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H A Feldman

Publications and source records attributed to H A Feldman.

At least 37 records · Page 2Linked to original sources

Construction and field validation of a self-administered screener for testosterone deficiency (hypogonadism) in ageing men.

To design a self-administered screening questionnaire to inform men about their risk for testosterone deficiency. The screener was developed in two phases. First was a construction phase in which relevant risk factors and a scoring algorithm were defined from multiple logistic regression analyses of survey data. In the second phase, the screener's accuracy (based on sensitivity, specificity, and Receiver Operating Characteristic (ROC) curves) was tested using patients from a primary care clinic. All subjects provided blood samples for endocrine testing. Survey data from 1660 men aged 40-79 years participating in the Massachusetts Male Ageing Study (MMAS) were analysed in the first phase. The clinic sample consisted of 304 men aged 40-79 years presenting at a large Massachusetts primary health care clinic for routine check-ups or minor medical problems. The primary outcome was testosterone deficiency, defined as serum total testosterone below 12.1 nmol/l. Self-reported variables considered as potential risk factors included age, obesity, chronic diseases, health behaviour, the Jackson dominance scale, and symptoms of stress. The prevalence of testosterone deficiency was 20.4% in the MMAS and 42.1% in the clinic sample. An eight-item screener was developed based on age, body mass index, diabetes, asthma, headaches, sleep patterns, dominance preferences, and smoking status. The screener performed significantly better than chance in identifying men with low testosterone levels; the area under the ROC curve was 0.66 in the MMAS sample and 0.67 in the clinic sample. The self-scored screener developed in this study reliably detects men at risk of hypogonadism. The screener encourages at risk men to seek professional evaluation of their testosterone levels.

Adult↗

Impact of community intervention to reduce patient delay time on use of reperfusion therapy for acute myocardial infarction: rapid early action for coronary treatment (REACT) trial. REACT Study Group.

BACKGROUND: Reperfusion therapy for acute myocardial infarction (AMI) is a time-dependent intervention that can reduce infarct-related morbidity and mortality. Out-of-hospital patient delay from symptom onset until emergency department (ED) presentation may reduce the expected benefit of reperfusion therapy. OBJECTIVE: To determine the impact of a community educational intervention to reduce patient delay time on the use of reperfusion therapy for AMI. METHODS: This was a randomized, controlled community-based trial to enhance patient recognition of AMI symptoms and encourage early ED presentation with resultant increased reperfusion therapy rates for AMI. The study took place in 44 hospitals in 20 pair-matched communities in five U.S. geographic regions. Eligible study subjects were non-institutionalized patients without chest injury (aged > or =30 years) who were admitted to participating hospitals and who received a hospital discharge diagnosis of AMI (ICD 410); n = 4,885. For outcome assessment, patients were excluded if they were without survival data (n = 402), enrolled in thrombolytic trials (n = 61), receiving reperfusion therapy >12 hours after ED arrival (n = 628), or missing symptom onset or reperfusion times (n = 781). The applied intervention was an educational program targeting community organizations and the general public, high-risk patients, and health professionals in target communities. The primary outcome was a change in the proportion of AMI patients receiving early reperfusion therapy (i.e., within one hour of ED arrival or within six hours of symptom onset). Trends in reperfusion therapy rates were determined after adjustment for patient demographics, presenting blood pressure, cardiac history, and insurance status. Four-month baseline was compared with the 18-month intervention period. RESULTS: Of 3,013 selected AMI patients, 40% received reperfusion therapy. Eighteen percent received therapy within one hour of ED arrival (46% of treated patients), and 32% within six hours of symptom onset (80% of treated patients). No significant difference in the trends in reperfusion therapy rates was attributable to the intervention, although increases in early reperfusion therapy rates were noted during the first six months of the intervention. A significant association of early reperfusion therapy use with ambulance use was identified. CONCLUSIONS: Community-wide educational efforts to enhance patient response to AMI symptoms may not translate into sustained changes in reperfusion practices. However, an increased odds for early reperfusion therapy use during the initiation of the intervention and the association of early therapy with ambulance use suggest that reperfusion therapy rates can be enhanced.

Adult↗

Trends in validated cases of fatal and nonfatal stroke, stroke classification, and risk factors in southeastern New England, 1980 to 1991 : data from the Pawtucket Heart Health Program.

