The complex connections between test properties and relevant outcomes: widening the perspective

Abstract

The formulation of analytical goals for the clinical laboratory should be based upon a wide perspective embracing multiple viewpoints. Mathematical consideration of analytical error is necessary but insufficient to address societal forces demanding increased effectiveness while also reducing costs. Appropriate goals also require the study of cognitive science, health policy research, and the measurement of subjective preferences and of predictive probability. Overall goals must focus on health outcomes that emphasize prevention or postponement of morbidity and the need for acute care. Care process variables that influence health outcomes must be identified. Process improvement through reduction in process variation can then improve health outcomes. Important process variables will be identified in the cognitive process as well as in the pre- and post-analytical phases of laboratory care. The impact of test characteristics upon the laboratory's contribution to health goals are exemplified by monitoring of oral anticoagulant, thyroxine, aminoglycoside and intensive insulin therapy plus identification of clinically occult diseases such as hypothyroidism and hemochromatosis.