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  1. AU="Rauch, Geraldine"
  2. AU="Ekoh, Okwukwe Faith"
  3. AU="A Rahim, Haslinda"
  4. AU="Richard Stahl"
  5. AU=Vazquez-Iglesias J L
  6. AU="Amundsen, David S"
  7. AU="Konios, Dimitrios"
  8. AU="Lindh, Ingrid"
  9. AU=Zhao Chunyan
  10. AU="Scalia, Jennifer B"
  11. AU="Balint, Lajos"
  12. AU="Liang, Siping"
  13. AU="Wong, Anthony"
  14. AU="Müjdat YENİCESU"
  15. AU="Brooks, M L"
  16. AU="Garcia-Gutierrez, Ania" AU="Garcia-Gutierrez, Ania"
  17. AU="Marina Paola Gardiman"
  18. AU="Labarthe, Simon"
  19. AU="Jiahui Li"
  20. AU="Geier, Johannes"
  21. AU=Thangaraju Pugazhenthan
  22. AU="Tapio, Joona"
  23. AU="Navaratnam, Dhasakumar"
  24. AU="Blank, Marissa Cathleen"
  25. AU="Sadeghi, Yasaman"
  26. AU=Ye Keqiang
  27. AU="Huda, Walter"
  28. AU="Petrova, Polina E"
  29. AU="Pond, Gregory"
  30. AU=Krzewski Konrad
  31. AU="Feng, Yuquan"
  32. AU="Schmermund, Ben Niklas"
  33. AU="Soni, Payal D"
  34. AU="Romero-García, Carolina"
  35. AU="Petty, Lloyd"
  36. AU="James E. Posey"

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  1. Buch ; Online ; E-Book: Zeig mir Health Data Science!

    Herrmann, Carolin / Berger, Ursula / Weiß, Christel / Burkholder, Iris / Rauch, Geraldine / Kruppa, Jochen

    Ideen und Material für guten Biometrie-Unterricht mit datenwissenschaftlichem Fokus

    2021  

    Verfasserangabe herausgegeben von Carolin Herrmann, Ursula Berger, Christel Weiß, Iris Burkholder, Geraldine Rauch, Jochen Kruppa
    Schlagwörter Statistics  ; Science education ; Bioinformatics
    Thema/Rubrik (Code) 519.5
    Sprache Deutsch
    Umfang 1 Online-Ressource (XVI, 159 Seiten)
    Verlag Springer
    Erscheinungsort Berlin
    Erscheinungsland Deutschland
    Dokumenttyp Buch ; Online ; E-Book
    Bemerkung Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT020839712
    ISBN 978-3-662-62193-6 ; 9783662621929 ; 3-662-62193-2 ; 3662621924
    DOI 10.1007/978-3-662-62193-6
    Datenquelle ZB MED Katalog Medizin, Gesundheit, Ernährung, Umwelt, Agrar

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  2. Buch ; Online ; E-Book: Medizinische Statistik für Dummies

    Rauch, Geraldine / Neumann, Konrad / Grittner, Ulrike / Herrmann, Carolin / Kruppa, Jochen / Burkholder, Iris

    (... für Dummies ; Lernen einfach gemacht)

    2019  

    Verfasserangabe Geraldine Rauch, Konrad Neumann, Ulrike Grittner, Carolin Herrmann und Jochen Kruppa ; Fachkorrektur von Prof. Dr. Iris Burkholder
    Serientitel ... für Dummies
    Lernen einfach gemacht
    Schlagwörter Statistik ; Medizinische Statistik
    Schlagwörter Mathematische Statistik ; Statistische Mathematik ; Statistische Methode ; Statistisches Verfahren ; Statistiken
    Sprache Deutsch
    Umfang 1 Online-Ressource ([386] Seiten), Illustrationen
    Ausgabenhinweis 1. Auflage
    Verlag Wiley, Wiley-VCH Verlag GmbH & Co. KGaA
    Erscheinungsort Weinheim
    Erscheinungsland Deutschland
    Dokumenttyp Buch ; Online ; E-Book
    Anmerkung "Erscheinungs-Termin Print: 2020-04-01" - Startseite ProQuest ; "Medizinische Statistik, Biostatistik und Biometrie; statistische Methoden in der medizinischen Forschung; viele verschiedene Anwendungsbeispiele" - Cover
    Bemerkung Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
    HBZ-ID HT020428478
    ISBN 978-3-527-82118-1 ; 978-3-527-82119-8 ; 9783527715848 ; 3-527-82118-X ; 3-527-82119-8 ; 3527715843
    Datenquelle ZB MED Katalog Medizin, Gesundheit, Ernährung, Umwelt, Agrar

