Composite end-points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end-points in the primary outcome rather than having to select only one, composite end-points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However there are a number of important considerations when designing and interpreting clinical trials that utilize composite end-points. In this Statistical Primer, issues with composite end-points such as competing events, halo effect, risk of bias, time to event limitations and the win ratio are discussed in the context of real world clinical trials.

Composite endpoints and competing risks analysis [Statistical primer] / V. Dayan, S.W. Grant, J.M. Brophy, F. Barili, N. Freemantle. - In: INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY. - ISSN 2753-670X. - 39:1(2024 Jul 02), pp. ivae126.1-ivae126.6. [10.1093/icvts/ivae126]

Composite endpoints and competing risks analysis [Statistical primer]

F. Barili
Penultimo
;
2024

Abstract

Composite end-points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end-points in the primary outcome rather than having to select only one, composite end-points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However there are a number of important considerations when designing and interpreting clinical trials that utilize composite end-points. In this Statistical Primer, issues with composite end-points such as competing events, halo effect, risk of bias, time to event limitations and the win ratio are discussed in the context of real world clinical trials.
Competing risks; Composite outcomes; Statistics;
Settore MED/23 - Chirurgia Cardiaca
Settore MED/01 - Statistica Medica
2-lug-2024
Article (author)
File in questo prodotto:
File Dimensione Formato  
ivae126.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 437.32 kB
Formato Adobe PDF
437.32 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1070648
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 1
  • ???jsp.display-item.citation.isi??? 1
social impact