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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Marshman, Philip Benson, Fiorella B. Colonio Salazar, Padhraig S. Fleming

Published in: Trials | Issue 1/2017

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Abstract

Background

Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people.

Methods/design

This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set.

Discussion

This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved.

Trial registration

The project has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) website, January 2016.
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Metadata
Title
Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study
Authors
Aliki Tsichlaki
Kevin O’Brien
Ama Johal
Zoe Marshman
Philip Benson
Fiorella B. Colonio Salazar
Padhraig S. Fleming
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2098-x

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