IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Secondary prevention of cardiovascular disease: a randomised trial of training in information management, evidence-based medicine, both or neither: the PIER trial. National Study of Physician Awareness and Adherence to Cardiovascular Disease Prevention Guidelines Electronic Health Record-Based Patient Identification and Individualized Mailed Outreach for Primary Cardiovascular Disease Prevention: A Cluster Randomized Trial Global Risk Assessment to Guide Blood Pressure Management in Cardiovascular Disease Prevention Impact of socioeconomic deprivation on screening for cardiovascular disease risk in a primary prevention population: a cross-sectional study 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 Cardiorespiratory Fitness in Childhood and Adolescence Affects Future Cardiovascular Risk Factors: A Systematic Review of Longitudinal Studies The systematic coronary risk evaluation (SCORE) for the prevention of cardiovascular diseases. Does evidence exist for its effectiveness? A systematic review Cardiovascular disease risk assessment in older women: can we improve on Framingham? British Women’s Heart and Health prospective cohort study Statins for Primary Prevention: The Debate Is Intense, but the Data Are Weak. Cardiovascular disease risk factors, depression symptoms and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes 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 Fremantle Primary Prevention Study: a multicentre randomised trial of absolute cardiovascular risk reduction. The Effectiveness of Pharmacist Interventions on Cardiovascular Risk: The Multicenter Randomized Controlled RxEACH Trial. Randomised controlled trial comparing uptake of NHS Health Check in response to standard letters, risk-personalised letters and telephone invitations Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization A simple risk score using routine data for predicting cardiovascular disease in primary care. Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods.
BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care .  Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 ) In 1998 , the American Heart Association convened Prevention Conference V to examine strategies for the identification of high-risk patients who need primary prevention . Among the strategies discussed was the measurement of markers of inflammation.1  The Conference concluded that “ many of these markers ( including inflammatory markers ) are not yet considered applicable for routine risk assessment because of : ( 1 ) lack of measurement st and ardization , ( 2 ) lack of consistency in epidemiological findings from prospect i ve studies with endpoints , and ( 3 ) lack of evidence that the novel marker adds to risk prediction over and above that already achievable through the use of established risk factors . ” The National Cholesterol Education Program Adult Treatment Panel III Guidelines identified these markers as emerging risk factors,1a which could be used as an optional risk factor measurement to adjust estimates of absolute risk obtained using st and ard risk factors . Since these publications , a large number of peer- review ed scientific reports have been published relating inflammatory markers to cardiovascular disease ( CVD ) . Several commercial assays for inflammatory markers have become available . As a consequence of the exp and ing research base and availability of assays , the number of inflammatory marker tests ordered by clinicians for CVD risk prediction has grown rapidly . Despite this , there has been no consensus from professional societies or governmental agencies as to how these assays of markers of inflammation should be used in clinical practice . On March 14 and 15 , 2002 , a workshop titled “ CDC/AHA Workshop on Inflammatory Markers and Cardiovascular Disease : Applications to Clinical and Public Health Practice ” was convened in Atlanta , Ga , to address these issues . The goals of this workshop were to determine which of the currently available tests should be used ; what results should be used to define high risk ; which patients should be tested ; and the indications for which the tests would be most useful . These BACKGROUND Sub-optimal management of cardiovascular disease ( CVD ) patients is widespread in primary and secondary care , with risk factors frequently unrecorded or untreated . AIM To investigate the effectiveness of educational interventions developed in primary care , on recording , prescribing and control of risk factors among all patients recorded by their general practitioner as having CVD . DESIGN OF STUDY Factorial , duster-r and omised controlled trial . SETTING Primary care teams representing the range of practice development in a geographically defined area in inner London . METHOD Participating practice s were r and omly allocated to one of the four intervention groups : information , evidence , both or neither . Interventions were tailored to suit individual practice needs . At a mean of 19 months after baseline , and three months after the end of intervention , practice s carried out the follow-up assessment of recording , treatment , and control of risk factors in the same CVD patients . RESULTS Adequate recording of all three risk factors , found inapproximately a third of patients at baseline , increased non-significantly by 10.5 % ( 95 % confidence interval [ CI ] = 3.9 to 24.9 ) in the information ( versus not information ) group and by 6.6 % ( 95 % [ CI ] = 8.9 to 22.0 ) in the evidence ( versus not evidence ) group . Factorial improvements in prescribing and control of risk factors tended not to be significant . Adequate recording of an three risk factors showed the greatest improvement in the information plus evidence group ( 19.9 % increase , P for heterogeneity across the four groups < or = 0.001 ) . Mean change from baseline to follow-up within the four intervention groups suggested improvements in the combined information plus evidence group in cholesterol recording ( 22.5 % increase ) , prescribing of lipid lowering drugs ( 4.4 % increase ) and mean cholesterol ( 0.7 mmol/l decrease ) . CONCLUSIONS Adequate risk factor recording did not differ between the information ( versus not information ) or the evidence ( versus not evidence ) intervention groups . Combined training in information systems and evidence -based medicine should be considered in the design of future interventions , to improve secondary prevention of CVD Background —Few data have evaluated physician adherence to cardiovascular disease ( CVD ) prevention guidelines according to physician specialty or patient characteristics , particularly gender . Methods and Results —An online study of 500 r and omly selected physicians ( 300 primary care physicians , 100 obstetricians/gynecologists , and 100 cardiologists ) used a st and ardized question naire to assess awareness of , adoption of , and barriers to national CVD prevention guidelines by specialty . An experimental case study design tested physician accuracy and determinants of CVD risk level assignment and application of guidelines among high- , intermediate- , or low-risk patients . Intermediate-risk women , as assessed by the Framingham risk score , were significantly more likely to be assigned to a lower-risk category by primary care physicians than men with identical risk profiles ( P<0.0001 ) , and trends were similar for obstetricians/gynecologists and cardiologists . Assignment of risk level significantly predicted recommendations for lifestyle  and preventive pharmacotherapy . After adjustment for risk assignment , the impact of patient gender on preventive care was not significant except for less aspirin ( P<0.01 ) and more weight management recommended ( P<0.04 ) for intermediate-risk women . Physicians did not rate themselves as very effective in their ability to help patients prevent CVD . Fewer than 1 in 5 physicians knew that more women than men die each year from CVD . Conclusions —Perception of risk was the primary factor associated with CVD preventive recommendations . Gender disparities in recommendations for preventive therapy were explained largely by the lower perceived risk despite similar calculated risk for women versus men . Educational interventions for physicians are needed to improve the quality of CVD preventive care and lower morbidity and mortality from CVD for men and women ABSTRACT BACKGROUND Many individuals at higher risk for cardiovascular disease ( CVD ) do not receive recommended treatments . Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness . OBJECTIVE AND DESIGN To perform a 9-month cluster-r and omized trial , comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care . PARTICIPANTS Patients of participating physicians with a Framingham Risk Score of at least 5 % , low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment , and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis .INTERVENTION Patients of physicians r and omized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin ( and controlling hypertension or quitting smoking when relevant).MAIN MEASURES The primary outcome was occurrence of a LDL-cholesterol level , repeated in routine practice , that was at least 