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Abstract Objectives To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria. Methods This post‐hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria. Results We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow‐up period of 1.8 (1.4–2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6–10.0)/100 women‐years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18–2.54; p = .005) and 3.56 (95% CI, 2.46–5.16; p

Abstract Background Little is known about the relationship between patients' cultural and linguistic backgrounds and patient activation, especially in people with diabetes and chronic kidney disease (CKD). We examined the association between culturally and linguistically diverse (CALD) background and patient activation and evaluated the impact of a codesigned integrated kidney and diabetes model of care on patient activation by CALD status in people with diabetes and CKD. Methods This longitudinal study recruited adults with diabetes and CKD (Stage 3a or worse) who attended a new diabetes and kidney disease service at a tertiary hospital. All completed the patient activation measure at baseline and after 12 months and had demographic and clinical data collected. Patients from CALD backgrounds included individuals who spoke a language other than English at home, while those from non‐CALD backgrounds spoke English only as their primary language. Paired t‐tests compared baseline and 12‐month patient activation scores by CALD status. Results Patients from CALD backgrounds had lower activation scores (52.1 ± 17.6) compared to those from non‐CALD backgrounds (58.5 ± 14.6) at baseline. Within‐group comparisons showed that patient activation scores for patients from CALD backgrounds significantly improved by 7 points from baseline to 12 months follow‐up (52.1 ± 17.6–59.4 ± 14.7), and no significant change was observed for those from non‐CALD backgrounds (58.5 ± 14.6–58.8 ± 13.6). Conclusions Among patients with diabetes and CKD, those from CALD backgrounds report worse activation scores. Interventions that support people from CALD backgrounds with comorbid diabetes and CKD, such as the integrated kidney and diabetes model of care, may address racial and ethnic disparities that exist in patient activation and thus improve clinical outcomes. Patient or Public Contribution Patients, caregivers and national consumer advocacy organisations (Diabetes Australia and Kidney Health Australia) codesigned a new model of care in partnership with healthcare professionals and researchers. The development of the model of care was informed by focus groups of patients and healthcare professionals and semi‐structured interviews of caregivers and healthcare professionals. Patients and caregivers also provided a rigorous evaluation of the new model of care, highlighting its strengths and weaknesses.

Introduction Cerebrovascular disease and neurodegeneration are causes of cognitive decline and dementia, for which primary prevention options are currently lacking. Statins are well-tolerated and widely available medications that potentially have neuroprotective effects. The STAREE-Mind Imaging Study is a randomised, double-blind, placebo-controlled clinical trial that will investigate the impact of atorvastatin on markers of neurovascular health and brain atrophy in a healthy, older population using MRI. This is a nested substudy of the ‘Statins for Reducing Events in the Elderly’ (STAREE) primary prevention trial.Methods Participants aged 70 years or older (n=340) will be randomised to atorvastatin or placebo. Comprehensive brain MRI assessment will be undertaken at baseline and up to 4 years follow-up, including structural, diffusion, perfusion and susceptibility imaging. The primary outcome measures will be change in brain free water fraction (a composite marker of vascular leakage, neuroinflammation and neurodegeneration) and white matter hyperintensity volume (small vessel disease). Secondary outcomes will include change in perivascular space volume (glymphatic drainage), cortical thickness, hippocampal volume, microbleeds and lacunae, prefrontal cerebral perfusion and white matter microstructure.Ethics and dissemination Academic publications from this work will address the current uncertainty regarding the impact of statins on brain structure and vascular integrity. This study will inform the utility of repurposing these well-tolerated, inexpensive and widely available drugs for primary prevention of neurological outcomes in older individuals. Ethics approval was given by Monash University Human Research Ethics Committee, Protocol 12206.Trial registration number ClinicalTrials.gov Identifier: NCT05586750.

Background: Diabetes is a common condition that often requires increasing intensity of glucose lowering regimens. We describe the population trends in the intensity of regimens, and associations of achieved HbA1c and treatment persistence. Methods: We performed an episode-based analysis of the EXTEND-45 dataset, assessing trends in glucose lowering therapy and the associated outcomes of HbA1c and treatment persistence. Trends from 2009 to 2014 were assessed for each intensity level of a glucose lowering therapy regimen, according to the year prescribed. Episodes were defined as the length of time that an individual adhered to a regimen through ongoing prescription, and this was used as to define persistence. Mean HbA1c were calculated for each episode. Persistence and HbA1c were compared across the different regimens of treatment intensity. Results: The intensity of glucose lowering therapy remained stable over time with around one third of episodes utilising a single glucose lowering agent. Mean HbA1c was higher for insulin-based treatment (mean 7.9 % SD = 1.3 %), and lowest for episodes of no glucose lowering treatment (mean 6.3 % (SD = 0.8 %). Around half of participants achieved glycemic targets of 7 %. While there was considerable variation in persistence, the median persistence was around 3 months (94 days, IQR 51–201 days). Conclusions: Therapeutic intensity for diabetes has remained stable over 9 years. Whilst there was considerable variability in persistence with glucose lowering regimens, the mean duration of all regimens was less than a year. Requirement for higher intensity treatment with insulin was related to poorer glycemic control.

BackgroundTechnology use, including continuous glucose monitoring (CGM) and insulin pump therapy, is associated with improved outcomes in youth with type 1 diabetes (T1D). In 2017 CGM was universally funded for youth with T1D in Australia. In contrast, pump access is primarily accessed through private health insurance, self-funding or philanthropy. The study aim was to investigate the use of diabetes technology across different socioeconomic groups in Australian youth with T1D, in the setting of two contrasting funding models.MethodsA cross-sectional evaluation of 4957 youth with T1D aged

