卒中研究中的非劣效性试验：它们是什么，我们应该如何解释它们？

IF 6 1区医学 Q1 CLINICAL NEUROLOGY

Journal of Stroke Pub Date : 2025-01-01 Epub Date: 2025-01-31 DOI:10.5853/jos.2024.03923

Linxin Li, Vasileios-Arsenios Lioutas, Ralph K Akyea, Stefan Gerner, Kui Kai Lau, Emily Ramage, Aristeidis H Katsanos, George Howard, Philip M Bath

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引用次数: 0

摘要

随着越来越多的新设计概念出现，随机临床试验在临床和学术中风社区都很重要。在过去十年中获得越来越多兴趣的“不太传统”设计之一是非劣效性试验。虽然这个概念可能看起来很简单，但非劣效性试验的设计和解释可能具有挑战性。在这篇综述中，我们将使用脑卒中领域临床试验的例子来概述非劣效性试验的优势和局限性，以及如何在脑卒中研究中解释它们。

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Non-Inferiority Trials in Stroke Research: What Are They, and How Should We Interpret Them?

Randomized clinical trials are important in both clinical and academic stroke communities with increasing numbers of new design concepts emerging. One of the "less traditional" designs that have gained increasing interest in the last decade is non-inferiority trials. Whilst the concept might appear straightforward, the design and interpretation of non-inferiority trials can be challenging. In this review, we will use exemplars from clinical trials in the stroke field to provide an overview of the advantages and limitations of non-inferiority trials and how they should be interpreted in stroke research.

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来源期刊

Journal of Stroke CLINICAL NEUROLOGYPERIPHERAL VASCULAR DISE-PERIPHERAL VASCULAR DISEASE

CiteScore

11.00

自引率

3.70%

发文量

审稿时长

12 weeks

期刊介绍： The Journal of Stroke (JoS) is a peer-reviewed publication that focuses on clinical and basic investigation of cerebral circulation and associated diseases in stroke-related fields. Its aim is to enhance patient management, education, clinical or experimental research, and professionalism. The journal covers various areas of stroke research, including pathophysiology, risk factors, symptomatology, imaging, treatment, and rehabilitation. Basic science research is included when it provides clinically relevant information. The JoS is particularly interested in studies that highlight characteristics of stroke in the Asian population, as they are underrepresented in the literature. The JoS had an impact factor of 8.2 in 2022 and aims to provide high-quality research papers to readers while maintaining a strong reputation. It is published three times a year, on the last day of January, May, and September. The online version of the journal is considered the main version as it includes all available content. Supplementary issues are occasionally published. The journal is indexed in various databases, including SCI(E), Pubmed, PubMed Central, Scopus, KoreaMed, Komci, Synapse, Science Central, Google Scholar, and DOI/Crossref. It is also the official journal of the Korean Stroke Society since 1999, with the abbreviated title J Stroke.