30 mg/dl lower than prior . A secondary outcome was lipid-lowering drug prescribing . Clinical trials.gov identifier : NCT01286311.KEY RESULTS Fourteen physicians with 218 patients were r and omized to intervention , and 15 physicians with 217 patients to control . The mean patient age was 60.7 years and 77 % were male . There was no difference in the primary outcome ( 11.0 % vs. 11.1 % , OR 0.99 , 95 % CI 0.56–1.74 , P = 0.96 ) , but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication ( 11.9 % , vs. 6.0 % , OR 2.13 , 95 % CI 1.05–4.32 , p = 0.038 ) . In post hoc analysis with extended follow-up to 18 months , the primary outcome occurred more often in the intervention group ( 22.5 % vs. 16.1 % , OR 1.59 , 95 % CI 1.05–2.41 , P = 0.029 ) . CONCLUSIONS In this effectiveness trial , individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions , but we observed no difference in proportions lowering LDL-cholesterol after 9 months . With longer follow-up , the intervention ’s effect on LDL-cholesterol levels was apparent 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 Objectives Investigate the association between socioeconomic deprivation and completeness of cardiovascular disease ( CVD ) risk factor recording in primary care , uptake of screening in people with incomplete risk factor recording and with actual CVD risk within the screened subgroup . Design Cross-sectional study . Setting Nine UK general practice s. Participants 7987 people aged 50–74 years with no CVD diagnosis . Methods CVD risk was estimated using the Framingham equation from data extracted from primary care electronic health records . Where there was insufficient information to calculate risk , patients were invited to attend a screening assessment . Analysis Proportion of patients for whom clinical data were sufficiently complete to enable CVD risk to be calculated ; proportion of patients invited to screening who attended ; proportion of patients who attended screening whose 10-year risk of a cardiovascular event was high ( > 20 % ) . For each outcome , a set of logistic regression models were run . Crude and adjusted ORs were estimated for person-level deprivation , age , gender and smoking status . We included practice -level deprivation as a continuous variable and practice as a r and om effect to account for clustering . Results People who had lower  Indices of Multiple Deprivation ( IMD ) scores ( less deprived ) had significantly worse routine CVD risk factor recording ( adjusted OR 0.97 ( 0.95 to 1.00 ) per IMD decile ; p=0.042 ) . Screening attendance was poorer in those with more deprivation ( adjusted OR 0.89 ( 0.86 to 0.91 ) per IMD decile ; p<0.001 ) . Among those who attended screening , the most deprived were more likely to have CVD risk > 20 % ( OR 1.09 ( 1.03 to 1.15 ) per IMD decile ; p=0.004 ) . Conclusions Our data suggest that those who had the most to gain from screening were least likely to attend , potentially exacerbating existing health inequalities . Future research should focus on tailoring the delivery of CVD screening to ensure engagement of socioeconomically deprived groups 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 Background Although cardiorespiratory fitness ( CRF ) in childhood and adolescence may be linked to future cardiovascular health , there is currently limited evidence for a longitudinal association . Objectives To provide a systematic review on the prospect i ve association between CRF in childhood and adolescence and cardiovascular disease ( CVD ) risk factors at least 2 years later . Methods Using a systematic search of Medline , Embase , and SPORTD iscus , relevant articles were identified by the following criteria : generally healthy children and adolescents between 3 and 18 years of age with CRF assessed at baseline , and a follow-up period of ≥ 2 years . The outcome measures were CVD risk factors . We appraised quality of the included articles with STROBE and QUIPS checklists . Results After screening 7524 titles and abstract s , we included 38 articles , assessing 44,169 children and adolescents followed up for a median of 6 years . Eleven articles were of high quality . There was considerable heterogeneity in methodology , measurement of CRF , and outcomes , which hampered meta- analysis . In approximately half of the included articles higher CRF in childhood and adolescence was associated with lower body mass index ( BMI ) , waist circumference , body fatness and lower prevalence of metabolic syndrome in later life . No associations between CRF in childhood and adolescence and future waist-to-hip ratio , blood pressure , lipid