title: A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol A Novel Family-Based Intervention Trial to Improve Heart Health: FIT Heart: Results of a Randomized Controlled Trial Improving lifestyle and risk perception through patient involvement in nurse-led cardiovascular risk management: a cluster-randomized controlled trial in primary care. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial An open cluster-randomized, 18-month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up. Multifactorial trial in the prevention of coronary heart disease: 3. Incidence and mortality results. The BioImage Study: novel approaches to risk assessment in the primary prevention of atherosclerotic cardiovascular disease--study design and objectives. Effectiveness of health checks conducted by nurses in primary care: final results of the OXCHECK study Evaluation of two contrasting types of screening programs. Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP) Estimating the population impact of screening strategies for identifying and treating people at high risk of cardiovascular disease: modelling study Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial Multiphasic Health Checkup Evaluation: a 16-year follow-up. Improving the reporting of randomised trials: the CONSORT Statement and beyond. The psychological impact of cardiovascular screening and intervention in primary care: a problem of false reassurance? British Family Heart Study Group. Ebeltoft project: baseline data from a five-year randomized, controlled, prospective health promotion study in a Danish population. Preventive health screenings and health consultations in primary care increase life expectancy without increasing costs Influence of cardiovascular absolute risk assessment on prescribing of antihypertensive and lipid-lowering medications: a cluster randomized controlled trial. Automated electronic reminders to facilitate primary cardiovascular disease prevention: randomised controlled trial. The Multifactor Primary Prevention Trial in Göteborg, Sweden. Comparison with a previously untreated population sample. Costs and cost effectiveness of cardiovascular screening and intervention: the British family heart study Effectiveness of nurse-delivered cardiovascular risk management in primary care: a randomised trial. Effects of a global risk educational tool on primary coronary prevention: the Atherosclerosis Assessment Via Total Risk (AVIATOR) study Costs and cost effectiveness of health checks conducted by nurses in primary care: the Oxcheck study Study protocol for a randomized controlled trial: the feasibility and impact of cardiovascular absolute risk assessment in Australian general practice. Preventing cardiovascular disease in women: an intervention-control randomized study. Cholesterol reduction following health screening in general practice A controlled trial of multiphasic screening in middle-age: results of the South-East London Screening Study. 1977. Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT Effects of an assessment of needs for medical and social services on long-term mortality: a randomized controlled study. No long-term psychological reaction to information about increased risk of coronary heart disease in general practice The Influence of Repeated Health Examinations on Mortality in a Prospective Cohort Study, with a Comment on the Autopsy Frequence: The Study of Men Born in 1913 A controlled trial of multiphasic screening. Systematic risk factor screening and education: a community-wide approach to prevention of coronary heart disease. Cardiovascular Health Awareness Program (CHAP): a community cluster-randomised trial among elderly Canadians.
abstract: Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the  intervention  group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372 Background —Family members of patients with cardiovascular disease ( CVD ) may be at increased risk due to shared genes and lifestyle . Hospitalization of a family member with CVD may represent a “ motivational moment ” to take preventive action . Methods and Results —A r and omized , controlled clinical trial was conducted in healthy adult family members ( N=501 ; 66 % female ; 36 % nonwhite ; mean age , 48 years ) of patients hospitalized with CVD to evaluate a special intervention ( SI )  with personalized risk factor screening , therapeutic lifestyle-change counseling , and progress reports to physicians versus a control intervention ( CIN ) on the primary outcome , mean percent change in low-density lipoprotein cholesterol ( LDL-C ) , and other risk factors . Vali date d dietary assessment s and st and ardized risk factors were obtained at baseline and 1 year ( 94 % follow-up ) . At baseline , for 93 % of subjects , saturated fat comprised ≥7 % of total caloric intake , and 79 % had nonoptimal LDL-C levels ( of which 50 % were unaware ) . There was no difference in the SI versus the CIN with respect to the mean percent change in LDL-C ( −1 % versus −2 % , respectively ; P=0.64 ) , owing to a similar significant reduction in LDL-C in both groups ( −4.4 mg/dL and −4.5 mg/dL , respectively ) . Diet score significantly improved in the SI versus the CIN ( P=0.04 ) . High-density lipoprotein cholesterol declined significantly in the CIN but not in the SI ( −3.2 % [ 95 % CI , −5.1 to −1.3 ] versus + 0.3 % [ 95 % CI , −1.7 to + 2.4 ] ; P=0.01 ) . At 1 year , SI subjects were more likely than controls to exercise > 3 days per week ( P=0.04 ) . Conclusion —The SI was not more effective than the CIN in reducing the primary end point , LDL-C. The screening process identified many family members of hospitalized patients with CVD who were unaware of their risk factors , and further work is needed to develop and test interventions to reduce their CVD risk OBJECTIVE To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse . METHODS The IMPALA study ( 2006 , the Netherl and s ) was a cluster-r and omised controlled trial involving 25 general practice s and 615 patients who were eligible for cardiovascular risk management . The intervention consisted of ( 1 ) individual 10-year cardiovascular risk assessment , ( 2 ) risk communication , ( 3 ) use of a decision aid and ( 4 ) adapted motivational interviewing , applied by practice nurses in two consultations . Outcomes were smoking , alcohol , diet , physical activity and the secondary outcomes risk perception , anxiety , confidence about the decision and satisfaction with the communication , measured at baseline and after 12 weeks . RESULTS Patients of both groups improved their lifestyle , but no relevant significant differences between the groups were found . Intervention group patients improved in terms of the appropriateness of risk perception , although not significantly . Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients . CONCLUSION The intervention seems to have improved the patients ' risk perception , anxiety and satisfaction with the communication , which are important conditions for shared decision making . However , we found no additional effect of the intervention on lifestyle Background Primary care provides most of the evidence -based chronic disease prevention and screening services offered by the healthcare system . However , there remains a gap between recommended preventive services and actual practice . This trial ( the BETTER Trial ) aim ed to improve preventive care of heart disease , diabetes , colorectal , breast and cervical cancers , and relevant lifestyle factors through a practice facilitation intervention set in primary care . Methods Pragmatic two-way factorial cluster RCT with Primary Care Physicians ’ practice s as the unit of allocation and individual patients as the unit of analysis . The setting was urban Primary Care Team practice s in two Canadian provinces . Eight Primary Care Team practice s were r and omly assigned to receive the practice -level intervention or wait-list control ;  4 physicians in each team ( 32 physicians ) were r and omly assigned to receive the patient-level intervention or wait-list control .  