"It's like a safety net for when things go wrong": key stakeholder and program user perspectives on a peer-led safe space program in Sydney, Australia.

BACKGROUND: Safe Spaces are a harm reduction approach commonly utilised in nightlife and festival settings to address alcohol and other drug-related harms. Despite increasing use, there has been little independent evaluation of safe space programs. This study aimed to explore (1) program user satisfaction with and use of a safe space program implemented in Sydney, Australia (The Take Kare Safe Space (TKSS)), and (2) the strengths and weaknesses of TKSS from the perspective of key stakeholders. METHODS: Semi-structured, in-depth, interviews lasting between 30 min to 1 h were conducted with 38 key program stakeholders, including staff from police (n = 4), ambulance (n = 4), a local hospital accident and emergency room (n = 4), local council (n = 2), city 'rangers' (n = 2), the TKSS program (n = 4), licensed venues and other nightlife service providers (n = 4), and program users (n = 14). Purposive sampling was used to identify key stakeholders to participate in interviews. RESULTS: Stakeholders stated that the TKSS program had a number of core benefits, including that it filled a service gap in nightlife settings; improved the efficiency and effectiveness of emergency services and other stakeholders operating in nightlife precincts; provided welfare services through proactive and non-judgmental interventions; and facilitated a means to de-escalate conflict without engaging police. Perceived weaknesses of the program included a lack of public awareness about the program; staff and volunteer levels; and misunderstandings regarding the scope and function of the TKSS program by some stakeholders. CONCLUSION: This study demonstrates the complex relationships that exist around the delivery of harm reduction in nightlife settings. In particular, it highlights the relative lack of servicing of public nightlife settings and the value of safe spaces/peer-to-peer safety ambassador programs in linking up care and filling this service gap. Further, it documents the extended benefit across key stakeholder groups of delivering proactive and non-judgemental harm reduction services and, in doing so, provides critical evidence around their efficacy in reducing AOD-related harms in the night-time economy.

SISTAQUIT: training health care providers to help pregnant Aboriginal and Torres Strait Islander women quit smoking. A cluster randomised controlled trial.

BACKGROUND: About 44% of Indigenous Australian women smoke during pregnancy, compared with 12% of pregnant non-Indigenous women. Health care providers can assist smoking cessation, but they are not typically trained in culturally appropriate methods. OBJECTIVES: To determine whether a health care worker training intervention increases smoking cessation rates among Indigenous pregnant smokers compared with usual care. METHODS AND ANALYSIS: Supporting Indigenous Smokers to Assist Quitting (SISTAQUIT) study is a multicentre, hybrid type 1, pragmatic, cluster randomised controlled trial that compares the effects of an intervention for improving smoking cessation by pregnant Indigenous women (16 years or older, 32 weeks' gestation or less) with usual care. Twenty-one health services caring for Indigenous people in five Australian jurisdictions were randomised to the intervention (ten sites) or control groups (eleven sites). Health care providers at intervention sites received smoking cessation care training based on the ABCD (ask/assess; brief advice; cessation; discuss psychosocial context) approach to smoking cessation for Indigenous women, an educational resource package, free oral nicotine replacement therapy for participating women, implementation support, and trial implementation training. Health care providers in control group services provided usual care. PRIMARY OUTCOME: abstinence from smoking (self-reported abstinence via survey, validated by carbon monoxide breath testing when possible) four weeks after enrolment in the study. SECONDARY OUTCOMES: health service process evaluations; knowledge, attitudes, and practices of health care providers; and longer term abstinence, perinatal outcomes, and respiratory outcomes for babies (to six months). Ethics approval: The human research ethics committees of the University of Newcastle (H-2015-0438) and the Aboriginal Health and Medical Research Council of NSW (1140/15) provided the primary ethics approval. Dissemination of results: Findings will be disseminated in peer-reviewed publications, at local and overseas conferences, and via public and social media, and to participating health services in art-based formats and reports. Policy briefs will be communicated to relevant government organisations. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12618000972224 (prospective).

Effect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.

