TY - JOUR

T1 - Development of a core outcome set for general intensive care unit patients - A protocol

AU - Kjær, Maj-Brit Nørregaard

AU - Granholm, Anders

AU - Vesterlund, Gitte Kingo

AU - Estrup, Stine

AU - Sivapalan, Praleene

AU - Bruun, Camilla Rahbek Lysholm

AU - Mortensen, Camilla Bekker

AU - Poulsen, Lone Musaeus

AU - Møller, Morten Hylander

AU - Christensen, Steffen

AU - Strøm, Thomas

AU - Laerkner, Eva

AU - Brøchner, Anne Craveiro

AU - Rasmussen, Bodil Steen

AU - Vestergaard, Stine Rom

AU - Barot, Emily

AU - Madsen, Martin Bruun

AU - Egerod, Ingrid

AU - Perner, Anders

AU - Collet, Marie Oxenbøll

N1 - Publisher Copyright: © 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2022

Y1 - 2022

N2 - Introduction: Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. Methods: The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi-structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi-structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A ‘patient and public involvement panel’ consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. Discussion: The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.

AB - Introduction: Different outcomes are reported in randomised clinical trials (RCTs) in intensive care unit (ICU) patients, and no core outcome set (COS) is available for ICU patients in general. Accordingly, we aim to develop a COS for ICU patients in general. Methods: The COS will be developed in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Handbook, using a modified Delphi consensus process and semi-structured interviews involving adults who have survived acute admission to an ICU, family members, clinicians, researchers and other stakeholders. The modified Delphi process will include two steps. Step 1: conduction of a modified Delphi survey, developed and informed by combining the outputs of a literature search of outcomes in previous COSs and semi-structured interviews with key stakeholders. We plan at least two survey rounds to obtain consensus and refine the COS. Step 2: a consensus process regarding instruments or definitions to be recommended for the measurements of the outcomes selected in Step 1. A ‘patient and public involvement panel’ consisting of a smaller group of patients, family members, clinicians and researchers will be included in the development, analysis and interpretation of the COS. Discussion: The outlined multiple method studies will establish a COS for ICU patients in general, which may be used to increase the standardisation and comparability of results of RCTs conducted in patients in the ICU setting.

U2 - 10.1111/aas.14024

DO - 10.1111/aas.14024

M3 - Journal article

C2 - 34961916

AN - SCOPUS:85122889743

VL - 66

SP - 415

EP - 424

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 3

ER -