Patients r and omly selected from physicians ’ rosters were stratified into two groups : 1 ) general and 2 ) moderate mental illness . The interventions involved a multifaceted , evidence -based , tailored practice -level intervention with a Practice Facilitator , and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored ‘ prevention prescription ’ . The primary outcome was a composite Summary Quality Index of 28 evidence -based chronic disease prevention and screening actions with pre-defined targets , expressed as the ratio of eligible actions at baseline that were met at follow-up . A cost-effectiveness analysis was conducted . Results 789 of 1,260 ( 63 % ) eligible patients participated . On average , patients were eligible for 8.96 ( SD 3.2 ) actions at baseline . In the adjusted analysis , control patients met 23.1 % ( 95 % CI : 19.2 % to 27.1 % ) of target actions , compared to 28.5 % ( 95 % CI : 20.9 % to 36.0 % ) receiving the practice -level intervention , 55.6 % ( 95 % CI : 49.0 % to 62.1 % ) receiving the patient-level intervention , and 58.9 % ( 95 % CI : 54.7 % to 63.1 % ) receiving both practice - and patient-level interventions ( patient-level intervention versus control , P < 0.001 ) . The benefit of the patient-level intervention was seen in both strata . The extra cost of the intervention was $ 26.43CAN ( 95 % CI : $ 16 to $ 44 ) per additional action met . Conclusions A Prevention Practitioner can improve the implementation of clinical ly important prevention and screening for chronic diseases in a cost-effective manner Background The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs , acid suppressive therapy , and antiplatelets . However , their effectiveness in changing actual practice is unknown . Methods The study will compare the effectiveness of educational outreach visits regarding the improvement of compliance with clinical guidelines in primary care against usual dissemination strategies . A cost-benefit analysis will also be conducted . We will carry out a parallel , open , superiority , r and omized trial directed to primary care physicians . Physicians will be recruited and allocated at a cluster-level ( primary care unit ) by minimization . Data will be analyzed at the physician level . Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate . Physicians in intervention units will be offered individual educational outreach visits ( one for each guideline ) at their workplace during a six-month period . Physicians in the control group will be offered a single unrelated group training session . Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class , and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention . Prescription data will be collected from the regional pharmacy cl aims data base . We estimated a sample size of 110 physicians in each group , corresponding to 19 clusters with a mean size of 6 physicians . Outcome collection and data analysis will be blinded to allocation , but due to the nature of the intervention , physicians and detailers can not be blinded . Discussion This trial will attempt to address unresolved issues in the literature , namely , long term persistence of effect , the importance of sequential visits in an outreach program , and cost issues . If successful , this trial may be the cornerstone for deploying large scale educational outreach programs within the Portuguese National Health Service . Trial registration Clinical Trials.gov number NCT01984034 OBJECTIVES To investigate the impact of general health screenings and discussion s with general practitioners on the cardiovascular risk profile of a r and om population of patients . STUDY DESIGN A population -based , r and omized , controlled , 5-year follow-up trial conducted in a primary care setting . POPULATION The study group consisted of 2000 patients , r and omly selected middle-aged men and women aged 30 to 50 years from family practice s in the district of Ebeltoft , Denmark . Of these patients , 1507 ( 75.4 % ) agreed to participate . Patients were r and omized into ( 1 ) a control group who did not receive health screenings , ( 2 ) an intervention group that received 2 health screenings , ( 3 ) an intervention group that received both the 2 screenings and a 45-minute follow-up consultation annually with their general practitioner . OUTCOMES MEASURED Cardiovascular risk score ( CRS ) , body mass index ( BMI ) , blood pressure , serum cholesterol , carbon monoxide in expiratory air , and tobacco use . RESULTS After 5 years , the CRS , BMI , and serum cholesterol levels were lower in the intervention groups compared with the control group . The improved outcome was greater in the baseline risk groups . The number of patients with elevated CRS in the intervention groups was approximately half the number of patients with elevated CRS in the control group . The difference was not a result of medication use . There was no difference between the group that received consultations after the screenings and the group that had health screenings alone . CONCLUSIONS Health screenings reduced the CRS in the intervention groups . After 5 years of follow-up , the number of persons at elevated cardiovascular risk was about half that expected , based on the prevalence/proportion in a population not receiving the health checks ( the control group ) . The impact of intervention was higher among at-risk individuals . Consultations about health did not appear to improve the cardiovascular profile of the study population Incidence and mortality results are presented from an international controlled trial of multifactorial prevention of coronary heart disease , involving r and omization of 66 factories ( 49 781 men ) in U.K. , Belgium , Italy and Pol and ( Cracow ) . Results for Pol and ( Warsaw ) are not yet complete . Net average reductions in risk factors ( all subjects ) were 1.2 % for plasma cholesterol , 8.9 % for daily cigarettes , 0.4 % for weight , 2.0 % for systolic blood pressure , and 11.1 % for a combined risk estimate . Greater reductions occurred in high-risk subjects ( 19.4 % for the combined estimate ) . The net overall reduction in CHD rates was 7.4 % ( 95 % confidence interval -29 to + 15 % ) for deaths ( 722 cases ) , and 3.9 % ( 95 % confidence interval -10 to + 2 % ) for fatal CHD + non-fatal myocardial infa rct ion ( 1502 cases ) . Among men aged 40 - 49 the reduction for this end-point was 15 % ; at ages 50 - 59 there was a small net increase . All-causes deaths after an early adverse trend showed 2.7 % reduction overall . There were large differences between centres , ranging from a 5 % net increase in CHD for U.K. to a decrease of 24 % in Belgium . In Belgium the decrease both in CHD and in all deaths was significant at the 5 % level . The effect on CHD in the different centres correlated broadly with their changes in risk factors . It is concluded that reduction in major coronary risk factors in industrial population s is possible , but it depends on adequate re sources ; the results support the hypotheses that CHD risk in middle-aged men is reversible and that community intervention can be beneficial The identification of asymptomatic individuals at risk for near-term atherothrombotic events to ensure optimal preventive treatment remains a challenging goal . In the BioImage Study , novel approaches are tested in a typical health-plan population . Based on certain demographic and risk characteristics on file with Humana Inc , a total of 7,687 men 55 to 80 years of age and women 60 to 80 years of age without evidence of atherothrombotic disease but presumed to be at risk for near-term atherothrombotic events were enrolled between January 2008 and June 2009 . Those who met the prespecified eligibility criteria were r and omized to a telephonic health