Abstract
BackgroundOrthodontic 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/designThis 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.DiscussionThis 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 registrationThe project has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) website, January 2016.
Highlights
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
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
Summary
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. Orthodontics is currently provided to approximately one third of young people in England and Wales at a cost to the National Health Service (NHS) of £273 million in 2013–2014, accounting for 11.2% of the dental budget [7]. While the number of clinical trials in biomedical and dental research is increasing, it has been suggested that the reported outcome measures may resonate more with clinicians than with our patients [9]. This is important because the usefulness of a study relies on the outcomes it explores. This situation has been exposed in the field of respiratory medicine with Sinha et al [10] bemoaning ‘wasted resources or misleading information that overestimates, underestimates or completely misses the potential benefits of an intervention’ secondary to the selection of inappropriate outcomes
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