Importance: Cytisine is more effective than placebo and nicotine replacement therapy for smoking cessation. However, cytisine has not been tested against the most effective smoking cessation medication, varenicline, which is associated with adverse events known to lead to discontinuation of therapy. Objective: To examine whether standard cytisine treatment (25 days) was at least as effective as standard varenicline treatment (84 days) for smoking cessation. Design, Setting, and Participants: This noninferiority, open-label randomized clinical trial with allocation concealment and blinded outcome assessment was undertaken in Australia from November 2017 through May 2019; follow-up was completed in January 2020. A total of 1452 Australian adult daily smokers willing to make a quit attempt were included. Data collection was conducted primarily by computer-assisted telephone interview, but there was an in-person visit to validate the primary outcome. Interventions: Treatments were provided in accordance with the manufacturers' recommended dosage: cytisine (n = 725), 1.5-mg capsules taken 6 times daily initially then gradually reduced over the 25-day course; varenicline (n = 727), 0.5-mg tablets titrated to 1 mg twice daily for 84 days (12 weeks). All participants were offered referral to standard telephone behavioral support. Main Outcomes and Measures: The primary outcome was 6-month continuous abstinence verified using a carbon monoxide breath test at 7-month follow-up. The noninferiority margin was set at 5% and the 1-sided significance threshold was set at .025. Results: Among 1452 participants who were randomized (mean [SD] age, 42.9 [12.7] years; 742 [51.1%] women), 1108 (76.3%) completed the trial. Verified 6-month continuous abstinence rates were 11.7% for the cytisine group and 13.3% for the varenicline group (risk difference, -1.62% [1-sided 97.5% CI, -5.02% to ∞]; P = .03 for noninferiority). Self-reported adverse events occurred less frequently in the cytisine group (997 events among 482 participants) compared with the varenicline group (1206 events among 510 participants) and the incident rate ratio was 0.88 (95% CI, 0.81 to 0.95; P = .002). Conclusions and Relevance: Among daily smokers willing to quit, cytisine treatment for 25 days, compared with varenicline treatment for 84 days, failed to demonstrate noninferiority regarding smoking cessation. Trial Registration: anzctr.org.au Identifier: ACTRN12616001654448.

The effectiveness and cost effectiveness of a hospital avoidance program in a residential aged care facility: a prospective cohort study and modelled decision analysis.

BACKGROUND: Residential aged care facility residents experience high rates of hospital admissions which are stressful, costly and often preventable. The EDDIE program is a hospital avoidance initiative designed to enable nursing and care staff to detect, refer and quickly respond to early signals of a deteriorating resident. The program was implemented in a 96-bed residential aged care facility in regional Australia. METHODS: A prospective pre-post cohort study design was used to collect data on costs of program delivery, hospital admission rates and length of stay for the 12 months prior to, and following, the intervention. A Markov decision model was developed to synthesize study data with published literature in order to estimate the cost-effectiveness of the program. Quality adjusted life years (QALYs) were adopted as the measure of effectiveness. RESULTS: The EDDIE program was associated with a 19% reduction in annual hospital admissions and a 31% reduction in the average length of stay. The cost-effectiveness analysis found the program to be both more effective and less costly than usual care, with 0.06 QALYs gained and $249,000 health system costs saved in a modelled cohort of 96 residents. A probabilistic sensitivity analysis estimated that there was an 86% probability that the program was cost-effective after taking the uncertainty of the model inputs into account. CONCLUSIONS: This study provides promising evidence for the effectiveness and cost-effectiveness of a nurse led, early intervention program in preventing unnecessary hospital admissions within a residential aged care facility. Further research in multi-site randomised studies is needed to confirm the generalisability of these results.

The cost of hospitalisation for youth self-harm: differences across age groups, sex, Indigenous and non-Indigenous populations.

OBJECTIVE: To report the comparative rates, average length of stay and cost per episode of hospital management for self-harm in three age cohorts: 15-19 years, 20-24 years and 25-29 years; by sex and indigeneity. DESIGN, SETTING, PARTICIPANTS: A secondary data analysis of the Australian Institute of Health and Welfare (AIHW) dataset between 1st January 2014 and 31st December 2014 inclusive. MAIN OUTCOME MEASURES: Cost per episode of hospitalised self-harm and rates by age group, sex and Indigenous status. RESULTS: The rate of hospitalised self-harm among Australian youth was 254.0 per 100,000 population. This rate resulted in an annual cost to the healthcare system of AU$55 million or an average cost per episode of $4649 (95% CI $4488:$4810). Hospitalised self-harm was 21 times higher than the rate of suicide (11,820 episodes of hospitalised self-harm/564 suicides). Indigenous youth had on average a 1.4 times higher rate of hospitalised self-harm and 2.2 times higher rate of suicide than non-Indigenous counterparts. When controlling for age and sex, the average cost per episode was significantly lower for Indigenous youth compared to non-Indigenous youth, estimated marginal means $4538 and $4954, respectively (p < 0.001). CONCLUSIONS: Hospitalised self-harm among Australian youth resulted in a substantial cost to the healthcare system. This cost is only part of the overall burden associated with self-harm. The rate of hospitalised self-harm was significantly higher in Indigenous youth, but the associated cost per episode was significantly lower.

