The Ashkelon Hypertension Detection and Control Program (AHDC Program): a community approach to reducing cardiovascular mortality☆

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Preventive Medicine 37 (2003) 571–576

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The Ashkelon Hypertension Detection and Control Program (AHDC Program): a community approach to reducing cardiovascular mortality夞 C. Yosefy, M.D.,a,* D. Dicker, M.D.,b J.R. Viskoper, M.D.,a T.H. Tulchinsky, M.D. M.P.H.,c G.M. Ginsberg, B.Sc., M.A. (econ), Ph.D.,d E. Leibovitz, M.D.,e and D. Gavish, M.D.e a

WHO Collaborative Center for Prevention and Treatment of Cardiovascular Disease, Barzilai Medical Center, Campus Ashkelon, Ben-Gurion University, Israel b Department of Internal Medicine D, Hasharon Medical Center, Petach-Tikva, Tel-Aviv University, Israel c Braun School of Public Health, Hebrew University—Hadassah Ein-Carem, Jerusalem d Department of Technology Assessment & Preventive Medicine, Ministry of Health, Israel e Department of Internal Medicine A, Wolfson Medical Center, Holon, Tel-Aviv University, Israel

Abstract Background. Blood pressure (BP) reduction is crucial in reducing cardiovascular (CV) morbidity and mortality in the community. Subjects aged 20 – 65 seldom visit the primary care clinics, so they are unlikely to be detected without an active outreach screening program. The aim of the project was to prepare a professional doctor–nurse screening team, who will instruct those found to be at high risk in control of their risk factors, in order to reduce CV morbidity and mortality. Methods. During a 10-year period (1980 –1990), teams examined 12,202 subjects, (mean age 51 ⫾ 7 years, range 20 – 65 years) accounting for 23.4% of the total regional population. High risk subjects underwent an intensive CV risk factor control program. Results. Subjects (3,506 or 28.6%) were found to have one or more CV risk factors (hypertension, obesity, smoking, hypercholesterolemia). During an average of 2 years, follow-up BP, weight reduction, and smoking cessation remained statistically significant. Total cholesterol was unchanged. Over this period, the standardized mortality ratio (SMR) in the area for acute MI fell from 100 to 76 (P ⬍ 0.01), for CV disease from 129 to 107 (P ⬍ 0.0001), and for hypertension from 121 to 87 (P ⬍ 0.1 NS). The project saved many life-years at no additional net cost to society, and cost effectiveness analysis showed positive results. Conclusions. A community approach with mainly nonpharmacological treatment is feasible and cost effective in reducing CV morbidity and mortality. © 2003 American Health Foundation and Elsevier Science (USA). All rights reserved. Keywords: Hypertension; Risk factors; Mortality ratio

Introduction The incidence of hypertension is increasing worldwide and most people will develop hypertension during their lifetime. Reports from the Framingham Study show that a diastolic blood pressure (DBP) that is persistently higher by 5.0 mmHg is associated with at least a 34% increase in 夞 This study did not receive any funding from sources other than the Barzilai Medical Center. * Corresponding author. WHO Collaborative for Prevention and Treatment of Cardiovascular Disease, Barzilai Medical Center, Ashkelon, 78306, Israel. Fax: ⫹972-8-6745526. E-mail address: [email protected] (C. Yosefy).

stroke risk and at least a 21% increase in coronary heart disease (CHD) risk [1]. The importance of this data is augmented when we view the capacity of a similar level of blood pressure (BP) reduction which results in reducing cardiovascular (CV) morbidity and mortality, with risks of stroke and myocardial infraction produced by a 5– 6 mmHg decline in DBP being 38 and 16%, respectively [2,3]. In many countries during the 1980s to the 1990s, programs were established aiming to increase prevention, treatment, and control of hypertension, in order to reduce morbidity and mortality from CV disease [4 –11]. From the 1976 – 80 National Health and Nutrition Examination Survey (NHANES II) to the 1988 –91 survey