BACKGROUND AND PURPOSE: Recent US data suggest there is a slowing of the decline in stroke mortality rates, accompanied by a constant morbidity rate. Hospital discharge rates for patients with stroke are influenced by numerous factors, and community-based surveillance data for validated cases are rare. Thus, reasons for the observed trends remain unclear. In the present study, we examined trends in validated cases of stroke for 1980 to 1991 in the combined populations of the Pawtucket Heart Health Program study communities and examined concomitant trends in classification, use of diagnostic procedures, and levels of risk factors. METHODS: Discharges for residents aged 35 to 74 years with International Classification of Diseases, Ninth Revision codes 431, 432, and 434 to 437 were identified through retrospective surveillance. A physician reviewed the medical records to validate case status. RESULTS: Between 1980 and 1991, 2269 discharges were confirmed as representing definite or probable strokes (59.5% of 3811 cases reviewed). The fatal stroke rate declined (P<0.005) and the nonfatal stroke rate remained constant in both sexes. Case-fatality rates declined significantly (P=0.003), and among strokes, the relative odds of death in 1990 versus 1980 was 0.50 (95% CI 0.34 to 0.72). The proportion of stroke discharges in which the patient received a CT scan or MRI increased 120%, and fewer strokes were classified as ill defined. Hypertension prevalence, treatment, and control rates remained constant in these populations. CONCLUSIONS: Although causes for the observed trends remain unclear, results suggest that the decline in mortality rates is due to improved survival rates for patients with stroke. However, constant morbidity rates combined with constant rates of hypertension highlight the need for improved prevention to reduce the impact of stroke.

Adult↗

Components of variance in a group-randomized trial analysed via a random-coefficients model: the Rapid Early Action for Coronary Treatment (REACT) trial.

Rapid Early Action for Coronary Treatment (REACT) was a multisite trial testing a community intervention to reduce the delay between onset of symptoms of acute myocardial infarction (MI) and patients' arrival at a hospital emergency department. The study employed a group-randomized trial design, with ten communities randomized from within matched pairs to each of two conditions. REACT also employed continuous data collection, based on surveillance of heart attack patients in community emergency departments. They analysed their data by comparing the mean slope for delay time in the ten intervention communities to the mean slope estimated in the ten control communities. Because no estimates of slope variation were available a priori, REACT was sized using approximations based on more traditional designs. In this paper, we present the slope and residual error variances as estimated from the REACT data and examine their influence on the power of the trial post hoc. We also examine the power of the trial as it would have been given a more traditional pretest-post-test design with analysis via a comparison of the net difference in condition means pretest vs post-test.

Ambulances↗

Diet and sex hormone-binding globulin.

The serum concentration of sex hormone-binding globulin (SHBG) is inversely related to weight and in animal studies is inversely related to protein intake. As SHBG can affect the biological activity of testosterone and estradiol, we wished to determine the role of protein intake on SHBG levels in men. Using data from the Massachusetts Male Aging Study we examined cross-sectional relationships between dietary components and SHBG levels in 1552 men (aged 40-70 yr) for whom these factors were known. Analyzed by multiple regression, controlling for testosterone and estradiol levels, age (P<0.001) and fiber intake (P = 0.02) were positively correlated to SHBG concentration, whereas body mass index (P<0.001) and protein intake (P<0.03) were negatively correlated to SHBG concentration. The intakes of calories, fat (animal or vegetable), and carbohydrate were not related to SHBG concentration. We conclude that age and body mass index are major determinants of SHBG concentrations in older men, and fiber and protein intake are also significant contributors to SHBG levels, but total caloric intake and the intake of carbohydrate or fat are not significant. Thus, diets low in protein in elderly men may lead to elevated SHBG levels and decreased testosterone bioactivity. The decrease in bioavailable testosterone can then result in declines in sexual function and muscle and red cell mass, and contribute to the loss of bone density.

Adult↗

Testosterone, sex hormone-binding globulin, and the development of type 2 diabetes in middle-aged men: prospective results from the Massachusetts male aging study.