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  3. Buch ; Online ; Konferenzbeitrag: German medical data sciences: Digital medicine : recognize - understand - heal

    Röhrig, Rainer / Beißbarth, Tim / König, Jochem / Ose, Claudia Melanie / Rauch, Geraldine / Sax, Ulrich / Schreiweis, Björn / Sedlmayr, Martin

    proceedings of the joint conference of the 66th Annual Meeting of the German Association of Medical Informatics, Biometry and Epidemiology, e.V. (gmds) ) and the 13th Annual Meeting of the TMF - Technology, Methods, and Infrastructure for Networked Medical Research e.V. 2021 online in Kiel, Germany

    (Studies in health technology and informatics ; 283)

    2021  

    Titelvarianten German medical data sciences ; Digital medicine : recognize - understand - heal
    Veranstaltung/Kongress Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Annual Meeting of the TMF - Technology, Methods, and Infrastructure for Networked Medical Research (66., 2021, KielOnline)
    Verfasserangabe Editors: Rainer Röhrig, Tim Beißbarth, Jochem König, Claudia Ose, Geraldine Rauch, Ulrich Sax, Björn Schreiweis, Martin Sedlmayr
    Serientitel Studies in health technology and informatics ; 283
    Überordnung
    Sprache Englisch
    Umfang 1 Online-Ressource (xix, 242 Seiten), Illustrationen, Diagramme
    Verlag IOS Press
    Erscheinungsort Amsterdam ; Berlin ; Tokyo ; Washington, DC
    Erscheinungsland Deutschland
    Dokumenttyp Buch ; Online ; Konferenzbeitrag
    Anmerkung Kostenfreier Zugang nach Registrierung ; Open Access
    HBZ-ID HT021177660
    ISBN 978-1-64368-207-5 ; 9781643682068 ; 1-64368-207-5 ; 1643682067
    Datenquelle ZB MED Katalog Medizin, Gesundheit, Ernährung, Umwelt, Agrar

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  4. Konferenzbeitrag: Platform trials – a new solution or a new problem?

    Rauch, Geraldine

    2021  , Seite(n) Abstr. 19

    Veranstaltung/Kongress 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS); Berlin; Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie; 2020
    Schlagwörter Medizin, Gesundheit ; platform trial ; basket trial ; umbrella trial
    Erscheinungsdatum 2021-02-26
    Verlag German Medical Science GMS Publishing House; Düsseldorf
    Dokumenttyp Konferenzbeitrag
    DOI 10.3205/20gmds104
    Datenquelle German Medical Science

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  5. Artikel ; Online: Optimal futility stopping boundaries for binary endpoints.

    Freitag, Michaela Maria / Li, Xieran / Rauch, Geraldine

    BMC medical research methodology

    2024  Band 24, Heft 1, Seite(n) 80

    Abstract: Background: Group sequential designs incorporating the option to stop for futility at the time point of an interim analysis can save time and resources. Thereby, the choice of the futility boundary importantly impacts the design's resulting performance ... ...

    Abstract Background: Group sequential designs incorporating the option to stop for futility at the time point of an interim analysis can save time and resources. Thereby, the choice of the futility boundary importantly impacts the design's resulting performance characteristics, including the power and probability to correctly or wrongly stop for futility. Several authors contributed to the topic of selecting good futility boundaries. For binary endpoints, Simon's designs (Control Clin Trials 10:1-10, 1989) are commonly used two-stage designs for single-arm phase II studies incorporating futility stopping. However, Simon's optimal design frequently yields an undesirably high probability of falsely declaring futility after the first stage, and in Simon's minimax design often a high proportion of the planned sample size is already evaluated at the interim analysis leaving only limited benefit in case of an early stop.
    Methods: This work focuses on the optimality criteria introduced by Schüler et al. (BMC Med Res Methodol 17:119, 2017) and extends their approach to binary endpoints in single-arm phase II studies. An algorithm for deriving optimized futility boundaries is introduced, and the performance of study designs implementing this concept of optimal futility boundaries is compared to the common Simon's minimax and optimal designs, as well as modified versions of these designs by Kim et al. (Oncotarget 10:4255-61, 2019).
    Results: The introduced optimized futility boundaries aim to maximize the probability of correctly stopping for futility in case of small or opposite effects while also setting constraints on the time point of the interim analysis, the power loss, and the probability of stopping the study wrongly, i.e. stopping the study even though the treatment effect shows promise. Overall, the operating characteristics, such as maximum sample size and expected sample size, are comparable to those of the classical and modified Simon's designs and sometimes better. Unlike Simon's designs, which have binding stopping rules, the optimized futility boundaries proposed here are not adjusted to exhaust the full targeted nominal significance level and are thus still valid for non-binding applications.
    Conclusions: The choice of the futility boundary and the time point of the interim analysis have a major impact on the properties of the study design. Therefore, they should be thoroughly investigated at the planning stage. The introduced method of selecting optimal futility boundaries provides a more flexible alternative to Simon's designs with non-binding stopping rules. The probability of wrongly stopping for futility is minimized and the optimized futility boundaries don't exhibit the unfavorable properties of an undesirably high probability of falsely declaring futility or a high proportion of the planned sample evaluated at the interim time point.
    Mesh-Begriff(e) Humans ; Medical Futility ; Research Design ; Sample Size ; Probability ; Algorithms
    Sprache Englisch
    Erscheinungsdatum 2024-03-28
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-024-02190-w
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  6. Artikel ; Online: 65th Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN: German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS) including the 66th Biometric Colloquium of the German Region