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(NHANES III, phase 1), the percentage of Americans who were aware that they have high BP increased from 51 to 73%. Among persons with hypertension, the percentage treated increased during that same period from 31 to 55%. The number of persons with high BP controlled to below 140/90 mmHg has increased from 10% in the NHANES II to 29% in the NHANES III, phase 1 [12]. These changes have contributed to dramatic reductions in morbidity and mortality attributable to hypertension. Age-adjusted death rates from stroke and CHD have declined by nearly 60 and 53%, respectively. Fifty-eight percent of excess CV deaths can be attributed to hypertension in the range of diastolic blood pressure (DBP) from 90 to 104 mmHg [13]. Subjects suffering from this are at risk of excess CV morbidity and mortality. These subjects, especially in the 20 – 65 age group, seldom visit their primary care clinics, so, they are unlikely to be detected without an active outreach screening program. The British Family Heart Study addressed this issue in a randomized controlled trial of nurses who led a screening program for CV risk factors and lifestyle intervention in families in general practices in towns throughout Britain. After 1 year, the reduction of coronary risk score was 16% (95% CI 11–21%) [14]. At the time we initiated this program (1980), we assumed that hypertension control alone is not sufficient to prevent the development of cardiovascular disease (CVD); therefore, one should adopt a multifactorial approach and deal with all CVD risk factors. Thus, the Ashkelon Hypertension Detection and Control program (AHDC program) was established, trying to follow this trend, using an outreach community-based approach in order to reduce CV mortality, especially stroke and myocardial infarction in the region.

Methods Ashkelon is a sea-shore Mediterranean town, situated in the south of Israel. In 1980 it had 52,000 inhabitants. Our initial assumptions were that 1. Hypertension control alone is not sufficient to prevent the development of CVD; therefore, one should apply a multifactorial approach and deal with all risk factors of CVD, while focusing mainly on dyslipidemia, obesity, smoking, and stress. 2. DBP should be reduced to less than 90 mmHg in order to prevent excess morbidity and mortality as compared to normotensives of the same age, sex, and risk factor distribution. 3. Cautious use should be made of pharmacological agents, as they may reduce BP but at the same time increase other risk factors of CHD. 4. The control of BP was aimed at that time to less than 160 mmHg and 95 mmHg. The AHDC program is based on two steps:

1. Recruitment and education of doctor–nurse teams, in which each team received a 6-month course in primary prevention of CVD, followed by continuous monthly follow-up training sessions. 2. An outreach program, using these teams to reach out into the community, to screen in primary clinics, at work sites, in community centers, and in homes, followed by finding and treating the high risk patients. The high risk subjects were defined using risk scores from 0 to 10, including 0 points for nonexisting risk factors, 1 or 2 points for moderate and marked obesity, and smoking below or above 20 cigarettes per day, respectively. Two points were given for positive family history, high total cholesterol, and blood pressure above 160/95. Subjects receiving 6 –10 points were defined as high risk. Promotion of health education was made by the doctor–nurse team, helped by a nutritionist, and psychologist, and smoking cessation with stress management relaxation specialists (using Jacobson relaxation techniques). We emphasized that health instructions must cover all CV risk factors detected in any of the screened subjects, as follows. For hypertension These instructions included salt reduction to below 4 grams per day, weight reduction to below BMI of 28 kg/m2, physical activity such as walking for at least four times a week for 30 minutes each time, and deep muscle relaxation (Jacobson technique) twice daily, performed at home. Antihypertensive drugs were given by the physicians according to their judgment, trying to follow the above assumptions. For obesity Instructions included 6 months monthly followed by bimonthly reinforced visits for diet management of low calories intake (1,000 –1,200 kilocalories for women and 1,200 –1,500 kilocalories for men), mainly carbohydrates, fewer fats and proteins, and physical activity as in the hypertensives. Each subject was reexamined after 6 and 24 months. For smokers Individual and group sessions of smoking cessation support were performed, together with physical activity (as mentioned above), and stress management. Nicotine-containing chewing gum (Nicorette, Upjohn AB Company) were used for nonresponding subjects. All were followed for 24 months.

