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SYMPOSIUM ON COMMUNITY INTERVENTION TRIALS
Donner, Allan
INTRODUCTION
Oxford University Press
1995-09-15 00:00:00.0
TEXT
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Design and Analysis of Community Trials: Lessons from the Minnesota Heart Health Program
Murray, David M.
SYMPOSIUM
Community trials remain the only design appropriate for the evaluation of lifestyle interventions that cannot be allocated to individuals. The Minnesota Heart Health Program, conducted in Minnesota and the Dakotas between 1980 and 1993, is one of the largest community trials ever conducted in the United States. That study suggests several lessons that should guide future community trials. Planners should 1) carefully assess the secular trends for their outcomes and be confident that they can demonstrate an intervention effect against those trends; 2) be confident that they have effective programs that can be delivered to a sufficiently large fraction of their target population; 3) avoid differences between study conditions in levels and trends for their outcomes through random allocation of a sufficient number of communities to each condition; 4) develop good estimates of community-level standard errors prior to launching future trials; and 5) take steps to ensure that power will be sufficient to test the hypotheses of interest. <it>Am J Epidemiol</it> 1995;142:569–75.
Oxford University Press
1995-09-15 00:00:00.0
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Community Intervention Trials: Reflections on the Stanford Five-City Project Experience
Fortmann, Stephen P.
Flora, June A.
Winkleby, Marilyn A.
Schooler, Caroline
Taylor, C.Barr
Farquhar, John W.
SYMPOSIUM
In the past two decades several community intervention studies designed to lower the risk of cardiovascular disease in populations have been completed. These trials shared the rationale that the community approach was the best way to address the large population attributable risk of mild elevations of multiple risk factors, the interrelation of several health behaviors, and the potential efficiency of large-scale interventions not limited to the medical care system. These trials also shared several threats to internal validity, especially the small number of intervention units (usually cities) that could be studied. The purpose of this paper is to reflect on the lessons learned in one of the studies, the Stanford Five-City Project, which began in 1978. The anticipated advantages were observed, including the generalizability of the intervention components, the potential for amplification of interventions through diffusion in the community, and the efficiency of the mass media and other community programs for reaching the entire population. Numerous components of the intervention proved effective when evaluated individually, as was true in other community studies. However, the design limitations proved difficult to overcome, especially in the face of unexpectedly large, favorable risk factor changes in control sites. As a result, definitive conclusions about the overall effectiveness of the communitywide efforts were not always possible. Nevertheless, in aggregate, these studies support the effectiveness of communitywide health promotion, and investigators in the field should turn to different questions. The authors have learned how little they know of the determinants of population-level change and the characteristics that separate communities that change quickly in response to general health information from those that do not. Future studies in communities must elucidate these characteristics, while improving the effectiveness of educational interventions and expanding the role of environmental and health policy components of health promotion. <it>Am J Epidemiol</it> 1995; 142:576–86.
Oxford University Press
1995-09-15 00:00:00.0
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Interplay between Design and Analysis for Behavioral Intervention Trials with Community as the Unit of Randomization
Green, Sylvan B.
Corle, Donald K.
Gail, Mitchell H.
Mark, Steven D.
Pee, David
Freedman, Laurence S.
Graubard, Barry I.
Lynn, William R.
SYMPOSIUM
This paper outlines an approach for the design and analysis of randomized controlled trials investigating community-based interventions for behavioral change aimed at health promotion. The approach is illustrated using the Community Intervention Trial for Smoking Cessation (COMMIT), conducted from 1988 to 1993, involving 11 pairs of communities in North America, matched on geographic location, size, and sociodemographic factors. The situation discussed is when assignment to intervention is done at the community level; for COMMIT, the very nature of the intervention required this. The number of communities is a key determinant of the statistical power of the trial. The use of matched pairs of communities can achieve a gain in statistical efficiency. Randomization is used to obtain an unbiased assessment of the intervention effect; randomization also provides the basis for the statistical analysis. Permutation tests (and corresponding test-based confidence intervals), using community as the unit of analysis, follow directly from the randomization distribution. Within this framework, individual-level covariates can be used for imputation of missing values and for adjusting analyses of intervention effect. <it>Am J Epidemiol</it> 1995; 142:587–93.
Oxford University Press
1995-09-15 00:00:00.0
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Invited Commentary: Symposium on Community Intervention Trials
Koepsell, Thomas D.
