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. 2017 Aug 4;18(1):366.
doi: 10.1186/s13063-017-2098-x.

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

Aliki Tsichlaki  1 , Kevin O'Brien  2 , Ama Johal  3 , Zoe Marshman  4 , Philip Benson  4 , Fiorella B Colonio Salazar  3   5 , Padhraig S Fleming  3
Affiliations

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

Aliki Tsichlaki et al. Trials. .

Erratum in

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.

Keywords: Core outcome set; Delphi; Mixed-methods; Orthodontics.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this study was granted in the UK by the NHS Health Research Authority (HRA) and the East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference 16/EE/0466, IRAS ID 204588). Informed consent will be obtained from all participants taking part in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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References

    1. Steele JG, White D, Rolland SL, Fuller E. Children’s dental health survey 2013, Report 4: The burden of dental disease in children, England, Wales and Northern Ireland. 2015.
    1. Seehra J, Fleming PS, Newton T, DiBiase AT. Bullying in orthodontic patients and its relationship to malocclusion, self-esteem and oral health-related quality of life. J Orthod. 2011;38:247–56. doi: 10.1179/14653121141641. - DOI - PubMed
    1. O’Brien K, Wright JL, Conboy F, Macfarlane T, Mandall N. The Child Perceptions Questionnaire is valid for malocclusions in the United Kingdom. Am J Orthod Dentofac Orthop. 2006;129:536–40. doi: 10.1016/j.ajodo.2004.10.014. - DOI - PubMed
    1. Rusanen J, Lahti S, Tolvanen M, Pirttiniemi P. Quality of life in patients with severe malocclusion before treatment. Eur J Orthod. 2010;32:43–8. doi: 10.1093/ejo/cjp065. - DOI - PubMed
    1. Javidi H, Vettore M, Benson PE. Does orthodontic treatment before the age of 18 years improve oral health-related quality of life? A systematic review and meta-analysis. Am J Orthod Dentofac Orthop. 2017;151(4):644–55. doi: 10.1016/j.ajodo.2016.12.011. - DOI - PubMed

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