survey only ( survey only : n = 865 ) , st and ard risk assessment ( Framingham only : n = 718 ) , or comprehensive risk assessment in a dedicated mobile facility equipped with advanced imaging tools ( n = 6,104 ) . Baseline examination included assessment of cardiovascular risk factors  and screening for sub clinical ( asymptomatic ) atherosclerosis with quantification of coronary artery calcification by computed tomography ( CT ) , measurement of intima-media thickness , presence of carotid atherosclerotic plaques and abdominal aortic aneurysm by ultrasound , and ankle brachial index . Participants with one or more abnormal screening test results underwent advanced imaging with contrast-enhanced magnetic resonance imaging for carotid and aortic plaques , contrast-enhanced coronary CT angiography for luminal stenosis and noncalcified plaques , and 18F-fluorodeoxyglucose-positron emission tomography/CT for  carotid and aortic plaque inflammation . Plasma , PAXgene RNA , and DNA sample s were obtained , frozen , and stored for future biomarker discovery studies . All individuals will be followed until 600 major atherothrombotic events have occurred in those undergoing imaging . The BioImage Study will help identify those patients with sub clinical atherosclerosis who are at risk for near-term atherothrombotic events and enable a more personalized management of care Abstract Objective : To determine the effectiveness of health checks , performed by nurses in primary care , in reducing risk factors for cardiovascular disease and cancer . Design : R and omised controlled trial . Setting : Five urban general practice s in Bedfordshire . Subjects : 2205 men and women who were r and omly allocated a first health check in 1989 - 90 and a re-examination in 1992 - 3 ( the intervention group ) ; 1916 men and women who were r and omly allocated an initial health check in 1992 - 3 ( the control group ) . All subjects were aged 35 - 64 at recruitment in 1989 . Main outcome measures : Serum total cholesterol concentration , blood pressure , body mass index , and smoking prevalence ( with biochemical validation of cessation ) ; self reported dietary , exercise , and alcohol habits . Results : Mean serum total cholesterol was 3.1 % lower in the intervention group than controls ( difference 0.19 mmol/l ( 95 % confidence interval 0.12 to 0.26 ) ; in women it was 4.5 % lower ( P<0.0001 ) and in men 1.6 % ( P<0.05 ) , a significant difference between the sexes ( P<0.01 ) . Self reported saturated fat intake was also significantly lower in the intervention group . Systolic and diastolic blood pressures and body mass index were respectively 1.9 % , 1.9 % , and 1.4 % lower in the intervention group ( P<0.005 in all cases ) . There was a 3.9 % ( 2.4 to 5.3 ) difference in the percentage of subjects with a cholesterol concentration > /=8 mmol/l , but no significant differences in the number with diastolic blood pressure > /=100 mm Hg or body mass index > /=30 kg/m2 . There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use . Annual rechecks were no more effective than a single recheck at three years , but health checks led to a significant increase in visits to the nurse according to patients ' degree of cardiovascular risk . Conclusions : The benefits of health checks were sustained over three years . The main effects were to promote dietary change and reduce cholesterol concentrations ; small differences in blood pressure may have been attributable to accommodation to measurement . The benefits of systematic health promotion in primary care are real , but must be weighed against the costs in relation to other priorities . Key messages Key messages There is little effect on smoking or alcohol use , and more targeted approaches to modifying these behaviours may be appropriate Systematic implementation of health checks might lead to a reduction in risk of myocardial infa rct ion among those who attend of about 5 - 15 % ; men , who are at higher risk , show less change than women Health checks consume substantial re sources , and their effect is attenuated by non-attendance The benefits of health promotion through primary care must be weighed against their costs and in relation to other Abstract Two quite different approaches have been taken to the evaluation of screening programs in the Health Insurance Plan of New York ( HIP ) . In one , a highly specific end result is at issue . The central question in this project is whether periodic screening with mammography and clinical examination of the breast results in a reduction in mortality from breast cancer in the female population . The project is being conducted as a r and omized clinical trial with study and control groups selected from the enrolled population of HIP . Of 31,000 study group women contacted , 20,200 , or 65 % participated in at least one examination . The other study is concerned with whether the impact of a multiple array of services , automated multiphasic health testing , and follow-up paramedical and medical services , on health status and health care behavior is greater among the poor than the rest of the population . The results of the breast cancer study provide clear evidence that over the short run period of 5 years of follow-up , the study women have about one-third lower mortality from breast cancer than the controls . Reduction in breast cancer mortality was found at ages 50 and over but not at ages 40–49 years . In the multiphasic health testing study , preliminary analysis of the data confirms one of the initial assumptions of the study , i.e. that a significant gap exists between the poverty and nonpoverty groups in the occurrence of health problems . A higher proportion of the poverty group reported a health complaint or specific condition . The study indicated that this group was also likely to report these problems with greater frequency and greater severity of the complaints Objective To evaluate the effectiveness of the community based Cardiovascular Health Awareness Program ( CHAP ) on morbidity from cardiovascular disease . Design Community cluster r and omised trial . Setting 39 mid-sized communities in Ontario , Canada , stratified by location and population size . Participants Community dwelling residents aged 65 years or over , family physicians , pharmacists , volunteers , community nurses , and local lead organisations . Intervention Communities were r and omised to receive CHAP ( n=20 ) or no intervention ( n=19 ) . In CHAP communities , residents aged 65 or over were invited to attend volunteer run cardiovascular risk assessment and education sessions held in community based pharmacies over a 10 week period ; automated blood pressure readings and self reported risk factor data were collected and shared with participants and their family physicians and pharmacists . Main outcome measure Composite of hospital admissions for acute myocardial infa rct ion , stroke , and congestive heart failure among all community residents aged 65 and over in the year before compared with the year after implementation of CHAP . Results All 20 intervention communities successfully implemented CHAP . A total of 1265 three hour long sessions were held in 129/145 ( 89 % ) pharmacies during the 10 week programme . 