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PubMedDate not supplied

Oral contraceptive use and venous thromboembolism: a consideration of the impact of bias and confounding factors on epidemiological studies.

Recent epidemiological studies have reported an approximately two-fold, significant, increased odds ratio for venous thromboembolism in users of third-generation oral contraceptives (OCs) compared to users of second-generation OCs. However, in each study, this association is of borderline statistical significance, and the studies do not indicate an increase in the absolute risk of venous thromboembolism for users of third-generation OCs compared with the data from prior studies primarily involving second-generation products. The data derived from these recent studies show a lower reported incidence of venous thromboembolism with the use of second-generation OCs over time compared to the prior studies, while the incidence of venous thromboembolism for use of third-generation OCs is approximately equal to that previously reported for second-generation products. Generally, evidence has shown that the risk of venous thromboembolism and the impact on hemostatic parameters are reduced with declining estrogen dose. In addition, there is no evidence of a clinically significant effect of the OC progestogen doses on hemostatic parameters. These inconsistencies point to factors other than a causal relationship to explain the higher risk of venous thromboembolism in users of third-generation OCs. An examination of factors not included in the recent studies has identified at least three potential biases that should be considered: prescription bias, a 'healthy-user' effect and referral bias. Available data on prescription bias come from marketing research surveys, databases of prescribing patterns, epidemiological databases and the recent studies. These data indicate that the recently introduced third-generation OCs have been more extensively used by younger women, for shorter periods of time, and by women with risk factors for venous thromboembolism that have the second-generation OCs. There is also evidence for a healthy-user effect, whereby women who were most susceptible for venous thromboembolism have left the cohort of users of second-generation OCs as a result of a venous thromboembolism during pregnancy or early OC use, and thus were possibly not included in these recent studies. The women remaining in the cohort, who are included in the recent studies, are less susceptible to venous thromboembolic events than are those making up the cohort of women using third-generation OCs. In addition, there are indications that referral bias has occurred because women with risk factors for venous thromboembolism (who disproportionately receive third-generation OCs) are more likely to be referred to a hospital for investigation of possible symptoms of venous thromboembolism, and thus users of third-generation OCs have the potential to be over-represented among cases. These biases act spuriously to increase the observed odds ratio for the first-time occurrence of venous thromboembolism amongst users of third-generation OCs, when compared to users of second-generation OCs. None of the recent epidemiological studies have been able to adjust for the three major biases. These biases are likely to contribute to, or even totally account, for the small increased risk of venous thromboembolism observed for users of third-generation OCs when compared to that for users of second-generation OCs.

Bias↗
PubMed1992

Two critical confounding factors in periodontal epidemiology.

The prevalence and severity of periodontitis is considerably lower than was previously estimated. The available epidemiological methods are based on the premise that loss of periodontal attachment is a unique sign of periodontitis. However, additional factors resulting in loss of periodontal attachment confound data obtained from modern studies. The physiological process of continuous tooth eruption results in loss of periodontal attachment over a lifetime, at an approximate rate of 0.1 mm/year. Anthropological and clinical evidence for continuous tooth eruption is reviewed. The position of the alveolar crest appears to be stable; loss of periodontal attachment occurs as the teeth erupt and less of the root is embedded in bone. Retrograde periodontitis caused by pulpal disease is a known cause of severe, localised destruction of periodontal tissues. Its signs and symptoms include periodontal pocket formation, purulent inflammatory exudates, angular bone loss, swelling and bleeding of the gingival tissues and increased tooth mobility. Anthropological, experimental and clinical evidence for retrograde periodontitis is discussed. Misdiagnosis of angular (hemiseptal), furcal and other forms of localised periodontal damage as periodontitis has probably resulted because of the inability to determine the quality of pulpal health and the assumption of a gingivitis-periodontitis continuum. New epidemiological methods need to be developed in which physiological and all pathological conditions which affect the periodontal attachment are recognised and appropriately categorised.

Confounding Factors, Epidemiologic↗
PubMed1997

Examination of "early mortality exclusion" as an approach to control for confounding by occult disease in epidemiologic studies of mortality risk factors.

