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Background: Previous reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials.Methods: Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design.Results: This review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used.Conclusions: Many studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power. [ABSTRACT FROM AUTHOR]

Background: Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations and generalised linear mixed models. A topic of much research into these methods has been their application to cluster randomised trial data and, in particular, the number of clusters required to make reasonable inferences about the intervention effect. However, for stepped wedge trials, which have been claimed by many researchers to have a statistical power advantage over the parallel cluster randomised trial, the minimum number of clusters required has not been investigated., Methods: We conducted a simulation study where we considered the most commonly used methods suggested in the literature to analyse cross-sectional stepped wedge cluster randomised trial data. We compared the per cent bias, the type I error rate and power of these methods in a stepped wedge trial setting with a binary outcome, where there are few clusters available and when the appropriate adjustment for a time trend is made, which by design may be confounding the intervention effect., Results: We found that the generalised linear mixed modelling approach is the most consistent when few clusters are available. We also found that none of the common analysis methods for stepped wedge trials were both unbiased and maintained a 5% type I error rate when there were only three clusters., Conclusions: Of the commonly used analysis approaches, we recommend the generalised linear mixed model for small stepped wedge trials with binary outcomes. We also suggest that in a stepped wedge design with three steps, at least two clusters be randomised at each step, to ensure that the intervention effect estimator maintains the nominal 5% significance level and is also reasonably unbiased.

Background: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T 3 ) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated., Methods: This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T 3 intervention or no additional support (control EDs). Our T 3 intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90 days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented., Discussion: This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke., Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12614000939695 . Registered 2 September 2014.

Background: Few studies explored the effects of nutritional changes on body mass index (BMI), weight (Wt), waist circumference (WC) and hypertension, especially for the older Chinese population., Methods: By using China Health and Nutrition Survey 2004-2011 waves, a total of 6348 observations aged ≥ 60 were involved in the study. The number of participants dropped from 2197 in 2004, to 1763 in 2006, 1303 in 2009, and 1085 in 2011. Dietary information was obtained from participants using 24 hour-recall over three consecutive days. Height, Wt, WC, systolic and diastolic blood pressure were also measured in each survey year. The dietary pattern was derived by exploratory factor analysis using principal component analysis methods. Linear Mixed Models were used to investigate associations of dietary patterns with BMI, Wt and WC. Generalized Estimating Equation models were used to assess the associations between dietary patterns and hypertension., Results: Over time, older people's diets were shifting towards a modern dietary pattern (high intake of dairy, fruit, cakes and fast food). Traditional and modern dietary patterns had distinct associations with BMI, Wt and WC. Participants with a diet in the highest quartile for traditional composition had a β (difference in mean) of -0.23 (95 % CI: -0.44; -0.02) for BMI decrease, β of -0.90 (95 % CI: -1.42; -0.37) for Wt decrease; and β of -1.57 (95 % CI: -2.32; -0.83) for WC decrease. However, participants with a diet in the highest quartile for modern diet had a β of 0.29 (95 % CI: 0.12; 0.47) for BMI increase; β of 1.02 (95 % CI: 0.58; 1.46) for Wt increase; and β of 1.44 (95 % CI: 0.78; 2.10) for Wt increase. No significant associations were found between dietary patterns and hypertension., Conclusions: We elucidate the associations between dietary pattern and change in BMI, Wt, WC and hypertension in a 7-year follow-up study. The strong association between favourable body composition and traditional diet, compared with an increase in BMI, WC and Wt with modern diet suggests that there is an urgent need to develop age-specific dietary guideline for older Chinese people.

Background: Australian General Practitioners (GPs) are generous prescribers of antibiotics, prompting concerns including increasing antimicrobial resistance in the community. Recent data show that GPs in vocational training have prescribing patterns comparable with the high prescribing rate of their established GP supervisors. Evidence-based guidelines consistently advise that antibiotics are not indicated for uncomplicated upper respiratory tract infections (URTI) and are rarely indicated for acute bronchitis. A number of interventions have been trialled to promote rational antibiotic prescribing by established GPs (with variable effectiveness), but the impact of such interventions in a training setting is unclear. We hypothesise that intervening while early-career GPs are still developing their practice patterns and prescribing habits will result in better adherence to evidence-based guidelines as manifested by lower antibiotic prescribing rates for URTIs and acute bronchitis., Methods/design: The intervention consists of two online modules, a face-to-face workshop for GP trainees, a face-to-face workshop for their supervisors and encouragement for the trainee-supervisor dyad to include a case-based discussion of evidence-based antibiotic prescribing in their weekly one-on-one teaching meetings. We will use a non-randomised, non-equivalent control group design to assess the impact on antibiotic prescribing for acute upper respiratory infections and acute bronchitis by GP trainees in vocational training., Discussion: Early-career GPs who are still developing their clinical practice and prescribing habits are an underutilized target-group for interventions to curb the growth of antimicrobial resistance in the community. Interventions that are embedded into existing training programs or are linked to continuing professional development have potential to increase the impact of existing interventions at limited additional cost., Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12614001209684 (registered 17/11/2014).

