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

Thomas Davies(Queen Mary University of London), Rob J. J. van Gassel(Maastricht University Medical Centre), Marcel C.G. van de Poll(Maastricht University Medical Centre), Jan Gunst(KU Leuven), Michaël P. Casaer(KU Leuven), Kenneth B. Christopher(Brigham and Women's Hospital), Jean‐Charles Preiser(Université Libre de Bruxelles), Aileen Hill(RWTH Aachen University), Kürşat Gündoğan(Erciyes University), Annika Reintam Blaser(University of Lucerne), A. Rousseau, Carol Hodgson(The Alfred Hospital), Dale M. Needham(Johns Hopkins University), Martha Moreira Cavalcante Castro(Hospital Israelita Albert Einstein), Stefan J. Schaller(TUM Klinikum), T. McClelland(Queen Mary University of London), Jeffrey J. Pilkington(Manchester Metropolitan University), Carla M. Sevin(Vanderbilt University Medical Center), Paul E. Wischmeyer(Duke University), Zheng Lee(University of Malaya), Deepak Govil(Medanta The Medicity), Andrew Li(Woodlands Health Campus), Lee‐anne S. Chapple(The University of Adelaide), Linda Denehy(The University of Melbourne), Juan Carlos Montejo(Hospital Universitario 12 De Octubre), Briana J. Taylor(Barnes-Jewish Hospital), Danielle E. Bear(Guy's and St Thomas' NHS Foundation Trust), Rupert M. Pearse(Queen Mary University of London), Angela McNelly(Queen Mary University of London), John R. Prowle(Queen Mary University of London), Zudin Puthucheary(Queen Mary University of London)
Critical Care
August 6, 2022
10.1186/s13054-022-04113-x
Cited by 82Open Access
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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.

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