Methods for the estimation of the effects of chronic disease risk factors on mortality continue to be an area that generates confusion and controversy. In response to the frequently observed U- or J-shaped relations between risk factors and mortality, some authors suggest that subjects dying during the first k years of follow-up (where k is some positive number less than the total length of follow-up) be excluded from statistical analyses. By excluded, the authors mean completely removed from the data set. The rationale is that persons dying during the first k years are likely to have a preexisting occult disease that confounds the relation between the risk factor under study and mortality. Excluding persons dying during the first k years of follow-up purportedly reduces this confounding. However, the authors are aware of no demonstration that this procedure effectively accomplishes its goal. They show that excluding subjects who die during the first k years of follow-up does not necessarily lead to a reduction in bias in the estimated effect of a risk factor on mortality when this relation is confounded by the presence of occult disease. Moreover, it is possible for such exclusion to exacerbate the confounding due to preexisting disease. Thus, excluding subjects dying during the first k years of follow-up is not necessarily an effective strategy for dealing with confounding due to occult disease. Investigators are encouraged to pursue alternative methods.

Confounding Factors, Epidemiologic↗
PubMed1998

Exposure to environmental tobacco smoke and risk factors for heart disease among never smokers in the Third National Health and Nutrition Examination Survey.

The relative risk of coronary artery disease among never smokers exposed to environmental tobacco smoke (ETS) versus never smokers not exposed to ETS is approximately 1.2 based on more than a dozen epidemiologic studies. Most of these studies have controlled for the major heart disease risk factors, but residual or uncontrolled confounding remains a possible explanation for the epidemiologic findings. The authors studied 3,338 never-smoking adults aged 17 years or older, who are representative of all US never smokers, in the 1988-1991 Third National Health and Nutrition Examination Survey (NHANES III) to determine whether selected risk factors for heart disease differ between ETS-exposed and -nonexposed persons. Both self-reported ETS exposure (at home and at work) and serum cotinine levels were available, the latter reflecting recent ETS exposure. After adjustments were made for age, sex, race, and education among adults aged 17 years or older, no significant differences were found between the ETS exposed and the nonexposed for any of 13 cardiovascular risk factors with the exception of dietary carotene, which was lower among the exposed. On the other hand, significant positive linear trends were found between serum cotinine and two risk factors (body mass index and alcohol consumption), and significant inverse trends were found with dietary carotene. There were also few differences between exposed and nonexposed never smokers among adults aged 40 years or older, who are most at risk of heart disease. In this group, however, there was an inverse linear trend between serum cotinine and high density lipoprotein cholesterol (p < 0.001). This finding could result from ETS exposure rather than be an indication of confounding; a similar inverse trend was found for children, confirming other results in the literature. Overall, these data suggest little potential for confounding by the heart disease risk factors studied here when ETS exposure is determined by self-report.

Adolescent↗
PubMed1995

Poppers, Kaposi's sarcoma, and HIV infection: empirical example of a strong confounding effect?

Are there empirical examples of strong confounding effects? Textbooks usually show examples of weak confounding or use hypothetical examples of strong confounding to illustrate the paradoxical consequences of not separating out the effect of the studied exposure from that of second factor acting as a confounder. HIV infection is a candidate strong confounder of the spuriously high association reported between consumption of poppers, a sexual stimulant, and risk of Kaposi's sarcoma in the early phase of the AIDS epidemic. To examine this hypothesis, assumptions must be made on the prevalence of HIV infection among cases of Kaposi's sarcoma and on the prevalence of heavy popper consumption according to HIV infection in cases and controls. Results show that HIV infection may have confounded the poppers-Kaposi's sarcoma association. However, it cannot be ruled out that HIV did not qualify as a confounder because it was either an intermediate variable or an effect modifier of the association between popper inhalation and Kaposi's sarcoma. This example provides a basis to discuss the mechanism by which confounding occurs as well as the practical importance of confounding in epidemiologic research.

Confounding Factors, Epidemiologic↗
PubMedDate not supplied

Dietary differences with green tea intake among middle-aged Japanese men and women.

