Intermediate Methods in Epidemiology Exercise No. 4 - Passive smoking and atherosclerosis

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1 Intermediate Methods in Epidemiology 2008 Exercise No. 4 - Passive smoking and atherosclerosis The purpose of this exercise is to allow students to recapitulate issues discussed throughout the course which affect the inferential process aimed at establishing whether results of observational studies are consistent with a cause-effect relationship. Active cigarette smoking is an important risk factor for numerous unhealthy outcomes, including lung cancer and cardiovascular diseases. In the 2006 report of the Surgeon General, Reducing the Health Consequences of Smoking, it is estimated that smoking is responsible for approximately 440,000 deaths each year, reflected in the 5,6 million years of life lost annually in the U.S. The importance of smoking as a hazardous exposure became widely recognized after the publication of the 1964 Surgeon General s Report based on a review of more than 7,000 scientific articles on smoking and health. As an interesting aside, the report was the first ever to systematically apply the causality criteria that should be considered when assessing observational data. Environmental tobacco smoke (passive smoking) has also been explored in relation to many different outcomes, including lung cancer, cardiovascular disease and reproductive outcomes. Based on both case-control and cohort studies, the 2006 report of the Surgeon General concluded that there is no threshold for the health effects of passive smoking, that is, there are no safe exposure levels. (1) Review Hill s causality criteria. Based on the above Surgeon General s conclusion on passive smoking, state which criterion has been met. This exercise will focus on the association of environmental tobacco smoke with the process underlying many cardiovascular diseases, namely, atherosclerosis. Atherosclerosis is a pathologic process involving the arterial intima and media, which comprise the inner and middle layers of arteries, respectively. Atherosclerosis may start as early as the second decade of life, and has a long natural history (Figure 1): It progresses from benign lipid deposits in the intima ( fatty streaks ) to fully developed atherosclerotic plaques, which are fibrous formations that may protrude into the arterial lumen and interfere with the blood flow, thereby causing ischemia and its attending symptoms (e.g., angina pectoris). The slowness and turbulence of the blood flow at the site of a narrowed arterial lumen facilitates the formation of clots (thrombi) which may occlude the artery, leading to acute ischemia and its attending severe clinical events (e.g., heart attack). E8-1

2 Figure 1 Natural History of Atherosclerosis Lesion: Fatty streaks Fibrous plaques Raised lesions Occlusion by thrombus Clinical expression: Decade of life: None None May cause symptoms if lumen is narrowed, e.g., intermittent claudication, angina pectoris 1 st / 2 nd / 3 rd 4 th / 5 th 6 th + Heart attack, stroke, etc. (2) What is the relevance of the natural history of atherosclerotic disease in relation to its primary prevention? In addition to hypertension, high serum cholesterol levels and diabetes, active smoking has been consistently identified as a strong determinant of atherosclerosis; it appears to be particularly important in the more advanced stages of atherosclerosis (Sharrett et al, Am J Epidemiol 1999;149: ). For example, active smoking cessation leads to the elimination of virtually all excess risk of sudden coronary death in about one year after cessation.. (3) What does this fact tell you about the mechanism whereby active smoking causes sudden coronary death? Is it appropriate to calculate rate per persontime using a long follow-up interval to study the relationship of active smoking to sudden coronary death? Sudden coronary death is usually defined as an unexpected out-of-hospital death occurring within 24 hours of the onset of symptoms (typically chest pain) and is caused by acute thrombosis leading to massive myocardial ischemia. E8-2

3 The concern that environmental tobacco exposure may be related to atherosclerosis was a logical outgrowth of the role of active smoking, and has been explored in numerous studies. Glantz & Parmley (Circulation 1991;83:1-12) showed that, of ten published studies conducted both in the U.S. and abroad (Japan, Scotland, China), only one (by Lee et al) did not yield a relative risk greater than 1.0 using clinical coronary heart disease death as an outcome (Figure 2). (4) Does the outcome used in these studies (mortality) allow firm conclusions on whether the association of environmental tobacco smoke with coronary heart disease risk is causal? Why? (5) Which causality criterion is met by the demonstration that all but one study showed a positive association between environmental tobacco smoke and death? (6) When conducting a review of the literature such as that reported by Glantz and Parmley, what possible bias may interfere with the interpretation of this causality criterion? Are there situations when this criterion is not met, and yet the association is still causal? What are these situations? Wells (Environ Int 1988;14:249-65) estimated a pooled risk of coronary heart disease death in persons exposed to environmental tobacco smoke relative to that in those not exposed of 1.3 (95% confidence interval, ) for men and 1.2 (95% confidence interval, ) for women. These estimates are consistent with those arrived at by Glantz & Palmer of 1.3 for both genders (95% confidence interval ), and have been confirmed by the 2006 report of the Surgeon General. (7) A relative risk close to one is often referred to as a small effect. Is that statement always true? Why? Using a relative risk estimate of 1.2 and an environmental tobacco smoke prevalence of approximately 26% (Howard et al, Arch Intern Med 1994;154: ), estimate the percentage of total clinical coronary deaths due to environmental tobacco smoking in women. E8-3

4 Recently, it has become possible to study not only clinical manifestations of atherosclerosis, but also subclinical atherosclerosis on a community-wide basis. In the Atherosclerosis Risk in Communities (ARIC) study, a cohort of approximately 15,800 people aged years at baseline recruited from four U.S. communities undergo periodic B-mode ultrasound examinations of the carotid arteries in the neck for the purpose of measuring arterial wall (intima plus media) thickness. An increased arterial thickness is a marker of subclinical atherosclerosis. ARIC s baseline visit was conducted between 1987 and 1989, and included in addition to ultrasound examination of the neck and risk factor measurements, questions about environmental tobacco smoking. Information on exposure to environmental tobacco smoke was obtained from non-active smokers by asking the following question: During the past year, about how many hours per week, on the average, were you in close contact with people when they were smoking? For example, in your home, in a car, at work, or other close quarters? Environmental tobacco smokers were defined as those who reported an exposure of 1 or more hours per week to environmental smoke. Using this definition, approximately 26% of the ARIC cohort participants were never active smokers exposed to environmental tobacco smoke, 33% were past active smokers, 27% were current active smokers, and only 14% had never smoked and were not exposed to environmental tobacco smoke. E8-4

5 The unadjusted cross-sectional relationships between carotid wall thickness and smoking in ARIC participants without clinically apparent atherosclerotic cardiovascular disease are shown in table 1. Table 1 also shows the average increases in the mean, median and 90 th percentile values of wall thickness associated with an average increase of one year of age in never-active smokers not exposed to environmental tobacco smoke. (These values were based on the cross-sectional relationships between age and wall thickness at the time of the baseline examination of the cohort.) Table 1. Unadjusted wall (intima + media) thickness of the carotid arteries by smoking status in the Atherosclerosis Risk in Communities (ARIC) study at baseline ( ), excluding persons with prevalent clinical cardiovascular disease Category Wall Thickness (mm) Smoking Status Never Active Smokers Unexposed to ETS (n=1774) Exposed to ETS (n=3358) Former Active smokers (n=4081) Current Active Smokers (n=3366) Estimated Increase/Year of Age (Standard Error) Mean (0.0006) 25 th percentile th percentile (0.0008) 75 th percentile th percentile (0.0019) Myocardial infarction, angina pectoris, stroke, intermittent claudication Environmental tobacco smoke (passive smoking) In never active smokers not exposed to ETS (Adapted from: Howard et al, Arch Intern Med 1994;154: ) (8) What biases may occur when examining the association between smoking and wall thickness in the ARIC baseline visit, as shown in table 1? Are these biases likely to occur when studying subclinical outcome only in persons without evidence of clinical disease? Why? (9) Why are different percentile values shown in the table, rather than just the mean (or median) values? (10) How would you describe the differences among smoking categories for the values of the mean, median and 90 th percentile wall thickness vis-à-vis the estimated increase/year of age? E8-5

6 Stratification by age, adjusting for race and gender, is shown in Figure 3. Figure 3. Race and gender-adjusted wall (intima + media) thickness of the carotid arteries (IMT): Percentiles by age and smoking in the Atherosclerosis Risk in Communities (ARIC) study at baseline ( ). In the box-whisker plots, the bottom whisker provides the 10 th percentile; the bottom of the box, the 25 th percentile; the horizontal line in the box, the 50 th percentile (median); the top of the box, the 75 th percentile; and the top of the whisker, the 90 th percentile. N=nonsmokers E=exposed to environmental tobacco smoking P=past smokers C=current smokers (11) What is the assumption underlying the presentation of data simultaneously adjusted for race and gender? Are the findings in Figure 3 consistent with those in table 1? E8-6

