Assessing Diagnostic Tests.
Assessment of a diagnostic test involves consideration of 3 components of effectiveness: accuracy, clinical utility, and patient benefit.
To be effective, a test must be accurate, which is determined by sensitivity (the true-positive rate) and specificity (the true-negative rate).
The most valid study design for assessing the accuracy of diagnostic tests is a non- experimental cross-sectional study that compares a test's classification of a diagnosis with a reference standard's classification, in a relevant study population.
Diagnostic efficacy of a test is measured by its ability to change the probability of disease (pre- versus post-test likelihood).
Management efficacy is a measure of how the test changes patient management.
Outcome efficacy, which may take years to evaluate, is the ultimate yardstick of usefulness.