The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411] A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies The effect of a smartphone-based coronary heart disease prevention (SBCHDP) programme on awareness and knowledge of CHD, stress, and cardiac-related lifestyle behaviours among the working population in Singapore: a pilot randomised controlled trial 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 Multiple risk factor intervention trial. Risk factor changes and mortality results. Multiple Risk Factor Intervention Trial Research Group. 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Treatment with Atorvastatin to the National Cholesterol Educational Program Goal Versus 'Usual' Care in Secondary Coronary Heart Disease Prevention Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare'): Study protocol
Background Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease ( CHD ) prevention medications and help patients choose medications to which they are likely to adhere . However , little data is available on decision aids design ed to promote adherence . Methods In this paper , we report on secondary analyses of a r and omized trial of a CHD adherence intervention ( second generation decision aid plus tailored messages ) versus usual care in an effort to underst and how the decision aid facilitates adherence . We focus on data collected from the primary study visit , when  intervention participants presented 45 minutes early to a previously scheduled provider visit ; viewed the decision aid , indicating their intent for CHD risk reduction after each decision aid component ( individualized risk assessment and education , values clarification , and coaching ) ; and filled out a post-decision aid survey assessing their knowledge , perceived risk , decisional conflict , and intent for CHD risk reduction . Control participants  did not present early and received usual care from their provider . Following the provider visit , participants in both groups completed post-visit surveys assessing the number and quality of CHD discussion s with their provider , their intent for CHD risk reduction , and their feelings about the decision aid . Results We enrolled 160 patients into our study ( 81 intervention , 79  control ) . Within the decision aid group , the decision aid significantly increased knowledge of effective CHD prevention strategies ( + 21 percentage points ; adjusted p<.0001 ) and the accuracy of perceived CHD risk ( + 33 percentage points ; adjusted p<.0001 ) , and significantly decreased decisional conflict ( -0.63 ; adjusted p<.0001 ) . Comparing between study groups , the decision aid also significantly increased CHD prevention discussion s with providers ( + 31 percentage points ; adjusted p<.0001 ) and improved perceptions of some features of patient-provider interactions . Further , it increased participants ’ intentions for any effective CHD risk reducing strategies ( + 21 percentage points ; 95 % CI 5 to 37 percentage points ) , with a majority of the effect from the educational component of the decision aid . Ninety-nine percent of participants found the decision aid easy to underst and and 93 % felt it easy to use . Conclusions Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussion s and intent to reduce CHD risk Background The aim of the SPHERE study is to design , implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease ( CHD ) in general practice across two different health systems on the isl and of Irel and .CHD is a common cause of death and a significant cause of morbidity in Irel and . Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives . Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the isl and of Irel and . The review literature recommends structured programmes with continued support and follow-up of patients ; the provision of training , tailored to practice needs of access to evidence of effectiveness of secondary prevention ; structured recall programmes that also take account of individual practice needs ; and patient-centred consultations accompanied by attention to disease management guidelines . Methods SPHERE is a cluster r and omised controlled trial , with practice -level r and omisation to intervention and control groups , recruiting 960 patients from 48 practice s in three study centres ( Belfast , Dublin and Galway ) . Primary outcomes are blood pressure , total cholesterol , physical and mental health status ( SF-12 ) and hospital re-admissions . The intervention takes place over two years and data is collected at baseline , one-year and two-year follow-up . Data is obtained from medical charts , consultations with practitioners , and patient postal question naires . The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice . It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients . General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD . Patients are invited to attend regular four-monthly consultations over two years , during which targets and goals for secondary prevention are set and review ed . The analysis will be strengthened by economic , policy and qualitative components Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov : Abstract Background Coronary heart disease ( CHD ) is the most prevalent type of cardiac disease among adults worldwide , including those in Singapore . Most of its risk factors , such as smoking , physical inactivity and high blood pressure , are preventable . mHealth has improved in the last decade , showing promising results in chronic disease prevention and health promotion worldwide . Our aim was to develop and examine the effect of a 4-week Smartphone-Based Coronary Heart Disease Prevention ( SBCHDP ) programme in improving awareness and knowledge of CHD , perceived stress as well as cardiac-related lifestyle behaviours in the working population of Singapore . Methods The smartphone app “ Care4Heart ” was developed as the main component of the programme . App content was review ed and vali date d by a panel of experts , including two cardiologists and two experienced cardiology-trained nurses . A pilot r and omised controlled trial was conducted . Eighty working people were recruited and r and omised to either the intervention group ( n = 40 ) or the control group ( n = 40 ) . The intervention group underwent a 4-week SBCHDP programme , whereas the control group were offered health promotion websites only . The participants ’ CHD knowledge , perceived stress and behavioural risk factors were measured at baseline and on the 4th week using the Heart Disease Fact Question naire-2 , Perceived Stress Scale , and Behavioural Risk Factor Surveillance System . Results After the SBCHDP programme , participants in the intervention group had a better awareness of CHD being the second leading cause of death in Singapore ( X2 = 6.486 , p = 0.039 ) , a better overall CHD knowledge level ( t = 3.171 , p = 0.002 ) , and better behaviour concerning blood cholesterol control ( X2 = 4.54 , p = 0.033 ) than participants in the control group . Conclusion This pilot study partially confirmed the positive effects of the SBCHDP programme in improving awareness and knowledge of CHD among the working population . Due to the small sample size and short follow-up period , this study was underpowered to detect significant differences between groups . A full-scale longitudinal study is required in the future to confirm the effectiveness of the SBCHDP programme 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 The Multiple Risk Factor Intervention