profile , and glucose homeostasis were observed . Conclusion Although about half of the included articles reported inverse associations between CRF in childhood and adolescence and future BMI , body fatness , and metabolic syndrome , evidence for other CVD risk factors was unconvincing . Many articles did not account for important confounding factors such as adiposity . Recommendations for future research include st and ardizing the measurement of CRF , i.e. by reporting VO2max , using st and ardized outcome assessment s , and performing individual patient data meta-analyses Objectives : The SCORE model predicts the ten-year risk of cardiovascular mortality but it is still unknown whether applying the SCORE in clinical practice subsequently improves cardiovascular disease ( CVD ) outcomes . The objective of this study is to assess the effect of total cardiovascular risk estimation using the SCORE in preventing serious cardiovascular events in European adults without prior CVD . Methods and results : Data sources : eight bibliographical data bases ( 2003 – August 2015 ) , other internet sources and reference lists of articles were checked . This was supplemented by contact with the board members of the European Society of Cardiology ( ESC ) and the authors of the SCORE model . Study eligibility criteria : all prospect i ve studies in any language investigating the effect of using the SCORE on the clinical outcome ( CVD death , major events and adverse outcomes ) in an adult population were examined . Two review ers assessed the studies independently ( titles , abstract s , full texts ) . After removal of duplicates , 5,256 records were screened and 14 full text papers considered . No eligible studies were identified . An extensive literature search revealed no r and omized control trial or other prospect i ve study comparing significant clinical outcomes between groups that used the SCORE and those who did not . Conclusions : The effect of using the SCORE ( with or without subsequent intervention ) on CVD death , all-cause mortality , major CVD events like myocardial infa rct ion and stroke , as well as adverse outcomes , is still unknown . A cluster r and omised controlled trial is warranted to evaluate the use of the SCORE on important outcomes Objectives : To develop a cardiovascular risk assessment tool that is feasible and easy to use in primary care ( general practice ( GP ) model ) . Design : Prospect i ve cohort study . Setting : 23 towns in the United Kingdom . Participants : 3582 women aged 60 to 79 years who were free of coronary heart disease ( CHD ) at entry into the British Women ’s Heart and Health Study . Main outcome measures : Predictive performance of a GP model compared with the st and ard Framingham model for both CHD and cardiovascular disease ( CVD ) . Results : The Framingham tool predicted CHD events over 5 years accurately ( predicted 5.7 % , observed 5.5 % ) but overpredicted CVD events ( predicted 10.5 % , observed 6.8 % ) . In higher-risk groups , Framingham overpredicted both CHD and CVD events and was poorly calibrated for this cohort . Including C-reactive protein and fibrinogen with st and ard Framingham risk factors did not improve discrimination of the model . The GP model , which used age , systolic blood pressure , smoking habit and self-rated health ( all of which can be easily obtained in one surgery visit ) performed as well as the Framingham risk tool : area under the receiver operating curve discrimination statistic was 0.66 ( 95 % confidence interval ( CI ) 0.62 to 0.70 ) for CHD and 0.67 ( 95 % CI 0.64 to 0.71 ) for CVD compared with 0.65 ( 95 % CI 0.61 to 0.68 ) and 0.66 ( 95 % CI 0.62 to 0.69 ) for the corresponding Framingham models . Conclusions : An alternative risk assessment based on only a simple routine examination and a small number of pertinent questions may be more useful in the primary care setting . This model appears to perform well but needs to be tested in different population 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 /hypothesisTo determine the associations of baseline depression symptoms and use of antidepressant medicines ( ADMs ) with baseline cardiovascular disease ( CVD ) risk factors in Look AHEAD ( Action for Health in Diabetes ) trial participants . Methods Look AHEAD participants ( n = 5,145 ; age 58.7 ± 6.8 years ; BMI 35.8 ± 5.8 kg/m2 ) were assessed for CVD risk factors ( elevated HbA1c or insulin use , elevated BP or antihypertensive use , elevated lipid levels or lipid-lowering medication , current smoking , BMI ≥30 kg/m2 , lower peak exercise capacity assessed as metabolic equivalents [ METs ] , and ankle – brachial index < 0.9 or > 1.3 ) . Participants also completed the Beck Depression Inventory ( BDI ) and reported their use of ADMs . Results Of the participants , 14.7 % had BDI scores ≥11 , consistent with mild-moderate depression , and 16.5 % took ADMs ; 4.4 % had both depression markers ( i.e. elevated symptom scores and took ADMs ) . In logistic regression analyses of CVD risk ( elevated risk factor or use of medication to control the risk factor ) , controlled for demographic factors , continuous BDI  scores and ADM use were each independently associated with elevated BP ( or medication ) , current smoking , BMI ≥30 kg/m2 and lower MET values . ADM use was also associated with elevated serum lipids or use of lipid-lowering medication . Conclusions /interpretationAmong Look AHEAD participants , depression symptoms or ADM use on entry to the study were each independently associated with a wide range of CVD risk factors . Future research should assess the temporal dynamics of the relationships  of depression symptoms and ADM use with CVD risk factors . Trial registration Clinical trials.gov NCT00017953 Funding This study is funded by the National Institutes of Health with additional support from the Centers for Disease Control and Prevention 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 Cardiovascular disease ( CVD ) is the leading cause of global mortality . Risk factor management in clinical practice often relies on relative risk modification rather than the more appropriate absolute risk assessment . AIM To determine whether patients receiving more-frequently design ated GP visits had increased benefit in terms of their absolute CVD risk assessment , as compared with patients in receipt of their usual GP care . DESIGN AND SETTING Prospect i ve , open , pragmatic block r and omised study in a 1:1 group allocation ratio in three Western Australian general practice s. METHOD A convenience sample ( n = 1200 ) of patients aged 40 - 80 years were r and omised to 3-monthly GP visits ( five in total for the intensive ) or usual GP care ( two in total for the opportunistic ) , with 12 months ' follow-up . The main outcome was absolute CVD risk scores based on the New Zeal and Cardiovascular Risk Calculator . Others outcome measures were weight , height , waist circumference , blood pressure , and fasting blood lipids and glucose . RESULTS There were 600 patients per group at baseline . At 12 months ' analysis there were 543 in the intensive group and 569 in the opportunistic group . Mean ( st and ard deviation [ SD ] ) absolute CVD risk reduced significantly between baseline and 12 months in the intensive group ( 6.28 % [ 5.11 ] to 6.10 % [ 4.94 ] ) but not in the opportunistic group ( 6.27 % [ 5.10 ] to 6.24 % [ 5.38 ] ) . There was a significant reduction between baseline and 12 months in mean ( SD ) total cholesterol ( 5.28 mmol/l [ 0.94 ] to 5.08 mmol/l [ 0.96 ] ) ; low-density lipoprotein cholesterol ( 3.08 mmol/l [ 0.87 ] to 2.95 mmol/l [ 0.89 ] ) ; triglyceride ( 1.45 mmol/l [ 0.86 ] to 1.36 mmol/l [ 0.84 ] ) ; and in mean ( SD ) waist circumference in men ( 98.74 cm [ 10.70 ] to 97.13 cm [ 10.20 ] ) and females ( 90.64 cm [ 14.62 ] to 88.96 cm [ 14.00 ] ) in the intensive group . CONCLUSION A targeted approach using absolute risk calculators can be used in primary care to modify global CVD risk assessment BACKGROUND Despite the cardiovascular disease ( CVD ) risk associated with hypertension , diabetes , dyslipidemia , and smoking , these risk factors remain poorly identified and controlled . OBJECTIVES The study sought to evaluate the effectiveness of a community pharmacy-based case finding and intervention on cardiovascular risk . METHODS The RxEACH ( Alberta Vascular Risk Reduction Community Pharmacy Project ) study was a r and omized trial conducted in 56 community pharmacies . Participants were recruited by their pharmacist , who enrolled adults at high risk for CVD . Patients were r and omized to usual care ( usual pharmacist care with no specific intervention ) or intervention , comprising a Medication Therapy Management review from their pharmacist and CVD risk assessment and education . Pharmacists prescribed medications and ordered laboratory tests as per their scope of practice to achieve treatment targets . Subjects received monthly follow-up visits for 3 months . The primary outcome was difference in change in estimated CVD risk between groups at 3 months . CVD risk was estimated using the greater of the Framingham , International , or United Kingdom Prospect i ve Diabetes Study risk scores . RESULTS We enrolled 723 patients ( mean 62 years of age ; 58 % male , and 27 % smokers ) . After adjusting for baseline values and center effect , there was a 21 % difference in change in risk for CVD events ( p < 0.001 ) between the intervention and usual care groups . The intervention group had greater improvements in low-density lipoprotein cholesterol ( -0.2 mmol/l ; p < 0.001 ) , systolic blood pressure ( -9.37 mm Hg ; p < 0.001 ) , glycosylated hemoglobin ( -0.92 % ; p < 0.001 ) , and smoking cessation ( 20.2 % ; p = 0.002 ) . CONCLUSIONS The RxEACH study was the first large r and omized trial of CVD risk reduction by community pharmacists , demonstrating a significant reduction in risk for CVD events . Engagement of community pharmacists with an exp and ed scope of practice could have significant public health implication s. ( The Alberta Vascular Risk Reduction Community Pharmacy Project : RxEACH [ RxEACH ] ; NCT01979471 ) Background NHS Health Check is a primary prevention programme offering cardiovascular disease ( CVD ) risk assessment to adults in Engl and aged 40–74 . Uptake remains a challenge and invitation method is a strong predictor of uptake . There is evidence of low uptake when using invitation letters . Telephone invitations might increase uptake , but are not widely used . We explored the potential to improve uptake through personalising letters to patient ’s CVD risk , and to compare this with generic letters and telephone invitations . Methods HEalth Check TRial ( HECTR ) was a three-arm r and omised controlled trial in nine general practice s in Staffordshire ( UK ) . Eligible patients were r and omised to be invited to a NHS Health Check using one of three methods : st and ard letter ( control ) ; telephone invitation ; letter personalised to the patient ’s CVD risk . The primary outcome was attendance/non-attendance . Data were collected on a range of patient- and practice -level factors ( e.g. , patient socio-demographics , CVD risk , practice size , Health Checks outside usual working hours ) . Multi-level logistic regression estimated the marginal effects to explore whether invitation method predicted attendance . Invitation costs were collated from practice s to estimate cost benefit . Results In total , 4614 patients were included in analysis ( mean age 50.2 ± 8.0 yr . ; 52.4 % female ) . Compared with patients invited by st and ard letter ( 30.9 % ) , uptake was significantly higher in those invited by telephone ( 47.6 % , P < .001 ) , but not personalised letter ( 31.3 % , p = .812 ) . In multi-level analysis , compared with the st and ard letter arm , likelihood of attendance was 18 percentage points higher in the telephone arm and 4 percentage points higher in the personalised letter arm . The effect of telephone calls appeared strongest in patients who were younger and had lower CVD risk . We estimated per 1000 patients invited , risk-personalised letters could result in 40 additional attended Health Checks ( at no extra cost ) and telephone invitations could result in 180 additional Health Checks at an additional cost of £ 240 . Conclusions Telephone invitations should be advocated to address the substantial deficit between current and required levels of NHS uptake , and could be targeted at younger and lower CVD risk adults .  Risk-personalised letters should be explored further in a larger sample of high risk individuals . Trial registration Registration number : IS RCT N15840751 date of registration : 24/10/2017 BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been " identified"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India Background The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear . More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease ( CVD ) , side effects , improvement in adherence and physician/patient " acceptability " of the Polypill . Methods We conducted an open-label , parallel-group , r and omized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD . The trial compared a Polypill ( 75 mg aspirin , 20 mg simvastatin , 10 mg lisinopril and 12.5 mg hydrochlorothiazide ) to St and ard Practice . After r and omization , patients were followed monthly for three months . Pre-specified primary outcomes included reduction in systolic blood pressure , total cholesterol and estimated 10-year CVD risk . We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients . Results Patients were recruited in a six-month period as planned . Two hundred three patients ( 94.0 % ) completed the treatment program and returned for their three-month follow-up visits . No safety concerns were reported . These findings suggest a high rate of