文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

调整肿瘤学试验中的治疗转换:系统评价和报告建议。

Adjusting for Treatment Switching in Oncology Trials: A Systematic Review and Recommendations for Reporting.

机构信息

SAHMRI Women & Kids, South Australian Health & Medical Research Institute, Adelaide, Australia; School of Public Health, The University of Adelaide, Adelaide, Australia.

School of Health and Related Research, The University of Sheffield, Sheffield, England, UK.

出版信息

Value Health. 2020 Mar;23(3):388-396. doi: 10.1016/j.jval.2019.10.015. Epub 2020 Jan 23.


DOI:10.1016/j.jval.2019.10.015
PMID:32197735
Abstract

OBJECTIVES: To systematically review the quality of reporting on the application of switching adjustment approaches in published oncology trials and industry submissions to the National Institute for Health and Care Excellence Although methods such as the rank preserving structural failure time model (RPSFTM) and inverse probability of censoring weights (IPCW) have been developed to address treatment switching, the approaches are not widely accepted within health technology assessment. This limited acceptance may partly be a consequence of poor reporting on their application. METHODS: Published trials and industry submissions were obtained from searches of PubMed and nice.org.uk, respectively. The quality of reporting in these studies was judged against a checklist of reporting recommendations, which was developed by the authors based on detailed considerations of the methods. RESULTS: Thirteen published trials and 8 submissions to nice.org.uk satisfied inclusion criteria. The quality of reporting around the implementation of the RPSFTM and IPCW methods was generally poor. Few studies stated whether the adjustment approach was prespecified, more than a third failed to provide any justification for the chosen method, and nearly half neglected to perform sensitivity analyses. Further, it was often unclear how the RPSFTM and IPCW methods were implemented. CONCLUSIONS: Inadequate reporting on the application of switching adjustment methods increases uncertainty around results, which may contribute to the limited acceptance of these methods by decision makers. The proposed reporting recommendations aim to support the improved interpretation of analyses undertaken to adjust for treatment switching.

摘要

目的:系统评价发表的肿瘤学试验和向英国国家卫生与保健优化研究所(National Institute for Health and Care Excellence,NICE)提交的行业报告中关于转换调整方法应用的报告质量。尽管已经开发了秩保持结构失效时间模型(rank preserving structural failure time model,RPSFTM)和逆概率 censoring 权重(inverse probability of censoring weights,IPCW)等方法来解决治疗转换问题,但这些方法在卫生技术评估中并未得到广泛接受。这种有限的接受度可能部分是由于其应用报告不佳所致。

方法:通过在 PubMed 和 nice.org.uk 上搜索,分别获得了已发表的试验和行业提交的材料。根据作者对这些方法的详细考虑,制定了一份报告建议清单,用于评估这些研究的报告质量。

结果:13 项已发表的试验和 8 项向 nice.org.uk 提交的材料符合纳入标准。RPSFTM 和 IPCW 方法实施情况的报告质量普遍较差。很少有研究表明调整方法是否是预先指定的,超过三分之一的研究没有为选择的方法提供任何理由,近一半的研究忽略了进行敏感性分析。此外,RPSFTM 和 IPCW 方法的实施方式往往不明确。

结论:对转换调整方法应用的报告不足增加了结果的不确定性,这可能是决策者对这些方法接受度有限的原因之一。所提出的报告建议旨在支持对调整治疗转换的分析进行更准确的解释。

相似文献

[1]
Adjusting for Treatment Switching in Oncology Trials: A Systematic Review and Recommendations for Reporting.

Value Health. 2020-1-23

[2]
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.

Cochrane Database Syst Rev. 2022-2-1

[3]
Adjusting survival time estimates to account for treatment switching in randomized controlled trials--an economic evaluation context: methods, limitations, and recommendations.

Med Decis Making. 2014-1-21

[4]
A cautionary tale: an evaluation of the performance of treatment switching adjustment methods in a real world case study.

BMC Med Res Methodol. 2024-1-22

[5]
Improved two-stage estimation to adjust for treatment switching in randomised trials: g-estimation to address time-dependent confounding.

Stat Methods Med Res. 2020-10

[6]
Two-stage estimation to adjust for treatment switching in randomised trials: a simulation study investigating the use of inverse probability weighting instead of re-censoring.

BMC Med Res Methodol. 2019-3-29

[7]
The future of Cochrane Neonatal.

Early Hum Dev. 2020-11

[8]
Impact of Nonrandomized Dropout on Treatment Switching Adjustment in the Relapsing-Remitting Multiple Sclerosis CLARITY Trial and the CLARITY Extension Study.

Value Health. 2019-5-17

[9]
Causal inference for long-term survival in randomised trials with treatment switching: Should re-censoring be applied when estimating counterfactual survival times?

Stat Methods Med Res. 2018-6-25

[10]
A rapid and systematic review of the clinical effectiveness and cost-effectiveness of topotecan for ovarian cancer.

Health Technol Assess. 2001

引用本文的文献

[1]
Further Practical Guidance on Adjusting Time-To-Event Outcomes for Treatment Switching.

Pharm Stat. 2025

[2]
[A comparative study of different methods for treatment switching analysis in clinical trials].

Nan Fang Yi Ke Da Xue Xue Bao. 2025-5-20

[3]
Addressing treatment switching in the ALTA-1L trial with g-methods: exploring the impact of model specification.

BMC Med Res Methodol. 2024-12-20

[4]
Exploring the characteristics, methods and reporting of systematic reviews with meta-analyses of time-to-event outcomes: a meta-epidemiological study.

BMC Med Res Methodol. 2024-11-25

[5]
Three new methodologies for calculating the effective sample size when performing population adjustment.

BMC Med Res Methodol. 2024-11-20

[6]
Lu-177 PSMA vs Comparator Treatments and Survival in Metastatic Castration-Resistant Prostate Cancer.

JAMA Netw Open. 2024-9-3

[7]
Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).

Trials. 2024-6-28

[8]
A Systematic Review of Modeling Approaches to Evaluate Treatments for Relapsed Refractory Multiple Myeloma: Critical Review and Considerations for Future Health Economic Models.

Pharmacoeconomics. 2024-9

[9]
A cautionary tale: an evaluation of the performance of treatment switching adjustment methods in a real world case study.

BMC Med Res Methodol. 2024-1-22

[10]
Comparative analysis of disease modelling for health economic evaluations of systemic therapies in advanced hepatocellular carcinoma.

PLoS One. 2023

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索