Does face-to-face pre-operative joint replacement education reduce hospital costs in a regional Australian hospital? A descriptive retrospective clinical audit.

OBJECTIVE: To evaluate whether attending a face-to-face pre-operative joint replacement education in a regional setting reduces overall hospital costs and length of stay (LOS) following total knee replacement (TKR) or total hip replacement (THR). METHODS: A retrospective clinical audit reviewed the medical records of all patients who underwent an elective THR or TKR at Rockhampton Hospital in regional Queensland, Australia, between 03/2015 and 12/2016 (22 months). The pre-operative joint replacement education class was provided by a multidisciplinary team that included a physiotherapist, an occupational therapist, a dietician, a pharmacist and a social worker. In addition to demographic data, we extracted and analysed data related to total acute care and total healthcare cost, prevalence of post-operative complications, discharge destination and comorbidities (using the Functional Comorbidity Index). RESULTS: Out of 326 cases that were included in the analysis, 115 cases with TKR and 51 cases with THR attended a pre-operative education class. Demographic characteristics between those attending and not attending the class were largely similar, except from more females attending in the THR group. There was no difference in hospital costs or LOS between those who attended the class compared to those who did not for both the TKR and THR groups. Outcomes related to total acute stay costs, total cost including travel and education and score for Functional Comorbidities Index were similar between those who attended the class and those who did not. CONCLUSION: Pre-operative education does not reduce hospital costs (surgery and hospital stay) in Central Queensland.

Comorbid tobacco and other substance use and symptoms of anxiety and depression among hospitalised orthopaedic trauma patients.

BACKGROUND: No study has examined the prevalence of tobacco, other substance use, and symptoms of anxiety and depression, and rates of comorbidities among the orthopaedic trauma population, despite the impact they have on recovery from surgery. This study aims to 1) describe the rates of symptoms and substance use; 2) compare rates of symptoms and substance use among smokers versus non-smokers; and 3) examine the relationship between symptoms and substance use with smoking status. METHODS: A cross-sectional survey of orthopaedic trauma patients was conducted in two Australian public hospitals. Demographic characteristics, smoking status, alcohol consumption, recent cannabis use, and symptoms of anxiety and/or depression were examined. Differences between current and non-smokers were compared using Pearson Chi2 tests. Multivariate logistic regression explored variables related to tobacco smoking. RESULTS: Eight hundred nineteen patients participated. Over one-fifth (21.8%) identified as a current smoker, half (51.8%) reported consuming alcohol at hazardous levels in the last 12 months, and about 10% stated that they had used cannabis in the last 30 days (9.7%), or experienced symptoms of either anxiety (12.4%), or depression (12.9%) in the last two weeks. Over one-fifth of current tobacco smokers (21.8%) reported drinking heavily in the last 12 months and using cannabis recently. Males, with a lower educational attainment, who were unmarried, had used cannabis recently, and report drinking heavily were more likely to be current smokers. CONCLUSIONS: Health behaviour interventions addressing comorbidities are warranted among the orthopaedic trauma population given the high rate of comorbidity and impact these may have on recovery.

Promotion of healthy eating in clubs with junior teams in Australia: A cross-sectional study of club representatives and parents.

ISSUES ADDRESSED: To: (i) describe the prevalence of policies and practices promoting healthy eating implemented by sports clubs with junior teams; (ii) examine differences in such practices across geographic and operational characteristics of clubs; and (iii) describe the attitudes of club representatives and parents regarding the acceptability of sports clubs implementing policies and practices to promote healthy eating. METHODS: Cross-sectional telephone surveys of junior community football club management representatives and parents/carers of junior players were conducted in the states of New South Wales and Victoria, Australia in 2016. RESULTS: Seventy-nine of the 89 club representatives approached to participate completed the telephone survey. All clubs (100%; 95% CI 96.2-100.0) reported recommending fruit or water be provided to players after games or at half-time, 24% (95% CI 14.4-33.7) reported promoting healthy food options through prominent positioning at point of sale and only 8% (95% CI 1.6-13.6) of clubs had a written healthy eating policy. There were no significant differences between the mean number of healthy eating policies and practices implemented by club socio-economic or geographic characteristics. Club representatives and parents/carers were supportive of clubs promoting healthy eating for junior players. CONCLUSIONS: While there is strong support within sporting clubs with junior teams for policies and practices to promote healthy eating, their implementation is highly variable. SO WHAT?: A considerable opportunity remains for health promotion policy and practice improvement in clubs with junior teams, particularly regarding policies related to nutrition.