Diehr, Paula H.
Cheadle, Allen
Kristal, Alan
SYMPOSIUM
Oxford University Press
1995-09-15 00:00:00.0
TEXT
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Association of Body Mass Index and Body Fat Distribution with Risk of Lung Cancer in Older Women
Drinkard, carol R.
Sellers, Thomas A.
Potter, John D.
Zheng, Wei
Bostlck, Roberd M.
Nelson, Christine L.
Folsom, Aaron R.
ORIGINAL CONTRIBUTIONS
Obesity has been associated with an increased risk of cancer at a number of sites. A notable exception appears to be lung cancer, for which several studies suggest a modest inverse association. However, cigarette smoking is directly associated with lung cancer and inversely associated with body mass index. To investigate the hypothesis that body mass index is associated with lung cancer independent of cigarette smoking, the authors analyzed data from a prospective cohort study of 41,837 lowa women aged 55–69 years at baseline in 1986. In addition, they examined whether central adiposity (high waist/hip ratio) was associated with lung cancer incidence. Through 1992 (6 years of follow-up), 233 cases of lung cancer were identified through the State Health Registry of lowa. The body mass index at several ages was calculated from self-reports of height at baseline and weights at ages 18,30,40, and 50 years and at baseline. Current and former smokers generally had lower mean body mass indices than did nonsmokers at all ages except 18 years. Cases generally had lower body mass indices than did noncases at all ages except 18 and 30 years but, among current smokers, cases had higher mean body mass indices than did noncases at all ages except baseline, although the differences were not statistically significant. An apparent positive association of a high waist/hip ratio with lung cancer in the total cohort was found to be primarily accounted for by a higher waist/hip ratio in current and former smokers. When stratified by smoking status and adjusted for other risk factors, including age and pack-years of smoking, the body mass index at baseline, body mass index at age 50 years, and waist/hip ratio were not associated with lung cancer. The results of multivariate analyses suggest that the inverse association of body mass index with lung cancer can be explained by smoking status and that the positive association of waist/hip ratio with lung cancer can be explained by pack-years of smoking. <it>Am J Epidemiol</it> 1995; 142:600–7.
Oxford University Press
1995-09-15 00:00:00.0
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Colon Cancer and Serum Vitamin D Metabolite Levels 10-17 Years prior to Diagnosis
Braun, M. Miles
Helzlsouer, Kathy J.
Hollis, Bruce W.
Comstock, George W.
ORIGINAL CONTRIBUTIONS
This study examines the hypothesis that low serum levels of vitamin D metabolites are associated with an increased risk for colon cancer. From August through November 1974, 20,305 residents of Washington County, Maryland, donated blood for storage at –70°C in a serum bank. Colon cancer was subsequently diagnosed among 57 of these residents during the period 1984–1991. Controls had donated blood in 1974 and remained free of colon cancer through the date ofdiagnosis of the case. Two controls were matched to each case on age (±1 year), race, sex, and date of blood draw (±1 month). Mean 25-hydroxyvitamin D levels were 23.6 ng/ml and 23.2 ng/ml, and mean 1,25-dihydroxyvitamin D levels were 34.7 pg/ml and 34.6 pg/ml, in cases and controls, respectively. Analysis by quintile of serum level similarly foundthat none of the 95% confidence intervals of the odds ratios excluded unity, and a dose-response effect was not observed. Our data provide no strong support for the hypothesis that vitamin D metabolite levels affect the subsequent risk for colon cancer. <it>Am J Epidemiol</it> 1995; 142:608–11.
Oxford University Press
1995-09-15 00:00:00.0
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International Analysis of Insulin-dependent Diabetes Mellitus Mortality: a Preventable Mortality Perspective: The Diabetes Epidemiology Research International (DERI) Study
DERI Mortality Study Group,
ORIGINAL CONTRIBUTIONS
Differential survival associated with insulin-dependent diabetes mellitus (IDDM) was evaluated in a crosscountry study using four population-based IDDM cohorts from Japan (n=1,374), Israel (n= 610), Allegheny County, Pennsylvania (n=995), and Finland (n=5,144).For the purpose of this cross-country comparison, the Allegheny County cohort was taken to be representative of the United States. The mortality status as of January 1, 1990, was determined for all individuals who were diagnosed with diabetes at the age of less than 18 years between 1965 and 1979 and who were taking insulin at the time of hospital discharge. The results showed that the mortality experience for IDDM individuals in Japan and the United States was much worse than that in Finland and Israel. The age-adjusted mortality rates (per 100,000 person-years) for the four cohorts were 760 (Japan), 158 (Israel), 408 (Allegheny County), and 250 (Finland). By using the mortality data from Allegheny County, Pennsylvania, to extrapolate to the US IDDM mortality experience, the authors estimated 2,396 deaths among individuals with IDDM in the United States. It was calculated that 1,261 (53%) of these deaths would not have occurred in the United States given Finland's mortality rates. It is critical to determine why individuals with IDDM in the United States have a poorer outcome. <it>Am J Epidemiol</it> 1995;142:612–18.
