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Uses and Limitations of the Restricted Mean Survival Time: Illustrative Examples From Cardiovascular Outcomes and Mortality Trials in Type 2 Diabetes.
Annals of Internal Medicine ( IF 39.2 ) Pub Date : 2020-03-24 , DOI: 10.7326/m19-3286
David E Kloecker 1 , Melanie J Davies 2 , Kamlesh Khunti 1 , Francesco Zaccardi 1
Affiliation  

The restricted mean survival time (RMST) has been advocated as an alternative or a supplement to the hazard ratio for reporting the effect of an intervention in a randomized clinical trial. The RMST difference allows quantification of the postponement of an outcome during a specified (restricted) interval and corresponds to the difference between the areas under the 2 survival curves for the intervention and control groups. This article presents examples of the use of the RMST in a research and a clinical context. First, the authors demonstrate how the RMST difference can answer research questions about the efficacy of different treatments. Estimates are presented for the effects of pharmacologic or strategy-driven glucose-lowering interventions for adults with type 2 diabetes from 36 trials and 9 follow-up studies reporting cardiovascular outcomes and mortality. The authors show how these measures may be used to mitigate uncertainty about the efficacy of intensive glucose control. Second, the authors demonstrate how the RMST difference may be used in the setting of a clinical consultation to guide the decision to start or discontinue a treatment. They then discuss the advantages of the RMST over the absolute risk difference, the number needed to treat, and the median survival time difference. They argue that the RMST difference is both easy to interpret and flexible in its application to different settings. Finally, they highlight the major limitations of the RMST, including difficulties in comparing studies of heterogeneous designs and in inferring the long-term effects of treatments using trials of short duration, and summarize the available statistical software for calculating the RMST.

中文翻译:

受限平均生存时间的使用和限制:来自2型糖尿病的心血管结果和死亡率试验的示例。

在随机临床试验中,已报道限制平均生存时间(RMST)是危险比的替代品或补充品,用于报告干预措施的效果。RMST差异允许量化指定(受限)间隔内结果的延迟,并且对应于干预组和对照组的2条生存曲线下的面积之间的差异。本文介绍了在研究和临床环境中使用RMST的示例。首先,作者证明了RMST差异如何回答有关不同疗法功效的研究问题。根据36项试验和9项跟踪研究报告了心血管结局和死亡率,对2型糖尿病成年人进行药理或策略驱动的降糖干预措施的效果进行了估算。作者展示了如何使用这些措施来减轻关于强化血糖控制功效的不确定性。其次,作者演示了如何在临床会诊中使用RMST差异来指导开始或终止治疗的决定。然后,他们讨论了RMST相对于绝对风险差异,需要治疗的数目以及中位生存时间差异的优势。他们认为,RMST差异既易于解释,又可以灵活地应用于不同的环境。最后,它们突出了RMST的主要局限性,
更新日期:2020-03-24
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