Hotelbuchung
Hotel Registration
Grußwort
Welcome address
Beteiligte Gesellschaften
Societies involved
DOG Information
DOG Information
Eröffnung des Kongresses
Opening Ceremony
Preise
Awards
Ablauf der Tagung 2003
General overview of congress
Lageplan der Räumlichkeiten
Map of Congress Center
Wissenschaftliche Themen
Scientific topics
Symposien
Symposia
Wissenschaftliches Programm
Scientific program
Posterpräsentationen
Poster Presentation
Kurse
Courses
Begleitende Veranstaltungen
Accompanying program
Arbeitssitzungen
Working sessions
Rahmenprogramm
Social program
Allgemeine Informationen
General Information
Autorenindex
Index of Authors
Industrieaussteller
Commercial exhibitors
Sponsoren
Sponsors
Impressum
DOG Homepage
Abstract
Abstract
Diagnostic Device Evaluation - What are Clinically Relevant Determinants?
Krummenauer F.1, Troost A.2
1Department of Medical Biometry, Epidemiology and Informatics, 2University Eye Hospital, Medical School, University of Mainz
Purpose: The demand for minimum invasive, but maximum valid and reliable diagnostic strategies catalyses increasing development of diagnostic devices in ophthalmology. Reductions in patient exposure can often be combined with a gain in diagnostic validity and / or reliability compared to previously established diagnostic standards. However, to substitute a diagnostic standard device by a diagnostic novelty, its diagnostic non-inferiority has to be proven in advance by means of biostatistical evaluation. Unfortunately, study reports and publications on diagnostic device comparisons do not always provide appropriate determinants of validity and reliability, but draw conclusions from rather subinformative measures.
Method: A valid biostatistical evaluation of a diagnostic novelty must not only concentrate on median agreement measures, but also consider the devices' measurement precisions and reliabilities. In general, one has to consider the scale level of the underlying data in addition: Are diagnostic findings of interest ("positive / negative finding") or rather continuous measurement values?. A check list for clinical authors will be provided, which summarizes flexible means for reporting device comparison trials; it will be illustrated by the result presentation of a recent trial on the comparison o