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

Paul S Myles; Jan M Dieleman; Andrew Forbes; Stephane Heritier; Julian A Smith

doi:10.1016/j.ahj.2018.06.008

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

Paul S Myles, Jan M Dieleman, Andrew Forbes, Stephane Heritier, Julian A Smith

Anesthesiology

Research output: Contribution to journal › Article › Academic › peer-review

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 language	English
Pages (from-to)	52-57
Number of pages	6
Journal	American Heart Journal
Volume	204
DOIs	https://doi.org/10.1016/j.ahj.2018.06.008
Publication status	Published - Oct 2018

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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}",

note = "Publisher Copyright: {\textcopyright} 2018 Elsevier, Inc.",

year = "2018",

month = oct,

doi = "10.1016/j.ahj.2018.06.008",

language = "English",

volume = "204",

pages = "52--57",

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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

Y1 - 2018/10

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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DO - 10.1016/j.ahj.2018.06.008

M3 - Article

C2 - 30081275

SN - 0002-8703

VL - 204

SP - 52

EP - 57

JO - American Heart Journal

JF - American Heart Journal

ER -

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

Abstract

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