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Showing papers by "Bruce Neal published in 2014"


Journal ArticleDOI
TL;DR: Lowering blood pressure provides similar relative protection at all levels of baseline cardiovascular risk, but progressively greater absolute risk reductions as baseline risk increases.

499 citations


Journal ArticleDOI
TL;DR: There was no evidence that intensive glucose control during the ADVANCE factorial trial led to long-term benefits with respect to mortality or macrovascular events.
Abstract: Background In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up. Methods We invited surviving participants, who had previously been assigned to perindopril–indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events. Results The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure–lowering comparison) or ...

492 citations


Journal ArticleDOI
TL;DR: In this article, an ordinal analysis of the modified Rankin score was performed for patients with intracerebral hemorrhage and showed that intensive lowering of blood pressure did not result in a significant reduction in the rate of death or severe disability.
Abstract: Background Whether rapid lowering of elevated blood pressure would improve the outcome in patients with intracerebral hemorrhage is not known. Methods We randomly assigned 2839 patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated systolic blood pressure to receive intensive treatment to lower their blood pressure (with a target systolic level of <140 mm Hg within 1 hour) or guideline-recommended treatment (with a target systolic level of <180 mm Hg) with the use of agents of the physician’s choosing. The primary outcome was death or major disability, which was defined as a score of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms, a score of 5 indicates severe disability, and a score of 6 indicates death) at 90 days. A prespecified ordinal analysis of the modified Rankin score was also performed. The rate of serious adverse events was compared between the two groups. Results Among the 2794 participants for whom the primary outcome could be determined, 719 of 1382 participants (52.0%) receiving intensive treatment, as compared with 785 of 1412 (55.6%) receiving guideline-recommended treatment, had a primary outcome event (odds ratio with intensive treatment, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P = 0.06). The ordinal analysis showed significantly lower modi fied Rankin scores with intensive treatment (odds ratio for greater disability, 0.87; 95% CI, 0.77 to 1.00; P = 0.04). Mortality was 11.9% in the group receiving intensive treatment and 12.0% in the group receiving guideline-recommended treatment. Nonfatal serious adverse events occurred in 23.3% and 23.6% of the patients in the two groups, respectively. Conclusions In patients with intracerebral hemorrhage, intensive lowering of blood pressure did not result in a significant reduction in the rate of the primary outcome of death or severe disability. An ordinal analysis of modified Rankin scores indi cated improved functional outcomes with intensive lowering of blood pressure. (Funded by the National Health and Medical Research Council of Australia; INTERACT2 ClinicalTrials.gov number, NCT00716079.)

299 citations


Journal ArticleDOI
16 Apr 2014-JAMA
TL;DR: Findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk and the trial was terminated on July 2, 2013 due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points.
Abstract: Importance No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications. Aleglitazar is a dual agonist of peroxisome proliferator–activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles. Objective To determine whether the addition of aleglitazar to standard medical therapy reduces cardiovascular morbidity and mortality among patients with type 2 diabetes mellitus and a recent acute coronary syndrome (ACS). Design, Setting, and Participants AleCardio was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial conducted in 720 hospitals in 26 countries throughout North America, Latin America, Europe, and Asia-Pacific regions. The enrollment of 7226 patients hospitalized for ACS (myocardial infarction or unstable angina) with type 2 diabetes occurred between February 2010 and May 2012; treatment was planned to continue until patients were followed-up for at least 2.5 years and 950 primary end point events were positively adjudicated. Interventions Randomized in a 1:1 ratio to receive aleglitazar 150 µg or placebo daily. Main Outcomes and Measures The primary efficacy end point was time to cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Principal safety end points were hospitalization due to heart failure and changes in renal function. Results The trial was terminated on July 2, 2013, after a median follow-up of 104 weeks, upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points. A total of 3.1% of patients were lost to follow-up and 3.2% of patients withdrew consent. The primary end point occurred in 344 patients (9.5%) in the aleglitazar group and 360 patients (10.0%) in the placebo group (hazard ratio, 0.96 [95% CI, 0.83-1.11]; P = .57). Rates of serious adverse events, including heart failure (3.4% for aleglitazar vs 2.8% for placebo, P = .14), gastrointestinal hemorrhages (2.4% for aleglitazar vs 1.7% for placebo, P = .03), and renal dysfunction (7.4% for aleglitazar vs 2.7% for placebo, P Conclusions and Relevance Among patients with type 2 diabetes and recent ACS, use of aleglitazar did not reduce the risk of cardiovascular outcomes. These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk. Trial Registration clinicaltrials.gov Identifier:NCT01042769

