BACKGROUND: Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care. METHODS/DESIGN: The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a "basal plus" regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia. DISCUSSION: This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial. TRIAL REGISTRATION: ACTRN12610000797077.

BACKGROUND: A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base. METHODS: Review of recent developments supporting primary care clinical research. RESULTS: Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output. CONCLUSION: Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment.

BACKGROUND: This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN) and tailored to meet the needs of a diversity of patients. METHODS/DESIGN: This study is a cluster randomised trial, with practices allocated to one of three groups 1) Quit with Practice Nurse 2) Quitline referral 3) GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches.Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI) with patients and semi-structured interviews with PNs and GPs.The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis. DISCUSSION: High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective, flexible support from the PN in partnership with the GP and the Quitline could become the preferred model for providing smoking cessation advice in Australian general practice. TRIAL REGISTRATION: ACTRN12609001040257.

BACKGROUND: Optimal glycaemia, reflected by glycated haemoglobin (HbA1c) levels, is key in reducing type 2 diabetes (T2D) complications. However, most people with T2D have suboptimal recall and understanding of HbA1c. Continuous glucose monitoring (CGM) measures glucose levels every 5 to 15-min over days and may be more readily understood. Given that T2D is more common in lower socioeconomic settings, we aim to study relationships between socioeconomic status (SES) and percentage time in glucose target range (TIR) which is a key metric calculated from CGM. METHODS: Analysis of baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) randomised controlled trial (October 2016 - November 2017) of 300 people with T2D from 25 Victorian General Practices. FreeStyle Libre Pro® sensor patch was used for this study. SES was defined by the Index of Relative Socio-economic Disadvantage (IRSD) and educational attainment. Univariable and multivariable mixed-effects linear regression analyses controlling for age, BMI, diet, exercise and study arm were performed. RESULTS: One hundred and sixty-seven (60.1%) participants were male, the mean (SD) participant age was 61.0 (9.7) years, and the mean (SD) duration of CGM use was 12.3 (2.5) days. The 10th IRSD decile (least disadvantaged) was associated with a 15% higher TIR vs. the 1st decile (most disadvantaged) (95% CI 5, 25; p = 0.003) and a 0.6% lower HbA1c (95% CI 0.1, 1; p = 0.03). There was no evidence of an association between educational attainment and TIR/HbA1c. CONCLUSION: Higher SES measured at an area level is associated with better achievement of glycaemic target using complementary measures of HbA1c and TIR in the GP-OSMOTIC cohort. Given that TIR may be more easily used in patient education and self-management support compared to HbA1c values, the social gradient identified in TIR provides an opportunity for clinicians and policy makers to address health inequities in T2D. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Trial ACTRN12616001372471 , prospective, Date registered 4/10/2016.

Objective: In a sample of adults with type 2 diabetes mellitus (T2DM), the aim of this study was to examine whether self-reported physical activity level is associated with recall of specific physical activity-related interactions used by general practitioners (GP). Research design and methods: Adults with T2DM completed an online survey reporting physical activity behaviors and recall of 14 GP-patient interactions about physical activity, mapped onto discrete behavior change techniques (BCT). Stepped logistical regression examined associations between recommended physical activity (≥600 MET-min/week) and GP-patient interactions, controlling for body mass index, diabetes-related comorbidities, depressive symptoms and self-efficacy. Results: In total, 381 respondents (55% men, mean±SD age: 62±10 years and T2DM duration 8±8 years) provided complete data. Most (73%) reported receiving 'general advice', while interactions related to goal setting, monitoring, and relapse prevention were least commonly reported (all <20%). Self-reported achievement of the recommended physical activity level was significantly associated with recall of GP interactions involving praise for 'efforts to be active' (OR 2.1; 95% CI 1.24 to 3.53), 'lost weight' (OR 1.81; 95% CI 1.05 to 3.12) or lowering 'glucose levels as a result of being active' (OR 1.75; 95% CI 1.03 to 2.96). Conclusions: Findings suggest GPs can be somewhat effective in promoting physical activity with simple, positive, reinforcing messages/interactions. Future research to develop and evaluate very brief primary care BCT-based physical activity interventions is needed.

