Composite endpoints in clinical trials

被引：0
作者：
Ferreira-Gonzalez, Ignacio [1 ]
Alonso-Coello, Pablo [2 ]
Sola, Ivan [2 ]
Pacheco-Huergo, Valeria [3 ]
Domingo-Salvany, Antonia [4 ]
Alonso, Jordi [4 ]
Montori, Victor [5 ]
Permanyer-Miralda, Gaieta [1 ]
机构：
[1] Hosp Gen Valle Hebron, Epidemiol Unit, Serv Cardiol, E-08035 Barcelona, Spain
[2] Univ Autonoma Barcelona, Hosp St Pau, Serv Epidemiol Clin & Salud Publ, Ctr Cochrane Iberoamer, E-08193 Barcelona, Spain
[3] Ctr Atenc Primaria Turo, Barcelona, Spain
[4] IMIM Hosp Mar, Unit Rec Serv Sanitaris, Barcelona, Spain
[5] Mayo Clin, Coll Med, Dept Med, Knowledge & Encounter Res Unit, Rochester, MN USA
来源：
REVISTA ESPANOLA DE CARDIOLOGIA | 2008年 / 61卷 / 03期
关键词：
clinical trials; composite endpoints; heterogeneity;
D O I：
暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
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.
引用
收藏
页码：283 / 290
页数：8
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