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Background: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.Methods: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.Results: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).Conclusion: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007). [ABSTRACT FROM AUTHOR]

Background: This paper presents a protocol for a randomised controlled trial of the Cardiac-Diabetes Transcare program which is a transitional care, multi-modal self-management program for patients with acute coronary syndrome comorbid with type 2 diabetes. Prior research has indicated people hospitalised with dual cardiac and diabetes diagnoses are at an elevated risk of hospital readmissions, morbidity and mortality. The primary aim of this study is to evaluate the effectiveness (and cost-effectiveness) of a Cardiac-Diabetes Transcare intervention program on 6-month readmission rate in comparison to usual care.Methods/design: A two-armed, randomised controlled trial with blinded outcome assessment will be conducted to evaluate the comparative effectiveness of two modes of care, including a Usual Care Group and a Cardiac-Diabetes Transcare Intervention (in addition to usual care) Group. The primary outcome is 6-month readmission rate, although a range of secondary outcomes will be collected (including self-efficacy) at baseline, 1, 3 and 6 month reassessments. The intervention group will receive in-hospital education tailored for people recovering from an acute coronary syndrome-related hospital admission who have comorbid diabetes, and they will also receive home visits and telephone follow-up by a trained Research Nurse to reinforce and facilitate disease-management-related behaviour change. Both groups will receive usual care interventions offered or referred from participating hospital facilities. A sample size of 432 participants from participating hospitals in the Australian states of Queensland and Victoria will be recruited for 90% power based on the most conservative scenarios modelled for sample size estimates.Discussion: The study outlined in this protocol will provide valuable insight into the effectiveness of a transitional care intervention targeted for people admitted to hospital with cardiac-related presentations commencing in the inpatient hospital setting and transition to the home environment. The purpose of theory-based intervention comprising face-to-face sessions and telephone follow up for patients with acute coronary syndrome and type 2 diabetes is to increase self-efficacy to enhance self-management behaviours and thus improve health outcomes and reduce hospital readmissions.Trial Registration: This study has been registered with the Australian New Zealand Clinical Trials Registry dated 16/12/2014: ACTRN12614001317684 . [ABSTRACT FROM AUTHOR]

Background: Insufficient sleep is potentially an important modifiable risk factor for obesity and poor physical activity and sedentary behaviours among children. However, inconsistencies across studies highlight the need for more objective measures. This paper examines the relationship between sleep duration and objectively measured physical activity, sedentary time and weight status, among a sample of Victorian Primary School children.Methods: A sub-sample of 298 grades four (n = 157) and six (n = 132) Victorian primary school children (aged 9.2-13.2 years) with complete accelerometry and anthropometry data, from 39 schools, were taken from a pilot study of a larger state based cluster randomized control trial in 2013. Data comprised: researcher measured height and weight; accelerometry derived physical activity and sedentary time; and self-reported sleep duration and hypothesised confounding factors (e.g. age, gender and environmental factors).Results: Compared with sufficient sleepers (67 %), those with insufficient sleep (<10 hrs/day) were significantly more likely to be overweight (OR 1.97, 95 % CI:1.11-3.48) or obese (OR 2.43, 95 % CI:1.26-4.71). No association between sleep and objectively measured physical activity levels or sedentary time was found.Conclusion: The strong positive relationship between weight status and sleep deprivation merits further research though PA and sedentary time do not seem to be involved in the relationship. Strategies to improve sleep duration may help obesity prevention initiatives in the future. [ABSTRACT FROM AUTHOR]

Background: Mastitis is an acute, debilitating condition that occurs in approximately 20 % of breastfeeding women who experience a red, painful breast with fever. This paper describes the factors correlated with mastitis and investigates the presence of Staphylococcus aureus in women who participated in the CASTLE (Candida and Staphylococcus Transmission: Longitudinal Evaluation) study. The CASTLE study was a prospective cohort study which recruited nulliparous women in late pregnancy in two maternity hospitals in Melbourne, Australia in 2009-2011. Methods: Women completed questionnaires at recruitment and six time-points in the first eight weeks postpartum. Postpartum questionnaires asked about incidences of mastitis, nipple damage, milk supply, expressing practices and breastfeeding problems. Nasal and nipple swabs were collected from mothers and babies, as well as breast milk samples. All samples were cultured for S. aureus. "Time at risk" of mastitis was defined as days between birth and first occurrence of mastitis (for women who developed mastitis) and days between birth and the last study time-point (for women who did not develop mastitis). Risk factors for incidence of mastitis occurring during the time at risk (Incident Rate Ratios [IRR]) were investigated using a discrete version of the multivariable proportional hazards regression model. Results: Twenty percent (70/346) of participants developed mastitis. Women had an increased risk of developing mastitis if they reported nipple damage (IRR 2.17, 95 % CI 1.21, 3.91), over-supply of breast milk (IRR 2.60, 95 % CI 1.58, 4.29), nipple shield use (IRR 2.93, 95 % CI 1.72, 5.01) or expressing several times a day (IRR 1.64, 95 % CI 1.01, 2.68). The presence of S. aureus on the nipple (IRR 1.72, 95 % CI 1.04, 2.85) or in milk (IRR 1.78, 95 % CI 1.08, 2.92) also increased the risk of developing mastitis. Conclusions: Nipple damage, over-supply of breast milk, use of nipple shields and the presence of S. aureus on the nipple or in breast milk increased the mastitis risk in our prospective cohort study sample. Reducing nipple damage may help reduce maternal breast infections. [ABSTRACT FROM AUTHOR]