The Effectiveness of a Web-Based Computer-Tailored Physical Activity Intervention Using Fitbit Activity Trackers: Randomized Trial.

BACKGROUND: Web-based interventions that provide personalized physical activity advice have demonstrated good effectiveness but rely on self-reported measures of physical activity, which are prone to overreporting, potentially reducing the accuracy and effectiveness of the advice provided. OBJECTIVE: This study aimed to examine whether the effectiveness of a Web-based computer-tailored intervention could be improved by integrating Fitbit activity trackers. METHODS: Participants received the 3-month TaylorActive intervention, which included 8 modules of theory-based, personally tailored physical activity advice and action planning. Participants were randomized to receive the same intervention either with or without Fitbit tracker integration. All intervention materials were delivered on the Web, and there was no face-to-face contact at any time point. Changes in physical activity (Active Australia Survey), sitting time (Workforce Sitting Questionnaire), and body mass index (BMI) were assessed 1 and 3 months post baseline. Advice acceptability, website usability, and module completion were also assessed. RESULTS: A total of 243 Australian adults participated. Linear mixed model analyses showed a significant increase in total weekly physical activity (adjusted mean increase=163.2; 95% CI 52.0-274.5; P=.004) and moderate-to-vigorous physical activity (adjusted mean increase=78.6; 95% CI 24.4-131.9; P=.004) in the Fitbit group compared with the non-Fitbit group at the 3-month follow-up. The sitting time and BMI decreased more in the Fitbit group, but no significant group × time interaction effects were found. The physical activity advice acceptability and the website usability were consistently rated higher by participants in the Fitbit group. Non-Fitbit group participants completed 2.9 (SD 2.5) modules, and Fitbit group participants completed 4.4 (SD 3.1) modules. CONCLUSIONS: Integrating physical activity trackers into a Web-based computer-tailored intervention significantly increased intervention effectiveness. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001555448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371793 (Archived by WebCite at http://www.webcitation.org/73ioTxQX2).

Improving adherence to colorectal cancer surveillance guidelines: results of a randomised controlled trial.

BACKGROUND: Colorectal cancer (CRC) survivors are at increased risk of developing the disease again. Surveillance guidelines are aimed at maximising the early detection of recurring or new cancers and pre-cancerous polyps. The frequency and type of surveillance recommended depends on the type of treatment for the initial CRC, the extent of colonoscopic investigation prior to treatment and the results of previous surveillance tests. This paper aimed to test the effect of a paper-based educational intervention to improve adherence to colonoscopy following treatment for colorectal cancer. METHODS: People with a diagnosis of colorectal cancer within the last 10 months, aged ≥18 and English speaking were recruited through a population-based cancer registry in Australia. Participants were randomly allocated to either the intervention or control. Participants completed an interview at baseline. Self-reported participation in colonoscopy was obtained at 12 month followup by survey. Those allocated to the control received a generic pamphlet on colorectal cancer treatment; while intervention participants received a letter which provided specific information about guideline recommendations for surveillance colonoscopy. Rates of guideline adherence were compared between groups. The guideline recommendations for the timing of surveillance colonoscopy changed part way through the study. This change occurred after all intervention materials had been sent, but prior to all participants completing the 12 month follow up. Post hoc analyses were conducted to assess adherence to the new guidelines. RESULTS: Of the 767 participants, 604 (79%) had had surgery, had stage I - III disease and completed the baseline interview within 12 months of diagnosis (intervention = 305; control = 299). There was no significant difference between those adherent to surveillance colonoscopy guidelines, in the control (67, 27%) and intervention groups (80, 31%) at followup (difference = 4.3% (95%CI:-3.7%, 12%), χ 2(1df) = 1.09, P = 0.296). Overall, 246 (49%) participants were adherent to the new guidelines, compared to 147 (29%) adherent to the old guidelines. CONCLUSIONS: Results indicate the paper-based educational intervention is not effective in improving adherence to colorectal cancer surveillance guidelines for colonoscopy. TRIAL REGISTRATION NUMBER: ACTRN12609000628246 Registration date: 28/07/2009.

Implementing exercise in cancer care: study protocol to evaluate a community-based exercise program for people with cancer.

