Diagnostic tests: Fundamentals of diagnostic studies, validity assessment and clinical interpretation of the results

Abstract

The purpose of this publication is to describe the fundamentals of diagnostic studies, providing elements of judgment to evaluate their validity, to point out their usefulness or performance measures, and to highlight the importance of diagnostic studies in usual clinical practice. Within the fundamentals of diagnostic tests, the basic principles of diagnostic tests, their structure, and how the results of the diagnostic test of interest and the results of the reference diagnostic test are analyzed and explained. The validity of a diagnostic test is eva-luated by examining three important criteria that support the methodological soundness of this type of study: representativeness, verification, and determination. On the other hand, the first type of performance measures of a diagnostic test are studied, the probability measures (sensitivity, specificity, positive predictive value, ne-gative predictive value). When the results of a diagnostic test are expressed on a continuous quantitative scale, it is necessary to choose the best cut-off point that corresponds to high sensitivity and specificity, in order to distinguish the sick from the healthy. To this end, we can use the properties of the ROC (Receiver Operating Characteristics) curve. In this publication, the construction of the ROC curve is described and detailed, and the best way to analyze it and take advantage of it is specified. Finally, it illustrates how a diagnostic study changes the paradigm of disease management.