Use of whole blood platelet lumi-aggregometry to optimize anti-platelet therapy in patients with chronic myeloproliferative disorders.

Twenty-seven patients with chronic myeloproliferative disorders and in vitro evidence of platelet hyperactivity on whole blood platelet lumi-aggregometry were commenced on anti-platelet therapy comprising aspirin, clopidogrel, and/or odorless garlic and the studies were repeated to assess the efficacy of the therapeutic agent(s). Only 8 patients showed clear evidence of anti-platelet effect while receiving the standard low-dose (100 mg/day) aspirin therapy. Thirteen patients required a higher dosage of aspirin and/or an additional anti-platelet agent to achieve therapeutic adequacy. Lumi-aggregometry also proved useful to optimize therapy in the 6 patients who received clopidogrel or odorless garlic because of aspirin intolerance.

Use of diabetes preventive care and complications risk in two African-American communities.

BACKGROUND: We examined levels of diabetes preventive care services and glycemic and lipid control among African Americans with diabetes in two North Carolina communities. METHODS: Cross-sectional, population-based study of 625 African-American adults with diagnosed diabetes. Participants had a household interview to determine receipt of preventive care services including glycosylated hemoglobin (HbA(1c)), blood pressure, lipid, foot, dilated eye, and dental examinations; diabetes education; and health promotion counseling. A total of 383 gave blood samples to determine HbA(1c) and lipid values. RESULTS: Annual dilated eye, foot, and lipid examinations were reported by 70% to 80% of the population, but only 46% reported HbA(1c) tests. Rates of regular physical activity (31%) and daily self-monitoring of blood glucose (40%) were low. Sixty percent of the population had an HbA(1c) level >8% and one fourth had an HbA(1c) level >10%. Half of the population had a low-density lipoprotein value >130 mg/dL. Lack of insurance was the most consistent correlate of inadequate care (odds ratio [OR]=2.3; 95% confidence interval [CI]=1.3-3.9), having HbA(1c) >9.5% (OR=2.1, 95% CI=1.1-4.2), and LDL levels >130 mg/dL (OR=2.1; 95% CI=1.0-4.5). CONCLUSIONS: Levels of diabetes preventive care services were comparable to U.S. estimates, but glycemic and lipid control and levels of self-management behaviors were poor. These findings indicate a need to understand barriers to achieving and implementing good glycemic and lipid control among African Americans with diabetes.

Cost of employee assistance programs: comparison of national estimates from 1993 and 1995.

The cost and financing of mental health services is gaining increasing importance with the spread of managed care and cost-cutting measures throughout the health care system. The delivery of mental health services through structured employee assistance programs (EAPs) could be undermined by revised health insurance contracts and cutbacks in employer-provided benefits at the workplace. This study uses two recently completed national surveys of EAPs to estimate the costs of providing EAP services during 1993 and 1995. EAP costs are determined by program type, worksite size, industry, and region. In addition, information on program services is reported to determine the most common types and categories of services and whether service delivery changes have occurred between 1993 and 1995. The results of this study will be useful to EAP managers, mental health administrators, and mental health services researchers who are interested in the delivery and costs of EAP services.

A project to reduce the burden of diabetes in the African-American Community: Project DIRECT.

Project DIRECT (Diabetes Interventions Reaching and Educating Communities Together) is the first comprehensive community diabetes demonstration project in the United States in an African-American community. This article describes its intervention components and evaluation design. The development and implementation of Project DIRECT has included the community since the project's beginning. Interventions are targeted in three areas: health promotion (improving diet and physical activity levels), outreach (improving diabetes awareness, detection of undiagnosed diabetes, and ensuring that persons with diabetes who are not receiving continuing diabetes care are integrated into the health-care system), and diabetes care (improving self-care, increasing access, and improving the quality of diabetes preventive care received within the health-care system). Evaluation will be internal (conducted by Project DIRECT staff to assess process outcomes in persons directly exposed to each specific intervention) and external (review of outcomes to assess the impact of the multi-intervention program at the level of the entire community). Because diabetes exacts a disproportionate toll among African Americans, the findings from this project should aid in developing strategies to lessen the burden of this disorder, particularly among minority populations.

