. 2022 Aug 6;26(1):240.

doi: 10.1186/s13054-022-04113-x.

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

T W Davies^{1

2}, R J J van Gassel^{3

4}, M van de Poll^{3

4}, J Gunst⁵, M P Casaer⁵, K B Christopher⁶, J C Preiser⁷, A Hill⁸, K Gundogan⁹, A Reintam-Blaser^{10

11}, A F Rousseau¹², C Hodgson^{13

14}, D M Needham^{15

16}, M Castro¹⁷, S Schaller^{18

19}, T McClelland^{1

2}, J J Pilkington²⁰, C M Sevin²¹, P E Wischmeyer²², Z Y Lee²³, D Govil²⁴, A Li^{25

26}, L Chapple²⁷, L Denehy^{28

29}, J C Montejo-González³⁰, B Taylor³¹, D E Bear³², R Pearse^{1

2}, A McNelly¹, J Prowle^{1

2}, Z A Puthucheary^{33

34}

Affiliations

¹ William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
² Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK.
³ Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
⁴ Department of Surgery, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
⁵ Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
⁶ Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, USA.
⁷ Medical Direction, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, Belgium.
⁸ Departments of Intensive Care and Anesthesiology, University Hospital RWTH Aachen University, 52074, Aachen, Germany.
⁹ Division of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine, Kayseri, Turkey.
¹⁰ Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia.
¹¹ Department of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland.
¹² Department of Intensive Care, University Hospital of Liège, Liege, Belgium.
¹³ 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.
¹⁴ Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
¹⁵ Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA.
¹⁶ Pulmonary and Critical Care Medicine, Department of Medicine, and Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁷ Clinical Nutrition, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
¹⁸ 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.
¹⁹ School of Medicine, Klinikum Rechts Der Isar, Department of Anesthesiology and Intensive Care, Technical University of Munich, Munich, Germany.
²⁰ Centre for Bioscience, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester, UK.
²¹ Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
²² Department of Anesthesiology, Duke University School of Medicine, DUMC, Box 3094 Mail # 41, 2301 Erwin Road, Durham, NC, 5692 HAFS27710, USA.
²³ Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia.
²⁴ Institute of Critical Care and Anesthesia, Medanta: The Medicty, Gurugram, Haryana, India.
²⁵ Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System, Singapore, Singapore.
²⁶ Department of Intensive Care Medicine, Woodlands Health, Singapore, Singapore.
²⁷ Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia.
²⁸ The University of Melbourne, School of Health Sciences, Melbourne, Australia.
²⁹ Department of Allied Health, Peter McCallum Cancer Centre, Melbourne, Australia.
³⁰ Department of Intensive Care Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.
³¹ Department of Research for Patient Care Services, Barnes-Jewish Hospital, St. Louis, MO, USA.
³² Department of Critical Care and Department of Nutrition and Dietetics, Guy´S and St Thomas' NHS Foundation Trust, London, UK.
³³ 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.
³⁴ Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK. z.puthucheary@qmul.ac.uk.

PMID: 35933433
PMCID: PMC9357332
DOI: 10.1186/s13054-022-04113-x

Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

T W Davies et al. Crit Care. 2022.

. 2022 Aug 6;26(1):240.

doi: 10.1186/s13054-022-04113-x.

