Article (Scientific journals)
Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).
Davies, T W; van Gassel, R J J; van de Poll, M et al.
2022In Critical Care, 26 (1), p. 240
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Keywords :
Core outcome set; Critical illness; Delphi; Metabolism; Nutrition; Critical Care and Intensive Care Medicine
Abstract :
[en] BACKGROUND: Clinical research on nutritional and metabolic interventions in critically ill patients is heterogenous regarding time points, outcomes and measurement instruments used, impeding intervention development and data syntheses, and ultimately worsening clinical outcomes. We aimed to identify and develop a set of core outcome domains and associated measurement instruments to include in all research in critically ill patients. METHODS: An updated systematic review informed a two-stage modified Delphi consensus process (domains followed by instruments). Measurement instruments for domains considered 'essential' were taken through the second stage of the Delphi and a subsequent consensus meeting. RESULTS: In total, 213 participants (41 patients/caregivers, 50 clinical researchers and 122 healthcare professionals) from 24 countries contributed. Consensus was reached on time points (30 and 90 days post-randomisation). Three domains were considered 'essential' at 30 days (survival, physical function and Infection) and five at 90 days (survival, physical function, activities of daily living, nutritional status and muscle/nerve function). Core 'essential' measurement instruments reached consensus for survival and activities of daily living, and 'recommended' measurement instruments for physical function, nutritional status and muscle/nerve function. No consensus was reached for a measurement instrument for Infection. Four further domains met criteria for 'recommended,' but not 'essential,' to measure at 30 days post-randomisation (organ dysfunction, muscle/nerve function, nutritional status and wound healing) and three at 90 days (frailty, body composition and organ dysfunction). CONCLUSION: The CONCISE core outcome set is an internationally agreed minimum set of outcomes for use at 30 and 90 days post-randomisation, in nutritional and metabolic clinical research in critically ill adults.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Davies, T W;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK ; Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK
van Gassel, R J J;  Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands ; Department of Surgery, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands
van de Poll, M;  Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands ; Department of Surgery, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands
Gunst, J;  Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium
Casaer, M P;  Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium
Christopher, K B;  Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, USA
Preiser, J C;  Medical Direction, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, Belgium
Hill, A;  Departments of Intensive Care and Anesthesiology, University Hospital RWTH Aachen University, 52074, Aachen, Germany
Gundogan, K;  Division of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine, Kayseri, Turkey
Reintam-Blaser, A;  Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia ; Department of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland
Rousseau, Anne-Françoise  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service des soins intensifs
Hodgson, C;  Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, 3/553 St Kilda Rd, Melbourne, VIC, 3004, Australia ; Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia
Needham, D M;  Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA ; Pulmonary and Critical Care Medicine, Department of Medicine, and Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Castro, M;  Clinical Nutrition, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Schaller, S;  Department of Anesthesiology and Operative Intensive Care Medicine (CVK, CCM), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, Berlin Institute of Health, Berlin, Germany ; School of Medicine, Klinikum Rechts Der Isar, Department of Anesthesiology and Intensive Care, Technical University of Munich, Munich, Germany
McClelland, T;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK ; Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK
Pilkington, J J;  Centre for Bioscience, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester, UK
Sevin, C M;  Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
Wischmeyer, P E;  Department of Anesthesiology, Duke University School of Medicine, DUMC, Box 3094 Mail # 41, 2301 Erwin Road, Durham, NC, 5692 HAFS27710, USA
Lee, Z Y;  Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia
Govil, D;  Institute of Critical Care and Anesthesia, Medanta: The Medicty, Gurugram, Haryana, India
Li, A;  Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System, Singapore, Singapore ; Department of Intensive Care Medicine, Woodlands Health, Singapore, Singapore
Chapple, L;  Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia
Denehy, L;  The University of Melbourne, School of Health Sciences, Melbourne, Australia ; Department of Allied Health, Peter McCallum Cancer Centre, Melbourne, Australia
Montejo-González, J C;  Department of Intensive Care Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
Taylor, B;  Department of Research for Patient Care Services, Barnes-Jewish Hospital, St. Louis, MO, USA
Bear, D E;  Department of Critical Care and Department of Nutrition and Dietetics, Guy´S and St Thomas' NHS Foundation Trust, London, UK
Pearse, R;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK ; Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK
McNelly, A;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Prowle, J;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK ; Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK
Puthucheary, Z A;  William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. z.puthucheary@qmul.ac.uk ; Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK. z.puthucheary@qmul.ac.uk
More authors (21 more) Less
Language :
English
Title :
Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE).
Publication date :
06 August 2022
Journal title :
Critical Care
ISSN :
1364-8535
eISSN :
1466-609X
Publisher :
Springer Science and Business Media LLC, England
Volume :
26
Issue :
1
Pages :
240
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 08 August 2022

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