Core Outcome Measures in Effectiveness Trials

Core outcomes measures for studies of nutritional interventions in pediatric critical care

General Information

Summary:
There is evidence of much heterogeneity in the outcome measures chosen and used in nutrition studies and trials in paediatric intensive care (PIC). As most studies in PIC are small and single centre (and frequently underpowered) the need to combine data sets for analysis can be of paramount importance. The heterogeneity in outcome measures used and their de?nition creates challenges for researchers and prevents comparison of multiple studies in a meta-analysis. As a result, there is an urgent need to systematically describe outcome measures used in these studies, speci?cally in children, before proceeding to an International Delphi study to agree a standardised core outcome set (COS) to be used in future nutrition trials.

Contributors:
Dr Lyvonne Tume (Lead)
Dr Kunal Gadvi
Dr Frederic Valla
Dr Nilesh Mehta
Dr Bodil Larsen
Dr Yara Moreno
Dr Alejandro Floh
Dr Praveen Goday
Dr Jan Hau Lee
Dr Nazima Patham
Dr Sascha Verbruggen
Dr Corinne Jotterand

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - December 2019
Funding source(s):
None

Health Area

Disease Category
Child health

Disease Name
Critical illness

Target Population

Age Range
0 - 17

Sex
Either


Nature / type of Intervention
Diet and nutrition
Intensive care

Method(s)

Delphi process
Systematic review

A systematic search for all studies involving an aspect of nutritional practice or intervention in pediatric critical care will be undertaken. First trials will be examined and then this will be extended to other study designs and published trial protocols where appropriate. Primary and secondary outcomes will be extracted using a standardised pre-tested data extraction tool. Two reviewers will independently screen articles for eligibility and conduct data extraction and review the study quality for al primary and secondary outcomes. This will be followed by a modified 3 round Delphi study of international experts.


Stakeholders Involved

Clinical experts
Methodologists
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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