Determining optimal outcome measures in a trial investigating no routine gastric residual volume measurement in critically ill children
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Published version
Author(s)
Type
Journal Article
Abstract
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.
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.
Date Issued
2021-01-01
Date Acceptance
2020-02-10
Citation
Journal of Parenteral and Enteral Nutrition, 2021, 45 (1), pp.79-86
ISSN
0148-6071
Publisher
Wiley
Start Page
79
End Page
86
Journal / Book Title
Journal of Parenteral and Enteral Nutrition
Volume
45
Issue
1
Copyright Statement
© 2020 The Authors. Journal of Parenteral and Enteral Nutrition published by Wiley Periodicals, Inc. on behalf of American Society for Parenteral and Enteral Nutrition
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Sponsor
Health Technology Assessment programme
Grant Number
16/94/02
Subjects
Science & Technology
Life Sciences & Biomedicine
Nutrition & Dietetics
child
enteral feeding
intensive care
nutrition
pediatric
trials
IMPACT
child
enteral feeding
intensive care
nutrition
pediatric
trials
Paediatric Intensive Care Society Study Group (PICS-SG)
11 Medical and Health Sciences
Nutrition & Dietetics
Publication Status
Published
Date Publish Online
2020-03-06