Diabetes mellitus and its complications in an African-American community: project DIRECT.

Project DIRECT (Diabetes Intervention Reaching and Educating Communities Together) is a multilevel community-based intervention project designed to address diabetes and its complications in an African-American community. This article presents results of the Project DIRECT pilot study and describes risk factors for diabetes, diabetes prevalence, complications, and care practices. During 1993, a pilot study was conducted among persons 20 to 74 years of age in Wake County, North Carolina. The study involved household interviews and examinations, and more extensive health center interviews and examinations based on the race of the head of the household, previous diagnosis of diabetes, and results of capillary glucose tests done in the household. Of the black population aged 20 to 74 years, 52 +/- 3% reported being inactive and 51 +/- 3% were overweight; the prevalence of diagnosed diabetes was 5.2 +/- 0.9%; the prevalence of undiagnosed diabetes was 5.7 +/- 2.7%; and the prevalence of impaired glucose tolerance was 11.4 +/- 7.5%. Blacks with diabetes were significantly more likely than nonblacks with diabetes to have uncontrolled hypertension and to smoke cigarettes. Blacks with diabetes were significantly less likely to report having health insurance or to have a private health-care provider. Diabetes mellitus is a major public health problem in the African-American community of Wake County. Modifiable risk factors for diabetes and undiagnosed diabetes are common. Project DIRECT is attempting to improve the health-related quality of life of this population by reducing the burden of diabetes and its complications through a multilevel, community-based intervention.

Predictors of smoking cessation in a cohort of adult smokers followed for five years.

OBJECTIVE: To identify variables predictive of smoking cessation in a cohort of cigarette smokers followed for five years. DESIGN: Data analysed in this paper come from a cohort tracking telephone survey of 13415 cigarette smokers aged 25-64 years from 20 American and two Canadian communities who were interviewed in 1988 and re-interviewed in 1993 as part of the National Cancer Institute's Community Intervention Trial for Smoking Cessation. Predictors of smoking cessation evaluated in this study included measures of past and current smoking behaviour, past quit attempts, stated desire to quit smoking, and demographic characteristics. OUTCOME MEASURES: Smoking cessation was based on self report. A "quitter" was defined as a cohort member who, at the final annual contact in 1993, reported not smoking any cigarettes for the preceding six months or longer. Any smoker who reported having made a serious quit attempt between 1988 and 1993 was asked to indicate reasons that contributed to their decision to try to stop smoking. RESULTS: 67% of smokers reported making at least one serious attempt to stop smoking between 1988 and 1993 and, of these, 33% were classified as having quit smoking in 1993. The most common reasons given for quitting smoking were concern over health (91%), expense (60%), concern about exposing others to secondhand smoke (56%), and wanting to set a good example for others (55%). Statistically significant predictors of smoking cessation included male gender, older age, higher income, less frequent alcohol intake, lower levels of daily cigarette consumption, longer time to first cigarette in the morning, the use of premium cigarettes, initiation of smoking after age 20, history of past quit attempts, a strong desire to stop smoking, and the absence of other smokers in the household. Predictor variations with the largest relative risks for smoking cessation were those associated with nicotine dependence such as amount smoked daily and time to first cigarette in the morning. CONCLUSIONS: Despite the fact that most smokers expressed a strong desire to stop smoking in 1988, the majority, especially the most dependent heavy smokers (>25 cigarettes/day), struggled unsuccessfully to achieve this goal.

Aiding troubled employees: the prevalence, cost, and characteristics of employee assistance programs in the United States.