    Rauch, Geraldine

    GMS Medizinische Informatik, Biometrie und Epidemiologie

    2020  Band 16, Heft 2, Seite(n) 8

    Titelübersetzung 65. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), Treffen des Central European Network (CEN: Regionen Deutschland, Österreich, Schweiz, Polen) der Internationalen Biometrischen Gesellschaft (IBS) einschließlich des 66. Biometrischen Kolloquiums der Deutschen Region
    Schlagwörter Medizin, Gesundheit
    Erscheinungsdatum 2020-09-18
    Verlag German Medical Science GMS Publishing House; Düsseldorf
    Dokumenttyp Artikel ; Online
    ISSN 1860-9171
    ISSN (online) 1860-9171
    DOI 10.3205/mibe000211
    Datenquelle German Medical Science

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  7. Artikel ; Online: 65 Annual Meeting of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS), Meeting of the Central European Network (CEN

    Rauch, Geraldine

    GMS Medizinische Informatik, Biometrie und Epidemiologie, Vol 16, Iss 2, p Doc

    German Region, Austro-Swiss Region and Polish Region) of the International Biometric Society (IBS) including the 66 Biometric Colloquium of the German Region

    2020  Band 08

    Schlagwörter Computer applications to medicine. Medical informatics ; R858-859.7 ; Infectious and parasitic diseases ; RC109-216
    Sprache Deutsch
    Erscheinungsdatum 2020-09-01T00:00:00Z
    Verlag German Medical Science GMS Publishing House
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  8. Artikel ; Online: Weighted composite time to event endpoints with recurrent events: comparison of three analytical approaches.

    Ozga, Ann-Kathrin / Rauch, Geraldine

    BMC medical research methodology

    2022  Band 22, Heft 1, Seite(n) 38

    Abstract: Background: In clinical trials the study interest often lies in the comparison of a treatment to a control regarding a time to event endpoint. A composite endpoint allows to consider several time to event endpoints at once. Usually, only the time to the ...

    Abstract Background: In clinical trials the study interest often lies in the comparison of a treatment to a control regarding a time to event endpoint. A composite endpoint allows to consider several time to event endpoints at once. Usually, only the time to the first occurring event for a patient is thereby analyzed. However, an individual may experience more than one non-fatal event. Including all observed events in the analysis can increase the power and provides a more complete picture of the disease. Thus, analytical methods for recurrent events are required. A challenge is that the different event types belonging to the composite often are of different clinical relevance. In this case, weighting the event types according to their clinical relevance is an option. Different weight-based methods for composite time to event endpoints were proposed. So far, there exists no systematic comparison of these methods.
    Methods: Within this work we provide a systematic comparison of three methods proposed for weighted composite endpoints in a recurrent event setting combining non-fatal and fatal events of different clinical relevance. We consider an extension of an approach proposed by Wei and Lachin, an approach by Rauch et al., and an approach by Bakal et al.. Comparison is done based on a simulation study and based on a clinical study example.
    Results: For all three approaches closed formula test statistics are available. The Wei-Lachin approach and the approach by Rauch et al. show similar results in mean squared error. For the approach by Wei and Lachin confidence intervals are provided. The approach by Bakal et al. is not related to a quantifiable estimand. The relevance weights of the different approaches work on different level, i.e. either on cause-specific hazard ratios or on event count.
    Conclusion: The provided comparison and simulations can help to guide applied researchers to choose an adequate method for the analysis of composite endpoints combining (recurrent) events of different clinical relevance. The approach by Wei and Lachin and Rauch et al. can be recommended in scenarios where the composite effect is time-independent. The approach by Bakal et al. should be applied carefully.
    Mesh-Begriff(e) Computer Simulation ; Eating ; Endpoint Determination/methods ; Humans ; Proportional Hazards Models ; Research Design
    Sprache Englisch
    Erscheinungsdatum 2022-02-05
    Erscheinungsland England
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-022-01511-1
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  9. Artikel ; Online: Extension of a conditional performance score for sample size recalculation rules to the setting of binary endpoints.