Abstract Background People living with diabetes must manage a range of factors for optimal control of glycaemia and to minimise the risk of diabetes-related complications. Diabetes practitioners are expected to follow guidelines for the key process of care and clinical outcomes, to help people living with diabetes achieve clinical targets. In Australia, the performance of diabetes centres against guidelines is evaluated by the Australian National Diabetes Audit, an annual clinical audit and feedback activity. Previous work has identified areas for improvement in the feedback provided to participating diabetes centres and suggested additional educational and support resources to assist in using audit feedback for the development of quality improvement activities. This cluster randomised trial will test the acceptability, utility and impact on selected clinical outcomes of the developed study intervention (audit feedback and a tailored educational and peer support cointervention). Methods Two-armed cluster randomised trial with Australian Diabetes Centres that participated in the Australian National Diabetes Audit in 2021 as the clusters, stratified by location and type of centre. We aim to recruit 35 diabetes centres in each arm. Both the intervention and control arms will receive an augmented feedback report, accompanied by a partially pre-populated slide deck. In addition, the intervention arm will receive a tailored theory-based intervention designed to address identified, modifiable barriers to utilising and implementing the recommendations from diabetes audit feedback. The co-primary outcomes are (1) HbA1c at the patient level, measured at 6 months after delivery of the intervention, and (2) the acceptability and utility of the augmented feedback and cointerventions at the practitioner level, measured at 3 months after delivery of the intervention. Discussion This trial aims to test the effects of systematic development and implementation of theory and evidence-informed changes to the audit feedback delivered to diabetes centres participating in an established national clinical diabetes audit. Potential benefits of improved audit feedback include more optimal engagement with the feedback by end clinical users which, ultimately, may lead to improvements in care for people living with diabetes. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12621000765820. Prospectively registered on June 21, 2021

Abstract Background Immune checkpoint inhibitors (ICI) are associated with immune-mediated adverse effects, potentially involving any organ. ICI has also been associated with an increased risk of cardiovascular disease in cancer populations. Objective To characterize the incidence and risk of major atherosclerotic cardiovascular events associated with ICI use in a high-risk and advanced melanoma population. Methods We conducted a retrospective cohort study of patients with high-risk or advanced melanoma (AJCC stage II, III or IV) presenting to an academic tertiary hospital between 2015–2020. The main outcome was major atherosclerotic cardiovascular events (MACE) including acute myocardial infarction, ischemic stroke, acute limb ischemia and coronary revascularization. Results The study cohort consisted of 646 patients, including 289 who had been treated with ICI. The incidence of MACE was higher in the ICI treated group (3.6 vs. 0.9 events per 100-person years). After adjusting for age, sex, smoking history and prior BRAF and/or MEK inhibitor use, ICI treatment was associated with an increased risk of MACE (HRadj 2.8, 95% CI 1.1–6.9, p = 0.03). Elevated risk was especially pronounced in patients with a past history of MACE (HR 14.4, 95% CI 1.9–112.3, p = 0.01). Conclusion Patients with high-risk or advanced melanoma are at an increased risk of atherosclerotic cardiovascular events following ICI treatment, particularly those with a history of cardiovascular disease.

Introduction The world is undergoing a demographic transition to an older population. Preventive healthcare has reduced the burden of chronic illness at younger ages but there is limited evidence that these advances can improve health at older ages. Statins are one class of drug with the potential to prevent or delay the onset of several causes of incapacity in older age, particularly major cardiovascular disease (CVD). This paper presents the protocol for the STAtins in Reducing Events in the Elderly (STAREE) trial, a randomised double-blind placebo-controlled trial examining the effects of statins in community dwelling older people without CVD, diabetes or dementia.Methods and analysis We will conduct a double-blind, randomised placebo-controlled trial among people aged 70 years and over, recruited through Australian general practice and with no history of clinical CVD, diabetes or dementia. Participants will be randomly assigned to oral atorvastatin (40 mg daily) or matching placebo (1:1 ratio). The co-primary endpoints are disability-free survival defined as survival-free of dementia and persistent physical disability, and major cardiovascular events (cardiovascular death or non-fatal myocardial infarction or stroke). Secondary endpoints are all-cause death, dementia and other cognitive decline, persistent physical disability, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, heart failure, atrial fibrillation, fatal and non-fatal cancer, all-cause hospitalisation, need for permanent residential care and quality of life. Comparisons between assigned treatment arms will be on an intention-to-treat basis with each of the co-primary endpoints analysed separately in time-to-first-event analyses using Cox proportional hazards regression models.Ethics and dissemination STAREE will address uncertainties about the preventive effects of statins on a range of clinical outcomes important to older people. Institutional ethics approval has been obtained. All research outputs will be disseminated to general practitioner co-investigators and participants, published in peer-reviewed journals and presented at national and international conferences.Trial registration number NCT02099123.

Abstract Background Diabetes has high burden on the health system and the individual, and many people living with diabetes struggle to optimally manage their condition. In Australia, people living with diabetes attend a mixture of primary, secondary and tertiary care centres. Many of these Diabetes Centres participate in the Australian National Diabetes Audit (ANDA), a quality improvement (QI) activity that collects clinical information (audit) and feeds back collated information to participating sites (feedback). Despite receiving this feedback, many process and care outcomes for Diabetes Centres continue to show room for improvement. The purpose of this qualitative study was to inform improvement of the ANDA feedback, identify the needs of those receiving feedback and elicit the barriers to and enablers of optimal feedback use. Methods Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR). De-identified transcripts were analysed thematically, underpinned by the domains and constructs of the CFIR. Results Representatives from 14 Diabetes centres participated in this study, including a diverse range of staff typical of the Diabetes Centres who take part in ANDA. In general, participants wanted a shorter report with a more engaging, simplified data visualisation style. Identified barriers to use of feedback were time or resource constraints, as well as access to knowledge about how to use the data provided to inform the development of QI activities. Enablers included leadership engagement, peer mentoring and support, and external policy and incentives. Potential cointerventions to support use include exemplars from clinical change champions and peer leaders, and educational resources to help facilitate change. Conclusions This qualitative study supported our contention that the format of ANDA feedback presentation can be improved. Healthcare professionals suggested actionable changes to current feedback to optimise engagement and potential implementation of QI activities. These results will inform redesign of the ANDA feedback to consider the needs and preferences of end users and to provide feedback and other supportive cointerventions to improve care, and so health outcomes for people with diabetes. A subsequent cluster randomised trial will enable us to evaluate the impact of these changes.