BACKGROUND: Clinical research has established the efficacy of exercise in reducing treatment-related side-effects and increasing wellbeing in people with cancer. Major oncology organisations have identified the importance of incorporating exercise in comprehensive cancer care but information regarding effective approaches to translating evidence into practice is lacking. This paper describes the implementation of a community-based exercise program for people with cancer and the protocol for program evaluation. METHODS/DESIGN: The Life Now Exercise program is a community-based exercise intervention designed to mitigate and rehabilitate the adverse effects of cancer and its treatment and improve physical and psychosocial wellbeing in people with cancer. Involvement in the program is open to people with any diagnosis of cancer who are currently receiving treatment or within 2 years of completing treatment. The 3-month intervention consists of twice weekly group-based exercise sessions administered in community exercise clinics under the supervision of exercise physiologists trained to deliver the program. Evaluation of the program involves measures of uptake, safety, adherence and effectiveness (including cost effectiveness) as assessed at the completion of the program and 6 months follow-up. DISCUSSION: To bridge the gap between research and practice, the Life Now Exercise program was designed and implemented to provide people with cancer access to evidence-based exercise medicine. The framework for program implementation and evaluation offers insight into the development of feasible, generalizable and sustainable supportive care services involving exercise. Community-based exercise programs specifically designed for people with cancer are necessary to facilitate adherence to international guidelines advising patients to participate in high-quality exercise. TRIAL REGISTRATION: ACTRN12616001669482 (retrospectively registered 5 Dec 2016).

Smoking and finances: baseline characteristics of low income daily smokers in the FISCALS cohort.

BACKGROUND: Financial stress is a barrier to successful smoking cessation and a key predictor of relapse. Little is known about the financial situation of low-income Australian daily smokers. This study aims to describe and investigate associations between the financial functioning, tobacco use and quitting behaviours of low income daily smokers. METHODS: Low-income Australian adult smokers in the 'Financial Intervention for Smoking Cessation Among Low-income Smokers (FISCALS) randomised clinical trial completed a structured telephone questionnaire. RESULTS: The median number of cigarettes typically smoked by the 1047 participants was 23 per day. The median spent on tobacco per week was AU$80. Three quarters (73.0%) reported some financial stress and 43.2% reported smoking-induced deprivation. Financial stress was significantly associated with deprivation (IRR: 1.23, 95% CI 1.21, 1.26, p < 0.001). There were no significant associations either between adjusted financial stress or deprivation and motivation to quit or certainty of quit success. CONCLUSIONS: Financial stress and smoking induced deprivation were prevalent among low-income daily smokers, but they were not associated with motivation to quit. Smoking cessation interventions need to be responsive to the role financial stress plays in reducing quit attempts and increasing relapse. TRIAL REGISTRATION: Australian and New Zealand Clinical trials Registry ACTRN12612000725864 6/07/2012.

Alcohol management plans in Aboriginal and Torres Strait Islander (Indigenous) Australian communities in Queensland: community residents have experienced favourable impacts but also suffered unfavourable ones.

BACKGROUND: In Australia, 'Alcohol Management Plans' (AMPs) provide the policy infrastructure for State and Commonwealth Governments to address problematic alcohol use among Aboriginal and Torres Strait Islanders. We report community residents' experiences of AMPs in 10 of Queensland's 15 remote Indigenous communities. METHODS: This cross-sectional study used a two-stage sampling strategy: N = 1211; 588 (48%) males, 623 (52%) females aged ≥18 years in 10 communities. Seven propositions about 'favourable' impacts and seven about 'unfavourable' impacts were developed from semi-structured interviews. For each proposition, one-sample tests of proportions examined participant agreement and multivariable binary logistic regressions assessed influences of gender, age (18-24, 25-44, 45-64, ≥65 years), residence (≥6 years), current drinking and Indigenous status. Confirmatory factor analyses estimated scale reliability (ρ), item loadings and covariances. RESULTS: Slim majorities agreed that: AMPs reduced violence (53%, p = 0.024); community a better place to live (54%, 0.012); and children were safer (56%, p < 0.001). More agreed that: school attendance improved (66%, p < 0.001); and awareness of alcohol's harms increased (71%, p < 0.001). Participants were equivocal about improved personal safety (53%, p = 0.097) and reduced violence against women (49%, p = 0.362). The seven 'favourable' items reliably summarized participants' experiences of reduced violence and improved community amenity (ρ = 0.90). Stronger agreement was found for six 'unfavourable' items: alcohol availability not reduced (58%, p < 0.001); drinking not reduced (56%, p < 0.001)); cannabis use increased (69%, p < 0.001); more binge drinking (73%, p < 0.001); discrimination experienced (77%, p < 0.001); increased fines, convictions and criminal records for breaching restrictions (90%, p < 0.001). Participants were equivocal (51% agreed, p = 0.365) that police could enforce restrictions effectively. 'Unfavourable' items were not reliably reflected in one group (ρ = 0.48) but in: i) alcohol availability and consumption not reduced and ii) criminalization and discrimination. In logistic regressions, longer-term (≥ 6 years) residents more likely agreed that violence against women had reduced and that personal safety had improved but also that criminalization and binge drinking had increased. Younger people disagreed that their community was a better place to live and strongly agreed about discrimination. Current drinkers' views differed little from the sample overall. CONCLUSIONS: The present Government review provides an opportunity to reinforce 'favourable' outcomes while targeting: illicit alcohol, treatment and diversion services and reconciliation of criminalization and discrimination issues.

