Developing a Core Outcome Measurement Set for Adult <scp>ICU</scp> Patients, the <scp>CoreMS</scp> ‐ <scp>ICU</scp> —A Protocol

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.

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Acta Anaesthesiologica Scandinavica
Published
2026-06-16
DOI
https://doi.org/10.1111/aas.70278
Primary Topic
Delphi Technique in Research
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article
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article

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

Lone Musaeus Poulsen, Johanna Hästbacka, Stine Estrup, Tomas Jovaiša et al.
Acta Anaesthesiologica Scandinavica
Delphi Technique in Research
article

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

Lone Musaeus Poulsen, Johanna Hästbacka, Stine Estrup, Tomas Jovaiša, Anne Craveiro Brøchner, Fredrike Blokzijl, Claudia Spies, Camilla Rahbek Lysholm Bruun, Anna Schandl, Anders Perner, Ingrid Egerod, Kristin Hofsø, Martin I. Sigurðsson, Louise Stenbryggen Herløv, Jacob Dye, Sheila Nainan Myatra, Kimberley Haines, Eva Lærkner, Rikke Fæbo Larsen, Thomas Strøm, Bharath Kumar Tirupakuzhi Vijayaraghavan, Jon Henrik Laake, Wojciech Szczeklik, Marek Nalos, Morten Hylander Møller, Carmen Andrea Pfortmueller, Jade Cole, Matt P. Wise, Louise Rose, S Gorst, Camilla Bekker Mortensen, Marlies Ostermann, Maj‐Brit Nørregaard Kjær, Marja Mäkinen, Anders Granholm, Maria Cronhjort, Naomi E. Hammond, Daniel Munblit, Praleene Sivapalan, Balasubramanian Venkatesh, Frederik Keus, Maurizio Cecconi, Anne‐Marie Gellert Bunzel, Dale M. Needham, Marie Oxenbøll Collet, Bodil Steen Rasmussen, Anna Holm, Aske Tøgern, Anna Włudarczyk, B; id_orcid 0000-0002-5676-5497 Connolly, Trine Haberlandt, Edward Litton, Carol Hodgson, Kavita Yadav
article en

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.

Acta Anaesthesiologica ScandinavicaVol. 70(6)
University of Copenhagen (DK), Queen's University Belfast (GB), Jagiellonian University (PL), Oslo University Hospital (NO), St Thomas' Hospital (GB), Apollo Hospitals (IN), University Medical Center Groningen (NL), University of Helsinki (FI), Humanitas University (IT), Johns Hopkins University (US), University of Liverpool (GB), Federation University (AU), Manipal Academy of Higher Education (IN), University of Iceland (IS), The University of Melbourne (AU), Vilnius University (LT), The University of Western Australia (AU), King's College London (GB), Homi Bhabha National Institute (IN), Charles University (CZ), Johns Hopkins Medicine (US), Aalborg University Hospital (DK), Royal North Shore Hospital (AU), Gold Coast Hospital (AU), Helsinki University Hospital (FI), Fiona Stanley Hospital (AU), University Hospital of Wales (GB), University Hospital of Bern (CH), Odense University Hospital (DK), The Alfred Hospital (AU), Aarhus University Hospital (DK), Copenhagen University Hospital (DK), Rigshospitalet (DK), Karolinska Institutet (SE), UNSW Sydney (AU), Zealand University Hospital (DK), Australian and New Zealand Intensive Care Society (AU), Stockholm South General Hospital (SE), Lovisenberg Diakonale Høgskole (NO), National University Hospital of Iceland (IS), Footscray Hospital (AU), The George Institute for Global Health (AU), Centre for Research in Intensive Care (DK), Tampere University Hospital (FI), Tampere University (FI), Expert System (Italy) (IT), George Institute for Global Health (IN), Lillebaelt Hospital (DK), IRCCS Humanitas Research Hospital (IT), Monash University (AU), Charité - Universitätsmedizin Berlin (DE)
Dagmar Marshalls Fond, Danmarks Frie Forskningsfond, Novo Nordisk Fonden, Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond
Openalex Percentile: Top 3%
Delphi Technique in Research
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