The latest guidelines on intravenous maintenance fluid therapy (IV-MFT) have shown that the results reported in trials and studies in this field are heterogeneous. It is therefore difficult to draw conclusions from an analysis of the literature and to compare one study with another. Before carrying out any further studies or reviews in the field of IV-MFT, it seems essential to determine a set of standardised outcomes. Our main objective is to provide a set of standardised outcomes for IV-MFT that would allow researchers to measure and report the same outcomes in future trials.
ContributorsThe ESPNIC-IVMFT group works on behalf of the Metabolism Endocrinology and Nutrition section of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC):
• David Brossier. CHU de Caen, Pediatric Intensive Care Unit, Caen, F-14000, France; Université Caen Normandie, medical school, Caen, F-14000, France; Université de Lille, CHU Lille, ULR 2694 - METRICS : Évaluation des technologies de santé et des pratiques médicales, F-59000 Lille, France; Orcid ID: 0000-0002-2059-9888; brossier-d@chu-caen.fr (SUPERVISORS)
• Frédéric V. Valla. Pediatric Intensive Care, Hospices Civils de Lyon, Lyon, France; Orcid ID : 0000-0001-5285-1104; frederic.valla@chu-lyon.fr (SUPERVISORS)
• Lyvonne N. Tume. Pediatric Intensive Care Unit Alder Hey Children’s Hospital, Liverpool, United Kingdom ; Faculty of Heath Social care & Medicine, Edge Hill University, United Kingdom; Orcid ID: 0000-0002-2547-8209; L.N.Tume@salford.ac.uk (SUPERVISORS)
• Fahad Alsohime, Pediatric Intensive Care, Pediatric department, College of Medicine, King Saud University, Riyadh, Saudi Arabia; fahad.alsohime@gmail.com
• Sophie Beldjilali, Pediatric Intensive Care, Assistance Publique Hopitaux de Marseille, Marseille, France ; beldjilali.sophie@gmail.com
• Fabrizio Chiusolo, Pediatric Intensive Care, Bambino Gesù Children’s Hospital, Rome, Italy; Orcid ID: 0000-0003-0265-609X; fabrizio.chiusolo@opbg.net
• Leonardo Costa, Pediatric Intensive Care, S.Orsola-Malpighi University Hospital, Bologna, Italy; leonardo.costa@aosp.bo.it
• Capucine Didier, Pediatric Intensive Care, Hospices Civils de Lyon, Lyon, France; capucined@gmail.com • Isabelle Goyer, Department of Pharmacy, CHU de Caen; goyer-i@chu-caen.fr
• Stavroula Ilia, Pediatric Intensive Care, University Hospital, Medical School, University of Crete, Heraklion, Greece; Orcid ID: 0000-0002-0936-368X; stavroula.ilia@uoc.gr
• Nyandat L Joram, Moi Teaching and Referral Hospital, Eldoret, Kenya; Orcid ID: 0000-0003-4107-3241; jnyandat@gmail.com
• Corinne Jotterand Chaparro, Department of Nutrition and Dietetics, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland; Orcid ID: 0000-0002-1538-7127, corinne.jotterand@hesge.ch
• Martin CJ Kneyber, Pediatric Intensive Care, Beatrix Children's Hospital, Groningen, the Netherlands; Orcid ID: 0000-0002-6008-3376; m.c.j.kneyber@umcg.nl
• Eva Kühlwein, Department of Intensive Care and Neonatology, and Children’s Research Center, University Children`s Hospital Zurich, Zurich, Switzerland; Eva.Kuehlwein@kispi.uzh.ch
• Jorge Lopez, Pediatric Intensive Care, Gregorio Marañón General University Hospital; Orcid ID: 0000-0002-9942-6399; jlopezgonz82@gmail.com
• Jesus López-Herce, Pediatric Intensive Care, Gregorio Marañón General University Hospital, Madrid, Spain; Orcid ID: 0000-0001-6105-9178; pielvi@hotmail.com
• Luise V. Marino, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Orcid ID: 0000-0002-1257-121X; luise.marino@uhs.nhs.uk
• Huw F. Mayberry, Pediatric Intensive Care, Alder Hey Childrens Hospital, Liverpool, United Kingdom; Orcid ID: 0000-0002-3769-2595 ; huw.mayberry@alderhey.nhs.uk
• Fortesa Mehmeti, Pediatric Intensive Care, University Hospital of Geneva, Geneva, Switzerland; fortesa.Mehmeti@hcuge.ch
• Magdalena Mierzewska-Schmidt, Department of Paediatric Anaesthesiology and Intensive Therapy, Medical University of Warsaw, Warsaw, Poland; mcdosia@gmail.com
• MarIa Miñambres Rodríguez, Pediatric Intensive Care, Virgen de la Arrixaca Hospital, Murcia, Spain; Orcid ID: 0000-0001-7955-5612; mariamiro@gmail.com
• Claire Morice, Pediatric Intensive Care, University Hospital of Geneva, Geneva, Switzerland; Claire.Morice@hcuge.ch
• Clémence Moullet, Department of Nutrition and Dietetics, Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland; Orcid ID: 0000-0003-1056-9869; clemence.moullet@hesge.ch
• John V. Pappachan, Pediatric Intensive Care, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Orcid IB: 0000-0002-3559-0595; jvp@soton.ac.uk