Background: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations.Methods: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70.Results: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures.Conclusion: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks. [ABSTRACT FROM AUTHOR]

Background: Walking among dog owners may be a means to achieve health benefits, yet almost half of owners (approximately 30% of households) are not regularly walking their dogs. Current research on the correlates of dog walking has generally considered intention as the primary determinant of behavior, yet the intention-behavior relationship is modest. The purpose of this paper was to apply a framework designed to evaluate the intention-behavior gap, known as multi-process action control (M-PAC), to understand daily walking among dog owners.Method: A community sample of adult dog owners (N = 227) in Victoria, Canada completed M-PAC measures of motivational (dog and human outcome expectations, affective judgments, perceived capability and opportunity), regulatory (planning), and reflexive (automaticity, identity) processes as well as intention to walk and behavior.Results: Three intention-behavior profiles emerged: a) non-intenders who were not active (26%; n = 59), b) unsuccessful intenders who failed to enact their positive intentions (33%; n = 75), and c) successful intenders who were active (40%; n = 91). Congruent with M-PAC, a discriminant function analysis showed that affective judgements (r = 0.33), automaticity (r = 0.38), and planning (r = 0.33) distinguished between all three intention-behavior profiles, while identity (r = 0.22) and dog breed size (r = 0.28) differentiated between successful and unsuccessful intenders.Conclusions: The majority of dog owners have positive intentions to walk, yet almost half fail to meet these intentions. Interventions focused on affective judgments (e.g., more enjoyable places to walk), behavioral regulation (e.g., setting a concrete plan), habit (e.g., making routines and cues) and identity formation (e.g., affirmations of commitment) may help overcome difficulties with translating these intentions into action, thus increasing overall levels of walking. [ABSTRACT FROM AUTHOR]

Background: The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.Methods: This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.Discussion: The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Trial Registration: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016. [ABSTRACT FROM AUTHOR]

Background: Multi-level, longer-term obesity prevention interventions that focus on inequalities are scarce. Fun 'n healthy in Moreland! aimed to improve child adiposity, school policies and environments, parent engagement, health behaviours and child wellbeing.Methods: All children from primary schools in an inner urban, culturally diverse and economically disadvantaged area in Victoria, Australia were eligible for participation. The intervention, fun 'n healthy in Moreland!, used a Health Promoting Schools Framework and provided schools with evidence, school research data and part time support from a Community Development Worker to develop health promoting strategies. Comparison schools continued as normal. Participants were not blinded to intervention status. The primary outcome was change in adiposity. Repeated cross-sectional design with nested longitudinal subsample.Results: Students from twenty-four primary schools (clusters) were randomised (aged 5-12 years at baseline). 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements. Despite increased prevalence of healthy weight across all schools, after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention (Mean (sd): Intervention 0.68(1.16); Comparison: 0.72(1.12); Adjusted mean difference (AMD): -0.05, CI: -0.19 to 0.08, p = 0.44). Children from intervention schools consumed more daily fruit serves (AMD: 0.19, CI:0.00 to 0.37, p = 0.10), were more likely to have water (AOR: 1.71, CI:1.05 to 2.78, p = 0.03) and vegetables (AOR: 1.23, CI: 0.99 to 1.55, p = 0.07), and less likely to have fruit juice/cordial (AOR: 0.58, CI:0.36 to 0.93, p = 0.02) in school lunch compared to children in comparison schools. More intervention schools (8/11) had healthy eating and physical activity policies compared with comparison schools (2/9). Principals and schools highly valued the approach as a catalyst for broader positive school changes. The cost of the intervention per child was $65 per year.Conclusion: The fun n healthy in Moreland! intervention did not result in statistically significant differences in BMI z score across trial arms but did result in greater policy implementation, increased parent engagement and resources, improved child self-rated health, increased fruit, vegetable and water consumption, and reduction in sweet drinks. A longer-term follow up evaluation may be needed to demonstrate whether these changes are sustainable and impact on childhood overweight and obesity.Clinical Trial Registration: ACTRN12607000385448 (Date submitted 31/05/2007; Date registered 23/07/2007; Date last updated 15/12/2009). [ABSTRACT FROM AUTHOR]

Background: Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care.Methods: The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group.Discussion: To our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR 12616000537459 ). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data. [ABSTRACT FROM AUTHOR]