Introduction Type 1 diabetes (T1D) is a chronic and incurable autoimmune disease, diagnosed in early childhood and managed initially in paediatric healthcare services. In many countries, including Australia, national audit data suggest that management and care of T1D, and consequently glycaemic control, are consistently poor. This can lead to adverse outcomes such as cardiovascular disease and nephropathy. T1D treatment is complex, multidisciplinary, multiagency and life-long and should involve patient-centred, developmentally appropriate care. Although an emerging body of literature describes T1D models of care, their components, implementation determinants and associated outcomes are poorly understood.Objectives To provide a study protocol to describe methods to map existing models of care for children and young adults living with T1D. It will identify the gaps and needs in care delivery as viewed by healthcare providers and by children, young people and their families accessing care in metropolitan and rural or remote regions throughout Australia.Methods and analysis A mixed-method study that includes provider and consumer-specific surveys and interviews about current T1D care provisions. Data will be analysed thematically (qualitative) and statistically (quantitative) and synthesised to describe the key characteristics of effective and sustainable models of care for T1D and to identify gaps.Ethics and dissemination Ethics approval was granted by the Macquarie University Human Research Ethics Committee in July 2022 (#520221154439676). Results will be disseminated via publication in peer-reviewed journals and at relevant conferences.

Abstract Background With the rapid development of technologies for type 1 diabetes, economic evaluations are integral in guiding cost-effective clinical and policy decisions. We therefore aimed to review and synthesise the current economic literature for available diabetes management technologies and outline key determinants of cost-effectiveness. Methods A systematic search was conducted in April 2019 that focused on modelling or trial based economic evaluations. Searched databases included Medline, Medline in-process and other non-indexed citations, EMBASE, PubMed, All Evidenced Based Medicine Reviews, EconLit, Cost-effectiveness analysis Registry, Research Papers in Economics, Web of Science, PsycInfo, CINAHL, and PROSPERO from inception. We assessed quality of included studies with the Questionnaire to Assess Relevance and Credibility of Modeling Studies for Informing Health Care Decision Making an ISPOR-AMCP-NPC good practice task force report. Screening of abstracts and full-texts, appraisal, and extraction were performed by two independent researches. Results We identified 16,772 publications, of which 35 were analysed and included 11 health technologies. Despite a lack of consensus, most studies reported that insulin pumps (56%) or interstitial glucose sensors (62%) were cost-effective, although incremental cost-effectiveness ratios ranged widely ($14,266–$2,997,832 USD). Cost-effectiveness for combined insulin pumps and glucose sensors was less clear. Determinants of cost-effectiveness included treatment effects on glycosylated haemoglobin and hypoglycaemia, costing of technologies and complications, and measures of utility. Conclusions Insulin pumps or glucose sensors appeared cost-effective, particularly in populations with higher HbA1c levels and rates of hypoglycaemia. However, cost-effectiveness for combined insulin pumps and glucose sensors was less clear. Registration The study was registered with PROSPERO, number CRD42017077221.

BackgroundIncreasing global diabetes incidence has profound implications for health systems and for people living with diabetes. Guidelines have established clinical targets but there may be variation in clinical outcomes including HbA1c, based on location and practice size. Investigating this variation may help identify factors amenable to systemic improvement interventions. The aims of this study were to identify centre-specific and patient-specific factors associated with variation in HbA1c levels and to determine how these associations contribute to variation in performance across diabetes centres.MethodsThis cross-sectional study analysed data for 5,872 people with type 1 (n = 1,729) or type 2 (n = 4,143) diabetes mellitus collected through the Australian National Diabetes Audit (ANDA). A linear mixed-effects model examined centre-level and patient-level factors associated with variation in HbA1c levels.ResultsMean age was: 43±17 years (type 1), 64±13 (type 2); median disease duration: 18 years (10,29) (type 1), 12 years (6,20) (type 2); female: 52% (type 1), 45% (type 2). For people with type 1 diabetes, volume of patients was associated with increases in HbA1c (p = 0.019). For people with type 2 diabetes, type of centre was associated with reduction in HbA1c (p ConclusionsCentre-level and patient-level factors were associated with variation in HbA1c, but patient-level factors had greater impact. Interventions targeting patient-level factors conducted at a centre level including sick-day management, smoking cessation programs and culturally appropriate diabetes education for and Aboriginal and Torres Strait Islander peoples may be more important for improving glycaemic control than targeting factors related to the Centre itself.

Objective: To examine adherence to physical activity (PA) and dietary guidelines, explore barriers to healthy lifestyle behaviours, and determine any associations with lipid-lowering drug therapy (LLT). Design: Cross-sectional analysis of self-reported PA using the International Physical Activity Questionnaire for Elderly (IPAQ-E), diet using the Australian Short Dietary Screener (Aus-SDS), and perceived barriers to healthy PA and dietary behaviours. Setting: Australia Participants: A convenience sample of 110 community-dwelling Australian adults aged ≥70 years. Results: Descriptive statistics and Pearson's χ2 were used to analyse adherence to guidelines and lifestyle barriers. Of 110 adults (mean age 76.8 ± 4.5y), 51.8% met PA guidelines, and none met all five dietary guidelines. Lipid-lowering drug therapy users engaged in less weekly PA (median 155, IQR = 70, 370 min) than non-users (median 420, IQR = 210, 675 min). Dietary intake did not differ by LLT status. Mobility and health concerns (68.1% vs 23.7%), and motivation (79.2% vs 36.8%) were more common barriers to PA among LLT users compared with non-users (p