OBJECTIVES: Employee assistance programs (EAPs) are job-based programs designed to identify and assist troubled employees. This study determines the prevalence, cost, and characteristics of these programs in the United States by worksite size, industry, and census region. METHODS: A stratified national probability sample of more than 6400 private, nonagricultural US worksites with 50 or more full-time employees was contacted with a computer-assisted telephone interviewing protocol. More than 3200 worksites responded and were eligible, with a response rate of 90%. RESULTS: Approximately 33% of all private, nonagricultural worksites with 50 or more full-time employees currently offer EAP services to their employees, an 8.9% increase over 1985. These programs are more likely to be found in larger worksites and in the communications/utilities/transportation industries. The most popular model is an external provider, and the median annual cost per eligible employee for internal and external programs was $21.83 and $18.09, respectively. CONCLUSIONS: EAPs are becoming a more prevalent point of access to health care for workers with personal problems such as substance abuse, family problems, or emotional distress.

Prevalence and consequences of smoking, alcohol use, and illicit drug use at five worksites.

Employers are becoming increasingly concerned about the consequences and costs of substance use in their workplaces. Despite this heightened awareness, little information is available to guide them in setting up worksite-based prevention and assistance programs. Most estimates of the prevalence or consequences of substance use are derived from large national surveys of households or individual persons. The primary contribution of this research to the public health literature is the empirical results from a unique data set. In particular, this study presents results of a survey administered to more than 1,200 employees at five different worksites. Descriptive statistics for the prevalence of smoking, alcohol and illicit drug use, prescription drug misuse, and workplace consequences, such as reduced performance and absenteeism, are reported, as well as findings from a multivariate analysis of substance use prevalence and consequences. Compared with national averages, workers at these five sites tended to have substance use profiles similar to or slightly lower than estimates from large national surveys. The study's estimates may help employers identify the extent of a substance abuse problem in their worksites and specific areas to target for possible intervention.

Smokers' baseline characteristics in the COMMIT trial.

BACKGROUND: Baseline telephone survey data from 10 COMMIT sites were submitted to statistical analyses to compare the smoking characteristics of non-Hispanic white (white), non-Hispanic black (black), Mexican-origin (Mexican), and Puerto Rican-origin (Puerto Rican) smokers. RESULTS: White men and women were more likely to be classified as "heavy smokers" than members of other racial/ethnic groups, although black and Puerto Rican smokers were more likely than whites to increase their smoking rates on weekends. Whites were less likely to report stopping smoking in the past. White and Mexican smokers were most likely to smoke light or ultralight brands and least likely to smoke menthol cigarettes. Blacks were most likely to report smoking their first cigarette of the day within 10 min of waking. CONCLUSION: The differences and similarities among different groups of smokers may have important implications for understanding patterns of tobacco-related disease in smokers from different racial/ethnic and sex groups.

Community stop-smoking contests in the COMMIT trial: relationship of participation to costs. Community Intervention trials.

BACKGROUND: This study quantifies resources used to conduct 26 community-wide quit-smoking contests, the percentage of smokers that participated in these contests, and the statistical associations between resource inputs and participation percentages. METHODS: Data collected from the 11 COMMIT intervention communities (adult population range 47,490-185,913) included number of contest participants, contest procedures, and resource inputs. Stepwise regression was used to find the most meaningful association(s) of independent variables with contest participation percentage. RESULTS: Contest participation percentages ranged from 0.27 to 3.11% of smokers (mean = 1.26%). Total cost (COMMIT and community-contributed resources and dollar expenditures) to conduct a contest averaged $24,857 (range $5,751-$74,556), or $78.57 per contest participant. Expenditures in various specific resource categories varied greatly. Total expenditures per smoker in the community (excluding expenditures for prizes) was the independent variable most highly correlated with contest participation percentage, accounting for 63% of the total variability in participation percentages. CONCLUSIONS: The percentage of smoker participation in community-wide stop-smoking contests appears primarily to be a function of total resource expenditures, regardless of the specific types of resources funded. Stop-smoking contests are judged to be quite cost effective. Study strengths and weaknesses are discussed.

Effect of lovastatin on early carotid atherosclerosis and cardiovascular events. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group.

