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

Aliki Tsichlaki1, Kevin O'Brien2, Ama Johal3

  • 1Department of Orthodontics, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, E1 1BB, UK. a.tsichlaki@qmul.ac.uk.

Trials
|August 6, 2017
PubMed

Insights

This study develops a core outcome set for orthodontic treatment in young people, ensuring patient priorities are central to research. This will standardize outcome measures for better clinical trial comparisons and informed decision-making.

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.
Abstract

Keywords:
Core outcome setDelphiMixed-methodsOrthodontics

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