Literature DB >> 18361902

[Composite endpoints in clinical trials].

Ignacio Ferreira-González1, Pablo Alonso-Coello, Ivan Solà, Valeria Pacheco-Huergo, Antònia Domingo-Salvany, Jordi Alonso, Víctor Montori, Gaietà Permanyer-Miralda.   

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.

Mesh:

Year:  2008        PMID: 18361902

Source DB:  PubMed          Journal:  Rev Esp Cardiol        ISSN: 0300-8932            Impact factor:   4.753


  4 in total

1.  Time Course of Ischemic and Bleeding Burden in Elderly Patients With Acute Coronary Syndromes Randomized to Low-Dose Prasugrel or Clopidogrel.

Authors:  Gabriele Crimi; Nuccia Morici; Maurizio Ferrario; Luca A Ferri; Luigi Piatti; Daniele Grosseto; Michele Cacucci; Alessandro Mandurino Mirizzi; Anna Toso; Federico Piscione; Marco De Carlo; Luigi Raffaele Elia; Bruno Trimarco; Leonardo Bolognese; Francesco M Bovenzi; Giuseppe De Luca; Stefano Savonitto; Stefano De Servi
Journal:  J Am Heart Assoc       Date:  2019-01-22       Impact factor: 5.501

Review 2.  Outcome Reporting in Cardiac Surgery Trials: Systematic Review and Critical Appraisal.

Authors:  Michael Goldfarb; Laura Drudi; Mohammad Almohammadi; Yves Langlois; Nicolas Noiseux; Louis Perrault; Nicolo Piazza; Jonathan Afilalo
Journal:  J Am Heart Assoc       Date:  2015-08-17       Impact factor: 5.501

Review 3.  Importance of achieving the composite endpoints in diabetes.

Authors:  Ambika Gopalakrishnan Unnikrishnan; Arpandev Bhattacharyya; Manash Pratim Baruah; Binayak Sinha; Mala Dharmalingam; Paturi V Rao
Journal:  Indian J Endocrinol Metab       Date:  2013-09

Review 4.  Choosing primary endpoints for clinical trials of health care interventions.

Authors:  Charlie McLeod; Richard Norman; Edward Litton; Benjamin R Saville; Steve Webb; Thomas L Snelling
Journal:  Contemp Clin Trials Commun       Date:  2019-11-12
  4 in total

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