Evidence-based medicine: Evaluation of biomarkers

Abstract

Evidence-based medicine (EBM) combines individual clinical expertise with the best available clinical evidence from systematic research in making decisions about the care of individual patients. Clinical expertise is the proficiency and judgment that individual clinicians acquire through knowledge, clinical experience, and practice. Clinical evidence comes from patient centered clinical research which investigates the accuracy and precision of diagnostic tests and biomarkers, the efficacy and safety of therapeutic regimes, and the reliability of prognostic indicators. The powerful combination of clinical expertise and documented evidence results in safer, more efficacious and accurate care of the patient. Evidence-based guidelines are commonly used tools for supporting medical decisions. Formulating evidence-based recommendations has become a leading principle in guideline development. Laboratory guidelines should be outcome oriented, be developed by a multidisciplinary team, and begin with a clear statement of the clinical question(s) that the use of the test(s) is addressing. The clinical questions define the type of study designs that offer the best evidence to answer those questions. Guidelines should be based on the critical appraisal and systematic review of literature and explicitly state the strength of evidence supporting each recommendation. Guidelines address not only the diagnostic value of a test, but also other clinically useful attributes of a test's performance. Preanalytical, analytical, postanalytical, and other technical or organizational elements of diagnostic performance should be seen as part of evidence-based laboratory medicine. We might not always be able to identify in quantitative terms the impact of all elements of test performance on clinical outcomes in laboratory medicine. Despite this fact, there is no doubt that there is such a relationship and that these characteristics therefore must be considered when defining the scope of evidence-based laboratory guidelines. Guidelines should be developed in a transparent process by a multidisciplinary team, with graded recommendations based on critically appraised scientific studies. Systematic, standardized, and explicit methodology, adapted to laboratory medicine, should be followed when developing recommendations involving the use of laboratory tests and biomarkers.