Trial Design in Critical Care Nutrition: The Past, Present and Future
Abstract
:1. Challenges of Critical Care Nutrition Research
2. Study Design in the Past
2.1. Methodology
2.2. Population
2.3. Interventions
2.4. Outcomes
2.5. Interpretation of Research and Translation into Clinical Practice
3. Study Design in the Present
3.1. Methodology
3.2. Population
3.3. Interventions
3.4. Outcomes
4. Study Design in the Future
4.1. Methodology
4.2. Population
4.3. Interventions
4.4. Outcomes
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Past | Present | Future | |
---|---|---|---|
Study methodology | Small physiological, observational, and single-centre comparative trials; poorly defined and underdeveloped processes | Large phase III trials (usually in the 1000s); a priori defined protocols, outcomes, and interim analyses | Sophisticated statistical techniques; larger sample sizes (tens of thousands); adaptive trial designs |
Population | Small, specific populations often from specialist centres | General, heterogenic populations | Homogenous; selected based on anticipated response to nutrition intervention (e.g., malnourished); includes non-invasively ventilated cohorts |
Intervention | Calories; early vs. late initiation; route of delivery e.g., gastric vs. jejunal, EN vs. PN, protein- vs. glucose-based PN, medium- vs. long-chain triglycerides and branched chain amino acids; immunonutrition | General interventions for general questions; focused only on the period in ICU | Synergistic; patient-specific; based on mechanisms; extension of interventions beyond ICU discharge considering illness trajectory |
Outcomes | Calorie delivery; nitrogen balance; incidence of infection; mortality (but underpowered to show an effect in the latter) | Robust clinical outcomes such as mortality | Patient recovery; functional outcomes; valid surrogate markers |
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Chapple, L.-a.S.; Ridley, E.J.; Chapman, M.J. Trial Design in Critical Care Nutrition: The Past, Present and Future. Nutrients 2020, 12, 3694. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123694
Chapple L-aS, Ridley EJ, Chapman MJ. Trial Design in Critical Care Nutrition: The Past, Present and Future. Nutrients. 2020; 12(12):3694. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123694
Chicago/Turabian StyleChapple, Lee-anne S., Emma J. Ridley, and Marianne J. Chapman. 2020. "Trial Design in Critical Care Nutrition: The Past, Present and Future" Nutrients 12, no. 12: 3694. https://0-doi-org.brum.beds.ac.uk/10.3390/nu12123694