Background: Relative to the general population, people with a mental illness are more likely to have modifiable chronic disease health risk behaviours. Care to reduce such risks is not routinely provided by community mental health clinicians. This study aimed to determine the effectiveness of an intervention in increasing the provision of preventive care by such clinicians addressing four chronic disease risk behaviours., Methods: A multiple baseline trial was undertaken in two groups of community mental health services in New South Wales, Australia (2011-2014). A 12-month practice change intervention was sequentially implemented in each group. Outcome data were collected continuously via telephone interviews with a random sample of clients over a 3-year period, from 6 months pre-intervention in the first group, to 6 months post intervention in the second group. Outcomes were client-reported receipt of assessment, advice and referral for tobacco smoking, harmful alcohol consumption, inadequate fruit and/or vegetable consumption and inadequate physical activity and for the four behaviours combined. Logistic regression analyses examined change in client-reported receipt of care., Results: There was an increase in assessment for all risks combined following the intervention (18 to 29 %; OR 3.55, p = 0.002: n = 805 at baseline, 982 at follow-up). No significant change in assessment, advice or referral for each individual risk was found., Conclusions: The intervention had a limited effect on increasing the provision of preventive care. Further research is required to determine how to increase the provision of preventive care in community mental health services., Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12613000693729.

Background: The primary aim of this study was to evaluate the effectiveness of an intervention to increase the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study also sought to determine if the intervention was effective in improving child dietary intake and increasing child physical activity levels while attending childcare., Methods: A parallel group, randomised controlled trial was conducted in a sample of 128 childcare services. Intervention strategies included provision of implementation support staff, securing executive support, staff training, consensus processes, academic detailing visits, tools and resources, performance monitoring and feedback and a communications strategy. The primary outcome of the trial was the proportion of services implementing all seven healthy eating and physical activity policies and practices targeted by the intervention. Outcome data were collected via telephone surveys with nominated supervisors and room leaders at baseline and immediately post-intervention. Secondary trial outcomes included the differences between groups in the number of serves consumed by children for each food group within the Australian Guide to Healthy Eating and in the proportion of children engaged in sedentary, walking or very active physical activity assessed via observation in a random subsample of 36 services at follow-up., Results: There was no significant difference between groups for the primary trial outcome (p = 0.44). Relative to the control group, a significantly larger proportion of intervention group services reported having a written nutrition and physical activity policy (p = 0.05) and providing adult-guided activities to develop fundamental movement skills (p = 0.01). There were no significant differences between groups at follow-up on measures of child dietary intake or physical activity., Conclusions: The findings of the trial were equivocal. While there was no significant difference between groups for the primary trial outcome, the intervention did significantly increase the proportion of intervention group services implementing two of the seven healthy eating and physical activity policies and practices. High levels of implementation of a number of policies and practices at baseline, significant obesity prevention activity in the study region and higher than previously reported intra-class correlation of child behaviours may, in part, explain the trial findings., Trial Registration: Australian Clinical Trials Registry (reference ACTRN12612000927820 ).

Background: Technical and Further Education (TAFE) colleges are the primary provider of vocational education in Australia. Most TAFE students are young adults, a period when health risk behaviours become established. Furthermore, high rates of smoking, risky alcohol consumption, inadequate fruit and vegetable intake and insufficient physical activity have been reported in TAFE students. There have been no intervention studies targeting multiple health risk behaviours simultaneously in this population. The proposed trial will examine the effectiveness of providing TAFE students with electronic feedback regarding health risk behaviours and referral to a suite of existing online and telephone services addressing smoking, risky alcohol consumption, fruit and vegetable intake, and physical activity levels., Methods/design: A two arm, parallel, cluster randomised trial will be conducted within TAFE campuses in New South Wales (NSW), Australia. TAFE classes will be randomly allocated to an intervention or control condition (50 classes per condition). To be eligible, students must be: enrolled in a course that runs for more than 6 months; aged 16 years or older; and not meet Australian health guideline recommendations for at least one of the following: smoking, alcohol consumption, fruit and/or vegetable intake, or physical activity. Students attending intervention classes, will undertake via a computer tablet a risk assessment for health risk behaviours, and for behaviours not meeting Australian guidelines be provided with electronic feedback about these behaviours and referral to evidence-based online programs and telephone services. Students in control classes will not receive any intervention. Primary outcome measures that will be assessed via online surveys at baseline and 6 months post-recruitment are: 1) daily tobacco smoking; 2) standard drinks of alcohol consumed per week; 3) serves of fruit consumed daily; 4) serves of vegetables consumed daily; and 5) metabolic equivalent minutes of physical activity per week., Discussion: Proactive enrolment to existing online and telephone services has the potential to address modifiable determinants of disease. This trial will be the first to examine a potentially scalable intervention targeting multiple health risk behaviours among students in the vocational training setting., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000105549; Registered 5/2/15.