7 Crude and adjusted estimates of the differences in mean carotid wall thickness in never active smokers according to exposure to environmental tobacco smoke are shown in table 2. Table 2. Differences in mean carotid wall thickness (mm) between never smokers exposed and those unexposed to environmental tobacco smoke, unadjusted and adjusted for combinations of selected factors in participants of the ARIC study baseline visit, excluding persons with prevalent clinical cardiovascular disease Difference in mean carotid wall thickness (mm) between never smokers exposed and those Adjusted for: unexposed to ETS (p-value) No factors (crude) Age, race and gender Age, race, gender plus life style factors (education, physical activity, fat intake, alcohol intake, body mass index) Age, race, gender, life style factors plus diabetes, hypertension and low density lipoprotein cholesterol Myocardial infarction, angina pectoris, stroke, intermittent claudication Environmental tobacco smoke From table 1 ( = 0.012) (p 0.001) (p=0.003) (p=0.001) (12) Why is it important to examine the association between passive smoking and carotid wall thickness adjusting for different combinations of risk factors (as opposed to using a single model in which all potential confounders are simultaneously adjusted)? What is the reason why the adjusted values are larger than the unadjusted ones? (13) What is the main shortcoming of assessing environmental tobacco smoke as a dichotomous variable, as done in tables 1 and 2, and Figure 3? E8-7

8 The relationship of reported number of hours of environmental tobacco smoking (ETS) exposure to carotid wall thickness has been also assessed in ARIC. Using the authors own words, the results (not shown in a table) were as follows: For the 885 men with ETS exposure, after controlling for age and race, there was an increase in IMT of mm per 10 hours of weekly ETS exposure, a relationship that proved statistically significant. Despite a larger sample of ETS women (n=2340), the increase in IMT per 10 hours of ETS exposure was only mm, a difference that proved statistically insignificant (p=0.43). (14) In the absence of any other data in the report, can you critically assess whether there is indeed a linear dose-response relationship in men? Why? (15) Assuming that these estimates of wall thickness increases are accurate and precise, what term would you use to describe the gender difference? What are some possible reasons for this difference? In one of the four communities included in the ARIC study, Washington County, Maryland (the Johns Hopkins site), the sampling frame used to select the ARIC cohort was based on current Motor Vehicle Administration data, supplemented by a private census conducted iun 1975 by the Johns Hopkins Training Center for Public Health Research. About 2,884 of the 4,023 individuals who participated in the Washington County ARIC baseline examination conducted in could be identified in the 1975 census, which collected information on smoking in the household (Figure 4). Of these persons, data on both smoking in 1975 and carotid wall thickness in were available for 2,073 (about 51% of the total ARIC Washington County cohort). These 2,073 Washington County ARIC cohort participants comprised the study group used by Diez-Roux et al to examine the relationship of both active and passive smoking in 1975 to carotid wall thickness measured in the ARIC baseline visit approximately 12 to 14 years later (Figure 5) (Preventive Medicine 1995;24:48-55). E8-8

9 Figure 4. Schematic representation of the connection between the ARIC study Washington County cohort at baseline ( ) and the Washington County census (1975) ARIC BASELINE VISIT ( ) Jackson, Miss Minneapolis, MN (n~3,600) (n~4,000) Wash Co, MD, linked to 1975 census (n~2,884) Wash Co, MD, not linked to 1975 census (n~1,139) Forsythe Co, NC (n~4,000) WASHINGTON COUNTY CENSUS (1975) E8-9