BACKGROUND: Although several epidemiologic investigations have suggested a protective role of green tea against cardiovascular diseases and cancer, few studies examined how consumption of green tea was associated with intake of other dietary factors. METHODS: In the winters of 1989-1991, 880 men ages 40-49 years were randomly sampled from the general populations of five Public Health Center districts of Japan. Response rate was 72% (n = 634). A convenience sample of 373 spouses also consented to participate. They were interviewed on the frequency of consumption of green tea and 37 food items. A 3-day weighed food record was collected from a subgroup of the subjects (207 men and 164 women) to calculate daily intake of 22 nutrient variables. Consumption of the foods and nutrients was compared with three levels of green tea intake (< 1, 1-4, and > 4 cups/days) after adjustment for potential confounders. RESULTS: Among men, green tea was associated significantly with consumption of 10 foods (P < 0.05) and at borderline significance with 4 nutrients (P < 0.1). These foods and nutrients included fruits (apple, orange juice), vegetables (green, yellow, and pickled), total lipid, cholesterol, and carotene. Among women, green tea was associated with 6 foods and total energy. CONCLUSION: The results indicate that consumption of green tea is associated with diets that could modify the risks of cardiovascular diseases and cancer, especially among men. When the health effects of green tea are examined by observational epidemiologic studies, potential confounding and effect modification by other dietary factors should be controlled thoroughly.

Adult↗
PubMed1996

Effect of sucrose consumption on level of Streptococcus mutans in saliva.

The aim of the present paper was to study whether sucrose consumption may affect the level of salivary Streptococcus mutans. The study was justified by the disagreement between results of "in vitro", animal and human experiments and results of epidemiological studies made on study-populations. According to experimental research, sucrose availability promotes Streptococcus mutans selection and development in the oral cavity. On the other hand, the results of epidemiological studies run counter to these experiments. In the present study, the main reasons for this disagreement were investigated and identified. From this, an epidemiological study was performed, taking into account these potentially confounding factors. The results show that sucrose consumption is actually able to promote Streptococcus mutans selection and development in the oral cavity, thus increasing the risk of dental caries.

Child↗
PubMed1999

A review of the healthy worker effect in occupational epidemiology.

This review article aims to anatomize sources of the healthy worker effect (HWE) and to summarize advantages and limitations of several approaches frequently proposed to eliminate the HWE. Although the HWE is frequently addressed in the context of selection bias, our review suggests that the selection of occupational cohorts with advantageous health status would preferably be addressed as a source of confounding biases. The authors also conclude that the exclusion of unhealthy workers at employment and the study of active workers are the two main sources of HWE, and that the use of the general population as a comparison group in occupational epidemiology should be avoided if possible. The authors encourage investigators to make distinctions between the underlying factors related to the use of the general population as the comparison group in occupational epidemiology.

Bias↗
PubMed1992

Aspects of misclassification of confounding factors.

Misclassification of exposure in epidemiologic investigations has been extensively studied and is now well understood. In contrast, misclassification of confounding factors has been much less investigated. First, we consider a situation with confounding by age, in which misclassification is introduced through stratification of this inherently continuous variable. This misclassification turns out to be benign: 75% of the original confounding is removed by stratification into two age classes and more than 90% by using three age classes. Second, we consider a situation with serious confounding and serious misclassification of the confounding factor but no misclassification of the exposure. In this situation, the misclassification turns out to be of importance. After stratification for the misclassified confounding factor, it appears as though the exposure has a stronger effect on the incidence than the confounder, which is the reverse of the true situation.

Adult↗
PubMed1999

Confounding by indication: an example of variation in the use of epidemiologic terminology.

Confounding by indication is a term used when a variable is a risk factor for a disease among nonexposed persons and is associated with the exposure of interest in the population from which the cases derive, without being an intermediate step in the causal pathway between the exposure and the disease. However, in the literature, the term confounding by indication is not always used consistently. The authors found three different situations in which the term has been applied or might have been used but was not: confounding by indication as protopathic bias, as confounding by severity, or as a form of selection bias. It might be helpful to limit use of the term confounding by indication to the situation in which the disease that forms the indication acts as a confounder irrespective of its severity and to apply the term confounding by severity if the severity of this disease acts as a confounder. Protopathic bias and selection bias should not be confused with these terms. The use of appropriate terms ultimately will improve communication among researchers and contribute to the clarity of their papers.

Confounding Factors, Epidemiologic↗
PubMed1995

Validity criteria for the use of biological markers of exposure to chemical agents in environmental epidemiology.

Biomarkers may prove very useful in increasing the precision of exposure estimates during field epidemiological studies of environmental and occupational exposures. However, the determination of validity of exposure biomarkers is a laborious process. It is also a process that needs collaboration between laboratory and field scientists if biological markers of exposure are to be useful tools in environmental epidemiology.

Biomarkers↗