C. Yosefy et al. / Preventive Medicine 37 (2003) 571–576 Table 1 The results of intervention on systolic (SBP) and diastolic (DBP) blood pressure, percentage of hypertensive patients treated, and BP controlled

SBP mmHg DBP mmHg Drug treated (%) BP ⬍ 140/90 mmHg (%)

Baseline

6 Months

24 Months

153.1 ⫾ 3.5 101.2 ⫾ 2.2 74.4 18.4

138.3 ⫾ 2.8** 90.1 ⫾ 2.0** 65.4 68.3*

137.2 ⫾ 3.0 86.2 ⫾ 2.4* 62.4* 64.4**

Note. * P ⬍ 0.05; ** P ⬍ 0.005. Drug treated (%): percentage of hypertensive patients treated with at least one antihypertensive drug. BP ⬍ 140/90 mmHg (%): percentage of hypertensive patients with BP controlled to below 140/90 mmHg.

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provide the number of estimated deaths for a region. The numbers of actual deaths in a region [15–17] were then multiplied by 100, and then divided by the numbers of expected deaths in order to obtain the regional SMR. Standard error (SE) and t test statistics were calculated for the regional SMRs, using the formula (SE) (SMR) No. of actual deaths, t statistic ⫽ (100-SMR)/SE. SMRs were also calculated by major ICD 9 A diagnostic groupings and by individual diagnostic category.

Results For dyslipidemic patients Instructions were given as low cholesterol (fewer then 300 g/day) and low caloric diet (as for obesity), with physical activity as instructed above. The teams’ instructions curriculum and their professional backup were developed by the regional hospital, Barzilai Medical Center, which is a WHO Collaborating Center for Prevention and Treatment of cardiovascular diseases. Standardized mortality ratio (SMR) Mortality data (based on the underlying cause of death) by region for 1987–1994, by age, gender, and continent of birth (Europe/America, Asia, Africa, or Israel) were analyzed for various diagnoses, according to the H list of 56 diagnostic categories [15–17]. Regions of residence are the 14 subdistricts (Nafot) of the country used by the Ministry of Interior and the Ministry of Health [18,19]. Mortality data were provided according to gender, and 11 age categories (0, 1– 4, 5–14, 15–24, 25–34, 35– 44, 45–54, 55– 64, 65–74, 75– 84, 85⫹). Out of a total of 222,121 deaths during the 8-year period under study, district of residence was unknown for only 54 cases (0.024%); these cases were omitted from the analysis. The small number of deaths (892, 0.40% of all deaths), which occurred among the Jewish residents of the West Bank and the Gaza Strip, were included in the calculation of age and sex specific national death rates, but were not reported in the regional and diagnosis-specific tables, owing to their relatively small numbers. Population estimates for the years 1987–1994 by the same age categories as the mortality data, were obtained by interpolating gender and continent of birth, age-specific data obtained from the Central Bureau of Statistics (Personal Communication: Paltiel Ari, Central Bureau of Statistics, CBS) for the years 1986 and 1996, according to the gender specific data published annually by the CBS [18,19]. Using an Excel spreadsheet, SMRs for the period 1987–1994 were calculated by the indirect method. The age, gender, and continent of birth-specific national mortality rates were applied to the Jewish regional population estimates in order to

During 10 years from 1980 to 1990, the outreach teams examined 12,002 subjects mean age 51 ⫾ 7 years (range 20 – 65 years), 6833 (56%) males and 5369 (44%) females, which account for 23.4% of all the area’s inhabitants (52,106). The mean follow up was 6.4 years. Ninety percent (10,981) were blue collar employees of factories, and the others were white collar. Seventy percent (8,542) were from Asian–African origin (Sepharadic), while 30% (3,660) were from European origin (Ashkenazi). Subjects with a mean age of 54 ⫾ 6 years (3,506 or 28.6%) were selected to have at least one of the following CV risk factors: hypertension. (SBP ⬎ 140 mmHg and/or DBP ⬎ 90 mmHg, measured with sphygmomanometer), obesity (BMI ⬎ 28 kg/m2). Smoking habit, or hypercholesterolemia (total cholesterol ⬎ 200 mg). Thirteen percent (1,586) of subjects were defined as high risk subjects (risk score of 6 –10 points). All subjects with any risk factors were referred to our treatment centers to start the special program directed toward reducing their risk factors. Out of all 12,202 subjects examined, 854 (7%) were found to have, in three different measurements (2 minutes apart), SBP, and/or DBP above 160/95 mmHg. When we used the first measurement only as an indicator, the numbers rose to 1,220 subjects (10%). Table 1 shows the results of the BP intervention for baseline 6 and 24 months of follow-up, for subjects with an average of three measurements higher than 160/95 mmHg. After 24 months of the project, 62 patients (25.3%) were still with one less antihypertensive drug. The drug saving analysis of the project cost results in a positive cost effectiveness in the ratio of 3.03:1. Table 2 shows the results of the intervention on weight reduction in subjects with BMI ⬎ 28 kg/m2 who agreed to enter the treatment program (N ⫽ 330). For smoking ces-

