty-four women (54 %) returned data for final analysis at 6 weeks postpartum (intervention n = 91; controls n = 93). Compared to controls the intervention group had a clinically meaningful but not statistically significant reduction in overall caesarean section (34 % vs 42 %, p = 0.27) and emergency CS rates (18 % vs 25 %, p = 0.23). Fewer women in the intervention group preferred caesarean section for a future pregnancy (18 % vs 30 %, p = 0.04). All other obstetric variables remained similar. There were no differences in postnatal depression symptoms scores, parenting confidence, or satisfaction wi

BACKGROUND: Childbirth fear has received considerable attention in Scandinavian countries, and the United Kingdom, but not in Australia. For first-time mothers, fear is often linked to a perceived lack of control and disbelief in the body's ability to give birth safely, whereas multiparous women may be fearful as a result of previous negative and/or traumatic birth experiences. There have been few well-designed intervention studies that test interventions to address women's childbirth fear, support normal birth, and diminish the possibility of a negative birth experience. METHODS/DESIGN: Pregnant women in their second trimester of pregnancy will be recruited and screened from antenatal clinics in Queensland, Australia. Women reporting high childbirth fear will be randomly allocated to the intervention or control group. The psycho-educational intervention is offered by midwives over the telephone at 24 and 34 weeks of pregnancy. The intervention aims to review birth expectations, work through distressing elements of childbirth, discuss strategies to develop support networks, affirm that negative childbirth events can be managed and develop a birth plan. Women in the control group will receive standard care offered by the public funded maternity services in Australia. All women will receive an information booklet on childbirth choices. Data will be collected at recruitment during the second trimester, 36 weeks of pregnancy, and 4-6 weeks after birth. DISCUSSION: This study aims to test the efficacy of a brief, midwife-led psycho-education counselling (known as BELIEF: Birth Emotions - Looking to Improve Expectant Fear) to reduce women's childbirth fear. 1) Relative to controls, women receiving BELIEF will report lower levels of childbirth fear at term; 2) less decisional conflict; 3) less depressive symptoms; 4) better childbirth self-efficacy; and 5) improved health and obstetric outcomes. TRIAL REGISTRATION: Australian New Zealand Controlled Trials Registry ACTRN126

BACKGROUND: Participation in coronary heart disease (CHD) secondary prevention programs is low. Telephone-delivered CHD secondary prevention programs may overcome the treatment gap. The telephone-based health coaching ProActive Heart trial intervention has previously been shown to be effective for improving health-related quality of life, physical activity, body mass index, diet, alcohol intake and anxiety. As a secondary aim, the current study evaluated the cost-effectiveness of the ProActive Heart intervention compared to usual care. METHODS: 430 adult myocardial infarction patients were randomised to a six-month CHD secondary prevention 'health coaching' intervention or 'usual care' control group. Primary outcome variables were health-related quality of life (SF-36) and physical activity (Active Australia Survey). Data were collected at baseline, six-months (post-intervention) and 12 months (six-months post-intervention completion) for longer term effects. Cost-effectiveness data [health utility (SF-6D) and health care utilisation] were collected using self-reported (general practitioner, specialist, other health professionals, health services, and medication) and claims data (hospitalisation rates). Intervention effects are presented as mean differences (95% CI), p-value. RESULTS: Improvements in health status (SF-6D) were observed in both groups, with no significant difference between the groups at six [0.012 (-0.016, 0.041), p = 0.372] or 12 months [0.011 (-0.028, 0.051) p = 0.738]. Patients in the health coaching group were significantly more likely to be admitted to hospital due to causes unrelated to cardiovascular disease (p = 0.042). The overall cost for the health coaching group was higher ($10,574 vs. $8,534, p = 0.021), mainly due to higher hospitalisation (both CHD and non-CHD) costs ($6,841 vs. $4,984, p = 0.036). The incremental cost-effectiveness ratio was $85,423 per QALY. CONCLUSIONS: There was no intervention effect measured using the SF-36/SF-6

BACKGROUND: Beyond examining their overall cost-effectiveness and mechanisms of effect, it is important to understand patient preferences for the delivery of different modes of chronic heart failure management programs (CHF-MPs). We elicited patient preferences around the characteristics and willingness-to-pay (WTP) for a clinic or home-based CHF-MP. METHODOLOGY/PRINCIPAL FINDINGS: A Discrete Choice Experiment was completed by a sub-set of patients (n = 91) enrolled in the WHICH? trial comparing home versus clinic-based CHF-MP. Participants provided 5 choices between hypothetical clinic and home-based programs varying by frequency of nurse consultations, nurse continuity, patient costs, and availability of telephone or education support. Participants (aged 71±13 yrs, 72.5% male, 25.3% NYHA class III/IV) displayed two distinct preference classes. A latent class model of the choice data indicated 56% of participants preferred clinic delivery, access to group CHF education classes, and lower cost programs (p<0.05). The remainder preferred home-based CHF-MPs, monthly rather than weekly visits, and access to a phone advice service (p<0.05). Continuity of nurse contact was consistently important. No significant association was observed between program preference and participant allocation in the parent trial. WTP was estimated from the model and a dichotomous bidding technique. For those preferring clinic, estimated WTP was ≈AU$9-20 per visit; however for those preferring home-based programs, WTP varied widely (AU$15-105). CONCLUSIONS/SIGNIFICANCE: Patient preferences for CHF-MPs were dichotomised between a home-based model which is more likely to suit older patients, those who live alone, and those with a lower household income; and a clinic-based model which is more likely to suit those who are more socially active and wealthier. To optimise the delivery of CHF-MPs, health care services should consider their patients' preferences when designing CHF-MPs.

