Statistical considerations when using a composite endpoint for comparing treatment groups

When comparing two treatment groups in a time‐to‐event analysis, it is common to use a composite event consisting of two or more distinct outcomes. The goal of this paper is to develop a statistical methodology to derive efficiency guidelines for deciding whether to expand a study primary endpoint f...

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Bibliographic Details
Published in:Statistics in medicine 2013-02, Vol.32 (5), p.719-738
Main Authors: Gómez, Guadalupe, Lagakos, Stephen W.
Format: Article
Language:English
Subjects:
Acute Coronary Syndrome - complications
Acute Coronary Syndrome - drug therapy
Acute Coronary Syndrome - mortality
AIDS Vaccines - administration & dosage
Anti-HIV Agents - administration & dosage
Anticholesteremic Agents - therapeutic use
Asymptotic methods
asymptotic relative efficiency
Biostatistics - methods
Clinical outcomes
clinical trials
combined outcomes
composite endpoints
Endpoint Determination - statistics & numerical data
Estadística aplicada
Heart attacks
HIV Infections - drug therapy
HIV Infections - immunology
Humans
log-rank test
Matemàtiques i estadística
Medicina
Medicine
Probucol - analogs & derivatives
Probucol - therapeutic use
Randomized Controlled Trials as Topic - statistics & numerical data
Statistics
Àrees temàtiques de la UPC
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Items that cite this one
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Summary:When comparing two treatment groups in a time‐to‐event analysis, it is common to use a composite event consisting of two or more distinct outcomes. The goal of this paper is to develop a statistical methodology to derive efficiency guidelines for deciding whether to expand a study primary endpoint from E1 (for example, non‐fatal myocardial infarction and cardiovascular death) to the composite of E1 and E2 (for example, non‐fatal myocardial infarction, cardiovascular death or revascularisation). We investigate this problem by considering the asymptotic relative efficiency of a log‐rank test for comparing treatment groups with respect to a primary relevant endpoint E1 versus the composite primary endpoint, say E蜧, of E1 and E2, where E2 is some additional endpoint. Copyright © 2012 John Wiley & Sons, Ltd.
ISSN:0277-6715
1097-0258
DOI:10.1002/sim.5547