OBJECTIVE: The objective was to examine prospectively the association between low testosterone and sex hormone-binding globulin (SHBG) levels and the subsequent development of type 2 diabetes in men. RESEARCH DESIGN AND METHODS: Analyses were conducted on the cohort of the Massachusetts Male Aging Study, a population-based random sample of men aged 40-70. Of the 1,709 men enrolled in 1987-1989 (T1), 1,156 were followed up 7-10 years later (T2). Testosterone and SHBG levels at T1 were used to predict new cases of diabetes between T1 and T2. RESULTS: After controlling for potential confounders, diabetes at follow-up was predicted jointly and independently by lower baseline levels of free testosterone and SHBG. The odds ratio for future diabetes was 1.58 for a decrease of 1SD in free testosterone (4 ng/dl) and 1.89 for a 1SD decrease in SHBG (16 nmol/l), both significant at P < 0.02. CONCLUSIONS: Our prospective findings are consistent with previous, mainly cross-sectional reports, suggesting that low levels of testosterone and SHBG play some role in the development of insulin resistance and subsequent type 2 diabetes.

Adult↗

Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study.

PURPOSE: We estimated the incidence of erectile dysfunction in men 40 to 69 years old at study entry during an average 8.8-year followup, and determined how risk varied with age, socioeconomic status and medical conditions. MATERIALS AND METHODS: Data from a randomly sampled population based longitudinal study of Massachusetts men were analyzed. A total of 1,709 men completed the baseline interview during 1987 to 1989 and 1,156 survivors completed followup from 1995 to 1997. The analysis sample consisted of 847 men without erectile dysfunction at baseline and with complete followup information. Erectile dysfunction was assessed by discriminant analysis of 13 questions from a self-administered sexual function questionnaire and a single global self-rating question. RESULTS: The crude incidence rate for erectile dysfunction was 25.9 cases per 1,000 man-years (95% confidence interval [CI] 22.5 to 29.9). The annual incidence rate increased with each decade of age and was 12.4 cases per 1,000 man-years (95% CI 9.0 to 16.9), 29.8 (24.0 to 37.0) and 46.4 (36.9 to 58.4) for men 40 to 49, 50 to 59 and 60 to 69 years old, respectively. The age adjusted risk of erectile dysfunction was higher for men with lower education, diabetes, heart disease and hypertension. Population projections for men 40 to 69 years old suggest that 17,781 new cases of erectile dysfunction in Massachusetts and 617,715 in the United States (white males only) are expected annually. CONCLUSIONS: Although prevalence estimates and cross-sectional correlates of erectile dysfunction have recently been established, incidence estimates were lacking. Incidence is necessary to assess risk, and plan treatment and prevention strategies. The risk of erectile dysfunction was about 26 cases per 1,000 men annually, and increased with age, lower education, diabetes, heart disease and hypertension.

Adult↗

Distribution of and factors associated with serum homocysteine levels in children: Child and Adolescent Trial for Cardiovascular Health.

CONTEXT: Although evidence suggests that homocysteine is a risk factor for cardiovascular disease in adults, little information exists on homocysteine levels in children. OBJECTIVES: To describe the distribution of serum homocysteine concentrations among children and to examine the association between homocysteine levels and several characteristics, including serum levels of folic acid and vitamins B12 and B6. DESIGN: Cross-sectional analysis. SETTING: School-based cohort from California, Louisiana, Minnesota, and Texas. PARTICIPANTS: A total of 3524 US schoolchildren, aged 13 and 14 years, from the Child and Adolescent Trial for Cardiovascular Health (completed in 1994). Measurement was conducted in 1997. MAIN OUTCOME MEASURE: Nonfasting serum total homocysteine concentration. RESULTS: The distribution of homocysteine values ranged from 0.1 to 25.7 micromol/L (median, 4.9 micromol/L). Geometric mean homocysteine concentration was significantly higher in boys (5.22 micromol/L) than girls (4.84 micromol/L); blacks (5.51 micromol/L) than whites (4.96 micromol/L) or Hispanics (4.93 micromol/L); nonusers of multivitamins (5.09 micromol/L) than users (4.82 micromol/L); and smokers (5.19 micromol/L) than nonsmokers (5.00 micromol/ L). Serum homocysteine was significantly inversely correlated with serum levels of folic acid (r= -0.36; P = .001), vitamin B12 (r = -0.21; P = .001), and vitamin B6 (r = -0.18; P = .001). Serum homocysteine was not significantly associated with serum lipid levels or family history of cardiovascular disease and was only weakly related to body mass index and systolic blood pressure. After multivariate adjustment, homocysteine remained independently associated with sex, race, serum folic acid and vitamin B12 levels, and systolic blood pressure. CONCLUSIONS: The distribution of homocysteine levels in children is substantially lower than that observed for adults; however, a small percentage of children are still potentially at elevated risk for future cardiovascular disease. Serum folic acid may be an important determinant of homocysteine levels in children.