We investigated the impact of pre-existing mental ill health on postpartum maternal outcomes. Women reporting childbirth trauma received counselling (Promoting Resilience in Mothers' Emotions; n = 137) or parenting support (n = 125) at birth and 6 weeks. The EuroQol Five dimensional (EQ-5D)-measured health-related quality of life at 6 weeks, 6 and 12 months. At 12 months, EQ-5D was better for women without mental health problems receiving PRIME (mean difference (MD) 0.06; 95 % confidence interval (CI) 0.02 to 0.10) or parenting support (MD 0.08; 95 % CI 0.01 to 0.14). Pre-existing mental health conditions influence quality of life in women with childbirth trauma.

Background: Beyond examining their overall cost-effectiveness and mechanisms of effect, it is important to understand patient preferences for the delivery of different modes of chronic heart failure management programs (CHF-MPs). We elicited patient preferences around the characteristics and willingness-to-pay (WTP) for a clinic or home-based CHF-MP. Methodology/Principal Findings: A Discrete Choice Experiment was completed by a sub-set of patients (n = 91) enrolled in the WHICH? trial comparing home versus clinic-based CHF-MP. Participants provided 5 choices between hypothetical clinic and home-based programs varying by frequency of nurse consultations, nurse continuity, patient costs, and availability of telephone or education support. Participants (aged 71±13 yrs, 72.5% male, 25.3% NYHA class III/IV) displayed two distinct preference classes. A latent class model of the choice data indicated 56% of participants preferred clinic delivery, access to group CHF education classes, and lower cost programs (p<0.05). The remainder preferred home-based CHF-MPs, monthly rather than weekly visits, and access to a phone advice service (p<0.05). Continuity of nurse contact was consistently important. No significant association was observed between program preference and participant allocation in the parent trial. WTP was estimated from the model and a dichotomous bidding technique. For those preferring clinic, estimated WTP was ≈AU$9-20 per visit; however for those preferring home-based programs, WTP varied widely (AU$15-105). Conclusions/Significance: Patient preferences for CHF-MPs were dichotomised between a home-based model which is more likely to suit older patients, those who live alone, and those with a lower household income; and a clinic-based model which is more likely to suit those who are more socially active and wealthier. To optimise the delivery of CHF-MPs, health care services should consider their patients' preferences when designing CHF-MPs. © 2013 Whitty et

BACKGROUND: Effective self-management of diabetes is essential for the reduction of diabetes-related complications, as global rates of diabetes escalate. METHODS: Randomised controlled trial. Adults with type 2 diabetes (n = 120), with HbA1c greater than or equal to 7.5 %, were randomly allocated (4 × 4 block randomised block design) to receive an automated, interactive telephone-delivered management intervention or usual routine care. Baseline sociodemographic, behavioural and medical history data were collected by self-administered questionnaires and biological data were obtained during hospital appointments. Health-related quality of life (HRQL) was measured using the SF-36. RESULTS: The mean age of participants was 57.4 (SD 8.3), 63% of whom were male. There were no differences in demographic, socioeconomic and behavioural variables between the study arms at baseline. Over the six-month period from baseline, participants receiving the Australian TLC (Telephone-Linked Care) Diabetes program showed a 0.8% decrease in geometric mean HbA(1c) from 8.7% to 7.9%, compared with a 0.2% HbA(1c) reduction (8.9% to 8.7%) in the usual care arm (p = 0.002). There was also a significant improvement in mental HRQL, with a mean increase of 1.9 in the intervention arm, while the usual care arm decreased by 0.8 (p = 0.007). No significant improvements in physical HRQL were observed. CONCLUSIONS: These analyses indicate the efficacy of the Australian TLC Diabetes program with clinically significant post-intervention improvements in both glycaemic control and mental HRQL. These observed improvements, if supported and maintained by an ongoing program such as this, could significantly reduce diabetes-related complications in the longer term. Given the accessibility and feasibility of this kind of program, it has strong potential for providing effective, ongoing support to many individuals with diabetes in the future.

