Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol

Maj-Brit Nørregaard Kjær; Camilla Rahbek Lysholm Bruun; Camilla Bekker Mortensen; Anna Schandl; Kimberley Haines; Kristin Hofsø; Fredrike Blokzijl; Anders Granholm; Morten Hylander Møller; Aske Tøgern; Bodil Steen Rasmussen; Lone Musaeus Poulsen; Thomas Strøm; Eva Laerkner; Anne Craveiro Brøchner; Trine Haberlandt; Anne-Marie Gellert Bunzel; Louise Stenbryggen Herløv; Anna Holm; Praleene Sivapalan; Stine Estrup; Maria Cronhjort; Jon Henrik Laake; Carmen Andrea Pfortmueller; Marlies Ostermann; Jade M Cole; Matt P Wise; Anna Wludarczyk; Wojciech Szczeklik; Tomas Jovaiša; Maurizio Cecconi; Martin Ingi Sigurdsson; Marek Nalos; Johanna Hästbacka; Marja Mäkinen; Jacob Dye; Naomi Hammond; Edward Litton; Frederik Keus; Sheila Nainan Myatra; Bharath Kumar Tirupakuzhi Vijayaraghavan; Kavita Yadav; Balasubramanian Venkatesh; Ingrid Egerod; Rikke Faebo Larsen; Dale M Needham; Louise Rose; Bronwen Connolly; Claudia Spies; Carol Hodgson; Daniel Munblit; Sarah Gorst; Anders Perner; Marie O Collet

doi:10.1111/aas.70278

Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol

Maj-Brit Nørregaard Kjær^*
, Camilla Rahbek Lysholm Bruun
, Camilla Bekker Mortensen
, Anna Schandl
, Kimberley Haines
, Kristin Hofsø
, Fredrike Blokzijl
, Anders Granholm
, Morten Hylander Møller
, Aske Tøgern
, Bodil Steen Rasmussen
, Lone Musaeus Poulsen
, Thomas Strøm
, Eva Laerkner
, Anne Craveiro Brøchner
, Trine Haberlandt
, Anne-Marie Gellert Bunzel
, Louise Stenbryggen Herløv
, Anna Holm
, Praleene Sivapalan

Stine Estrup, Maria Cronhjort, Jon Henrik Laake, Carmen Andrea Pfortmueller, Marlies Ostermann, Jade M Cole, Matt P Wise, Anna Wludarczyk, Wojciech Szczeklik, Tomas Jovaiša, Maurizio Cecconi, Martin Ingi Sigurdsson, Marek Nalos, Johanna Hästbacka, Marja Mäkinen, Jacob Dye, Naomi Hammond, Edward Litton, Frederik Keus, Sheila Nainan Myatra, Bharath Kumar Tirupakuzhi Vijayaraghavan, Kavita Yadav, Balasubramanian Venkatesh, Ingrid Egerod, Rikke Faebo Larsen, Dale M Needham, Louise Rose, Bronwen Connolly, Claudia Spies, Carol Hodgson, Daniel Munblit, Sarah Gorst, Anders Perner, Marie O Collet

^*Corresponding author for this work

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

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Abstract

BACKGROUND: Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.

METHODS: This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.

CONCLUSIONS: We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.

Original language	English
Article number	e70278
Number of pages	8
Journal	Acta Anaesthesiologica Scandinavica
Volume	70
Issue number	6
DOIs	https://doi.org/10.1111/aas.70278
Publication status	Published - Jul-2026

Keywords

Humans
Intensive Care Units
Outcome Assessment, Health Care/methods
Critical Care
Adult
Quality of Life
Research Design

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Kjær, M.-B. N., Bruun, C. R. L., Mortensen, C. B., Schandl, A., Haines, K., Hofsø, K., Blokzijl, F., Granholm, A., Møller, M. H., Tøgern, A., Rasmussen, B. S., Poulsen, L. M., Strøm, T., Laerkner, E., Brøchner, A. C., Haberlandt, T., Bunzel, A.-M. G., Herløv, L. S., Holm, A., ... Collet, M. O. (2026). Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol. Acta Anaesthesiologica Scandinavica, 70(6), Article e70278. https://doi.org/10.1111/aas.70278

