Title
Composite endpoints in clinical trials
Date Issued
01 January 2008
Access level
metadata only access
Resource Type
review
Author(s)
Ferreira-González I.
Alonso-Coello P.
Solà I.
Pacheco-Huergo V.
Domingo-Salvany A.
Alonso J.
Permanyer-Miralda G.
Mayo Clinic
Publisher(s)
Ediciones Doyma, S.L.
Abstract
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 risk are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, number of events, or magnitude of treatment effect exist. In the following review we present a conceptual discussion about the rationale and interpretation of such variables. Also, a user's friendly guide to interpret the results of clinical trials based on composite endpoints is presented. We also present an empirical study that provides evidence of the use of misleading composite endpoints in cardiovascular clinical trials.
Start page
283
End page
290
Volume
61
Issue
3
Language
English
OCDE Knowledge area
Sistema cardiaco, Sistema cardiovascular Tecnología médica de laboratorio (análisis de muestras, tecnologías para el diagnóstico)
Scopus EID
2-s2.0-44449156429
PubMed ID
Source
Revista Espanola de Cardiologia
ISSN of the container
03008932
DOI of the container
10.1157/13116656
Sources of information: Directorio de Producción Científica Scopus