BACKGROUND: HMG CoA reductase inhibitors (or statins), a new class of lipid-lowering compounds, have raised expectations for more widespread use than that of the older lipid-lowering drugs. Not only are they more effective in lowering LDL cholesterol, but they are better tolerated as well. No data exist concerning the effect of statins on early carotid atherosclerosis and clinical events in men and women who have moderately elevated LDL cholesterol levels but are free of symptomatic cardiovascular disease. METHODS AND RESULTS: Lovastatin (20 to 40 mg/d) or its placebo was evaluated in a double-blind, randomized clinical trial with factorial design along with warfarin (1 mg/d) or its placebo. This report is limited to the lovastatin component of the trial. Daily aspirin (81 mg/d) was recommended for everyone. Enrollment included 919 asymptomatic men and women, 40 to 79 years old, with early carotid atherosclerosis as defined by B-mode ultrasonography and LDL cholesterol between the 60th and 90th percentiles. The 3-year change in mean maximum intimal-medial thickness (IMT) in 12 walls of the carotid arteries was the primary outcome; change in single maximum IMT and incidence of major cardiovascular events were secondary outcomes. LDL cholesterol fell 28%, from 156.6 mg/dL at baseline to 113.1 mg/dL at 6 months (P < .0001), in the lovastatin groups and was largely unchanged in the lovastatin-placebo groups. Among participants not on warfarin, regression of the mean maximum IMT was seen after 12 months in the lovastatin group compared with the placebo group; the 3-year difference was statistically significant (P = .001). A larger favorable effect of lovastatin was observed for the change in single maximum IMT but was not statistically significant (P = .12). Five lovastatin-treated participants suffered major cardiovascular events--coronary heart disease mortality, nonfatal myocardial infarction, or stroke--versus 14 in the lovastatin-placebo groups (P = .04). One lovastatin-treated participant died, compared with eight on lovastatin-placebo (P = .02). CONCLUSIONS: In men and women with moderately elevated LDL cholesterol, lovastatin reverses progression of IMT in the carotid arteries and appears to reduce the risk of major cardiovascular events and mortality. Results from ongoing large-scale clinical trials may further establish the clinical benefit of statins.

Smoking cessation factors among African Americans and whites. COMMIT Research Group.

OBJECTIVES: This study was undertaken to explore smoking patterns and attitudes that influence smoking cessation and relapse among African Americans. METHODS: Baseline data from eight Community Intervention Trial for Smoking Cessation (COMMIT) sites were analyzed. RESULTS: Compared with Whites, African Americans who smoke less than 25 cigarettes per day were 1.6 times more likely to smoke within 10 minutes of awakening (a behavioral indicator of nicotine dependence), adjusting for education, age, and gender (OR = 1.2 for heavier smokers). African Americans reported a stronger desire to quit smoking and reported serious quit attempts in the past year. African Americans favored tobacco restrictions (they were 1.8 times more likely than Whites to view smoking as a serious community problem, 1.7 times more likely to favor restrictions on cigarette vending machines, and 2.1 times more likely to prohibit smoking in their car). African Americans were lighter/moderate, menthol smokers. CONCLUSIONS: African Americans find smoking socially unacceptable and are strongly motivated to quit, but their "wake-up" smoking may indicate high nicotine dependence, making abstinence difficult even for lighter smokers.

Reproducibility of noninvasive ultrasonic measurement of carotid atherosclerosis. The Asymptomatic Carotid Artery Plaque Study.