Objective Genetic variants that disrupt the function of the PCSK9 (proprotein convertase subtilisin kexin type 9) and APOB (apolipoprotein B)genes result in lower serum low-density lipoprotein cholesterol (LDL-C) levels and subsequently confer protection against coronary heart disease (CHD). The objective of this study was to measure the prevalence and selective advantage of such variants among healthy older individuals without a history of CHD.Methods We performed targeted sequencing of the PCSK9 and APOB genes in 13 131 healthy individuals without CHD aged 70 years or older enrolled into the ASPirin in Reducing Events in the Elderly trial. We detected variants in the PCSK9 and APOB genes with predicted loss-of-function. We associated variant carrier status with serum LDL-C and total cholesterol (TC) levels at the time of study enrolment, adjusting for statin use.Results We detected 22 different rare PCSK9/APOB candidate variants with putative lipid-lowering effect, carried by 104 participants (carrier rate 1 in 126). Serum LDL-C and TC concentrations for rare PCSK9/APOB variant carriers were consistently lower than non-carriers. Rare variant carrier status was associated with 19.4 mg/dL (14.6%) lower LDL-C, compared with non-carriers (p≤0.001, adjusted for statin use). Statin prescriptions were less prevalent in rare variant carriers (16%) than non-carriers (35%). The more common PCSK9 R46L variant (rs11591147-T) was associated with 15.5 mg/dL (11.8%) lower LDL-C in heterozygotes, and 25.2 mg/dL (19.2%) lower LDL-C in homozygotes (both p≤0.001).Conclusions Lipid-lowering genetic variants are carried by healthy older individuals and contribute to CHD-free survival.Trial registration number NCT01038583.

Abstract Background Self-management education needs have not been assessed in patients with complex co-morbid conditions such as diabetes and chronic kidney disease (CKD). The objectives of this study were to 1) determine the self-management education needs for patients with co-morbid diabetes and CKD and 2) co-develop an educational resource meeting the self-management education needs of patients with co-morbid diabetes and CKD. Methods Patients with co-morbid diabetes and CKD attending a co-designed, patient-centred outpatient diabetes and kidney clinic at a tertiary metropolitan hospital were recruited for semi-structured interviews. Maximal variation sampling was used, ensuring adequate representation of different gender, age, diabetes duration and stage of CKD. Data were thematically analysed using grounded theory. Results Forty-two patients participated. Most were male (67%) and the mean age was 64.8 (11.1) years. The majority of patients preferred an educational resource in the form of a Digital Versatile Disc (DVD) and they thought that current education could be improved. In particular patients wanted further education on 1) management of diabetes and kidney disease (including nutrition and lifestyle, and prevention of the progression of kidney disease) and 2) complications of comorbid diabetes and kidney disease. Conclusion Patients with co-morbid diabetes and kidney disease have education gaps on the management of, and complications of diabetes and kidney disease. Interventions aimed at improving patient education need to be delivered through education resources co-developed by patients and health staff. A targeted education resource in the form of a DVD, addressing these needs, may potentially close these gaps.

Abstract Background Little is known about how patient reported barriers to health care impact the quality of life (HRQoL) of patients with comorbid disease. We investigated patient reported barriers to health care and low physical and mental well-being among people with diabetes and chronic kidney disease (CKD). Methods Adults with diabetes and CKD (estimated Glomerular Filtration Rate

Aims: To use linked routinely-collected health data to estimate diabetes prevalence and incidence in an Australian cohort of adults aged ≥45 years, and examine risk factors associated with incident disease. Research design and methods: The EXamining ouTcomEs in chroNic Disease in the 45 and Up Study (EXTEND45) Study is a linked data study that combines baseline questionnaire responses from the population-based 45 and Up Study (2006–2009, n = 267,153) with multiple routinely-collected health databases up to December 2014. Among participants with ≥1 linked result for any laboratory test, diabetes status was determined from multiple data sources according to standard biochemical criteria, use of glucose-lowering medication or self-report, and the prevalence and incidence rate calculated. Independent risk factors of incident diabetes were examined using multivariable Cox regression. Results: Among 152,169 45 and Up Study participants with ≥1 linked laboratory result in the EXTEND45 database (mean age 63.0 years; 54.9% female), diabetes prevalence was 10.8% (95% confidence interval [CI] 10.6%–10.9%). Incident disease in those without diabetes at baseline (n = 135,810; mean age 62.5 years; 56.1% female) was 10.0 per 1,000 person-years (95% CI 9.8–10.2). In all age groups, diabetes incidence was lower in women compared to men, an association that persisted in the fully adjusted analyses. Other independent risk factors of diabetes were older age, being born outside of Australia (with the highest rate of 19.2 per 1,000 person-years observed in people born in South and Central Asia), lower education status, lower annual household income, residence in a major city, family history of diabetes, personal history of cardiovascular disease or hypertension, higher body mass index, smoking and long sleeping hours. Conclusions: Our study represents an efficient approach to assessing diabetes frequency and its risk factors in the community. The infrastructure provided by the EXTEND45 Study will be useful for diabetes surveillance and examining other important clinical and epidemiological questions.

Objective: This study aimed to qualitatively explore perspectives, practices, and barriers to self-care practices (eating habits, physical activity, self-monitoring of blood glucose, and medicine intake behavior) in urban Pakistani adults with type 2 diabetes mellitus (T2DM).Methods: Pakistani adults with T2DM were recruited from the outpatient departments of two hospitals in Lahore. Semistructured interviews were conducted and audiorecorded until thematic saturation was reached. Two researchers thematically analyzed the data independently using NVivo® software with differences resolved by a third researcher.Results: Thirty-two Pakistani adults (aged 35–75 years, 62% female) participated in the study. Six themes were identified from qualitative analysis: role of family and friends, role of doctors and healthcare, patients' understanding about diabetes, complication of diabetes and other comorbidities, burden of self care, and life circumstances. A variable experience was observed with education and healthcare. Counseling by healthcare providers, family support, and fear of diabetes-associated complications are the key enablers that encourage study participants to adhere to diabetes-related self-care practices. Major barriers to self care are financial constraints, physical limitations, extreme weather conditions, social gatherings, loving food, forgetfulness, needle phobia, and a hectic job.Conclusion: Respondents identified many barriers to diabetes self care, particularly related to life situations and diabetes knowledge. Family support and education by healthcare providers were key influencers to self-care practices among Pakistani people with diabetes.

