Kunal R Gadhvi1,2, Frédéric V Valla2,3, Lyvonne N Tume1,2. 1. Bristol Royal Hospital for Children, Bristol, UK. 2. Faculty of Health and Applied Sciences, The University of the West of England, Stapleton, Bristol, UK. 3. Pediatric Intensive Care Unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, CarMEN INSERM UMR 1060, Lyon-Bron, France.
Abstract
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.
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.
Authors: Graeme O'Connor; Luise V Marino; Lyvonne N Tume; Alexandra Stewart; Simon Gates; Julie Lanigan; Harish Bangalore; Suzannah Kinsella Journal: Crit Care Explor Date: 2022-03-04