@article{c8ab5179ece04e0e9197110a8930172e,

title = "Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol",

abstract = "BACKGROUND: Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.METHODS: This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.CONCLUSIONS: We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.",

keywords = "Humans, Intensive Care Units, Outcome Assessment, Health Care/methods, Critical Care, Adult, Quality of Life, Research Design",

author = "Kj{\ae}r, \{Maj-Brit N{\o}rregaard\} and Bruun, \{Camilla Rahbek Lysholm\} and Mortensen, \{Camilla Bekker\} and Anna Schandl and Kimberley Haines and Kristin Hofs{\o} and Fredrike Blokzijl and Anders Granholm and M{\o}ller, \{Morten Hylander\} and Aske T{\o}gern and Rasmussen, \{Bodil Steen\} and Poulsen, \{Lone Musaeus\} and Thomas Str{\o}m and Eva Laerkner and Br{\o}chner, \{Anne Craveiro\} and Trine Haberlandt and Bunzel, \{Anne-Marie Gellert\} and Herl{\o}v, \{Louise Stenbryggen\} and Anna Holm and Praleene Sivapalan and Stine Estrup and Maria Cronhjort and Laake, \{Jon Henrik\} and Pfortmueller, \{Carmen Andrea\} and Marlies Ostermann and Cole, \{Jade M\} and Wise, \{Matt P\} and Anna Wludarczyk and Wojciech Szczeklik and Tomas Jovai{\v s}a and Maurizio Cecconi and Sigurdsson, \{Martin Ingi\} and Marek Nalos and Johanna H{\"a}stbacka and Marja M{\"a}kinen and Jacob Dye and Naomi Hammond and Edward Litton and Frederik Keus and Myatra, \{Sheila Nainan\} and Vijayaraghavan, \{Bharath Kumar Tirupakuzhi\} and Kavita Yadav and Balasubramanian Venkatesh and Ingrid Egerod and Larsen, \{Rikke Faebo\} and Needham, \{Dale M\} and Louise Rose and Bronwen Connolly and Claudia Spies and Carol Hodgson and Daniel Munblit and Sarah Gorst and Anders Perner and Collet, \{Marie O\}",

note = "{\textcopyright} 2026 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley \& Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.",

year = "2026",

month = jul,

doi = "10.1111/aas.70278",

language = "English",

volume = "70",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

publisher = "Wiley",

number = "6",

}

Kjær, M-BN, Bruun, CRL, Mortensen, CB, Schandl, A, Haines, K, Hofsø, K, Blokzijl, F, Granholm, A, Møller, MH, Tøgern, A, Rasmussen, BS, Poulsen, LM, Strøm, T, Laerkner, E, Brøchner, AC, Haberlandt, T, Bunzel, A-MG, Herløv, LS, Holm, A, Sivapalan, P, Estrup, S, Cronhjort, M, Laake, JH, Pfortmueller, CA, Ostermann, M, Cole, JM, Wise, MP, Wludarczyk, A, Szczeklik, W, Jovaiša, T, Cecconi, M, Sigurdsson, MI, Nalos, M, Hästbacka, J, Mäkinen, M, Dye, J, Hammond, N, Litton, E, Keus, F, Myatra, SN, Vijayaraghavan, BKT, Yadav, K, Venkatesh, B, Egerod, I, Larsen, RF, Needham, DM, Rose, L, Connolly, B, Spies, C, Hodgson, C, Munblit, D, Gorst, S, Perner, A & Collet, MO 2026, 'Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol', Acta Anaesthesiologica Scandinavica, vol. 70, no. 6, e70278. https://doi.org/10.1111/aas.70278

