A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour Global Risk Assessment to Guide Blood Pressure Management in Cardiovascular Disease Prevention Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial Effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes: a systematic review Tracking Women’s Awareness of Heart Disease: An American Heart Association National Study Global, Regional, and National Burden of Cardiovascular Diseases for 10 Causes, 1990 to 2015 The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale Estimated Global, Regional, and National Disease Burdens Related to Sugar-Sweetened Beverage Consumption in 2010 Development of a set of mobile phone text messages designed for prevention of recurrent cardiovascular events Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare The Cholesterol, Hypertension, and Glucose Education (CHANGE) study for African Americans with diabetes: study design and methodology. Uric Acid Levels Are Associated With All-Cause and Cardiovascular Disease Mortality Independent of Systemic Inflammation in Men From the General Population: The MONICA/KORA Cohort Study Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Statins for Primary Prevention: The Debate Is Intense, but the Data Are Weak. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Evaluating the use of mobile phone technology to enhance cardiovascular disease screening by community health workers Effect of an Educational Program (PEGASE) on Cardiovascular Risk in Hypercholesterolaemic Patients The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation Reducing salt intake for prevention of cardiovascular diseases in high-risk patients by advanced health education intervention (RESIP-CVD study), Northern Thailand: study protocol for a cluster randomized trial Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial
Background Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide . Despite the widespread availability of evidence -based clinical guidelines and vali date d risk predication equations for prevention and management of CVD , their translation into routine practice is limited . We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal . The intervention was implemented in a cluster r and omised controlled trial in 60 primary healthcare services in Australia . Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use . This information is necessary to optimise intervention impact and maximally implement it in a post-trial context . In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention . Our aims are to underst and how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination . Methods / Design We will conduct four discrete but inter-related studies taking a mixed methods approach . Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale . The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to underst and how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention . We will also assess the costs of implementing the intervention in Australian primary healthcare setting s which will inform scale-up considerations . Discussion This mixed methods evaluation will provide a detailed underst and ing of the process of implementing a  quality improvement intervention and identify the factors that might influence scalability and sustainability . Trials registration 12611000478910 Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 Elevated blood pressure ( BP ) is a causal risk factor for cardiovascular disease ( CVD ) . Epidemiological analyses have established the grade d and continuous association between higher BP and CVD . Moreover , r and omized clinical trials among individuals with hypertension have demonstrated , in aggregate , a reduction in CVD events by 20 % , coronary heart disease ( CHD ) by 17 % , stroke by 27 % , and heart failure by 28 % for every 10 mm Hg systolic BP ( SBP ) lowering with medical therapy.1 Therefore , prevention , detection , treatment , and control of elevated BP , and its clinical correlate hypertension , is an important public health priority and a primary target for CVD prevention . Although national health surveys have demonstrated improvements in hypertension awareness and treatment , strategic opportunities to improve the efficiency and efficacy of applying BP-lowering therapy in patients most likely to benefit remain.2 Global CVD risk assessment , using multivariable prediction models that estimate absolute CVD risk from routinely measured clinical variables , has been promulgated in several CVD prevention guidelines for cholesterol management to target the most intensive preventive therapies to those at highest absolute CVD risk.3–5 Hypertension guidelines , however , have instead relied solely on isolated BP thresholds and BP goals to guide treatment initiation and intensity . In this review , we provide a rationale for incorporating global CVD risk assessment in BP treatment decision-making and propose a framework to guide its implementation in future CVD prevention guidelines . Epidemiological analyses have firmly established that CVD is a multifactorial condition and that modest increases of several CVD risk factors can often lead to greater overall risk than a severe elevation of a Abstract Background Cardiovascular disease ( CVD ) is an important worldwide cause of mortality . In The Netherl and s , CVD is the leading cause of death for women and the second cause of death for men . Recommendations for diagnosis and treatment of CVD are not well implemented in primary care . In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD . Methods / design A two-arm cluster r and omized trial is planned . We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice . Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) . They are also advised to screen for the presence and severity of depressive symptoms in patients . We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression . Patients with mild depressive symptoms are referred to a physical exercise group . We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM .  Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practice s in several geographical areas in The Netherl and s. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients . Patients ’ health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with vali date d question naires and medical record audit will be performed to document estimated CVD risk . Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change . The control practice s will provide usual care . Discussion Tailored interventions can improve healthcare . An underst and ing of the methods to reach the improved healthcare can be improved . This research contributes a share of it . Identification of the determinants of practice and developing implementation interventions were two steps which were completed . The subsequent step was implementation of the tailored intervention program . Trial registration Name trial register : Nederl and s trial registerWeb address of trial register : http://www.trialregister.nl Data of registration : 11 July 2013Number of registration : Executive summary Background As a chronic condition , the prevalence of Type 2 diabetes is increasing worldwide and adherence to oral medications , an essential component of self‐management , has been shown to improve glycaemic control . However compliance with oral medication adherence remains poor . Educating people with Type 2 diabetes is an important strategy to enhance self‐management ability , including medication‐taking behaviour . Objectives The overall objective of the review was to determine the effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes . Inclusion criteria Types of participants Studies involving adults over 18 years old with Type 2 diabetes , with or without co‐morbidities , currently taking oral hypoglycaemic medication without insulin treatment , and with aglycated haemoglobin ( HbA1c ) > 7.0 % prior to the intervention were considered . Aglycated haemoglobin ( HbA1c ) concentration of less than 7.0 % , is important in order to delay or prevent diabetes‐related complications . Participants could be from the primary , tertiary or acute care setting . Types of intervention The review focused on various forms of educational interventions delivered by healthcare professionals aim ed at improving participants ’ knowledge . Types of outcomes The review evaluated outcomes measuring oral hypoglycaemic adherence including HbA1c , fasting blood glucose levels and other relevant indicators . Types of studies Studies that were r and omized controlled trials ( RCTs ) or case‐control studies were considered . Search strategy A three‐stage search strategy was employed . Papers in English and between the years 1990‐2009 were search ed in the following data bases : CINAHL , Medline , Mosby 's Nursing Consult , PsycINFO , PubMed , ScienceDirect , Scopus , TRIP and Web of Science . Full text was retrieved when the titles and abstract s of studies fulfilled the inclusion criteria . Method ological quality Full papers were assessed for method ological quality independently by two review ers using critical appraisal checklists from the Joanna Briggs Institute ( JBI ) . A third review er was consulted whenever there were disagreements between the two review ers . Data collection / extraction Details of each study included in the review were extracted using st and ardized data extraction forms developed by JBI . Extraction was conducted independently by two review ers . Data synthesis Meta‐ analysis was not possible due to method ological and statistical heterogeneity of the included studies . Hence study findings are presented in narrative form . Results Seven studies included in the final review consisted of seven RCTs . Five studies concluded that the educational intervention was effective in promoting oral hypoglycaemic adherence compared to usual care . These included pharmacist‐led interventions , individual diabetes education provided by nurses and diabetes group education based on a self‐management approach . Similarities among these interventions were provision of information on oral hypoglycaemic medication and the need for regular education sessions . However , small sample s in some studies limited generalization of results . Conclusions Implication s for practice Increased knowledge of oral hypoglycaemic issues and reinforcement of the importance of medication adherence were useful in promoting adherence . Regular education sessions allow individuals to reinforce information and educators to identify barriers to medication adherence . Educational interventions focusing on self‐management strategies appear more likely to achieve positive outcomes . Implication s for research Further trials involving larger sample s and population s with poor glycaemic control are needed . The effects of educational interventions , influence of additional take‐home written material , the optimal interval length of follow‐up and duration of education sessions , and specific processes of individual or group education which have been identified as effective need further exploration Background —Cardiovascular disease ( CVD ) is the leading cause of mortality in men and women in the United States , yet prior research has shown a lack of awareness of risk among women . The purpose of this study was to assess the contemporary awareness , knowledge , and perceptions related to CVD risk among American women and to evaluate trends since 1997 , when the American Heart Association initiated a national campaign to improve awareness of CVD among women . Methods and Results —A telephone survey of a nationally representative r and om sample of women was conducted in June and July 2003 , with an oversampling of black and Hispanic women ; results were compared with those of similar surveys in 2000 and 1997 . The present survey included 1024 respondents age ≥25 years ; 68 % were white , 12 % black , 12 % Hispanic , and 8 % other ethnicities .  