• Florence Porcheret, Department of Pediatric nephrology, CHU de Nantes, Nantes, France; florence.porcheret@chu-nantes.fr
• Leonor Reis Boto, Pediatric Intensive Care, Departament of Pediatrics, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte, Lisbon, Portugal, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Orcid ID: 0000-0001-6144-1617; boto.leonor@gmail.com
• Shancy Rooze, Pediatric Intensive Care, HUDERF, Brussels, Belgium; shancy.rooze@huderf.be • Luregn J Schlapbach. Department of Intensive Care and Neonatology, and Children’s Research Center, University Children`s Hospital Zurich, Zurich, Switzerland; Orcid ID: 0000-0003-2281-259; Luregn.Schlapbach@kispi.uzh.ch
• Hakan Tekguc, Pediatric Intensive Care, Dr. Burhan Nalbantoglu State Hospital, Nicosia, North Cyprus; Orcid ID: 0000-0001-6424-6761 ; tekguchakan@gmail.com
• Konstantinos Tziouvas, Pediatric Intensive Care, Aglaia Kyriakou Children’s Hospital, Athens, Greece; Orcid ID: 0000-0002-6863-7708; ktziouvas@yahoo.com
• Sascha CAT Verbruggen, Pediatric Intensive Care, Erasmus MC - Sophia Childrens Hospital, Rotterdam, The Netherlands; Orcid ID: 0000-0003-4866-9865; s.verbruggen@erasmusmc.nl
Disease Category: Child health
Disease Name: Critical illness , Acute illness
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
PHASE 1) Systematic review of the literature
- Systematic review of the literature
- Removal of non-relevant manuscripts: Screening of the Title/abstract list extracted by the librarian.
o For data extraction: RCT, cohort studies, before/after studies, case series
o To ensure exhaustive extraction of literature: Reviews, editorials, commentaries
o Exclusion of: animal studies, conference abstracts and letters
Two members per group to avoid missing papers. If disagreement: discussion +/- intervention of third member (one of the 3 leaders: Lyvonne, Frederic, David)
This will be performed thanks to the open access software Rayyan: https://www.rayyan.ai/
- Search for full text articles via the academic librarian – Lyon, France (free support)
- Removal of non-relevant manuscripts: Screening of the remaining full text manuscripts
Two members per group to avoid missing papers. If possible, the member who evaluates the full text article is different from the one that have screened the title and abstract.
If disagreement: discussion +/- intervention of third member (one of the 3 leaders: Lyvonne, Frederic, David)
PHASE 2) Data extraction
- Completion of a standardized data extraction form
Each paper analyzed by 2 members (excluding authors of the paper)
- Outcome (Definition, Value and units, Timing)
- Corresponding author of the article with mailing address. (At least 1 per article)
PHASE 3) Delphi procedure
After the outcomes have been extracted and summarised into categories, a consensus process will be undertaken to agree on a minimum core outcome set.
- Voting Rounds
A modified 2 round Delphi study will be undertaken.
Round 1
All outcomes identified in the previous phase of the study will be input into an E-survey (using SurveyMonkey Professional). For each outcome item, participants will be asked to rank he importance of the outcome for trials of intravenous fluids on a Likert Scale (1-9). One free text question at the end will allow participants to add any outcome they believe is important, but which has not already been listed.
Basic demographic details of respondents will be collected, for example: Professional role, type of PICU working in, years of experience and country/city unit in.
Round 2:
Mean, median and SD of the ranked items will be summarised from R1. Items meeting the apriori defined threshold for importance will be carried through into the R2 survey. This R2 survey will have the outcomes along with the group mean score from R1 and ask participants to re-rank the outcomes on the same Likert scale. They were also asked to score any additional outcomes suggested in round 1. Finally, they will be asked to specify a single primary outcome.
Sample
- Experts in the field of pediatric IV fluids
o Authors of article on the subject identified through authorship on publications included in the review.
o Members of the IVMFT group
- Non experts
o The survey will also be sent to a wider group of PICU professionals through the professional societies: ESPNIC, ASPEN, PCCS and WFPICS. The survey will be English only (or also in French?) hence the use of these societies where the official language is English.
- Parents and patients
o Each member of the active group will be asked to survey from 2 to 5 patients and/or parents.