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Development of a core outcome set for idiopathic clubfoot management
Donato Giuseppe Leo1,2, Aisling Russell2, Anna Bridgens2
1Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Science, University of Liverpool, Liverpool, UK.
Insights
This study defines a core set of outcomes (COS) for idiopathic clubfoot research. This will standardize reporting, enabling better treatment decisions and study comparisons for this condition.
Area of Science:
- Orthopedics
- Pediatric Orthopedics
- Clinical Trial Methodology
Background:
- Idiopathic clubfoot treatment lacks standardized outcome reporting.
- Inconsistent reporting hinders treatment success evaluation and comparative analysis.
Purpose of the Study:
- To establish a core set of outcomes (COS) for idiopathic clubfoot.
- To enable consistent reporting and facilitate treatment decisions.
- To improve comparability of research findings in idiopathic clubfoot.
Main Methods:
- Literature review and stakeholder engagement (patients, parents, clinicians).
- Systematic review and OMERACT filter application.
- Two-round Delphi survey and consensus meeting.
Main Results:
- A consensus-driven core set of outcomes was developed.
- The COS provides a minimum standard for data collection.
- This framework addresses the need for consistent reporting in clubfoot studies.
Conclusions:
- A standardized core set of outcomes (COS) is crucial for idiopathic clubfoot research.
- The developed COS will enhance the reliability and comparability of clinical trial results.
- This initiative aims to improve patient care through evidence-based treatment decisions.
Aims:
This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot.
Methods:
A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders.
Conclusion:
The inconsistency in outcomes reporting in studies investigating idiopathic clubfoot has made it difficult to define the success rate of treatments and to compare findings between studies. The development of a COS seeks to define a minimum standard set of outcomes to collect in all future clinical trials for this condition, to facilitate comparisons between studies and to aid decisions in treatment. Cite this article: Bone Jt Open 2021;2(4):255-260.
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