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Published on: September 20, 2019
Review of Outcomes Used in Nutrition Trials in Pediatric Critical Care
Kunal R Gadhvi1,2, Frédéric V Valla2,3, Lyvonne N Tume1,2
1Bristol Royal Hospital for Children, Bristol, UK.
Insights
Pediatric intensive care (PIC) nutrition trials show wide variation in outcome measures and definitions. Standardizing key nutrition and non-nutrition outcomes is crucial for future research and evidence generation in PIC settings.
Area of Science:
- Pediatric Intensive Care
- Clinical Nutrition Research
- Evidence-Based Medicine
Background:
- Generating robust evidence in pediatric intensive care (PIC) is challenging due to small patient numbers and heterogeneity.
- Systematic reviews face limitations from non-standardized outcome measures and definitions.
- The increasing number of nutrition intervention trials in PIC necessitates an examination of current outcome measures.
Purpose of the Study:
- To systematically describe the outcome measures utilized in randomized controlled trials evaluating nutrition interventions in PIC.
- To identify variations and inconsistencies in outcome reporting within this field.
Main Methods:
- A systematic literature review was conducted for PIC nutrition intervention trials published between January 1, 1996, and February 20, 2018.
- Twenty-nine trials, involving 3226 patients, were analyzed.
Main Results:
- A total of 37 primary and 83 secondary outcomes were identified, categorized into PIC-related (infection, dependency, organ dysfunction, mortality) and nutrition-specific outcomes (energy targets, nutrition parameters, feeding tolerance).
- Significant variation was observed in the chosen outcome measures.
- Key outcome domains, including energy targets, feeding tolerance, and infection, lacked adequate definition.
Conclusions:
- Considerable variation in outcome measures and definitions exists in PIC nutrition trials.
- There is a need to establish consensus on optimal nutrition outcomes, including nutrition efficiency, tolerance, and relevant non-nutrition PIC outcomes.
- The next step involves an international Delphi study to develop a core outcome set for future pediatric nutrition trials.
Background:
Generating robust evidence within pediatric intensive care (PIC) can be challenging because of low patient numbers and patient heterogeneity. Systematic reviews may overcome small study biases but are limited by lack of standardization in outcome measures and their definition. Trials of nutrition interventions in PIC are increasing; thus, we wanted to examine the outcome measures being used in these trials.
Objective:
Our objective was to systematically describe outcome measures used when a nutrition intervention has been evaluated in a PIC randomized controlled trial.
Methods:
A systematic literature review of all studies involving a PIC trial of a nutrition intervention was undertaken from January 1, 1996, until February 20, 2018.
Results:
Twenty-nine trials met the criteria and were reviewed. They included a total of 3226 patients across all trials. Thirty-seven primary outcomes and 83 secondary outcomes were found. These were categorized into PIC-related outcomes (infection, intensive care dependency, organ dysfunction, and mortality) and nutrition outcomes (energy targets, nutrition parameters, and feeding tolerance). We found large variation in the outcome measures used. Outcome domains of energy targets, feeding tolerance, and infection were not adequately defined.
Conclusions:
Considerable variation in the outcome measures chosen and their definitions exist within PIC nutrition trials. Optimal nutrition outcomes for PIC must be agreed upon and defined, specifically domains of nutrition efficiency, nutrition tolerance, and non-nutrition PIC outcomes. The next step is to conduct an international Delphi study to gain expert consensus and develop a core outcome set to be reported in future pediatric nutrition trials.
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