Which interventions offer best value for money in primary prevention of cardiovascular disease?

Background
Despite many decades of declining mortality rates in the Western world, cardiovascular disease remains the leading cause of death worldwide. In this research we evaluate the optimal mix of lifestyle, pharmaceutical and population-wide interventions for primary prevention of cardiovascular disease.

Methods and Findings
In a discrete time Markov model we simulate the ischaemic heart disease and stroke outcomes and cost impacts of intervention over the lifetime of all Australian men and women, aged 35 to 84 years, who have never experienced a heart disease or stroke event. Best value for money is achieved by mandating moderate limits on salt in the manufacture of bread, margarine and cereal. A combination of diuretic, calcium channel blocker, ACE inhibitor and low-cost statin, for everyone with at least 5% five-year risk of cardiovascular disease, is also cost-effective, but lifestyle interventions aiming to change risky dietary and exercise behaviours are extremely poor value for money and have little population health benefit.

Conclusions
There is huge potential for improving efficiency in cardiovascular disease prevention in Australia. A tougher approach from Government to mandating limits on salt in processed foods and reducing excessive statin prices, and a shift away from lifestyle counselling to more efficient absolute risk-based prescription of preventive drugs, could cut health care costs while improving population health.

Co-morbid cardiovascular disease and depression : sequence of disease onset is linked to mental but not physical self-rated health. Results from a cross-sectional, population-based study

Purpose: Self-rated health has been linked to important health and survival outcomes in individuals with co-morbid depression and cardiovascular disease (CVD). It is not clear how the timing of depression onset relative to CVD onset affects this relationship. We aimed to first identify the prevalence of major depressive disorder (MDD) preceding CVD and secondly determine whether sequence of disease onset is associated with mental and physical self-rated health. Methods: This study utilised cross-sectional, populationbased data from 224 respondents of the 2007 Australian National Survey of Mental Health and Wellbeing (NSMHWB). Participants were those diagnosed with MDD and reported ever having a heart/circulatory condition over their lifetime. Age of onset was reported for each condition. Logistic regression was used to explore differences in self-rated mental and physical health for those reporting pre-cardiac and post-cardiac depression. Results: The proportion of individuals in whom MDD preceded CVD was 80.36% (CI: 72.57-88.15). One-fifth (19.64%, CI: 11.85-27.42) reported MDD onset at the time of, or following, CVD. After controlling for covariates, the final model demonstrated that those reporting post-cardiac depression were significantly less likely to report poor selfrated mental health (OR:0.36, CI: 0.14-0.93) than those with pre-existing depression. No significant differences were found in self-rated physical health between groups (OR:0.90 CI: 0.38-2.14). Conclusions: MDD is most common prior to the onset of CVD. Further, there is an association between pre-morbid MDD and poorer self-rated mental health. To our knowledge, this is the first time this has been demonstrated in a national, population-based survey. As self-rated health has been shown to predict important outcomes such as survival, we recommend that those with MDD be identified as vulnerable to CVD onset and poorer health outcomes

Effect of timing of dialysis commencement on clincial outcomes of patients with planned initiation of peritoneal dialysis in the ideal trial

Background: Since the mid-1990s, early dialysis initiation has dramatically increased in many countries. The Initiating Dialysis Early and Late (IDEAL) study demonstrated that, compared with late initiation, planned early initiation of dialysis was associated with comparable clinical outcomes and increased health care costs. Because residual renal function is a key determinant of outcome and is better preserved with peritoneal dialysis (PD), the present pre-specified subgroup analysis of the IDEAL trial examined the effects of early-compared with late-start dialysis on clinical outcomes in patients whose planned therapy at the time of randomization was PD.

Methods: Adults with an estimated glomerular filtration rate (eGFR) of 10 - 15 mL/min/1.73 m2 who planned to be treated with PD were randomly allocated to commence dialysis at an eGFR of 10 - 14 mL/min/1.73 m2 (early start) or 5 - 7 mL/min/1.73 m2 (late start). The primary outcome was all-cause mortality.

