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The use of a binary composite endpoint and sample size requirement: influence of endpoints overlap

Author
Ramon, J.; Ferreira González, I.; Bertrán, S.; Ribera, A.; Permanyer-Miralda, G.; Garcia-Dorado, D.; Gómez Melis, Guadalupe
Type of activity
Journal article
Journal
American journal of epidemiology
Date of publication
2017-04-10
Volume
185
Number
9
First page
832
Last page
841
DOI
https://doi.org/10.1093/aje/kww105 Open in new window
Repository
http://hdl.handle.net/2117/110928 Open in new window
URL
https://academic.oup.com/aje/article-abstract/doi/10.1093/aje/kww105/3573392/The-Use-of-a-Binary-Composite-Endpoint-and-Sample?redirectedFrom=fulltext Open in new window
Abstract
Although composite endpoints (CE) are common in clinical trials, the impact of the relationship between the components of a binary CE on the sample size requirement (SSR) has not been addressed. We performed a computational study considering 2 treatments and a CE with 2 components: the relevant endpoint (RE) and the additional endpoint (AE). We assessed the strength of the components’ interrelation by the degree of relative overlap between them, which was stratified into 5 groups. Within each ...
Citation
Ramon, J., Ferreira González, I., Bertrán, S., Ribera, A., Permanyer-Miralda, G., Garcia-Dorado, D., Gomez, G. The use of a binary composite endpoint and sample size requirement: influence of endpoints overlap. "American journal of epidemiology", 10 Abril 2017, vol. 185, núm. 9, p. 832-841.
Keywords
association measures, binary endpoints, composite endpoint, correlated endpoints, outcome assessment, sample size
Group of research
GRBIO - Biostatistics and Bioinformatics Research Group

Participants

  • Ramon Marsal, Josep  (author)
  • Ferreira González, Ignacio  (author)
  • Bertrán, Sandra  (author)
  • Ribera, Aida  (author)
  • Permanyer-Miralda, Gaietà  (author)
  • Garcia Dorado, Antonio David  (author)
  • Gomez Melis, Guadalupe  (author)

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