Background: Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed., Methods: This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression., Discussion: If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

Background: A broad case-mix in family physicians' (general practitioners', GPs') vocational trainee experience is deemed essential in producing competent independent practitioners. It is suggested that the patient-mix should include common and significant conditions and be similar to that of established GPs. But the content of contemporary GP trainees' clinical experience in training is not well-documented. In particular, how well trainees' experience reflects changing general practice demographics (with an increasing prevalence of chronic disease) is unknown. We aimed to establish levels of trainees' clinical exposure to chronic disease in training (and associations of this exposure) and to establish content differences in chronic disease consultations (compared to other consultations), and differences in trainees' actions arising from these consultations., Methods: A cross-sectional analysis from the Registrars' Clinical Encounters in Training (ReCEnT) study, a cohort study of GP registrars' (trainees') consultations in four Australian GP training organisations. Trainees record detailed data from 60 consecutive consultations per six-month training term. Diagnoses/problems encountered are coded using the International Classification of Primary Care-2 PLUS (ICPC-2 PLUS). A classification system derived from ICPC-2 PLUS was used to define diagnoses/problems as chronic/non-chronic disease. The outcome factor for analyses was trainees' consultations in which chronic disease was encountered. Independent variables were a range of patient, trainee, practice, consultation and educational factors., Results: Of 48,112 consultations (of 400 individual trainees), 29.5% included chronic disease problems/diagnoses. Associations of a consultation including chronic disease were the patient being older, male, and having consulted the trainee previously, and the practice routinely bulk-billing (not personally charging) patients. Consultations involving a chronic disease lasted longer, dealt with more problems/diagnoses, and were more likely to result in specialist referrals and trainees generating a personal learning goal. They were associated with less pathology tests being ordered., Conclusions: Trainees saw chronic disease less frequently than have established GPs in comparable studies. The longer duration and more frequent generation of learning goals in chronic disease-containing consultations suggest trainees may find these consultations particularly challenging. Our findings may inform the design of measures aimed at increasing the chronic disease component of trainees' patient-mix.

Background: Early life exposure to inorganic arsenic may be related to adverse health effects in later life. However, there are few data on postnatal arsenic exposure via human milk. In this study, we aimed to determine arsenic levels in human milk and the correlation between arsenic in human milk and arsenic in mothers and infants urine., Methods: Between March 2011 and March 2012, this prospective study identified a total of 120 new mother-baby pairs from Kashiani (subdistrict), Bangladesh. Of these, 30 mothers were randomly selected for human milk samples at 1, 6 and 9 months post-natally; the same mother baby pairs were selected for urine sampling at 1 and 6 months. Twelve urine samples from these 30 mother baby pairs were randomly selected for arsenic speciation., Results: Arsenic concentration in human milk was low and non-normally distributed. The median arsenic concentration in human milk at all three time points remained at 0.5 μg/L. In the mixed model estimates, arsenic concentration in human milk was non-significantly reduced by -0.035 μg/L (95% CI: -0.09 to 0.02) between 1 and 6 months and between 6 and 9 months. With the progression of time, arsenic concentration in infant's urine increased non-significantly by 0.13 μg/L (95% CI: -1.27 to 1.53). Arsenic in human milk at 1 and 6 months was not correlated with arsenic in the infant's urine at the same time points (r = -0.13 at 1 month and r = -0.09 at 6 month). Arsenite (AsIII), arsenate (AsV), monomethyl arsonic acid (MMA), dimethyl arsinic acid (DMA) and arsenobetaine (AsB) were the constituents of total urinary arsenic; DMA was the predominant arsenic metabolite in infant urine., Conclusions: We observed a low arsenic concentration in human milk. The concentration was lower than the World Health Organization's maximum permissible limit (WHO Permissible Limit 15 μg/kg-bw/week). Our findings support the safety of breastfeeding even in arsenic contaminated areas.

