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CC BY-NC-ND 4.0 · Diabetologie und Stoffwechsel 2023; 18(05): 381-393
DOI: 10.1055/a-2149-3554
DOI: 10.1055/a-2149-3554
Übersicht
Endpunkte zu mikrovaskulären Folgekomplikationen: klinische Endpunkte, patientenberichtete Endpunkte und Surrogatendpunkte, Methodik von Surrogatvalidierungsstudien
Endpoints for microvascular complications: clinical outcomes, patient reported outcomes and surrogate endpoints, methodology for validating surrogate parameters
1
Medicine IV, University Hospital Tübingen, Tübingen, Germany
,
Monika Kellerer
2
Zentrum für Innere Medizin, Marien Hospital Stuttgart, Stuttgart, Germany (Ringgold ID: RIN39659)
,
Dirk Müller-Wieland
3
Medicine 1, Uniklinikum Aaachen, Aachen, Germany
,
Christoph Wanner
4
Dept. Medicine 1, Universitätsklinikum Würzburg, Wurzburg, Germany (Ringgold ID: RIN27207)
,
Focke Ziemssen
5
Augenklinik, University Hospital Leipzig, Leipzig, Germany (Ringgold ID: RIN39066)
› Author Affiliations
Zusammenfassung
Für die Bewertung und die Vergleichbarkeit klinischer Langzeitstudien zur Sicherheit und/oder Effektivität verschiedener Therapieformen bei chronischen Erkrankungen sind möglichst vergleichbare und homogene vorab festgelegte Endpunkte und Surrogatparameter wichtig. Am Beispiel des Diabetes mellitus Typ 2 als chronische Erkrankung wird die Erhebung mikrovaskulärer Endpunkte und von Surrogatparametern bei der diabetesbedingten Retinopathie und Nephropathie dargelegt und diskutiert.
Abstract
For the assessment and comparability of clinical long-term studies on the safety and/or efficacy of different forms of therapy in chronic diseases, it is important that endpoints and surrogate parameters that are prespecified are as comparable and homogeneous as possible. Using the example of type 2 diabetes mellitus as a chronic disease, the collection of microvascular endpoints and surrogate parameters in diabetes-related retinopathy and nephropathy is presented and discussed.
Schlüsselwörter
Endpunktstudien - Typ-2-Diabetes - Retinopathie - Nephropathie - mikrovaskuläre Endpunkte - SurrogatparameterKeywords
Outcome studies - type-2-diabetes - retinopthy - nephropathy - microvascular endpoints - surrogate parameters* Für die Deutsche Diabetes Gesellschaft (DDG).
Publication History
Received: 02 July 2023
Accepted: 02 August 2023
Article published online:
12 October 2023
© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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