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The collection and interpretation of epidemiological data about the cardiovascular risks associated with the use of steroid contraceptives.

Abstract：

:A variety of epidemiological approaches have been used to assess the safety of steroid contraceptives. Each study design has its own strengths and weaknesses, especially with respect to susceptibility to bias and confounding. Randomized controlled trials provide the strongest evidence of a cause and effect relationship, but the low incidence of cardiovascular disease in women of reproductive age precludes the use of this study design to examine these clinical endpoints. Consequently, observational cohort and case-control studies have provided the most useful clinical information about the main cardiovascular effects of steroid contraceptives. Data from epidemiological research need to be interpreted carefully taking into consideration which of the potential biases or sources of confounding are likely to have affected a particular study, and what effect these may have on any inferences from the study. Additional factors that need to be considered before deciding whether a causal relationship exists include evidence that the exposure preceded the disease, the strength of association, consistency of findings with other studies, presence of dose gradients, and agreement with animal or laboratory research. Even if a casual link is thought to be plausible, the public health implications may be minimal; absolute (attributable) risks are required in order to assess these. An understanding of these epidemiological issues will enable clinicians to advise their clients whether steroid contraceptives alter the risk of cardiovascular disease and, if so, the clinical significance of such changes. :The collection and interpretation of epidemiologic data on the cardiovascular risks associated with use of combined oral contraceptives are compromised by the potential for bias and confounding. Randomized controlled trials provide the strongest evidence of a cause-and-effect relationship, but the low incidence of cardiovascular disease in women of reproductive age precludes the use of this method with clinical endpoints. Cohort studies are prone to confounding since women do not use contraceptives randomly. The large amount of data collected in case-control studies permits more detailed assessment of potential diagnostic bias and confounding. Observational studies remain the principal source of information about the risks and benefits associated with OC use, but there must be clear evidence that the exposure preceded disease development. In addition, it must be determined whether the risk of disease is related to the steroid hormone dose or the duration of use and the relative importance of the estrogen versus progestogen component must be assessed. Inconsistencies in the pattern of relative risks from different studies often reflect variations in the prevalence of effect modifiers such as smoking. Even if a causal link seems plausible, a measure of absolute risk is required to assess the public health significance of the findings.

journal_name

Contraception

journal_title

Contraception

authors

Hannaford P

doi

10.1016/s0010-7824(98)00013-4

subject

Has Abstract

pub_date

1998-03-01 00:00:00

pages

137-42

issue

eissn

0010-7824

issn

1879-0518

pii

S0010-7824(98)00013-4

journal_volume

pub_type

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The collection and interpretation of epidemiological data about the cardiovascular risks associated with the use of steroid contraceptives.