Dexamethasone for Cardiac Surgery trial (DECS-II): Rationale and a novel, practice preference-randomized consent design

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Abstract

Background: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. Methods: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). Conclusions: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.

Original languageEnglish
Pages (from-to)52-57
Number of pages6
JournalAmerican Heart Journal
Volume204
DOIs
Publication statusPublished - 1 Oct 2018

Cite this

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title = "Dexamethasone for Cardiac Surgery trial (DECS-II): Rationale and a novel, practice preference-randomized consent design",
abstract = "Background: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. Methods: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). Conclusions: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.",
author = "Myles, {Paul S.} and Dieleman, {Jan M.} and Andrew Forbes and Stephane Heritier and Smith, {Julian A.}",
year = "2018",
month = "10",
day = "1",
doi = "10.1016/j.ahj.2018.06.008",
language = "English",
volume = "204",
pages = "52--57",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby International",

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TY - JOUR

T1 - Dexamethasone for Cardiac Surgery trial (DECS-II)

T2 - Rationale and a novel, practice preference-randomized consent design

AU - Myles, Paul S.

AU - Dieleman, Jan M.

AU - Forbes, Andrew

AU - Heritier, Stephane

AU - Smith, Julian A.

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Background: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. Methods: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). Conclusions: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.

AB - Background: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. Methods: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). Conclusions: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.

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