A Core Outcome Set for Adult General ICU Patients

doi:10.1097/CCM.0000000000006556

. 2025 Mar 1;53(3):e575-e589.

doi: 10.1097/CCM.0000000000006556. Epub 2025 Jan 6.

A Core Outcome Set for Adult General ICU Patients

Maj-Brit Nørregaard Kjær^{1

2}, Camilla Rahbek Lysholm Bruun¹, Anders Granholm^{1

2}, Morten Hylander Møller^{1

2

3}, Bodil Steen Rasmussen^{2

4}, Camilla Bekker Mortensen⁵, Lone Museaus Poulsen^{2

5}, Thomas Strøm^{2

6}, Eva Laerkner⁶, Anne Craveiro Brøchner^{2

7}, Trine Haberlandt⁷, Anne-Marie Gellert Bunzel⁴, Louise Stenbryggen Herløv⁵, Anna Holm⁸, Praleene Sivapalan¹, Stine Estrup¹, Maria Cronhjort^{2

9

10}, Anna Schandl^{9

11}, Jon Henrik Laake^{2

12}, Kristin Hofsø^{2

13

14}, Fredrike Blokzijl¹⁵, Frederik Keus¹⁵, Carmen Andrea Pfortmueller^{2

16}, Marlies Ostermann^{2

17}, Jade M Cole¹⁸, Matt P Wise^{2

18}, Wojciech Szczeklik^{2

19}, Anna Wludarczyk¹⁹, Tomas Jovaiša²⁰, Maurizio Cecconi^{21

22}, Martin Ingi Sigurdsson^{2

23

24}, Marek Nalos^{2

25}, Johanna Hästbacka^{2

26}, Marja Mäkinen²⁷, Naomi Hammond^{28

29}, Edward Litton^{30

31}, Kimberley Haines^{32

33}, Sheila Nainan Myatra³⁴, Bharath Kumar Tirupakuzhi Vijayaraghavan^{35

36}, Kavita Yadav³⁶, Vivekanand Jha^{29

36

37

38}, Balasubramanian Venkatesh^{28

39}, Ingrid Egerod¹, Anders Perner^{1

2

3}, Marie O Collet¹

Affiliations

¹ Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
² Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
³ Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark.
⁴ Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
⁵ Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.
⁶ Department of Anaesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.
⁷ Department of Anaesthesia and Intensive Care, Lillebælt Hospital, Kolding, Denmark.
⁸ Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
⁹ Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
¹⁰ Department of Clinical Sciences, Danderyd Hospital, Karolinska Institut, Stockholm, Sweden.
¹¹ Department of Perioperative and intensive care, Södersjukhuset, Stockholm, Sweden.
¹² 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.
¹³ Department of Postoperative and Intensive Care Nursing, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.
¹⁴ Lovisenberg Dioconal University College, Oslo, Norway.
¹⁵ Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
¹⁶ Department of Intensive Care Medicine, Inselspital, University Hospital Bern, Bern, Switzerland.
¹⁷ Department of Intensive Care, Guy's and St Thomas' Hospital, London, The United Kingdom.
¹⁸ Adult Critical Care, University Hospital of Wales, Cardiff, The United Kingdom.
¹⁹ Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.
²⁰ Clinic of Anaesthesiology and Intensive Care, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²¹ Department of Biomedical Sciences, Humanitas University, Milan, Italy.
²² Department of Anaesthesiology and Intensive Care, IRCCS Humanitas Research Hospital, Milan, Italy.
²³ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
²⁴ Landspitali-the National University Hospital of Reykjavik, Reykjavik, Iceland.
²⁵ Medical ICU, First Department of Internal Medicine, Charles University, Faculty of Medicine, Teaching Hospital and Biomedical Center in Pilsen, Pilsen, Czech Republic.
²⁶ Faculty of Medicine and Health Technology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
²⁷ Department of Emergency Medicine and Services, Helsinki University and Helsinki University Hospital, Helsinki, Finland.
²⁸ The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
²⁹ Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, NSW, Australia.
³⁰ Intensive Care Unit, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA.
³¹ School of Medicine, University of Western Australia, Crawley, WA.
³² Department of Physiotherapy, Western Health, Melbourne, VIC, Australia.
³³ Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia.
³⁴ Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
³⁵ Apollo Hospitals, Chennai, India.
³⁶ The George Institute for Global Health, New Delhi, India.
³⁷ Prasanna School of Public Health, Manipal Academy of Medical Sciences, Manipal, India.
³⁸ School of Public Health, Imperial College, London, United Kingdom.
³⁹ Department of Intensive Care, Gold Coast University Hospital, Southport, QLD, Australia.