192 citations


Journal ArticleDOI
TL;DR: Systolic blood pressure variability seems to predict a poor outcome in patients with acute intracerebral haemorrhage, and the benefits of early treatment to reduce systolics blood pressure to 140 mm Hg might be enhanced by smooth and sustained control, and particularly by avoiding peaks in systolicBlood pressure.
Abstract: Summary Background High blood pressure is a prognostic factor for acute stroke, but blood pressure variability might also independently predict outcome. We assessed the prognostic value of blood pressure variability in participants of INTERACT2, an open-label randomised controlled trial (ClinicalTrials.gov number NCT00716079). Methods INTERACT2 enrolled 2839 adults with spontaneous intracerebral haemorrhage (ICH) and high systolic blood pressure (150–220 mm Hg) without a definite indication or contraindication to early intensive treatment to reduce blood pressure. Participants were randomly assigned to intensive treatment (target systolic blood pressure Findings We studied 2645 (93·2%) participants in the hyperacute phase and 2347 (82·7%) in the acute phase. In both treatment cohorts combined, SD of systolic blood pressure had a significant linear association with the primary outcome for both the hyperacute phase (highest quintile adjusted OR 1·41, 95% CI 1·05–1·90; p trend =0·0167) and the acute phase (highest quintile adjusted OR 1·57, 95% CI 1·14–2·17; p trend =0·0124). The strongest predictors of outcome were maximum systolic blood pressure in the hyperacute phase and SD of systolic blood pressure in the acute phase. Associations were similar for the secondary outcome (for the hyperacute phase, highest quintile adjusted OR 1·43, 95% CI 1·14–1·80; p trend =0·0014; for the acute phase OR 1·46, 95% CI 1·13–1·88; p trend =0·0044). Interpretation Systolic blood pressure variability seems to predict a poor outcome in patients with acute intracerebral haemorrhage. The benefits of early treatment to reduce systolic blood pressure to 140 mm Hg might be enhanced by smooth and sustained control, and particularly by avoiding peaks in systolic blood pressure. Funding National Health and Medical Research Council of Australia.

186 citations


Journal ArticleDOI
TL;DR: A mobile phone app that would provide consumers with easy-to-understand nutrition information and support the selection of healthier choices when shopping for food is developed and downloaded by about 400,000 users in the first 18 months.
Abstract: Background: Front-of-pack nutrition labeling (FoPL) schemes can help consumers understand the nutritional content of foods and may aid healthier food choices. However, most packaged foods in Australia carry no easily interpretable FoPL, and no standard FoPL system has yet been mandated. About two thirds of Australians now own a smartphone. Objective: We sought to develop a mobile phone app that would provide consumers with easy-to-understand nutrition information and support the selection of healthier choices when shopping for food. Methods: An existing branded food database including 17,000 Australian packaged foods underpinned the project. An iterative process of development, review, and testing was undertaken to define a user interface that could deliver nutritional information. A parallel process identified the best approach to rank foods based on nutritional content, so that healthier alternative products could be recommended. Results: Barcode scanning technology was identified as the optimal mechanism for interaction of the mobile phone with the food database. Traffic light labels were chosen as the preferred format for presenting nutritional information, and the Food Standards Australia New Zealand nutrient profiling method as the best strategy for identifying healthier products. The resulting FoodSwitch mobile phone app was launched in Australia in January 2012 and was downloaded by about 400,000 users in the first 18 months. FoodSwitch has maintained a 4-plus star rating, and more than 2000 users have provided feedback about the functionality. Nutritional information for more than 30,000 additional products has been obtained from users through a crowdsourcing function integrated within the app. Conclusions: FoodSwitch has empowered Australian consumers seeking to make better food choices. In parallel, the huge volume of crowdsourced data has provided a novel means for low-cost, real-time tracking of the nutritional composition of Australian foods. There appears to be significant opportunity for this approach in many other countries. [JMIR Mhealth Uhealth 2014;2(3):e37]