Awareness , knowledge , and perceptions about heart disease were evaluated by use of a st and ard interviewer-assisted question naire . A shift in awareness of heart disease as the leading killer of women has occurred since 1997 . In 2003 , 46 % of respondents spontaneously identified heart disease as the leading cause of death in women , up from 30 % in 1997 ( P < 0.05 ) and 34 % in 2000 ( P < 0.05 ) . In contrast , the percentage of women citing cancer as leading cause of death has significantly decreased . Black , Hispanic , and younger women ( < 45 years old ) had lower awareness of heart disease as their leading cause of death than did white and older women . Nearly all women reported comfort in discussing prevention with healthcare providers , but only 38 % of women reported that their doctors had ever discussed heart disease with them . Conclusions —Awareness of CVD has increased , although a significant gap between perceived and actual risk of CVD remains . Educational interventions to improve awareness and knowledge are needed , particularly for minority and younger women Background The burden of cardiovascular diseases ( CVDs ) remains unclear in many regions of the world . Objectives The GBD ( Global Burden of Disease ) 2015 study integrated data on disease incidence , prevalence , and mortality to produce consistent , up-to- date estimates for cardiovascular burden . Methods CVD mortality was estimated from vital registration and verbal autopsy data . CVD prevalence was estimated using modeling software and data from health surveys , prospect i ve cohorts , health system administrative data , and registries . Years lived with disability ( YLD ) were estimated by multiplying prevalence by disability weights . Years of life lost ( YLL ) were estimated by multiplying age-specific CVD deaths by a reference life expectancy . A sociodemographic index ( SDI ) was created for each location based on income per capita , educational attainment , and fertility . Results In 2015 , there were an estimated 422.7 million cases of CVD ( 95 % uncertainty interval : 415.53 to 427.87 million cases ) and 17.92 million CVD deaths ( 95 % uncertainty interval : 17.59 to 18.28 million CVD deaths ) . Declines in the age-st and ardized CVD death rate occurred between 1990 and 2015 in all high-income and some middle-income countries . Ischemic heart disease was the leading cause of CVD health lost globally , as well as in each world region , followed by stroke . As SDI increased beyond 0.25 , the highest CVD mortality shifted from women to men . CVD mortality decreased sharply for both sexes in countries with an SDI > 0.75 . Conclusions CVDs remain a major cause of health loss for all regions of the world . Sociodemographic change over the past 25 years has been associated with dramatic declines in CVD in regions with very high SDI , but only a gradual decrease or no change in most regions . Future up date s of the GBD study can be used to guide policymakers who are focused on reducing the overall burden of noncommunicable disease and achieving specific global health targets for CVD Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background In re source -poor areas of China and India , the cardiovascular disease burden is high , but availability of and access to quality healthcare is limited . Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management . The study aims to develop , implement , and evaluate the feasibility and effectiveness of a simplified , evidence -based cardiovascular management program delivered by community healthcare workers in re source -constrained areas in Tibet , China and Haryana , India . Methods / design This yearlong cluster-r and omized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana . R and omization of villages to usual care or intervention will be stratified by country . High cardiovascular disease risk individuals ( aged 40 years or older , history of heart disease , stroke , diabetes , or measured systolic blood pressure of 160 mmHg or higher ) will be screened at baseline . Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ‘ 2 + 2 ’ intervention model involving two lifestyle recommendations and the appropriate prescription of two medications . A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management . Baseline and follow-up surveys will be conducted in a st and ardized fashion in all villages . The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention . Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure . Process and economic evaluations will also be conducted . Discussion To our knowledge , this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients . If effective , this intervention strategy can serve as a model that can be implemented , where applicable , in rural China , India , and other re source -constrained areas .Trial registration The trial was registered in the clinical trials.gov data base on 30 December , 2011 and the registration number is NCT01503814 Background — Sugar-sweetened beverages ( SSBs ) are consumed globally and contribute to adiposity . However , the worldwide impact of SSBs on burdens of adiposity-related cardiovascular diseases ( CVDs ) , cancers , and diabetes mellitus has not been assessed by nation , age , and sex . Methods and Results — We modeled global , regional , and national burdens of disease associated with SSB consumption by age/sex in 2010 . Data on SSB consumption levels were pooled from national dietary surveys worldwide . The effects of SSB intake on body mass index and diabetes mellitus , and of elevated body mass index on CVD , diabetes mellitus , and cancers