PMID: 40036020
DOI: 10.1097/CCM.0000000000006556

A Core Outcome Set for Adult General ICU Patients

Maj-Brit Nørregaard Kjær et al. Crit Care Med. 2025.

. 2025 Mar 1;53(3):e575-e589.

doi: 10.1097/CCM.0000000000006556. Epub 2025 Jan 6.

Authors

Affiliations

¹ Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
² Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
³ Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark.
⁴ Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.
⁵ Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark.
⁶ Department of Anaesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.
⁷ Department of Anaesthesia and Intensive Care, Lillebælt Hospital, Kolding, Denmark.
⁸ Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark.
⁹ Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
¹⁰ Department of Clinical Sciences, Danderyd Hospital, Karolinska Institut, Stockholm, Sweden.
¹¹ Department of Perioperative and intensive care, Södersjukhuset, Stockholm, Sweden.
¹² 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.
¹³ Department of Postoperative and Intensive Care Nursing, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.
¹⁴ Lovisenberg Dioconal University College, Oslo, Norway.
¹⁵ Department of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
¹⁶ Department of Intensive Care Medicine, Inselspital, University Hospital Bern, Bern, Switzerland.
¹⁷ Department of Intensive Care, Guy's and St Thomas' Hospital, London, The United Kingdom.
¹⁸ Adult Critical Care, University Hospital of Wales, Cardiff, The United Kingdom.
¹⁹ Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.
²⁰ Clinic of Anaesthesiology and Intensive Care, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
²¹ Department of Biomedical Sciences, Humanitas University, Milan, Italy.
²² Department of Anaesthesiology and Intensive Care, IRCCS Humanitas Research Hospital, Milan, Italy.
²³ Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
²⁴ Landspitali-the National University Hospital of Reykjavik, Reykjavik, Iceland.
²⁵ Medical ICU, First Department of Internal Medicine, Charles University, Faculty of Medicine, Teaching Hospital and Biomedical Center in Pilsen, Pilsen, Czech Republic.
²⁶ Faculty of Medicine and Health Technology, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
²⁷ Department of Emergency Medicine and Services, Helsinki University and Helsinki University Hospital, Helsinki, Finland.
²⁸ The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.
²⁹ Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, NSW, Australia.
³⁰ Intensive Care Unit, Fiona Stanley Hospital, Robin Warren Drive, Murdoch, WA.
³¹ School of Medicine, University of Western Australia, Crawley, WA.
³² Department of Physiotherapy, Western Health, Melbourne, VIC, Australia.
³³ Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, Australia.
³⁴ Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
³⁵ Apollo Hospitals, Chennai, India.
³⁶ The George Institute for Global Health, New Delhi, India.
³⁷ Prasanna School of Public Health, Manipal Academy of Medical Sciences, Manipal, India.
³⁸ School of Public Health, Imperial College, London, United Kingdom.
³⁹ Department of Intensive Care, Gold Coast University Hospital, Southport, QLD, Australia.

PMID: 40036020
DOI: 10.1097/CCM.0000000000006556

Abstract

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.