Experiences of colorectal cancer patients in the 2-years post-diagnosis and patient factors predicting poor outcome.

PURPOSE: There are few recent longitudinal studies investigating the quality of life of colorectal cancer patients in the early years following diagnosis. This study aimed to (i) compare the health status of people with colorectal cancer less than 1 year from diagnosis with health status 1 year later and (ii) determine the characteristics associated with a change in overall health status. METHODS: The study was conducted as part of a larger trial. Participants (n = 539) were identified via the Victorian Cancer Registry in Australia, completed a computer-assisted baseline telephone interview (including the EQ-5D-3L) within 6-12 months of diagnosis, and mailed a survey 12 months later. RESULTS: At baseline, the majority of participants (55 %) reported some problems, including difficulties in usual activities (26 %), pain or discomfort (25 %), anxiety or depression (23 %) and mobility issues (15 %). Sixty-nine percent had either an unchanged or increased health utility score from baseline to follow-up. The largest proportion reporting an increase in problems between baseline and follow-up related to pain or discomfort (18 %). While visual analogue scale scores indicated a significantly improved health state over time overall, 32 % reported a decreased health utility score from baseline to follow-up. Those aged over 80 years were more likely to report a decreased health utility score compared to 60-80-year-olds. CONCLUSIONS: A sizeable minority of patients experience ongoing problems in their daily lives and should be offered assistance in overcoming disabilities and returning to best possible functioning, particularly older patients who appear to be vulnerable to poor outcomes.

The Breathing for Life Trial: a randomised controlled trial of fractional exhaled nitric oxide (FENO)-based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health.

BACKGROUND: Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. METHODS/DESIGN: BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, a marker of eosinophilic airway inflammation) compared to usual care, with prospective infant follow-up. Women with physician-diagnosed asthma, asthma symptoms and/or medication use in the previous 12 months, who are 12-22 weeks gestation, will be eligible for inclusion. Women randomised to the control group will have one clinical assessment of their asthma, including self-management education. Any treatment changes will be made by their general practitioner. Women randomised to the intervention group will have clinical assessments every 3-6 weeks during pregnancy, and asthma treatments will be adjusted every second visit based on an algorithm which uses FENO to adjust inhaled corticosteroid (ICS) dose (increase in dose when FENO >29 parts per billion (ppb), decrease in dose when FENO <19 ppb, and no change when FENO is between 19 and 29 ppb). A long acting beta agonist (LABA) will be added when symptoms remain uncontrolled. Both the control and intervention groups will report on exacerbations at a postpartum phone interview. The primary outcome is adverse perinatal outcome (a composite measure including preterm birth, intrauterine growth restriction, neonatal hospitalisation at birth or perinatal mortality), assessed from hospital records. Secondary outcomes will be each component of the primary outcome, maternal exacerbations requiring medical intervention during pregnancy (both smokers and non-smokers), and hospitalisation and emergency department presentation for wheeze, bronchiolitis or croup in the first 12 months of infancy. Outcome assessment and statistical analysis of the primary outcome will be blinded. To detect a reduction in adverse perinatal outcomes from 35 % to 26 %, 600 pregnant women with asthma per group are required. DISCUSSION: This trial will provide evidence for the effectiveness of a FENO-based management strategy in improving perinatal outcomes in pregnant women with asthma. If successful, this would improve the management of pregnant women with asthma worldwide. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000202763 .

Does evidence influence policy? Resource allocation and the Indigenous Burden of Disease study.

