Developing a Core Outcome Measurement Set for Adult ICU Patients, the CoreMS ‐ ICU —A Protocol
Year: 2026
Type: article
Study design: Study 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.
DOI: 10.1111/aas.70278
Authors: 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
Institutions: Copenhagen University Hospital, Rigshospitalet, Centre for Research in Intensive Care, Zealand University Hospital, Karolinska Institutet, Stockholm South General Hospital, The University of Melbourne, Western Health, Oslo University Hospital, Lovisenberg Diakonale Høgskole, University Medical Center Groningen, University of Groningen, University of Copenhagen, Aalborg University Hospital, Odense University Hospital, Kolding Hospital, Lillebaelt Hospital, Aarhus University Hospital, Danderyds sjukhus, University of Bern, University Hospital of Bern, St Thomas' Hospital, University Hospital of Wales, Jagiellonian University, Vilnius University, Humanitas University, IRCCS Humanitas Research Hospital, University of Iceland, National University Hospital of Iceland, Charles University, Tampere University Hospital, University of Helsinki, Helsinki University Hospital, Federation University, UNSW Sydney, The George Institute for Global Health, Royal North Shore Hospital, Northern Sydney Local Health District, The University of Western Australia, Fiona Stanley Hospital, Homi Bhabha National Institute, Tata Memorial Hospital, Apollo Hospitals, George Institute for Global Health, Manipal Academy of Higher Education, Gold Coast Hospital, Gold Coast Health, Johns Hopkins University, Johns Hopkins Medicine, King's College London, Queen's University Belfast, Charité - Universitätsmedizin Berlin, The Alfred Hospital, Monash University, University of Liverpool
Language: English
Topic: Delphi Technique in Research
Subfield: Sociology and Political Science
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
Estimated APC paid: $4,430
Awards: G1643469013, G322298489
OpenAlex ID: W7164924454