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1.  Assessment of vitamin D and its association with cardiovascular disease risk factors in an adult migrant population: an audit of patient records at a Community Health Centre in Kensington, Melbourne, Australia 
Vitamin D deficiency is a global public health problem associated with increased risk of cardio-metabolic diseases and osteoarthritis. Migrants with dark skin settled in temperate climates are at greater risk of both vitamin D deficiency and cardiovascular diseases. This study aims to identify the risk of vitamin D deficiency and associations with cardiovascular disease in a migrant population in Australia.
An audit was carried out at a Community Health Service in Kensington, Melbourne which, services a large migrant population. Data from the clinical records of all adults who visited the medical centre at least once during the period from 1st January 2010 to 31st December 2012 was extracted. The future (10 year) coronary heart disease risk was estimated using Framingham Risk Score.
The centre has given higher priority to vitamin D testing in migrants, those middle-aged, females and those with diabetes and osteoarthritis. Migrants from countries located in lower latitude regions (Latitude N230 to S230) were 1.48 (95% C.I. 1.32-1.65) times more likely to develop vitamin D deficiency post migration and 0.44 (95% C.I. 0.31-0.62) times less likely to have a >15% 10-year risk of coronary heart disease when compared to their Australian-born counterparts.
Adherence to a high risk strategy for vitamin D testing was observed in the centre. Pre-migration latitude is an important factor for vitamin D deficiency (lower the latitude higher the risk) and in predicting future risk of cardiovascular disease in migrants. These findings suggest that a targeted approach for vitamin D testing, including zone of origin might better identify individuals at higher risk of both vitamin D deficiency and cardiovascular disease.
PMCID: PMC4233056  PMID: 25387481
Vitamin D deficiency; Migrants; Cardiovascular diseases; Framingham 10 year risk score
2.  Effect of dietary prebiotic supplementation on advanced glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes: a study protocol for a double-blind placebo-controlled randomised crossover clinical trial 
Advanced glycation endproducts (AGEs) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes. Since AGEs are generated within foodstuffs upon food processing, it is increasingly recognised that the modern diet is replete with AGEs. AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance. Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals. Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host, but its effect on advanced glycation is unknown. The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12 week consumption of a prebiotic dietary supplement on the advanced glycation pathway, insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes.
Thirty adults with pre-diabetes (Impaired Glucose Tolerance or Impaired Fasting Glucose) aged between 40–60 years will be randomly assigned to receive either 10 grams of prebiotic (inulin/oligofructose) daily or 10 grams placebo (maltodextrin) daily for 12 weeks. After a 2-week washout period, study subjects will crossover to receive the alternative dietary treatment for 12 weeks. The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine (CML) and methylglyoxal (MG) between experimental and control treatments. Secondary outcomes include HbA1c, insulin sensitivity, lipid levels, blood pressure, serum glutathione, adiponectin, IL-6, E-selectin, myeloperoxidase, C-reactive protein, Toll-like Receptor 4 (TLR4), soluble receptor for AGE (sRAGE), urinary 8-isoprostanes, faecal bacterial composition and short chain fatty acid profile. Anthropometric measures including BMI and waist circumference will be collected in addition to comprehensive dietary and lifestyle data.
Prebiotics which selectively stimulate the growth of beneficial bacteria in the human colon might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes.
Trial registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12613000130763.
PMCID: PMC4099169  PMID: 25011647
Advanced glycation end products; Maillard reaction; Prebiotics; Gut microbiota; Type 2 diabetes mellitus; Insulin resistance; Inflammation
3.  The Heart of the Matter: Health Status of Aged Care Clients Receiving Home- and Community-Based Care 
Journal of Aging Research  2010;2010:275303.
Objective. To determine the current health status of home based elderly clients receiving government funded aged care packages. Design. Prospective Observational study. Setting. Community based, home care program in Australia. Participants. Community-dwelling older adults receiving aged care packages. Measurements. A comprehensive test battery of physical, mental and social scales were completed including a Caregiver Strain Index where appropriate. Results. 37% of the 334 subjects were male and the mean age was 81 ± 8 years. Physical functioning was low compared to the Australian population. Depression was highly prevalent with 15.9% severely depressed and 38.7% mildly depressed. 26% of clients screened positive for dementia. Relatively good levels of social support were reported, however social networking activity levels were low. Sixty one percent of clients had caregivers, of whom 63.3% had high levels of strain. Strain was higher in caregivers of clients on higher levels of care (78.5% versus 50.6% highly strained). Conclusion. The data suggests that as a group there is a high degree of comorbidity, and depression, dementia and caregiver strain are highly prevalent. The findings may aid administrators and health policy planners in directing resources to key areas impacting on health outcomes in this group.
PMCID: PMC2989748  PMID: 21152197
4.  Predictors of Mean Arterial Pressure Morning Rate of Rise and Power Function in Subjects Undergoing Ambulatory Blood Pressure Recording 
PLoS ONE  2014;9(3):e93186.
We determined clinical predictors of the rate of rise (RoR) in blood pressure in the morning as well as a novel measure of the power of the BP surge (BPpower) derived from ambulatory blood pressure recordings.
BPpower and RoR were calculated from 409 ambulatory blood pressure (ABP) recordings from subjects attending a cardiovascular risk clinic. Anthropometric data, blood biochemistry, and history were recorded. The 409 subjects were 20–82 years old (average 57, SD = 13), 46% male, 9% with hypertension but not on medication and 34% on antihypertensive medication.
Average RoR was 11.1 mmHg/hour (SD = 8) and BPpower was 273 mmHg2/hour (SD = 235). Only cholesterol, low density lipoprotein and body mass index (BMI) were associated with higher BPpower and RoR (P<0.05) from 25 variables assessed. BPpower was lower in those taking beta-blockers or diuretics. Multivariate analysis identified that only BMI was associated with RoR (4.2% increase/unit BMI, P = 0.020) while cholesterol was the only remaining associated variable with BPpower (17.5% increase/mmol/L cholesterol, P = 0.047). A follow up of 213 subjects with repeated ABP after an average 1.8 years identified that baseline cholesterol was the only predictor for an increasing RoR and BPpower (P<0.05). 37 patients who commenced statin subsequently had lower BPpower whereas 90 age and weight matched controls had similar BPpower on follow-up.
Cholesterol is an independent predictor of a greater and more rapid rise in morning BP as well as of further increases over several years. Reduction of cholesterol with statin therapy is very effective in reducing the morning blood pressure surge.
PMCID: PMC3965554  PMID: 24667944
5.  Validity of Self-Reported Hypertension: Findings From The Thai Cohort Study Compared to Physician Telephone Interview 
Surveys for chronic diseases, and large epidemiological studies of their determinants, often acquire data through self-report since it is feasible and efficient. We examined validity and associations of self-reported hypertension, as verified by physician telephone interview among participants in a large ongoing Thai Cohort Study (TCS).
The TCS investigates the health-risk transition among distance learning Open University students living all over Thailand. It began in 2005 and at 4-year follow-up, 60 569 self-reported having or not having doctor diagnosed hypertension. Two hundred and forty participants were randomly selected from each of the “hypertension” and “normotension” self -report groups. A Thai physician conducted a structured telephone interview with the sampled participants and classified them as having hypertension or normotension. The sensitivity, specificity, positive and negative predictive value (PPV and NPV) and overall accuracy of self-report were calculated.
The sensitivity of self-reported hypertension was 82.4% and the specificity was 70.7%. As true prevalence was simulated to vary from 1% to 50% the overall accuracy of self-report varied little from 71% to 75%. High sensitivity and negative predictive value related to female gender, younger age (≤40 years), higher education attainment and not visiting a physician in the last 12 months. High specificity and positive predictive value related to female gender, older age, higher education attainment and visiting a doctor in the previous year.
Self-report of hypertension had high sensitivity and good overall accuracy. This is acceptable for use in large studies of hypertension, and for estimating its population prevalence to help formulate health policy in Thailand.