TY - JOUR

T1 - Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol

AU - Kjær, Maj-Brit Nørregaard

AU - Bruun, Camilla Rahbek Lysholm

AU - Mortensen, Camilla Bekker

AU - Schandl, Anna

AU - Haines, Kimberley

AU - Hofsø, Kristin

AU - Blokzijl, Fredrike

AU - Granholm, Anders

AU - Møller, Morten Hylander

AU - Tøgern, Aske

AU - Rasmussen, Bodil Steen

AU - Poulsen, Lone Musaeus

AU - Strøm, Thomas

AU - Laerkner, Eva

AU - Brøchner, Anne Craveiro

AU - Haberlandt, Trine

AU - Bunzel, Anne-Marie Gellert

AU - Herløv, Louise Stenbryggen

AU - Holm, Anna

AU - Sivapalan, Praleene

AU - Estrup, Stine

AU - Cronhjort, Maria

AU - Laake, Jon Henrik

AU - Pfortmueller, Carmen Andrea

AU - Ostermann, Marlies

AU - Cole, Jade M

AU - Wise, Matt P

AU - Wludarczyk, Anna

AU - Szczeklik, Wojciech

AU - Jovaiša, Tomas

AU - Cecconi, Maurizio

AU - Sigurdsson, Martin Ingi

AU - Nalos, Marek

AU - Hästbacka, Johanna

AU - Mäkinen, Marja

AU - Dye, Jacob

AU - Hammond, Naomi

AU - Litton, Edward

AU - Keus, Frederik

AU - Myatra, Sheila Nainan

AU - Vijayaraghavan, Bharath Kumar Tirupakuzhi

AU - Yadav, Kavita

AU - Venkatesh, Balasubramanian

AU - Egerod, Ingrid

AU - Larsen, Rikke Faebo

AU - Needham, Dale M

AU - Rose, Louise

AU - Connolly, Bronwen

AU - Spies, Claudia

AU - Hodgson, Carol

AU - Munblit, Daniel

AU - Gorst, Sarah

AU - Perner, Anders

AU - Collet, Marie O

PY - 2026/7

Y1 - 2026/7

N2 - BACKGROUND: Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.METHODS: This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.CONCLUSIONS: We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.

AB - BACKGROUND: Core outcome measurement sets (COMS) enhance the consistency and comparability of outcome reporting in clinical research. However, their effectiveness depends on the selection of valid, reliable, and feasible measurement instruments. Core outcome sets (COS) and COMS have been developed for specific intensive care unit (ICU) patient subgroups. The aim of this study is to establish a standardised approach to outcome measurement and operationalisation for adults acutely admitted to the ICU who are participating in clinical trials and other clinical research.METHODS: This protocol describes the development of a COMS for adults acutely admitted to the ICU, the CoreMS-ICU, consisting of six core outcomes: survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function. We will follow the Consensus-based Standards for the Selection of Health Measurement Instruments guideline and report according to the Core Outcome Set-STAndardised Protocol Items guideline. The development of the CoreMS-ICU will follow five predefined steps: (1) conceptual considerations for the six core outcomes; (2) systematic searches for outcome measurement instruments, including consideration of existing COMS; (3) quality assessment of relevant outcome measurement instruments; (4) consensus-based selection of outcome measurement instruments; and (5) recommendations and guidance on how to operationalise and report the measurement of the six core outcomes. We will involve research panels consisting of key stakeholders: patients, family members, healthcare professionals, and researchers in steps 1 and 4.CONCLUSIONS: We aim to develop a COMS for adults acutely admitted to ICU patients to facilitate the consistent use of outcomes in trials and enhance the translation of research findings into clinical practice.

KW - Humans

KW - Intensive Care Units

KW - Outcome Assessment, Health Care/methods

KW - Critical Care

KW - Adult

KW - Quality of Life

KW - Research Design

U2 - 10.1111/aas.70278

DO - 10.1111/aas.70278

M3 - Article

C2 - 42302862

SN - 0001-5172

VL - 70

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 6

M1 - e70278

ER -

Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS-ICU-A Protocol

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