دورية أكاديمية
أعرض في EDS

Methods for non-proportional hazards in clinical trials: A systematic review.

التفاصيل البيبلوغرافية
العنوان: Methods for non-proportional hazards in clinical trials: A systematic review.
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.
References: Stat Methods Med Res. 2018 Mar;27(3):765-784. (PMID: 27114326)
Biometrics. 2023 Mar;79(1):203-215. (PMID: 34608996)
Biostatistics. 2000 Dec;1(4):423-39. (PMID: 12933565)
Lifetime Data Anal. 2015 Apr;21(2):259-79. (PMID: 25073864)
Trials. 2020 Apr 6;21(1):315. (PMID: 32252820)
J Am Coll Cardiol. 2019 Oct 22;74(16):2102-2112. (PMID: 31623769)
Pharm Stat. 2021 Jan;20(1):129-145. (PMID: 32830428)
BMC Med Res Methodol. 2019 May 16;19(1):103. (PMID: 31096924)
Stat Methods Med Res. 2020 Oct;29(10):2830-2850. (PMID: 32183613)
Lifetime Data Anal. 2013 Jan;19(1):100-16. (PMID: 23104317)
BMC Med Res Methodol. 2012 Feb 01;12:9. (PMID: 22297116)
Epidemiology. 2010 Jan;21(1):13-5. (PMID: 20010207)
Stat Med. 2009 Aug 30;28(19):2473-89. (PMID: 19472308)
Methods Inf Med. 2018 May;57(3):89-100. (PMID: 29719915)
BMJ. 2017 May 25;357:j2250. (PMID: 28546261)
Crit Rev Oncol Hematol. 2021 Jun;162:103350. (PMID: 33989767)
Science. 2018 Mar 2;359(6379):. (PMID: 29496846)
Contemp Clin Trials. 2023 May;128:107165. (PMID: 36972865)
BMC Med Res Methodol. 2022 Jan 30;22(1):34. (PMID: 35094686)
PLoS Med. 2021 Mar 29;18(3):e1003583. (PMID: 33780438)
N Engl J Med. 2015 Oct 22;373(17):1627-39. (PMID: 26412456)
Biometrics. 2010 Mar;66(1):30-8. (PMID: 19397582)
Biometrics. 2002 Jun;58(2):305-15. (PMID: 12071403)
Stat Med. 2007 Jun 15;26(13):2666-85. (PMID: 17072918)
PLoS One. 2015 Jan 23;10(1):e0116774. (PMID: 25615624)
Stat Med. 2019 Feb 20;38(4):530-544. (PMID: 29671899)
Bioinformatics. 2010 Mar 15;26(6):784-90. (PMID: 20118118)
J Clin Oncol. 2014 Aug 1;32(22):2380-5. (PMID: 24982461)
Lifetime Data Anal. 2020 Oct;26(4):833-855. (PMID: 32654089)
JAMA Oncol. 2022 Sep 1;8(9):1294-1300. (PMID: 35862037)
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
الوصف
تدمد:1477-0334
DOI:10.1177/09622802241242325