Adolescent↗

Three-year maintenance of improved diet and physical activity: the CATCH cohort. Child and Adolescent Trial for Cardiovascular Health.

OBJECTIVE: To assess differences through grade 8 in diet, physical activity, and related health indicators of students who participated in the Child and Adolescent Trial for Cardiovascular Health (CATCH) school and family intervention from grades 3 through 5. DESIGN: Follow-up of the 4-center, randomized, controlled field trial with 56 intervention and 40 control elementary schools. PARTICIPANTS: We studied 3714 (73%) of the initial CATCH cohort of 5106 students from ethnically diverse backgrounds in California, Louisiana, Minnesota, and Texas at grades 6, 7, and 8. RESULTS: Self-reported daily energy intake from fat at baseline was virtually identical in the control (32.7%) and intervention (32.6%) groups. At grade 5, the intake for controls remained at 32.2%, while the intake for the intervention group declined to 30.3% (P<.001). At grade 8, the between-group differential was maintained (31.6% vs 30.6%, P = .01). Intervention students maintained significantly higher self-reported daily vigorous activity than control students (P = .001), although the difference declined from 13.6 minutes in grade 5 to 11.2, 10.8, and 8.8 minutes in grades 6, 7, and 8, respectively. Significant differences in favor of the intervention students also persisted at grade 8 for dietary knowledge and dietary intentions, but not for social support for physical activity. No impact on smoking behavior or stages of contemplating smoking was detected at grade 8. No significant differences were noted among physiologic indicators of body mass index, blood pressure, or serum lipid and cholesterol levels. CONCLUSION: The original CATCH results demonstrated that school-level interventions could modify school lunch and school physical education programs as well as influence student behaviors. This 3-year follow-up without further intervention suggests that the behavioral changes initiated during the elementary school years persisted to early adolescence for self-reported dietary and physical activity behaviors.

Adolescent↗

Prehospital delay in patients hospitalized with heart attack symptoms in the United States: the REACT trial. Rapid Early Action for Coronary Treatment (REACT) Study Group.

BACKGROUND: The use of thrombolytic therapy for patients with myocardial infarction has been limited by patient delay in seeking care. We sought to characterize prehospital delay in patients hospitalized for evaluation of heart attack symptoms. METHODS AND RESULTS: The Rapid Early Action for Coronary Treatment (REACT) is a multicenter, randomized community trial designed to reduce patient delay. At baseline, data were abstracted from the medical records of 3783 patients hospitalized for evaluation of heart attack symptoms in 20 communities. The median prehospital delay was 2.0 hours; 25% of patients delayed longer than 5.2 hours. In a multivariable analysis, delay time was longer among non-Hispanic blacks than among non-Hispanic whites, longer at older ages, longer among Medicaid-only recipients and shorter among Medicare recipients than among privately insured patients, and shorter among patients who used an ambulance. CONCLUSIONS: The observed pattern of differences is consistent with the contention that demographic, cultural, and/or socioeconomic barriers exist that impede rapid care seeking.

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Relation of dehydroepiandrosterone and dehydroepiandrosterone sulfate with cardiovascular disease risk factors in women: longitudinal results from the Massachusetts Women's Health Study.

Low circulating levels of the adrenal steroids dehydroepiandrosterone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) are thought to be associated with increased risk of cardiovascular disease (CVD) in men. In women, either a positive or null association with CVD has been found. The nature of the relation between DHEAS and CVD risk factors in women is unclear and is based on cross-sectional data. We present results from a longitudinal investigation of serum DHEA and DHEAS and cardiovascular disease risk factors in 236 women, initially 50-60 years old, from a population-based prospective (1986-1995) study of the menopausal transition. We used generalized estimating equations to model the relation of serum DHEA and DHEAS to systolic and diastolic blood pressure and serum levels of total cholesterol, high density lipoprotein cholesterol, and apolipoproteins A and B, adjusting for other factors related to CVD. Both DHEA and DHEAS were positively related to diastolic and systolic blood pressure, and DHEAS was negatively related to apolipoprotein A. DHEA and DHEAS were also positively related to smoking, alcohol use, estrone, and estradiol levels, and inversely related to age. Our results suggest that higher levels of DHEA and DHEAS in middle-aged women may indicate increased CVD risk.