170 citations


Journal ArticleDOI
TL;DR: Physician review of verbal autopsy questionnaires is less accurate than automated methods in determining both individual and population causes of death and Tariff performs as well or better than other methods and should be widely applied in routine mortality surveillance systems with poor cause of death certification practices.
Abstract: Monitoring progress with disease and injury reduction in many populations will require widespread use of verbal autopsy (VA). Multiple methods have been developed for assigning cause of death from a VA but their application is restricted by uncertainty about their reliability. We investigated the validity of five automated VA methods for assigning cause of death: InterVA-4, Random Forest (RF), Simplified Symptom Pattern (SSP), Tariff method (Tariff), and King-Lu (KL), in addition to physician review of VA forms (PCVA), based on 12,535 cases from diverse populations for which the true cause of death had been reliably established. For adults, children, neonates and stillbirths, performance was assessed separately for individuals using sensitivity, specificity, Kappa, and chance-corrected concordance (CCC) and for populations using cause specific mortality fraction (CSMF) accuracy, with and without additional diagnostic information from prior contact with health services. A total of 500 train-test splits were used to ensure that results are robust to variation in the underlying cause of death distribution. Three automated diagnostic methods, Tariff, SSP, and RF, but not InterVA-4, performed better than physician review in all age groups, study sites, and for the majority of causes of death studied. For adults, CSMF accuracy ranged from 0.764 to 0.770, compared with 0.680 for PCVA and 0.625 for InterVA; CCC varied from 49.2% to 54.1%, compared with 42.2% for PCVA, and 23.8% for InterVA. For children, CSMF accuracy was 0.783 for Tariff, 0.678 for PCVA, and 0.520 for InterVA; CCC was 52.5% for Tariff, 44.5% for PCVA, and 30.3% for InterVA. For neonates, CSMF accuracy was 0.817 for Tariff, 0.719 for PCVA, and 0.629 for InterVA; CCC varied from 47.3% to 50.3% for the three automated methods, 29.3% for PCVA, and 19.4% for InterVA. The method with the highest sensitivity for a specific cause varied by cause. Physician review of verbal autopsy questionnaires is less accurate than automated methods in determining both individual and population causes of death. Overall, Tariff performs as well or better than other methods and should be widely applied in routine mortality surveillance systems with poor cause of death certification practices.

146 citations



Journal ArticleDOI
01 Jan 2014-BMJ Open
TL;DR: In countries where salt is pervasive and cannot easily be avoided, estimates of consumption obtained from volunteer samples may be valid and less costly.
Abstract: Objective The gold standard method for measuring population sodium intake is based on a 24 h urine collection carried out in a random population sample. However, because participant burden is high, response rates are typically low with less than one in four agreeing to provide specimens. At this low level of response it is possible that simply asking for volunteers would produce the same results. Setting Lithgow, New South Wales, Australia. Participants We randomly selected 2152 adults and obtained usable 24 h urine samples from 306 (response rate 16%). Specimens were also collected from a further 113 volunteers. Estimated salt consumption and the costs for each strategy were compared. Results The characteristics of the ‘random’ and ‘volunteer’ samples were moderately different in mean age 58 (SD 14.6 vs 49(17.7) years, respectively; p Conclusions The estimated salt consumption derived from the two samples was comparable and was not substantively different to estimates obtained from other surveys. In countries where salt is pervasive and cannot easily be avoided, estimates of consumption obtained from volunteer samples may be valid and less costly.

85 citations


Journal ArticleDOI
TL;DR: In patients with type 2 diabetes, moderate alcohol use, particularly wine consumption, is associated with reduced risks of cardiovascular events and all-cause mortality.
Abstract: OBJECTIVE Moderate alcohol consumption has been associated with a reduced risk of mortality and coronary artery disease. The relationship between cardiovascular health and alcohol use in type 2 diabetes is less clear. The current study assesses the effects of alcohol use among participants in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation (ADVANCE) trial. RESEARCH DESIGN AND METHODS The effects of alcohol use were explored using Cox regression models, adjusted for potential confounders. The study end points were cardiovascular events (cardiovascular death, myocardial infarction, and stroke), microvascular complications (new or worsening nephropathy or retinopathy), and all-cause mortality. RESULTS During a median of 5 years of follow-up, 1,031 (9%) patients died, 1,147 (10%) experienced a cardiovascular event, and 1,136 (10%) experienced a microvascular complication. Compared with patients who reported no alcohol consumption, those who reported moderate consumption had fewer cardiovascular events (adjusted hazard ratio [aHR] 0.83; 95% CI 0.72–0.95; P = 0.008), less microvascular complications (aHR 0.85; 95% CI 0.73–0.99; P = 0.03), and lower all-cause mortality (aHR 0.87; 96% CI 0.75–1.00; P = 0.05). The benefits were particularly evident in participants who drank predominantly wine (cardiovascular events aHR 0.78, 95% CI 0.63–0.95, P = 0.01; all-cause mortality aHR 0.77, 95% CI 0.62–0.95, P = 0.02). Compared with patients who reported no alcohol consumption, those who reported heavy consumption had dose-dependent higher risks of cardiovascular events and all-cause mortality. CONCLUSION In patients with type 2 diabetes, moderate alcohol use, particularly wine consumption, is associated with reduced risks of cardiovascular events and all-cause mortality.