ObjectiveTo evaluate the impact of an integrated diabetes and kidney disease model of care on health-related quality of life (HRQOL) of patients with comorbid diabetes and chronic kidney disease (CKD).Research design and methodsA longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (stage 3a or worse) who attended a new diabetes kidney disease service was conducted at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Kidney Disease Quality of Life (KDQOL-36) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12-month scores. A subgroup analysis examined the effects by patient gender. Multiple regression analysis examined the factors associated with changes in scores.Results179 patients, 36% of whom were female, with baseline mean±SD age of 65.9±11.3 years, were studied. Across all subscales, HRQOL did not significantly change over time (p value for all mean differences >0.05). However, on subgroup analysis, symptom problem list and physical composite summary scores increased among women (MD=9.0, 95% CI 1.25 to 16.67; p=0.02 and MD=4.5, 95% CI 0.57 to 8.42; p=0.03 respectively) and physical composite scores decreased among men (MD=−3.35, 95% CI −6.26 to −0.44; p=0.03).ConclusionThe HRQOL of patients with comorbid diabetes and CKD attending a new codesigned, integrated diabetes and kidney disease model of care was maintained over 12 months. Given that HRQOL is known to deteriorate over time in this high-risk population, the impact of these findings on clinical outcomes warrants further investigation.

Aims: To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF). Methods: This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version. Participants who attended a subsequent baseline screening visit were guided through a comprehensive informed consent process. Results: During the screening phase of the trial, the likelihood of refusing trial participation was lower in Group 2 compared to Group 1 equating to an overall 23% reduction in risk (RR 0.77, P = 0.005, 95% CI 0.62–0.95). Group 2 had a 6.4% higher randomisation rate compared with Group 1 (65.3% versus 58.9% respectively) but this difference was not statistically significant. Factors associated with trial participation were male gender, age between 70 and 75 years and living alone (all p

Abstract Background Self-management support interventions may potentially delay kidney function decline and associated complications in patients with comorbid diabetes and chronic kidney disease. However, the effectiveness of these interventions remains unclear. We investigated the effectiveness of current self-management support interventions and their specific components and elements in improving patient outcomes. Methods Electronic databases were systematically searched from January 1, 1994, to December 19, 2017. Eligible studies were randomized controlled trials on self-management support interventions for adults with comorbid diabetes and chronic kidney disease. Primary outcomes were systolic blood pressure, diastolic blood pressure, estimated glomerular filtration rate, and glycated hemoglobin. Secondary outcomes included self-management activity, health service utilization, health-related quality of life, medication adherence, and death. Results Of the 48 trials identified, eight studies (835 patients) were eligible. There was moderate-quality evidence that self-management support interventions improved self-management activity (standard mean difference 0.56, 95% CI 0.15 to 0.97, p

Abstract Background Cardiovascular risk stratification is complex in type 1 diabetes. We hypothesised that traditional and diabetes-specific cardiovascular risk factors were prevalent and strongly associated with cardiovascular disease (CVD) among adults with type 1 diabetes attending Australian diabetes centres. Methods De-identified, prospectively collected data from patients with type 1 diabetes aged ≥ 18 years in the 2015 Australian National Diabetes Audit were analysed. The burden of cardiovascular risk factors [age, sex, diabetes duration, glycated haemoglobin (HbA1c), blood pressure, lipid profile, body mass index, smoking status, retinopathy, renal function and albuminuria] and associations with CVD inclusive of stroke, myocardial infarction, coronary artery bypass graft surgery/angioplasty and peripheral vascular disease were assessed. Restricted cubic splines assessed for non-linearity of diabetes duration and likelihood ratio test assessed for interactions between age, diabetes duration, centre type and cardiovascular outcomes of interest. Discriminatory ability of multivariable models were assessed with area under the receiver operating characteristic (ROC) curves. Results Data from 1169 patients were analysed. Mean (± SD) age and median diabetes duration was 40.0 (± 16.7) and 16.0 (8.0–27.0) years respectively. Cardiovascular risk factors were prevalent including hypertension (21.9%), dyslipidaemia (89.4%), overweight/obesity (56.4%), ever smoking (38.5%), albuminuria (31.1%), estimated glomerular filtration rate 7.0% (53 mmol/mol) (81.0%). Older age, longer diabetes duration, smoking and antihypertensive therapy use were positively associated with CVD, while high density lipoprotein-cholesterol and diastolic blood pressure were negatively associated (p

Abstract Background Technology has been implemented since the 1970s with the hope of improving glycaemic control and reducing the burden of complications for those living with type 1 diabetes. A clinical and cost-effectiveness comparison of all available technologies including continuous subcutaneous insulin infusion (CSII), continuous glucose monitors (CGMs), sensor-augmented pump therapy (including either low-glucose suspend or predictive low-glucose suspend), hybrid closed-loop systems, closed-loop (single-hormone or dual-hormone) systems, flash glucose monitoring (FGM), insulin bolus calculators, and ‘smart-device’ applications is currently lacking. This systematic review, network meta-analysis, and narrative synthesis aims to summarise available evidence regarding the clinical and cost-effectiveness of available technologies in the management of patients with type 1 diabetes. Methods Relevant studies will be searched using a comprehensive strategy through MEDLINE, MEDLINE in-process and other non-indexed citations, EMBASE, PubMed, all evidenced-based medicine reviews, EconLit, Cost-effectiveness Analysis Registry, Research Papers in Economics, Web of Science, PsycInfo, CINAHL, and PROSPERO for randomised controlled trials and economic evaluations. The search strategy will assess if there are combinations of currently available technologies that are superior to each other or to insulin injections and capillary blood glucose testing with regard to glycaemic control, morbidity/mortality, quality of life, and cost-effectiveness. Two reviewers will screen all articles for eligibility and then independently evaluate risk of bias, complete quality assessment, and extract data for included studies. Network meta-analyses will be performed where there is sufficient homogenous clinical data. Narrative synthesis will be performed for heterogeneous clinical data that cannot be pooled for network meta-analysis with critical appraisal of economic evaluations. Discussion This systematic review protocol utilises rigorous methodology and pre-determined eligibility criteria to provide a uniquely comprehensive search for a broad spectrum of clinical and economic outcomes in comparing multiple currently available technologies for managing type 1 diabetes. Evidence on which technologies may be most appropriate for particular patient groups will be examined as well as the economic justification for funding of different technologies. Systematic review registration PROSPERO (CRD42017077221)

