title: [The benefit of diagnostic tests--from surrogate endpoints to patient-relevant endpoints].
abstract: The patient-relevant benefit of diagnostic tests should be evaluated; addressing diagnostic accuracy alone is not sufficient, though. Several phased evaluation schemes for diagnostic tests have been proposed in the literature. They all have in common that studies evaluating the effect on patient outcome have a central position. Various designs are available to evaluate the effect of a diagnostic test on patient outcome. Five design options are presented and their pros and cons discussed. Indeed, such studies are feasible. Under exceptional conditions, however, it may be sufficient to base evaluation on diagnostic accuracy studies combined with further information (mostly from treatment trials).
authors.affiliation: Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e.V. (MDS), Essen.
authors.forename: Sandra
authors.initials: S
authors.lastname: Janatzek
mesh_terms: D015415:Biomarkers; D003955:Diagnostic Tests, Routine / Q000706:statistics & numerical data*; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D005069:Evaluation Studies as Topic; D005858:Germany; D006801:Humans; D008403:Mass Screening / Q000706:statistics & numerical data; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers