中止
临床试验
医学
重症监护医学
心理学
精神科
内科学
作者
Anurika De Silva,Kate Leslie,Sabine Braat,Anneke Grobler
出处
期刊:Anesthesiology
[Ovid Technologies (Wolters Kluwer)]
日期:2024-05-14
卷期号:141 (1): 13-23
标识
DOI:10.1097/aln.0000000000004966
摘要
SUMMARY Events occurring after randomization, such as use of rescue medication, treatment discontinuation, or death, are common in randomized trials. These events can change either the existence or interpretation of the outcome of interest. However, appropriate handling of these intercurrent events is often unclear. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9(R1) addendum introduced the estimand framework, which aligns trial objectives with the design, conduct, statistical analysis, and interpretation of results. This article describes how the estimand framework can be used in anesthesia trials to precisely define the treatment effect to be estimated, key attributes of an estimand, common intercurrent events in anesthesia trials with strategies for handling them, and use of the estimand framework in a hypothetical anesthesia trial on postoperative delirium. When planning anesthesia trials, clearly defining the estimand is vital to ensure that what is being estimated is clearly understood, is clinically relevant, and helps answer the clinical questions of interest.
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