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Abstract Background Although primary health care (PHC) is a key component of all health care systems, services are not always readily available, accessible or affordable. This systematic review examines effective strategies to enhance access to best practice processes of PHC in three domains: chronic disease management, prevention and episodic care. Methods An extensive search of bibliographic data bases to identify peer and non-peer reviewed literature was undertaken. Identified papers were screened to identify and classify intervention studies that measured the impact of strategies (singly or in combination) on change in use or the reach of services in defined population groups (evaluated interventions). Results The search identified 3,148 citations of which 121 were intervention studies and 75 were evaluated interventions. Evaluated interventions were found in all three domains: prevention (n = 45), episodic care (n = 19), and chronic disease management (n = 11). They were undertaken in a number of countries including Australia (n = 25), USA (n = 25), and UK (n = 15). Study quality was ranked as high (31% of studies), medium (61%) and low (8%). The 75 evaluated interventions tested a range of strategies either singly (n = 46 studies) or as a combination of two (n = 20) or more strategies (n = 9). Strategies targeted both health providers and patients and were categorised to five groups: practice re-organisation (n = 43 studies), patient support (n = 29), provision of new services (n = 19), workforce development (n = 11), and financial incentives (n = 9). Strategies varied by domain, reflecting the complexity of care needs and processes. Of the 75 evaluated interventions, 55 reported positive findings with interventions using a combination of strategies more likely to report positive results. Conclusions This review suggests that multiple, linked strategies targeting different levels of the health care system are most likely to improve access to best practice PHC. The proposed changes in the structure of PHC in Australia may provide opportunities to investigate the factors that influence access to best practice PHC and to develop and implement effective, evidence based strategies to address these.

Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE) monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7%) subjects completed this study: 209 of the 279 subjects (75%) in the 6-month group and 55 of the 111 subjects (50%) in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects) were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs) were reported by 36 (9%) subjects. The AE profile in this study was qualitatively similar to those of other studies in adult subjects with schizophrenia and in other psychiatric studies of risperidone in pediatric populations. Conclusions Risperidone maintenance treatment in adolescents over 6 to 12 months was well tolerated, consistent with related studies in this clinical population, and associated with continued efficacy. Clinical trials ClinicalTrials.gov registration number: NCT00246285 http://clinicaltrials.gov/ct2/show/NCT00246285?term=NCT00246285&rank=1

Abstract Background Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone. Methods/Design A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an Advice or Rehabilitation group. Participants in the Advice group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the Rehabilitation group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years. Discussion This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.

Abstract Background Type 2 diabetes is a major public health problem in Australia with prevalence increasing in parallel with increasing obesity. Prevention is an essential component of strategies to reduce the diabetes burden. There is strong and consistent evidence from randomised controlled trials that type 2 diabetes can be prevented or delayed through lifestyle modification which improves diet, increases physical activity and achieves weight loss in at risk people. The current challenge is to translate this evidence into routine community settings, determine feasible and effective ways of delivering the intervention and providing on-going support to sustain successful behavioural changes. Methods/Design The Sydney Diabetes Prevention Program (SDPP) is a translational study which will be conducted in 1,550 participants aged 50-65 years (including 100 indigenous people aged 18 years and older) at high risk of future development of diabetes. Participants will be identified through a screening and recruitment program delivered through primary care and will be offered a community-based lifestyle modification intervention. The intervention comprises an initial individual session and three group sessions based on behaviour change principles and focuses on five goals: 5% weight loss, 210 min/week physical activity (aerobic and strength training exercise), limit dietary fat and saturated fat to less than 30% and 10% of energy intake respectively, and at least 15 g/1000 kcal dietary fibre. This is followed by 3-monthly contact with participants to review progress and offer ongoing lifestyle advice for 12 months. The effectiveness and costs of the program on diabetes-related risk factors will be evaluated. Main outcomes include changes in weight, physical activity, and dietary changes (fat, saturated fat and fibre intake). Secondary outcomes include changes in waist circumference, fasting plasma glucose, blood pressure, lipids, quality of life, psychological well being, medication use and health service utilization. Discussion This translational study will ascertain the reach, feasibility, effectiveness and cost-effectiveness of a lifestyle modification program delivered in a community setting through primary health care. If demonstrated to be effective, it will result in recommendations for policy change and practical methods for a wider community program for preventing or delaying the onset of type 2 diabetes in high risk people.

Abstract Background Maintaining a healthy weight and undertaking regular physical activity are important for the secondary prevention of cardiovascular disease (CVD). However, many people with CVD are overweight and insufficiently active. In addition, in Australia only 20-30% of people requiring cardiac rehabilitation (CR) for CVD actually attend. To improve outcomes of and access to CR the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR need to be established. This research will determine the efficacy of a telephone-delivered lifestyle intervention, promoting healthy weight and physical activity, in people with CVD in urban and rural settings. The control group will also act as a replication study of a previously proven physical activity intervention, to establish whether those findings can be repeated in different urban and rural locations. The cost-effectiveness and acceptability of the intervention to CR staff and participants will also be determined. Methods/Design This study is a randomised controlled trial. People referred for CR at two urban and two rural Australian hospitals will be invited to participate. The intervention (healthy weight) group will participate in four telephone delivered behavioural coaching and goal setting sessions over eight weeks. The coaching sessions will be on weight, nutrition and physical activity and will be supported by written materials, a pedometer and two follow-up booster telephone calls. The control (physical activity) group will participate in a six week intervention previously shown to increase physical activity, consisting of two telephone delivered behavioural coaching and goal setting sessions on physical activity, supported by written materials, a pedometer and two booster phone calls. Data will be collected at baseline, eight weeks and eight months for the intervention group (baseline, six weeks and six months for the control group). The primary outcome is weight change. Secondary outcomes include physical activity, sedentary time and nutrition habits. Costs will be compared with outcomes to determine the relative cost-effectiveness of the healthy weight and physical activity interventions. Discussion This study addresses a significant gap in public health practice by providing evidence for the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. The replication arm of the study, undertaken by the control group, will demonstrate whether the findings of the previously proven physical activity intervention can be generalised to new settings. This population-based approach could potentially improve access to and outcomes of secondary prevention programs, particularly for rural or disadvantaged communities. Trial Registration ACTRN12610000102077

Abstract Background Recent evidence suggests that CD4+CD25+FoxP3+ regulatory T-cells (Treg) may be responsible for the failure of host anti-tumour immunity by suppressing cytotoxic T- cells. We assessed the prognostic significance of tumour infiltrating lymphocytes (TIL) in intestinal-type gastric cardiac cancer. Methods Tumour infiltrating lymphocyte (TIL) subsets and tumour infiltrating macrophages (TIM) were investigated in 52 cases using tissue microarrays. The interrelationship between the cell populations (CD3+, CD8+, CD20+, CD68+, GranzymeB+, FoxP3+) in different compartments and NED-survival was investigated (median follow-up time: 61 months). Results Intraepithelial infiltration with TIL and TIM including Treg was generally low and not related to NED-survival. However, patients with large numbers of FoxP3+ Treg in the tumour stroma (>125.9 FoxP3+TILs/mm2) had a median survival time of 58 months while those with low FoxP3+ TIL counts (+TILs/mm2) had a median survival time of 32 months (p = 0.006). Patients with high versus low stromal CD68+/FoxP3+ cell ratios in primary tumour displayed median survivals of 32 and 55 months, respectively (p = 0.008). Conclusion Our results suggest that inflammatory processes within the tumour stroma of gastric intestinal-type adenocarcinomas located at the gastric cardia may affect outcome in two ways. Tumour-infiltrating macrophages are likely to promote carcinogenesis while large numbers of Treg are associated with improved outcome probably by inhibiting local inflammatory processes promoting carcinogenesis. Thus, inhibition of Treg may not be a feasible treatment option in gastric adenocarcinoma.

Abstract Background Passive joint mobilisation is a technique frequently used by physiotherapists to reduce pain, improve joint movement and facilitate a return to activities after injury, but its use after ankle fracture is currently based on limited evidence. The primary aim of this trial is to determine if adding joint mobilisation to a standard exercise programme is effective and cost-effective after cast immobilisation for ankle fracture in adults. Methods/Design Ninety participants will be recruited from the physiotherapy departments of three teaching hospitals and randomly allocated to treatment or control groups using a concealed procedure. All participants will perform an exercise programme. Participants in the treatment group will also receive joint mobilisation twice a week for four weeks. Blinded follow-up assessments will be conducted four, 12 and 24 weeks after randomisation. The primary outcome measures will be the Lower Extremity Functional Scale and the Assessment of Quality of Life. Secondary outcomes will include measures of impairments, activity limitation and participation. Data on the use of physiotherapy services and participants' out-of-pocket costs will be collected for the cost-effective and cost-utility analyses. To test the effects of treatment, between-group differences will be examined with analysis of covariance using a regression approach. The primary conclusions will be based on the four-week follow-up data. Discussion This trial incorporates features known to minimise bias. It uses a pragmatic design to reflect clinical practice and maximise generalisability. Results from this trial will contribute to an evidence-based approach for rehabilitation after ankle fracture.