Oxford University Press
1995-09-15 00:00:00.0
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Sudden Infant Death Syndrome in Sweden, 1983-1990: Season at Death, Age at Death, and Maternal Smoking
Haglund, Bengt
Cnattingius, Sven
Otterblad-Olausson, Petra
ORIGINAL CONTRIBUTIONS
Several risk factors for sudden infant death syndrome (SIDS) have been consistently reported, while results regarding seasonally and age at death of SIDS victims are conflicting. In the present population-based cohort study, single births in Sweden from 1983 through 1990 were used to estimate the relative and absolute risks for SIDS associated with season at death, age at death, and maternal smoking. In the winter period, 283 SIDS deaths occurred, while only 98 infants died during summer (winter/summer ratio= 2.9). Taking person-time at risk into account and restricting the analysis to infants aged 7–180 days, the authors determined the relative risk for SIDS to be 3.5 times higher in winter than in summer. When comparing incidence rate differences, they found a more noticeable seasonal variation for early SIDS (7–90 days at death) than for late SIDS (91–180 days at death). For early SIDS, the incidence rate was 0.6 cases per 100,000 person-days higher among smokers than among nonsmokers; for late SIDS, the corresponding difference was 0.3. The effect of smoking on SIDS was not associated with seasonality. Since exposure to passive smoking is likely to vary by season, the results suggest that the effect of smoking on SIDS is prenatal rather than the result of passive smoking after birth. <it>Am J Epidemiol</it> 1995;142:619–24.
Oxford University Press
1995-09-15 00:00:00.0
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A BRIEF: Correlation of Estrogen Levels between Successive Pregnancies
Bernstein, L.
Lipworth, L.
Ross, R. K.
Trichopoulos, D.
ORIGINAL CONTRIBUTIONS
To date, no study has attempted to correlate hormone levels between successive pregnancies in the same woman. Serum levels of total estradiol and total free estradiol have been measured between the eighth and the 17th weeks in the first and second full-term pregnancies of 34 white women participating in the Collaborative Perinatal Study, 1959–1965. Intraindividual interpregnancy Pearson's product moment correlations were calculated. Partial correlation coefficients (adjusted for gestational age) for log pregnancy total estradiol and total free estradiol were 0.78 and 0.73, respectively (p < 0.001). These findings provide evidence that levels of pregnancy estradiol are significantly and strongly correlated in successive pregnancies of the same woman. This phenomenon can provide an explanation for the higher concordance of breast cancer incidence between two sisters than between a mother and daughter in the familial pattern of breast cancer. <it>Am J Epidemiol</it> 1995;142:625–8.
Oxford University Press
1995-09-15 00:00:00.0
TEXT
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Articles
Macera, Caroline A.
Croft, Janet B.
Brown, David R.
Ferguson, James E.
Lane, Marcia J.