10 Figure 5. Passive smoking collected in the 1975 Washington County Census carried out by the Training Center for Public Health Research and carotid wall thickness measured in as part of ARIC s baseline visit (n=2,073). Passive smoking (census) in 1975 Carotid Wall thickness (ARIC baseline visit) in (16) What important causality criterion can be partly assessed in the study by Diez- Roux, but not in Howard s study? (The results of the latter are shown in tables 1 and 2 and Figure 3.) What are the major shortcomings of Diez-Roux s design which prevent a full assessment of the criterion? When comparing the final study group with ARIC participants not linked to the 1975 census, some differences were noted, as shown in table 3: Table 3. Characteristics of ARIC Participants Not Linked to the 1975 Census and the Study Group in the Analysis by Diez-Roux et al Characteristic (measured at the time of the ARIC baseline visit) ARIC Participants Not Linked to the 1975 Census (n=1139) Study Group (n=2073) Mean Age in years (standard deviation) 51.4 (5.7) 54.9 (5.5) Percentage with High School Education LDL Cholesterol in mg/dl (Standard Deviation) (35.9) (38.6) Systolic Blood Pressure in mmhg (Standard Deviation) (16.7) (17.6) Percentage with Diabetes Mean Carotid Wall Thickness in (0.188) (0.212) mm (Standard Deviation) The characteristics of the 811 ARIC Washington County cohort participants who were linked to the 1975 census, but with missing information on passive smoking or wall thickness were very similar to those of the study group. E8-10

11 (17) Could these differences have affected the results pertaining to the relationship between exposure to smoke in 1975 and wall thickness in ? Why or why not? The results of the analysis by Diez-Roux are shown in table 4. Table 4. Crude and adjusted mean carotid wall thickness (mm) by exposure to tobacco smoke, excluding persons with prevalent clinical cardiovascular disease, Washington County, 1975 and Exposure status Never Active Smokers: Sample Size Crude Mean (mm) Adjusted mean ± standard error (mm) [p-value ] No ETS ± ETS 1975 only ± [0.29] ETS only ± [0.02] ETS 1975 and ± [0.13] Never Active Smokers Ever Exposed to ETS ± [0.03] Current active smoking in both 1975 & ± [0.0001] Myocardial infarction, angina pectoris, stroke, intermittent claudication Adjusted for age, gender, systolic blood pressure, LDL cholesterol, presence of diabetes, fat intake, physical activity scores, alcohol intake, education, body mass index P value vis-à-vis never active smokers not exposed to environmental tobacco smoke Environmental tobacco smoke (18) Do the results of the study by Diez-Roux et al confirm those of the study by Howard et al? Are the results in table 4 entirely consistent with the hypothesis that intensity of exposure is related to carotid wall thickness? How can the consistency or lack thereof be explained? (19) The results of the adjustment presented in table 4 were based on a multiple linear regression model. Why? E8-11

12 Matanoski et al compared the characteristics of about 2,500 non-active smoking women whose husbands were smokers with those of approximately 1,400 non-active smoking women whose husbands did not smoke. The study population was identified among women who had participated in the first National Health and Nutrition Examination Survey (NHANES I) carried out in and the NHANES I Epidemiologic Follow-up Study conducted in (Am J Epidemiol 1995;142:149-57). The odds of having a smoking husband relative to that of having a nonsmoking husband according to selected demographic and dietary characteristics are shown in table 5. Table 5. Odds ratios of having a smoking husband in women who were not active smokers according to selected demographic and dietary variables: first National Health and Nutrition Examination Survey (NHANES I) and NHANES I Epidemiologic Follow-up Study. Characteristic/Food Odds Ratio (95% confidence interval) Age 60 years vs. < ( ) White vs. Nonwhite 0.79 ( ) Urban vs. Rural residence 1.17 ( ) Education > 12 years vs. < 12 years 0.48 ( ) Raw vegetables 1 or more times daily vs. less than once daily 0.87 ( ) Eats poultry skin: Yes vs. No 1.19 ( ) Odds ratio = [Odds of exposure to factor with smoking spouse] [Odds of exposure to factor with nonsmoking spouse] Age-adjusted E8-12

13 The relationship between education and atherosclerosis measured by average carotid intima-media thickness using baseline data from the ARIC study is shown in table 6 (Am J Epidemiol 1995;141:960-72). Table 6. Age and gender-adjusted mean differences (mm) in intima-media carotid artery average thickness by education and race. Age and gender-adjusted mean differences (mm) between each category and the reference category Educational Level Blacks (n=3,318) Whites (n=9,140) 8 th grade or less th 11 th grade th grade or GED years of vocational school years of college Graduate or Professional school Reference Reference General Education Development degree (20) How do the results shown in tables 5 and 6 affect your inference that passive smoking is a risk factor for atherosclerosis in general? (21) Do you believe that passive smoking causes atherosclerosis? Why? E8-13

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