TY - JOUR
T1 - Development of a core outcome set for general intensive care unit patients - a protocol
AU - Kjaer, 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 - © 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
PY - 2022/3
Y1 - 2022/3
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.
UR - http://www.scopus.com/inward/record.url?scp=85122889743&partnerID=8YFLogxK
U2 - 10.1111/aas.14024
DO - 10.1111/aas.14024
M3 - Journal article
C2 - 34961916
SN - 0001-5172
VL - 66
SP - 415
EP - 424
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
IS - 3
ER -