Background: Few studies have examined young adults with type 1 diabetes use of health services and the development of vascular complications. As part of the Youth Outreach for Diabetes (YOuR-Diabetes) project, this study identified health service usage, the prevalence and factors predictive of development of vascular complications (hypertension, retinopathy and nephropathy) in a cohort of young adults (aged 16-30 years) with type 1 diabetes in Hunter New England and the Lower Mid-North Coast area of New South Wales, Australia., Methods: A cross-sectional retrospective documentation survey was undertaken of case notes of young adults with type 1 diabetes accessing Hunter New England Local Health District public health services in 2010 and 2011, identified through ambulatory care clinic records, hospital attendances and other clinical records. Details of service usage, complications screening and evidence of vascular complications were extracted. Independent predictors were modelled using linear and logistic regression analyses., Results: A cohort of 707 patients were reviewed; mean (SD) age was 23.0 (3.7) years, with mean diabetes duration of 10.2 (5.8, range 0.2 - 28.3) years; 42.4% lived/ 23.1% accessed services in non-metropolitan areas.Routine preventative service usage was low and unplanned contacts high; both deteriorated with increasing age. Low levels of complications screening were found. Where documented, hypertension, particularly, was common, affecting 48.4% across the study period. Diabetes duration was a strong predictor of vascular complications along with glycaemic control; hypertension was linked with renal dysfunction., Conclusion: Findings indicate a need to better understand young people's drivers and achievements when accessing services, and how services can be reconfigured or delivered differently to better meet their needs and achieve better outcomes. Regular screening is required using current best practice guidelines as this affords the greatest chance for early complication detection, treatment initiation and secondary prevention.

Background: There is a clear disparity in smoking rates according to social disadvantage. In the absence of sufficiently robust data regarding effective strategies for reducing smoking prevalence in disadvantaged populations, understanding the views of tobacco control experts can assist with funding decisions and research agendas., Methods: A web-based cross-sectional survey was conducted with 192 respondents (response rate 65%) sampled from the Australian and New Zealand Tobacco Control Contacts list and a literature search. Respondents were asked to indicate whether a number of tobacco control strategies were perceived to be effective for each of: the general population; Aboriginal and Torres Strait Islander people; those with a low income; and people with a mental illness., Results: A high proportion of respondents indicated that mass media and increased tobacco taxation (84% and 89% respectively) were effective for the general population. Significantly lower proportions reported these two strategies were effective for sub-populations, particularly Aboriginal and Torres Strait Islanders (58% and 63% respectively, p's < .0001). Subsidised medication was the only strategy associated with a greater proportion of respondents perceiving it to be effective in disadvantaged sub-populations compared to the general population. Tailored quit programs and culturally relevant programs were nominated as additional effective strategies for disadvantaged populations., Conclusions: Views about subsidised medications in particular, suggest the need for robust cost-effectiveness data relevant to disadvantaged groups to avoid wastage of scarce tobacco control resources. Strategies perceived to be effective for disadvantaged populations such as tailored or culturally relevant programs require rigorous evaluation so that potential adoption of these approaches is evidence-based.

Background: Electronic screening and brief intervention (e-SBI) is a promising alternative to screening and brief intervention by health-care providers, but its efficacy in the hospital outpatient setting, which serves a large proportion of the population, has not been established. The aim of this study is to estimate the effect of e-SBI in hospital outpatients with hazardous or harmful drinking., Methods/design: This randomized controlled trial will be conducted in the outpatient department of a large tertiary referral hospital in Newcastle (population 540,000), Australia. Some 772 adults with appointments at a broad range of medical and surgical outpatient clinics who score 5-9 inclusive on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) subscale will be randomly assigned in a 1:1 ratio to electronic alcohol screening alone (control) or to e-SBI. As randomization will be effected by computer, researchers and participants (who will be invited to participate in a study of alcohol use over time) will be blinded to group assignment. The primary analysis will be based on the intention-to-treat principle and compare weekly volume (grams of alcohol) and the full AUDIT score with a six-month reference period between the groups six months post randomization. Secondary outcomes, assessed six and 12 months after randomization, will include drinking frequency, typical occasion quantity, proportion who report binge drinking, proportion who report heavy drinking, and health-care utilization., Discussion: If e-SBI is efficacious in outpatient settings, it offers the prospect of systematically and sustainably reaching a large number of hazardous and harmful drinkers, many of whom do not otherwise seek or receive help., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12612000905864.

Background: People with a mental illness experience substantial disparities in health, including increased rates of morbidity and mortality caused by potentially preventable chronic diseases. One contributing factor to such disparity is a higher prevalence of modifiable health risk behaviors, such as smoking, inadequate fruit and vegetable intake, harmful alcohol consumption, and inadequate physical activity. Evidence supports the effectiveness of preventive care in reducing such risks, and guidelines recommend that preventive care addressing such risks be incorporated into routine clinical care. Although community-based mental health services represent an important potential setting for ensuring that people with a mental illness receive such care, research suggests its delivery is currently sub-optimal. A study will be undertaken to evaluate the effectiveness of a clinical practice change intervention in increasing the routine provision of preventive care by clinicians in community mental health settings., Methods/design: A two-group multiple baseline design will be utilized to assess the effectiveness of a multi-strategic intervention implemented over 12 months in increasing clinician provision of preventive care. The intervention will be implemented sequentially across the two groups of community mental health services to increase provision of client assessment, brief advice, and referral for four health risk behaviors (smoking, inadequate fruit and vegetable consumption, harmful alcohol consumption, and inadequate physical activity). Outcome measures of interest will be collected via repeated cross-sectional computer-assisted telephone interviews undertaken on a weekly basis for 36 months with community mental health clients., Discussion: This study is the first to assess the effectiveness of a multi-strategic clinical practice change intervention in increasing routine clinician provision of preventive care for chronic disease behavioral risk factors within a network of community mental health services. The results will inform future policy and practice regarding the ability of clinicians within mental health settings to improve preventive care provision as a result of such interventions., Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000693729.