Table 2 Results of nutritional intervention on body weight

Body weight (kg) BMI (kg/m2)

Initial value

6 months

24 months

88.7 ⫾ 3.5 30 ⫾ 1.5

81.4 ⫾ 3.4* 27 ⫾ 1.5*

82.6 ⫾ 3.6* 28 ⫾ 1.5*

Note. n ⫽ 330. Baseline BMI over 30 in the total population ⫽ 23%. * P ⬍ 0.005. BMI, body mass index.

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Table 3 Standardized mortality ratio (SMR) in the Ashkelon area before and after 10 years of the Ashkelon Hypertension Detection and Control (AHDC) program From

1983–1986

1987–1994

Acute myocardial infraction Cerebrovascular disease Hypertension

100

76

129

107

121

87

P value P ⬍ 0.0001 P ⬍ 0.01 P ⬍ 0.1 (NS)

sation intervention we have only the data for 30 “hard core,” subject who were smoking more than 20 cigarettes per day and failed to follow the individual doctor–nurse team instructions. They were sent to our collaborative center for further smoking cessation efforts. Enhancement stress management, biofeedback, and Nicorrette use caused 18 subjects (60%) to stop smoking and the remaining 12 (40%) reduced smoking to less than half of the original amount. Dyslipidemia We do not have the follow-up data of all lipidogram levels, except for the data on cholesterol levels. These revealed no statistically significant changes in the plasma levels during the study. SMR results Table 3 shows that between the periods 1983–1986 and 1987–1994 there was a highly significant decrease in SMR from acute myocardial infarction, from 100 to 87 (P ⬍ 0.0001), and in the cardiovascular disease SMR from 129 to 107 (P ⬍ 0.01) (adjusted by age, gender, and continent of origin) in the Ashkelon Region of Israel. Nonsignificant

relative improvements were found for hypertension SMR (121 in 1983–1986, to 87 in 1987–1994; P ⬍ 0.1). Over the period 1987–1994, the Ashkelon region had on average 554 cardio- and cerebrovascular fatalities annually in persons over 25 years of age, around 145 fewer deaths than the annual expected death rate of 693. Thus, over the 8-year period 1987–1994, there were 1,160 fewer persons dying 11.3 years earlier than expected from cardio- and cerebrovascular diagnoses in the Ashkelon region. Table 4 shows the standardized mortality rates from all causes among the Jewish population of Israel by subdistrict of residence in the years 1983–1994. Discussion The prevention of CHD and stroke is a priority for governments in the health of nations. Throughout the world targets have been set for the major cardiovascular risk factors—smoking, diet in relation to obesity, and blood pressure—and a voluntary health promotion package for primary care aimed at modifying these factors, among both high risk groups and the population as a whole, is now being put into place [20 –24]. The AHDC program doctor–nurse team led CV screening and lifestyle modifications in the Ashkelon region in the south of Israel throughout the 10-year period of the intervention with a mean follow-up of 6.4 years. Standardized mortality ratio (SMR) of cerebrovascular disease fell from 129 to 107 (P ⬍ 0.01) and for acute MI from 100 to 76 (P ⬍ 0.0001). The reduction in SMR from hypertension was from 121 to 87 (P ⫽ 0.1,NS). During the same period, reductions in SMRs for other regions were less than in the Ashkelon region [18,19]. Only one other region showed the same rate of reduction. At the same time, SMR for all causes of mortality in the Ashkelon region showed the same

Table 4 Standardized mortality rates, all causes, Jewish population of Israel by subdistrict of residence, 1983–1986 Subdistrict

Jerusalem Zefat Kinneret Yizreel Akko Haifa Hadera Sharon Petah Tikva Ramla Rehovot Tel Aviv Ashkelon Beer Sheva

