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Klinische Studien außerhalb des Arzneimittelgesetzes

Diagnosestudien

Clinical studies beyond the German Drug Law

Studies for evaluating diagnostic tests

  • Leitthema
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Die Bewertung diagnostischer Tests (DT) oder Maßnahmen unterliegt keinen einheitlichen Regularien. Jedoch ist eine gründliche Evaluierung von DT, die für den Einsatz in der medizinischen Routinepraxis vorgesehen sind, aus wirtschaftlichen, medizinischen und ethischen Gründen empfehlenswert beziehungsweise häufig sogar unabdingbar. Der vorliegende Beitrag handelt wichtige Aspekte dieser Evaluierung ab: die Facetten des Bewertungsproblems bei DT, einschlägige Validitätsmaße für qualitative und quantitative DT, Probleme der Aussagekraft und Übertragbarkeit von Validitätsschätzungen, Ziele und Aufbau von Evaluierungsstudien sowie spezifische methodische Probleme dieser Studien.

Abstract

The evaluation of diagnostic tests (DT) or procedures is not subject to uniform regulations. However, a thorough evaluation of DT which are intended for use in routine medical practice is advisable or even indispensible for economic, medical, and ethical reasons. This article addresses some important aspects of this evaluation: the facets of “evaluating a DT”, common validity measures for qualitative and quantitative DT, the applicability and generalizability of estimates of diagnostic accuracy, objectives and design of studies for evaluating DT, as well as specific methodological problems of theses studies.

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Notes

  1. GMDS: Deutsche Gesellschaft für Medizinische Dokumentation, Informatik und Statistik

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Authors and Affiliations

  1. Tumorzentrum Heidelberg/Mannheim und Nationales Centrum für Tumorerkrankungen Heidelberg, Universität Heidelberg, Im Neuenheimer Feld 305, 69120, Heidelberg, Deutschland

    U. Abel

  2. Institut für Medizinische Biometrie und Informatik, Universität Heidelberg, Heidelberg, Deutschland

    K. Jensen

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  1. U. Abel
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Correspondence to U. Abel.

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Abel, U., Jensen, K. Klinische Studien außerhalb des Arzneimittelgesetzes. Bundesgesundheitsbl. 52, 425–432 (2009). https://doi.org/10.1007/s00103-009-0825-5

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