The association between loneliness with health service use and quality of life among informal carers in Australia.

OBJECTIVE: The demanding nature of caregiving and limited social support can lead to informal carers experiencing loneliness, which can impact their well-being and overall health service use (HSU). The study aims to examine the association between loneliness with HSU and Health state utility values among informal carers in Australia. METHODS: Data were derived from three waves (2009, 2013, and 2017) of the nationally representative longitudinal Household Income and Labour Dynamics of Australia (HILDA) survey, focusing on adult informal carers. Outcome measures included visits to the General Practitioner, the number of hospital admissions, and the SF-6D score. Generalized Estimating Equations (GEE) analysis was conducted to explore the associations between loneliness and HSU, as well as loneliness and utility values (based on SF-6D) while adjusting for age, sex, education, marital status, income, and physical/mental health conditions. RESULTS: After controlling for covariates, lonely carers reported lower utility values (IRR = 0.91, 95%CI [0.89, 0.93], p < 0.001) compared to non-lonely carers. Lonely carers reported a higher number of GP visits (IRR = 1.18, 95% CI [1.04, 1.36], p < 0.05) as well as a higher likelihood of visiting specialists (AOR = 1.31, p = 0.046) and hospital doctors (AOR = 1.42, p = 0.013) compared to the non-lonely carers. CONCLUSIONS: The findings of this study highlight the relationship between loneliness on both healthcare utilization and carers' overall well-being. Addressing loneliness through targeted interventions and social support systems can help improve health outcomes and potentially reduce the overall healthcare costs among informal carers in Australia.

Health service and medication costs associated with common mental disorders and subthreshold symptoms in women: Findings from the Geelong Osteoporosis Study in Australia.

OBJECTIVE: This analysis estimated 2013 annual healthcare costs associated with the common mental disorders of mood and anxiety disorders and psychological symptoms within a representative sample of Australian women. METHODS: Data from the 15-year follow-up of women in the Geelong Osteoporosis Study were linked to 12-month Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data. A Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Non-patient edition identified common mental disorders and the General Health Questionnaire 12 assessed psychological symptoms. Participants were categorised into mutually exclusive groups: (1) common mental disorder (past 12 months), (2) subthreshold (no common mental disorder and General Health Questionnaire 12 score ⩾4) or (3) no common mental disorder and General Health Questionnaire 12 score <4. Two-part and hurdle models estimated differences in service use, and adjusted generalised linear models estimated mean differences in costs between groups. RESULTS: Compared to no common mental disorder, women with common mental disorders utilised more Medicare Benefits Schedule services (mean 26.9 vs 20.0, p < 0.001), had higher total Medicare Benefits Schedule cost ($1889 vs $1305, p < 0.01), received more Pharmaceutical Benefits Scheme prescriptions (35.8 vs 20.6, p < 0.001), had higher total Pharmaceutical Benefits Scheme cost ($1226 vs $740, p < 0.05) and had significantly higher annual out-of-pocket costs for Pharmaceutical Benefits Scheme prescriptions ($249 vs $162, p < 0.001). Compared to no common mental disorder, subthreshold women were less likely to use any Medicare Benefits Schedule service (89.6% vs 97.0%, p < 0.01), but more likely to use mental health services (11.4% vs 2.9%, p < 0.01). The subthreshold group received more Pharmaceutical Benefits Scheme prescriptions (mean 43.3 vs 20.6, p < 0.001) and incurred higher total Pharmaceutical Benefits Scheme cost ($1268 vs $740, p < .05) compared to no common mental disorder. CONCLUSIONS: Common mental disorders and subthreshold psychological symptoms place a substantial economic burden on Australian healthcare services and consumers.

Global Prevalence of Adolescent Use of Nonprescription Weight-Loss Products: A Systematic Review and Meta-Analysis.