1983–1986

1987–1990

1991–1994

SMR

SE

SMR

SE

SMR

SE

88.7*** 97.2 99.3 107.7*** 108.8*** 103.8*** 108.1*** 96.7** 91.4***

0.97 2.65 2.99 1.86 2.04 0.85 1.90 1.43 1.08

90.5*** 103.8 98.8 105.8** 104.4* 107.1*** 109.3*** 92.5*** 91.4***

0.97 2.78 3.01 1.82 1.92 0.88 1.91 1.36 1.05

93.4*** 115.7*** 107.1* 110.6*** 99.2 106.3*** 111.2*** 92.7*** 89.6***

0.95 2.81 3.04 1.69 1.65 1.83 1.81 1.24 0.96

107.7*** 91.1*** 102.1*** 103.4* 103.6**

2.13 1.22 0.53 1.47 1.48

108.5*** 89.1*** 104.3*** 97.0* 102.0

2.11 1.17 0.54 1.35 1.44

105.5** 94.0*** 103.3*** 91.5*** 102.1

1.95 1.10 0.52 1.14 1.29

Note. * P ⬍ 0.05; ** P ⬍ 0.01; *** P ⬍ 0.001.

C. Yosefy et al. / Preventive Medicine 37 (2003) 571–576

trend toward reduction, reinforcing our results (see Table 4). These SMRs looked quite impressive and the study population seemed too large to attribute much change to the program. We looked for various indicators of change in the general population with regard to CV risk factors. There was no other national or regional health promotion or education, or any planned, during that time in Ashkelon, that was different or unique in comparison to other regions in the country. We could argue these facts in terms of the health authorities’ point of view and from knowing each of the work sites, health care centers etc., in our home town Ashkelon. We have taken the 3,506 (28.6%) patients having one or more risk factors, who were detected from the 52,202 inhabitants, who were those expected to undergo CV events. These high risk patients went through a long, intensive lifestyle modification process. Thus, even though we cannot guarantee it, the most likely cause of the improvement is the AHDC program. It is important to note that while one uses only one measurement as a screening tool, one ends up with a higher prevalence rate of the disease (10% in 20 – 60-year olds in our program), whereas when using an average of three consecutive measurements, 2 minutes apart, the prevalence rate is lowered to 7%. This “white coat phenomena” is a very important factor in defining and measuring the prevalence of hypertension in each community. Today, according to new guidelines [25], BP of above 140/90 mmHg is already defined as high risk, and SBP is considered important at least as DBP, and pulse pressure. However, we must emphasize that 20 years ago, when we started to run the AHDC program, DBP was the main target for treatment and for the various studies, and therefore we concentrated on it. Today, retrospectively, when we look at our results, SBP reached the target of below 140 mmHg in most patients (64.4% after 2 years) (see Table 1). The new JNC-VII BP guidelines instruct clinicians to start early and treat aggressively. Furthermore, they emphasize that in people over age 50, SBP is more important than DBP. The guidelines also say that SBP of 140 mmHg or greater, in that age group, should be treated, regardless of the DBP level. Additionally, for patients over age 50 with stage one hypertension (SBP 140 –159 mmHg) and additional CV risk factors, 12 mmHg reduction in SBP sustained for more than 10 years, is likely to prevent one death for every 11 patients [25]. In our AHDC program we reached this goal in two-thirds of the patients. Thus if we had pushed more for lower SBP, perhaps the CV morbidity and mortality would have been lower (see Table 3) and the SMRs for hypertension would have been statistically significant. In this study, SBP reduction of 16 mmHg (from 153.1 ⫾ 3.5 mmHg to 137.2 ⫾ 3.0 mmHg) and DBP reduction of 15 mmHg (from 101.2 ⫾ 2.2 to 86.2 ⫾ 2.4 mmHg) were maintained for at least 2 years. These achievements together with a weight reduction (⫺7.3 kg), and smoking cessation, were the main results promoting CV death

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reduction. At the beginning of the project, 74.4% of our high risk hypertensive patients were treated with at least one antihypertensive drug, but only 18.4% were controlled to BP ⬍ 140/90 mmHg. At that time, nonpharmacological treatment was not used as a cornerstone of their treatment. After 24 months of the AHDC program, 62.4% of patients were treated with at least one antihypertensive drug and the percentage of patients with BP controlled to below 140/90 mmHg, was raised to 64.4% (see Table 1). Unlike the British Family Heart Study [14], we are not able to calculate which part of these factors was responsible for most of the results. Assuming that 5– 6 mmHg reduction in SBP accounts for 38% reduction in stroke and 16% reduction ischemic heart disease mortality [2,3] we can agree that most of the risk reduction in the AHDC program is due to the BP reduction. From a review of epidemiological and clinical literature, we know that using the cholesterol test as a component of the strategies to prevent coronary heart disease in asymptomatic adults is strongest in the middle-aged and weaker in the elderly. Even though we had a long standing weight reduction (7.3 kg on average) in the high risk group, we faced no change in cholesterol levels of these subjects, which makes this parameter less likely to affect the overall reduction in CV morbidity and mortality. Cost effectiveness The program cost (at 1999 price levels, including overheads) was $245.05 per participant in the initial year, and $54.43 in subsequent years for maintenance visits. Using a 5% discount rate, the average cost per program participant for the 1980 –1994 period was $542, with a total program cost of 1 million. Under the assumption that the program saved 1,160 lives and 13,091 life years, the gross cost was around $506 per life year saved. The project also saved around $17.5 million from 50,889 fewer hospital days (or 8,441 fewer hospital admissions) and 1 million from reduction in the use of hypertension medications ($108.37 per person in the initial and $167.94 in subsequent years). The total value of these benefits ($30.0 million) exceeds the costs ($6.6 million) of the project (benefit to cost ratio of 4.5:1). Thus the project not only saved around $23.4 million in health service resources, but also saved 13,091 life years, giving the project in effect a net negative cost per life year saved. These cost effectiveness results are reinforced by the conclusions of Wondering et al. [26]. The results of the Oxcheck and British Family Heart Studies show that it requires years duration in order to get on a positive economic effect for a CVD prevention program (at least 5 years for the former or at least 10 years for the latter) [26]. In our program, 10 years were needed to show positive cost effectiveness results.

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Summary We report the AHDC program as a community-based screening and intervention program. The high risk patients went through a doctor–nurse team instruction program. We show BP reduction, weight reduction, and smoking cessation with no change in cholesterol levels associated with an SMR reduction from 107 to 87/100,000 during 10 years of the program, with positive cost effectiveness. References [1] MacMahon S, Peto R, Cutler J, Collins R, Sorley P, Neaton J, et al. Blood pressure, stroke and coronary heart disease. Part 1, Prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet 1990;335:765–74. [2] Staessen JA, Gasowski J, Wang JG, Thijs L, Den Hond E, Boissel JP, et al. Risks of untreated and treated isolated systolic hypertension in the elderly: meta-analysis of outcome trials. Lancet 2000;355:865–72. [3] Collins R, MacMahon S. Blood pressure, antihypertensive drug treatment and the risks of stroke and of coronary heart disease. Br Med Bull 1994;50:272–98. [4] McMenamin JP. Screening for coronary heart disease risk among men in a general practice. NZ Med J 1995;108:167– 8. [5] Langeluddecke PM. The role of behavioral change procedures in multifactorial coronary heart disease prevention programs. Prog Behav Modif 1986;20:199 –225. [6] Lefebvre RC, Lasater TM, Carleton RA, Paterson G. Theory and delivery of health programming in the community: the Pawtucket Heart Health Program. Prev Med 1987;16:80 –95. [7] Neaton JD, Grimm RH Jr, Cutler JA. Recruitment of participants for the multiple risk factor intervention trial (MRFIT). Control Clin Trials 1987;8(4 Suppl):41S–53S. [8] Bennett P, Blackall M, Clapham M, Little S, Player D. A multidisciplinary approach to the prevention of coronary heart disease. Health Educ J 1988;47:164 – 6. [9] Jones A, Davies DH, Dove JR, Collinson MA, Brown PM. Identification and treatment of risk factors for coronary heart disease in general practice: a possible screening model. Br Med J (Clin Res Ed) 1988;296:1711– 4. [10] Knutsen SF, Knutsen R. The Tromso Heart Study: family approach to intervention on CHD. Feasibility of risk factor reduction in high-risk persons—project description. Scand J Soc Med 1989;17:109 –19.

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