Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre...

Area of Science:

• Orthodontic research
• Clinical trial methodology
• Patient-centered outcomes

Background:

• Orthodontic treatment is common in young people, with significant NHS costs.
• Current research lacks patient perspectives and consistent outcome measures.
• This study addresses these gaps by developing a core outcome set for pediatric orthodontic interventions.

Framework:

• Mixed-methods approach integrating literature review, patient interviews, and Delphi surveys.
• Scoping review to identify existing outcome measures in orthodontic trials.
• Qualitative interviews and focus groups with patients (10-16 years) to capture their priorities.

Implementation:

• Electronic Delphi surveys with clinicians and patients to rank outcome importance.
• Face-to-face consensus meetings with stakeholders to finalize the core outcome set.
• Study registered on the Core Outcome Measures in Effectiveness Trials (COMET) website.

Implications:

• Informs patients, parents, clinicians, and commissioners on key orthodontic outcomes.
• Standardizes outcome measures for improved comparability and synthesis of clinical trial results.
• Enhances decision-making for all stakeholders in pediatric orthodontic care.