were derived from large prospect i ve cohort pooling studies . Disease-specific mortality/morbidity data were obtained from Global Burden of Diseases , Injuries , and Risk Factors 2010 Study . We computed cause-specific population -attributable fractions for SSB consumption , which were multiplied by cause-specific mortality/morbidity to compute estimates of SSB-attributable death/disability . Analyses were done by country/age/sex ; uncertainties of all input data were propagated into final estimates . Worldwide , the model estimated 184 000 ( 95 % uncertainty interval , 161 000–208 000 ) deaths/y attributable to SSB consumption : 133 000 ( 126 000–139 000 ) from diabetes mellitus , 45 000 ( 26 000–61 000 ) from CVD , and 6450 ( 4300–8600 ) from cancers . Five percent of  SSB-related deaths occurred in low-income , 70.9 % in middle-income , and 24.1 % in high-income countries . Proportional mortality attributable to SSBs ranged from < 1 % in Japanese > 65 years if age to 30 % in Mexicans < 45 years of age . Among the 20 most populous countries , Mexico had largest absolute ( 405 deaths/million adults ) and proportional ( 12.1 % ) deaths from SSBs . A total of 8.5 ( 2.8 , 19.2 ) million disability-adjusted life years were related to SSB intake ( 4.5 % of diabetes mellitus – related disability-adjusted life years ) . Conclusions — SSBs are a single , modifiable component of diet that can impact preventable death/disability in adults in high- , middle- , and low-income countries , indicating an urgent need for strong global prevention programs Background : Supporting lifestyle change is an effective way of preventing recurrent events in people with cardiovascular disease ( CVD ) . However , there is a need to develop innovative strategies that increase access to programmes for individuals at high risk of CVD . This study aim ed to develop a bank of text messages design ed to provide advice , motivation , and support for decreasing cardiovascular risk . Design : Iterative development process with mixed methods Methods : An initial bank of 120 text messages was drafted based on behaviour change techniques , guidelines , and input from clinicians and public health experts . A question naire was then administered to participants ( n = 53 ) for evaluation of message content , usefulness , and language . To test the process of delivery , a pilot study was conducted using a specifically design ed computer programme that delivered messages to multiple mobile phones according to a pre-specified schedule . Data were collected regarding message timing , delivery , and usefulness . Results : In the qualitative question naire , 92 % of participants found the messages easy to underst and and 86 % found the messages contained useful information . Positive feedback was also obtained from the pilot study . Based on these results , together with suggestions provided , several messages were reworded and an additional 44 were written . The need for semi-personalization was also identified and a r and om set of 103 individualized messages was created . Conclusions : A final bank of 137 mobile telephone text messages design ed to support behaviour change and decrease cardiovascular risk have been developed through a multistep iterative process . This provides a scientific approach for future developers of health-related text messages Background Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries . While several interventions to stop smoking have been proved successful , the question of how to increase their effectiveness and practicality in developing countries remains . In this study , a newly devised evidence -based smoking cessation service package will be compared with the existing service in a r and omized controlled trial within the community setting of Thail and . Method / Design This r and omized control trial will recruit 440 current smokers at CVD risk because of being diabetic and /or hypertensive . Informed , consented participants will be r and omly allocated into the new service-package arm and the routine service arm . The study will take place in the non-communicable disease clinics of the Maetha District Hospital , Lampang , northern Thail and . The new smoking-cessation service-package comprises ( 1 ) regular patient motivation and coaching from the same primary care nurse over a 3-month period ; ( 2 ) monthly application of piCO + smokerlyzer to sustain motivation of smoker ’s quitting attempt and provide positive feedback over a 3-month period ; ( 3 ) assistance by an assigned family member ; ( 4 ) nicotine replacement chewing gum to relieve withdrawal symptoms . This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up . Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-r and omized arm , where they will be just followed up and monitored . Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air . Secondary outcomes are smoking cessation rate at the 6-month follow-up , blood pressure and heart rate , CVD risk according to the Framingham general cardiovascular risk score , CVD events and deaths at the 12-month follow-up , and the cost-effectiveness of the health service packages . Intention-to-treat analysis will be followed . Factors influencing smoking cessation will be analyzed by the structure equation model . Discussion This multicomponent intervention , accessible at primary healthcare clinics , and focusing on the individual as well as the family and social environment , is unique and expected to work effectively . Trial registration Current Controlled Trials IS RCT Background Large gaps exist in the implementation of guideline recommendations for cardiovascular disease ( CVD ) risk management .  