15 889 unique participants had a total of 27 358 cardiovascular assessment s with the assistance of 577 peer volunteers . After adjustment for hospital admission rates in the year before the intervention , CHAP was associated with a 9 % relative reduction in the composite end point ( rate ratio 0.91 , 95 % confidence interval 0.86 to 0.97 ; P=0.002 ) or 3.02 fewer annual hospital admissions for cardiovascular disease per 1000 people aged 65 and over . Statistically significant reductions favouring the intervention communities were seen in hospital admissions for acute myocardial infa rct ion ( rate ratio 0.87 , 0.79 to 0.97 ; P=0.008 ) and congestive heart failure ( 0.90 , 0.81 to 0.99 ; P=0.029 ) but not for stroke ( 0.99 , 0.88 to 1.12 ; P=0.89 ) . Conclusions A collaborative , multi-pronged , community based health promotion and prevention programme targeted at older adults can reduce cardiovascular morbidity at the population level . Trial registration Current controlled trials IS RCT N50550004 Objective To estimate the potential population impact of different screening strategies for identifying and treating people at high risk of cardiovascular disease , including strategies using routine data for cardiovascular risk stratification , in light of the UK government ’s recommended national strategy to screen all adults aged 40 - 74 for cardiovascular risk . Design Modelling study using data from a prospect i ve cohort , EPIC-Norfolk ( European Prospect i ve Investigation of Cancer-Norfolk ) . Setting An English county . Participants 16 970 men and women aged 40 - 74 and free from cardiovascular disease and diabetes at baseline . Main outcome measures The main outcomes were the population attributable fraction , the number needed to screen to prevent one new case of cardiovascular disease , the number needed to treat to prevent one new case of cardiovascular disease , and the number of new cardiovascular events that could be prevented . Relative risk reductions for estimated treatment effects were derived from meta-analyses of clinical trials or guidelines from the National Institute for Health and Clinical Excellence . Results 1362 cardiovascular events occurred over 183 586 person years of follow-up . Compared with the recommended government strategy , a stepwise screening approach using a simple risk score incorporating routine data could prevent a similar number ( lower to upper estimates ) of new cardiovascular events annually in the United Kingdom ( 26 789 , 20 778 to 36 239 ) and 25 134 ( 19 450 to 34 134 ) , respectively ) but requiring only 60 % of the population to be invited to attend a vascular risk assessment . A similar number of cardiovascular events ( 25 016 , 19 563 to 33 372 ) could also be prevented by inviting everyone aged 50 - 74 for a vascular assessment . Using a participant completed Finnish diabetes risk score question naire or anthropometric cut-off points for risk prestratification was less effective . Conclusions Compared with the UK government ’s recommended national strategy to screen all adults aged 40 - 74 for cardiovascular risk , an approach using routine data for cardiovascular risk stratification before inviting people at high risk for a vascular risk assessment may be similarly effective at preventing new cases of cardiovascular disease , with potential cost savings Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level . Design R and omised controlled community based trial . Setting Suburbs of Copenhagen , Denmark Participants 59 616 people aged 30 - 60 years r and omised with different age and sex r and omisation ratios to an intervention group ( n=11 629 ) and a control group ( n=47 987 ) . Intervention The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period . All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity . After five years all were invited for a final counselling session . Participants were referred to their general practitioner for medical treatment , if relevant . The control group was not invited for screening . Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group .  Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality . Results 6091 ( 52.4 % ) people in the intervention group participated at baseline . Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended . A total of 3163 people died in the 10 year follow-up period . Among 58 308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease . Among 58 940 without a history of stroke at baseline , 1726 developed stroke . No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) . Conclusion A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years . Trial registration Clinical trials NCT00289237 The Multiphasic Health Checkup Evaluation Study , a long-term clinical trial , has been completed . A study group of 5156 men and women age 35 - 54 at entry was urged to have annual multiphasic health checkups ( MHCs ) for 16 years . A control group of 5557 comparable subjects was not so urged but was followed up in a comparable fashion . The mean and median number of MHCs per person were 6.8 and 6 , respectively , in the study group and 2.8 and 1 , respectively , in the control group . During 16 years the study group experienced a 30 % reduction ( p less than 0.05 ) in deaths from pre-specified " potentially postponable " causes , largely associated with lower death rates from colorectal cancer and hypertension . This reduction was most pronounced in the early years of the study . The two groups did not differ to a statistically significant degree in mortality from all other causes ( 84 % of total mortality ) or in total mortality . There was no difference in self-reported disability in the overall groups . In the setting of our prepaid health care plan where MHCs were already available on a voluntary basis , a program of urging middle-aged persons to undergo regular MHCs brought about a substantial reduction in mortality from preselected diseases An extensive and growing number of review s of the published literature demonstrate that health research publications have frequent deficiencies . Of particular concern are poor reports of r and omised trials , which make it difficult or impossible for readers to assess how the research was conducted , to evaluate the reliability of the findings , or to place them in the context of existing research evidence . As a result , published reports of trials often can not be used by clinicians to inform patient care or to inform public health policy , and the data can not be included in systematic review s. Reporting guidelines are design ed to identify the key information that research ers should include in a report of their research . We describe the history of reporting guidelines for r and omised trials culminating in the CONSORT Statement in 1996 . We detail the subsequent development and extension of CONSORT and consider related initiatives aim ed at improving the reliability of the medical research literature BACKGROUND There have been many reports of the adverse psychological effects of screening . Here we discuss the results of a r and omized controlled study --one of the first to address this issue . AIM To determine the extent to which participation in a population -based intervention programme that aims to reduce the risk of cardiovascular diseases raises concerns about health , or undermines a belief in the ability to reduce that risk . METHOD A r and omized controlled trial involving 13 general practice s in Engl and , Wales and Scotl and was conducted . Two thous and , nine hundred and eighty-four middle-aged men and women undergoing cardiovascular risk-screening and intervention , and a r and omized comparison group of 3,576 men and women from the same practice s , who were not offered the intervention  , were compared on three outcomes : perception of current health , perceived risk of suffering a heart attack , and perceived ability to reduce the risk of suffering a heart attack . RESULTS We found no evidence to suggest that participation in this one-year , population -based intervention programme , to reduce the risk of cardiovascular disease raised concerns about health or risk of a heart attack ; indeed , those in the intervention group were slightly more optimistic about their health . Alterations in perceptions of current health and the risk of suffering a heart attack were associated directly with true alterations in risk factors . A more noticeable effect on participants in this intervention programme was a reduction in their perceived ability to further reduce their risks of a heart attack . This was associated with