Authors

Affiliations

¹ William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
² Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK.
³ Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
⁴ Department of Surgery, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands.
⁵ Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
⁶ Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, USA.
⁷ Medical Direction, Erasme University Hospital, Universite Libre de Bruxelles, Brussels, Belgium.
⁸ Departments of Intensive Care and Anesthesiology, University Hospital RWTH Aachen University, 52074, Aachen, Germany.
⁹ Division of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine, Kayseri, Turkey.
¹⁰ Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia.
¹¹ Department of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland.
¹² Department of Intensive Care, University Hospital of Liège, Liege, Belgium.
¹³ 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.
¹⁴ Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
¹⁵ Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, USA.
¹⁶ Pulmonary and Critical Care Medicine, Department of Medicine, and Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁷ Clinical Nutrition, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
¹⁸ 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.
¹⁹ School of Medicine, Klinikum Rechts Der Isar, Department of Anesthesiology and Intensive Care, Technical University of Munich, Munich, Germany.
²⁰ Centre for Bioscience, Manchester Metropolitan University, John Dalton Building, Chester Street, Manchester, UK.
²¹ Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
²² Department of Anesthesiology, Duke University School of Medicine, DUMC, Box 3094 Mail # 41, 2301 Erwin Road, Durham, NC, 5692 HAFS27710, USA.
²³ Department of Anesthesiology, University of Malaya, Kuala Lumpur, Malaysia.
²⁴ Institute of Critical Care and Anesthesia, Medanta: The Medicty, Gurugram, Haryana, India.
²⁵ Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System, Singapore, Singapore.
²⁶ Department of Intensive Care Medicine, Woodlands Health, Singapore, Singapore.
²⁷ Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia.
²⁸ The University of Melbourne, School of Health Sciences, Melbourne, Australia.
²⁹ Department of Allied Health, Peter McCallum Cancer Centre, Melbourne, Australia.
³⁰ Department of Intensive Care Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain.
³¹ Department of Research for Patient Care Services, Barnes-Jewish Hospital, St. Louis, MO, USA.
³² Department of Critical Care and Department of Nutrition and Dietetics, Guy´S and St Thomas' NHS Foundation Trust, London, UK.
³³ 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.
³⁴ Critical Care and Perioperative Medicine Research Group, Adult Critical Care Unit, Royal London Hospital, London, E1 1BB, UK. z.puthucheary@qmul.ac.uk.

PMID: 35933433
PMCID: PMC9357332
DOI: 10.1186/s13054-022-04113-x

Abstract

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.

Keywords: Core outcome set; Critical illness; Delphi; Metabolism; Nutrition.

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Conflict of interest statement

ZP has received honoraria for consultancy and/or speaker fees from Nestle, Fresenius Kabi, Nutricia, Baxter and Faraday Pharmaceuticals, and research and educational grants from Nestle and Baxter. ARB has received honoraria for consultancy and/or speaker fees from Nestlé, Fresenius Kabi, VIPUN Medical and Nutricia, and a research grant from Fresenius Kabi. SS reports grants from Reactive Robotics GmbH (Munich, Germany), grants and non-financial support from STIMIT AG (Biel, Switzerland), Liberate Medical LLC (Crestwood USA), ESICM (Geneva, Switzerland), grants, personal fees and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany), personal fees from Springer Verlag GmbH (Vienna Germany) for educational purposes, non-financial support from Technical University of Munich (Munich, Germany) and from National and international societies (and their congress organisers) in the field of anesthesiology and intensive care medicine, outside the submitted work. SS held stocks in small amounts from Rhön-Klinikum AG and holds stocks in small amounts from Alphabeth Inc., Bayer AG and Siemens AG; these holdings have not affected any decisions regarding his research or this study. AH’s position is currently supported by a stipend from the Medical Faculty RWTH Aachen ‘Habilitationsstipendium.’ Within the last 36 months AH received lecture fees from Fresenius Kabi Germany and grants for investigator initiated trials from the DFG, Fresenius Kabi Germany, and Lotte & John Hecht Memorial foundation. None of the disclosed financial relationships may be perceived as inappropriately influencing AH’s contribution to this project or this manuscript. MVP received research funding from Fresenius-kabi and Nutricia Research, speakers fee from Nutricia. MVP is principal investigator of the PRECISe trial, which uses a COS for resp failure by DN. MPC receives funding from the Research Foundation Flanders (FWO) (Grant No. 1832817 N) and Onderzoeksraad, KU Leuven (Grant No. C24/17/070) and from the Private Charity Organisation ‘Help Brandwonden Kids.’ DEB has received speaker fees from Baxter Healthcare and has received research grant funding from Nutricia Ltd. All other authors declare that they have no competing interests.

Figures

**Fig. 1**
Graphic representation of outcomes identified in the updated systematic review. Bubble size denotes the frequency of outcome, bubble colour the variation in the definition of the measurement tool. Greater detail is available in Additional file 1

**Fig. 2**
Modified Delphi Process Flow Diagram. 30STS = 30 s sit-to-stand; 6MWT = 6-min walk test; ADL = Activities of daily living; GLIM = Global leadership on malnutrition; IADL = Instrumental activities of daily living; PCS SF-36 = Physical component score of the short form 36; SPPB = Short physical performance battery

See this image and copyright information in PMC

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Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

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Core outcome measures for clinical effectiveness trials of nutritional and metabolic interventions in critical illness: an international modified Delphi consensus study evaluation (CONCISE)

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