Trial was a r and omized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease ( CHD )  in 12,866 high-risk men aged 35 to 57 years . Men were r and omly assigned either to a special intervention ( SI ) program consisting of stepped-care treatment for hypertension , counseling for cigarette smoking , and dietary advice for lowering blood cholesterol levels , or to their usual sources of health care in the community ( UC ) . Over an average follow-up period of seven years , risk factor levels declined in both groups , but to a greater degree for the SI men . Mortality from CHD was 17.9 deaths per 1,000 in the SI group and 19.3 per 1,000 in the UC group , a statistically nonsignificant difference of 7.1 % ( 90 % confidence interval , -15 % to 25 ) . Total mortality rates were 41.2 per 1,000 ( SI ) and 40.4 per 1,000 ( UC ) . Three possible explanations for these findings are considered : ( 1 ) the overall intervention program , under these circumstances , does not affect CHD mortality ; ( 2 ) the intervention used does affect CHD mortality , but the benefit was not observed in this trial of seven years ' average duration , with lower-than-expected mortality and with considerable risk factor change in the UC group ; and ( 3 ) measures to reduce cigarette smoking and to lower blood cholesterol levels may have reduced CHD mortality within subgroups of the SI cohort , with a possibly unfavorable response to antihypertensive drug therapy in certain but not all hypertensive subjects . This last possibility was considered most likely , needs further investigation , and lends support to some preventive measures while requiring re assessment of others Background Lifestyle measures of coronary heart disease ( CHD ) prevention have been overshadowed by the efficacy of drug treatments . This is particularly the case in the setting of secondary prevention where the benefits of lipid lowering , anti-platelet and anti-hypertensive drugs have been emphasised in numerous trials . Lifestyle measures address several CHD risk factors at once and are generally free of serious side effects . Objectives The objective of the present study was to determine whether a comprehensive programme of lifestyle modification could favourably influence dietary and exercise habits in addition to smoking cessation over two years . In addition , an attempt was made to evaluate if this programme could favourably influence the five-year CHD-risk in the male population included in the study . Design A total of 197 patients with proven coronary heart disease were included and r and omised to a lifestyle intervention programme or to usual care . Follow-up was after a period of two years . Methods Intervention comprised a low fat diet , regular exercise , smoking cessation , psychosocial support and education , delivered by nurses on the rationale for pharmacological and lifestyle measures . Usual care comprised follow-up in the routine outpatient clinic . Both groups were given the same comprehensive medication according to recent guidelines . Results Patients in the lifestyle intervention group reduced the intake of saturated fat , sugar and cholesterol ( P<0.001 ) , increased their exercise level ( P<0.01 ) and stopped smoking ( P<0.05 ) when compared with the usual care group . A sub analysis of the influence of five-year CHD calculated risk in males result ed in a relative risk reduction of 22 % ( 95 % confidence intervals 9 - 35 ) . Although significant , this result must be interpreted with caution due to poor statistical power and reproducibility of the method . Conclusions In the presence of modern drug treatments for secondary cardiovascular disease prevention it remains possible through a favourable diet , exercise and smoking cessation to show an additional reduction in the five-year risk for CHD in males The Multiple Risk Factor Intervention Trial ( MRFIT ) was a r and omized primary prevention trial to test whether a special intervention ( SI ) program to reduce high blood pressure , elevated blood cholesterol , and /or cigarette smoking could lower  coronary heart disease ( CHD ) mortality in middle-aged men at above average risk . After an average follow-up period of 7 years , risk factor levels were reduced substantially more in SI than in usual-care ( UC ) men ; however , SI-UC differences in CHD mortality ( 7.1 % ) and total mortality ( -2.1 % ) were not statistically significant . Subgroup analysis showed 35 % fewer SI than UC CHD deaths ( P = 0.14 ) but no all-causes mortality difference in men comparable to the cohort having dietary and smoking intervention in Oslo ( the " Oslo-like " cohort ) . Among the subgroup hypertensive at entry , SI-UC differences in CHD and total mortality appeared to be heterogeneous : CHD mortality was 24 % lower in SI than UC men with a normal resting ECG at baseline , but 67 % higher if baseline ECG abnormalities were present ( nominal P = 0.02 , for difference in relative risk estimates ) . These findings were supported by within-group analyses and are generally consistent with results of other CHD/cardiovascular disease prevention trials . They pose a new hypothesis about possible adverse effects of diuretic therapy in a minority of the hypertensive population IMPORTANCE Most primary care clinicians lack the skills and re sources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk . Thus , effective and feasible CHD prevention programs are needed for typical practice setting s. OBJECTIVE To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats . DESIGN , SETTING , AND PARTICIPANTS A comparative effectiveness trial in 5 diverse family medicine practice s in North Carolina . Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , ≥10 % ) . INTERVENTIONS Participants were r and omized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions . After r and omization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies . Participants chose the risk-reducing strategies they wished to follow . MAIN OUTCOMES AND MEASURES The primary outcome was within-group change in FRS at 4-month follow-up . Other measures included st and ardized assessment s of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence . Acceptability and cost-effectiveness were also assessed . Outcomes were assessed at 4 and 12 months . RESULTS Of 2274 screened patients , 385 were r and omized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % . Follow-up at 4 and 12 months included 91 % and 87 % of the r and omized participants , respectively . There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) . At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) . The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor- and web-based interventions , respectively . CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up . The web format was less expensive . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01245686 Abstract Background Low utilization of effective coronary heart disease ( CHD ) prevention strategies may be due to many factors , but chief among them is the lack of patient involvement in prevention decisions . We undertook this study to test the effectiveness of an individually-tailored , computerized decision aid about CHD on patients ' discussion s with their doctor and their plans for CHD prevention . Methods We conducted a pilot r and omized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored , computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor . Results We enrolled 75 adults . Mean age was 53 . 59 % were female , 73 % white , and 23 % African-American . 66 % had some college education . 43 % had a 10-year CHD risk of 0–5 % , 25 % a risk of 6–10 % , 24 % a risk of 11–20 % , and 5 % a risk of > 20 % . 78 % had at least one option to reduce their CHD risk , but only 45 % accurately identified the strategies best supported by evidence . 41 patients received the decision aid  , 34 received  usual care . In unadjusted analysis , the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % ( absolute difference 16 % ; 95 % CI -4 % to + 37 % ) and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % ( absolute difference 13 % ; 95 % CI -7 % to + 34 % ) . In pre-post testing , the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk ( absolute increase ranging from 21 % to 47 % for planned medication use and 5 % to 16 % for planned behavioral interventions ) . Conclusion Our study confirms patients ' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients ' discussion s about CHD prevention with their doctor and their plans for CHD risk reduction . These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD . Trial Registration : Clinical Trials.gov CONTEXT Observational studies have found lower rates of coronary heart disease ( CHD ) in postmenopausal women who take estrogen than in women who do not , but this potential benefit has not been confirmed in clinical trials . OBJECTIVE To determine if estrogen plus progestin therapy alters the risk for CHD events in postmenopausal women with established coronary disease . DESIGN R and omized , blinded , placebo-controlled secondary prevention trial . SETTING Outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 women with coronary disease , younger than 80 years , and postmenopausal with an intact uterus . Mean age was 66.7 years . INTERVENTION Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate in 1 tablet daily ( n = 1380 ) or a placebo of identical appearance ( n = 1383 ) . Follow-up averaged 4.1 years ; 82 % of those assigned to hormone treatment were taking it at the end of 1 year , and 75 % at the end of 3 years . MAIN OUTCOME MEASURES The primary outcome was the occurrence of nonfatal myocardial infa rct ion ( MI ) or CHD death . Secondary cardiovascular outcomes included coronary revascularization , unstable angina , congestive heart failure , resuscitated cardiac arrest , stroke or transient ischemic attack , and peripheral arterial disease . All-cause mortality was also considered . RESULTS Overall , there were no significant differences between groups in the primary outcome or in any of the secondary cardiovascular outcomes : 172 women in the hormone group and 176 women in the placebo group had MI or CHD death ( relative hazard [ RH ] , 0.99 ; 95 % confidence interval [ CI ] , 0.80 - 1.22 ) . The lack of an overall effect occurred despite a net 11 % lower low-density lipoprotein cholesterol level and 10 % higher high-density lipoprotein cholesterol level in the hormone group compared with the placebo group ( each P<.001 ) . Within the overall null effect , there was a statistically significant time trend , with more CHD events in the hormone group than in the placebo group in year 1 and fewer in years 4 and 5 . More women in the hormone group than in the placebo group experienced venous thromboembolic events ( 34 vs 12 ; RH , 2.89 ; 95 % CI , 1.50 - 5.58 ) and gallbladder disease ( 84 vs 62 ; RH , 1.38 ; 95 % CI , 1.00 - 1.92 ) . There were no significant differences in several other end points for which power was limited , including fracture , cancer , and total mortality ( 131 vs 123 deaths ; RH , 1.08 ; 95 % CI , 0.84 - 1.38 ) . CONCLUSIONS During an average follow-up of 4.1 years , treatment with oral conjugated equine estrogen plus medroxyprogesterone acetate did not reduce the overall rate of CHD events in postmenopausal women with established coronary disease . The treatment did increase the rate of thromboembolic events and gallbladder disease . Based on the finding of no overall cardiovascular benefit and a pattern of early increase in risk of CHD events , we do not recommend starting this treatment for the purpose of secondary prevention of CHD . However , given the favorable pattern of CHD events after several years of therapy , it could be appropriate for women already receiving this treatment to continue BACKGROUND Although lifestyle and medications are effective for coronary heart disease ( CHD ) risk reduction , few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction . In this paper , we report on the design and baseline characteristics of participants for just such a trial . METHODS We conducted a r and omized trial of the same lifestyle and medication intervention delivered in two alternate formats : counselor-delivered or web-based . The trial was conducted at 5 diverse practice s in a family medicine research network and included men and women age 35 - 79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10 % or a known history of cardiovascular disease . After individual-level r and omization , participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months . The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease . Secondary outcomes , measured among all participants , included changes in CHD risk factors , cost-effectiveness , and acceptability at 4 and 12-month follow-up . RESULTS We r and omized 489 eligible patients : 389 without and 100 with a known history of cardiovascular disease . Mean age was 62.3 . 75 % were white , 25 % African-American . 45 % had a college education . 88 % had health insurance . Mean 10-year predicted CHD risk was 16.9 % . CONCLUSION We have successfully recruited a diverse sample of practice s and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention The Multiple Risk Factor Intervention Trial was a r and omized clinical study to test whether a special-intervention ( SI ) program aim ed at reducing serum cholesterol levels , blood pressure and cigarette smoking would prevent coronary heart disease ( CHD ) in middle-aged men . The main endpoint reported here is the percentage of participants experiencing first major CHD events ( either nonfatal acute myocardial infa rct ion [ AMI ] or CHD death ) during 7 years of follow-up . This outcome was slightly less frequent in the 6,428 SI men than in the 6,438 men assigned to their usual source of care ( UC ) . However , the relative difference -- either 1 % ( 95 % confidence interval -17 % to 16 % ) or 8 % ( 95 % confidence interval -5 % to 20 % ) , depending on how AMI was classified -- was not statistically significant . Regression analyses within the SI and UC groups suggested that the cholesterol and cigarette smoking interventions reduced the number of first major CHD events : the associations between lowering the levels of these 2 factors and reductions in CHD rates were significant ( p less than 0.001 ) and of the anticipated magnitude . A similar analysis of antihypertensive treatment in the SI group revealed no favorable association between lowering blood pressure and CHD rate , and other subgroup comparisons suggested that a mixture of beneficial and adverse effects may underlie this finding . Thus , the nonsignificant overall UC/SI contrast in CHD rates may reflect a combination of the expected beneficial effects of the cholesterol and smoking interventions with unexpected heterogeneous effects of the antihypertensive intervention . Seven of 8 other prespecified cardiovascular endpoints occurred less frequently among SI than among UC men , the difference being nominally significant ( p less than 0.05 ) for angina pectoris , congestive heart failure and peripheral arterial disease Background : The Mediterranean Lifestyle Program was evaluated for its effects on multiple behavioral risk factors for coronary heart disease ( CHD )  among postmenopausal women with diabetes . Purpose : Our purpose is to test a comprehensive lifestyle management intervention to reduce CHD risk in postmenopausal women with type 2 diabetes . Methods : Participants ( N = 279 ) were r and omized to usual care ( UC ) or Mediterranean Lifestyle Program , a lifestyle change intervention aim ed at the behavioral risk factors ( eating patterns , physical activity , stress management , and social support ) affecting risk for CHD in postmenopausal women with type 2 diabetes . Results : In original and intent-to-treat analyses ,  Mediterranean Lifestyle Program participants showed significantly greater improvement in dietary behaviors , physical activity , stress management , perceived support , and weight loss at 6 months compared to UC . Conclusions : This study demonstrated the effectiveness of the Mediterranean Lifestyle Program in improving self-care among women with type 2 diabetes , showed that postmenopausal women could make comprehensive lifestyle changes , and provided evidence that a program using social-cognitive strategies and peer support can be used to modify multiple lifestyle behaviors OBJECTIVE Primary prevention of Coronary Heart Disease ( CHD ) in diabetic patients should be based on absolute CHD risk calculation . This study was aim ed to determine the levels of 10-year CHD risk in Caribbean type 2 diabetic patients using the diabetes specific United Kingdom Prospect i ve Diabetes Study ( UKPDS ) risk engine calculator . SUBJECTS AND METHODS Three hundred and twenty-five ( 106 males , 219 females ) type 2 diabetic patients resident in two Caribbean Isl and s of Tobago and Trinidad met the UKPDS risk engine inclusion criteria . Records of their sex , age , ethnicity , smoking habit , diabetes duration , systolic blood pressure , total cholesterol , HDL-cholesterol and glycated haemoglobin were entered into the UKPDS risk engine calculator programme and the absolute 10-year CHD and stroke risk levels were computed . The 10-year CHD and stroke risks were statistically stratified into < 15 % , 15 - 30 % and > 30 % CHD risk levels and differences between patients of African and Asian-Indian origin were compared . RESULTS In comparison with patients in Tobago , type 2 diabetic patients in Trinidad , irrespective of gender , had higher proportion of 10-year CHD risk ( 10.4 vs. 23.6 % , P<0.001 ) whereas the overall 10-year stroke risk prediction was higher in patients resident in Tobago ( 16.9 vs. 11.4 % , P<0.001 ) . Ethnicity-based analysis revealed that irrespective of gender , higher proportion of patients of Indian origin scored > 30 % of absolute 10-year CHD risk compared with patients of African descent ( 3.2 vs. 28.2 % , P<0.001 ) . CONCLUSIONS The results of the study identified diabetic patients resident in Trinidad and patients of Indian origin as the most vulnerable groups for CHD . These groups of diabetic patients should have priority in primary or secondary prevention of coronary heart disease Background Case management has emerged as a promising alternative approach to supplement traditional one-on-one sessions between patients and doctors for improving the quality of care in chronic diseases such as coronary heart disease ( CHD ) . However , data are lacking in terms of its efficacy and cost-effectiveness when implemented in ethnic and low-income population s. Methods The Stanford and San Mateo Heart to Heart ( HTH ) project is a r and omized controlled clinical trial design ed to rigorously evaluate the efficacy and cost-effectiveness of a multi-risk cardiovascular case management program in low-income , primarily ethnic minority patients served by a local county health care system in California . R and omization occurred at the patient level . The primary outcome measure is the absolute CHD risk over 10 years . Secondary outcome measures include adherence to guidelines on CHD prevention practice . We documented the study design , methodology , and baseline sociodemographic , clinical and lifestyle characteristics of 419 participants . Results We achieved equal distributions of the sociodemographic , biophysical and lifestyle characteristics between the two r and omization groups . HTH participants had a mean age of 56 years , 63 % were Latinos/Hispanics , 65 % female , 61 % less educated , and 62 % were not employed . Twenty percent of participants reported having a prior  cardiovascular event . 10-year CHD risk averaged 18 % in men and 13 % in women despite a modest low-density lipoprotein cholesterol level and a high on-treatment percentage at baseline . Sixty-three percent of participants were diagnosed with diabetes and an additional 22 % had metabolic syndrome . In addition , many participants had depressed high-density lipoprotein ( HDL ) cholesterol levels and elevated values of total cholesterol-to-HDL ratio , triglycerides , triglyceride-to-HDL ratio , and blood pressure . Furthermore , nearly 70 % of participants were obese , 45 % had a family history of CHD or stroke , and 16 % were current smokers . Conclusion We have recruited an ethnically diverse , low-income cohort in which to implement a case management approach and test its efficacy and cost-effectiveness . HTH will advance the scientific underst and ing of better strategies for CHD prevention among these priority sub population s and aid in guiding future practice that will reduce health disparities Despite race , ethnic , and regional differences in cardiovascular disease risk , many worldwide hypertension management guidelines recommend the use of the Framingham coronary heart disease ( CHD ) risk equation to guide treatment decisions . This sub analysis of the recently published CRUCIAL trial compared the treatment-related reductions in calculated CHD and stroke risk among Pacific Asian ( PA ) patients using a variety of region-specific risk assessment models . As a result , greater reductions in systolic and diastolic blood pressure , low-density lipoprotein cholesterol , and triglycerides were observed in the proactive multifactorial intervention ( PMI ) arm compared with the usual care arm at Week 52 for PA patients . The relative percentage change in 10-yr CHD risk between baseline and Week 52 in the PMI versus usual care arms was greatest using the NIPPON DATA 80 fatal CHD model ( LS [ least square ] mean difference -42.6 % ) , and similar in the SCORE fatal CHD and Framingham total CHD models ( LS mean difference -29.4 % and -30.8 % , respectively ) . The single-pill based PMI approach is consistently effective in reducing cardiovascular disease risk , evaluated using a variety of risk assessment models . ( Clinical Trials.gov registration number : NCT00407537 BACKGROUND Although primary care is the major target of coronary heart disease ( CHD ) clinical recommendations , little is known of how community physicians view guidelines and their implementation . The REACT survey was design ed to assess the views , and perceived implementation , of CHD and lipid treatment guidelines among primary care physicians . METHODS Semi-structured vali date d telephone interviews were conducted , in the relevant native tongue , with 754 r and omly selected primary care physicians ( GPs and family doctors ) in five European countries ( France , Germany , Italy , Sweden and the UK ) . RESULTS Most physicians ( 89 % ) agreed with the content of current guidelines and reported use of them ( 81 % ) . However , only 18 % of physicians believed that guidelines were being implemented to a major extent . Key barriers to greater implementation of guidelines were seen as lack of time ( 38 % of all physicians ) , prescription costs ( 30 % ) , and patient compliance ( 17 % ) . Suggestions for ways to improve implementation centred on more education , both for physicians themselves ( 29 % ) and patients ( 25 % ) ; promoting , publicizing or increasing guideline availability ( 23 % ) ; simplifying the guidelines ( 17 % ) ; and making them clearer ( 12 % ) . Physicians perceived diabetes to be the most important risk factor for CHD , followed by hypertension and raised LDL-C. Most physicians ( 92 % ) believe their patients do associate high cholesterol levels with CHD . After establishing that a patient is ' at risk ' of CHD , physicians reported spending an average of 16.5 minutes discussing risk factors and lifestyle changes or treatment that is required . Factors preventing this included insufficient time ( 42 % ) , having too many other patients to see ( 27 % ) and feeling that patients did not listen or underst and anyway ( 21 % ) . CONCLUSIONS Primary care physicians need more information and support on the implementation of CHD and cholesterol guideline recommendations . This need is recognized by clinicians BACKGROUND Low intakes or blood levels of eicosapentaenoic and docosahexaenoic acids ( EPA + DHA ) are independently associated with increased risk of death from coronary heart disease ( CHD ) . In r and omized secondary prevention trials , fish or fish oil have been demonstrated to reduce total and CHD mortality at intakes of about 1 g/day . Red blood cell ( RBC ) fatty acid ( FA ) composition reflects long-term intake of EPA + DHA . We propose that the RBC EPA + DHA ( hereafter called the Omega-3 Index ) be considered a new risk factor for death from CHD . METHODS We conducted clinical and laboratory experiments to generate data necessary for the validation of the Omega-3 Index as a CHD risk predictor . The relationship between this putative marker and risk for CHD death , especially sudden cardiac death ( SCD ) , was then evaluated in several published primary and secondary prevention studies . RESULTS The Omega-3 Index was inversely associated with risk for CHD mortality . An Omega-3 Index of > or = 8 % was associated with the greatest cardioprotection , whereas an index of < or = 4 % was associated with the least . CONCLUSION The Omega-3 Index may represent a novel , physiologically relevant , easily modified , independent , and grade d risk factor for death from CHD that could have significant clinical utility Background Weight reduction limits disease progression in obese people with coronary heart disease ( CHD ) and /or type 2 diabetes mellitus ( T2DM ) . Purpose To test a 16-week group-based weight reduction intervention combining exercise , diet and behaviour change strategies aim ed to increase self-efficacy  ( Healthy Eating and Exercise Lifestyle Program — HEELP ) on weight , body mass index ( BMI ) , waist circumference and exercise . Methods Participants with CHD and /or T2DM and BMI between 27 to 39 kg/m2 were r and omised to HEELP  ( n = 83 ) or usual care ( n = 65 ) . Results Participants were aged a mean 63.47 years ( SD 8.9 ) , male ( 58 % ) and Caucasian ( 79 % ) . HEELP participants lost significantly more weight , BMI and waist circumference and exercised more days/week for a longer duration /week than usual care . Clinical ly significant weight loss ( ≥5 % ) was more common in HEELP than usual care . Conclusion The HEELP result ed in weight loss and improved exercise behaviour in obese people with CHD and T2DM The authors conducted a r and omized , controlled , multicenter trial , in which they assigned well-controlled hypertensive participants aged 55 years and older with moderate hypercholesterolemia to receive pravastatin ( n=5170 ) or usual care ( n=5185 ) for 4 to 8 years , when trial therapy was discontinued . Passive surveillance using national data bases to ascertain deaths and hospitalizations continued for a total follow-up of 8 to 13 years to assess whether mortality and morbidity differences persisted or new differences developed . During the post-trial period , fatal and nonfatal outcomes were available for 98 % and 64 % of participants , respectively . The primary outcome was all-cause mortality and the secondary outcomes included cardiovascular mortality , coronary heart disease ( CHD ) , stroke , heart failure , cardiovascular disease , and end-stage renal disease . No significant differences appeared in mortality for pravastatin vs usual care ( hazard ratio [ HR ] , 0.96 ; 95 % confidence interval [ CI ] , 0.89 - 1.03 ) or other secondary outcomes . Similar to the previously reported in-trial result , there was a significant treatment effect for CHD in black patients ( HR , 0.79 ; 95 % CI , 0.64 - 0.98 ) . However , the in-trial result showing a significant treatment by race effect did not remain significant during the entire follow-up ( P=.08 ) . These findings are consistent with evidence from other large trials that show statins prevent CHD and add evidence that they are effective for CHD prevention in black patients Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p < 0.001 ) , and 29.3 % of smokers in the intervention group quit smoking vs. 21.4 % of those receiving usual care ( p = 0.04 ) . Conclusions A physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice Aims : To evaluate the effect of a disease management programme for patients with coronary heart disease ( CHD ) and chronic heart failure ( CHF ) in primary care . Methods : A cluster r and omised controlled trial of 1316 patients with CHD and CHF from 20 primary care practice s in the UK was carried out . Care in the intervention practice s was delivered by specialist nurses trained in the management of patients with CHD and CHF . Usual care was delivered by the primary healthcare team in the control practice s. Results : At follow up , significantly more patients with a history of myocardial infa rct ion in the intervention group were prescribed a beta-blocker compared to the control group ( adjusted OR 1.43 , 95 % CI 1.19 to 1.99 ) . Significantly more patients with CHD in the intervention group had adequate management of their blood pressure ( < 140/85 mm Hg ) ( OR 1.61 , 95 % CI 1.22 to 2.13 ) and their cholesterol ( < 5 mmol/l ) ( OR 1.58 , 95 % CI 1.05 to 2.37 ) compared to those in the control group . Significantly more patients with an unconfirmed diagnosis of CHF had a diagnosis of left ventricular systolic dysfunction confirmed ( OR 4.69 , 95 % CI 1.88 to 11.66 ) or excluded ( OR 3.80 , 95 % CI 1.50 to 9.64 ) in the intervention group compared to the control group . There were significant improvements in some quality -of-life measures in patients with CHD in the intervention group . Conclusions : Disease management programmes can lead to improvements in the care of patients with CHD and presumed CHF in primary care Background Participation in coronary heart disease ( CHD ) secondary prevention programs is low . Telephone-delivered CHD secondary prevention programs may overcome the treatment gap . The telephone-based health coaching ProActive Heart trial intervention has previously been shown to be effective for improving health-related quality of life , physical activity , body mass index , diet , alcohol intake and anxiety . As a secondary aim , the current study evaluated the cost-effectiveness of the ProActive Heart intervention compared to usual care . Methods 430 adult myocardial infa rct ion patients were r and omised to a six-month  CHD secondary prevention ‘ health coaching ’ intervention or ‘ usual care ’ control group . Primary outcome variables were health-related quality of life ( SF-36 ) and physical activity ( Active Australia Survey ) . Data were collected at baseline , six-months ( post-intervention ) and 12 months ( six-months post-intervention completion ) for longer term effects . Cost-effectiveness data [ health utility ( SF-6D ) and health care utilisation ] were collected using self-reported ( general practitioner , specialist , other health professionals , health services , and medication ) and cl aims data ( hospitalisation rates ) . Intervention effects are presented as mean differences ( 95 % CI ) , p-value . Results Improvements in health status ( SF-6D ) were observed in both groups , with no significant difference between the groups at six [ 0.012 ( -0.016 , 0.041 ) , p = 0.372 ] or 12 months [ 0.011 ( -0.028 , 0.051 ) p = 0.738 ] . Patients in the health coaching group were significantly more likely to be admitted to hospital due to causes unrelated to cardiovascular disease ( p = 0.042 ) . The overall cost for the health coaching group was higher ( $ 10,574 vs. $ 8,534 , p = 0.021 ) , mainly due to higher hospitalisation ( both CHD and non-CHD ) costs ( $ 6,841 vs. $ 4,984 , p = 0.036 ) . The incremental cost-effectiveness ratio was $ 85,423 per QALY . Conclusions There was no intervention effect measured using the SF-36/SF-6D and ProActive Heart result ed in significantly increased costs . The cost per QALY gained from ProActive Heart was high and above acceptable limits compared to usual care Purpose Given the public health significance of poorly treatable co-morbid major depressive disorders ( MDD ) among patients with type 2 diabetes mellitus ( DM2 ) and coronary heart disease ( CHD ) , we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease . We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and /or CHD . Methods A cluster r and omized controlled trial , with 27 primary care centers serving as clusters . A total of 236 DM2 and /or CHD patients with subthreshold depression ( nine item Patient Health Question naire ( PHQ-9 ) score ≥ 6 , no current MDD according to DSM-IV criteria ) were allocated to the intervention group ( N = 96 ) or usual care group ( n = 140 ) . The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps : watchful waiting , guided self-help , problem solving treatment and referral to the general practitioner . The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview ( MINI ) . Secondary outcomes included severity of depression ( measured by PHQ-9 ) at 3 , 6 , 9 and 12 months . Results Of 236 patients ( mean age , 67,5 ( SD 10 ) years ; 54.7 % men ) , 210 ( 89 % ) completed the MINI at 12 months . The cumulative incidence of MDD was 9 of 89 ( 10.1 % ) participants in the intervention group and 12 of 121 ( 9.9 % ) participants in the usual care group . We found no statistically significant overall effect of the intervention ( OR = 1.21 ; 95 % confidence interval ( 0.12 to 12.41 ) ) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups . Conclusions This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and /or CHD and subthreshold depression CONTEXT Studies have demonstrated that statins administered to individuals with risk factors for coronary heart disease ( CHD ) reduce CHD events . However , many of these studies were too small to assess all-cause mortality or outcomes in important subgroups . OBJECTIVE To determine whether pravastatin compared with usual care reduces all-cause mortality in older , moderately hypercholesterolemic , hypertensive participants with at least 1 additional CHD risk factor . DESIGN AND SETTING Multicenter ( 513 primarily community-based North American clinical centers ) , r and omized , nonblinded trial conducted from 1994 through March 2002 in a subset of participants from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) . PARTICIPANTS Ambulatory persons ( n = 10 355 ) , aged 55 years or older , with low-density lipoprotein cholesterol ( LDL-C ) of 120 to 189 mg/dL ( 100 to 129 mg/dL if known CHD ) and triglycerides lower than 350 mg/dL , were r and omized to  pravastatin  ( n = 5170 ) or to  usual care  ( n = 5185 ) . Baseline mean total cholesterol was 224 mg/dL ; LDL-C , 146 mg/dL ; high-density lipoprotein cholesterol , 48 mg/dL ; and triglycerides , 152 mg/dL. Mean age was 66 years , 49 % were women , 38 % black and 23 % Hispanic , 14 % had a history of CHD , and 35 % had type 2 diabetes . INTERVENTION Pravastatin , 40 mg/d , vs usual care . MAIN OUTCOME MEASURES The primary outcome was all-cause mortality , with follow-up for up to 8 years . Secondary outcomes included nonfatal myocardial infa rct ion or fatal CHD ( CHD events ) combined , cause-specific mortality , and cancer . RESULTS Mean follow-up was 4.8 years . During the trial , 32 % of usual care participants with and 29 % without CHD started taking lipid-lowering drugs . At year 4 , total cholesterol levels were reduced by 17 % with pravastatin vs 8 % with usual care ; among the r and om sample who had LDL-C levels assessed , levels were reduced by 28 % with pravastatin vs 11 % with usual care .  All-cause mortality was similar for the 2 groups ( relative risk [ RR ] , 0.99 ; 95 % confidence interval [ CI ] , 0.89 - 1.11 ; P = .88 ) , with 6-year mortality rates of 14.9 % for pravastatin vs 15.3 % with usual care .  CHD event rates were not significantly different between the groups ( RR , 0.91 ; 95 % CI , 0.79 - 1.04 ; P = .16 ) , with 6-year CHD event rates of 9.3 % for pravastatin and 10.4 % for usual care . CONCLUSIONS Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL-C. The results may be due to the modest differential in total cholesterol ( 9.6 % ) and LDL-C ( 16.7 % ) between pravastatin and usual care compared with prior statin trials supporting cardiovascular disease prevention The relationship between selected baseline risk factors and subsequent coronary heart disease ( CHD ) death and total mortality among participants in the Multiple Risk Factor Intervention Trial ( MRFIT ) was studied in order to determine whether the three risk factors used to identify high-risk men for the trial were associated with CHD death ; whether other risk factors measured at baseline , especially lipoprotein cholesterol levels , were associated with CHD and total mortality ; and whether there were any differences between special intervention ( SI ) and usual care ( UC )  participants in the relationship of the specific levels of risk factors to CHD or total mortality . The three main risk factors ( blood cholesterol , cigarette smoking , and diastolic blood pressure ) and age were significantly associated with CHD mortality ; age , diastolic blood pressure , and cigarette smoking were associated with total mortality . The risk score based on the multiple logistic equation developed from the Framingham Study was also strongly associated with CHD mortality . When the joint associations of selected baseline risk factors with CHD and total mortality were considered , age , diastolic blood pressure , cigarette smoking , and low- and high-density lipoprotein cholesterol were significantly associated with CHD mortality ; age , cigarette smoking , and low-density lipoprotein cholesterol were positively associated with total mortality . Systolic blood pressure significantly improved the prediction of CHD mortality for SI and UC men when it was added to a regression model that included age , diastolic blood pressure , cigarettes smoked per day , body mass index , and lipoprotein levels , but improved the prediction of total mortality only for SI men . In similar analyses , serum thiocyanate improved the prediction of both CHD and total mortality for UC men . Among SI men the improved prediction gained by considering serum thiocyanate was less pronounced and not significant for CHD death . This latter finding may be due in part to the changes made in smoking behavior by SI participants during the course of the study . The estimated regression coefficients for CHD and total mortality endpoints were not significantly different between the SI and UC groups In a r and omised controlled evaluation of multifactorial prevention of coronary heart disease ( CHD ) among 60 881 men employed in 80 factories in Belgium , Italy , Pol and , and the UK intervention was associated with reductions of 10.2 % in total CHD , 6.9 % in fatal CHD , 14.8 % in non-fatal myocardial infa rct ion , and 5.3 % in total deaths , with a neutral result for non-CHD deaths . Benefit was significantly related to the extent of risk factor change . The observed reduction in total CHD was 62 % of that predicted by means of a multiple logistic function summary of risk factor changes . Advice on risk factor reduction in middle-aged men is effective to the extent that it is accepted and it appears to be safe BACKGROUND Effective therapies for reducing mortality rates in persons with coronary heart disease ( CHD ) remain underused . We report the results of an effectiveness trial of a quality improvement effort to increase the use of 3-hydroxy-3methylglutaryl coenzyme A ( HMG CoA ) reductase inhibitors , beta-blockers , and angiotensin-converting enzyme ( ACE ) inhibitors in patients with CHD in a network-model managed-care setting . METHODS Patients with CHD were identified by search ing a cl aims data base . The use of therapies was assessed by linkage with a pharmacy data base . An intervention , consisting of a guideline summary , peer comparison performance feedback , and patient specific chart reminders was evaluated in a r and omized , practice -based effectiveness trial . RESULTS Data were available for > 700 patients per year ( 1999 - 2002 ) in 131 practice s. At baseline ( 1999 ) , 55 % of patients were receiving HMG CoA reductase inhibitors , 39 % of patients were receiving beta-blockers , and 24 % of patients were receiving ACE inhibitors . The use of all 3 types of medications increased steadily with time , with the exception of a decrease in the use of HMG CoA reductase inhibitors in the final year ( 2002 ) . No difference in medication use was observed between r and omized groups . CONCLUSIONS The observed pattern of care supports the contention that the quality of outpatient care for secondary prevention of CHD improved from 1999 to 2002 in this setting . The basis for the inconsistent pattern of use of HMG CoA reductase inhibitors is not certain , but may relate to concerns about toxicity . Central ized mailings of guideline summaries , performance feedback reports , and chart reminders had no observable impact on quality of care in this setting . More intensive intervention may be required to improve the quality of outpatient care for the secondary prevention of CHD CONTEXT Coronary heart disease ( CHD ) mortality has declined substantially in Canada since 1994 . OBJECTIVE To determine what proportion of this decline was associated with temporal trends in CHD risk factors and advancements in medical treatments . DESIGN , SETTING , AND PATIENTS Prospect i ve analytic study of the Ontario , Canada , population aged 25 to 84 years between 1994 and 2005 , using an up date d version of the vali date d IMPACT model , which integrates data on population size , CHD mortality , risk factors , and treatment uptake changes . Relative risks and regression coefficients from the published literature quantified the relationship between CHD mortality and ( 1 ) evidence -based therapies in 8 distinct CHD sub population s ( acute myocardial infa rct ion [ AMI ] , acute coronary syndromes , secondary prevention post-AMI , chronic coronary artery disease , heart failure in the hospital vs in the community , and primary prevention for hyperlipidemia or hypertension ) and ( 2 ) population trends in 6 risk factors ( smoking , diabetes mellitus ,  systolic blood pressure ,  plasma cholesterol level , exercise , and obesity  ) . MAIN OUTCOME MEASURES The number of deaths prevented or delayed in 2005 ; secondary outcome measures were improvements in medical treatments and trends in risk factors . RESULTS Between 1994 and 2005 , the  age-adjusted CHD mortality rate  in Ontario decreased by 35 % from 191 to 125 deaths per 100,000 inhabitants , translating to an estimated 7585 fewer CHD deaths in 2005 . Improvements in medical and surgical treatments were associated with 43 % ( range , 11 % to 124 % ) of the total mortality decrease , most notably in AMI ( 8 % ; range , -5 % to 40 % ) , chronic stable coronary artery disease ( 17 % ; range , 7 % to 35 % ) , and heart failure occurring while in the community ( 10 % ; range , 6 % to 31 % ) . Trends in risk factors accounted for 3660 fewer CHD deaths prevented or delayed ( 48 % of total ; range , 28 % to 64 % ) , specifically , reductions in total cholesterol ( 23 % ; range , 10 % to 33 % ) and systolic blood pressure ( 20 % ; range , 13 % to 26 % ) . Increasing diabetes prevalence and body mass index had an inverse relationship associated with higher CHD mortality of 6 % ( range , 4 % to 8 % ) and 2 % ( range , 1 % to 4 % ) , respectively . CONCLUSION Between 1994 and 2005 , there was a decrease in CHD mortality rates in Ontario that was associated primarily with trends in risk factors and improvements in medical treatments , each explaining about half of the decrease BACKGROUND Despite the large body of evidence confirming the effectiveness of lipid lowering for the secondary prevention of coronary heart disease ( CHD ) events , undertreatment of hyperlipidemia is common . This study tested the effectiveness of a nurse case management program to lower blood lipids in patients with CHD . METHODS A total of 228 consecutive , eligible adults with hypercholesterolemia and CHD were recruited during hospitalization after coronary revascularization . Patients were r and omized to receive lipid management , including individualized lifestyle modification and pharmacologic intervention , from a nurse practitioner for 1 year after discharge in addition to their usual care ( NURS ) , or to usual care enhanced with feedback on lipids to their primary provider and /or cardiologist ( EUC ) . RESULTS Significantly more patients in the NURS group than in the EUC group achieved low-density lipoprotein cholesterol ( LDL-C ) levels < 2.59 mmol/dL ( 100 mg/dL , 65 % vs 35 % , P = .0001 ) . Favorable changes in lipids and lipoproteins were accompanied by significant improvements in dietary and exercise patterns in the NURS group . In a multivariate analysis adjusting for other covariates , being assigned to the NURS group ( P = .0001 ) and being on a lipid-lowering medication ( P = .001 ) were significant independent predictors of LDL-C level . CONCLUSIONS Control of hypercholesterolemia in patients who have undergone coronary revascularization can be improved by a nurse