patient acceptability , a finding that is bolstered by the majority of patients completing the trial ( 90 % ) indicating that they would take the Polypill " for life " if proven to be effective in reducing CVD risk . Approximately 86 % of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93 % for secondary prevention of CVD . Both the Polypill and St and ard Practice result ed in marked reductions in systolic blood pressure , total cholesterol and 10-year risk of CVD . However , the differences between the treatment groups were not statistically significant . Conclusions We successfully completed a Polypill feasibility trial in Sri Lanka . We were able to document high acceptability of the Polypill to patients and physicians . We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs . The Polypill was however simpler and achieved comparable risk factor reductions , highlighting its potential usefulness in the prevention of CVD.Trial registration number Clinical trials.gov : BACKGROUND Population -based screening for cardiovascular disease ( CVD ) risk , incorporating blood tests , is proposed in several countries . AIM The aim of this study was to evaluate whether a simple approach to identifying individuals at high risk of CVD using routine data might be effective . DESIGN OF STUDY Prospect i ve cohort study ( EPIC-Norfolk ) . SETTING Norfolk area , UK . METHOD A total of 21 867 men and women aged 40 - 74 years , who were free from CVD and diabetes at baseline , participated in the study . The discrimination ( the area under the receiver operating characteristic curve [ aROC ] ) , calibration , sensitivity/specificity , and positive/negative predictive value were evaluated for different risk thresholds of the Framingham risk equations and the Cambridge diabetes risk score ( as an example of a simple risk score using routine data from electronic general practice records ) . RESULTS During 203 664 person-years of follow-up , 2213 participants developed a first CVD event ( 10.9 per 1000 person-years ) . The Cambridge diabetes risk score predicted CVD events reasonably well ( aROC 0.72 ; 95 % confidence interval [ CI ] = 0.71 to 0.73 ) , while the Framingham risk score had the best predictive ability ( aROC 0.77 ; 95 % CI = 0.76 to 0.78 ) . The Framingham risk score overestimated risk of developing CVD in this representative British population by 60 % . CONCLUSION A risk score incorporating routinely available data from GP records performed reasonably well at predicting CVD events . This suggests that it might be more efficient to use routine data as the first stage in a stepwise population screening programme to identify people at high risk of developing CVD before more time- and re source -consuming tests are used OBJECTIVE People living with HIV infection are at increased risk for developing cardiovascular disease ( CVD ) . Safe and effective interventions for lowering CVD risk in HIV infection are high priorities . We conducted a prospect i ve , r and omized , controlled study to evaluate whether a yoga lifestyle intervention improves CVD risk factors , virological or immunological status , or quality of life ( QOL ) in HIV-infected adults relative to st and ard of care treatment in a matched control group . METHODS Sixty HIV-infected adults with mild-moderate CVD risk were assigned to 20 weeks of supervised yoga practice or st and ard of care treatment . Baseline and week 20 measures were : 2-h oral glucose tolerance test with insulin monitoring , body composition , fasting serum lipid/lipoprotein profile , resting blood pressures , CD4 T-cell count and plasma HIV RNA , and the Medical Outcomes Study Short Form (SF)-36 health-related QOL inventory . RESULTS Resting systolic and diastolic blood pressures improved more ( P=0.04 ) in the yoga group ( -5 + /- 2 and -3 + /- 1 mmHg , respectively ) than in the st and ard of care group ( + 1 + /- 2 and + 2 + /- 2 mmHg , respectively ) . However , there was no greater reduction in body weight , fat mass or proatherogenic lipids , or improvements in glucose tolerance or overall QOL after yoga . Immune and virological status was not adversely affected . CONCLUSION Among traditional lifestyle modifications , yoga is a low-cost , simple to administer , nonpharmacological , popular behavioural intervention that can lower blood pressure in pre-hypertensive HIV-infected adults with mild-moderate CVD risk factors Background Intensive diet and physical activity interventions have been found to reduce cardiovascular disease ( CVD ) risk , but are re source intensive . The American Heart Association recently recommended motivational