Background: Consumption of non-core foods in childhood is associated with excessive weight gain in childhood. Parents play a vital role in establishing healthy diet behaviours in young children. The aim of this study was to assess the effectiveness of a telephone-based intervention in reducing child consumption of non-core foods, and to examine parent and home food environment mediators of change in child consumption., Methods: The 'Healthy Habits' trial utilised a clustered randomised controlled design., Setting/participants: Parents were recruited from 30 preschools (N=394 participants, mean age 35.2±5.6 years). Parents randomized to the intervention group received four telephone contacts and print materials. Parents allocated to the control condition receive generic print materials only. Non-core food consumption was assessed using a validated child dietary questionnaire at baseline, 2 and 6 months post recruitment in 2010., Results: The intervention was effective in reducing child consumption of non-core foods at 2 months (intention to treat analysis: z=-2.83, p<.01), however this effect was not maintained at 6 months. Structural equation modelling using 2 month data indicated that child access to non-core foods in the home and child feeding strategies mediated the effect of the intervention., Conclusion: The telephone-based intervention shows promise in improving short term dietary behaviour in preschool age children, however further development is needed to sustain the effect in the long-term., Trial Registration: Australian Clinical Trials Registry: ACTRN12609000820202.

Background: Type 2 diabetes is one of the fastest growing chronic diseases internationally. The health complications associated with type 2 diabetes can be prevented, delayed, or improved via early diagnosis and effective management. This research aims to examine the impact of a primarily web-based educational intervention on the diabetes care provided by general practitioners (GPs) in rural areas, and subsequent patient outcomes. A population-level approach to outcome assessment is used, via whole-town de-identified pathology records., Methods/design: The study uses a cluster randomised controlled trial with rural communities as the unit of analysis. Towns from four Australian states were selected and matched on factors including rurality, population size, proportion of the population who were Indigenous Australians, and socio-economic status. Eleven pairs of towns from two states were suitable for the trial, and one town from each pair was randomised to the experimental group. GPs in the towns allocated to the experimental group are offered an intervention package comprising education on best practice diabetes care via an on-line active learning module, a moderated discussion forum, access to targeted and specialist advice through an on-line request form, and town-based performance feedback on diabetes monitoring and outcomes. The package is offered via repeated direct mail., Discussion: The benefits of the outcomes of the trial are described along with the challenges and limitations associated with the methodology., Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12611000553976.

Background: Although it is known both patients' and partners' reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients' partners' reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples' illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD., Methods/design: In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1) Coping-Together or 2) a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety) and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping) will be assessed at baseline (before receiving study material) and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted., Discussion: As partners' distress rates exceed not only population norms, but also those reported by patients themselves, it is imperative that coping skills interventions target the couple as a unit and enhance both partners' ability to overcome cancer challenges. This pilot study will examine the feasibility and potential efficacy of Coping-Together in optimising couples' illness adjustment. This is one of the first feasibility studies to test this innovative coping intervention, which in turn will contribute to the larger literature advocating for psychosocial care of couples affected by prostate cancer., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000438954.

Background: Due to early detection and advances in treatment, the number of women surviving breast cancer is increasing. Whilst there are many positive aspects of improved survival, breast cancer survival is associated with many long-term health and psychosocial sequelae. Engaging in regular physical activity post-diagnosis can reduce this burden. Despite this evidence, the majority of breast cancer survivors do not engage in regular physical activity. The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way. This article describes the protocol for the Move More for Life Study, which aims to assess the relative efficacy of two promising theory-based, print interventions designed to promote regular physical activity amongst breast cancer survivors., Method and Design: Breast cancer survivors were recruited from across Australia. Participants will be randomised into one of three groups: (1) A tailored-print intervention group, (2) a targeted-print intervention group, or (3) a standard recommendation control group. Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period. Participants in the targeted-print group will receive a previously developed physical activity guidebook designed specifically for breast cancer survivors immediately after baseline. Participants in the standard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults. All participants will be assessed at baseline, and at 4 and 10 months post-baseline. Intervention efficacy for changing the primary outcomes (mins/wk aerobic physical activity; sessions/exercises per week resistance physical activity) and secondary outcomes (steps per day, health-related quality life, compliance with physical activity guidelines, fatigue) will be assessed. Mediation and moderation analyses will also be conducted., Discussion: Given the growing number of cancer survivors, distance-based behaviour change programs addressing physical activity have the potential to make a significant public health impact., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) identifier: ACTRN12611001061921.