Background: Lower back pain is a global health issue affecting approximately 80% of people at some stage in their life. The current literature suggests that any exercise is beneficial for reducing back pain. However, as pain is a subjective evaluation and physical deficits are evident in low back pain, using it as the sole outcome measure to evaluate superiority of an exercise protocol for low back pain treatment is insufficient. The overarching goal of the current clinical trial is to implement two common, conservative intervention approaches and examine their impact on deficits in chronic low back pain.Methods/design: Forty participants, 25-45 years old with chronic (>3 months), non-specific low back pain will be recruited. Participants will be randomised to receive either motor control and manual therapy (n = 20) or general strength and conditioning (n = 20) exercise treatments for 6 months. The motor control/manual therapy group will receive twelve 30-min sessions, ten in the first 3 months (one or two per week) and two in the last 3 months. The general exercise group will attend two 1-hour sessions weekly for 3 months, and one or two a week for the following 3 months. Primary outcome measures are average lumbar spine intervertebral disc T2 relaxation time and changes in thickness of the transversus abdominis muscle on a leg lift using magnetic resonance imaging (MRI). Secondary outcomes include muscle size and fat content, vertebral body fat content, intervertebral disc morphology and water diffusion measured by MRI, body composition using dual energy X-ray absorptiometry, physical function through functional tests, changes in corticospinal excitability and cortical motor representation of the spinal muscles using transcranial magnetic stimulation and self-reported measure of pain symptoms, health and disability. Outcome measures will be conducted at baseline, at the 3-month follow-up and at 6 months at the end of intervention. Pain, depressive symptomology and emotions will be captured fortnightly by questionnaires.Discussion: Chronic low back pain is ranked the highest disabling disorder in Australia. The findings of this study will inform clinical practice guidelines to assist with decision-making approaches where outcomes beyond pain are sought for adults with chronic low back pain.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12615001270505 . Registered on 20 November 2015. [ABSTRACT FROM AUTHOR]

Background: The need for healthcare strengthening to enhance equity is critical, requiring systematic approaches that focus on those experiencing lesser access and outcomes. This project developed and tested the Ophelia (OPtimising HEalth LIteracy and Access) approach for co-design of interventions to improve health literacy and equity of access. Eight principles guided this development: Outcomes focused; Equity driven, Needs diagnosis, Co-design, Driven by local wisdom, Sustainable, Responsive and Systematically applied. We report the application of the Ophelia process where proof-of-concept was defined as successful application of the principles.Methods: Nine sites were briefed on the aims of the project around health literacy, co-design and quality improvement. The sites were rural/metropolitan, small/large hospitals, community health centres or municipalities. Each site identified their own priorities for improvement; collected health literacy data using the Health Literacy Questionnaire (HLQ) within the identified priority groups; engaged staff in co-design workshops to generate ideas for improvement; developed program-logic models; and implemented their projects using Plan-Do-Study-Act (PDSA) cycles. Evaluation included assessment of impacts on organisations, practitioners and service users, and whether the principles were applied.Results: Sites undertook co-design workshops involving discussion of service user needs informed by HLQ (n = 813) and interview data. Sites generated between 21 and 78 intervention ideas and then planned their selected interventions through program-logic models. Sites successfully implemented interventions and refined them progressively with PDSA cycles. Interventions generally involved one of four pathways: development of clinician skills and resources for health literacy, engagement of community volunteers to disseminate health promotion messages, direct impact on consumers' health literacy, and redesign of existing services. Evidence of application of the principles was found in all sites.Conclusions: The Ophelia approach guided identification of health literacy issues at each participating site and the development and implementation of locally appropriate solutions. The eight principles provided a framework that allowed flexible application of the Ophelia approach and generation of a diverse set of interventions. Changes were observed at organisational, staff, and community member levels. The Ophelia approach can be used to generate health service improvements that enhance health outcomes and address inequity of access to healthcare. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up.Methods/design: This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia.Discussion: This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection.Trial Registration: ACTRN12615001369516 (Registered on December 16, 2015). [ABSTRACT FROM AUTHOR]

Background: The Safety Attitudes Questionnaire (SAQ) is commonly used to assess staff perception of safety climate within their clinical environment. The psychometric properties of the SAQ have previously been explored with confirmatory factor analysis and found to have some issues with construct validity. This study aimed to extend the psychometric evaluations of the SAQ by using Rasch analysis.Methods: Assessment of internal construct validity included overall fit to the Rasch model (unidimensionality), response formats, targeting, differential item functioning (DIF) and person-separation index (PSI).Results: A total of 420 nurses completed the SAQ (response rate 60 %). Data showed overall fit to a Rasch model of expected item functioning for interval scale measurement. The questionnaire demonstrated unidimensionality confirming the appropriateness of summing the items in each domain. Score reliabilities were appropriate (internal consistency PSI 0.6-0.8). However, participants were not using the response options on the SAQ in a consistent manner. All domains demonstrated suboptimal targeting and showed compromised score precision towards higher levels of safety climate (substantial ceiling effects).Conclusion: There was general support for the reliability of the SAQ as a measure of safety climate although it may not be able to detect small but clinically important changes in safety climate within an organisation. Further refinement of the SAQ is warranted. This may involve changing the response options and including new items to improve the overall targeting of the scale.Trial Registration: This study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 (21 March 2011). [ABSTRACT FROM AUTHOR]

