当比例风险假设不成立时，累积模式和随访持续时间如何影响危害比的估计？
How Do the Accrual Pattern and Follow-Up Duration Affect the Hazard Ratio Estimate When the Proportional Hazards Assumption Is Violated?
机构信息
Department of Clinical Medicine (Biostatistics), Kitasato University Graduate School of Pharmaceutical Sciences, Tokyo, Japan.
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
出版信息
Oncologist. 2019 Jul;24(7):867-871. doi: 10.1634/theoncologist.2018-0141. Epub 2018 Sep 10.
Abstract
In randomized clinical trials, the magnitude of the treatment effect is often reported using the hazard ratio (HR) even when the proportional hazards (PH) assumption is not met. Conducting numerical studies, this commentary illustrates how/why the HR estimate via the standard Cox's procedure is difficult to interpret even as an “average” treatment effect for non‐PH cases.
摘要
在随机临床试验中，即使不符合比例风险（PH）假设，也常使用风险比（HR）来报告治疗效果的大小。通过数值研究，本评论说明了即使对于非 PH 情况，标准 Cox 程序的 HR 估计值作为“平均”治疗效果也很难解释。
相似文献
1
How Do the Accrual Pattern and Follow-Up Duration Affect the Hazard Ratio Estimate When the Proportional Hazards Assumption Is Violated?当比例风险假设不成立时，累积模式和随访持续时间如何影响危害比的估计？
Oncologist. 2019 Jul;24(7):867-871. doi: 10.1634/theoncologist.2018-0141. Epub 2018 Sep 10.
2
The Average Hazard Ratio - A Good Effect Measure for Time-to-event Endpoints when the Proportional Hazard Assumption is Violated?平均风险比——当比例风险假设不成立时，用于事件发生时间终点的良好效应量度？
Methods Inf Med. 2018 May;57(3):89-100. doi: 10.3414/ME17-01-0058. Epub 2018 May 2.
3
Utilizing the integrated difference of two survival functions to quantify the treatment contrast for designing, monitoring, and analyzing a comparative clinical study.利用两个生存函数的综合差异来量化治疗对比，以用于设计、监测和分析比较性临床研究。
Clin Trials. 2012 Oct;9(5):570-7. doi: 10.1177/1740774512455464. Epub 2012 Aug 22.
4
A new modeling and inference approach for the Systolic Blood Pressure Intervention Trial outcomes.一种用于收缩压干预试验结果的新型建模与推理方法。
Clin Trials. 2018 Jun;15(3):305-312. doi: 10.1177/1740774518769865. Epub 2018 Apr 19.
5
An empirical comparison of statistical tests for assessing the proportional hazards assumption of Cox's model.评估Cox模型比例风险假设的统计检验的实证比较。
Stat Med. 1997 Mar 30;16(6):611-26. doi: 10.1002/(sici)1097-0258(19970330)16:6<611::aid-sim437>3.0.co;2-t.
6
Analysis of time to event outcomes in randomized controlled trials by generalized additive models.通过广义相加模型分析随机对照试验中的事件发生时间结局
PLoS One. 2015 Apr 23;10(4):e0123784. doi: 10.1371/journal.pone.0123784. eCollection 2015.
7
Ratio and difference of average hazard with survival weight: New measures to quantify survival benefit of new therapy.平均风险与生存权重的比值和差值：量化新疗法生存获益的新指标。
Stat Med. 2023 Mar 30;42(7):936-952. doi: 10.1002/sim.9651. Epub 2023 Jan 5.
8
Cancer Biology and Survival Analysis in Cancer Trials: Restricted Mean Survival Time Analysis versus Hazard Ratios.癌症生物学与癌症试验中的生存分析：限制平均生存时间分析与风险比。
Clin Oncol (R Coll Radiol). 2018 Sep;30(9):e75-e80. doi: 10.1016/j.clon.2018.04.011.
9
Testing the proportional hazards assumption in cox regression and dealing with possible non-proportionality in total joint arthroplasty research: methodological perspectives and review.检验 Cox 回归中比例风险假设及处理全关节置换研究中潜在的非比例性：方法学视角与综述。
BMC Musculoskelet Disord. 2021 May 28;22(1):489. doi: 10.1186/s12891-021-04379-2.
10
Augmenting the logrank test in the design of clinical trials in which non-proportional hazards of the treatment effect may be anticipated.在可能预期治疗效果存在非比例风险的临床试验设计中增强对数秩检验。
BMC Med Res Methodol. 2016 Feb 11;16:16. doi: 10.1186/s12874-016-0110-x.
引用本文的文献
1
Comparison between asymptotic and re-randomisation tests under non-proportional hazards in a randomised controlled trial using the minimisation method.最小化法在非比例风险随机对照试验中渐近检验和再随机检验的比较。
BMC Med Res Methodol. 2024 Jul 30;24(1):166. doi: 10.1186/s12874-024-02295-2.