Abstract Background Microvascular disease is associated with a high risk of macrovascular events in patients with type 2 diabetes, but the impact of macrovascular disease on the risk of microvascular events remains unknown. We sought to evaluate the respective effects of prior microvascular and macrovascular disease on the risk of major outcomes, including microvascular events, in these patients. Methods Participants in the Action in Diabetes and Vascular Disease: PreterAx and DiamicroN Modified-Release Controlled Evaluation (ADVANCE) trial (n = 11,140) and the ADVANCE-ON post-trial study (n = 8494) were categorized into 4 groups at baseline: dual absence of microvascular or macrovascular disease (n = 6789), presence of microvascular disease alone (n = 761), macrovascular disease alone (n = 3196), and both (n = 394). Outcomes were all-cause mortality, major macrovascular events (MACE), and major clinical microvascular events. Results All-cause mortality, MACE, and major clinical microvascular events occurred in 2265 (20%), 2166 (19%), and 807 (7%) participants respectively, during a median follow-up of 9.9 (inter-quartile interval 5.6–10.9) years. The adjusted hazard ratios [95% CI] of death, MACE, and major clinical microvascular events were each greater in patients with baseline microvascular disease (1.43 [1.20–1.71], 1.64 [1.37–1.97], and 4.74 [3.86–5.82], respectively), macrovascular disease (1.43 [1.30–1.57], 2.04 [1.86–2.25], and 1.26 [1.06–1.51]) or both (2.01 [1.65–2.45], 2.92 [2.40–3.55], and 6.30 [4.93–8.06]) compared with those without these conditions. No interaction was observed between baseline microvascular and macrovascular disease for these events. The addition of microvascular disease (change in c-statistic [95% CI] 0.005 [0.002–0.008], p = 0.02) or macrovascular disease (0.005 [0.002–0.007], p

Abstract Background Acute diabetic emergencies are often managed by prehospital Emergency Medical Services (EMS). The projected growth in prevalence of diabetes is likely to result in rising demand for prehospital EMS that are already under pressure. The aims of this study were to model the temporal trends and provide forecasts of prehospital attendances for diabetic emergencies. Methods A time series analysis on monthly cases of hypoglycemia and hyperglycemia was conducted using data from the Ambulance Victoria (AV) electronic database between 2009 and 2015. Using the seasonal autoregressive integrated moving average (SARIMA) modelling process, different models were evaluated. The most parsimonious model with the highest accuracy was selected. Results Forty-one thousand four hundred fifty-four prehospital diabetic emergencies were attended over a seven-year period with an increase in the annual median monthly caseload between 2009 (484.5) and 2015 (549.5). Hypoglycemia (70%) and people with type 1 diabetes (48%) accounted for most attendances. The SARIMA (0,1,0,12) model provided the best fit, with a MAPE of 4.2% and predicts a monthly caseload of approximately 740 by the end of 2017. Conclusions Prehospital EMS demand for diabetic emergencies is increasing. SARIMA time series models are a valuable tool to allow forecasting of future caseload with high accuracy and predict increasing cases of prehospital diabetic emergencies into the future. The model generated by this study may be used by service providers to allow appropriate planning and resource allocation of EMS for diabetic emergencies.

Abstract Objective: Obesity is a major public health concern and women living in rural settings present a high‐risk group. With contributing factors poorly explored, we evaluated their association with weight in rural Australian women. Methods: Women aged 18–50 years of any body mass index (BMI) were recruited between October 2012 and April 2013 as part of a larger, randomised controlled trial within 42 rural towns. Measured weight and height as well as self‐reported measures of individual health, physical activity, dietary intake, self‐management, social support and environmental perception were collected. Statistical analysis included linear regression for continuous variables as well as chi‐squared and logistic regression for categorical variables with all results adjusted for clustering. Results: 649 women with a mean baseline age and BMI of 39.6±6.7 years and 28.8±6.9 kg/m2 respectively, were studied. Overall, 65% were overweight or obese and 60% overall reported recent weight gain. There was a high intention to self‐manage weight, with 68% attempting to lose weight recently, compared to 20% of women reporting health professional engagement for weight management. Obese women reported increased weight gain, energy intake, sitting time and prevalence of pre‐existing health conditions. There was an inverse relationship between increased weight and scores for self‐management, social support and health environment perception. Conclusions: Many women in rural communities reported recent weight gain and were attempting to self‐manage their weight with little external support. Implications for public health: Initiatives to prevent weight gain require a multifaceted approach, with self‐management strategies and social support in tandem with building a positive local environmental perception.

BackgroundTo address guideline-practice gaps and improve management of patients with both diabetes and chronic kidney disease (CKD), we involved patients, health professionals and patient advocacy groups in the co-design and implementation of an integrated diabetes-kidney service.ObjectiveIn this study, we explored the experiences of patients and health-care providers, within this integrated diabetes and kidney service.Methods5 focus groups and 2 semi-structured interviews were conducted amongst attending patients, referring primary health professionals, and attending specialist health professionals. Maximal variation sampling was used for both patients and referring primary health professionals to ensure an equal representation of males and females, and patients of different CKD stages. All discussions were audiotaped and transcribed verbatim, before being thematically analysed independently by 2 researchers.ResultsThe mean age (SD) for specialist health professionals, primary care professionals and patients who participated was 45 (11), 44 (15) and 68 (5) years with men being 50%, 80% and 76% of the participants respectively. Key strengths of the diabetes and kidney service were noted to be better integration of care and a perception of improved health and management of health. Whilst some aspects of access such as time between referral and initial appointment and having fewer appointments improved, other aspects such as in-clinic waiting times and parking remained problematic. Specialist health professionals noted that health professional education could be improved. Patient self-management was also noted by to be an issue with some patients requesting more information and some health professionals expressing difficulty in empowering some patients.ConclusionsHealth professionals and patients reported that a co-designed integrated diabetes kidney service improved integration of care and improved health and management of health. However, some aspects of the process of care, health professional education and patient self-management remained challenging.