Importance: Use of nonprescribed weight-loss products in adolescents is a public health concern that is associated with negative physical and psychological consequences. However, the prevalence of nonprescribed weight-loss product use in adolescents is unknown. Objective: To determine the global prevalence of nonprescription weight-loss product use in children and adolescents. Data Sources: Four databases, including MEDLINE, PsycINFO, CINAHL (Cumulative Index of Nursing and Allied Health), and EMBASE, were searched for quantitative studies that reported prevalence data on use of nonprescription weight-loss products with no restrictions on publication date. The search was performed December 1, 2020, and updated March 6, 2023. Study Selection: Studies were included in the meta-analysis if they reported the prevalence of weight-loss product use, were published in English, and included individuals 18 years or younger. Data Extraction and Synthesis: Data extraction was completed by 2 independent reviewers. Data analysis determined the overall pooled proportion of weight-loss product use in total and during the past week, past 30 days, past year, or lifetime. Inverse variance heterogeneity effect models were used. Main Outcomes and Measures: The main outcome measure was the prevalence of nonprescription weight-loss product use in adolescents for all included studies and over the past week, past month, past year, or lifetime. Subgroup analysis included separation of groups by sex, specific weight-loss product types, geographical location, and study publication time. Results: A total of 90 articles (604 552 unique participants) were included in the meta-analysis. Of these, 50 studies (56%) were from North America. The reported prevalence of weight-loss product use in adolescents was 5.5% (96% CI, 5.5%-5.6%) overall. When identifying use of weight-loss products in the general population, prevalence was 2.0% (95% CI, 1.9%-2.1%) in the past week, 4.4% (95% CI, 4.3%-4.5%) in the past month, 6.2% (95% CI, 6.1%-6.3%) in the past year, and 8.9% (95% CI, 8.6%-9.2%) in their lifetime. Use of weight-loss products was higher among girls than boys. Conclusions and Relevance: This meta-analysis found that use of weight-loss products occurs at high levels in adolescents, especially girls. These findings suggest that, given the ineffectiveness of these products for weight loss coupled with their harmful long-term health consequences, interventions are required to reduce use of weight-loss products in this group.

A randomized wait-list controlled trial of Men in Mind: Enhancing mental health practitioners' self-rated clinical competencies to work with men.

Improved engagement of men in psychotherapy is an essential element in improving male health outcomes. This trial examined whether the Men in Mind intervention improved practitioners' self-rated clinical competencies to engage and respond to male clients in therapy. A parallel, single-blind, wait-list randomized controlled trial was conducted with Australian-based mental health practitioners, currently administering psychotherapy to males, fluent in English, and not currently completing their undergraduate degree. Participants were randomly assigned 1:1, through variable-sized blocks stratified by gender, to either the intervention (Men in Mind) or wait-list control. Men in Mind was offered as a self-led 6-week, five-module online program to upskill practitioners to engage and respond to male clients. The primary outcome was self-reported competency in engaging men in psychotherapy, measured by the Engaging Men in Therapy Scale (EMITS) at 6 weeks. All analyses were by intention-to-treat. Between January 16 and March 17, 2022, 587 participants were randomly assigned to the intervention (n = 300) or wait-list control (n = 287). In total, 492 (84%) participants completed the primary endpoint assessment at 6 weeks. Men in Mind demonstrated a large effect of improved EMITS scores compared to the control group (d = 2.63, 95% CI [2.39, 2.87], p < .001). Men in Mind was effective at increasing mental health practitioners' self-reported efficacy to work with men, which is potentially a key change mechanism in their ability to improve health outcomes for male clients. A limitation of the trial was the use of a bespoke, self-reported primary outcome, while a strength was the gender-responsive intervention design. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Measuring the importance of different barriers to opioid agonist treatment using best-worst scaling in an Australian setting.

OBJECTIVE: Opioid agonist treatment (OAT) is an effective treatment for opioid use disorder (OUD), however several client barriers to OAT are reported. Client importance of these barriers using economic preference elicitation measures have not been identified. This paper determines the most important OAT barriers using best-worst scaling (BWS) and compares the results of BWS to Likert scale. METHODS: Cross-sectional self-completed survey with 191 opioid dependent clients who attended Australian needle and syringe sites. Participants were presented 15 Likert scale barriers and 15 BWS barrier scenarios. The BWS data was presented using count analysis, multinomial logit and mixed logit models. The ranking of barrier items was completed using three BWS methods and one Likert scale method, with share preference results (BWS) or mean scores (Likert) used to rank the 15 barriers. RESULTS: The most important client barriers were 'enjoy using opioids', 'lack of support services' and 'hard to access'. The four ranking methods produced different barrier rankings for the most important barriers, but similar results for the least important barriers. CONCLUSION: Policies around OAT as a harm reduction approach, increased support services and increased availability of OAT services would be beneficial in improving OAT uptake. Comparing BWS and Likert methods produced different highest ranked barriers, indicating the method used to identify preferences has significant implications on the type of intervention prioritised.

Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents.

BACKGROUND: Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia. METHODS: A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12-14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the OurFutures Vaping Program intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term. DISCUSSION: If effective, the intervention will be readily accessible to schools via the OurFutures platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023).

Identifying the most common barriers to opioid agonist treatment in an Australian setting.

BACKGROUND: Opioid use disorder is a public health concern in Australia. Opioid agonist treatment (OAT) is effective at treating and minimising harm from opioid use disorder, yet is underused in Australia due to client barriers. Although these barriers have been reported, the barriers that are most important to clients is unclear. The aim of this paper was to determine the most important OAT barriers to Australian clients. METHODS: A cross-sectional, self-completed survey was given to 204 opioid-dependent clients who attended needle and syringe sites in Australia. Participants were given 15 OAT barrier statements, which they answered using a 5-point Likert scale (1=strongly disagree, 2=disagree, 3=neutral, 4=agree and 5=strongly agree). The Likert scale data are presented using the count method and the mean Likert scores (for the whole sample and for subgroups). RESULTS: The two methods determined that the four most important barriers to OAT were stigma, lack of support services, no flexibility and enjoy using opioids. Furthermore, those who used prescription opioids (compared with heroin) were female or non-binary (compared with male), were not currently using OAT (compared with current OAT), were younger (compared with older) and had high dependence scores (compared with low dependence scores) were impacted more by certain OAT barriers. CONCLUSIONS: Policies around improving support services, reducing stigma and increasing flexibility would be beneficial to reduce barriers to OAT in Australia. Second, certain groups were more vulnerable to OAT barriers, emphasising the importance to better tailor opioid treatment programs to these specific populations to increase treatment engagement.

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT.

BACKGROUND: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. OBJECTIVE: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? DESIGN: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. SETTINGS: Glasgow, UK, and Melbourne, Australia. PARTICIPANTS: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. INTERVENTIONS: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. MAIN OUTCOME MEASURES: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. RESULTS: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference -4.29, 95% confidence interval -7.29 to -1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. LIMITATIONS: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. CONCLUSIONS: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. FUTURE WORK: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3-0.4). TRIAL REGISTRATION: This trial is registered as ISRCTN99559262. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).

WHAT WAS THE PROBLEM?: Relapse is a considerable problem for people with a diagnosis of schizophrenia. Relapse can be predicted by early warning signs that are unique to the person. They include withdrawal, fear and paranoia. WHAT WAS THE QUESTION?: Is it possible to investigate the effectiveness of an intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? WHAT DID WE DO?: We spoke with 88 mental health staff, 40 carers and 21 service users before we designed a system that used a mobile phone to help people monitor early warning signs. We included peer support to help people using the system reflect on their experiences. We hoped the overall system, called EMPOWER, would help people to be more in charge of their mental health. After consenting 86 people to the study, we were able to randomly assign 73 people either to use the EMPOWER system (42 people) or to receive their normal treatment alone (31 people). We used research measures over 1 year to help us better understand people's experiences. We also involved carers (for example family or friends) and mental health service providers in the research. WHAT DID WE FIND?: We found that it was possible to recruit people to the study and to gather research data. We also found that people used the EMPOWER system and found it acceptable. We found that those who used EMPOWER had a lower rate of relapse over 12 months than people who did not. They were also less likely to be fearful of relapse. We found that EMPOWER was likely to be cost-effective. WHAT DOES THIS MEAN?: This means that a study to investigate the effectiveness of a system to recognise and respond to early warning signs of relapse in schizophrenia is possible.

The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia.

BACKGROUND: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. METHODS: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). FINDINGS: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference -7·53 (95% CI -14·45 to 0·60; Cohen's d -0·53). INTERPRETATION: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited. FUNDING: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

Cannabidiol for at risk for psychosis youth: A randomized controlled trial.