Electronic decision support ( EDS ) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia . We have developed HealthTracker , a multifaceted EDS and quality improvement intervention to improve the management of CVD risk . Methods / design It is hypothesised that the use of HealthTracker over a 12-month period will result in : ( 1 ) an increased proportion of patients receiving guideline -indicated measurements of CVD risk factors and ( 2 ) an increased proportion of patients at high risk will receive guideline -indicated prescriptions for lowering their CVD risk . Sixty health services ( 40 general practice s and 20 Aboriginal Community Controlled Health Services ( ACCHSs ) will be r and omised in a 1:1 allocation to receive either the intervention package or continue with usual care , stratified by service type , size and participation in existing quality improvement initiatives . The intervention consists of point-of-care decision support ; a risk communication interface ; a clinical audit tool to assess performance on CVD-related indicators ; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance .  The control arm will continue with usual care without access to these intervention components . Quantitative data will be derived from cross-sectional sample s at baseline and end of study via automated data extraction . Detailed process and economic evaluations will also be conducted . Ethics and dissemination The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee ( HREC ) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC . Formal agreements with each of the participating sites have been signed . In addition to the usual scientific forums , results will be disseminated via newsletters , study websites , face-to-face feedback forums and workshops . Trial registration The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910 BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for over one third of the mortality difference between African Americans and white patients . The increased CVD risk in African Americans is due in large part to the clustering of multiple CVD risk factors . OBJECTIVES The current study is aim ed at improving CVD outcomes in African-American adults with diabetes by addressing the modifiable risk factors of systolic blood pressure , glycosylated hemoglobin , and low-density lipoprotein cholesterol . METHODS A sample of African American patients with diabetes ( N = 400 ) will receive written education material at baseline and be r and omized to one of 2 arms : ( 1 ) usual primary care or ( 2 ) nurse-administered disease-management intervention combining patient self-management support and provider medication management . The nurse administered intervention is delivered monthly over the telephone . The nurses also interacts with the primary care providers at 3 , 6 , and 9 months to provide concise patient up date s and facilitate changes in medical management . All patients are followed for 12 months after enrollment . The primary outcomes are change in glycosylated hemoglobin , systolic blood pressure , and low-density lipoprotein cholesterol over 12-months . Secondary outcomes include change in overall cardiovascular risk , aspirin use , and health behaviors . CONCLUSION Given the continued racial disparities in CVD , the proposed study could result in significant contributions to cardiovascular risk reduction in African-American patients Objective —The purpose of this study was to assess whether increasing serum uric acid ( UA ) levels are related to cardiovascular disease ( CVD ) mortality , all-cause mortality , and incident ( fatal and nonfatal ) myocardial infa rct ion ( MI )  in men from the general population taking into account C-reactive protein ( CRP ) , a sensitive marker of systemic inflammation . Methods and Results —The study was based on 3604 men ( 45 to 74 years of age ) who participated in 1 of the 3 MONICA Augsburg surveys between 1984 and 1995 . All participants were prospect ively followed within the framework of the Cooperative Health Research in the Region of Augsburg ( KORA ) . Up to December 31 , 2002 , there occurred 809 total deaths , 359 CVD deaths , and 297 incident MIs . In a Cox model , comparing extreme quartiles of the UA distribution , the hazard ratio for CVD mortality was 1.44 ( 95 % confidence interval [ CI ] 1.04 to 2.0 ) , and for all-cause mortality it was 1.40 ( 95 % CI 1.13 to 1.74 ) after adjustment for conventional cardiovascular risk factors , CRP , and diuretic intake . However , UA was not associated with incident MI after multivariable adjustment . Conclusions —High UA levels were independently associated with CVD mortality as well as all-cause mortality but not with incident MI in middle-aged men from the general population AIM The Vein Consult Program is an international , observational , prospect i ve survey aim ing to collect global epidemiological data on chronic venous disorders ( CVD ) based on the CEAP classification , and to identify CVD management worldwide . The survey was organized within the framework of ordinary consultations , with general practitioners ( GPs ) properly trained on the use of the CEAP classification . METHODS Screening for CVD was to be performed by enrolling in the survey  all consecutive out patients > 18 years whatever the reason for consultation , to record patient 's data and classify them according to the CEAP , from the stage C0s to C6 . The program enrolled 6232 GPs 91545 subjects were analysed . Their mean age was 50.6±16.9 years , younger patients being in the Middle East and older ones in Europe , and the proportion of women was higher than that of men . RESULTS The worldwide prevalence of CVD was 83.6 % : 63.9 % of the subjects ranging C1 to C6 , and 19.7 % being C0s subjects . C0s patients were more frequently men whatever the age and the geographical zone . C1-C3 appeared to be more frequent among women whatever the country but the rate of severe stages ( C4-C6 ) did not differ between men and women . GPs consider CVD subjects as patients eligible to specialist referral beginning