PMCID: PMC3939357  PMID: 24576360
self-reported hypertension; physician telephone interview; agreement; validity; population prevalence; Thailand
6.  Smoking and primary total hip or knee replacement due to osteoarthritis in 54,288 elderly men and women 
The reported association of smoking with risk of undergoing a total joint replacement (TJR) due to osteoarthritis (OA) is not consistent. We evaluated the independent association between smoking and primary TJR in a large cohort.
The electronic records of 54,288 men and women, who were initially recruited for the Second Australian National Blood Pressure study, were linked to the Australian Orthopaedic Association National Joint Replacement Registry to detect total hip replacement (THR) or total knee replacement (TKR) due to osteoarthritis. Competing risk regressions that accounted for the competing risk of death estimated the subhazard ratios for TJR. One-way and probabilistic sensitivity analyses were undertaken to represent uncertainty in the classification of smoking exposure and socioeconomic disadvantage scores.
An independent inverse association was found between smoking and risk of THR and TKR observed in both men and women. Compared to non-smokers, male and female smokers were respectively 40% and 30% less likely to undergo a TJR. This significant association persisted after controlling for age, co-morbidities, body mass index (BMI), physical exercise, and socioeconomic disadvantage. The overweight and obese were significantly more likely to undergo TJR compared to those with normal weight. A dose–response relationship between BMI and TJR was observed (P < 0.001). Socioeconomic status was not independently associated with risk of either THR or TKR.
The strengths of the inverse association between smoking and TJR, the temporal relationship of the association, together with the consistency in the findings warrant further investigation about the role of smoking in the pathogenesis of osteoarthritis causing TJR.
PMCID: PMC3844303  PMID: 24006845
Total joint replacement; Smoking; Socioeconomic status; Exposure misclassification; Sensitivity analysis
7.  Health risk factors and the incidence of hypertension: 4-year prospective findings from a national cohort of 60 569 Thai Open University students 
BMJ Open  2013;3(6):e002826.
This study evaluates the impact of a number of demographic, biological, behavioural and lifestyle health risk factors on the incidence of hypertension in Thailand over a 4-year period.
A 4-year prospective study of health risk factors and their effects on the incidence of hypertension in a national Thai Cohort Study from 2005 to 2009.
As Thailand is transitioning from a developing to a middle-income developed country, chronic diseases (particularly cardiovascular disease) have emerged as major health issues. Hypertension is a major risk factor for heart attack and stroke and cross-sectional studies have indicated that the prevalence is increasing.
Study participants
A total of 57 558 Sukhothai Thammathirat Open University students who participated in both the 2005 and 2009 questionnaire surveys and who were normotensive in 2005 were included in the analysis.
Adjusted relative risks associating each risk factor and incidence of hypertension by sex, after controlling for confounders such as age, socioeconomic status, body mass index (BMI) and underlying diseases.
The overall 4-year incidence of hypertension was 3.5%, with the rate in men being remarkably higher than that in women (5.2% vs 2.1%). In both sexes, hypertension was associated with age, higher BMI and comorbidities but not with income and education. In men, hypertension was associated with physical inactivity, smoking, alcohol and fast food intake. In women, hypertension was related to having a partner.
In both men and women, hypertension was strongly associated with age, obesity and comorbidities while it had no association with socioeconomic factors. The cohort patterns of socioeconomy and hypertension reflect that the health risk transition in Thais is likely to be at the middle stage. Diet and lifestyle factors associate with incidence of hypertension in Thais and may be amenable targets for hypertension control programmes.
PMCID: PMC3696868  PMID: 23801711
8.  Early and late outcomes after isolated aortic valve replacement in octogenarians: an Australasian Society of Cardiac and Thoracic Surgeons Cardiac Surgery Database Study 
The advent of percutaneous aortic valve implantation has increased interest in the outcomes of conventional aortic valve replacement in elderly patients. The current study critically evaluates the short-term and long-term outcomes of elderly (≥80 years) Australian patients undergoing isolated aortic valve replacement.