Objective The Indigenous Burden of Disease (IBoD) report is the most comprehensive assessment of Indigenous disease burden in Australia. The aim of the present study was to investigate the potential effect of the IBoD report on Australian Indigenous health policy, service expenditure and research funding. Findings have significance for understanding factors that may influence Indigenous health policy. Methods The potential effect of the IBoD report was considered by: (1) conducting a text search of pertinent documents published by the federal government, Council of Australian Governments and the National Health and Medical Research Council of Australia (NHMRC) and observing the quantity and quality of references to IBoD; (2) examining data on government Indigenous healthcare expenditure for trends consistent with the findings and policy implications of the IBoD report; and (3) examining NHMRC Indigenous grant allocation trends consistent with the findings and policy implications of the IBoD report. Results Of 110 government and NHMRC documents found, IBoD was cited in 27. Immediately after publication of the IBoD report, federal and state governments increased Indigenous health spending (relative to non-Indigenous), notably for community health and public health at the state level. Expenditure on Indigenous hospital separations for chronic diseases also increased. These changes are broadly consistent with the findings of the IBoD report on the significance of chronic disease and the need to address certain risk factors. However, there is no evidence that such changes had a causal connection with the IBoD study. After publication of the IBoD report, changes in NHMRC Indigenous research funding showed little consistency with the findings of the IBoD report. Conclusions The present study found only indirect and inconsistent correlational evidence of the potential influence of the IBoD report on Indigenous health expenditure and research funding. Further assessment of the potential influence of the IBoD report on Indigenous health policy will require more targeted research, including interviews with key informants involved in developing health policy. What is known about the topic? There are currently no publications that consider the potential effed of the IBoD study on Indigenous health expenditure and research funding. What does this paper add? This paper offers the first consideration of the potential effect of the IBoD report. It contains analyses of data from readily available sources, examining national expenditures on Indigenous health and NHMRC Indigenous research, before and after the publication of the IBoD report. What are the implications for practitioners? The paper is relevant to analysts interested in drivers of Indigenous health policy. Although it finds correlations between the release of the IBoD report and some subsequent health spending decisions, other factors should be investigated to better understand the complexity of processes that drive government efforts to improve Indigenous health.

The impact of a community-based risky drinking intervention (Beat da Binge) on Indigenous young people.

BACKGROUND: Alcohol misuse imposes substantial harm on Indigenous Australians whose health status is poorer than non-Indigenous Australians. Although Indigenous youth are over represented in Indigenous alcohol harms, few interventions addressing alcohol-related harm among Indigenous youth have been evaluated. Given this paucity of evidence, a survey was designed to evaluate the effects of a whole-of-community, anti-binge drinking intervention for young people in an Indigenous community in far north Queensland, Australia. METHODS: A cross sectional, baseline-post intervention study assessed the impact of a two year anti-binge drinking intervention targeting young people (18-24 years). A survey was developed and implemented at baseline and again two-years post-intervention, administered by young local people employed as research assistants. Survey respondents were recruited through snowballing techniques. Survey items asked about respondents' knowledge of binge drinking and standard drinks, involvement in alcohol-free social activities, frequency of short-term risky drinking (binge drinking), and mean alcohol expenditure during short-term risky drinking occasions. The intervention was called Beat da Binge. Two major events and multiple minor activities each year were implemented, focusing on drinking education, alcohol-free community-wide social events, and youth-specific sporting and social activities to facilitate self-empowerment. RESULTS: Beat da Binge was associated with a statistically significant 10% reduction in the proportion of survey respondents who reported that they had engaged in an episode of short-term risky drinking, in the frequency of short-term risky drinking for all beverage types except wine (ranging from 4% to 31% reductions), in mean expenditure on alcohol during short-term risky drinking sessions ($6.25) and in the proportion of activities with family/friends that usually include alcohol (7%). There were also statistically significant increases in awareness of binge drinking and standard drinks (28% and 21% respectively). In addition to alcohol-specific outcomes, there was a statistically significant 8 % increase in the proportions of respondents engaged in training as their main weekday activity, which was partly off-set by a 13% reduction in those whose main weekday activity was family care or home-related tasks. CONCLUSIONS: Reductions in the proportion of survey respondents who reported binge drinking, along with increases in awareness and involvement in alcohol-free social activities suggest the community-based intervention was effective. The potential impact of sample selection and self-reporting limitations on results need further investigation. There is an urgent need for Indigenous, community-driven public health programs that are well evaluated to both improve Indigenous health and the strength of the current evidence base to inform future community interventions.

