A Core Outcome Set for Adult General ICU Patients

被引：1

作者：

Kjaer, Maj-Brit Norregaard ^{[1
,2
]}

Bruun, Camilla Rahbek Lysholm ^{[1
]}

Granholm, Anders ^{[1
,2
]}

Moller, Morten Hylander ^{[1
,2
,3
]}

Rasmussen, Bodil Steen ^{[2
,4
]}

Mortensen, Camilla Bekker ^{[5
]}

Poulsen, Lone Museaus ^{[2
,5
]}

Strom, Thomas ^{[2
,6
]}

Laerkner, Eva ^{[6
]}

Brochner, Anne Craveiro ^{[2
,7
]}

Haberlandt, Trine ^{[7
]}

Bunzel, Anne-Marie Gellert ^{[4
]}

Herlov, Louise Stenbryggen ^{[5
]}

Holm, Anna ^{[8
]}

Sivapalan, Praleene ^{[1
]}

Estrup, Stine ^{[1
]}

Cronhjort, Maria ^{[2
,9
,10
]}

Schandl, Anna ^{[9
,11
]}

Laake, Jon Henrik ^{[2
,12
,13
]}

Hofso, Kristin ^{[2
,14
,15
]}

Blokzijl, Fredrike ^{[16
]}

Keus, Frederik ^{[16
]}

Pfortmueller, Carmen Andrea ^{[2
,17
]}

Ostermann, Marlies ^{[2
,18
]}

Cole, Jade M. ^{[19
]}

Wise, Matt P. ^{[2
,19
]}

Szczeklik, Wojciech ^{[2
,20
]}

Wludarczyk, Anna ^{[20
]}

Jovaisa, Tomas ^{[21
]}

Cecconi, Maurizio ^{[22
]}

Sigurdsson, Martin Ingi ^{[2
,23
,24
]}

Nalos, Marek ^{[2
,25
,26
]}

Hastbacka, Johanna ^{[2
,27
,28
]}

Makinen, Marja ^{[29
,30
]}

Hammond, Naomi ^{[31
,32
]}

Litton, Edward ^{[33
]}

Haines, Kimberley ^{[34
,35
]}

Myatra, Sheila Nainan ^{[36
]}

Vijayaraghavan, Bharath Kumar Tirupakuzhi ^{[37
,38
]}

Yadav, Kavita ^{[38
]}

Jha, Vivekanand ^{[32
,38
,39
,40
]}

Venkatesh, Balasubramanian ^{[31
,41
]}

Egerod, Ingrid ^{[1
]}

Perner, Anders ^{[1
,2
,3
]}

Collet, Marie O. ^{[1
]}

机构：

[1] Rigshosp, Copenhagen Univ Hosp, Dept Intens Care, Copenhagen, Denmark

[2] Collaborat Res Intens Care CR, Copenhagen, Denmark

[3] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark

[4] Aalborg Univ Hosp, Dept Anaesthesia & Intens Care, Aalborg, Denmark

[5] Zealand Univ Hosp, Dept Anaesthesiol, Roskilde, Denmark

[6] Odense Univ Hosp, Dept Anaesthesiol & Intens Care, Odense, Denmark

[7] Lillebaelt Hosp, Dept Anaesthesia & Intens Care, Kolding, Denmark

[8] Aarhus Univ Hosp, Dept Intens Care, Aarhus, Denmark

[9] Soder Sjukhuset, Karolinska Inst, Dept Clin Sci & Educ, Stockholm, Sweden

[10] Danderyd Hosp, Karolinska Inst, Dept Clin Sci, Stockholm, Sweden

[11] Soder Sjukhuset, Dept Perioperat & intens care, Stockholm, Sweden

[12] Oslo Univ Hosp, Dept Anaesthesiol & Intens Care Med, Rikshosp, Oslo, Norway

[13] Oslo Univ Hosp, Dept Res & Dev, Div Emergencies & Crit Care, Rikshosp, Oslo, Norway

[14] Oslo Univ Hosp, Dept Postoperat & Intens Care Nursing, Div Emergencies & Crit Care, Oslo, Norway

[15] Kristiania Univ Coll, Oslo, Norway

[16] Univ Groningen, Univ Med Ctr Groningen, Dept Crit Care, Groningen, Netherlands

[17] Inselspital Bern Univ Hosp, Dept Intens Care Med, Bern, Switzerland

[18] Guys & St Thomas Hosp, Dept Haematol, London, England

[19] Univ Hosp Wales, Adult Crit Care, Cardiff, Wales

[20] Jagiellonian Univ, Ctr Intens Care & Perioperat Med, Med Coll, Krakow, Poland

[21] Vilnius Univ, Fac Med, Clin Anaesthesiol & Intens Care, Vilnius, Lithuania

[22] IRCCS, Dept Pathol, Humanitas Res Hosp, Milan, Italy

[23] Univ Iceland, Fac Med, Reykjavik, Iceland

[24] Landspitali Natl Univ Hosp Iceland, Reykjavik, Iceland

[25] Charles Univ Prague, Med Sch & Teaching Hosp, Fac Med,Dept Internal Med 1, Biomed Ctr Pilsen,Med ICU, Plzen, Czech Republic

[26] Biomed Ctr Pilsen, Plzen, Czech Republic

[27] Tampere Univ Hosp, Fac Med & Hlth Technol, Wellbeing Serv Cty Pirkanmaa, Tampere, Finland

[28] Tampere Univ, Tampere, Finland

[29] Univ Helsinki, Dept Emergency Med & Serv, Helsinki, Finland

[30] Helsinki Univ Hosp, Helsinki, Finland

[31] Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia

[32] Royal North Shore Hosp, Malcolm Fisher Dept Intens Care, Sydney, NSW, Australia

[33] Fiona Stanley Hosp, Intens Care Unit, Robin Warren Dr, Murdoch, WA, Australia

[34] Western Hlth, Dept Physiotherapy, Melbourne, Vic, Australia

[35] Univ Melbourne, Melbourne Med Sch, Dept Crit Care, Melbourne, Vic, Australia

[36] Tata Mem Hosp, Homi Bhabha Natl Inst, Dept Anaesthesiol Crit Care & Pain, Mumbai, India

[37] Apollo Hosp, Chennai, India

[38] George Inst Global Hlth, New Delhi, India

[39] Manipal Acad Med Sci, Prasanna Sch Publ Hlth, Manipal, India

[40] Imperial Coll London, Sch Publ Hlth, London, England

[41] Gold Coast Univ Hosp, Dept Intens Care, Southport, Qld, Australia

来源：

CRITICAL CARE MEDICINE | 2025年 / 53卷 / 03期

关键词：

clinical trials; core outcome set; critical care; intensive care; patient and public involvement; patient-important outcomes; RESPIRATORY-FAILURE SURVIVORS; CLINICAL-RESEARCH; CARE;

D O I：

10.1097/CCM.0000000000006556

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

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.

引用

页码：e575 / e589

页数：15

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