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.
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
Disease Category: Other
Disease Name: Critical illness
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Diet and nutrition
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Systematic review of outcome measures/measurement instruments
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
Stakeholders
• The participants will comprise representatives from three key stakeholder categories: clinical academics, patients and caregivers, and healthcare professionals.
• A large panel will be convened, using national and international professional society organisations. They will be identified using existing national and international critical care networks.
Information Sources/Systematic Review
• An initial list of outcomes will be identified based on a systematic review related to outcomes used in randomised controlled trials (RCTs) of nutrition in the critically ill. This systematic review included RCTs published and/or registered between January 2000 and August 2018.
• We will conduct an additional systematic review based on the same protocol to capture any further research literature from August 2018 to present day. This is registered on the International Prospective register of Systematic Reviews (PROSPERO CRD42021242457).
• We will refine our outcome list based on a thorough review of the literature.
• Outcomes will be identified from the above, extracted and mapped to a standard taxonomy for COS development. This outcome list will be peer reviewed by our international collaborators, including healthcare professionals, researchers and patients prior to being finalised for use in the Delphi.
Delphi Consensus Process
• Stage 1: Determining the Core Outcome Measures
• Stage 2: Determining the Core Outcome Measurement Instruments
Consensus Meeting
• This will be held via web conference comprising of at least 30% of the participants to ratify findings and deal with any uncertainty which may require additional voting.