    Bokelmann, Björn / Rauch, Geraldine / Meis, Jan / Kieser, Meinhard / Herrmann, Carolin

    BMC medical research methodology

    2024  Band 24, Heft 1, Seite(n) 15

    Abstract: Background: Sample size calculation is a central aspect in planning of clinical trials. The sample size is calculated based on parameter assumptions, like the treatment effect and the endpoint's variance. A fundamental problem of this approach is that ... ...

    Abstract Background: Sample size calculation is a central aspect in planning of clinical trials. The sample size is calculated based on parameter assumptions, like the treatment effect and the endpoint's variance. A fundamental problem of this approach is that the true distribution parameters are not known before the trial. Hence, sample size calculation always contains a certain degree of uncertainty, leading to the risk of underpowering or oversizing a trial. One way to cope with this uncertainty are adaptive designs. Adaptive designs allow to adjust the sample size during an interim analysis. There is a large number of such recalculation rules to choose from. To guide the choice of a suitable adaptive design with sample size recalculation, previous literature suggests a conditional performance score for studies with a normally distributed endpoint. However, binary endpoints are also frequently applied in clinical trials and the application of the conditional performance score to binary endpoints is not yet investigated.
    Methods: We extend the theory of the conditional performance score to binary endpoints by suggesting a related one-dimensional score parametrization. We moreover perform a simulation study to evaluate the operational characteristics and to illustrate application.
    Results: We find that the score definition can be extended without modification to the case of binary endpoints. We represent the score results by a single distribution parameter, and therefore derive a single effect measure, which contains the difference in proportions [Formula: see text] between the intervention and the control group, as well as the endpoint proportion [Formula: see text] in the control group.
    Conclusions: This research extends the theory of the conditional performance score to binary endpoints and demonstrates its application in practice.
    Mesh-Begriff(e) Humans ; Sample Size ; Research Design ; Computer Simulation ; Control Groups
    Sprache Englisch
    Erscheinungsdatum 2024-01-19
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-024-02150-4
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  10. Artikel ; Online: Using short-term endpoints to improve interim decision making and trial duration in two-stage phase II trials with nested binary endpoints.

    Zocholl, Dario / Kunz, Cornelia U / Rauch, Geraldine

    Statistical methods in medical research

    2023  Band 32, Heft 9, Seite(n) 1749–1765

    Abstract: In oncology, phase II clinical trials are often planned as single-arm two-stage designs with a binary endpoint, for example, progression-free survival after 12 months, and the option to stop for futility after the first stage. Simon's two-stage design is ...

    Abstract In oncology, phase II clinical trials are often planned as single-arm two-stage designs with a binary endpoint, for example, progression-free survival after 12 months, and the option to stop for futility after the first stage. Simon's two-stage design is a very popular approach but depending on the follow-up time required to measure the patients' outcomes the trial may have to be paused undesirably long. To shorten this forced interruption, it was proposed to use a short-term endpoint for the interim decision, such as progression-free survival after 3 months. We show that if the assumptions for the short-term endpoint are misspecified, the decision-making in the interim can be misleading, resulting in a great loss of statistical power. For the setting of a binary endpoint with nested measurements, such as progression-free survival, we propose two approaches that utilize all available short-term and long-term assessments of the endpoint to guide the interim decision. One approach is based on conditional power and the other is based on Bayesian posterior predictive probability of success. In extensive simulations, we show that both methods perform similarly, when appropriately calibrated, and can greatly improve power compared to the existing approach in settings with slow patient recruitment. Software code to implement the methods is made publicly available.
    Mesh-Begriff(e) Humans ; Bayes Theorem ; Endpoint Determination/methods ; Research Design ; Probability ; Decision Making
    Sprache Englisch
    Erscheinungsdatum 2023-07-25
    Erscheinungsland England
    Dokumenttyp Clinical Trial, Phase II ; Journal Article
    ZDB-ID 1136948-6
    ISSN 1477-0334 ; 0962-2802
    ISSN (online) 1477-0334
    ISSN 0962-2802
    DOI 10.1177/09622802231188515
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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