75 citations


Journal ArticleDOI
TL;DR: Data show that the Australian food industry can reduce salt levels of processed foods and provide a strong case for broadening and strengthening of the Food and Health Dialogue (FHD) process.
Abstract: The Australian Food and Health Dialogue set sodium reduction targets for three food categories (breads, ready-to-eat breakfast cereals and processed meats) to be achieved by December, 2013. Sodium levels for 1849 relevant packaged foods on the shelves of Australian supermarkets between 2010 and 2013 were examined. Changes in mean sodium content were assessed by linear mixed models, and the significance of differences in the proportion of products meeting targets was determined using chi-squared or McNemar’s tests. The mean sodium level of bread products fell from 454 to 415 mg/100 g (9% lower, p < 0.001), and the proportion reaching target rose from 42% to 67% (p < 0.005). The mean sodium content of breakfast cereals also fell substantially from 316 to 237 mg/100 g (25% lower, p < 0.001) over the study period. The decline in mean sodium content of bacon/ham/cured meats from 1215 to 1114 mg/100 g (8% lower, p = 0.001) was smaller, but associated with a rise in the proportion meeting the target from 28% to 47%. Declines in mean sodium content did not appreciably differ between companies that did and did not make public commitments to the targets. These data show that the Australian food industry can reduce salt levels of processed foods and provide a strong case for broadening and strengthening of the Food and Health Dialogue (FHD) process.


Journal ArticleDOI
TL;DR: NT-proBNP and hs-cTnT appear to greatly improve the accuracy with which the risk of cardiovascular events or death can be estimated in patients with type 2 diabetes.
Abstract: OBJECTIVE Current methods of risk stratification in patients with type 2 diabetes are suboptimal. The current study assesses the ability of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin T (hs-cTnT) to improve the prediction of cardiovascular events and death in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A nested case-cohort study was performed in 3,862 patients who participated in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. RESULTS Seven hundred nine (18%) patients experienced a major cardiovascular event (composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and 706 (18%) died during a median of 5 years of follow-up. In Cox regression models, adjusting for all established risk predictors, the hazard ratio for cardiovascular events for NT-proBNP was 1.95 per 1 SD increase (95% CI 1.72, 2.20) and the hazard ratio for hs-cTnT was 1.50 per 1 SD increase (95% CI 1.36, 1.65). The hazard ratios for death were 1.97 (95% CI 1.73, 2.24) and 1.52 (95% CI 1.37, 1.67), respectively. The addition of either marker improved 5-year risk classification for cardiovascular events (net reclassification index in continuous model, 39% for NT-proBNP and 46% for hs-cTnT). Likewise, both markers greatly improved the accuracy with which the 5-year risk of death was predicted. The combination of both markers provided optimal risk discrimination. CONCLUSIONS NT-proBNP and hs-cTnT appear to greatly improve the accuracy with which the risk of cardiovascular events or death can be estimated in patients with type 2 diabetes.

Journal ArticleDOI
TL;DR: In this article, a single 24-hour urine sample and a questionnaire describing knowledge, attitudes and behaviours was obtained from 306 randomly selected participants and 113 volunteers from a regional town in Australia.
Abstract: Salt reduction efforts usually have a strong focus on consumer education. Understanding the association between salt consumption levels and knowledge, attitudes and behaviours towards salt should provide insight into the likely effectiveness of education-based programs. A single 24-hour urine sample and a questionnaire describing knowledge, attitudes and behaviours was obtained from 306 randomly selected participants and 113 volunteers from a regional town in Australia. Mean age of all participants was 55 years (range 20–88), 55% were women and mean 24-hour urinary salt excretion was 8.8(3.6) g/d. There was no difference in salt excretion between the randomly selected and volunteer sample. Virtually all participants (95%) identified that a diet high in salt can cause serious health problems with the majority of participants (81%) linking a high salt diet to raised blood pressure. There was no difference in salt excretion between those who did 8.7(2.1) g/d and did not 7.5(3.3) g/d identify that a diet high in salt causes high blood pressure (p = 0.1). Nor was there a difference between individuals who believed they consumed “too much” 8.9(3.3) g/d “just the right amount” 8.4(2.6) g/d or “too little salt” 9.1(3.7) g/d (p = 0.2). Likewise, individuals who indicated that lowering their salt intake was important 8.5(2.9) g/d vs. not important 8.8(2.4) g/d did not have different consumption levels (p = 0.4). The absence of a clear association between knowledge, attitudes and behaviours towards salt and actual salt consumption suggests that interventions focused on knowledge, attitudes and behaviours alone may be of limited efficacy.

Journal ArticleDOI
TL;DR: Evaluated whether the Food and Health Dialogue, established by the Australian Government in 2009, is having an impact on reducing premature death and disability caused by poor diet in Australia.
Abstract: Objective To evaluate whether the Food and Health Dialogue (the Dialogue), established by the Australian Government in 2009, is having an impact on reducing premature death and disability caused by poor diet in Australia. Design and setting We used information derived from the Dialogue website, media releases, communiques and e-newsletters to evaluate the Dialogue's achievements from October 2009 to September 2013, using the RE-AIM (reach, efficacy, adoption, implementation and maintenance) framework. Data describing the processed foods marketed in Australia were extracted from an existing food composition database. Main outcome measures Achievements of the Dialogue (goals, targets, actions and health outcomes). Results The primary goal of the Dialogue was identified as "raising the nutritional profile of foods" to be achieved "through reformulation, consumer education and portion standardisation". Employing a public-private partnership model, the Dialogue has established a framework for collaboration between government, public health groups and industry. In the first 4 years, targets were set for 11 (8.9%) of a total of 124 possible action areas for food reformulation and portion standardisation. None were yet due to have been achieved. There was no evidence that any education programs had been implemented by the Dialogue. There are no indicators of the extent to which population exposure to target nutrients has changed or whether any positive or negative health impacts have ensued. Conclusions The Dialogue has highly creditable goals but the mechanism for delivering on them has proved inadequate. Explicit processes and the outcomes to be delivered within defined timelines are required, along with a clear plan for remediation if they are not achieved.

