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

Maj-Brit Nørregaard Kjær; Anders Granholm; Gitte Kingo Vesterlund; Stine Estrup; Praleene Sivapalan; Camilla Rahbek Lysholm Bruun; Camilla Bekker Mortensen; Lone Musaeus Poulsen; Morten Hylander Møller; Steffen Christensen; Thomas Strøm; Eva Laerkner; Anne Craveiro Brøchner; Bodil Steen Rasmussen; Stine Rom Vestergaard; Emily Barot; Martin Bruun Madsen; Ingrid Egerod; Anders Perner; Marie Oxenbøll Collet

doi:10.1111/aas.14024

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

Maj-Brit Nørregaard Kjær^*, Anders Granholm, Gitte Kingo Vesterlund, Stine Estrup, Praleene Sivapalan, Camilla Rahbek Lysholm Bruun, Camilla Bekker Mortensen, Lone Musaeus Poulsen, Morten Hylander Møller, Steffen Christensen, Thomas Strøm, Eva Laerkner, Anne Craveiro Brøchner, Bodil Steen Rasmussen, Stine Rom Vestergaard, Emily Barot, Martin Bruun Madsen, Ingrid Egerod, Anders Perner, Marie Oxenbøll Collet

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

11 Citationer (Scopus)

50 Downloads (Pure)

Abstract

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.

Originalsprog	Engelsk
Tidsskrift	Acta Anaesthesiologica Scandinavica
Vol/bind	66
Udgave nummer	3
Sider (fra-til)	415-424
Antal sider	10
ISSN	0001-5172
DOI	https://doi.org/10.1111/aas.14024
Status	Udgivet - 2022

Bibliografisk note

Funding Information:
The Department of Intensive Care at Rigshospitalet (MNK, AG, GVK, PS, CRLB, MHM, EB, MBM, IE, AP and MOC) has received funding for other projects from the Novo Nordisk Foundation, Pfizer, Ferring Pharmaceuticals and Fresenius Kabi and conducts contract research for AM‐Pharma (the REVIVAL trial). The Department of Anaesthesiology, Zealand University Hospital in Køge (SE, CBM and LMK) has received funding for other projects from the Novo Nordisk Foundation and conducts contract research for AM‐Pharma (the REVIVAL trial). The Department of Anaesthesia and Intensive Care at Aalborg University Hospital (BSR and SRV) have received funding for other projects from the Novo Nordisk Foundation, Ministry of Higher Education and Science and conducts contract research for AM‐Pharma (the REVIVAL trial). Aarhus University Hospital, Department of Intensive Care (SC) conducts contract research for AM‐Pharma (the REVIVAL trial).

Funding Information:
The development of this COS is part of the Intensive Care Platform Trial (INCEPT) research programme ( www.incept.dk ) which has received funding from Sygeforsikringen ‘danmark’, Ehrenreich's Foundation and Dagmar Marshalls Fond. The funders had no influence on any aspects of this study.

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

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Citationsformater

Kjær, M.-B. N., Granholm, A., Vesterlund, G. K., Estrup, S., Sivapalan, P., Bruun, C. R. L., Mortensen, C. B., Poulsen, L. M., Møller, M. H., Christensen, S., Strøm, T., Laerkner, E., Brøchner, A. C., Rasmussen, B. S., Vestergaard, S. R., Barot, E., Madsen, M. B., Egerod, I., Perner, A., & Collet, M. O. (2022). Development of a core outcome set for general intensive care unit patients - A protocol. Acta Anaesthesiologica Scandinavica, 66(3), 415-424. https://doi.org/10.1111/aas.14024

Kjær, M-BN, Granholm, A, Vesterlund, GK, Estrup, S, Sivapalan, P, Bruun, CRL, Mortensen, CB, Poulsen, LM, Møller, MH, Christensen, S, Strøm, T, Laerkner, E, Brøchner, AC, Rasmussen, BS, Vestergaard, SR, Barot, E, Madsen, MB, Egerod, I , Perner, A & Collet, MO 2022, 'Development of a core outcome set for general intensive care unit patients - A protocol', Acta Anaesthesiologica Scandinavica, bind 66, nr. 3, s. 415-424. https://doi.org/10.1111/aas.14024

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abstract = "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 {\textquoteleft}patient and public involvement panel{\textquoteright} 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.",

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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

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

SN - 0001-5172

VL - 66

SP - 415

EP - 424

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 3

ER -