A Core Outcome Set for Adult General ICU Patients

Maj-Brit Nørregaard Kjær; Camilla Rahbek Lysholm Bruun; Anders Granholm; Morten Hylander Møller; Bodil Steen Rasmussen; Camilla Bekker Mortensen; 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; Bharath Kumar Tirupakuzhi Vijayaraghavan; Kavita Yadav; Vivekanand Jha; Balasubramanian Venkatesh; Ingrid Egerod; Anders Perner; Marie O Collet

doi:10.1097/CCM.0000000000006556

A Core Outcome Set for Adult General ICU Patients

Maj-Brit Nørregaard Kjær, Camilla Rahbek Lysholm Bruun, Anders Granholm, Morten Hylander Møller, Bodil Steen Rasmussen, Camilla Bekker Mortensen, 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 HofsøFredrike 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, Bharath Kumar Tirupakuzhi Vijayaraghavan, Kavita Yadav, Vivekanand Jha, Balasubramanian Venkatesh, Ingrid Egerod, Anders Perner, Marie O Collet

Anæstesiologisk Afdeling

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

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.

Originalsprog	Engelsk
Antal sider	15
Tidsskrift	Critical care medicine
DOI	https://doi.org/10.1097/CCM.0000000000006556
Status	Udgivet, E-publikation før trykning - 6 jan. 2025

Bibliografisk note

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10.1097/CCM.0000000000006556

Citationsformater

Kjær, M.-B. N., Bruun, C. R. L., Granholm, A., Møller, M. H., Rasmussen, B. S., Mortensen, C. B., Poulsen, L. M., Strøm, T., Laerkner, E., Brøchner, A. C., Haberlandt, T., Bunzel, A.-M. G., Herløv, L. S., Holm, A., Sivapalan, P., Estrup, S., Cronhjort, M., Schandl, A., Laake, J. H., ... Collet, M. O. (2025). A Core Outcome Set for Adult General ICU Patients. Critical care medicine. Advance online publication. https://doi.org/10.1097/CCM.0000000000006556

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title = "A Core Outcome Set for Adult General ICU Patients",

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.",

author = "Kj{\ae}r, {Maj-Brit N{\o}rregaard} and Bruun, {Camilla Rahbek Lysholm} and Anders Granholm and M{\o}ller, {Morten Hylander} and Rasmussen, {Bodil Steen} and Mortensen, {Camilla Bekker} and Poulsen, {Lone Museaus} and Thomas Str{\o}m and Eva Laerkner and Br{\o}chner, {Anne Craveiro} and Trine Haberlandt and Bunzel, {Anne-Marie Gellert} and Herl{\o}v, {Louise Stenbryggen} and Anna Holm and Praleene Sivapalan and Stine Estrup and Maria Cronhjort and Anna Schandl and Laake, {Jon Henrik} and Kristin Hofs{\o} and Fredrike Blokzijl and Frederik Keus and Pfortmueller, {Carmen Andrea} and Marlies Ostermann and Cole, {Jade M} and Wise, {Matt P} and Wojciech Szczeklik and Anna Wludarczyk and Tomas Jovai{\v s}a and Maurizio Cecconi and Sigurdsson, {Martin Ingi} and Marek Nalos and Johanna H{\"a}stbacka and Marja M{\"a}kinen and Naomi Hammond and Edward Litton and Kimberley Haines and Myatra, {Sheila Nainan} and Vijayaraghavan, {Bharath Kumar Tirupakuzhi} and Kavita Yadav and Vivekanand Jha and Balasubramanian Venkatesh and Ingrid Egerod and Anders Perner and Collet, {Marie O}",

year = "2025",

month = jan,

day = "6",

doi = "10.1097/CCM.0000000000006556",

language = "English",

journal = "Critical care medicine",

issn = "0090-3493",

publisher = "Lippincott Williams and Wilkins Ltd.",

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Kjær, M-BN, Bruun, CRL, Granholm, A, Møller, MH, Rasmussen, BS, Mortensen, CB , Poulsen, LM, Strøm, T, Laerkner, E, Brøchner, AC, Haberlandt, T, Bunzel, A-MG, Herløv, LS, Holm, A, Sivapalan, P, Estrup, S, Cronhjort, M, Schandl, A, Laake, JH, Hofsø, K, Blokzijl, F, Keus, F, Pfortmueller, CA, Ostermann, M, Cole, JM, Wise, MP, Szczeklik, W, Wludarczyk, A, Jovaiša, T, Cecconi, M, Sigurdsson, MI, Nalos, M, Hästbacka, J, Mäkinen, M, Hammond, N, Litton, E, Haines, K, Myatra, SN, Vijayaraghavan, BKT, Yadav, K, Jha, V, Venkatesh, B, Egerod, I, Perner, A & Collet, MO 2025, 'A Core Outcome Set for Adult General ICU Patients', Critical care medicine. https://doi.org/10.1097/CCM.0000000000006556

TY - JOUR

T1 - A Core Outcome Set for Adult General ICU Patients

AU - Kjær, Maj-Brit Nørregaard

AU - Bruun, Camilla Rahbek Lysholm

AU - Granholm, Anders

AU - Møller, Morten Hylander

AU - Rasmussen, Bodil Steen

AU - Mortensen, Camilla Bekker

AU - Poulsen, Lone Museaus

AU - Strøm, Thomas

AU - Laerkner, Eva

AU - Brøchner, Anne Craveiro

AU - Haberlandt, Trine

AU - Bunzel, Anne-Marie Gellert

AU - Herløv, Louise Stenbryggen

AU - Holm, Anna

AU - Sivapalan, Praleene

AU - Estrup, Stine

AU - Cronhjort, Maria

AU - Schandl, Anna

AU - Laake, Jon Henrik

AU - Hofsø, Kristin

AU - Blokzijl, Fredrike

AU - Keus, Frederik

AU - Pfortmueller, Carmen Andrea

AU - Ostermann, Marlies

AU - Cole, Jade M

AU - Wise, Matt P

AU - Szczeklik, Wojciech

AU - Wludarczyk, Anna

AU - Jovaiša, Tomas

AU - Cecconi, Maurizio

AU - Sigurdsson, Martin Ingi

AU - Nalos, Marek

AU - Hästbacka, Johanna

AU - Mäkinen, Marja

AU - Hammond, Naomi

AU - Litton, Edward

AU - Haines, Kimberley

AU - Myatra, Sheila Nainan

AU - Vijayaraghavan, Bharath Kumar Tirupakuzhi

AU - Yadav, Kavita

AU - Jha, Vivekanand

AU - Venkatesh, Balasubramanian

AU - Egerod, Ingrid

AU - Perner, Anders

AU - Collet, Marie O

PY - 2025/1/6

Y1 - 2025/1/6

N2 - 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.

AB - 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.

U2 - 10.1097/CCM.0000000000006556

DO - 10.1097/CCM.0000000000006556

M3 - Article

C2 - 39761440

SN - 0090-3493

JO - Critical care medicine

JF - Critical care medicine

ER -

A Core Outcome Set for Adult General ICU Patients

Abstract

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