Journal ArticleDOI
TL;DR: The rationale and methods for a randomized controlled trial designed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices and secondary prevention of CVD are outlined.
Abstract: Cardiovascular disease (CVD) is the leading cause of early death worldwide, responsible for an estimated 29% of all global deaths. Reducing salt intake lowers blood pressure and risk of secondary cardiac events. However, identifying low salt foods can be challenging. SaltSwitch is a simple smartphone application (app) that enables shoppers to scan the barcode of packaged foods and receive an immediate, interpretive, traffic light nutrition label on the screen, along with suggestions for healthier lower-salt alternatives. A growing body of evidence suggests mobile technologies can support healthy behaviour change. However, robust evidence for the impact of smartphone interventions is lacking. This manuscript outlines the rationale and methods for a randomized controlled trial designed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices. A 6-week, two-arm, parallel, randomized controlled trial is being undertaken in New Zealand (2 weeks baseline and 4 weeks intervention). Three hundred adults aged 40 years and older with CVD and their main household shoppers are recruited from research lists, cardiac rehabilitation clinics, and communities in Auckland. Participants are randomized to receive either the SaltSwitch smartphone app or no intervention (control). Randomisation is stratified by ethnicity and age. The primary outcome is the salt content of household food purchases. Secondary outcomes are the saturated fat and energy content of household food purchases, household food expenditure, use and acceptability of the SaltSwitch app by shoppers, and urinary sodium and blood pressure of participants with CVD. Ambulatory blood pressure and potential longer-term impact (12 weeks) of SaltSwitch will be assessed in sub-studies (n ~ 40 and n ~ 20, respectively). Household purchases of salt and other nutrients will be assessed using till receipt data electronically linked with branded food composition data. The results of the SaltSwitch trial will determine the effectiveness, use and acceptability of a smartphone application to support lower salt food choices and secondary prevention of CVD. ACTRN12614000206628 . Registered 30 March 2014.

Journal ArticleDOI
TL;DR: Reducing dietary sodium decreases BP in adults and children,[1] with a linear relationship down to the lowest levels of sodium intake tested in randomized controlled trials (about 1200 mg/d of sodium).
Abstract: Extensive research supports the harmful effects of high dietary sodium.[1-11] In several animal species, including chimpanzees, diets with added sodium result in increased blood pressure (BP), and, in all settings, sodium-induced hypertension is harmful.[12] Further, in several animal models, increased dietary sodium directly causes inflammation and vascular, cardiac, and renal target organ damage independent of BP.[1, 13] Increased dietary sodium is a procarcinogen for gastric cancer in animal studies and a probable procarcinogen in humans, as shown in epidemiological studies that have found close associations between sodium intake and gastric cancer.[14, 15] Reducing dietary sodium decreases BP in adults and children,[1] with a linear relationship down to the lowest levels of sodium intake tested in randomized controlled trials (about 1200 mg/d of sodium). Increased dietary sodium is also associated with increased vascular events in healthy populations and was estimated to cause more than 3 million sodium-related deaths in 2010 (http://viz.healthmetricsandevaluation.org/gbd-compare/). Reducing dietary sodium is projected to be one of the most effective (and cost-effective) interventions to improve health.[16] Major health and scientific organizations around the world have recommended that dietary sodium levels be reduced.

Journal ArticleDOI
TL;DR: There is a need for standardisation of the sample collection, transportation, storage and analysis methods before the technique can be considered mainstream, and HbA1c and selected blood lipids associations are clearly associated with standard venous samples.
Abstract: Levels of haemoglobin A1c (HbA1c) and blood lipids are important determinants of risk in patients with diabetes. Standard analysis methods based upon venous blood samples can be logistically challenging in resource-poor settings where much of the diabetes epidemic is occurring. Dried blood spots (DBS) provide a simple alternative method for sample collection but the comparability of data from analyses based on DBS is not well established. We conducted a systematic review and meta-analysis to define the association of findings for HbA1c and blood lipids for analyses based upon standard methods compared to DBS. The Cochrane, Embase and Medline databases were searched for relevant reports and summary regression lines were estimated. 705 abstracts were found by the initial electronic search with 6 further reports identified by manual review of the full papers. 16 studies provided data for one or more outcomes of interest. There was a close agreement between the results for HbA1c assays based on venous and DBS samples (DBS = 0.9858venous + 0.3809), except for assays based upon affinity chromatography. Significant adjustment was required for assays of total cholesterol (DBS = 0.6807venous + 1.151) but results for triglycerides (DBS = 0.9557venous + 0.1427) were directly comparable. For HbA1c and selected blood lipids, assays based on DBS samples are clearly associated with assays based on standard venous samples. There are, however, significant uncertainties about the nature of these associations and there is a need for standardisation of the sample collection, transportation, storage and analysis methods before the technique can be considered mainstream. This should be a research priority because better elucidation of metabolic risks in resource poor settings, where venous sampling is infeasible, will be key to addressing the global epidemic of cardiovascular diseases.

Journal ArticleDOI
TL;DR: The social gradients in cigarette smoking and level of consumption contrasted those for indigenous forms of tobacco (bidi smoking and chewing) and international prevention and cessation initiatives designed at modifying Western-style cigarette usage will need to be tailored to the social context of rural Andhra Pradesh to effectively influence the use of cigarettes.
Abstract: BackgroundTobacco use is common in India and a majority of users are in rural areas. We examine tobacco use and smoking quit rates along gender and socioeconomic dimensions in rural Andhra Pradesh.Design and methodsData come from a cross-sectional survey. Markers of socioeconomic status (SES) were education, occupation, and income. Regression analyses were undertaken to examine determinants of current smoking, smoking quit rates, tobacco use by type (cigarettes, bidis, and chewing), and quantity consumed (number per day, pack-years).ResultsThe weighted prevalence of current smoking and tobacco chewing was higher in men (50.3%, 95% confidence interval, CI, 48.1–52.6 and 5.0%, 95% CI 4.1–5.9, respectively) compared with women (4.8%, 95% CI 3.9–5.7 and 1.0%, 95% CI 0.6–1.4, respectively) and higher among older age groups. The quit rate was higher in women (45.5%, 95% CI 38.7–52.2) compared to men (18.8%, 95% CI 16.7–20.9). Illiterate individuals were more likely to be current smokers of any type compared to ...

Journal ArticleDOI
TL;DR: There is little evidence that all Australian manufacturers of pasta sauces systematically reduced the Na content of their products between 2008 and 2011, and even if all manufacturers achieve the current voluntary commitment by 2014, average salt levels in Australian products would still be above the 2012 UK target.
Abstract: Objective To assess the change in Na content of Australian pasta sauces between 2008 and 2011. A secondary objective was to project the mean Na content of these same products in 2014 using the Australian Food and Health Dialogue Na commitment and compare projections with the 2012 UK Na target for pasta sauce. Design Na data were collected from the product labels of pasta sauce products. Mean Na content was calculated for 2008 and 2011 and change assessed. Projected mean values for 2014 were derived by applying a 15 % reduction to the 2011 products above the ‘action point’ of 420 mg Na/100 g, consistent with the Food and Health Dialogue commitment (scenario 1). A 15 % reduction was applied to products already below the ‘action point’ (scenario 2). Projections were compared with the 2012 UK target. Setting Na data for pasta sauce products in Australian supermarkets (July–September) in 2008 and 2011. Subjects Not applicable. Results Data were available for 124 (2008) and 187 (2011) products, and mean Na levels were not significantly different (451 mg/100 g v . 423 mg/100 g; P = 0·16). The projected means (381 mg Na/100 g in scenario 1; 375 mg Na/100 g in scenario 2) exceeded the 2012 UK target (330 mg Na/100 g) and to attain this would require a 22 % reduction from 2011 levels. Conclusions There is little evidence that all Australian manufacturers of pasta sauces systematically reduced the Na content of their products between 2008 and 2011. Even if all manufacturers achieve the current voluntary commitment by 2014, average salt levels in Australian products would still be above the 2012 UK target.

Journal ArticleDOI
TL;DR: The study described by this protocol will be the first to provide a robust assessment of salt intake and the impact of salt reduction interventions in the Pacific Islands and inform the development of strategies for other Pacific Island countries and comparable low and middle-income settings around the world.
Abstract: There is broad consensus that diets high in salt are bad for health and that reducing salt intake is a cost-effective strategy for preventing chronic diseases. The World Health Organization has been supporting the development of salt reduction strategies in the Pacific Islands where salt intakes are thought to be high. However, there are no accurate measures of salt intake in these countries. The aims of this project are to establish baseline levels of salt intake in two Pacific Island countries, implement multi-pronged, cross-sectoral salt reduction programs in both, and determine the effects and cost-effectiveness of the intervention strategies.