The aim of this study was to assess the relative validity and reproducibility of a six-item Australian Short Dietary Screener (Aus-SDS). The Aus-SDS assessed the daily intake of core food groups (vegetables, fruits, legumes and beans, cereals, protein sources and dairy sources) in 100 Australians (52 males and 48 females) aged ≥70 years. Relative validity was assessed by comparing intakes from the Aus-SDS1 with an average of three 24-h recalls (24-HRs), and reproducibility using two administrations of the Aus-SDS (Aus-SDS1 and Aus-SDS2). Cohen’s kappa statistic between the Aus-SDS1 and 24-HRs showed moderate to good agreement, ranging from 0.44 for fruits and dairy to 0.64 for protein. There was poor agreement for legume intake (0.12). Bland–Altman plots demonstrated acceptable limits of agreement between the Aus-SDS1 and 24-HRs for all food groups. Median intakes obtained from Aus-SDS1 and Aus-SDS2 did not differ. For all food groups, Cohen’s kappa statistic ranged from 0.68 to 0.89, indicating acceptable agreement between the Aus-SDS1 and Aus-SDS2. Spearman’s correlation coefficient between Aus-SDS1 and 24-HRs across all food groups ranged from 0.64 for fruit to 0.83 for protein. We found the Aus-SDS to be a useful tool in assessing daily intake of core food groups in this population.

Background 8‐Oxo‐2′‐deoxyguanosine (8‐oxo‐2′‐dG) is a biomarker of oxidative DNA damage that is associated with cardiovascular disease and premature mortality in the general population. Although oxidative stress has a proven role in cardiovascular complications in diabetes mellitus, evidence for a relationship between plasma 8‐oxo‐2′‐dG and major cardiovascular outcomes in diabetes mellitus is weak. Methods and Results A case‐cohort study was performed in 3766 participants with prevalent diabetes mellitus in the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial (ClinicalTrials.gov number NCT00145925). The hazard ratios for mortality and major acute cardiovascular events were derived using Cox regression models. During a median of 5 years of follow‐up, 695 (18.4%) participants in this enriched cohort died (including 354 deaths from cardiovascular disease). Individuals with higher levels of 8‐oxo‐2′‐dG were more likely to die. After adjusting for cardiovascular disease risk factors, the hazard ratio for a 1‐SD increase in plasma 8‐oxo‐2′‐dG was 1.10 (95% confidence interval, 1.01–1.20; P=0.03). This was driven by an independent association between plasma 8‐oxo‐2′‐dG and cardiovascular death (hazard ratio, 1.23; 95% confidence interval, 1.10–1.37 [P

This study examines prehospital Emergency Medical Service (EMS) utilisation and patterns of demand for hyperglycaemia management, including characteristics of individuals and factors related to hospital transport.A state-wide, community-based observational study of all patients requiring prehospital EMS for hyperglycaemia during a 7 year study period (Jan 2009-Dec 2015) using electronic data from the Ambulance Victoria data warehouse was conducted. Pre-specified variables related to patient demographics, comorbidities, examination findings, paramedic treatment and transport outcomes were obtained. Logistic regression was used to assess factors associated with transport to hospital.There were 11,417 cases of hyperglycaemia attended by paramedics during the study period, accounting for 0.3-0.4% of the total annual EMS caseload, and equating to 0.54 attendances per 100 people with diabetes in the state of Victoria, Australia, per year. There was a significant increase in annual utilisation, with a rate ratio of 1.62 between 2009 (2.42 cases per 10,000 population) and 2015 (3.91 cases per 10,000 population). Fifty-one percent of cases had type 2 diabetes, 37% had type 1 diabetes, 4% had diabetes with the type unspecified and 8% had no recorded history of diabetes. Ninety percent of cases were transported to hospital. Factors associated with increased odds of transport to hospital included no known history of diabetes, regional/rural locations, case time between 0600 and

Lipid-lowering therapy (LLT) should be accompanied by dietary guidance for cardiovascular risk reduction; however, current evidence suggests sub-optimal dietary behaviors in those on LLT. We examined the associations between the dietary intake of key food groups (vegetables, fruit, cereal, protein, and dairy) and LLT use in Australian adults using quantile regression. We used data from the Australian Diabetes, Obesity and Lifestyle Study (AusDiab), a prospective population-based study of adults aged ≥25 years, conducted over 5 years (1999−2005). Measurements included a 121-item food frequency questionnaire and LLT use. LLT use was categorized as: LLT users (n = 446), commenced LLT (n = 565), ceased LLT (n = 71), and non-users (n = 4813). Less than 1% of the cohort met recommended intakes of all food groups at the baseline and follow up. The median daily dietary intake at the follow up among LLT users was 2.2 serves of vegetables, 1.4 serves of fruit, 2.8 serves of cereal, 2.0 serves of protein, and 1.4 serves of dairy. Adjusted analysis showed no differences across the quantiles of intake of key food groups in LLT users and commenced LLT compared to non-users. The LLT medication status is not associated with any difference in meeting recommended intakes of key foods.

Background: The increasing burden of chronic (medical) conditions (CCs) is a major issue for healthcare systems across the world. We aimed to examine the changes in the rate of medication dispensation for multiple CCs among Australians aged ≥65 years. Methods: A repeated cross-sectional study was performed using the 2013⁻2016 Pharmaceutical Benefits Scheme (PBS) data on reimbursed prescriptions for a 10% random sample of the Australian population. Twenty-two CCs were identified via the RxRisk-V tool. The yearly changes in the proportion of older adults dispensed medications for ≥2 CCs were determined through Poisson regression modelling using 2013 as the reference year. The occurrence of CC dyads and triads for which medications were dispensed within a 180-day window were characterised, and the observed and expected rate of medication dispensation for each CC dyad or triad were calculated to identify the top 15 combinations. Results: The proportion of older adults dispensed medications for ≥2 CCs remained stable from 2013 to 2016, at >79% in each year. The proportion who were dispensed medications for multiple CCs increased with age. No gender differences in the dispensation of medications for multiple CCs were observed. Over 60% had medications dispensed for ≥3 CCs. The most frequent CC dyad and triad for which medications were dispensed were dyslipidaemia + hypertension (38.6%) and dyslipidaemia + gastroesophageal reflux disease + hypertension (18.7%), respectively. For the majority of CC dyads and all triads examined, the observed rate of medication dispensation exceeded that expected by chance. Conclusions: A high proportion of older Australians are dispensed medications for multiple CCs, suggestive of multimorbidity. The results reiterate the need for increased research into understanding the causal mechanisms of multimorbidity to inform the design of cost-effective interventions.

