منابع مشابه
Multiple Analyses and Composite Endpoints
In this chapter, we continue our discussion of the combined endpoint in clinical trials. Examples of the use of combined endpoints are provided, and illustrations of both exemplary and somewhat questionable incorporations of these complex entities within clinical trials are provided. Finally, we focus on the uses of the two tools 1) unequal allocation of type I error and 2) measures of dependen...
متن کاملComposite Endpoints in Clinical Trials
Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risks are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, n...
متن کاملMultiplicity adjustment for composite binary endpoints.
BACKGROUND Binary composite outcome measures are increasingly used as primary endpoints in clinical trials. Composite endpoints combine several events of interest within a single variable. However, as the effect observed for the composite does not necessarily reflect the effects for the individual components, it is recommended in the literature to additionally evaluate each component separately...
متن کاملCombining composite endpoints: counterintuitive or a mathematical impossibility?
or a Mathematical Impossibility? To the Editor: In their excellent article, DeMets and Califf1 discuss composite endpoints. I would appreciate their further thoughts. When the use of a treatment “X” reduces the composite endpoint of death, non-fatal myocardial infarction, and a softer endpoint such as revascularization or hospitalization rates, we are led to the illusion that all 3 endpoints ar...
متن کاملBehaviour of the Hazard ratio in Composite endpoints
The assessment of treatment efficacy in time-to-event confirmatory clinical trials is commonlybased on the hazard ratio (HR) of the primary endpoint. When designing a study, the propor-tionality of the hazard ratios to determine sample size is usually assumed. However, when theprimary endpoint consists of a combination of several components, i.e. a composite endpointE∗, the haza...
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ژورنال
عنوان ژورنال: Journal of Clinical Epidemiology
سال: 2020
ISSN: 0895-4356
DOI: 10.1016/j.jclinepi.2020.07.017