Background: The burden of patients with heart failure on health care systems is widely recognised, although there have been few attempts to quantify individual patterns of care and differences in health service utilisation related to age, socio-economic factors and the presence of co-morbidities. The aim of this study was to assess the typical profile, trajectory and resource use of a cohort of Australian patients with heart failure using linked population-based, patient-level data., Methods: Using hospital separations (Admitted Patient Data Collection) with death registrations (Registry of Births, Deaths and Marriages) for the period 2000-2007 we estimated age- and gender-specific rates of index admissions and readmissions, risk factors for hospital readmission, mean length of stay (LOS), median survival and bed-days occupied by patients with heart failure in New South Wales, Australia., Results: We identified 29,161 index admissions for heart failure. Admission rates increased with age, and were higher for males than females for all age groups. Age-standardised rates decreased over time (256.7 to 237.7/100,000 for males and 235.3 to 217.1/100,000 for females from 2002-3 to 2006-7; p = 0.0073 adjusted for gender). Readmission rates (any cause) were 27% and 73% at 28-days and one year respectively; readmission rates for heart failure were 11% and 32% respectively. All cause mortality was 10% and 28% at 28 days and one year. Increasing age was associated with more heart failure readmissions, longer LOS and shorter median survival. Increasing age, increasing Charlson comorbidity score and male gender were risk factors for hospital readmission. Cohort members occupied 954,888 hospital bed-days during the study period (any cause); 383,646 bed-days were attributed to heart failure admissions., Conclusions: The rates of index admissions for heart failure decreased significantly in both males and females over the study period. However, the impact on acute care hospital beds was substantial, with heart failure patients occupying almost 200,000 bed-days per year in NSW over the five year study period. The strong age-related trends highlight the importance of stabilising elderly patients before discharge and community-based outreach programs to better manage heart failure and reduce readmissions.

Background: The primary behavioural risks for the most common causes of mortality and morbidity in developed countries are tobacco smoking, poor nutrition, risky alcohol use, and physical inactivity. Evidence, guidelines and policies support routine clinician delivery of care to prevent these risks within primary care settings. Despite the potential afforded by community health services for the delivery of such preventive care, the limited evidence available suggests it is provided at suboptimal levels. This study aims to assess the effectiveness of a multi-strategic practice change intervention in increasing clinician's routine provision of preventive care across a network of community health services., Methods/design: A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being 'at risk'. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity) will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken prior to and following the intervention with randomly selected samples of clinicians from each facility group to assess the reported provision of preventive care, and the acceptability of the practice change intervention and implementation., Discussion: The study will provide novel evidence regarding the ability to increase clinician's routine provision of preventive care across a network of community health facilities., Trial Registration: Australian Clinical Trials Registry ACTRN12611001284954 UNIVERSAL TRIAL NUMBER (UTN): U1111-1126-3465.

Background: Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men., Methods and Design: The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology) study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II) and randomised to one of three groups: (1) SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure) with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group (Resources, Online, and Control), time (treated as categorical with levels baseline, 3-months and 6-months) and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants., Discussion: Our study will compare evidence-based and theoretically driven, low cost and easily disseminated strategies specifically targeting weight loss in men. The SHED-IT community trial will provide evidence to inform development and dissemination of sustainable strategies to reduce obesity in men., Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000699066).

Background: Obesity rates in adults continue to rise and effective treatment programs with a broad reach are urgently required. This paper describes the study protocol for a web-based randomized controlled trial (RCT) of a commercially available program for overweight and obese adult males and females. The aim of this RCT was to determine and compare the efficacy of two web-based interventions for weight loss and maintenance of lost weight., Methods/design: Overweight and obese adult males and females were stratified by gender and BMI and randomly assigned to one of three groups for 12-weeks: waitlist control, or basic or enhanced online weight-loss. Control participants were re-randomized to the two weight loss groups at the end of the 12-week period. The basic and enhanced group participants had an option to continue or repeat the 12-week program. If the weight loss goal was achieved at the end of 12, otherwise on completion of 24 weeks of weight loss, participants were re-randomized to one of two online maintenance programs (maintenance basic or maintenance enhanced), until 18 months from commencing the weight loss program. Assessments took place at baseline, three, six, and 18 months after commencing the initial weight loss intervention with control participants repeating the initial assessment after three month of waiting. The primary outcome is body mass index (BMI). Other outcomes include weight, waist circumference, blood pressure, plasma markers of cardiovascular disease risk, dietary intake, eating behaviours, physical activity and quality of life.Both the weight loss and maintenance of lost weight programs were based on social cognitive theory with participants advised to set goals, self-monitor weight, dietary intake and physical activity levels. The enhanced weight loss and maintenance programs provided additional personalized, system-generated feedback on progress and use of the program. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention programs, assessments and statistical analyses are described., Discussion: Importantly, this paper describes how an RCT of a currently available commercial online program in Australia addresses some of the short falls in the current literature pertaining to the efficacy of web-based weight loss programs.Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12610000197033.

