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Biostatistics

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642 CHAPTER 12 THE CHI-SQUARE DISTRIBUTION AND THE ANALYSIS OF FREQUENCIES<br />

of interest to clinicians and other health sciences professionals. Another important class of<br />

scientific investigation that is widely used is the observational study.<br />

DEFINITION<br />

An observational study is a scientific investigation in which neither the<br />

subjects under study nor any of the variables of interest are manipulated<br />

in any way.<br />

An observational study, in other words, may be defined simply as an investigation<br />

that is not an experiment. The simplest form of observational study is one in which there are<br />

only two variables of interest. One of the variables is called the risk factor, or independent<br />

variable, and the other variable is referred to as the outcome, or dependent variable.<br />

DEFINITION<br />

The term risk factor is used to designate a variable that is thought to be<br />

related to some outcome variable. The risk factor may be a suspected<br />

cause of some specific state of the outcome variable.<br />

In a particular investigation, for example, the outcome variable might be subjects’<br />

status relative to cancer and the risk factor might be their status with respect to cigarette<br />

smoking. The model is further simplified if the variables are categorical with only two<br />

categories per variable. For the outcome variable the categories might be cancer present<br />

and cancer absent. With respect to the risk factor subjects might be categorized as smokers<br />

and nonsmokers.<br />

When the variables in observational studies are categorical, the data pertaining to<br />

them may be displayed in a contingency table, and hence the inclusion of the topic in the<br />

present chapter. We shall limit our discussion to the situation in which the outcome variable<br />

and the risk factor are both dichotomous variables.<br />

Types of Observational Studies There are two basic types of observational<br />

studies, prospective studies and retrospective studies.<br />

DEFINITION<br />

A prospective study is an observational study in which two random<br />

samples of subjects are selected. One sample consists of subjects who<br />

possess the risk factor, and the other sample consists of subjects who do<br />

not possess the risk factor. The subjects are followed into the future (that<br />

is, they are followed prospectively), and a record is kept on the number of<br />

subjects in each sample who, at some point in time, are classifiable into<br />

each of the categories of the outcome variable.<br />

The data resulting from a prospective study involving two dichotomous variables can<br />

be displayed in a 2 2 contingency table that usually provides information regarding the<br />

number of subjects with and without the risk factor and the number who did and did not

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