a decrease in weight and with quitting smoking . CONCLUSION Contemporary screening and intervention programmes in primary care , aim ed at reducing risk of cardiovascular disease , do not necessarily lead to raised anxiety or concern about health . A more subtle effect of screening would appear to be one of reassurance in the face of continuing , albeit reduced , risk BACKGROUND There is increasing political pressure on the medical profession to approach welfare diseases , such as coronary heart disease and diabetes , through prevention . General practitioners are required to offer regular health checks to healthy people  , in spite of the lack of scientific evidence for the universal need , usefulness and side effects of such an intervention . R and omized controlled trials are needed . AIM A study was carried out to investigate people 's interest in participating in health checks and in discussion s about health with their own general practitioner , participants ' health status , the proportion who received health advice following health checks , and the lifestyle goals they set following discussion with their general practitioner . This study reports the baseline data from a five-year r and omized , controlled , prospect i ve , population -based study in general practice s in Ebeltoft , Denmark . METHOD All general practitioners from the four practice s in Ebeltoft and a r and om sample of 2000 people aged between 30 and 50 years were invited to participate . Participants were r and omly divided into three groups -- one control group and two intervention groups . One intervention group were given a health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner . The other intervention group were also given a health check and written feedback ; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health . RESULTS A total of 1370 people participated in the study ( 69 % response rate ) . Health advice was given to 76 % of 905 participants following health checks . Almost all of the 456 participants ( 96 % ) who were offered the opportunity of discussing their health with their general practitioner took up the offer ; 64 % of the 456 participants reported that they had decided to undertake lifestyle changes . Eleven of those who discussed their health with the doctor were referred to a specialist ( 2 % ) . CONCLUSION There was considerable interest in participating in health promotion . Three out of four of those having a health check were given health advice . Two out of three of those offered a health talk with the general practitioner appeared willing to make relevant lifestyle changes . Long-term follow up is needed to determine effects and side effects of health checks and health talks Aims : The intention was to investigate whether preventive health checks and health discussion s are cost effective . Methods : In a r and omized trial the authors compared two intervention groups ( A and B ) and one control group . In 1991 2,000 30- to 49-year-old persons were invited and those who accepted were r and omized . Both intervention groups were offered a broad ( multiphasic ) screening including cardiovascular risk and a personal letter including screening results and advice on healthy living . Individuals in group A could contact their family physician for a normal consultation whereas group B were given fixed appointments for health consultations . The follow-up period was six years . Analysis was carried out on the ` ` intention to treat ' ' principle . Outcome parameters were life years gained , and direct and total health costs ( including productivity costs ) , discounted by 3 % annually . Costs were based on register data . Univariate sensitivity analysis was carried out . Results : Both intervention groups have significantly better life expectancy than the control group ( no intervention ) . Group B and ( A ) significantly gain 0.14 ( 0.08 ) life years more than the control group . There were no differences in average direct ( 3,255 ( 3,703 ) versus 4,186 ) and total costs ( 10,409 ( 9,399 ) versus 10,667 ) . The effect in group B is , however , better than in group A with no significant differences in costs . The results are insensitive to a range of assumptions regarding costs , effects , and discount rates . Conclusions : Preventive health screening and consultation in primary care in 30- to 49-year-olds produce significantly better life expectancy without extra direct and total costs over a six-year follow-up period BACKGROUND Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients . This r and omized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication . METHODS A cluster r and omized controlled trial was conducted from 2008 to 2010 in Sydney , Australia . Family practice s were r and omized , and patients aged 45 to 69 years were invited to participate . Intervention  family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation . Control practice patients received a general health check . Primary outcome analyzed was the proportion of patients in each group on antihypertensive and /or lipid-lowering medication  at 12 months . Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy . RESULTS The study recruited 36 FPs from 34 practice s and 1,074 patients , of which 906 ( 84.4 % ) completed 12-month follow-up . At 12 months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( 31.2 % vs 34.3 % , P = .31 ) , but control group patients were more likely to be on lipid-lowering medications ( 30.2 % vs 22.7 % , P = .01 ) . After multilevel analysis , this difference was not present . Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group . CONCLUSIONS Single-risk factor management remains a strong influence on FP prescribing practice s. Shifting to an approach based on CVAR will require more intensive intervention BACKGROUND Primary care data bases contain cardiovascular disease risk factor data , but practical tools are required to improve identification of at-risk patients . AIM To test the effects of a system of electronic reminders ( the ' e-Nudge ' ) on cardiovascular events and the adequacy of data for cardiovascular risk estimation . DESIGN OF STUDY R and omised controlled trial . SETTING Nineteen general practice s in the West Midl and s , UK . METHOD The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers . Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary . The proportion of the study population in the four groups was measured , as well as the rate of cardiovascular events in each arm after 2 years . RESULTS Over 38 000 patients ' electronic records were r and omised . The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk , with a difference of 1.94 % compared to the control group ( 95 % confidence interval [ CI ] = 1.38 to 2.50 , P<0.001 ) . A corresponding reduction occurred in the proportion potentially at risk but requiring further data for a risk estimation ( difference = -3.68 % , 95 % CI = -4.53 to -2.84 , P<0.001 ) . No significant difference was observed in the incidence of cardiovascular events ( rate ratio = 0.96 , 95 % CI = 0.85 to 1.10 , P = 0.59 ) . CONCLUSION Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population All male inhabitants of the city of Göteborg , who were born between 1915 - 1922 and 1924 - 1925 were included in the trial , and were 47 to 55 years of age on entry to the study in 1970 to 1973 . One-third of these men were r and omly allocated to an intervention group , whilst the other two-thirds acted as controls . Men of all social classes , employed as well as unemployed , health conscious as well as careless , were invited , with 75 % of these responding to the invitation . The intervention group contained 10,000 men and the control group 20,000 men . The intervention group were given advice on diet , both individually and in groups , the type of advice depending upon serum cholesterol level .  