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Determining optimal outcome measures in a trial investigating no routine gastric residual volume measurement in critically ill children

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Title: Determining optimal outcome measures in a trial investigating no routine gastric residual volume measurement in critically ill children
Authors: Tume, L
Arch, B
Woolfall, K
Roper, L
Deja, E
Jones, A
Latten, L
Eccleston, H
Nazima, P
Preston, J
Beissel, A
Andrzejewska, I
Gale, C
Valla, F
Dorling, J
Item 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.
Issue Date: 1-Jan-2021
Date of Acceptance: 10-Feb-2020
URI: http://hdl.handle.net/10044/1/77875
DOI: 10.1002/jpen.1817
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.
Sponsor/Funder: Health Technology Assessment programme
Funder's Grant Number: 16/94/02
Keywords: 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
Online Publication Date: 2020-03-06
Appears in Collections:Faculty of Medicine
School of Public Health