TY - JOUR
T1 - Composite endpoints in clinical trials
AU - Ferreira-González, Ignacio
AU - Alonso-Coello, Pablo
AU - Solà, Ivan
AU - Pacheco-Huergo, Valeria
AU - Domingo-Salvany, Antònia
AU - Alonso, Jordi
AU - Montori, Víctor
AU - Permanyer-Miralda, Gaietà
PY - 2008/1/1
Y1 - 2008/1/1
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Composite endpoints
KW - Heterogeneity
U2 - 10.1157/13116656
DO - 10.1157/13116656
M3 - Review article
SN - 0300-8932
VL - 61
SP - 283
EP - 290
JO - Revista Espanola de Cardiologia
JF - Revista Espanola de Cardiologia
IS - 3
ER -