ORIGINAL CONTRIBUTIONS
Literature on the correlates and predictors of leisure-time physical activity among African-American populations is sparse. This cohort study assessed correlates of leisure-time physical activity (specific large muscle activities during the past month at least three times a week) in a biracial population in 1987 and predictors for the adoption of this behavior 4 years later among those initially inactive. Random digit dialing methods were used to identify residents of two South Carolina communities in 1987. In 1991, 3,223 of these residents were resurveyed (62% response rate). In general, the correlates of leisure-time physical activity (education, ≥12 years; nonsmoking; weight loss behaviors; and physician advice) were similar for each sex and race group. In 1987, the definition of leisure-time physical activity was not met by 831 (54% of 1,542) white women, 374 (76% of 489) African-American women, 586 (59% of 991) white men, and 126 (63% of 201) African-American men. Among those who were inactive in 1987, 22–24% of white adults and African-American men and 14% of African-American women adopted physical activity 4 years later. Twelve years or more of education was a predictor among white women (risk ratio = 1.7, 95% confidence interval 1.2-2.6) and African-American women (risk ratio = 3.1, 95% confidence interval 1.4-6.9), but not among men. Having a physician discuss physical activity was a predictor among white women (risk ratio = 1.9, 95% confidence interval 1.3–2.7), African-American women (risk ratio = 1.7, 95% confidence interval 0.9–3.2), white men (risk ratio = 2.0, 95% confidence interval 1.3–3.1), and African-American men (risk ratio = 2.7, 95% confidence interval 1.0–7.6). These results highlight the strong effect of educational attainment on adoption of healthy behaviors and support the involvement of physicians to promote physical activity among all race and sex groups. <it>Am J Epidemiol</it> 1995;142:629–35.
Oxford University Press
1995-09-15 00:00:00.0
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Evalution of Secular Trends in CD4+ Lymphocyte Loss among Human Immunodeficiency Virus Type 1 (HIV-1)-infected Men with Known Dates of Seroconversion
O'Brien, Thomas R.
Hoover, Donald R.
Rosenberg, Philip S.
Chen, Baibai
Detels, Roger
Kingsley, Lawrence A.
Phair, John
Saah, Alfred J.
ORIGINAL CONTRIBUTIONS
The rate at which immunodeficiency develops in untreated human immunodeficiency virus type 1 (HIV-1)- infected persons might be increasing or decreasing over time because of viral evolution or other factors. Beginning in 1984, Multicenter AIDS Cohort Study investigators recruited HIV-1-seronegathve homosexual/ bisexual men from four US metropolitan areas and examined them semiannually for HIV-1 seroconversion. To assess possible secular changes in the natural history of HIV-1 infection, the authors examined CD4+ lymphocyte data from 354 men who seroconverted between 1984 and 1991. To control for measurement differences among centers and over time, the authors adjusted CD4+ lymphocyte values to those of persistently seronegative participants. CD4+ lymphocyte percentage measurements at the first seropositive visit formed a U-shaped pattern, with the lowest values observed in 1988 and 1989. The authors observed no consistent secular pattern of CD4+ percentages at later visit dates, except that mean CD4+ percentages were consistently lowest in men who seroconverted in 1988. In a proportional hazards model, the time to the adjusted CD4+ lymphocyte count of <500 cells/mm3 was not associated with the secular time of seroconversion (relative hazard = 1.05, 95% confidence interval 0.97–1.13). The authors' data do not suggest a major change in the natural history of HIV-1 infection in this population. <it>Am J Epidemiol</it> 1995;142:636–42.
Oxford University Press
1995-09-15 00:00:00.0
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Role of Immunizations in the Recent Decline in Childhood Mortality and the Changes in the Female/Male Mortality Ratio in Rural Senegal
du Loû, A. Desgrées
Pison, G.
Aaby, P.
ORIGINAL CONTRIBUTIONS
In early 1987, immunizations were introduced to an isolated area of eastern Senegal where there had previously been no regular immunizations. Since immunizations were the only change introduced in the area during this period, this allowed the authors to study the impact of immunizations on mortality in different age groups and the possible interaction with sex differences in mortality. They compared mortality rates for the 6 years before and the 6 years after the introduction of immunization. Neonatal mortality declined 31% (95% confidence interval (Cl) 17 to 43); between 1 and 8 months of age, the reduction was 20% (95% Cl -2 to 37); and between 9 and 59 months of age, mortality declined 48% (95% Cl 39 to 56). Excluding acute measles deaths, the reduction was 16% (95% Cl –8 to 35) between 1 and 8 months of age and 32% (95% Cl 20 to 43) between 9 and 59 months of age. The decline was stronger in villages that maintained high coverage after the initial national campaign, whereas mortality increased again in the villages where the coverage declined. Since the reduction in mortality was most marked after 9 months of age, measles immunization is likely to have been the most important vaccination. Both female and male mortality declined but not equally quickly. The reduction in mortality in the neonatal period was significantly greater in males than in females, resulting in an increase in the female/male mortality ratio from 0.64 (95% Cl 0.50 to 0.83) to 0.96 (95% Cl 0.71 to 1.30), p = 0.04. After 9 months of age, the reduction in mortality was somewhat greater in females than in males, resulting in a decrease in the female/male mortality ratio from 1.04 (95% Cl 0.85 to 1.28) to 0.79 (95% Cl 0.62 to 1.02), р = 0.10. <it>Am J Epidemiol</it> 1995;142:643–52.