Background: A number of health benefits including improvements in acid/base balance, bone metabolism, and cardiovascular risk factors have been attributed to the intake of magnesium rich alkaline mineral water. This study was designed to investigate the effects of the regular consumption of magnesium bicarbonate supplemented spring water on pH, biochemical parameters of bone metabolism, lipid profile and blood pressure in postmenopausal women., Findings: In this double-blind, placebo-controlled, parallel-group, study, 67 postmenopausal women were randomised to receive between 1500 mL and 1800 mL daily of magnesium bicarbonate supplemented spring water (650 mg/L bicarbonate, 120 mg/L magnesium, pH 8.3-8.5) (supplemented water group) or spring water without supplements (control water group) over 84 days. Over this period biomarkers of bone turnover (serum parathyroid hormone (PTH), 1,25-dihydroxyvitamin D, osteocalcin, urinary telopeptides and hydroxyproline), serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides), venous and urinary pH were measured together with measurements of standard biochemistry, haematology and urine examinations.Serum magnesium concentrations and urinary pH in subjects consuming the magnesium bicarbonate supplemented water increased significantly at Day 84 compared to subjects consuming the spring water control (magnesium - p = 0.03; pH - p = 0.018). The consumption of spring water led to a trend for an increase in parathyroid hormone (PTH) concentrations while the PTH concentrations remained stable with the intake of the supplemented spring water. However there were no significant effects of magnesium bicarbonate supplementation in changes to biomarkers of bone mineral metabolism (n-telopeptides, hydroxyproline, osteocalcin and 1,25-dihydroxyvitamin D) or serum lipids or blood pressure in postmenopausal women from Day 0 to Day 84., Conclusions: Short term regular ingestion of magnesium bicarbonate supplemented water provides a source of orally available magnesium. Long term clinical studies are required to investigate any health benefits., Trial Registration: ACTRN12609000863235.

Background: Individuals of South-Asian origin have a comparatively higher cardiovascular disease burden, but there is uncertainty about whether this is due to differences in risk factor levels and trends. We therefore studied comparative levels and time trends in blood pressure (BP), total cholesterol, body mass index (BMI) and current smoking among UK Caucasian and South-Asian individuals., Methods: Repeatable cross-sectional survey of men and women aged 35-60 attending for first screening as part of a primary-care based cardiovascular risk factor screening programme 1989 and 1999., Results: Of 34,122 men and 37,294 women participants, 499 men (1.5%)and 381 women (1%) were of South-Asian origin. South-Asian men had lower systolic [(-4.91 mmHg (95% Confidence Iterval (CI): -3.58 to -6.23)] and diastolic BP [-2.87 mmHg (-2.02 to -3.72)], with no significant differences in cholesterol and BMI. South-Asian women had lower systolic BP [-1.77 mmHg, 95% (-0.21 to -3.33)], diastolic BP [-1.87 mmHg (-0.92 to -2.82)], cholesterol [-0.24 mmol/l (-0.08 to -0.39)]; and higher BMI [+0.78 kg/m2 (0.25 to 1.3)]. South-Asian men and women had significantly lower prevalence of self-reported current smoking (29.0% and 1.8% respectively). With the exception of self-reported current smoking, between ethnic group risk factor trends were not converging., Conclusion: With the exception of women's BMI, South-Asian individuals had either lower or similar levels of the examined cardiovascular risk factor levels, compared with Caucasian individuals. Although time trends in smoking were converging, other risk factors trends were similar between the two ethnic groups. Overall the findings do not support the hypothesis that the relatively high cardiovascular disease burden in UK South-Asians is due to higher levels exposure to the examined risk factors. Other hypotheses, such as higher frequency of diabetes and increased genetic predisposition, require further exploration.