Background: Stroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers.Methods: This study is a prospective randomised controlled trial. It will include a total of 168 stroke survivors and carers randomly allocated into an intervention group (SCOHP) or a control group (usual care). Participants randomised to the intervention group will receive nine (8 + 1 booster) sessions guided by a structured workbook. The primary outcome measures for stroke survivors and carers will be health-related quality of life (AQoL-6D and EQ-5D) and self-efficacy (GSE). Secondary outcome measures will include: anxiety and depression (HADS); coping (Brief COPE); work and social adjustment (WSAS); carer strain (MCSI); carer satisfaction (CASI); and treatment evaluation (TEI-SF and CEQ). Process evaluation and a health economic cost analysis will also be conducted.Discussion: We believe that this is an innovative intervention that engages the stroke survivor and carer and will be significant in improving the psychosocial health, increasing independence and reducing treatment-related costs in this vulnerable patient-carer dyad. In addition, we expect that the intervention will assist carers and stroke survivors to negotiate the complexity of health services across the trajectory of care and provide practical skills to improve self-management.Trial Registration: ACTRN12615001046594 . Registered on 7 October 2015. [ABSTRACT FROM AUTHOR]

Background: Some degree of cognitive decline after surgery occurs in as many as one quarter of elderly surgical patients, and this decline is associated with increased morbidity and mortality. Cognition may be affected across a range of domains, including memory, psychomotor skills, and executive function. Whilst the exact mechanisms of cognitive change after surgery are not precisely known, oxidative stress and subsequent neuroinflammation have been implicated. N-acetylcysteine (NAC) acts via multiple interrelated mechanisms to influence oxidative homeostasis, neuronal transmission, and inflammation. NAC has been shown to reduce oxidative stress and inflammation in both human and animal models. There is clinical evidence to suggest that NAC may be beneficial in preventing the cognitive decline associated with both acute physiological insults and dementia-related disorders. To date, no trials have examined perioperative NAC as a potential moderator of postoperative cognitive changes in the noncardiac surgery setting.Methods and Design: This is a single-centre, randomised, double-blind, placebo-controlled clinical trial, with a between-group, repeated-measures, longitudinal design. The study will recruit 370 noncardiac surgical patients at the University Hospital Geelong, aged 60 years or older. Participants are randomly assigned to receive either NAC or placebo (1:1 ratio), and groups are stratified by age and surgery type. Participants undergo a series of neuropsychological tests prior to surgery, 7 days, 3 months, and 12 months post surgery. It is hypothesised that the perioperative administration of NAC will reduce the degree of postoperative cognitive changes at early and long-term follow-up, as measured by changes on individual measures of the neurocognitive battery, when compared with placebo. Serum samples are taken on the day of surgery and on day 2 post surgery to quantitate any changes in levels of biomarkers of inflammation and oxidative stress.Discussion: The PANACEA trial aims to examine the potential efficacy of perioperative NAC to reduce the severity of postoperative cognitive dysfunction in an elderly, noncardiac surgery population. This is an entirely novel approach to the prevention of postoperative cognitive dysfunction and will have high impact and translatable outcomes if NAC is found to be beneficial.Trial Registration: The PANACEA trial has been registered with the Therapeutic Goods Administration, and the Australian New Zealand Clinical Trials Registry: ACTRN12614000411640 ; registered on 15 April 2014. [ABSTRACT FROM AUTHOR]

Background: Involvement in a compensation process following a motor vehicle collision is consistently associated with worse health status but the reasons underlying this are unclear. Some compensation systems are hypothesised to be more stressful than others. In particular, fault-based compensation systems are considered to be more adversarial than no-fault systems and associated with poorer recovery. This study compares the perceived fairness and recovery of claimants in the fault-based compensation system in New South Wales (NSW) to the no-fault system in Victoria, Australia.Methods: One hundred eighty two participants were recruited via claims databases of the compensation system regulators in Victoria and NSW. Participants were > 18 years old and involved in a transport injury compensation process. The crash occurred 12 months (n = 95) or 24 months ago (n = 87). Perceived fairness about the compensation process was measured by items derived from a validated organisational justice questionnaire. Health outcome was measured by the initial question of the Short Form Health Survey.Results: In Victoria, 84 % of the participants considered the claims process fair, compared to 46 % of NSW participants (χ(2) = 28.54; p < .001). Lawyer involvement and medical assessments were significantly associated with poorer perceived fairness. Overall perceived fairness was positively associated with health outcome after adjusting for demographic and injury variables (Adjusted Odds Ratio = 2.8, 95 % CI = 1.4 - 5.7, p = .004).Conclusion: The study shows large differences in perceived fairness between two different compensation systems and an association between fairness and health. These findings are politically important because compensation processes are designed to improve recovery. Lower perceived fairness in NSW may have been caused by potential adversarial aspects of the scheme, such as liability assessment, medical assessments, dealing with a third party for-profit insurance agency, or financial insecurity due to lump sum payments at settlement. This study should encourage an evidence informed discussion about how to reduce anti-therapeutic aspects in the compensation process in order to improve the injured person's health. [ABSTRACT FROM AUTHOR]

