Determining Optimal Outcome Measures in a Trial Investigating No Routine Gastric Residual Volume Measurement in Critically Ill Children.
child
enteral feeding
intensive care
nutrition
pediatric
trials
Journal
JPEN. Journal of parenteral and enteral nutrition
ISSN: 1941-2444
Titre abrégé: JPEN J Parenter Enteral Nutr
Pays: United States
ID NLM: 7804134
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
26
11
2019
revised:
05
02
2020
accepted:
10
02
2020
pubmed:
8
3
2020
medline:
20
3
2021
entrez:
8
3
2020
Statut:
ppublish
Résumé
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. A mixed-methods approach was used: a focused literature review, parent and clinician interviews, a modified 2-round Delphi, and a stakeholder consensus meeting. 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. We have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians.
Sections du résumé
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.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
79-86Informations de copyright
© 2020 The Authors. Journal of Parenteral and Enteral Nutrition published by Wiley Periodicals, Inc. on behalf of American Society for Parenteral and Enteral Nutrition.
Références
Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.
Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials. 2007;8(1):39.
Duffet M. Database of Randomized Controlled Trials in Pediatric Intensive Care. McMaster University. Accessed October 2019.http://picutrials.net/rcts-characteristics/
Tume LN, Arch B, Woolfall K, et al. Gastric residual volume measurement in U.K. PICUs. Pediatr Crit Care Med. 2019;20(8):707-713.
O'Hara CB, Canter RR, Mouncey PR, et al. A qualitative feasibility study to inform a randomised controlled trial of fluid bolus therapy in septic shock. Arch Dis Child. 2017;103(1):28-32.
Saunders B, Sim J, Kingstone T, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907.
Woolfall K, O'Hara C, Deja E, et al; PERUKI (Pediatric Emergency Research in the UK and Ireland) and PICS (Pediatric Intensive Care Society). Parents’ prioritised outcomes for trials investigating treatments for paediatric severe infection: a qualitative synthesis. Arch Dis Child. 2019;104(11):1077-1082.
Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107-115.
Keeney S, Hasson F, McKenna H. The Delphi Technique in Nursing and Health Research. Chichester, UK: Wiley-Blackwell; 2011.
Delphi Manager Software. http://www.comet-initiative.org/delphimanager/docs/DelphiManagerBrochureV4.0.pdf. Accessed October 1, 2018.
Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395-400.
Tume LN, Bickerstaff A, Latten L, et al. Routine gastric residual volume measurement and energy target achievement in the PICU: a comparison study. Eur J Pediatr. 2017;176(12):1637-1644. https://doi.org/10.1007/s00431-017-3015-8
Reignier J, Mercier E, Le Gouge A, et al. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding. JAMA. 2013;309(3):249-256.
Poulard F, Dimet J, Martin-Lefevre L, et al. Impact of not measuring residual gastric volume in mechanically ventilated patients receiving early enteral feeding. JPEN J Parenter Enteral Nutr. 2010;34(2):125-130.
Ozen N, Nuran T, Yamanel L, Altintas N, Kilciler G Ozen V. Evaluation of the effect on patient parameters of not monitoring gastric residual volume in intensive care patients on a mechanical ventilator receiving enteral feeding: a randomized clinical trial. J Crit Care. 2016;33:137-144.
Riskin A, Cohen K, Kugelman A, Toropine A, Said W, Bader D. The impact of routine evaluation of gastric residual volumes on the time to achieve full enteral feeding in preterm infants. J Pediatr. 2017;189:128-134.
Torrazza RM, Parker LA, Li Y, Talaga E, Shuster J, Neu J. The value of routine evaluation of gastric residuals in very low birth weight infants. J Perinatol Off J Calif Perinat Assoc. 2015;35(1):57-60.
Peters MJ, Khan I, Woolfal K, et al. Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT. Health Technol Assess. 2019;23(5):1-148
Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267-276. https://doi.org/10.1016/S0140-6736(13)62228-X.
Prinsen CA, Vohra S, Rose MR, et al. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15(1):247. https://doi.org/10.1186/1745-6215-15-247.
Tume LN, Latten L, Kenworthy L. Paediatric intensive care nurses' decision-making around gastric residual volume measurement. Nurs Crit Care. 2017;22(5):293-297.
Richardson M, Hines S, Dixon G, Highe L, Brierley J. Establishing nurse-led ventilator-associated pneumonia surveillance in paediatric intensive care. J Hosp Infect. 2010;75(3):220-224.
Ismail N, Darbyshire A, Thorburn K. Ventilator-associated pneumonia (VAP): a UK PICU experience. Arch Dis Child. 2012;97(suppl 1):A153.3-A154. http://doi.org/10.1136/archdischild-2012-301885.361
Maayan-Metzger A, Itzchak A, Mazkereth R, Kuint J. Necrotizing enterocolitis in full-term infants: case-control study and review of the literature. J Perinatology. 2004;24(8):494-499.