Results: Of the 828 IDEAL trial participants, 466 (56%) planned to commence PD and were randomized to early start (n = 233) or late start (n = 233). The median times from randomization to dialysis initiation were, respectively, 2.03 months [interquartile range (IQR):1.67 - 2.30 months] and 7.83 months (IQR: 5.83 - 8.83 months). Death occurred in 102 early-start patients and 96 late-start patients [hazard ratio: 1.04; 95% confidence interval (CI): 0.79 - 1.37]. No differences in composite cardiovascular events, composite infectious deaths, or dialysis-associated complications were observed between the groups. Peritonitis rates were 0.73 episodes (95% CI: 0.65 - 0.82 episodes) per patient-year in the early-start group and 0.69 episodes (95% CI: 0.61 - 0.78 episodes) per patient-year in the late-start group (incidence rate ratio: 1.19; 95% CI: 0.86 - 1.65; p = 0.29). The proportion of patients planning to commence PD who actually initiated dialysis with PD was higher in the early-start group (80% vs 70%, p = 0.01).

Conclusion: Early initiation of dialysis in patients with stage 5 chronic kidney disease who planned to be treated with PD was associated with clinical outcomes comparable to those seen with late dialysis initiation. Compared with early-start patients, late-start patients who had chosen PD as their planned dialysis modality were less likely to commence on PD.

A systematic review of the impact of including both waist and hip circumference in risk models for cardiovascular diseases, diabetes and mortality

Both a larger waist and narrow hips are associated with heightened risk of diabetes, cardiovascular diseases and premature mortality. We review the risk of these outcomes for levels of waist and hip circumferences when terms for both anthropometric measures were included in regression models. MEDLINE and EMBASE were searched (last updated July 2012) for studies reporting the association with the outcomes mentioned earlier for both waist and hip circumferences (unadjusted and with both terms included in the model). Ten studies reported the association between hip circumference and death and/or disease outcomes both unadjusted and adjusted for waist circumference. Five studies reported the risk associated with waist circumference both unadjusted and adjusted for hip circumference. With the exception of one study of venous thromboembolism, the full strength of the association between either waist circumference or hip circumference with morbidity and/or mortality was only apparent when terms for both anthropometric measures were included in regression models. Without accounting for the protective effect of hip circumference, the effect of obesity on risk of death and disease may be seriously underestimated. Considered together (but not as a ratio measure), waist and hip circumference may improve risk prediction models for cardiovascular disease and other outcomes.

Nursing care practices following a percutaneous coronary intervention : results of a survey of Australian and New Zealand cardiovascular nurses

Background: Although there is high-level evidence to guide optimal medical care for percutaneous coronary interventions, there are less explicit guidelines to support nurses in providing care. Aim: This study describes the practice standards and priorities of care of cardiovascular nurses in Australia and New Zealand. Method: Item generation for the survey was informed by an integrative literature review and existing clinical guidelines. A 116-item Web-based survey was administered to cardiovascular nurses, via electronic mail lists of professional cardiovascular nursing organizations, using a secure online data collection system. Results: Data were collected from March 2008 to March 2009. A total of 148 respondents attempted the survey, with 110 (74.3%) completing all items. All respondents were registered nurses with an average of 12.3 (SD, 7.61) years of clinical experience in the cardiovascular setting. A range of practice patterns was evident in ambulation time after percutaneous coronary intervention, methods of sheath removal, pain relief, and patient positioning. Respondents consistently rated psychosocial care a lower priority than other tasks and also identified a knowledge deficit in this area. Conclusion: This survey identified diversity of practice patterns and a range of educational needs. Increasing evidence to support evidence-based practice and guideline development is necessary to promote high-quality care and improved patient outcomes.

Cardiovascular disease risk in the offspring of diabetic women: the impact of the intrauterine environment

The incidence of gestational diabetes is increasing worldwide, exposing large numbers of infants to hyperglycaemia whilst in utero. This exposure may have a long-term negative impact on the cardiovascular health of the offspring. Novel methods to assess cardiovascular status in the neonatal period are now available—including measuring arterial intima-media thickness and retinal photography. These measures will allow researchers to assess the relative impact of intrauterine exposures, distinguishing these from genetic or postnatal environmental factors. Understanding the long-term impact of the intrauterine environment should allow the development of more effective health policy and interventions to decrease the future burden of cardiovascular disease. Initiating disease prevention aimed at the developing fetus during the antenatal period may optimise community health outcomes.