Data obtained prospectively between June 2001 and December 2009 by the Australasian Society of Cardiac and Thoracic Surgeons National Cardiac Surgery Database Program were retrospectively analysed. Isolated aortic valve replacement was performed in 2791 patients; of these, 531 (19%) were at least 80 years old (group 1). The patient characteristics, morbidity and short-term mortality of these patients were compared with those of patients who were <80 years old (group 2). The long-term outcomes in elderly patients were compared with the age-adjusted Australian population.
Group 1 patients were more likely to be female (58.6% vs 38.0%, p < 0.001) and presented more often with co-morbidities including hypertension, cerebrovascular disease and peripheral vascular disease (all p < 0.05). The 30-day mortality rate was not independently higher in group 1 patients (4.0% vs 2.0%, p = 0.144). Group 1 patients had an independently increased risk of complications including new renal failure (11.7% vs 4.2%, p < 0.001), prolonged (≥24 h) ventilation (12.4% vs 7.2%, p = 0.003), gastrointestinal complications (3.0% vs 1.3%, p = 0.012) and had a longer mean length of intensive care unit stay (64 h vs 47 h, p < 0.001). The 5-year survival post-aortic valve replacement was 72%, which is comparable to that of the age-matched Australian population.
Conventional aortic valve replacement in elderly patients achieves excellent outcomes with long-term survival comparable to that of an age-adjusted Australian population. In an era of percutaneous aortic valve implantation, it should still be regarded as the gold standard in the management of aortic stenosis.
PMCID: PMC3241124  PMID: 21601470
Cardiac surgery; Aortic valve replacement; Octogenarian; Mortality; Morbidity; Survival
9.  Ankle-Brachial Index determination and peripheral arterial disease diagnosis by an oscillometric blood pressure device in primary care: validation and diagnostic accuracy study 
BMJ Open  2012;2(5):e001689.
To determine the level of agreement between a ‘conventional’ Ankle-Brachial Index (ABI) measurement (using Doppler and mercury sphygmomanometer taken by a research nurse) and a ‘pragmatic’ ABI measure (using an oscillometric device taken by a practice nurse) in primary care. To ascertain the utility of a pragmatic ABI measure for the diagnosis of peripheral arterial disease (PAD) in primary care.
Cross-sectional validation and diagnostic accuracy study. Descriptive analyses were used to investigate the agreement between the two procedures using the Bland and Altman method to determine whether the correlation between ABI readings varied systematically. Diagnostic accuracy was assessed via sensitivity, specificity, accuracy, likelihood ratios, positive and negative predictive values, with ABI readings dichotomised and Receiver Operating Curve analysis using both univariable and multivariable logistic regression.
Primary care in metropolitan and rural Victoria, Australia between October 2009 and November 2010.
250 persons with cardiovascular disease (CVD) or at high risk (three or more risk factors) of CVD.
Despite a strong association between the two method's measurements of ABI there was poor agreement with 95% of readings within ±0.4 of the 0.9 ABI cut point. The multivariable C statistic of diagnosis of PAD was 0.89. Other diagnostic measures were sensitivity 62%, specificity 92%, positive predictive value 67%, negative predictive value 90%, accuracy 85%, positive likelihood ratio 7.3 and the negative likelihood ratio 0.42.
Oscillometric ABI measures by primary care nurses on a population with a 22% prevalence of PAD lacked sufficient agreement with conventional measures to be recommended for routine diagnosis of PAD. This pragmatic method may however be used as a screening tool high-risk and overt CVD patients in primary care as it can reliably exclude the condition.
PMCID: PMC3488728  PMID: 23100446
Primary Care; Vascular Medicine; Public Health
10.  Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion) 
BMC Neurology  2012;12:3.
This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH) lesions and silent brain infarction (SBI). Additional aims include determining whether a) changes in retinal vascular imaging (RVI) parameters parallel changes in brain magnetic resonance imaging (MRI); b) changes in RVI parameters are observed with aspirin therapy; c) baseline cognitive function correlates with MRI and RVI parameters; d) changes in cognitive function correlate with changes in brain MRI and RVI and e) whether factors such as age, gender or blood pressure influence the above associations.
Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis.
This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline.