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Conflict of interest statement

Drs. Kjær’s and Granholm’s institutions received funding from Sygeforsikringen and the Novo Nordisk Foundation. Dr. Kjær’s institution received funding from the Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond, Savværksejer Jeppe Juhl og Hustru Ovita Juhls Mindelegat, and Dagmar Marshalls Fond; they received support for article research from the National Institutes of Health. Dr. Drnaholm’s institution received funding from the Independent Research Fund Denmark. Dr. Laerkner received funding from National Health and Medical Research Council (NHMRC) Investigator Fellowship (GNT2017081), The George Institute for Global Health, and the Fiona Stanley Hospital Intensive Care Unit; they received support for article research from Sygeforsikringen, the Novo Nordisk Foundation, Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond, Savværksejer Jeppe Juhl og Hustru Ovita Juhls Mindelegat, and Dagmar Marshalls Fond. Dr. Sivapalan received funding from Rigshospitalet, the Ehrenreich Foundation, Sygeforsikringen, the Novo Nordisk Foundation, Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond, Savværksejer Jeppe Juhl og Hustru Ovita Juhls Mindelegat, and Dagmar Marshalls Fond. Dr. Wise’s institution received funding from the National Institute of Health and Care Research National Institute for Health and Care Excellence (NICE) Rolling Call (health technology assessment programme). Dr. Hästbacka received funding from Paion. Dr. Litton received support for article research from the NHMRC Investigator Fellowship. Dr. Jha’s institution received funding from Astra Zeneca, Ousuka, and Visterra; he received funding from Visterra, Vera Therapeutics, Biocryst, Chinook, Alpine, GlaxoSmithKline (GSK), Astra Zeneca and Boehringer Ingelheim. Dr. Venkatesh received funding from the NHMRC Leadership Fellowship and Baxter. Dr. Collet’s institution received funding from Dagmar Marshall Fond. The remaining authors have disclosed that they do not have any potential conflicts of interest.

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References

1. Blackwood B, Marshall J, Rose L: Progress on core outcome sets for critical care research. Curr Opin Crit Care 2015; 21:439–444
1. Møller MH: Patient-important outcomes and core outcome sets: Increased attention needed! Br J Anaesth 2019; 122:408–410
1. Meyhoff TS, Hjortrup PB, Wetterslev J, et al.; CLASSIC Trial Group: Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med 2022; 386:2459–2470
1. Kjær M-BN, Meyhoff TS, Sivapalan P, et al.: Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med 2023; 81:154737–154830
1. Andersen-Ranberg NC, Poulsen LM, Perner A, et al.; AID-ICU Trial Group: Haloperidol for the treatment of delirium in ICU patients. N Engl J Med 2022; 387:2425–2435

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NNF23OC0085106/Sygeforsikring Danmark

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[1] Blackwood B, Marshall J, Rose L: Progress on core outcome sets for critical care research. Curr Opin Crit Care 2015; 21:439–444

[2] Blackwood B, Marshall J, Rose L: Progress on core outcome sets for critical care research. Curr Opin Crit Care 2015; 21:439–444

[3] Møller MH: Patient-important outcomes and core outcome sets: Increased attention needed! Br J Anaesth 2019; 122:408–410

[4] Møller MH: Patient-important outcomes and core outcome sets: Increased attention needed! Br J Anaesth 2019; 122:408–410

[5] Meyhoff TS, Hjortrup PB, Wetterslev J, et al.; CLASSIC Trial Group: Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med 2022; 386:2459–2470

[6] Meyhoff TS, Hjortrup PB, Wetterslev J, et al.; CLASSIC Trial Group: Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med 2022; 386:2459–2470

[7] Kjær M-BN, Meyhoff TS, Sivapalan P, et al.: Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med 2023; 81:154737–154830

[8] Kjær M-BN, Meyhoff TS, Sivapalan P, et al.: Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med 2023; 81:154737–154830

[9] Andersen-Ranberg NC, Poulsen LM, Perner A, et al.; AID-ICU Trial Group: Haloperidol for the treatment of delirium in ICU patients. N Engl J Med 2022; 387:2425–2435

[10] Andersen-Ranberg NC, Poulsen LM, Perner A, et al.; AID-ICU Trial Group: Haloperidol for the treatment of delirium in ICU patients. N Engl J Med 2022; 387:2425–2435

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A Core Outcome Set for Adult General ICU Patients

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A Core Outcome Set for Adult General ICU Patients

Authors

Affiliations

Abstract

Conflict of interest statement

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