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

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

*Corresponding author for this work

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    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. Findings: 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. Impact: Both a COS and MRS for growth restriction in the newborn were developed.This study provides the first international combined health-care professional and patient consensus on outcomes and baseline characteristics for intervention and treatment studies in growth-restricted newborns.The use of COS and MRS results in the development of more uniform study protocols, thereby facilitating data synthesis/meta-analysis of multiple studies aiming to optimize treatment and interventions in growth restriction in the newborn. [Figure not available: see fulltext. Caption: Flow chart of study selection for identifying outcomes and baseline characteristics.] [Figure not available: see fulltext. Caption: aBoth stakeholder groups >70% with a Likert score of 5 and <15% with a Likert score of 1 OR one stakeholder group >90% with a Likert score of 5. bGreater than 70% with a Likert score of 5 and <15% with a Likert score (professional experts only). cAgreement on inclusion >70 in both stakeholder groups or >90% in one stakeholder group. dAgreement on inclusion >70% (professional experts only). eConsensus criteria: five out of six agreement (>83%). fConsensus criteria: three out of three agreement (100%).]

    Original languageEnglish
    Pages (from-to)1380-1385
    Number of pages6
    JournalPediatric Research
    Early online date14-Sep-2020
    Publication statusPublished - May-2021

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