GUIDELINES FOR THE ASSESSMENT OF NEW DIAGNOSTIC-TESTS

RATIONALE AND OBJECTIVES. Because new diagnostic tests become availabl e rapidly, the authors determined a need for proper assessment of test s before their implementation in clinical practice, Three factors are of pivotal importance: the selection of the proper study population, t he determination of the diagnostic power including its related statist ical analysis, and the relation of the new test to current diagnostic tools, Patients suspected of having a disease are those who would bene fit from the application of a new test, Therefore, only those patients need be involved in the assessment study. METHODS. Summary measures o f diagnostic power other than sensitivity and specificity are advocate d because these conventional measures depend on cutoff points and are susceptible to selection bias, The relation between the new test and e xisting diagnostic tools must be established to determine if the new t est contributes to the diagnostic process. RESULTS AND CONCLUSION. TO avoid waste of effort and money, the authors suggest a prudent assessm ent approach in phases, Whereas the initial challenge consists of sele ction of an adequate patient population, subsequently all determinants of disease (signs, symptoms, comorbidity, and other diagnostic factor s) and factors influencing the decision to use a test (patient burden and cost) are considered,