OBJECTIVES: Randomized 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. DESIGN: We 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. SETTING: There 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. SUBJECTS: Adult ICU survivors, family members, clinicians, and researchers. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We 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. CONCLUSIONS: We 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.

Adult Critical Care University Hospital of Wales Cardiff The United Kingdom

Apollo Hospitals Chennai India

Centre for Intensive Care and Perioperative Medicine Jagiellonian University Medical College Krakow Poland

Clinic of Anaesthesiology and Intensive Care Faculty of Medicine Vilnius University Vilnius Lithuania

Collaboration for Research in Intensive Care Copenhagen Denmark

Department of Anaesthesia and Intensive Care Aalborg University Hospital Aalborg Denmark

Department of Anaesthesia and Intensive Care Lillebælt Hospital Kolding Denmark

Department of Anaesthesiology and Intensive Care IRCCS Humanitas Research Hospital Milan Italy

Department of Anaesthesiology and Intensive Care Medicine and Department of Research and Development Division of Emergencies and Critical Care Rikshospitalet Oslo University Hospital Oslo Norway

Department of Anaesthesiology and Intensive Care Odense University Hospital Odense Denmark

Department of Anaesthesiology Critical Care and Pain Tata Memorial Hospital Homi Bhabha National Institute Mumbai India

Department of Anaesthesiology Zealand University Hospital Roskilde Denmark

Department of Biomedical Sciences Humanitas University Milan Italy

Department of Clinical Medicine Faculty of Health and Medical Science University of Copenhagen Copenhagen Denmark

Department of Clinical Science and Education Södersjukhuset Karolinska Institutet Stockholm Sweden

Department of Clinical Sciences Danderyd Hospital Karolinska Institut Stockholm Sweden

Department of Critical Care Melbourne Medical School The University of Melbourne Melbourne VIC Australia

Department of Critical Care University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Emergency Medicine and Services Helsinki University and Helsinki University Hospital Helsinki Finland

Department of Intensive Care Aarhus University Hospital Aarhus Denmark

Department of Intensive Care Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Department of Intensive Care Gold Coast University Hospital Southport QLD Australia

Department of Intensive Care Guy's and St Thomas' Hospital London The United Kingdom

Department of Intensive Care Medicine Inselspital University Hospital Bern Bern Switzerland

Department of Perioperative and intensive care Södersjukhuset Stockholm Sweden

Department of Physiotherapy Western Health Melbourne VIC Australia

Department of Postoperative and Intensive Care Nursing Division of Emergencies and Critical Care Oslo University Hospital Oslo Norway

Faculty of Medicine and Health Technology Tampere University Hospital Wellbeing Services County of Pirkanmaa and Tampere University Tampere Finland

Faculty of Medicine University of Iceland Reykjavik Iceland

Intensive Care Unit Fiona Stanley Hospital Robin Warren Drive Murdoch WA

Landspitali the National University Hospital of Reykjavik Reykjavik Iceland

Lovisenberg Dioconal University College Oslo Norway

Malcolm Fisher Department of Intensive Care Royal North Shore Hospital Sydney NSW Australia

Medical ICU 1st Department of Internal Medicine Charles University Faculty of Medicine Teaching Hospital and Biomedical Center in Pilsen Pilsen Czech Republic

Prasanna School of Public Health Manipal Academy of Medical Sciences Manipal India

School of Medicine University of Western Australia Crawley WA

School of Public Health Imperial College London United Kingdom

The George Institute for Global Health New Delhi India

The George Institute for Global Health University of New South Wales Sydney NSW Australia

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