• Maj-Brit Nørregaard Kjær, Camilla Rahbek Lysholm Bruun, Anders Granholm, MøllerMorten HylanderMHDepartment of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.Department of Clinical Medicine, Faculty of Health and Medical, Bodil Steen Rasmussen, MortensenCamilla BekkerCBDepartment of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark., Lone Museaus 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, Anna Schandl, Jon Henrik Laake, Kristin Hofsø, Fredrike Blokzijl, Frederik Keus, Carmen Andrea Pfortmueller, Marlies Ostermann, Jade M Cole, Matt P Wise, Wojciech Szczeklik, Anna Wludarczyk, Tomas Jovaiša, Maurizio Cecconi, Martin Ingi Sigurdsson, Marek Nalos, Johanna Hästbacka, Marja Mäkinen, Naomi Hammond, Edward Litton, Kimberley Haines, Sheila Nainan Myatra, VijayaraghavanBharath Kumar TirupakuzhiBKTApollo Hospitals, Chennai, India.The George Institute for Global Health, New Delhi, India., Kavita Yadav, Vivekanand Jha, Balasubramanian Venkatesh, Ingrid Egerod, Anders Perner, and Marie O Collet.
• Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
• Crit. Care Med. 2025 Jan 6.

ObjectivesRandomized clinical trials informing clinical practice (e.g., like large, pragmatic, and late-phase trials) should ideally mostly use harmonized outcomes that are important to patients, family members, clinicians, and researchers. Core outcome sets for specific subsets of ICU patients exist, for example, respiratory failure, delirium, and COVID-19, but not for ICU patients in general. Accordingly, we aimed to develop a core outcome set for adult general ICU patients.DesignWe developed a core outcome set in Denmark following the Core Outcome Measures in Effectiveness Trials Handbook. We used a modified Delphi consensus process with multiple methods design, including literature review, survey, semi-structured interviews, and discussions with initially five Danish research panels. The core outcome set was internationally validated and revised based on feedback from research panels in all countries.SettingThere were five Danish research panels and 17 panels in 13 other countries. Interviews and the three-round Delphi survey was conducted in Denmark, followed by validation of the core outcome set across 14 countries in Europe, Australasia, and India.SubjectsAdult ICU survivors, family members, clinicians, and researchers.InterventionsNone.Measurements And Main ResultsWe identified 329 published outcomes, of which 50 were included in the 264 participant Delphi survey. In semi-structured interviews of 82, no additional outcomes were added. The first Delphi survey round was completed by 249 (94%) participants, and 202 (82%) contributed to the third and final round. The initial core outcome set comprised six outcomes. International validation involved 217 research panel members and resulted in the final core outcome set comprising survival, free of life support, free of delirium, out of hospital, health-related quality of life, and cognitive function.ConclusionsWe developed and internationally validated a core outcome set with six core outcomes to be used in research, specifically clinical trials involving adult general ICU patients.Copyright © 2025 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

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