Background: It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss of employment, delayed return to work, financial and familial stress, and increased medical and compensation costs. The major aim of this research is to investigate the efficacy of interventions for preventing the development of psychological distress following a motor vehicle crash. The efficacy of two brief interventions will be examined: a cognitive behaviour therapy (CBT) programme, targeting mood and anxiety, and a lifestyle programme, targeting sleep, diet and physical activity.Methods/design: This is a randomized, controlled multisite study. Participants include at least 180 adults injured in a motor vehicle crash who have entered a compensation process. Research will compare outcomes in three groups randomly assigned to: one group of 60 adults, who receive a brief email-delivered CBT programme, with one session every 2 weeks for 10 weeks and telephone contact every 2 weeks; a second group of 60 adults, who receive a brief email-delivered lifestyle intervention involving one session every 2 weeks for 10 weeks with telephone contact; and an active waiting-list control group of 60 adults who are provided claims processing-related reading material along with telephone contact every 2 weeks for 10 weeks. Participants will be recruited within 12 weeks of the motor vehicle crash, and will be comprehensively assessed before and after treatment, and 6 and 12 months post-injury. Assuming an α probability level of 0.05 and a power of 80 %, at least 180 participants will be recruited. The primary outcome measure is the presence and severity of psychological distress or disorder. Secondary outcome measures include assessment of self-efficacy, resilience employment status, social activity and support, lifestyle and physical health factors, along with process outcome measures of treatment acceptability, feasibility and generalizability.Discussion: This study will determine whether brief email-delivered interventions distributed soon after the injury and entry into the claims process can be effective in preventing the development of psychological distress.Trial Registration: ANZCTR, ACTRN12615000326594 . Registered on 9 April 2015. [ABSTRACT FROM AUTHOR]

Background: The impact of elective induction of labour at term on the increasing caesarean section (CS) rate is unclear. A Cochrane Systematic Review that concluded that elective induction was associated with a reduction in CS was based on trials that mostly reflect outdated obstetric care, or were flawed. The findings of other studies vary widely in the magnitude and direction of the relationship between elective induction and CS. This inconsistency may be due to the heterogeneity in the methods used to induce or augment labour, such that the relationship with CS is not constant across methods.Methods: Using validated, routinely-collected data on all births in Victoria in 2000-2005, all singleton, cephalic, first births following uncomplicated pregnancies at 37-40 completed weeks' gestation ('standard primiparae') were identified (n = 42,950). As well as comparing induced with non-induced labour, method of birth was compared between those women experiencing spontaneous labour without augmentation, and women undergoing each method of augmentation or induction using adjusted multinomial logistic regression. Proportions, chi-square tests, adjusted Relative Risk Ratios (aRRR) and 95% confidence intervals are presented.Results: Ten percent of "standard primiparae" had labour induced for no apparent medical indication. Women whose labour was induced were significantly more likely than those who laboured spontaneously to have a CS (26.5 and 12.5% respectively (OR 2.54, 95% CI 2.4, 2.7, p < 0.001). After adjustment for maternal age, epidural analgesia, birthweight, gestation, and public/private admission status, each method of induction or augmentation remained associated with a significant increase in the risk of CS (adjusted ORs range 1.48 to 4.13, p-values all <0.0001). Perinatal death did not differ by onset of labour.Conclusion: Induction of labour in medically uncomplicated nulliparous women at term carries a more than doubling of risk of emergency CS, compared with spontaneous labour, with no impact on perinatal mortality. All methods of induction and augmentation of labour were associated with an increase in the rate of CS. Women included in this study had no apparent medical indication for induction of labour or any complication of pregnancy, so the increase in CS was not due to identifiable underlying risk factors. These results suggest that, in the absence of direction from well-designed, contemporary RCTs, minimising unindicated inductions before 41 weeks' gestation has the potential to reduce the rate of CS. [ABSTRACT FROM AUTHOR]