BACKGROUND: No biological treatment has been firmly established for the at-risk stage of psychotic disorder. In this study we aim to test if subthreshold psychotic symptoms can be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa. The question has taken on increased importance in the wake of evidence questioning both the need and efficacy of specific pharmacological interventions in the ultra-high risk (UHR) for psychosis group. METHODS: Three-arm randomized controlled trial of 405 patients (135 per arm) aged 12-25 years who meet UHR for psychosis criteria. The study includes a 6-week lead-in phase during which 10% of UHR individuals are expected to experience symptom remission. Participants will receive CBD (per oral) at doses 600 or 1000 mg per day (fixed schedule) for 12 weeks. Participants in the third arm of the trial will receive matching placebo capsules. Primary outcome is severity of positive psychotic symptoms as measured by the Comprehensive Assessment of At-Risk Mental States at 12 weeks. We hypothesize that CBD will be significantly more effective than placebo in improving positive psychotic symptoms in UHR patients. All participants will also be followed up 6 months post baseline to evaluate if treatment effects are sustained. CONCLUSION: This paper reports on the rationale and protocol of the Cannabidiol for At Risk for psychosis Youth (CanARY) study. This study will test CBD for the first time in the UHR phase of psychotic disorder.

Treatment-seeking behaviour among people with opioid use disorder in the high-income countries: A systematic review and meta-analysis.

OBJECTIVES: To determine treatment seeking behaviour in those with opioid use disorder (OUD) in the high-income countries. METHODS: Five databases were searched in November 2019 for quantitative studies that reported OUD treatment seeking behaviour. Data analysis involved determining an overall pooled proportion estimate of treatment seeking behaviour for the two base groups, lifetime treatment and past 12-month or less treatment using the IVhet effect model. Subgroup analysis included heroin OUD, prescription OUD and general OUD. The sensitivity analysis included removal of outliers, separating adults and adolescents and the metaXL sensitivity analysis (studies are excluded if outside the pooled proportion confidence interval of the base case). Systematic review Prospero database registration number [CRD42020159531]. RESULTS: There were 13 quantitative studies included in the systematic review, with all studies being from the United States of America (USA). IVhet models showed that 40% (95% CI: 23%, 58%) and 21% (95% CI: 16%, 26%) sought treatment in their lifetime and past 12 months respectively. Sub-group analysis found that lifetime treatment seeking for prescription OUD, 29% (95% CI: 27%, 31%), was less than for heroin plus combined OUD, 54% (95% CI: 26%, 82%). Most of the pooled results had high heterogeneity statistics except for results of lifetime treatment seeking for prescription OUD and past 12-month treatment seeking for prescription OUD. CONCLUSION: All included studies in this meta-analysis were from the USA and indicate modest levels of treatment seeking for those with OUD. In particular, this review found that in the USA one in five people with OUD sought OUD treatment in the previous 12 months and two in five people with OUD sought OUD treatment in their lifetime. Further research is urgently required to explore the barriers and facilitators that can improve this low treatment seeking in those with OUD.

Does the treatment of anxiety in children with Attention-Deficit/Hyperactivity Disorder (ADHD) using cognitive behavioral therapy improve child and family outcomes? Protocol for a randomized controlled trial.

BACKGROUND: Up to 60% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) meet diagnostic criteria for at least one anxiety disorder, including Social, Generalized and/or Separation Disorder. Anxiety in children with ADHD has been shown to be associated with poorer child and family functioning. Small pilot studies suggest that treating anxiety in children with ADHD using cognitive-behavioral therapy (CBT) has promising benefits. In a fully powered randomized controlled trial (RCT), we aim to investigate the efficacy of an existing CBT intervention adapted for children with ADHD and comorbid anxiety compared with usual care. METHODS: This RCT is recruiting children aged 8-12 years (N = 228) from pediatrician practices in Victoria, Australia. Eligibility criteria include meeting full diagnostic criteria for ADHD and at least one anxiety disorder (Generalized, Separation or Social). Eligible children are randomized to receive a 10 session CBT intervention (Cool Kids) versus usual clinical care from their pediatrician. The intervention focuses on building child and parent skills and strategies to manage anxiety and associated impairments including cognitive restructuring and graded exposure. Minor adaptations have been made to the delivery of the intervention to meet the needs of children with ADHD including increased use of visual materials and breaks between activities. The primary outcome is change in the proportion of children meeting diagnostic criteria for an anxiety disorder at 5 months randomization. This will be assessed via diagnostic interview with the child's parent (Anxiety Disorders Interview Schedule for Children V) conducted by a researcher blinded to intervention condition. Secondary outcomes include a range of child (e.g., anxiety symptoms, ADHD severity, behavior, quality of life, sleep, cognitive functioning, school attendance) and parent (e.g., mental health, parenting behaviors, work attendance) domains of functioning assessed at 5 and 12 months post-randomization. Outcomes will be analyzed using logistic and mixed effects regression. DISCUSSION: The results from this study will provide evidence on whether treating comorbid anxiety in children with ADHD using a CBT approach leads to improvements in anxiety and/or broader functional outcomes. TRIAL REGISTRATION: This trial was prospectively registered: Current Controlled Trials ISRCTN59518816 (https://doi.org/10.1186/ISRCTN59518816). The trial was first registered 29/9/15 and last updated 15/1/19.

Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients [PROTECT]: rationale and design of a randomized controlled trial.

BACKGROUND: Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted. METHODS/DESIGN: This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs. DISCUSSION: This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.

The cost-effectiveness of call-back counselling for smoking cessation.

OBJECTIVE: To assess the cost-effectiveness of the Quitline, a call-back counselling service for smoking cessation, in the states of Queensland, Western Australia and the Northern Territory. METHODS: A cost-effectiveness analysis using a deterministic Markov model, and cost per disability-adjusted life year (DALY) averted over a lifetime as the outcome measure. POPULATION: Current smokers, motivated to quit. RESULTS: Call-back counselling for smoking cessation provided by the Quitline is an intervention that both improves health with additional quitters, and achieves net cost savings due to the cost offsets being greater than the cost of the intervention. If cost offsets are excluded, the cost per quitter is $A773 (95% uncertainty interval $A769$-$A779), and the incremental cost-effectiveness ratio is $A294 per DALY (95% uncertainty interval $A293-$A298). CONCLUSIONS: Call-back counselling is a cost-effective intervention for smoking cessation that can be provided by a centralised service for a large population, and to reach people in isolated communities.

'Out of pocket' costs to stroke patients during the first year after stroke - results from the North East Melbourne Stroke Incidence Study.

Non-reimbursed 'out of pocket' costs to stroke patients have not been included in existing cost of illness studies. We aimed to determine the nature and magnitude of 'out of pocket' costs to stroke patients during the first year after stroke. 'Out of pocket' costs during the first year after stroke were documented for 165 persons registered in a community-based stroke incidence study during 1996/1997. Virtually all cases reported some 'out of pocket' costs. The average cost over 12 months was A$1110. The highest cost items were home modifications, aids and equipment. The most commonly incurred expense was for prescription medications. Total 'out of pocket' costs incurred by first-ever stroke patients in Australia in 1997 were estimated to be A$29 million or 5% of the total cost of stroke. The majority of 'out of pocket' costs relate to post-acute care aimed at minimising disability and handicap rather than to 'acute' healthcare.

Lifetime cost of stroke subtypes in Australia: findings from the North East Melbourne Stroke Incidence Study (NEMESIS).

BACKGROUND AND PURPOSE: Little is known about any variations in resource use and costs of care between stroke subtypes, especially nonhospital costs. The purpose of this study was to describe the patterns of resource use and to estimate the first-year and lifetime costs for stroke subtypes. METHODS: A cost-of-illness model was used to estimate the total first-year costs and lifetime costs of stroke subtypes for all strokes (subarachnoid hemorrhages excluded) that occurred in Australia during 1997. For each subtype, average cost per case during the first year and the present value of average cost per case over a lifetime were calculated. Resource use data obtained in the North East Melbourne Stroke Incidence Study (NEMESIS) were used. RESULTS: The present value of total lifetime costs for all strokes was Aus 1.3 billion dollars (US 985 million dollars). Total lifetime costs were greatest for ischemic stroke (72%; Aus 936.8 million dollars; US 709.7 million dollars), followed by intracerebral hemorrhage (26%; Aus 334.5 million dollars; US 253.4 million dollars) and unclassified stroke (2%; Aus 30 million dollars; US 22.7 million dollars). The average cost per case during the first year was greatest for total anterior circulation infarction (Aus 28 266 dollars). Over a lifetime, the present value of average costs was greatest for intracerebral hemorrhage (Aus 73 542 dollars), followed by total anterior circulation infarction (Aus 53 020 dollars), partial anterior circulation infarction (Aus 50 692 dollars), posterior circulation infarction (Aus 37 270 dollars), lacunar infarction (Aus 34 470 dollars), and unclassified stroke (Aus 12 031 dollars). CONCLUSIONS: First-year and lifetime costs vary considerably between stroke subtypes. Variation in average length of total hospital stay is the main explanation for differences in first-year costs.