Background: In the UK, obesity is associated with a clear socioeconomic gradient, with individuals of lower socioeconomic status being more likely to be obese. Several previous studies, using individual measures of soecioeconomic status, have shown a more rapid increase in Body Mass Index (BMI) over time among adults of lower socioeconomic status. We conducted a study to further examine whether ecologically defined deprivation status influences within-individual BMI change during middle life, as the answer to this question can help determine optimal preventive strategies both for obesity per se, and its' associated socioeconomic disparities., Methods: Anonymised records of participants to the Stockport population-based cardiovascular disease risk factor screening programme were analysed. Individuals aged 35-55 who had a first screening episode between 1989 and 1993, and a subsequent screening episode were included in the study. Deprivation status was defined using quintiles of the Townsend score. Mean annual BMI change by deprivation group was calculated using linear regression. Subsequently, deprivation group was included in the model as an ordinal variable, to test for trend. The modelling was repeated separately for individuals who were obese (BMI < 30) and non-obese at the time of first screening. In supplementary analysis, regression models were also adjusted for baseline BMI., Results: Of 21,976 women and 19,158 men initially screened, final analysis included just over half of all individuals [11,158 (50.8%) women and 9,831 (51.3%) men], due to the combined effect of loss to follow-up and incomplete BMI ascertainment. In both sexes BMI increased by 0.19 kg/m2 annually (95% Confidence Intervals 0.15-0.24 for women and 0.16-0.23 for men). All deprivation groups had similar mean annual change, and there was no evidence of a significant deprivation trend (p = 0.801, women and 0.892, men). Restricting the analysis to individuals who were non-obese at baseline did not alter the results in relation to the lack of a deprivation effect. When restricting the analysis to individuals who were obese at baseline however, the findings were suggestive of an association of BMI increase with higher deprivation group, which was further supported by a significant association when adjusting for baseline BMI., Conclusion: In the study setting, the BMI of non-obese individuals aged 35-55 was increasing over time independently of deprivation status; among obese individuals a positive association with higher deprivation was found. The findings support that socioeconomic differences in mean BMI and obesity status are principally attained prior to 35 years of age. Efforts to tackle inequalities in mean BMI and obesity status should principally concentrate in earlier life periods, although there may still be scope for focusing inequality reduction efforts on obese individuals even in middle life.

Background: The assessment of the impact of healthcare interventions may help commissioners of healthcare services to make optimal decisions. This can be particularly the case if the impact assessment relates to specific patient populations and uses timely local data. We examined the potential impact on readmissions and mortality of specialist heart failure services capable of delivering treatments such as b-blockers and Nurse-Led Educational Intervention (N-LEI)., Methods: Statistical modelling of prevented or postponed events among previously hospitalised patients, using estimates of: treatment uptake and contraindications (based on local audit data); treatment effectiveness and intolerance (based on literature); and annual number of hospitalization per patient and annual risk of death (based on routine data)., Results: Optimal treatment uptake among eligible but untreated patients would over one year prevent or postpone 11% of all expected readmissions and 18% of all expected deaths for spironolactone, 13% of all expected readmisisons and 22% of all expected deaths for b-blockers (carvedilol) and 20% of all expected readmissions and an uncertain number of deaths for N-LEI. Optimal combined treatment uptake for all three interventions during one year among all eligible but untreated patients would prevent or postpone 37% of all expected readmissions and a minimum of 36% of all expected deaths., Conclusion: In a population of previously hospitalised patients with low previous uptake of b-blockers and no uptake of N-LEI, optimal combined uptake of interventions through specialist heart failure services can potentially help prevent or postpone approximately four times as many readmissions and a minimum of twice as many deaths compared with simply optimising uptake of spironolactone (not necessarily requiring specialist services). Examination of the impact of different heart failure interventions can inform rational planning of relevant healthcare services.

Background: Primary care organisations are faced with implementing a large number of guideline recommendations. We present methods by which the number of eligible patients requiring treatment, and the relative benefits to the whole population served by a general practice or Primary Care Trust, can be calculated to help prioritise between different guideline recommendations., Methods: We have developed measures of population impact, "Number to be Treated in your Population (NTP)" and "Number of Events Prevented in your Population (NEPP)". Using literature-based estimates, we have applied these measures to guidelines for pharmacological methods of secondary prevention of myocardial infarction (MI) for a hypothetical general practice population of 10,000., Results: Implementation of the NICE guidelines for the secondary prevention of MI will require 176 patients to be treated with aspirin, 147 patients with beta-blockers and with ACE-Inhibitors and 157 patients with statins (NTP). The benefit expressed as NEPP will range from 1.91 to 2.96 deaths prevented per year for aspirin and statins respectively. The drug cost per year varies from euro 1940 for aspirin to euro 60,525 for statins. Assuming incremental changes only (for those not already on treatment), aspirin post MI will be added for 37 patients and produce 0.40 of a death prevented per year at a drug cost of euro 410 and statins will be added for 120 patients and prevent 2.26 deaths per year at a drug cost of euro 46,150. An appropriate policy might be to reserve the use of statins until eligible patients have been established on aspirin, ACE-Inhibitors and beta blockers., Conclusions: The use of population impact measures could help the Primary Care Organisation to prioritise resource allocation, although the results will vary according to local conditions which should be taken into account before the measures are used in practice.