Background: Sub-Saharan African women are often treated as a single group in epidemiological studies of immigrant birth outcomes, potentially masking variations across countries.Methods: Cross-sectional population-based study of 432,567 singleton births in Victoria, Australia comparing mothers born in one of four East African countries (453 Eritreans, 1094 Ethiopians, 1,861 Somali and 1,404 Sudanese) relative to 427,755 Australian-born women was conducted using the Victorian Perinatal Data Collection. Pearson's chi-square test and logistic regression analyses were performed to investigate disparities and estimate risks of perinatal mortality and other adverse perinatal outcomes after adjustment for confounders selected a priori.Results: Compared with mothers born in Australia, East African immigrants as a group had elevated odds of perinatal mortality (ORadj1.83, 95% CI 1.47, 2.28), small for gestational age births (SGA) (ORadj1.59 95% CI 1.46, 1.74), very low birthweight (ORadj1.33, 95% CI 1.11, 1.58) and very preterm birth (ORadj1.55, 95% CI 1.27, 1.90). However, they had lower odds of preterm birth (ORadj0.86 95% CI 0.76, 0.98) and macrosomia (ORadj0.65 95% CI 0.51, 0.83). Individual country of birth analyses indicated significant variations, with Eritrean women having higher odds of very low birthweight (ORadj1.80, 95% CI 1.09, 2.98), very preterm birth (ORadj 1.96, 95% CI 1.08, 3.58), small for gestational age births (ORadj 1.52, 95% CI 1.14, 2.03) and perinatal mortality (ORadj 2.69, 95% CI 1.47, 4.91). Sudanese women had higher odds of low birthweight (ORadj 1.36, 95% CI 1.10, 1.68), very low birthweight (ORadj 1.53, 95% CI 1.13, 2.07), very preterm birth (ORadj 1.78, 95% CI 1.26, 2.53), small for gestational age births (ORadj 2.13, 95% CI 1.84, 2.47) and perinatal mortality (ORadj 2.10, 95% CI 1.44, 3.07)]. Ethiopian women differed from Australian-born women only in relation to higher odds of very preterm birth, (ORadj1.70 95% CI 1.16, 2.50), and only Somali-women had significantly lower odds of preterm birth (ORadj0.70 95% CI 0.56, 0.88).Conclusions: Overall, East African countries of birth were associated with increased perinatal death and some adverse perinatal outcomes; suggesting the need for strategies to enhance surveillance and health care delivery for these women. Analysis by individual country of birth groups has shown women from Eritrea and Sudan are particularly at increased risk of adverse outcomes, demonstrating the importance of antenatal identification of maternal country of birth. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines globally recommend lifestyle modification including diet and exercise training as first-line treatment for obesity. The clinical benefits of exercise training in adults with obesity is well-documented; however, there is no strong evidence for the effectiveness of exercise training for weight loss in class II and class III obesity. The purpose of the randomised controlled trial described in this protocol article is to examine the effect of exercise training, in addition to a very low energy diet (VLED), in clinically severe obese women for changes in body composition, physical function, quality of life, and markers of cardiometabolic risk.Methods/design: Sixty women, aged 18-50 years with a body mass index (BMI) greater than 34.9 kg.m(2) and at least one obesity-related co-morbidity, will be recruited for this 12-month study. Participants will be randomised to either exercise plus energy restriction (n = 30), or energy restriction alone (n = 30). All participants will follow an energy-restricted individualised diet incorporating a VLED component. The exercise intervention group will also receive exercise by supervised aerobic and resistance training and a home-based exercise programme totalling 300 minutes per week. Primary outcome measures include body composition and aerobic fitness. Secondary outcome measures include: physical function, cardiometabolic risk factors, quality of life, physical activity, and mental health. All outcome measures will be conducted at baseline, 3, 6 and 12 months.Discussion: Previous research demonstrates various health benefits of including exercise training as part of a healthy lifestyle at all BMI ranges. Although clinical practice guidelines recommend exercise training as part of first-line treatment for overweight and obesity, there are few studies that demonstrate the effectiveness of exercise in class II and class III obesity. The study aims to determine whether the addition of exercise training to a VLED provides more favourable improvements in body composition, physical function, quality of life, and markers of cardiometabolic risk for women with clinically severe obesity, compared to VLED alone.Trial Registration: Australian New Zealand Clinical Trials Registry ( ACTRN12611000694910 ). Date registered: 4 July 2011. [ABSTRACT FROM AUTHOR]

Background: Cognitive behaviour therapy for insomnia (CBT-I) is a well-established treatment; however, the evidence is largely limited to homogenous samples. Although emerging research has indicated that CBT-I is also effective for comorbid insomnia, CBT-I has not been tested among a complex sample of older adults with comorbid insomnia and depression. Furthermore, no study has explored whether modifying CBT-I to target associated depressive symptoms could potentially enhance sleep and mood outcomes. Therefore, this study aims to report a protocol designed to test whether an advanced form of CBT for insomnia and depression (CBT-I-D) is more effective at reducing insomnia and depressive symptoms compared to a standard CBT-I and psychoeducation control group (PCG) for older adults in a community mental health setting.Methods/design: We aim to recruit 150 older adults with comorbid insomnia who have presented to community mental health services for depression. Eligible participants will be randomly allocated via block/cluster randomisation to one of three group therapy conditions: CBT-I, CBT-I-D, or PCG. Participants who receive CBT-I will only practice strategies designed to improve their sleep, whereas participants who receive CBT-I-D will practice additional strategies designed to also improve their mood. This trial will implement a mixed-methods design involving quantitative outcome measures and qualitative focus groups. The primary outcome measures are insomnia and depression severity, and secondary outcomes are anxiety, hopelessness, beliefs about sleep, comorbid sleep conditions, and health. Outcomes will be assessed at pre-intervention (week 0), post-intervention (week 8), and 3-month follow-up (week 20).Discussion: This CBT study protocol has been designed to address comorbid insomnia and depression for older adults receiving community mental health services. The proposed trial will determine whether CBT-I is more effective for older adults with comorbid insomnia and depression compared to a PCG. It will also establish whether an advanced form of CBT-I-D generates greater reductions in insomnia and depression severity compared to standard CBT-I. The results from the proposed trial are anticipated to have important clinical implications for older adults, researchers, therapists, and community mental health services.Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN: 12615000067572 , Date Registered 12 December 2014. [ABSTRACT FROM AUTHOR]

