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Hamostaseologie 2020; 40(04): 420-429
DOI: 10.1055/a-1227-8008
Review Article

Translating Laboratory Tests into Clinical Practice: A Conceptual Framework

Michael Nagler
1   University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
› Author Affiliations Funding M. Nagler is supported by a research grant of the Swiss National Science Foundation (SNSF; #179334).
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Abstract

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.

Keywords

biomarkers/analysis - predictive value of tests - laboratory methods - laboratory tests


Publication History

Received: 14 March 2020

Accepted: 25 August 2020

Article published online:
22 September 2020

© 2020. Thieme. All rights reserved.

Georg Thieme Verlag KG
Stuttgart · New York

 

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