A Core Outcome Set and minimum reporting set for intervention studies in growth restriction in the NEwbOrN: the COSNEON study

Background
Different interventions and treatments are available for growth-restricted newborns to improve neonatal and long-term outcomes. Lack of outcome standardization across trials of feeding interventions limits pooled analysis of intervention effects. This study aimed to develop a core outcome set (COS) and minimum reporting set (MRS) for this research field.

Methods
A scoping search identified relevant outcomes and baseline characteristics. These outcomes were presented to two stakeholder groups (lay experience and professional experts) in three rounds of online Delphi surveys. The professional experts were involved in the development of the MRS. All items were rated for their importance on a 5-point Likert scale and re-rated in subsequent rounds after presentation of the results at the group level. During a face-to-face consensus meeting the final COS and MRS were determined.

Results
Forty-seven of 53 experts (89%) who completed the first round completed all three survey rounds. After the consensus meeting, consensus was reached on 19 outcomes and 17 baseline characteristics.

Conclusions
A COS and MRS for feeding interventions in the newborn after growth restriction were developed. Use of these sets will promote uniform reporting of study characteristics and improve data synthesis and meta-analysis of multiple studies.

Contributors

Stefanie E. Damhuis, Frank H. Bloomfield, Asma Khalil, Mandy Daly, Wessel Ganzevoort & Sanne J. Gordijn

Publication

Journal: Paediatric Research
Volume:
Issue:
Pages: -
Year: 2020
DOI: 10.1038/s41390-020-01119-5

Further Study Information

Current Stage: Completed
Date: September 2017 - September 2018
Funding source(s): none so far


Health Area

Disease Category: Neonatal care

Disease Name: Neonatal Growth

Target Population

Age Range: 0 - 0

Sex: Either

Nature of Intervention: Diet and nutrition

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Delphi process
- Consensus meeting
- Literature review

Linked Studies

    No related studies


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