Background: The prevalence and impact of musculoskeletal conditions are predicted to rapidly escalate in the coming decades. Effective strategies are required to minimise 'evidence-practice', 'burden-policy' and 'burden-service' gaps and optimise health system responsiveness for sustainable, best-practice healthcare. One mechanism by which evidence can be translated into practice and policy is through Models of Care (MoCs), which provide a blueprint for health services planning and delivery. While evidence supports the effectiveness of musculoskeletal MoCs for improving health outcomes and system efficiencies, no standardised national approach to evaluation in terms of their 'readiness' for implementation and 'success' after implementation, is yet available. Further, the value assigned to MoCs by end users is uncertain. This qualitative study aimed to explore end users' views on the relevance of musculoskeletal MoCs to their work and value of a standardised evaluation approach.Methods: A cross-sectional qualitative study was undertaken. Subject matter experts (SMEs) with health, policy and administration and consumer backgrounds were drawn from three Australian states. A semi-structured interview schedule was developed and piloted to explore perceptions about musculoskeletal MoCs including: i) aspects important to their work (or life, for consumers) ii) usefulness of standardised evaluation frameworks to judge 'readiness' and 'success' and iii) challenges associated with standardised evaluation. Verbatim transcripts were analysed by two researchers using a grounded theory approach to derive key themes.Results: Twenty-seven SMEs (n = 19; 70.4 % female) including five (18.5 %) consumers participated in the study. MoCs were perceived as critical for influencing and initiating changes to best-practice healthcare planning and delivery and providing practical guidance on how to implement and evaluate services. A 'readiness' evaluation framework assessing whether critical components across the health system had been considered prior to implementation was strongly supported, while 'success' was perceived as an already familiar evaluation concept. Perceived challenges associated with standardised evaluation included identifying, defining and measuring key 'readiness' and 'success' indicators; impacts of systems and context changes; cost; meaningful stakeholder consultation and developing a widely applicable framework.Conclusions: A standardised evaluation framework that includes a strong focus on 'readiness' is important to ensure successful and sustainable implementation of musculoskeletal MoCs. [ABSTRACT FROM AUTHOR]

Background: Borderline personality disorder is a severe mental disorder that usually has its onset in youth, but its diagnosis and treatment are often delayed. Psychosocial 'early intervention' is effective in improving symptoms and behaviours, but no trial has studied adaptive functioning as a primary outcome, even though this remains the major persistent impairment in this patient group. Also, the degree of complexity of treatment and requirements for implementation in mainstream health services are unclear. The primary aim of this trial is to evaluate the effectiveness of three forms of early intervention for borderline personality disorder in terms of adaptive functioning. Each treatment is defined by combining either a specialised or a general service delivery model with either an individual psychotherapy or a control psychotherapy condition.Methods/design: The study is a parallel-group, single-blind, randomised controlled trial, which has randomised permuted blocking, stratified by depression score, sex and age. The treatments are: (1) the specialised Helping Young People Early service model plus up to 16 sessions of individual cognitive analytic therapy; (2) the Helping Young People Early service plus up to 16 sessions of a control psychotherapy condition known as 'befriending'; (3) a general youth mental health care model plus up to 16 sessions of befriending. Participants will comprise 135 help-seeking youth aged 15-25 years with borderline personality disorder. After baseline assessment, staff blind to the study design and treatment group allocation will conduct assessments at 3, 6, 12 and 18 months. At the 12-month primary endpoint, the primary outcome is adaptive functioning (measures of social adjustment and interpersonal problems); secondary outcomes include measures of client satisfaction, borderline personality disorder features, depression and substance use.Discussion: The results of this trial will help to clarify the comparative effectiveness of a specialised early intervention service model over and above general youth mental health care, along with the contribution of individual cognitive analytic therapy over and above specialised general clinical care in early intervention for borderline personality disorder. Consequently, the findings will also inform the level of training and competency required for effective delivery of early intervention services.Trial Registration: Registered with the Australian New Zealand Clinical Trial Registry ACTRN12610000100099 on 1 February 2010. [ABSTRACT FROM AUTHOR]

Background: Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines.Methods/design: A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families.Discussion: This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families.Trial Registration: This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192. [ABSTRACT FROM AUTHOR]

Background: Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema.Methods/design: We have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children's Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period.Discussion: Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema.Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014. [ABSTRACT FROM AUTHOR]

