Adaptive (seamless) designs for real-time evaluation of diagnostic tests and their usefulness for the parameterisation of dynamic infection spread models in epidemic and pandemic settings

  • The early and accurate diagnosis of infection in the case of epidemic or pandemic processes is the central component for the model-based evaluation for assessing the effectiveness of infection control measures at the individual and population levels. Especially during emerging infections such as SARS-CoV-2, the essential diagnostic tests need to be newly developed and further optimised and should be tested for their diagnostic quality within a short time frame. Therefore, accelerating research for innovative diagnostic tests is a key goal. This may be of even greater importance when the amendment of the National Medical Device Law in the EU is implemented in practice and the new standards for the regulation of diagnostic tests are introduced.

    This interdisciplinary project combines two research areas: Adaptive designs for diagnostic studies that allow for adjustments during the course of a study, thereby accelerating the development of diagnostic tests, and dynamic mathematical models that use realistic concepts of infection spread as the basis for simulating interventions. A correct parameterisation of the basic epidemiological measures in such models is crucial for the interpretability of model results. These parameters are derived directly from aggregated results of diagnostic tests and should take into account the diagnostic accuracy of the respective tests. This project aims to create a flexible study design for accelerated development of diagnostic tests that can support real-time modelling of infectious disease dynamics during epidemic or pandemic outbreaks.

    The developed approach will lead to earlier and better evidence in a decision making process for or against infection control measures for the emerging epidemic or pandemic containment and may further help to minimise the health as well as economic harm.

    The results will be prepared in such a manner so that they can easily be implemented in future epidemic or pandemic outbreaks. For this purpose, guidelines are written that include flowcharts, study designs and models with the corresponding explanations. Furthermore, all methods will be implemented in a user-friendly way in freely available software with necessary explained applications.

  • Duration: 2021 - 2024

  • Prof. Dr. André Karch (University Hospital Münster)

    • Patrick Bossuyt (University of Amsterdam, Niederlande)
    • Oke Gerke (Odense University Hospital, Dänemark)
    • Mirjam Kretzschmar (UMC Utrecht, Niederlande)
    • Hans Reitsma (University Medical Center Utrecht & University Utrecht, Niederlande)
    • Uwe Siebert (UMIT, Hall in Tirol, Österreich)

  • Workshop 2021

    If you are keen to participate in an upcoming workshop, you can be added to our e-mail distribution list. To do so, please write an e-mail to Frau Prof. Dr. Antonia Zapf .

  • Link:

    DFG-Portal

    Further publications from the subject area are:

    Studies for the Evaluation of Diagnostic Tests- Part 28 of a Series on Evaluation of Scientific Publications
    Hoyer A, Zapf A
    DTSCH ARZTEBL INT. 2021;118:555-560.

    A Deep Learning Approach for Histopathological Diagnosis of Onychomycosis: Not Inferior to Analogue Diagnosis by Histopathologists
    Decroos F, Springenberg S, Lang T, Päpper M, Zapf A, Metze D, Steinkraus V, Böer-Auer A
    ACTA DERM-VENEREOL. 2021;101(8):adv00532.

    Meta-analysis of diagnostic accuracy studies with multiple thresholds: Comparison of different approaches
    Zapf A, Albert C, Frömke C, Haase M, Hoyer A, Jones H, Rücker G
    BIOMETRICAL J. 2021;63(4):699-711.

    Neutrophil Gelatinase-Associated Lipocalin Measured on Clinical Laboratory Platforms for the Prediction of Acute Kidney Injury and the Associated Need for Dialysis Therapy: A Systematic Review and Meta-analysis
    Albert C, Zapf A, Haase M, Röver C, Pickering J, Albert A, Bellomo R, Breidthardt T, Camou F, Chen Z, Chocron S, Cruz D, de Geus H, Devarajan P, Di Somma S, Doi K, Endre Z, Garcia-Alvarez M, Hjortrup P, Hur M, Karaolanis G, Kavalci C, Kim H, Lentini P, Liebetrau C, Lipcsey M, Mårtensson J, Müller C, Nanas S, Nickolas T, Pipili C, Ronco C, Rosa-Diez G, Ralib A, Soto K, Braun-Dullaeus R, Heinz J, Haase-Fielitz A
    AM J KIDNEY DIS. 2020;76(6):826-841.e1.