Aged↗

Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multisite community trial with continual data collection.

Unusual problems in statistical design were faced by Rapid Early Action for Coronary Treatment (REACT), a multisite trial testing a community intervention to reduce the delay between onset of symptoms of acute myocardial infarction (MI) and patients' arrival at a hospital emergency department. In 20 pair-matched U.S. communities, hospital staff members recorded delay time throughout a 4-month baseline period and the subsequent 18-month intervention period, during which one randomly selected community of each pair received a campaign of public and professional education. To exploit the continual nature of its data-collection protocol, REACT estimated the trend of delay time separately in each community by linear regression, adjusting for age, sex, and history of MI, and compared the ten adjusted slopes from intervention communities with those from control communities by a paired t-test. Power calculations based on the analytical model showed that with K=600-800 cases per community, REACT would have 80% power to demonstrate a differential reduction of 30 min in mean delay time between intervention and control communities, as well as effects on a variety of secondary outcomes. Sensitivity analysis confirmed that the number of communities was optimal within constraints of funding and that the detectable effect depended weakly on the effectiveness of matching but strongly on K, helping the investigators set operational priorities. The methodologic strategy developed for REACT should prove useful in the design of similar trials in the future.

Emergencies↗

HDL cholesterol: trends in two southeastern New England communities, 1981-1993.

PURPOSE: Although public health interventions have not specifically targeted high density lipoprotein (HDL) cholesterol, observed changes in the prevalence of other cardiovascular risk factors would be expected to have differential effects on HDL. This study examined secular trends in HDL in relation to changes in other cardiovascular risk factors for the years 1981 through 1993 in the Pawtucket Heart Health Program (PHHP) study communities. METHODS: Nonfasting HDL levels were assessed in 12,223 respondents to six biennial population random sample surveys. RESULTS: Between 1981 and 1993, mean HDL cholesterol declined by 0.08 mmol/L in both men and women after adjustment for age, city, education, hormone use, medications, recent alcohol use, smoking, regular exercise, body mass index (BMI), and total cholesterol, (p for trend < 0.001). There was no apparent laboratory explanation for the trend which occurred concurrent with decreased smoking prevalence, increasing BMI and decreased prevalence of recent alcohol use. Decreasing HDL cholesterol was observed consistently across subgroups defined by smoking, alcohol use and BMI. CONCLUSIONS: Although several favorable cardiovascular risk factor trends have been observed in recent decades, declining HDL cholesterol is also of interest, particularly in conjunction with population increases in BMI.

Adult↗

Low dehydroepiandrosterone sulfate and heart disease in middle-aged men: cross-sectional results from the Massachusetts Male Aging Study.

PURPOSE: Serum concentrations of the adrenal androgen dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS), both of which decline with age more markedly than other sex hormone levels, have been alternately credited and discredited as "protective" correlates of heart disease. Baseline data from the Massachusetts Male Aging Study (MMAS), collected in 1987-89, provided a large population-based random sample (n = 1709) in which to examine cross-sectionally the relation of DHEA and DHEAS levels to heart disease, while controlling for a comprehensive set of potential confounders including serum lipid and hormone levels as well as smoking, alcohol intake, obesity, hypertension, diabetes, diet, medication, physical activity, and psychological measures. METHODS: The subjects were men aged 40-70 years, randomly sampled from the Massachusetts state census listing, measured and interviewed at home. Nonfasting blood samples were assayed for hormones and lipids. RESULTS: In all strata of age, smoking, and alcohol intake, the age-adjusted odds ratio for self-reported heart disease was between 0.55 and 0.85 per standard deviation (SD) of log DHEA and DHEAS concentration. Multiple logistic regression analysis indicated a strong independent role for DHEAS as a predictor of self-reported heart disease, controlling for age and the potential confounders listed above. The multiply-adjusted odds ratio for heart disease was 0.64 per SD log DHEAS concentration, with 95% confidence interval (CI) 0.50-0.83 (P = 0.0002). The DHEAS effect was not diminished by controlling for use of cardiac, vasodilator, antihypertensive, or lipid-lowering medication. CONCLUSIONS: These findings suggest that serum DHEAS levels bear an inverse relationship to heart disease, independently of a large set of established cardiovascular risk factors. The cross-sectional nature of this study requires that the findings be interpreted with caution.