Background: Dialysis patients experience high rates of foot ulceration. Although risk factors for ulceration have been extensively studied in patients with diabetes, there is limited high-quality, longitudinal evidence in the dialysis population. Therefore, this study investigated risk factors for foot ulceration in a stable dialysis cohort.Methods: We prospectively collected clinical, demographic, health status, and foot examination information on 450 adults with end-stage renal disease from satellite and home-therapy dialysis units in Melbourne, Australia over 12 months. The primary outcome was foot ulceration. Cox proportional hazard modelling and multinomial regression were used to investigate risk factors.Results: Among 450 dialysis patients (mean age, 67.5 years; 64.7% male; 94% hemodialysis; 50.2% diabetes), new cases of foot ulceration were identified in 81 (18%) participants. Overall, risk factors for foot ulceration were neuropathy (HR 3.02; 95% CI 1.48 to 6.15) and previous ulceration (HR 2.86; CI 1.53 to 5.34). In those without history of ulceration, nail pathology (RR 3.85; CI 1.08 to 13.75) and neuropathy (RR 2.66; CI 1.04 to 6.82) were risk factors. In those with history of ulceration, neuropathy (RR 11.23; CI 3.16 to 39.87), peripheral arterial disease (RR 7.15; CI 2.24 to 22.82) and cerebrovascular disease (RR 2.08; CI 1.04 to 4.16) were risk factors. There were 12 (2.7%) new amputations, 96 (21.3%) infections, 24 (5.3%) revascularizations, 42 (9.3%) foot-related hospitalizations, and 52 (11.6%) deaths.Conclusions: Neuropathy and previous ulceration are major risk factors for foot ulceration in dialysis patients. Risk factors differ between those with and without prior ulceration. The risk factors identified will help to reduce the incidence of ulceration and its associated complications. [ABSTRACT FROM AUTHOR]

Background: Older adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model exists in this setting in Australia. We aimed to determine the clinical, person-centered, and economic effectiveness of a novel eye care model, the Residential Ocular Care (ROC).Methods/design: This protocol describes a multicentered, prospective, randomized controlled trial. A total of 395 participants with distance vision < 6/12 (0.30 LogMAR) and/or near vision N8 (1.00 M) or worse will be recruited from 38 urban and rural aged care facilities across Victoria, Australia. Aged care facilities will be randomized (1:1) to one of two parallel groups. Participants in the ROC group will receive a comprehensive and tailored eye care pathway that includes, as necessary, refraction and spectacle provision, cataract surgery, low vision rehabilitation, and/or a referral to an ophthalmologist for funded treatment. Usual care participants will be referred for an evaluation to the eye care service associated with the facility or an eye care provider of their choice. The primary outcome will be presenting near and distance vision assessed at the two- and six-month follow-up visits, post baseline. Secondary outcomes will include vision-specific quality of life, mobility, falls, depression, and eye care utilization at two and six months. An incremental cost-effectiveness analysis will also be undertaken.Discussion: The ROC study is the first multicentered, prospective, customized, and cluster randomized controlled trial in Australia to determine the effectiveness of a comprehensive and tailored eye care model for people residing in aged care facilities. Results from this trial will assist health and social care planners in implementing similar innovative models of care for this growing segment of the population in Australia and elsewhere.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12615000587505 . Registered on 4 June 2015 - retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Several studies have now demonstrated the benefits of peer support in promoting diabetes control. The aim of this study is to evaluate the implementation of a cluster randomised controlled trial of a group-based, peer support program to improve diabetes self-management and thereby, diabetes control in people with Type 2 Diabetes in Victoria, Australia.Methods: The intervention program was designed to address four key peer support functions i.e. 1) assistance in daily management, 2) social and emotional support, 3) regular linkage to clinical care, and 4) ongoing and sustained support to assist with the lifelong needs of diabetes self-care management. The intervention participants attended monthly group meetings facilitated by a trained peer leader for 12 months. Data was collected on the intervention's reach, participation, implementation fidelity, groups' effectiveness and participants' perceived support and satisfaction with the intervention. The RE-AIM and PIPE frameworks were used to guide this evaluation.Results: The trial reached a high proportion (79%) of its target population through mailed invitations. Out of a total of 441 eligible individuals, 273 (61.9%) were willing to participate. The intervention fidelity was high (92.7%). The proportion of successful participants who demonstrated a reduction in 5 years cardiovascular disease risk score was 65.1 and 44.8% in the intervention and control arm respectively. Ninety-four percent (94%) of the intervention participants stated that the program helped them manage their diabetes on a day to day basis. Overall, attending monthly group meetings provided 'a lot of support' to 57% and 'moderate' support to 34% of the participants.Conclusion: Peer support programs are feasible, acceptable and can be used to supplement treatment for patients motivated to improve behaviours related to diabetes. However, program planners need to focus on the participation component in designing future programs. The use of two evaluation frameworks allowed a comprehensive evaluation of the trial from the provider-, participant- and public health perspective. The learnings gained from this evaluation will guide and improve future implementation by improving program feasibility for adoption and acceptability among participants, and will ultimately increase the likelihood of program effectiveness for the participants.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009. [ABSTRACT FROM AUTHOR]