from C2 but some geographical disparities were observed . CONCLUSION The VCP survey provides reliable results on CVD global epidemiology and shows that CVD affects a significant part of the population s worldwide , underlining the importance of adequate screening for CVD and training of both GPs and specialist physicians This issue of JAMA contains the latest US Preventive Services Task Force ( USPSTF ) recommendation statement on statins for prevention of cardiovascular disease in adults,1 along with the accompanying evidence report and systematic review 2 on which the recommendations are based . The evidence report summarized data from 19 trials including a total of 71 344 patients and concluded that statin therapy was associated with reduced risk of all-cause and cardiovascular mortality and cardiovascular disease ( CVD ) events . Thus , the task force recommended “ initiating use of lowto moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10 % or greater ( B recommendation ) ” or “ 7.5 % to 10 % ( C recommendation ) .”1 Although the task force did their usual careful job of review ing the evidence , the evidence for treating asymptomatic persons with statins does not appear to merit a grade B or even a grade C recommendation . The task force evidence report estimated an absolute benefit for use of statins of 0.40 % for all-cause mortality and 0.43 % for cardiovascular mortality and indicated that the absolute benefit was greater for patients at greater baseline risk.2 Notably , the evidence report did not exclude studies that included patients taking statins for secondary prevention , who have a higher baseline risk of cardiac events and death and thus are more likely to benefit from therapy that inflates the benefit attributed to a primary prevention population . The task force did perform a sensitivity analysis that excluded 3 trials with persons for whom there were prior “ hard ” cardiovascular events and obtained similar results of benefits ( eTable 5 in the article by Chou et al2 ) . This sensitivity analysis did not exclude WOSCOPS , which included patients receiving statins for secondary prevention—5 % had angina and 3 % had intermittent claudication,3 accounting for 15 % of the total weight in the meta- analysis . In contrast , a meta- analysis of 11 studies and 65 229 patients receiving statins for primary prevention , in which patients receiving statins for secondary prevention were excluded , found no benefit of statins for reducing all-cause mortality.4 The confidence intervals of these 2 analyses overlap , and the difference between these findings likely reflects differences in studies included . The USPSTF and authors of the evidence report did not have access to the primary data ( clinical study reports and anonymized patient-level data ) from the statin clinical trials . Rather , they had to rely on peer- review ed published reports as the basis for these recommendations . Exacerbating the potential bias , all of the trials included in the task force evidence report2 were industry-sponsored except 1 trial,5 and that trial contributed 0.2 % of the weight to the mortality calculation . Industry-sponsored studies have been shown to report greater benefit and lesser adverse effects than noncommercially sponsored trials of the same drugs.6 Whether this is true for statins and primary prevention of CVD is unknown . Among the 19 r and omized clinical trials of statins vs placebo or no statin included in the evidence report for the task force recommendations , only 15 reported all-cause mortality , 10 reported cardiovascular mortality , 12 reported fatal and nonfatal myocardial infa rct ion  , and 13 reported fatal and nonfatal stroke.2,7  Reliance on selective reporting of the most important outcomes , which are likely included in the clinical trial data , makes reporting bias possible . Furthermore , after allcause mortality , the comparative incidence of serious adverse events between treatment and control groups is arguably the second most important measure of the effect of active therapy in r and omized clinical trials . Underst and ing the evidence base in evaluating harms of statin therapy is also critically important . Although the benefits of any preventive therapy accrue according to risk of disease ( greater benefit in higher-risk patients ) , the harms of therapy usually distribute equally over all risk levels . Thus , persons at low risk have little chance of benefit but equal chance of harms and thus are more likely to have a net harm . The evidence base for harms of statins , despite the introduction of these drugs more than 20 years ago , is incomplete . Many of the trials did not ask about commonly reported statin effects , such as muscle pains and weakness , and only recorded myopathy , for which an increase in creatine kinase levels was required . Because most muscle problems do not involve an increase in creatine kinase levels , this leads to a significant underestimate of muscle problems . Other studies have estimated that closer to 20 % of statin users have muscle problems.8 Additionally , the actual trial data are largely held by the Cholesterol Treatment Trialists ’ Collaboration on behalf of the industry sponsor and have not been made available to other research ers , despite multiple requests over many years.9 Although reported rates of adverse events in clinical trials are low , this does not reflect the experience of clinicians who see patients who are taking statins . For instance , the experience of an NPR reporter with a calculated 2.9 % risk of heart disease over 10 years using the recommended American College of Cardiology/American Heart Association ( ACC/AHA ) risk calculator,10 but still prescribed a statin , and experiencing adverse effects from the medication , is typical of what many Related articles at jama.com AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 ) BACKGROUND Primary prevention of cardiovascular disease (CVD),by identifying individuals at risk is a well-established , but costly strategy when based on measurements that depend on laboratory analyses . A non-laboratory , paper-based CVD risk assessment chart tool has previously been developed to make screening more affordable in developing countries . Task shifting to community health workers ( CHWs ) is being investigated to further scale CVD risk screening . This study aim ed to develop a mobile phone CVD risk assessment application and to evaluate its impact on CHW training and the duration of screening for CVD in the community by CHWs . METHODS A feature phone application was developed using the open source online platform , CommCare ( © ) . CHWs ( n=24 ) were trained to use both paper-based and mobile phone CVD risk assessment tools . They were r and omly allocated to using one of the risk tools to screen 10 - 20 community members and then crossed over to screen the same number , using the alternate risk tool . The impact on CHW training time , screening time and margin of error in calculating risk scores was recorded . A focus group discussion evaluated experiences of CHWs using the two tools . RESULTS The training time was 12.3h for the paper-based chart tool and 3h for the mobile phone application . 537 people were screened . The mean screening time was 36 min ( SD=12.6 ) using the paper-base chart tool and 21 min ( SD=8.71 ) using the mobile phone application , p=<0.0001 . Incorrect calculations ( 4.3 % of average systolic BP measurements , 10.4 % of BMI and 3.8 % of CVD risk score ) were found when using the paper-based chart tool while all the mobile phone calculations were correct . Qualitative findings from the focus group discussion corresponded with the findings of the pilot study . CONCLUSION The reduction in CHW training time , CVD risk screening time , lack of errors in calculation of a CVD risk score and end user satisfaction when using a mobile phone application , has implication s in terms of adoption and sustainability of this primary prevention strategy to identify people with high CVD risk who can be referred for appropriate diagnoses and treatment Background Many studies have demonstrated a gap between guidelines for the prevention of cardiovascular disease ( CVD ) and their implementation in clinical practice . Aim The PEGASE education program has been devised with an aim to improve the management of patients at high risk of CVD . Methods In a multicentre study carried out from 2001–2004 in France , 96 participating physicians were r and omized into a “ trained ”  group , which included 398 “ educated ” patients , and a  “ non-trained ” group  , which included 242 “ non-educated ” patients . Educated patients received six hospital-based educational sessions , four collective and two individual .  Framingham score , smoking , lipid levels , glycaemia , blood pressure , dietary intake and drug compliance , as well as quality of life , were evaluated at baseline ( M0 ) and 6 months ( M6 ) . The primary endpoint of the study was the efficacy of the PEGASE program in reducing global CVD risk in high-risk patients . Results The Framingham score was calculated for 473 patients .  The Framingham score improved significantly at M6 vs M0 in the educated group ( 13.0 ± 8.21 vs 13.6 ± 8.48 , d = −0.658 , p = 0.016 ) , but not in the non-educated group ( 12.5 ± 8.19 vs 12.4 ± 7.81 , d = + 0.064 , p = 0.836 ) ; the mean change between the two groups did not reach significance . Quality of life , LDL-c level and diet scores improved in the “ educated ” group only . Conclusions The PEGASE education program  improved risk factors for CVD , although global assessment by Framingham score was not significantly different between groups . This program , aim ed at meeting needs and expectations of patients and physicians , was easily implemented in all hospital centres Objectives To assess the effect of a point of care ( POC ) device for testing lipids  and HbA1c in addition to testing by community laboratory facilities ( usual practice ) on the completion of cardiovascular disease ( CVD ) risk assessment s in general practice . Methods We conducted a pragmatic , cluster r and omised controlled trial in 20 New Zeal and general practice s stratified by size and rurality and r and omised to POC device plus usual practice or usual practice alone ( controls ) . Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment . Data on CVD risk assessment s were aggregated using a web-based decision support programme common to each practice . Data entered into the on-line CVD risk assessment form could be saved pending blood test results . The primary outcome was the proportion of completed CVD risk assessment s. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and question naire . The POC testing was supported by a comprehensive quality assurance programme . Results A CVD risk assessment entry was recorded for 7421 patients in 10 POC practice s and 6217 patients in 10 control practice s ; 99.5 % of CVD risk assessment s had complete data in both groups ( adjusted odds ratio 1.02 [ 95%CI 0.61–1.69 ] ) . There were major external influences that affected the trial : including a national performance target for CVD risk assessment and changes to CVD guidelines . All practice s had invested in systems and dedicated staff time to identify and follow up patients to completion . However , the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussion s. Shortly after commencement , the trial was halted due to a change in the HbA1c test assay performance . The trial restarted after the manufacturing issue was rectified but this affected the end use of the device . Conclusions Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion . The promise of combining risk assessment , communication