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,
R. J. J. van Gassel,
M. van de Poll,
J. Gunst,
M. P. Casaer,
K. B. Christopher,
J. C. Preiser,
A. Hill,
K. Gundogan,
A. Reintam-Blaser,
A. F. Rousseau,
C. Hodgson,
D. M. Needham,
M. Castro,
S. Schaller,
T. McClelland,
J. J. Pilkington,
C. M. Sevin,
P. E. Wischmeyer,
Z. Y. Lee,
D. Govil,
A. Li,
L. Chapple,
L. Denehy,
J. C. Montejo-González,
B. Taylor,
D. E. Bear,
R. Pearse,
A. McNelly,
J. Prowle,
Z. A. Puthucheary
Affiliations
T. W. Davies
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
R. J. J. van Gassel
Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+
M. van de Poll
Department of Intensive Care Medicine, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+
J. Gunst
Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven
M. P. Casaer
Clinical Department and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven
K. B. Christopher
Division of Renal Medicine, Channing Division of Network Medicine, Brigham and Women’s Hospital
J. C. Preiser
Medical Direction, Erasme University Hospital, Universite Libre de Bruxelles
A. Hill
Departments of Intensive Care and Anesthesiology, University Hospital RWTH Aachen University
K. Gundogan
Division of Intensive Care Medicine, Department of Internal Medicine, Erciyes University School of Medicine
A. Reintam-Blaser
Department of Anaesthesiology and Intensive Care, University of Tartu
A. F. Rousseau
Department of Intensive Care, University Hospital of Liège
C. Hodgson
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University
D. M. Needham
Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University
M. Castro
Clinical Nutrition, Hospital Israelita Albert Einstein
S. Schaller
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
T. McClelland
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
J. J. Pilkington
Centre for Bioscience, Manchester Metropolitan University
C. M. Sevin
Department of Medicine, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center
P. E. Wischmeyer
Department of Anesthesiology, Duke University School of Medicine, DUMC
Z. Y. Lee
Department of Anesthesiology, University of Malaya
D. Govil
Institute of Critical Care and Anesthesia, Medanta: The Medicty
A. Li
Division of Respiratory and Critical Care Medicine, Department of Medicine, National University Hospital, National University Health System
L. Chapple
Adelaide Medical School, Faculty of Health and Medical Sciences, The University of Adelaide
L. Denehy
The University of Melbourne, School of Health Sciences
J. C. Montejo-González
Department of Intensive Care Medicine, Hospital Universitario 12 de Octubre
B. Taylor
Department of Research for Patient Care Services, Barnes-Jewish Hospital
D. E. Bear
Department of Critical Care and Department of Nutrition and Dietetics, Guy´S and St Thomas’ NHS Foundation Trust
R. Pearse
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
A. McNelly
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
J. Prowle
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
Z. A. Puthucheary
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
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.