Estimating the economic costs of skin cancer in New South Wales, Australia.

BACKGROUND: Skin cancer is one of the most common cancers in the world. The increased incidence of skin cancer, combined with limited health care resources and tight budgetary conditions, has increased the importance of understanding the economic impact of skin cancer. This research estimates the economic cost of skin cancer in the Australian state of New South Wales. METHOD: An incidence based approach is used to estimate lifetime costs of skin cancer. Both direct and indirect costs are considered - direct costs include resources associated with the management of skin cancer and indirect costs refer to productivity costs associated with morbidity and premature mortality. Diagnosis of skin cancer was determined according to ICD-10 codes using principal diagnosis. Linked administrative data and regression modelling are used to calculate costs; presented as Australian dollars for the year 2010. The human capital approach is used to value present and future productivity losses. RESULTS: The lifetime cost of the 150,000 incident cases of skin cancer diagnosed in NSW in 2010 is estimated at $536 million ($44,796 per melanoma and $2459 per non-melanoma). Direct costs accounted for 72 % of costs ($10,230 per melanoma and $2336 per non-melanoma) and indirect costs accounted for 28 % of costs ($34,567 per melanoma and $123 per non-melanoma). Direct costs are, on average, higher for females than males with indirect costs, on average, higher for males than females. CONCLUSION: This research provides new evidence on the economic cost of skin cancer and provides policy makers with information of the potential monetary savings that may arise from efforts to reduce the incidence of skin cancer.

The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

BACKGROUND: The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data. METHODS AND FINDINGS: We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2,255, respectively) were the following: long-term risky drinking, short-term high-risk drinking, short-term risky drinking, weekly consumption, hazardous/harmful alcohol use, and experience of alcohol harm. At the 5% level of statistical significance, there was insufficient evidence to conclude that the interventions were effective in the experimental, relative to control, communities for alcohol-related crime, traffic crashes, and hospital inpatient admissions, and for rates of risky alcohol consumption and hazardous/harmful alcohol use. Although respondents in the experimental communities reported statistically significantly lower average weekly consumption (1.90 fewer standard drinks per week, 95% CI = -3.37 to -0.43, p = 0.01) and less alcohol-related verbal abuse (odds ratio = 0.58, 95% CI = 0.35 to 0.96, p = 0.04) post-intervention, the low survey response rates (40% and 24% for the pre- and post-intervention surveys, respectively) require conservative interpretation. The main limitations of this study are as follows: (1) that the study may have been under-powered to detect differences in routinely collected data outcomes as statistically significant, and (2) the low survey response rates. CONCLUSIONS: This RCT provides little evidence that community action significantly reduces risky alcohol consumption and alcohol-related harms, other than potential reductions in self-reported average weekly consumption and experience of alcohol-related verbal abuse. Complementary legislative action may be required to more effectively reduce alcohol harms. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12607000123448.

Determinants of virological failure after 1 year's antiretroviral therapy in Vietnamese people with HIV: findings from a retrospective cohort of 13 outpatient clinics in six provinces.

OBJECTIVE: This study examines the proportions and causes of virological failure after one year of antiretroviral therapy (ART) among people living with HIV (PLHIV) in Vietnam. It also evaluates the positive predictive value (PPV) of immunological criteria to detect treatment failure. METHOD: A retrospective cohort of 3449 people with HIV who started ART between 1 January 2005 and 31 December 2009 in 13 outpatient clinics in Vietnam was studied. Multivariate logistic regression modeling was used to calculate crude and adjusted ORs and 95% CIs for associations between patient characteristics and virological failure. RESULTS: An estimated 6.5% (226/3449) of HIV patients in the participating clinics in Vietnam had confirmed virological failure one year after the start of ART. After adjusting for other factors, patients with a baseline CD4 count of 50-100 cells/mm(3) and 101-200 cells/mm(3) were statistically significantly less likely to have virological failure, compared to those with a baseline CD4 count lower than 50 cells/mm(3) (OR=0.61, 95% CI 0.23-0.89; and OR=0.43, 0.18-0.78, respectively). In contrast, patients with a history of injecting drug use were statistically significantly more likely to have viraemia than otherwise (OR=1.32, 1.16-1.67). The PPV of the WHO immunological criteria was 60.1% (57.1-69.3%). CONCLUSIONS: Routine viral load tests should be conducted early to detect virological failure and prevent unnecessary changes to second-line treatments. To improve treatment outcomes, timely ART initiation and adherence to treatment among those with history of injecting drug use should be promoted.