Trial Registration Identifier: NCT01038583
PMCID: PMC3297524  PMID: 22315948
11.  Cardio classics revisited: focus on the role of amlodipine 
Amlodipine is a long-acting, dihydropyridine calcium antagonist now widely used for lowering of elevated blood pressure. In recent years it has been shown to be effective in reducing both blood pressure and risk of cardiovascular (CV) events when used in combination with other antihypertensive agents of different classes. Strong evidence of cardiovascular benefit has been attained for combination of amlodipine with diuretics or angiotensin converting enzyme (ACE) inhibitors in a number of high-risk CV groups, including those with established coronary artery disease, diabetes, and at risk of renal disease. Combination therapies of amlodipine with other agents eliciting renin-angiotensin-aldosterone system blockade (angiotensin II receptor blockers or renin inhibitors) have been shown to be effective blood pressure-lowering strategies, but await the results of ongoing trials for direct evidence of benefit for renal disease progression and CV morbidity and mortality.
PMCID: PMC3278207  PMID: 22346362
hypertension; amlodipine; cardiovascular disease; calcium antagonist; antihypertensive
12.  Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008 
Trials  2010;11:26.
The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds require a significant amount of health care resources for treatment. Based on current knowledge multi-layer high compression system is described as the gold standard for treating venous ulcers. However, to date, despite our advances in venous ulcer therapy, no convincing low cost compression therapy studies have been conducted and there are no clear differences in the effectiveness of different types of high compression.
The trial is designed as a pilot multicentre open label parallel group randomised trial. Male and female participants aged greater than 18 years with a venous ulcer confirmed by clinical assessment will be randomised to either the intervention compression bandage which consists of graduated lengths of 3 layers of elastic tubular compression bandage or to the short stretch inelastic compression bandage (control). The primary objective is to assess the percentage wound reduction from baseline compared to week 12 following randomisation. Randomisation will be allocated via a web based central independent randomisation service (nQuery v7) and stratified by study centre and wound size ≤ 10 cm2 or >10 cm2. Neither participants nor study staff will be blinded to treatment. Outcome assessments will be undertaken by an assessor who is blinded to the randomisation process.
The aim of this study is to evaluate the efficacy and safety of two compression bandages; graduated three layer straight tubular bandaging (3L) when compared to standard short stretch (SS) compression bandaging in healing venous ulcers in patients with chronic venous ulceration. The trial investigates the differences in clinical outcomes of two currently accepted ways of treating people with venous ulcers. This study will help answer the question whether the 3L compression system or the SS compression system is associated with better outcomes.
Trial Registration
PMCID: PMC2847559  PMID: 20214822
13.  The effectiveness and cost effectiveness of dark chocolate consumption as prevention therapy in people at high risk of cardiovascular disease: best case scenario analysis using a Markov model 
Objective To model the long term effectiveness and cost effectiveness of daily dark chocolate consumption in a population with metabolic syndrome at high risk of cardiovascular disease.
Design Best case scenario analysis using a Markov model.
Setting Australian Diabetes, Obesity and Lifestyle study.
Participants 2013 people with hypertension who met the criteria for metabolic syndrome, with no history of cardiovascular disease and not receiving antihypertensive therapy.
Main outcome measures Treatment effects associated with dark chocolate consumption derived from published meta-analyses were used to determine the absolute number of cardiovascular events with and without treatment. Costs associated with cardiovascular events and treatments were applied to determine the potential amount of funding required for dark chocolate therapy to be considered cost effective.
Results Daily consumption of dark chocolate (polyphenol content equivalent to 100 g of dark chocolate) can reduce cardiovascular events by 85 (95% confidence interval 60 to 105) per 10 000 population treated over 10 years. $A40 (£25; €31; $42) could be cost effectively spent per person per year on prevention strategies using dark chocolate. These results assume 100% compliance and represent a best case scenario.
Conclusions The blood pressure and cholesterol lowering effects of dark chocolate consumption are beneficial in the prevention of cardiovascular events in a population with metabolic syndrome. Daily dark chocolate consumption could be an effective cardiovascular preventive strategy in this population.
PMCID: PMC3365141  PMID: 22653982

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