Determining Optimal Outcome Measures in a Trial Investigating No Routine Gastric Residual Volume Measurement in
Lyvonne N Tume1, Barbara Arch2, Kerry Woolfall3
1University of Salford, Manchester, UK.
Insights
Selecting relevant outcomes is crucial for pediatric critical care trials. This study identified 12 key outcome measures for trials evaluating no routine gastric residual volume (GRV) measurement, incorporating parent and clinician input.
Area of Science:
- Pediatric critical care research
- Clinical trial methodology
- Outcome measure development
Background:
- Clinical trial outcomes must be relevant to patients and parents for effective implementation.
- Lack of relevant outcomes can hinder the adoption of trial evidence into practice.
- Determining optimal outcome measures is essential for high-quality research in pediatric intensive care.
Purpose of the Study:
- To identify and establish optimal outcome measures for a clinical trial.
- The trial focuses on the practice of withholding routine gastric residual volume (GRV) measurement in critically ill children.
- Incorporate perspectives of parents and clinicians in outcome selection.
Main Methods:
- A mixed-methods approach was employed.
- Included a focused literature review, parent and clinician interviews, a modified Delphi method (2 rounds), and a stakeholder consensus meeting.
- Multistage process involving iterative rating and voting by participants.
Main Results:
- An initial 13 outcomes were identified from the literature review.
- Parents and clinicians proposed additional outcomes, leading to a total of 22 considered.
- A final set of 12 outcome measures was selected through consensus, including time to energy targets, VAP, vomiting, and feed intolerance markers.
Conclusions:
- Identified 12 essential outcome measures for a trial on omitting routine gastric residual volume measurements.
- The selection process prioritized input from parents and clinicians.
- These outcomes will enhance the relevance and applicability of trial findings in pediatric critical care.
Background:
Choosing trial outcome measures is important. When outcomes are not clinically relevant or important to parents/patients, trial evidence is less likely to be implemented into practice. This study aimed to determine optimal outcome measures for a trial of no routine gastric residual volume (GRV) measurement in critically ill children.
Methods:
A mixed-methods approach was used: a focused literature review, parent and clinician interviews, a modified 2-round Delphi, and a stakeholder consensus meeting.
Results:
The review generated 13 outcomes. Fourteen pediatric intensive care unit (PICU) parents proposed 3 additional outcomes; these 16 were then rated by 28 clinicians in Delphi round 1. Six further outcomes were proposed, and 22 outcomes were rated in the second round. No items were voted "consensus out." The 18 "no-consensus" items were voted in a face-to-face meeting by 30 participants. The final 12 outcome measures were time to reach energy targets, ventilator-associated pneumonia, vomiting, time enteral feeds withheld per 24 hours, necrotizing enterocolitis, length of invasive ventilation, PICU length of stay, mortality, change in weight and markers of feed intolerance (parenteral nutrition administered), feed formula altered, and change to postpyloric feeds all secondary to feed intolerance.
Conclusion:
We have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians.
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