2
Biomarkers in Oncology: Complexities in Biomarker-Driven Studies and Statistical Analysis.肿瘤标志物：生物标志物驱动研究和统计分析中的复杂性。
JCO Precis Oncol. 2024 Jul;8:e2400358. doi: 10.1200/PO.24.00358.
3
Regression models for average hazard.平均风险的回归模型。
Biometrics. 2024 Mar 27;80(2). doi: 10.1093/biomtc/ujae037.
4
Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails.生存曲线具有发散尾部时受限平均生存时间的敏感性分析
Ther Innov Regul Sci. 2023 May;57(3):467-471. doi: 10.1007/s43441-022-00484-z. Epub 2023 Jan 3.
5
Analysis of survival data with nonproportional hazards: A comparison of propensity-score-weighted methods.非比例风险生存数据分析：倾向评分加权法的比较。
Biom J. 2024 Jan;66(1):e202200099. doi: 10.1002/bimj.202200099. Epub 2022 Dec 21.
6
Challenges of modelling approaches for network meta-analysis of time-to-event outcomes in the presence of non-proportional hazards to aid decision making: Application to a melanoma network.存在非比例风险时用于事件发生时间结局的网络荟萃分析的建模方法在辅助决策方面面临的挑战：应用于黑色素瘤网络。
Stat Methods Med Res. 2022 May;31(5):839-861. doi: 10.1177/09622802211070253. Epub 2022 Jan 19.
7
Impact of limited sample size and follow-up on single event survival extrapolation for health technology assessment: a simulation study.有限样本量和随访对单事件生存外推在健康技术评估中的影响：一项模拟研究。
BMC Med Res Methodol. 2021 Dec 18;21(1):282. doi: 10.1186/s12874-021-01468-7.
8
Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes.在具有事件发生时间结局的肿瘤生物类似药试验中评估临床等效性。
JNCI Cancer Spectr. 2019 Aug 1;3(4):pkz058. doi: 10.1093/jncics/pkz058. eCollection 2019 Dec.
9
Statistical Test/Estimation Methods Used in Contemporary Phase III Cancer Randomized Controlled Trials with Time-to-Event Outcomes.当代癌症 III 期随机对照试验中具有时间事件结局的统计检验/估计方法。
Oncologist. 2020 Feb;25(2):91-93. doi: 10.1634/theoncologist.2019-0464. Epub 2019 Nov 19.
本文引用的文献
1
Efficiency of two sample tests via the restricted mean survival time for analyzing event time observations.通过受限平均生存时间进行两样本检验以分析事件时间观测值的效率
Biometrics. 2018 Jun;74(2):694-702. doi: 10.1111/biom.12770. Epub 2017 Sep 12.
2
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.纳武利尤单抗用于复发性头颈部鳞状细胞癌
N Engl J Med. 2016 Nov 10;375(19):1856-1867. doi: 10.1056/NEJMoa1602252. Epub 2016 Oct 8.
3
Restricted Mean Survival Time: An Obligatory End Point for Time-to-Event Analysis in Cancer Trials?受限平均生存时间：癌症试验中事件发生时间分析的必要终点？
J Clin Oncol. 2016 Oct 1;34(28):3474-6. doi: 10.1200/JCO.2016.67.8045. Epub 2016 Aug 9.
4
The Net Chance of a Longer Survival as a Patient-Oriented Measure of Treatment Benefit in Randomized Clinical Trials.作为随机临床试验中治疗效益的一种以患者为中心的衡量指标，净生存机会。
JAMA Oncol. 2016 Jul 1;2(7):901-5. doi: 10.1001/jamaoncol.2015.6359.
5
Describing Differences in Survival Curves.描述生存曲线的差异。
JAMA Oncol. 2016 Jul 1;2(7):906-7. doi: 10.1001/jamaoncol.2016.0001.
6
Comparison of Treatment Effects Measured by the Hazard Ratio and by the Ratio of Restricted Mean Survival Times in Oncology Randomized Controlled Trials.肿瘤学随机对照试验中风险比和受限平均生存时间比测量的治疗效果比较。
J Clin Oncol. 2016 May 20;34(15):1813-9. doi: 10.1200/JCO.2015.64.2488. Epub 2016 Feb 16.
7
Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.纳武利尤单抗对比多西他赛治疗晚期非鳞状非小细胞肺癌
N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
8
On the restricted mean survival time curve in survival analysis.生存分析中受限平均生存时间曲线的研究
Biometrics. 2016 Mar;72(1):215-21. doi: 10.1111/biom.12384. Epub 2015 Aug 24.
9
Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies.非劣效性研究中用于比较治疗效果或安全性的风险比替代方法。
Ann Intern Med. 2015 Jul 21;163(2):127-34. doi: 10.7326/M14-1741.
10
Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial.雷莫芦单抗联合紫杉醇对比安慰剂联合紫杉醇治疗既往治疗的晚期胃或胃食管结合部腺癌患者（RAINBOW）：一项双盲、随机、III 期临床试验。
Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.
Zotero 插件