Smokers were advised to stop smoking , and men with elevated blood pressure were treated with antihypertensive drugs . Due to the large size of the groups and because they formed a r and om population sample , it was assumed that they had similar characteristics at the start of the trial . Risk factors were only measured in the intervention group at this time , followed by intervention . This design feature solved several ethical problems with regard to no treatment in the control group . These men were , however , subjected to health examinations and treatment as well as general health advice . Risk factor levels were measured in the intervention group , and also in r and om sub sample s ( 11 % ) of the control group after 4 and 10 years . Serum cholesterol , blood pressure and smoking decreased among men in both groups , and only slightly more in the intervention group . ( ABSTRACT TRUNCATED AT 250 WORDS Abstract Objective : To measure costs and cost effectiveness of the British family heart study cardiovascular screening and intervention programme . Design : Cost effectiveness analysis of r and omised controlled trial . Clinical and re source use data taken from trial and unit cost data from external estimates . Setting : 13 general practice s across Britain . Subjects : 4185 men aged 40 - 59 and their 2827 partners . Intervention : Nurse led programme using a family centred approach , with follow up according to degree of risk . Main outcome measures : Cost of the programme itself ; overall short term cost to NHS ; cost per 1 % reduction in coronary risk at one year . Results : Estimated cost of putting the programme into practice for one year was £ 63 per person ( 95 % confidence interval £ 60 to £ 65 ) . The overall short term cost to the health service was £ 77 per man ( £ 29 to £ 124 ) but only £ 13 per woman ( -£48 to £ 74 ) , owing to differences in utilisation of other health service re sources . The cost per 1 % reduction in risk was £ 5.08 per man ( £ 5.92 including broader health service costs ) and £ 5.78 per woman ( £ 1.28 taking into account wider health service savings ) . Conclusions : The direct cost of the programme to a four partner practice of 7500 patients would be approximately £ 58 000 . Annually , £ 8300 would currently be paid to a practice of this size working to the maximum target on the health promotion b and s , plus any additional reimbursement of practice staff salaries for which the practice qualified . The broader short term costs to the NHS may augment these costs for men but offset them considerably for women . Key messages Patient specific data from the British family heart study are used in this detailed cost effectiveness analysis The costs of the programme to general practitioners was estimated with reasonable precision : an average four partner practice of 7500 patients will require 1.75 nurse years to implement this programme , costing £ 58 000 The direct costs of the programme may not be fully reimbursed under the current health promotion b and ing scheme The broader impact on drug costs and use of other health care re sources is uncertain , and larger trials will be needed to estimate these important BACKGROUND A substantial part of cardiovascular disease prevention is delivered in primary care . Special attention should be paid to the assessment of cardiovascular risk factors . According to the Dutch guideline for cardiovascular risk management , the heavy workload of cardiovascular risk management for GPs could be shared with advanced practice nurses . AIM To investigate the clinical effectiveness of practice nurses acting as substitutes for GPs in cardiovascular risk management after 1 year of follow-up . DESIGN OF STUDY Prospect i ve pragmatic r and omised trial . SETTING Primary care in the south of the Netherl and s. Six centres ( 25 GPs , six nurses ) participated . METHOD A total of 1626 potentially eligible patients at high risk for cardiovascular disease were r and omised to a practice nurse group ( n = 808 ) or a GP group ( n = 818 ) in 2006 . In total , 701 patients were included in the trial . The Dutch guideline for cardiovascular risk management was used as the protocol , with st and ardised techniques for risk assessment . Changes in the following risk factors after 1 year were measured : lipids , systolic blood pressure , and body mass index . In addition , patients in the GP group received a brief question naire . RESULTS A larger decrease in the mean level of risk factors was observed in the practice nurse group compared with the GP group . After controlling for confounders , only the larger decrease in total cholesterol in the practice nurse group was statistically significant ( P = 0.01 , two-sided ) . CONCLUSION Advanced practice nurses are achieving results , equal to or better than GPs for the management of risk factors . The findings of this study support the involvement of practice nurses in cardiovascular risk management in Dutch primary care ABSTRACT Objective : The use of Framingham equations to determine 10-year absolute coronary risk ( “ global risk ” ) represents an accepted strategy to target coronary prevention measures and enhance clinical outcomes . The aim of this study was to determine the effects of providing global risk scores to physicians on the prescription of lipid-lowering therapy for patients at increased coronary risk . Research design and methods : This prospect i ve , r and omized controlled trial enrolled 368 primary -care patients without a history of coronary heart disease and not on therapy with a hydroxymethylglutaryl coenzyme A reductase inhibitor ( i.e. statin ) .  The study was conducted in the general medical clinics of an academic US teaching hospital . In the intervention group ( n = 186 ) patients ’ charts were review ed , 10‐year absolute coronary risk computed , and this information conveyed via a simple educational tool appended to charts . In the control group ( n = 182 ) , charts were accompanied by a form with general information on coronary prevention goals and strategies . Main outcome measure : The primary endpoint was the proportion of high-risk patients receiving a new statin prescription . Secondary and tertiary endpoints included ( 1 ) the proportion of moderate-risk patients receiving a statin prescription ; and ( 2 ) the proportion of patients in the whole cohort who had other coronary prevention measures recommended . Results : There was no significant difference in statin prescription to high-risk individuals in the intervention group ( 40.0 % ) compared with the control group ( 37.9 % ; p = 0.86 ) . Moderate-risk individuals who were not eligible for treatment according to the National Cholesterol Education Program Adult Treatment Panel II guidelines were more likely to receive a statin prescription in the intervention group versus the control group ( 28.8 % vs. 12.5 % . p = 0.036 ) Conclusions : Although a simple global risk educational tool did not improve the targeting of statin therapy to patients at high absolute coronary risk , it may be of benefit in targeting moderate-risk individuals who do not have markedly elevated low-density lipoprotein cholesterol ( LDL‐C ) levels . Future research should evaluate the effects of physicians performing their own Framingham risk calculations on statin prescribing and on cholesterol goal attainment Abstract Objective : To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme . Design : Cost effectiveness analysis of a r and omised controlled trial using clinical and economc data taken from the trial . Setting : Five general practice s in Luton and Dunstable , Engl and . Subjects : 2205 patients who attended a health check in 1989 - 90 and were scheduled for re-examination in 1992 - 3 ( intervention group ) ; 1916 patients who attended their initial health check in 1992 - 3 ( control group ) . Participants were men and women aged 35 - 64years . Intervention : Health check conducted by nurse , with health education and