Multiple pharmacological interventions targeting cardiovascular disease risk factors in individuals with type 2 diabetes - systematic review

Background:
The use of pharmacological agents has been shown to slow down the progression of microvascular and macrovascular complications. Most clinical trials address one pharmacological intervention at a time. To date, only a few studies explored multi-factorial pharmacological interventions in T2DM individuals for preventing CVD related complications. Given the current therapeutic inertia in pharmacological management of CVD risk factors, it is important to establish the benefits of a more holistic approach. Therefore, the aim of this review is to assess the efficacy of multiple pharmacological interventions for cardiovascular diseases (CVD) risk factors with or without conventional care in reducing all cause mortality, CVD mortality, stroke and cardiovascular events among adults with type 2 diabetes. Current evidence fails to support the benefit of multiple pharmacological interventions on all cause mortality and death from cardiovascular causes. However, beneficial effects were seen on the reduction of the overall number of cardiovascular events and there were promising trends for secondary outcomes such as stroke, myocardial infarction, revascularisation and amputation.

A comparison of Australian rural and metropolitan cardiovascular risk and mortality: the Greater Green Triangle and North West Adelaide population surveys

Objectives:
Cardiovascular (CVD) mortality disparities between rural/regional and urban-dwelling residents of Australia are persistent. Unavailability of biomedical CVD risk factor data has, until now, limited efforts to understand the causes of the disparity. This study aimed to further investigate such disparities.

Intervention fidelity for a complex behaviour change intervention in community pharmacy addressing cardiovascular disease risk

BACKGROUND: Delivery of cardiovascular disease (CVD) prevention programs by community pharmacists appears effective and enhances health service access. However, their capacity to implement complex behavioural change processes during patient counselling remains largely unexplored. This study aims to determine intervention fidelity by pharmacists for behavioural components of a complex educational intervention for CVD prevention. After receiving training to improve lifestyle and medicines adherence, pharmacists recruited 70 patients aged 50-74 years without established CVD, and taking antihypertensive or lipid lowering therapy. Patients received five counselling sessions, each at monthly intervals. Researchers assessed biomedical and behavioural risk factors at baseline and six months. Pharmacists documented key outcomes from counselling after each session. Most patients (86%) reported suboptimal cardiovascular diets, 41% reported suboptimal medicines adherence, and 39% were physically inactive. Of those advised to complete the intervention, 85% attended all five sessions. Pharmacists achieved patient agreement with most recommended goals for behaviour change, and overwhelmingly translated goals into practical behavioural strategies. Barriers to changing behaviours were regularly documented, and pharmacists reported most behavioural strategies as having had some success. Meaningful improvements to health behaviours were observed post-intervention. Findings support further exploration of pharmacists' potential roles for delivering interventions with complex behaviour change requirements.

A mobile phone intervention increases physical activity in people with cardiovascular disease: Results from the HEART randomized controlled trial.

AIM: To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease (IHD).

METHODS AND RESULTS: In this single-blind, parallel, two-arm, randomized controlled trial adults (n = 171) with IHD were randomized to receive a mobile phone delivered intervention (HEART; n = 85) plus usual care, or usual care alone (n = 86). Adult participants aged 18 years or more, with a diagnosis of IHD, were clinically stable as outpatients, able to perform exercise, able to understand and write English, and had access to the Internet. The HEART (Heart Exercise And Remote Technologies) intervention involved a personalized, automated package of text messages and a secure website with video messages aimed at increasing exercise behaviour, delivered over 24 weeks. All participants were able to access usual community-based cardiac rehabilitation, which involves encouragement of physical activity and an offer to join a local cardiac support club. All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake (PVO2; primary outcome), self-reported physical activity, health-related quality of life, self-efficacy and motivation (secondary outcomes). Results showed no differences in PVO2 between the two groups (difference -0.21 ml kg(-1)min(-1), 95% CI: -1.1, 0.7; p = 0.65) at 24 weeks. However significant treatment effects were observed for selected secondary outcomes, including leisure time physical activity (difference 110.2 min/week, 95% CI: -0.8, 221.3; p = 0.05) and walking (difference 151.4 min/week, 95% CI: 27.6, 275.2; p = 0.02). There were also significant improvements in self-efficacy to be active (difference 6.2%, 95% CI: 0.2, 12.2; p = 0.04) and the general health domain of the SF36 (difference 2.1, 95% CI: 0.1, 4.1; p = 0.03) at 24 weeks. The HEART programme was considered likely to be cost-effective for leisure time activity and walking.

CONCLUSIONS: A mobile phone intervention was not effective at increasing exercise capacity over and above usual care. The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services.

Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study

Purpose The main purpose of this study was to investigate the effects of a 12-week, clinician-referred, community-based exercise training program with supervised and unsupervised sessions for men with prostate cancer. The secondary purpose was to determine whether androgen deprivation therapy (ADT) modified responses to exercise training.

Methods Secondary analysis was undertaken on data from a multicentre cluster randomised controlled trial in which 15 clinicians were randomly assigned to refer eligible patients to an exercise training intervention (n = 8) or to provide usual care (n = 7). Data from 119 patients (intervention n = 53, control n = 66) were available for this analysis. Outcome measures included fitness and physical function, anthropometrics, resting heart rate, and blood pressure.

Results Compared to the control condition, men in the intervention significantly improved their 6-min walk distance (Mdiff = 49.98 m, padj = 0.001), leg strength (Mdiff = 21.82 kg, padj = 0.001), chest strength (Mdiff = 6.91 kg, padj = 0.001), 30-s sit-to-stand result (Mdiff = 3.38 reps, padj = 0.001), and reach distance (Mdiff = 4.8 cm, padj = 0.024). A significant difference (unadjusted for multiplicity) in favour of men in the intervention was also found for resting heart rate (Mdiff = −3.76 beats/min, p = 0.034). ADT did not modify responses to exercise training.

Conclusions Men with prostate cancer who act upon clinician referrals to community-based exercise training programs can improve their strength, physical functioning, and, potentially, cardiovascular health, irrespective of whether or not they are treated with ADT.

Implications for Cancer Survivors Clinicians should inform men with prostate cancer about the benefits of exercise and refer them to appropriately qualified exercise practitioners and suitable community-based programs.

Self-management support and training for patients with chronic and complex conditions improves health-related behaviour and health outcomes

The Sharing Health Care SA chronic disease self-management (CDSM) project in rural South Australia was designed to assist patients with chronic and complex conditions (diabetes, cardiovascular disease and arthritis) to learn how to participate more effectively in the management of their condition and to improve their self-management skills. Participants with chronic and complex conditions were recruited into the Sharing Health Care SA program and offered a range of education and support options (including a 6-week peer-led chronic disease self-management program) as part of the Enhanced Primary Care care planning process. Patient self-reported data were collected at baseline and subsequent 6-month intervals using the Partners in Health (PIH) scale to assess self-management skill and ability for 175 patients across four data collection points. Health providers also scored patient knowledge and self-management skills using the same scale over the same intervals. Patients also completed a modified Stanford 2000 Health Survey for the same time intervals to assess service utilisation and health-related lifestyle factors. Results show that both mean patient self-reported PIH scores and mean health provider PIH scores for patients improved significantly over time, indicating that patients demonstrated improved understanding of their condition and improved their ability to manage and deal with their symptoms. These results suggest that involvement in peer-led self-management education programs has a positive effect on patient self-management skill, confidence and health-related behaviour.

Review : regular brisk walking improves cardiovascular risk factors in healthy sedentary adults

QUESTION In healthy sedentary adults, does regular brisk walking improve cardiovascular risk factors?

METHODS Data sources: Medline and Web of Science (1971 to September 2004) and reference lists.Study selection and assessment:English-language, randomised controlled trials (RCTs) with duration ⩾4 weeks that assessed the effects of walking as the only intervention on changes in cardiovascular risk factors in sedentary, but otherwise healthy, adults. 24 RCTs (n = 1128, mean age 52 y, 83% women) met the selection criteria. The mean length of the walking programmes was 35 weeks (range 8–104 wk). On average, walking was done 4.4 days/week for 38 minutes per session. The mean intensity of the walking interventions was 70% of predicted maximum heart rate or 56% of VO2 max. Quality of individual studies was assessed based on allocation concealment. Outcomes: cardiovascular fitness (VO2 max), body weight, percent body fat, body mass index, and systolic and diastolic blood pressure (BP).

MAIN RESULTS Brisk walking increased cardiovascular fitness and reduced body weight, body mass index, body fat composition, and diastolic BP more than the control condition (table). No effect on systolic BP was observed (table).

CONCLUSION In healthy sedentary adults, regular brisk walking improves cardiovascular fitness, body composition, and diastolic blood pressure.

Text2PreventCVD: Protocol for a systematic review and individual participant data meta-analysis of text-message based interventions for the prevention of cardiovascular diseases.

Introduction Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs). Methods and analysis Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings. Ethics and dissemination Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences.