دورية أكاديمية
Methods for non-proportional hazards in clinical trials: A systematic review.
العنوان: | Methods for non-proportional hazards in clinical trials: A systematic review. |
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المؤلفون: | Bardo M; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Maximilian Bardo and Cynthia Huber contributed equally to this study., Huber C; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Maximilian Bardo and Cynthia Huber contributed equally to this study., Benda N; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Brugger J; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Fellinger T; Agentur für Gesundheit und Ernährungssicherheit (AGES), Vienna, Austria., Galaune V; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Heinz J; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany., Heinzl H; Center for Medical Data Science, Section of Clinical Biometrics, Medical University of Vienna, Vienna, Austria., Hooker AC; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Klinglmüller F; Agentur für Gesundheit und Ernährungssicherheit (AGES), Vienna, Austria., König F; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Mathes T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany., Mittlböck M; Center for Medical Data Science, Section of Clinical Biometrics, Medical University of Vienna, Vienna, Austria., Posch M; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Ristl R; Center for Medical Data Science, Section of Medical Statistics, Medical University of Vienna, Vienna, Austria., Friede T; Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany. |
المصدر: | Statistical methods in medical research [Stat Methods Med Res] 2024 Jun; Vol. 33 (6), pp. 1069-1092. Date of Electronic Publication: 2024 Apr 09. |
نوع المنشور: | Journal Article; Systematic Review; Review |
اللغة: | English |
بيانات الدورية: | Publisher: SAGE Publications Country of Publication: England NLM ID: 9212457 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-0334 (Electronic) Linking ISSN: 09622802 NLM ISO Abbreviation: Stat Methods Med Res Subsets: MEDLINE |
أسماء مطبوعة: | Publication: London : SAGE Publications Original Publication: Sevenoaks, Kent, UK : Edward Arnold, c1992- |
مواضيع طبية MeSH: | Proportional Hazards Models* , Clinical Trials as Topic*/statistics & numerical data, Humans ; Sample Size ; Software |
مستخلص: | For the analysis of time-to-event data, frequently used methods such as the log-rank test or the Cox proportional hazards model are based on the proportional hazards assumption, which is often debatable. Although a wide range of parametric and non-parametric methods for non-proportional hazards has been proposed, there is no consensus on the best approaches. To close this gap, we conducted a systematic literature search to identify statistical methods and software appropriate under non-proportional hazard. Our literature search identified 907 abstracts, out of which we included 211 articles, mostly methodological ones. Review articles and applications were less frequently identified. The articles discuss effect measures, effect estimation and regression approaches, hypothesis tests, and sample size calculation approaches, which are often tailored to specific non-proportional hazard situations. Using a unified notation, we provide an overview of methods available. Furthermore, we derive some guidance from the identified articles. Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. |
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فهرسة مساهمة: | Keywords: Cox model; log-rank test; non-proportional hazards; right-censored observations; survival analysis |
تواريخ الأحداث: | Date Created: 20240409 Date Completed: 20240607 Latest Revision: 20240611 |
رمز التحديث: | 20240612 |
مُعرف محوري في PubMed: | PMC11162097 |
DOI: | 10.1177/09622802241242325 |
PMID: | 38592333 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1477-0334 |
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DOI: | 10.1177/09622802241242325 |