follow up according to degree of risk . Main outcome measures : Cost of health check programme ; cost per 1 % reduction in coronary risk . Results : Health check and follow up cost £ 29.27 per patient . Estimated programme cost per 1 % reduction in coronary risk per participant was between £ 1.46 and £ 2.25 ; it was nearly twice as much for men as women . Conclusions : The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , a proportion of which could be paid for through staff pay reimbursements and B and Three health promotion target payments . This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme . Economic evaluations should be integrated into the protocol s of r and omised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies . Key messages Research was undertaken to estimate the cost of the health checks and relate the cost to changes in the relative risk of cardiovascular disease The immediate cost of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , which is comparable with the immediate cost of a cervical screening programme The actual costs to the practice would be substantially reduced by staff pay reimbursements and health promotion target payments Further research is required to estimate the wider costs of health checks result ing from the additional use of health care BACKGROUND Although cardiovascular absolute risk ( CVAR ) assessment has been recommended for use in Australian general practice for a number of years , there is continuing uncertainty about its implementation and impact . Our previous work has developed a multifaceted implementation model . This study aims to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care . STUDY DESIGN This cluster r and omized controlled trial will be conducted in general practice s in Sydney , involving general practitioners ( GPs ) , other practice staff , and patients aged 45 to 69 years without existing cardiovascular disease . METHODS A total of 32 practice s ( 40 GPs ) and 1,320 patients will be recruited . R and omization will be conducted at the practice level . The intervention group of GPs will be trained to use a CVAR implementation model , whereas the control group of GPs will continue usual care . Study outcomes include clinical processes , patient risk , use of lifestyle intervention , and prescription of antihypertensive and lipid-lowering medications .  Data will be collected and analyzed using mixed methods . Study outcomes before and after the intervention will be compared , and the 2 groups will also be compared after adjusting for baseline difference and clustering factors . DISCUSSION This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management . Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives This 1-year , group-r and omized , intervention-control study looked at the effectiveness of a primary prevention , community-based program for reducing  cardiovascular ( CV ) risk factors in women . Women between the ages of 20 and 50 were recruited through community contacts , including religious and academic institutions , health clinics , and large local employers in the Duluth , Minnesota , and Superior , Wisconsin , area . All study activities took place in neighborhood places of worship . Screenings at baseline and 12 months included physical and laboratory measurements  addressing  CV risk factors  and assessment of the women 's knowledge about CV disease in women . All participants received an individualized review of their CV risk factors and recommendations for modifying them , along with educational literature about CV disease in women . The control group had limited follow-up compared with the intervention group , who participated in general CV health classes and received a follow-up phone call and information about health re sources . The study showed that education and one-on-one follow-up significantly change behavior . Comprehensive community-based screening and individualized review decrease women 's risk for CV disease Objectives - To evaluate changes in plasma cholesterol following health screening and health discussion s in general practice . Design - R and omised prospect i ve population -based study conducted over a period of 5 years . Setting - Primary care , all general practitioners ( GPs ) in a welldefined area . Subjects - A r and om sample of inhabitants aged 30 - 49 years in January 1991 , registered with a local GP was invited to participate . The participants ( 1507 persons , or 75.4 % of the 2000 invited ) were r and omly allocated to two intervention groups and a control group . Main outcome measures - Plasma cholesterol , percentage of subjects with plasma cholesterol higher than 7 mmol/l . Results - After 5 years of intervention , plasma cholesterol in the whole population was significantly lower in the intervention groups compared to the control group . The decrease was most pronounced ( 0.5 mmol/l ) in subjects at high cardiovascular risk . The percentage of high-risk individuals with a cholesterol level higher than 7 mmol/l was significantly lower in the intervention groups compared to the control group ( 9.8 % vs 6.2 % , p = 0.04 ) , corresponding to a 37 % reduction . Conclusions - The study shows that the health checks had a measurable impact on plasma cholesterol levels , the most pronounced effect is seen among individuals at high cardiovascular risk South-East London Screening Study Group ( Department of Community Medicine , St Thomas 's Hospital and Medical School , London SE1 1EH , Engl and ) . A controlled trial of  multiphasic screening in middle-age : results of the South-East London Screening Study . International Journal of Epidemiology 1977;6:357 - 63 . The results of a controlled trial of multiphasic screening in general practice are presented . In 1967 , 7229 individuals aged between 40 and 64 years were r and omly allocated into either a  Screening or Control group .  The Screening group were invited to attend two screening sessions held about two years apart , while the Control group continued to receive conventional medical care . Both groups were then invited to undergo a health survey in 1972 - 73 which revealed no significant differences in morbidity between the two groups . Careful follow-up permitted detailed Screening-Control comparisons of various outcome measures -consultation and hospital admission rates , certified sickness absence from work , and mortality . Nine years after the initial screening , no significant differences were found between the two groups in any of the outcome measures . It is estimated that a similar screening programme for the entire middle-aged UK population would cost 142 million pounds at 1976 prices Background A pilot project cardiovascular prevention was implemented in S and well ( West Midl and s , UK ) . This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice . Those found to be eligible for treatment were offered treatment . During the pilot a higher proportion of high risk patients were started on treatment in the intervention practice s than in control practice s. Following the apparent success of the prevention project , it was intended to extend the service to all practice s across the S and well area . However the pilot project was not a robust evaluation . There was a need for an efficient evaluation that would not disrupt the planned rollout of the project . Methods / design Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practice s , with the sequence of general practice s determined r and omly . This is a stepped wedge r and omised controlled trial design . The target population is patients aged 35 to 74 , without diabetes or cardiovascular disease whose ten-year cardiovascular risk , ( determined from data in their electronic records ) is ≥20 % . The primary outcome is the number of high risk patients started on treatment , because these data could be efficiently obtained from electronic primary care records . From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practice s before and after implementation of targeted case finding . Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs . Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians . Practical considerations meant that 26 practice s in S and well could be r and omised , including about 6,250 patients at high risk of cardiovascular disease . This gives sufficient power for evaluation . Discussion It is possible to design a stepped wedge r and omised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme BACKGROUND The aim of this study was to investigate the long-term effects of one general health screening on mortality . METHOD After stratification and r and omization of a population of 450,000 inhabitants , two groups were formed , an  intervention group of 3064 people and a control group of 29,122 people .  From the National Cause of Death Register , data were collected as regards death and causes of deaths for 1970 - 1990 . RESULTS Multivariate analysis was used to correct for known confounders . We then found no differences between the groups regarding deaths from all causes , cardiovascular diseases , cancer or accidents and poisoning . CONCLUSIONS One general health screening seems to have little , if any value in preventing fatal diseases Background R and omised , controlled trials focusing on long-term psychological reactions to information about increased risk of coronary heart disease are scarce . Design A population -based r and omised , controlled , 5-year follow-up trial was conducted in general practice . Methods In 1991 , invitations were sent to 2,000 middle-aged people registered in the general practice s in the district of Ebeltoft , Denmark . A total of 1,507 ( 75.4 % ) agreed to participate and were r and omised into a control group and two intervention groups : one included health screening , a written feedback and an optional follow-up visit with the general practitioner ; the other included health screening , written feedback and a planned 45-min follow-up visit with the general practitioner . The participants were informed at screening about their risk of developing coronary heart disease . Psychological distress was measured by the GHQ-12 before screening and at the 1 and the 5-year follow-up . Results Before the screening ( 0 year ) , 1 and 5 years after there were no significant differences in the GHQ-12 score between the control group and the two intervention groups . Nor were there any differences related to information about increased risk of coronary heart disease between scores obtained at the 1 and the 5-year follow-up . Conclusion Middle-aged persons had no long-term psychological reaction after information about increased risk of developing coronary heart disease following a health screening in general practice evaluated by the GHQ-12,1 year and 5 years after the examinations In the Study of Men Born in 1913 it was possible to investigate the influence of repeated health examinations on mortality in a prospect i ve cohort study . On January 1 , 1963 , 1010 men in the experimental grop and 1956 in the control group were alive . The experimental group took part in repeated examinations in 1963 , 1967 , 1973 and 1980 . Overt diseases were treated accordingly . Newly detected hypertension was also treated . By the end of a 15-year-long observation period , the cumulative mortality in the experimental group ( 14.5 % ) was not significantly lower than that in the control group ( 15.7 % ) . In the experimental group , 855 took part . The mortality was significantly higher in the non-participating group . The autopsy frequency decreased for in-hospital deaths but increased for deaths outside hospital during the study period A clinical controlled trial was design ed to determine the impact of Automated Multiphasic Health Testing on morbidity and attitudes .  Three strata comprising 574 families ( lower-income group enrolled in health maintenance organization , lower-income not enrolled in such a project , and a middle-income group employed by a utility company ) were interviewed to obtain information on utilization , morbidity , health status , and attitudes .  Sixty percent of adults in each stratum were then screened . All families were interviewed again one year later . The only significant difference found between screened and non-screened subjects was an increase in nights hospitalized for screened subjects . Physicians were interviewed to determine what abnormalities were found and what treatment was required for project and privately referred patients of these physicians . Previously unknown abnormalities prompted retesting for confirmation in only 28 per cent of the cases and even less often led to treatment Within a community-wide heart disease prevention effort , it was hypothesized that personalized risk factor screening and education would result in modified health behaviors and reduced risk factor levels for coronary heart disease . Adults from a population sample were r and omized to a community-wide screening and education program or were excluded from that program for 1 year . At the end of that year , both groups were measured for risk factor levels and related health behaviors . Those who received the screening and education program had significantly lower risk factor levels and other evidence of health behavior change , including lower blood cholesterol ( 206.9 vs 211.5 mg/dl ) , lower diastolic blood pressure ( 68.7 vs 70.0 mm Hg ) , lower resting heart rate ( 71.4 vs 72.7 bpm ) , and increased selection of low-fat and low-sodium meals in local restaurants . These data suggest that systematic risk factor screening and education may result in lower population risk for coronary heart disease OBJECTIVE High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated . Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in population s. The present study is a community cluster-r and omised trial testing the effectiveness of CHAP ( Cardiovascular Health Awareness Program ) on the cardiovascular health of older adults . METHODS Thirty-nine mid-sized communities in Ontario , Canada were stratified by geographic location and size of the population aged > or=65 years and r and omly allocated to receive CHAP or no intervention . In CHAP communities , residents aged > or=65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall , 2006 . Sessions included blood pressure measurement and feedback to family physicians . Trained volunteers delivered the program with support from pharmacists , community nurses and local organisations . RESULTS The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infa rct ion , congestive heart failure and stroke ( composite end-point ) among residents aged > or=65 years in intervention and control communities , using routinely collected , population -based administrative health data . CONCLUSION This paper highlights considerations in design , implementation and evaluation of a large-scale , community-wide cardiovascular health promotion initiative
target: Limited data suggest that systematic risk assessment for CVD has no statistically significant effects on clinical endpoints .
  There is limited evidence to suggest that CVD systematic risk assessment may have some favourable effects on cardiovascular risk factors .
background: BACKGROUND Screening programmes can potentially identify people at high cardiovascular risk and reduce cardiovascular disease ( CVD ) morbidity and mortality .
  However , there is currently not enough evidence showing clear clinical or economic benefits of systematic screening-like programmes over the widely practised opportunistic risk assessment of CVD in primary care setting s. OBJECTIVES The primary objective of this review was to assess the effectiveness , costs and adverse effects of systematic risk assessment compared to opportunistic risk assessment for the primary prevention of CVD .