Oxford University Press
1995-09-15 00:00:00.0
TEXT
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Methodology for Evaluating the Incidence of Second Primary Cancers with Application to Smoking-relted Cancers from the Surveillance, Epidmiology, and End Results (SEER) Program
Begg, Colin B.
Zhang, Zuo-feng
Sun, Ming
Herr, Harry W.
Schantz, Stimson P.
ORIGINAL CONTRIBUTIONS
The Surveillance, Epidemiology, and End Results (SEER) database is used to estimate the standardized incidence ratios (SIRs) of second primaries for all pairs of smoking-related cancers and to interpret the results in the context of our knowledge of the known effects of smoking on the incidence of each of the individual cancers. In evaluating the simultaneous incidence of two cancers, one must recognize the inherent duality of the two relevant SIRs linking the two cancers (e.g., A and B), namely, the SIRs of A following B and B following A. Under fairly general assumptions, the two SIRs are seen to be equal, and departures from equality suggest changes in risk status or the introduction of new risk factors after the Incidence of the first primary. Based on these observations, a methodological strategy is developed. The data reveal several clear patterns. First, short-term incidence is uniformly much greater than long-term incidence. Second, the SIRs are consistently much higher for women than for men, for every pair of cancers studied. Third, the magnitudes of the SIRs are generally high and often substantially higher than would be expected on the basis of the known risks of smoking. Exceptionally high SIRs are observed between kidney and bladder cancer and between head and neck and esophageal cancer. Various influences may affect these high observed SIRs, including artifactual influences such as diagnostic, surveillance, and misclassification biases, and the effect of different exposure prevalences on subsequent SIRs, which may to some extent explain the strong sex differences. However, these artifacts do not appear to explain the magnitude of the observed SIRs, especially the very strong associations between kidney and bladder cancer and between head and neck and esophageal cancer. It seems likely that other factors play a role, including, possibly, host susceptibility factors or additional common risk factors other than smoking. Although multiple primary cancers are rare, they represent an especially fruitful population for detailed epidemiologic study. <it>Am J Epidemiol</it> 1995;142:653-65.
Oxford University Press
1995-09-15 00:00:00.0
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AN AUTHOR'S REPLY
Attili, A. F.
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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RE; "RISK FACTORS FOR TRANSMISSION OF MYCOBACTERIUM TUBERCULOSIS IN A PRIMARY SCHOOL OUTBREAK: LACK OF RACIAL DIFFERENCE IN SUSCEPTIBILITY TO INFECTION"
Comer, W. Jefferson
Felix, Rebecca
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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RE: "EPIDEMIOLOGY OF GALLSTONE DISEASE IN ITALY: PREVALENCE DATA OF THE MULTICENTER ITALIAN STUDY ON CHOLELITHIASIS (M.I.COL)."
Feinstein, Alvan R.
Wells, Carolyn K.
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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FOUR AUTHORS REPLY
Hoge, Charles W.
Fisher, Linda
Donnell, H. Denny
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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THE AUTHORS REPLY
Kuhn, Louise
Davidson, Leslie L.
Durkin, Maureen S.
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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RE: "USE OF POISSON REGRESSION AND TIME SERIES ANALYSIS FOR DETECTING CHANGES OVER TIME IN RATES OF CHILD INJURY FOLLOWING A PREVENTION PROGRAM"
Takei, Noriyoshi
Sham, Pak C.
Eadbhard O'Callaghan,
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
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Re: "Epidemiology of gallstone disease in Italy: prevalence data of the Multicenter Italian Study on Cholelithiasis (M.I.COL.)"
Feinstein, AR
Wells, CK
ARTICLES
Oxford University Press
1995-09-15 00:00:00.0
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Re: "Risk factors for transmission of Mycobacterium tuberculosis in a primary school outbreak: lack of radical difference in susceptibility to infection"
Comer, WJ
Felix, R
LETTERS TO THE EDITOR
Oxford University Press
1995-09-15 00:00:00.0
TEXT
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