CORE-Kids: a protocol for the development of a core outcome set for childhood fractures
Ben Arthur Marson1, Joseph C Manning2, Marilyn James3
1Trauma Outcomes Group, University of Nottingham, Nottingham, UK ben.marson@nottingham.ac.uk.
Insights
This study aims to develop a core outcome set for childhood limb fracture research. This will standardize outcome reporting in pediatric orthopedic trials, benefiting families and clinicians.
Area of Science:
- Pediatric Orthopedics
- Clinical Trial Methodology
- Outcome Measurement
Background:
- Childhood limb fractures are common, but treatment research lacks standardized outcome reporting.
- Heterogeneity in reported outcomes hinders comparison and conclusion drawing in pediatric orthopedics.
- A core outcome set is needed to minimize bias and improve research consistency.
Purpose of the Study:
- To develop a core outcome set for research on childhood limb fractures.
- To ensure outcomes measured in trials are relevant to both families and clinicians.
- To include specific modules for upper and lower limb fractures.
Main Methods:
- Systematic review of existing trials to identify outcome domains.
- Semi-structured interviews with families to capture patient-centered outcomes.
- Three-round Delphi study with diverse stakeholders (parents, clinicians, researchers).
- Consensus meeting to finalize the core outcome set.
Main Results:
- The study is in the development phase of a core outcome set.
- Methodology includes systematic reviews, interviews, Delphi study, and consensus meeting.
- Ethical approval obtained (HRA/REC IRAS 262503) and trial registered (CORE-IM 1274).
Conclusions:
- A standardized core outcome set is crucial for improving the quality and comparability of childhood limb fracture research.
- This initiative will reduce outcome reporting heterogeneity and bias in pediatric orthopedic trials.
- The developed set will ensure research outcomes reflect the priorities of both patients and healthcare providers.
Introduction:
Limb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability to compare study results and draw firm conclusions. The aim of the CORE-Kids Study is to develop a core outcome set for use in research studies of childhood limb fractures. A core outcome set will provide a minimum set of outcomes to be measured in all trials to minimise the heterogeneity of outcomes reported and minimise reporting bias. A core outcome set ensures that outcomes are reported that are relevant to families as well as clinicians. The core outcome set will include additional upper and lower limb modules.
Methods:
The development of the core outcome set will require four phases to evaluate:What are the outcomes that are relevant to professionals?What are the outcomes that are relevant to families?What are the most important of these outcomes?Which outcomes should be included in the core outcome set?This will be completed through a systematic review of trials to identify the outcomes domains that are relevant to trialists. A series of semi-structured interviews will be completed with families to identify the outcome domains that are relevant to families. These outcome domains will be used in a three-round Delphi Study to analyse the importance of these outcome domains to a range of stakeholders including parents, clinicians and researchers. Following this, the core outcome set will be decided at a consensus meeting.
Ethics And Dissemination:
Ethical approval has been awarded HRA/REC IRAS number 262503. Date of approval 06/08/2019. Dissemination will be through scientific literature and international societies.
Trial Registration:
Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1274. Date of registration 13/12/2018.
Prospero Registration Number:
CRD42018106605.
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