and management within one consultation was not realised . With shifts in policy focus , the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting . Trial registration Australian New Zeal and Clinical Trials Registry Background Decreasing salt consumption can prevent cardiovascular diseases ( CVD ) . Practically , it is difficult to promote people ’s awareness of daily salt intake and to change their eating habits in terms of reducing salt intake for better cardiovascular health . Health education programs visualizing daily dietary salt content and intake may promote lifestyle changes in patients at high risk of cardiovascular diseases . Methods / Design This is a cluster r and omized trial . A total of 800 high-CVD-risk patients attending diabetes and hypertension clinics at health centers in Muang District , Chiang Rai province , Thail and , will be studied with informed consent . A health center recruiting 100 participants is a cluster , the unit of r and omization . Eight clusters will be r and omized into intervention and control arms and followed up for 1 year . Within the intervention clusters the following will be undertaken : ( 1 )  salt content in the daily diet will be measured and shown to study participants ; ( 2 )  24-hour salt intake will be estimated in overnight-collected urine and the results shown to the participants ; ( 3 ) a dietician will assist small group health education classes in cooking meals with less salt . The primary outcome is blood pressure change at the 1-year follow-up . Secondary outcomes at the 1-year follow-up are estimated 24-hoursalt intake , incidence of CVD events and CVD death . The intention-to-treat analysis will be followed . Blood pressure and estimated 24-hour salt intake will be compared between intervention and control groups at the cluster and individual level at the 1-year follow-up . Clinical CVD events and deaths will be analyzed by time-event analysis . Retinal blood vessel calibers of CVD-risk patients will be assessed cross-sectionally . Behavioral change to reduce salt intake and the influencing factors will be determined by structured equation model ( SEM ) . Multilevel regression analyses will be applied . Finally , the cost effectiveness of the intervention will be analyzed . Discussion This study is unique as it will recruit the individuals most vulnerable to CVD morbidity and mortality by applying the general Framingham CVD risk scoring system . Dietary salt reduction will be applied as a prioritized , community level intervention for the prevention of CVD in a developing country . Trial registration IS RCT Background Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management . The aim of this study is to investigate whether a best- practice model that applies major elements of case management and patient education , can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events . Methods This 24-month cluster-r and omized trial will be performed with 690 adult patients from 46 practice s. The trial intervention will be a complex intervention involving general practitioners , healthcare assistants , and patients with an indication for oral anticoagulation . To assess adherence to medication and symptoms in patients , as well as to detect complications early , healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List ( Co-MoL ) to regularly monitor patients . Patients will receive information ( leaflets and a video ) , treatment monitoring via the Co-MoL and be motivated to perform self-management . Patients in the control group will continue to receive treatment as usual from their general practitioners . The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications . Secondary endpoints are mortality , hospitalization , strokes , major bleeding and thromboembolic complications , severe treatment interactions , the number of adverse events , quality of anticoagulation , health-related quality of life , and costs . Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective : patients ’ assessment of chronic illness care , self-reported adherence to medication , general practitioners ’ and healthcare assistants ’ knowledge , and patients ’ knowledge and satisfaction with shared decision making . Practice recruitment is expected to take place between July and December 2012 . Recruitment of eligible patients will start in July 2012 . Assessment will occur at three time points : baseline and follow-up after 12 months and after 24 months . Discussion The efficacy and effectiveness of individual elements of the intervention , such as antithrombotic interventions , self-management concepts in orally anticoagulated patients , and the method ological tool of case management , have already been extensively demonstrated . This project foresees the combination of several proven instruments , as a result of which we expect to profit from a reduction in the major complications associated with antithrombotic treatment . Trial registration Current Controlled Trials IS RCT
The study showed that the computerized decision aid appears to increase the proportion of patients who responded to invitations to discuss CVD prevention with their doctor .
We tentatively conclude that CAHTS can provide individually-tailored information about CVD prevention .
BACKGROUND AND OBJECTIVES CVD is an important global healthcare issue ; it is the leading cause of global mortality , with an increasing incidence identified in both developed and developing countries .
It is also an extremely costly disease for healthcare systems unless managed effectively .
In this review we aim ed to : - Assess the effect of computer-assisted versus oral- and -written history taking on the quality of collected information for the prevention and management of CVD . -
Assess the effect of computer-assisted versus oral- and -written history taking on the prevention and management of CVD .