INTRODUCTION: Data supporting external validity of trial results allows clinicians to assess the applicability of a study's findings to their practice population. Socio-economic status (SES) of trial participants may be critical to external validity given the relationship between social and economic circumstances and health. We explored how this is documented in reports of RCTs in four major general medical journals. METHODS: The contents lists of four leading general medical journals were hand searched to identify 25 consecutive papers reporting RCT results in each journal (n = 100). Data on demographic characteristics were extracted from each paper's Table 1 only (or equivalent). RESULTS: Authors infrequently reported key demographic characteristics relating to SES of RCT participants. Age and gender of participants were commonly reported. Less than 10% reported occupational group, employment status, income or area based measures of disadvantage. CONCLUSIONS: Without adequate reporting of key indicators of SES in trial participants it is unclear if lower SES groups are under-represented. If such groups are systematically under-recruited into trials, this may limit the external validity and applicability of study findings to these groups. This is in spite of the higher health-care need in more disadvantaged populations. Under-representation of low SES groups could underestimate the reported effect of an intervention for those with a higher baseline risk. The marginal benefit identified in a trial with poor or no representation of lower SES participants could significantly underestimate the potential benefit to a low SES community. More transparency in this reporting and greater attention to the impact of SES on intervention outcomes in clinical trials is needed. This could be considered in the next revision of the CONSORT statement.

Healthcare systems redesign and service improvement approaches are adopting participatory tools, techniques and mindsets. Participatory methods increasingly used in healthcare improvement coalesce around the concept of coproduction, and related practices of cocreation, codesign and coinnovation. These participatory methods have become the new Zeitgeist-the spirit of our times in quality improvement. The rationale for this new spirit of participation relates to voice and engagement (those with lived experience should be engaged in processes of development, redesign and improvements), empowerment (engagement in codesign and coproduction has positive individual and societal benefits) and advancement (quality of life and other health outcomes and experiences of services for everyone involved should improve as a result). This paper introduces Mental Health Experience Co-design (MH ECO), a peer designed and led adapted form of Experience-based Co-design (EBCD) developed in Australia. MH ECO is said to facilitate empowerment, foster trust, develop autonomy, self-determination and choice for people living with mental illnesses and their carers, including staff at mental health services. Little information exists about the underlying mechanisms of change; the entities, processes and structures that underpin MH ECO and similar EBCD studies. To address this, we identified eight possible mechanisms from an assessment of the activities and outcomes of MH ECO and a review of existing published evaluations. The eight mechanisms, recognition, dialogue, cooperation, accountability, mobilisation, enactment, creativity and attainment, are discussed within an 'explanatory theoretical model of change' that details these and ideal relational transitions that might be observed or not with MH ECO or other EBCD studies. We critically appraise the sociocultural and political movement in coproduction and draw on interdisciplinary theories from the humanities-narrative theory, dialogical ethics, cooperative and empowerment theory. The model advances theoretical thinking in coproduction beyond motivations and towards identifying underlying processes and entities that might impact on process and outcome. TRIAL REGISTRATION NUMBER: The Australian and New Zealand Clinical Trials Registry, ACTRN12614000457640 (results).

Depression is a complex phenomenon thought to be due to the interaction of biological, psychological and social factors. Currently depression assessment uses self-reported depressive symptoms but this is limited in the degree to which it can characterise the different expressions of depression emerging from the complex causal pathways that are thought to underlie depression. In this study, we aimed to represent the different patterns of depression with pattern values unique to each individual, where each value combines all the available information about an individual's depression. We considered the depressed individual as a subsystem of an open complex system, proposed Generalized Information Entropy (GIE) to represent the general characteristics of information entropy of the system, and then implemented Maximum Entropy Estimates to derive equations for depression patterns. We also introduced a numerical simulation method to process the depression related data obtained by the Diamond Cohort Study which has been underway in Australia since 2005 involving 789 people. Unlike traditional assessment, we obtained a unique value for each depressed individual which gives an overall assessment of the depression pattern. Our work provides a novel way to visualise and quantitatively measure the depression pattern of the depressed individual which could be used for pattern categorisation. This may have potential for tailoring health interventions to depressed individuals to maximize health benefit.

Background: Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care.Methods: This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D. 224 patients between the ages of 18 and 80 years with T2D, on two or more oral hypoglycaemic agents and with an HbA1c >= 7.5% in the last six months will be recruited from 74 general practices. The unit of randomization is the practice. Primary outcome is change in glycated haemoglobin HbA1c (measured as a continuous variable). We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5% lower than control group at 12 months follow up. Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of <7.0%. We will also collect data on patient psychosocial outcomes and healthcare utilization and costs.Discussion: The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.