BACKGROUND:Multi-morbidity due to diabetes and chronic kidney disease (CKD) remains challenging for current health-systems, which focus on single diseases. As a first step toward health-care improvement, we explored the perspectives of patients and their carers on factors influencing the health-care of those with co-morbid diabetes and CKD. METHODS:In this qualitative study participants with co-morbid diabetes and CKD were purposively recruited using maximal variation sampling from 4 major tertiary health-services from 2 of Australia's largest cities. Separate focus groups were conducted for patients with CKD stages 3, 4 and 5. Findings were triangulated with semi-structured interviews of carers of patients. Discussions were transcribed verbatim and thematically analysed. RESULTS:Twelve focus groups with 58 participants and 8 semi-structured interviews of carers were conducted. Factors influencing health-care of co-morbid diabetes and CKD grouped into patient and health service level factors. Key patient level factors identified were patient self-management, socio-economic situation, and adverse experiences related to co-morbid diabetes and CKD and its treatment. Key health service level factors were prevention and awareness of co-morbid diabetes and CKD, poor continuity and coordination of care, patient and carer empowerment, access and poor recognition of psychological co-morbidity. Health-service level factors varied according to CKD stage with poor continuity and coordination of care and patient and carer empowerment emphasized by participants with CKD stage 4 and 5, and access and poor recognition of psychological co-morbidity emphasised by participants with CKD stage 5 and carers. CONCLUSIONS:According to patients and their carers the health-care of co-morbid diabetes and CKD may be improved via a preventive, patient-centred health-care model which promotes self-management and that has good access, continuity and coordination of care and identifies and manages psychological morbidity.

Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters) randomised using a computer-generated randomisation list for intervention (n = 21) or control (n = 20). Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her) consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7) and BMI of 28.8 kg/m(2) (+/- SD 6.9) with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97) and in the intervention group -0.48 kg (95% CI -0.99 to 0.03) with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16) or -0.87 kg (95% CI -1.62 to -0.13) adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence.

People living with diabetes and chronic kidney disease (CKD) experience compromised quality of life. Consequently, it is critical to identify and understand factors influencing their health-related quality of life (HRQoL). This study examined factors associated with HRQoL among patients with diabetes and CKD.A cross sectional study among adults with comorbid diabetes and CKD (eGFR

Although South Asian populations have high cardiovascular disease (CVD) burden in the world, their patterns of individual CVD risk factors have not been fully studied. None of the available algorithms/scores to assess CVD risk have originated from these populations. To explore the relevance of CVD risk scores for these populations, literature search and qualitative synthesis of available evidence were performed. South Asians usually have higher levels of both “classical” and nontraditional CVD risk factors and experience these at a younger age. There are marked variations in risk profiles between South Asian populations. More than 100 risk algorithms are currently available, with varying risk factors. However, no available algorithm has included all important risk factors that underlie CVD in these populations. The future challenge is either to appropriately calibrate current risk algorithms or ideally to develop new risk algorithms that include variables that provide an accurate estimate of CVD risk.

BackgroundOverweight and obesity are thought to significantly influence a person's risk of cardiovascular disease, possibly via its effect on the microvasculature. Retinal vascular caliber is a surrogate marker of microvascular disease and a predictor of cardiovascular events. The aim of this systematic review and meta-analysis was to determine the association between body mass index (BMI) and retinal vascular caliber.Methods and findingsRelevant studies were identified by searches of the MEDLINE and EMBASE databases from 1966 to August 2011. Standardized forms were used for data extraction. Among over 44,000 individuals, obese subjects had narrower arteriolar and wider venular calibers when compared with normal weight subjects, independent of conventional cardiovascular risk factors. In adults, a 1 kg/m(2) increase in BMI was associated with a difference of 0.07 μm [95% CI: -0.08; -0.06] in arteriolar caliber and 0.22 μm [95% CI: 0.21; 0.23] in venular caliber. Similar results were found for children.ConclusionsHigher BMI is associated with narrower retinal arteriolar and wider venular calibers. Further prospective studies are needed to examine whether a causative relationship between BMI and retinal microcirculation exists.

Endpoint adjudication committees (EPAC) are widely used in clinical trials. The aim of the present analysis is to assess the effects of the endpoint adjudication process on the main findings of the ADVANCE trial (Trial registration: ClinicalTrials.gov NCT00145925).The ADVANCE trial was a multicentre, 2 × 2 factorial randomised controlled trial of blood pressure lowering and intensive blood glucose control in 11140 patients with type 2 diabetes. Primary outcomes were major macrovascular (nonfatal myocardial infarction, nonfatal stroke and cardiovascular death) and microvascular (new or worsening nephropathy and retinopathy) events. Suspected primary outcomes were initially reported by the investigators at the 215 sites with subsequent adjudication by the EPAC. The EPAC also adjudicated upon potential events identified directly by ongoing screening of all reported events. Over a median follow-up of 5 years, the site investigators reported one or more primary outcomes among 2443 participants. After adjudication these events were confirmed for 2077 (85%) with 48 further events added through the EPAC-led database screening process. The estimated relative risk reductions (95% confidence intervals) in the primary outcome for the blood pressure lowering comparison were 8% (-1 to 15%) based on the investigator-reported events and 9% (0 to 17%) based on the EPAC-based events (P for homogeneity = 0.70). The corresponding findings for the glucose comparison were 8% (1 to 15%) and 10% (2% to 18%) (P for homogeneity = 0.60). The effect estimates were also highly comparable when studied separately for macrovascular events and microvascular events for both comparisons (all P for homogeneity>0.6).The endpoint adjudication process had no discernible impact on the main findings in ADVANCE. These data highlight the need for careful consideration of the likely impact of an EPAC on the findings and conclusions of clinical trials prior to their establishment.