PASS

Tests for Independent Sensitivities of Two Groups

This procedure gives power or required sample size for comparing two diagnostic tests when the outcome is sensitivity (or specificity). In this design, the outcome of each of two diagnostic screening tests is compared to a gold standard.

Specifically, a set of n subjects is randomly divided into two groups. In each group, a portion of the subjects have the disease (condition of interest) and a portion does not. Each subject is given the one of the diagnostic tests. Subsequently, a gold standard test is used to obtain the true presence or absence of the disease. The gold standard may be a more expensive test, difficult to determine, or require the sacrifice of the subject.

The measures of diagnostic accuracy are sensitivity and specificity. Sensitivity (Se) is the probability that the diagnostic test is positive for the disease, given that the subject actually has the disease. Specificity (Sp) is the probability that the diagnostic test is negative, given that the subject does not have the disease.

Li and Fine (2004) present sample size methodology for testing sensitivity and specificity using a two-group, prospective design. Their methodology is used in this procedure.

 
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