Aged↗

Physician variability and uncertainty in the management of breast cancer. Results from a factorial experiment.

OBJECTIVES: The purpose of this research was to determine the influence of patient and physician characteristics on physicians' level of variability and certainty in breast cancer care. METHODS: One hundred twenty-eight physicians viewed a videotape of a simulated physician-patient interaction in which the patient has an "atypical" breast lump. Six patient characteristics (age, race, socioeconomic status, physical mobility, comorbidity, presentation style) were manipulated experimentally, resulting in a balanced set of 32 different "patients." Physician subjects were recruited to fill four equal strata defined by specialty (surgeons versus nonsurgeons) and experience (< or = 15 or > 15 years since graduation from medical school). RESULTS: More than half of the physicians offered a diagnosis of benign breast disease, a third offered a diagnosis of breast cancer, and the rest believed that the patient had a normal breast or something "other." Results also indicated that physicians' level of certainty and test ordering behavior varied with the diagnosis that was offered. Of the six patient characteristics, only socioeconomic status influenced physician certainty; physicians were more certain of their diagnosis when the patient was of a higher socioeconomic status. Surgeons were found to be more certain of their diagnosis compared with nonsurgeons. However, surgeons were less likely to order radiologic tests or a tissue sample for metastatic evaluation than were nonsurgeons. CONCLUSIONS: Overall, physicians displayed considerable variability and uncertainty when diagnosing and managing possible breast cancer.

Adult↗

Rapid early action for coronary treatment: rationale, design, and baseline characteristics. REACT Research Group.

OBJECTIVE: Early reperfusion for acute myocardial infarction (AMI) can reduce morbidity and mortality, yet there is often delay in accessing medical care after symptom onset. This report describes the design and baseline characteristics of the Rapid Early Action for Coronary Treatment (REACT) community trial, which is testing community intervention to reduce delay. METHODS: Twenty U.S. communities were pair-matched and randomly assigned within pairs to intervention or comparison. Four months of baseline data collection was followed by an 18-month intervention of community organization and public, patient, and health professional education. Primary cases were community residents seen in the ED with chest pain, admitted with suspected acute cardiac ischemia, and discharged with a diagnosis related to coronary heart disease. The primary outcome was delay time from symptom onset to ED arrival. Secondary outcomes included delay time in patients with MI/unstable angina, hospital case-fatality rate and length of stay, receipt of reperfusion, and ED/emergency medical services utilization. Impact on public and patient knowledge, attitudes, and intentions was measured by telephone interviews. Characteristics of communities and cases and comparability of paired communities at baseline were assessed. RESULTS: Baseline cases are 46% female, 14% minorities, and 73% aged > or =55 years, and paired communities have similar demographics characteristics. Median delay time (available for 72% of cases) is 2.3 hours and does not vary between treatment conditions (p > 0.86). CONCLUSIONS: REACT communities approximate the demographic distribution of the United States and there is baseline comparability between the intervention and comparison groups. The REACT trial will provide valuable information for community educational programs to reduce patient delay for AMI symptoms.

Adult↗

Joint analysis of three U.S. community intervention trials for reduction of cardiovascular disease risk.

During the 1980s three comprehensive community-based heart disease prevention trials were conducted in the United States. The Stanford Five-City Project, Minnesota Heart Health Program, and Pawtucket Heart Health Program involved 12 cities; six received a 5-8 year multifactorial risk reduction program. This analysis pools data from the three studies to delineate the common intervention effects with greater sample size and power than could be attained by the single studies. Time trends were estimated for cigarette smoking, blood pressure, total cholesterol, body mass index, and coronary heart disease mortality risk in women and men aged 25-64 years. The joint estimates of intervention effect were in the expected direction in nine of 12 gender-specific comparisons; however, these were not statistically significant. The results illustrate the analytic challenges of evaluating community-based prevention trials and point to the smaller than expected net differences, rather than small sample size, as the reason for few statistically significant effects in the three U.S. prevention trials.

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