Objectives: The goal of this study was to make a head-to-head comparison of 2 common forms of multidisciplinary chronic heart failure (CHF) management. Background: Although direct patient contact appears to be best in delivering CHF management overall, the precise form to optimize health outcomes is less clear. Methods: This prospective, multicenter randomized controlled trial with blinded endpoint adjudication comprised 280 hospitalized CHF patients (73% male, age 71 ± 14 years, and 73% with left ventricular ejection fraction ≤45%) randomized to home-based intervention (HBI) or specialized CHF clinic-based intervention (CBI). The primary endpoint was all-cause, unplanned hospitalization or death during 12- to 18-month follow-up. Secondary endpoints included type/duration of hospitalization and healthcare costs. Results: The primary endpoint occurred in 102 of 143 (71%) HBI versus 104 of 137 (76%) CBI patients (adjusted hazard ratio [HR]: 0.97 [95% confidence interval (CI): 0.73 to 1.30], p = 0.861): 96 (67.1%) HBI versus 95 (69.3%) CBI patients had an unplanned hospitalization (p = 0.887), and 31 (21.7%) versus 38 (27.7%) died (p = 0.252). The median duration of each unplanned hospitalization was significantly less in the HBI group (4.0 [interquartile range (IQR): 2.0 to 7.0] days vs. 6.0 [IQR: 3.5 to 13] days; p = 0.004). Overall, 75% of all hospitalization was attributable to 64 (22.9%) patients, of whom 43 (67%) were CBI patients (adjusted odds ratio: 2.55 [95% CI: 1.37 to 4.73], p = 0.003). HBI was associated with significantly fewer days of all-cause hospitalization (-35%; p = 0.003) and from cardiovascular causes (-37%; p = 0.025) but not for CHF (-24%; p = 0.218). Consequently, healthcare costs ($AU3.93 vs. $AU5.53 million) were significantly less for the HBI group (median: $AU34 [IQR: 13 to 81] per day vs. $AU52 [17 to 140] per day; p = 0.030). Conclusions: HBI was not superior to CBI in reducing all-cause death or hospitalization. However, HBI was associat

Aims To describe the rationale and design of the Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care (WHICH?) trial. Methods WHICH? is a pragmatic, multicentre, randomized controlled trial that seeks to determine if multidisciplinary management of chronic heart failure (CHF) patients post-acute hospitalization delivered in a patients own home is superior to care delivered via a specialist CHF outpatient clinic. The composite primary endpoint is all-cause, unplanned recurrent hospitalization or death during 1218 months of follow-up. Of 688 eligible patients, 280 patients (73 male and 66 principal diagnosis of CHF) with a mean age of 71 ± 14 years have been randomized to home- (n 143) or clinic-based (n 137) post-discharge management. This will provide 80 power (two-sided alpha of 0.05) to detect a 15 absolute difference in both the primary end-point and rate of all-cause hospital stay. Preliminary data suggest that the two groups are well matched in nearly all baseline socio-economic and clinical parameters. The majority of patients have significant co-morbidity, including hypertension (63), coronary artery disease (55), and atrial fibrillation (53) with an accordingly high Charlson Index of Comorbidity Score (6.1 ± 2.4). Perspective Despite its relatively small size, the WHICH? trial is well placed to examine the relative impact of two of the most commonly applied forms of face-to-face management designed to reduce recurrent hospitalization and prolong survival in CHF patients. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2011. For permissions please email: journals.permissionsoup.com.2011 © Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2011. For permissions please email: journals.permissionsoup.com.

BACKGROUND: An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours. METHODS/DESIGN: A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned. DISCUSSION: Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore

Background: QALYs combine survival and health-related quality of life (QOL) into a single index, enabling judgements about the relative value for money of healthcare interventions. Objective: To investigate the methods used for estimating QALY weights included in submissions by industry for listing of their products on the Australian Pharmaceutical Benefits Scheme. Study design: Retrospective descriptive review of submissions considered by the Pharmaceutical Benefits Advisory Committee (PBAC) 2002-4. Data sources: The database of submissions considered at PBAC meetings was obtained from the Pharmaceutical Evaluation Section of the Australian Government Department of Health and Ageing. Further information on each included submission was obtained in the form of the Pharmaceutical Evaluation Section commentary (expert report) on the submission. Methods: Submissions to the PBAC over 2002-4 presenting QALYs as an outcome measure were reviewed to identify the methods used to obtain preference-based QALY weights. Information was analyzed according to the approach taken to obtain QALY weights (multi-attribute utility instrument [MAUI], health state valuation [HSV] experiment for scaling the health states, or non-preference-based approach); the population from whom the QALY weights were obtained; the appropriateness of the population for the instrument; the recommendation made by the PBAC; and the main indicated category for use of the pharmaceutical. The approach and the population were classified as 'more appropriate' and 'less appropriate'. The 'more appropriate' approaches were where a MAUI was administered to patients who were currently experiencing the health states being valued, or when an HSV experiment was undertaken in either the general population to value a health state derived from clinical and QOL studies or a population of patients to value their own health state. All other approaches were considered 'less appropriate'. Results: MAUIs were used in 39% of appro