BACKGROUND AND PURPOSE: To determine the effect of a lipid-lowering agent and/or a low-dose antithrombotic agent on the progression of early-stage carotid atherosclerosis, noninvasive B-mode ultrasound was used to measure intimal-medial thickness in asymptomatic individuals with moderately elevated lipids as part of the ongoing multicenter Asymptomatic Carotid Artery Plaque Study. METHODS: Uniform ultrasonic scanning and reading protocols were implemented to obtain maximum intimal-medial thickness measurements in 12 standard segments in patients having a small to moderate wall thickness (1.5-3.5 mm) in at least one of the carotid arteries. Paired B-mode image recordings on 858 patients, performed 1 month apart and read at a core laboratory (each pair by the same reader), determined both within-sonographer (W, n = 405) and between-sonographer (B, n = 453) reproducibility. RESULTS: The primary end point (mean +/- SD), defined in each individual as the mean value of the 12 maximum intimal-medial thickness measurements, was 1.31 +/- 0.21 mm (W) and 1.32 +/- 0.22 (B) at the time of the second examination. The mean difference in the primary end point (exam 2-exam 1) was -0.01 +/- 0.13 mm (W) and 0.00 +/- 0.15 mm (B). The Pearson correlation coefficients were 0.79 (W) and 0.75 (B). In 90% of the patients, the absolute difference in the primary end point was less than 0.22 mm (W) and less than 0.24 mm (B). Variability of the secondary end point, defined as the single largest intimal-medial thickness measurement in a patient, was between three and four times larger than the variability for the primary end point. Differences in sonographer performance between clinical centers were very small. CONCLUSIONS: The results demonstrate that standardized noninvasive ultrasonic techniques yield highly reproducible measures of carotid intimal-medial thickness, which can serve as a measure of carotid atherosclerosis in clinical trials that monitor small rates of lesion progression.

Analysis strategies for serial multivariate ultrasonographic data that are incomplete.

Ultrasonographic measurement of intima-media thickness in the carotid artery has emerged as an important non-invasive means of assessing atherosclerosis, and has served to define primary outcome measures related to progression of arterial lesions in several large clinical trials and epidemiologic studies. It is characteristic that measurements often cannot be obtained from all sites during repeated examinations. This leads to incomplete multivariate serial data, for which the set and number of visualized sites may vary across time. We have contrasted several conditional and unconditional maximum likelihood analytical approaches, and have evaluated these with a simulation experiment based on characteristics of ultrasound measurements collected during the course of the Asymptomatic Carotid Artery Plaque Study. We examined analyses based on unweighted and generalized least squares regression in which we estimated cross-sectional summary statistics using raw means, unconditional maximum likelihood estimates and full maximum likelihood estimates. Since the genesis of missing data is not fully clear, and since the approaches we examined are based, to some degree, on the assumption that data are missing at random, we also examined the relative impact of deviations from such an assumption on each of the approaches considered. We found that maximum likelihood based approaches increased the expected efficiency of the analysis of serial ultrasound data over ignoring missing data by up to 21 per cent.

The Los Angeles TEAM Study: personal exposures, indoor-outdoor air concentrations, and breath concentrations of 25 volatile organic compounds.

The U.S. Environmental Protection Agency and the California Air Resources Board studied the exposures of 51 residents of Los Angeles, California, to 25 volatile organic chemicals (VOCs) in air and drinking water in 1987. A major goal of the study was to measure personal, indoor, and outdoor air concentrations, and breath concentrations of VOCs in persons living in households that had previously been measured in 1984. Other goals were to confirm the marked day-night and seasonal differences observed in 1984; to determine room-to-room variability within homes; to determine source emission rates by measuring air exchange rates in each home; and to extend the coverage of chemicals by employing additional sampling and analysis methods. A total of 51 homes were visited in February of 1987, and 43 of these were revisited in July of 1987. The results confirmed previous TEAM Study findings of higher personal and indoor air concentrations than outdoor concentrations of all prevalent chemicals (except carbon tetrachloride); higher personal, indoor, and outdoor air concentrations in winter than in summer; and (in winter only) higher outdoor concentrations at night than in the daytime. New findings included the following: (1) room-to-room variability of 12-hour average concentrations was very small, indicating that a single monitor may be adequate for estimating indoor concentrations over this time span; (2) "whole-house" source emission rates were relatively constant during both seasons, with higher rates for odorous chemicals such as p-dichlorobenzene and limonene (often used in room air fresheners) than for other classes of chemicals; (3) breath concentrations measured during morning and evening were similar for most participants, suggesting the suitability of breath measurements for estimating exposure in the home; (4) limited data obtained on two additional chemicals-toluene and methylene chloride-indicated that both were prevalent at fairly high concentrations and that indoor air concentrations exceeded outdoor concentrations by a factor of about three.