interviewing ( MI ) as an effective approach for low-intensity interventions to promote health-related outcomes such as weight loss . However , there is limited research evaluating the long-term effectiveness of MI-based interventions on health-related outcomes associated with CVD risk . The current research evaluated the effectiveness of a six-month low-intensity MI intervention in a UK primary -care setting in maintaining reductions in CVD risk factors at12 months post-intervention . Methods Primary -care patients were r and omised to an intervention group that received st and ard exercise and nutrition information plus up to five face-to-face MI sessions , delivered by a physical activity specialist and registered dietician over a 6-month period , or to a minimal intervention comparison group that received the st and ard information only . Follow-up measures of behavioural ( vigorous and moderate physical activity , walking , physical activity stage-of-change , fruit and vegetable intake , and dietary fat intake ) and biomedical ( weight , body mass index [ BMI ] , blood pressure , cholesterol ) outcomes were taken immediately post-intervention and at a 12-month follow-up occasion . Results Intent-to-treat analyses revealed significant differences between groups for walking and cholesterol .  Obese and hypercholesterolemic patients at baseline exhibited significant improvements in BMI and cholesterol respectively among those allocated to the intervention group compared to the comparison group . Post-intervention improvements in other health-related outcomes including blood pressure , weight , and BMI were not maintained . Conclusions The present study suggests that a low-intensity MI counselling intervention is effective in bringing about long-term changes in some , but not all , health-related outcomes ( walking , cholesterol levels ) associated with CVD risk . The intervention was particularly effective for patients with elevated levels of CVD risk factors at baseline . Based on these findings future interventions should be conducted in a primary care setting and target patients with high risk of CVD . Future research should investigate how the long-term gains in health-related outcomes brought about by the MI-counselling intervention in the current study could be extended to a wider range of health outcomes Disseminating and implementing evidence -based , cardiovascular disease ( CVD ) prevention lifestyle interventions in community setting s and in ethnic minority population s is a challenge . We describe the design and methods for the South Asian Heart Lifestyle Intervention ( SAHELI ) study , a pilot study design ed to determine the feasibility and initial efficacy of a culturally-targeted , community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians ( SAs ) . Participants with at least one CVD risk factor will be r and omized to either a lifestyle intervention or a control group .  Participants in both groups will be screened in a community setting and receive a primary care referral after r and omization . Intervention participants will receive 6weeks of group classes , followed by 12weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal . Control participants will receive their screening results and monthly mailings on CVD prevention . Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline , 3- , and 6-month follow-up . Secondary outcomes will be changes in weight , clinical risk factors , primary care visits , self-efficacy , and social support . This study will be one of the first to pilot-test a lifestyle intervention for SAs , one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk . Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population
The impact of TRA on global CVD risk as well as individual risk factors is ambiguous , but a tendency towards slight reduction of blood pressure , total cholesterol and smoking levels , especially in high risk patient groups was observed .
TRA had no influence on lifestyle behaviour .
Conclusions There is limited evidence , of low overall quality , suggesting a possible lack of effectiveness of TRA in reducing CVD events and mortality , as well as a clinical ly insignificant influence on individual risk factor levels .
Background Our objectives were to critically appraise and summarise the current evidence for the effectiveness of using cardiovascular disease ( CVD ) risk scoring ( total risk assessment - TRA ) in routine risk assessment in primary prevention of CVD compared with st and ard care with regards to patients outcomes , clinical risk factor levels , medication prescribing , and adverse effects .