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A Core Outcome Set and minimum reporting set for intervention studies in growth restriction in the NEwbOrN: the
Stefanie E Damhuis1, Frank H Bloomfield2, Asma Khalil3
1Department of Obstetrics and Gynaecology, University Medical Center of Groningen, University of Groningen, Groningen, The Netherlands. s.e.damhuis@umcg.nl.
Insights
This study developed a core outcome set (COS) and minimum reporting set (MRS) to standardize reporting for feeding interventions in growth-restricted newborns. This will improve data synthesis and meta-analyses for better infant outcomes.
Area of Science:
- Neonatology
- Pediatric Research
- Clinical Trial Methodology
Background:
- Standardization of outcomes is lacking in feeding intervention trials for growth-restricted newborns.
- This limits the ability to pool data and analyze intervention effects effectively.
- A core outcome set (COS) and minimum reporting set (MRS) are needed for this field.
Purpose of the Study:
- To develop a consensus-based core outcome set (COS).
- To develop a consensus-based minimum reporting set (MRS).
- For studies involving feeding interventions in growth-restricted newborns.
Main Methods:
- Scoping search to identify relevant outcomes and baseline characteristics.
- Three rounds of online Delphi surveys with lay and professional stakeholders.
- Face-to-face consensus meeting to finalize the COS and MRS.
Main Results:
- Consensus was reached on 19 outcomes and 17 baseline characteristics.
- 89% of initial experts completed all three survey rounds.
- The developed sets represent an international consensus.
Conclusions:
- A COS and MRS for feeding interventions in growth-restricted newborns have been established.
- These sets will standardize reporting and improve data synthesis.
- Facilitates meta-analysis of multiple studies to optimize interventions.
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.
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.
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