Journal ArticleDOI
TL;DR: This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease and is expected to provide important information to guide policy making for rural China as well as other resource-limited countries.
Abstract: Background The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.

Journal ArticleDOI
TL;DR: The Starlight randomised, controlled trial will determine the effects of interpretive front-of-pack nutrition labels on the healthiness of consumer food purchases in the real world.
Abstract: Background: Interpretive front-of-pack nutrition labels are better understood than non-interpretive labels. However, robust evidence on the effects of such labels on consumer food purchases in the real-world is lacking. Our aim is to assess the effects of two interpretive front-of-pack nutrition labels, compared with a non-interpretive label, on the healthiness of consumer food purchases. Methods/Design: A five-week (1-week baseline and 4-week intervention) three-arm parallel randomised controlled trial will be conducted using a bespoke smartphone application, which will administer study questionnaires and deliver intervention (Multiple Traffic Light and Health Star Rating) and control (Nutrition Information Panel) labels. To view their allocated nutrition label, participants scan the barcode of packaged food products using their smartphone camera. The assigned label is displayed instantly on the smartphone screen.1500 eligible participants (New Zealand adult smartphone owners who shop in a supermarket at least once a week and are main household shoppers) will be randomised in a 1:1:1 ratio to one of the three nutrition label formats, using computer-generated randomisation sequences. Randomisation will be stratified by ethnicity and interest in healthy eating. Food and beverage purchase data will be collected continuously throughout the study via hard copy till receipts and electronic grocery purchase lists recorded and transmitted using the smartphone application. The primary outcome will be healthiness of food purchases in each trial arm, assessed as mean Food Standards Australia New Zealand nutrient profiling score criterion score for all food and beverages purchased over the intervention period. Secondary outcomes will include saturated fat, sugar, sodium and energy content of food purchases; food expenditure; labelling profile of food purchases (i.e. mean number of Health Star Rating stars and proportion of red, green and amber traffic lights); nutrient profiling score over time and by food categories; purchases of unpackaged foods; self-reported nutrition knowledge and recorded use of assigned labelling system. Discussion: The Starlight randomised, controlled trial will determine the effects of interpretive front-of-pack nutrition labels on the healthiness of consumer food purchases in the real world.

Journal ArticleDOI
TL;DR: To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk.
Abstract: Objective: To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk. Design: A within-trial cost analysis of polypill-based care versus usual care with separate medications, using data from the Kanyini Guidelines Adherence with the Polypill (GAP) trial and linked health service and medication administrative claims data. Participants: Kanyini GAP participants who consented to Australian Medicare record access. Main outcome measures: Mean health service and pharmaceutical expenditure per patient per year, estimated with generalised linear models. Costs during the trial (randomisation January 2010 – May 2012, median follow-up 19 months, maximum follow-up 36 months) were inflated to 2012 costs. Results: Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $989 (95% CI, $648–$1331) per patient per year in the polypill arm compared with usual care (P Conclusions: This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy. The savings will be less now than during the trial due to subsequent reductions in the costs of usual care. Nonetheless, given the prevalence of CVD in Australia, the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia.

Journal ArticleDOI
TL;DR: Assessment of the impact of the Drop the Salt! campaign on government policy indicated that the AWASH campaign increased the priority of salt reduction on the government's agenda, but a coordinated government strategy on salt reduction is still required to ensure that the potential health benefits are fully realised.
Abstract: Objective In 2007 the Australian Division of World Action on Salt and Health (AWASH) launched a campaign to encourage the Australian government to take action to reduce population salt intake. The objective of the present research was to assess the impact of the Drop the Salt! campaign on government policy. Design A review of government activities related to salt reduction was conducted and an advocacy strategy implemented to increase government action on salt. Advocacy actions were documented and the resulting outcomes identified. An analysis of stakeholder views on the effectiveness of the advocacy strategy was also undertaken. Settings Advocacy activities were coordinated through AWASH at the George Institute for Global Health in Sydney. Subjects All relevant State and Federal government statements and actions were reviewed and thirteen stakeholders with known interests or responsibilities regarding dietary salt, including food industry, government and health organisations, were interviewed. Results Stakeholder analysis affirmed that AWASH influenced the government's agenda on salt reduction and four key outputs were attributed to the campaign: (i) the Food Regulation Standing Committee discussions on salt, (ii) the Food and Health Dialogue salt targets, (iii) National Health and Medical Research Council partnership funding and (iv) the New South Wales Premier's Forum on Fast Foods. Conclusions While it is not possible to definitively attribute changes in government policy to one organisation, stakeholder research indicated that the AWASH campaign increased the priority of salt reduction on the government's agenda. However, a coordinated government strategy on salt reduction is still required to ensure that the potential health benefits are fully realised.