case-management program . Because the National Cholesterol Education Program Adult Treatment Panel III guidelines have broadened the definition of high-risk population s that warrant aggressive treatment , nurse case-management programs may offer key opportunities to enhance appropriate application of new treatment paradigms To assess the combined influence of blood pressure ( BP ) , serum cholesterol level , and cigarette smoking on death from coronary heart disease ( CHD ) and to describe how these associations vary with age , data on those factors and on mortality for 316,099 men screened for the Multiple Risk Factor Intervention Trial ( MRFIT ) were examined . Vital status of participants has been determined after an average follow-up of 12 years ; 6327 deaths from CHD have been identified . Strong grade d relationships between serum cholesterol levels above 4.65 mmol/L ( 180 mg/dL ) , systolic BP above 110 mm Hg , and diastolic BP above 70 mm Hg and mortality due to CHD were evident . Smokers with serum cholesterol and systolic BP levels in the highest quintiles had CHD death rates that were approximately 20 times greater than nonsmoking men with systolic BP and cholesterol levels in the lowest quintile . Systolic and diastolic BP , serum cholesterol level , and cigarettes per day were significant predictors of death due to CHD in all age groups . Systolic BP was a stronger predictor than diastolic BP . These results , together with the findings of clinical trials , offer strong support for intensified preventive efforts in all age groups Summary Background : Atorvastatin is very effective in reducing plasma low-density lipoprotein cholesterol ( LDL-C ) levels . However , there is no long-term survival study that evaluated this statin . Patients − Methods : To assess the effect of atorvastatin on morbidity and mortality ( total and coronary ) of patients with established coronary heart disease ( CHD ) , 1600 consecutive patients were r and omised either to  atorvastatin  or to  ' usual ' medical care . The dose of atorvastatin was titrated from 10 to 80mg/day , in order to reach the National Cholesterol Education Program ( NCEP ) goal of LDL-C < 100mg/dl ( 2.6mmol/l ) . All patients were followed up for a mean period of 3 years . Main Outcome Measures : Primary endpoints of the study were defined as death , non-fatal myocardial infa rct ion , unstable angina , congestive heart failure , revascularisation ( coronary morbidity ) and stroke . Secondary endpoints were the safety and efficacy of the hypolipidaemic drugs as well as the cost-effectiveness of atorvastatin . Results : The mean dosage of atorvastatin was 24 mg/day . This statin reduced total cholesterol by 36 % , LDL-C by 46 % , triglycerides by 31 % , and non-high-density lipoprotein cholesterol ( non-HDL-C ) by 44 % , while it increased HDL-C by 7 % ; all these changes were significant . The NCEP LDL-C and non-HDL-C treatment goals were reached by 95 % ( n = 759 ) and 97 % ( n = 776 ) , respectively , of patients on atorvastatin . Only 14 % of the ' usual ' care patients received any hypolipidaemic drugs throughout the study and 3 % of them reached the NCEP LDL-C treatment goal . The cost per quality -adjusted life-year gained with atorvastatin was estimated at $ US 8350 . During this study 196 ( 24.5 % ) CHD patients on ' usual ' care had a CHD recurrent event or died vs. 96 ( 12 % ) CHD patients on atorvastatin ; risk ratio ( RR ) 0.49 , confidence interval ( CI ) 0.27 - 0.73 , p < 0.0001 . In detail , atorvastatin reduced , in comparison to ' usual ' care , total mortality ( RR 0.57 , CI 0.39 - 0.78 , p = 0.0021 ) , coronary mortality ( RR 0.53 , CI 0.29 - 0.74 , p = 0.0017 ) , coronary morbidity ( RR 0.46 , CI 0.25 - 0.71 , p < 0.0001 ) , and stroke ( RR 0.53 , CI 0.30 - 0.82 , p = 0.034 ) . All subgroups of patients ( women , those with diabetes mellitus , arterial hypertension , age 60 to 75 years , congestive heart failure , recent unstable angina or prior revascularisation ) benefited from treatment with atorvastatin . Withdrawal of patients because of side-effects from the atorvastatin group was low ( 0.75 % ) and similar to that of the ' usual ' care group ( 0.4 % ) . Conclusions : Long-term treatment of CHD patients with atorvastatin  to achieve NCEP lipid targets significantly reduces total and coronary mortality , coronary morbidity and stroke , in comparison to patients receiving ' usual ' medical care . Treatment with atorvastatin is well tolerated and cost-effective Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Background Coronary heart disease ( CHD ) and depression are leading causes of disease burden globally and the two often co-exist . Depression is common after Myocardial Infa rct ion ( MI ) and it has been estimated that 15 - 35 % of patients experience depressive symptoms . Co-morbid depression can impair health related quality of life ( HRQOL ) , decrease medication adherence and appropriate utilisation of health services , lead to increased morbidity and suicide risk , and is associated with poorer CHD risk factor profiles and reduced survival . We aim to determine the feasibility of conducting a r and omised , multi-centre trial design ed to compare a tele-health program ( MoodCare ) for depression and CHD secondary prevention , with Usual Care ( UC ) . Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome ( ACS ) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensl and . Consenting participants are then contacted at two weeks post-discharge for baseline assessment . One hundred eligible participants are to be r and omised to an intervention or a usual medical care control group ( 50 per group ) . The intervention consists of up to 10 × 30 - 40 minute structured telephone sessions , delivered by registered psychologists , commencing within two weeks of baseline screening . The intervention focuses on depression management , lifestyle factors ( physical activity , healthy eating , smoking cessation , alcohol intake ) , medication adherence and managing co-morbidities . Data collection occurs at baseline ( Time 1 ) , 6 months ( post-intervention ) ( Time 2 ) , 12 months ( Time 3 ) and 24 months follow-up for longer term effects ( Time 4 ) . We are comparing depression ( Cardiac Depression Scale [ CDS ] ) and HRQOL ( Short Form-12 [ SF-12 ] ) scores between treatment and UC groups , assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects . A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government . Discussion This manuscript presents the protocol for a r and omised , multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients . The results of this trial will provide valuable new information about potential psychological and wellbeing benefits , cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression . Trial Registration NumberAustralia and New Zeal and Clinical Trials Register ( ANZCTR ) :
Multifactorial lifestyle interventions aim ed at improving modifiable risk factors in patients with established CHD reduce the risk for fatal cardiovascular events .
Therefore , they may have added value in secondary prevention of CHD
CONTEXT Coronary heart disease ( CHD ) is responsible for about 15 % of all deaths worldwide and is identified as a top priority for decision makers .
Both primary and secondary prevention are considered key strategies in the prevention of CHD .
The aim of this study was to assess the efficacy of nonpharmacologic interventions with multiple lifestyle components in patients with established CHD in comparison to usual care .