Translating Laboratory Tests into Clinical Practice: A Conceptual Framework.

The use of laboratory biomarkers in clinical practice is rapidly increasing. Laboratory tests are, however, rarely evaluated adequately before implementation, and the utility of many tests is essentially unclear. An important reason for this knowledge gap is that a comprehensive and generally accepted methodological framework supporting evaluation studies is essentially lacking. Researchers, clinicians, and decision-makers are often not aware of the methodological tools available and face problems with the appraisal of a test's utility. With the present article, I aim to summarize current concepts and methodological tools and propose a framework for a phased approach that could be used in future evaluation projects. Future research will refine this suggested framework by identifying problems in current evaluation projects, specifying methodological criteria for all phases, as well as developing advanced methodological tools.