Journal ArticleDOI
TL;DR: The present analysis provided no evidence of an increase in recurrent stroke associated with larger reductions in SBP produced by treatment among patients with cerebrovascular disease.
Abstract: Objective There is ongoing controversy regarding a ‘J-curve’ phenomenon such that low and high blood pressure (BP) levels are associated with increased risks of recurrent stroke. We aimed to determine whether large treatment-related BP reductions are associated with increased risks of recurrent stroke. Design Data are from the PROGRESS trial, where 6105 patients with cerebrovascular disease were randomly assigned to either active treatment (perindopril±indapamide) or placebo(s). There were no BP criteria for entry. BP was measured at every visit, and participant groups defined by reduction in systolic BP (SBP) from baseline were used for the analyses. Outcome was recurrent stroke. Results During a mean follow-up of 3.9 years, 727 recurrent strokes were observed. There were clear associations between the magnitude of SBP reduction and the risk of recurrent stroke. After adjustment for cardiovascular risk factors and randomised treatment, annual incidence was 2.08%, 2.10%, 2.31% and 2.96% for participant groups defined by SBP reductions of ≥20, 10–19, 0–9 and Conclusions The present analysis provided no evidence of an increase in recurrent stroke associated with larger reductions in SBP produced by treatment among patients with cerebrovascular disease.

Journal ArticleDOI
TL;DR: The changes in sodium levels of Australian fast foods between 2009 and 2012 overall, in major food subcategories and by company are defined.
Abstract: Fast foods have become lower in salt at the rate of about two to three percent per year, according to this four-year study of six Australian fast food chains. Introduction: The burden of ill health attributable to obesity, type 2 diabetes and other diet-related health risks is increasing in both developed and developing countries. Fast foods, which are convenient, quick and cheap, are generally nutrient-poor and eaten in large portions that can contribute significantly to energy, fat, sugar and sodium intake. Links between fast-food consumption and a range of chronic diseases have been made, with excess dietary sodium causing high blood pressure and a range of vascular diseases. Although there is no current definitive estimate of population dietary salt intake in Australia, it is widely accepted that average consumption is well above the government’s suggested dietary target of 4 g/day. About three-quarters of salt in the diet comes from processed and restaurant foods,with fast foods known to be a significant contributor in Western populations. In Australia, expenditure on fast foods has risen substantially over recent years and there is evidence that children who are exposed to unhealthy dietary patterns carry these behaviours into adulthood.The Australian Government’s 2009 National Preventative Health Strategy - the roadmap for action identified the need to improve the healthiness of fast foods in Australia, and the Food and Health Dialogue has commenced a food reformulation program. Neither, however, has set targets for fast foods, although some companies and non-government organisations have been working to lower salt levels in these products.These efforts have been informed by data that systematically describe the salt levels in Australian fast foods and how they compare with those in other countries. The primary objective of this study was to determine whether there have been any changes in the sodium content of leading Australian fast-food products in the 4 years from 2009 to 2012.

Journal ArticleDOI
01 Oct 2014-BMJ Open
TL;DR: The findings from this research will be synthesised and proposals for a national salt reduction strategy for India will be developed in collaboration with key stakeholders.
Abstract: Introduction The scientific evidence base in support of salt reduction is strong but the data required to translate these insights into reduced population salt intake are mostly absent The aim of this research project is to develop the evidence base required to formulate and implement a national salt reduction programme for India Methods and analysis The research will comprise three components: a stakeholder analysis involving government, industry, consumers and civil society organisations; a population survey using an age-stratified and sex-stratified random samples drawn from urban (slum and non-slum) and rural areas of North and South India; and a systematic quantitative evaluation of the nutritional components of processed and restaurant foods The stakeholder interviews will be analysed using qualitative methods to summarise the main themes and define the broad range of factors influencing the food environment in India The population survey will estimate the mean daily salt consumption through the collection of 24 h urine samples with concurrent dietary surveys identifying the main sources of dietary sodium/salt The survey of foods will record the nutritional composition of the chief elements of food supply The findings from this research will be synthesised and proposals for a national salt reduction strategy for India will be developed in collaboration with key stakeholders Ethics and dissemination This study has been approved by the Human Research Ethics Committees of the University of Sydney and the Centre for Chronic Disease Control in New Delhi, and also by the Indian Health Ministry9s Screening Committee The project began fieldwork in February 2014 and will report the main results in 2016 The findings will be targeted primarily at public health policymakers and advocates, but will be disseminated widely through other mechanisms including conference presentations and peer-reviewed publications, as well as to the participating communities

01 Jan 2014
TL;DR: The absence of a clear association between knowledge, attitude and behaviours towards salt and actual salt consumption suggests that interventions focused on knowledge, attitudes and behaviours alone may be of limited efficacy.
Abstract: Aim: Salt reduction efforts usually have a strong focus on consumer education. Understanding the association between salt consumption levels and knowledge, attitudes and behaviours towards salt should provide insight into the likely effectiveness of education-based programs.