Development of a core outcome set for use in routine orthodontic clinical trials

Tsichlaki, Aliki, O'Brien, Kevin, Benson, Philip E, Marshman, Zoe, Johal, Ama, Colonio-Salazar, Fiorella B, Harman, Nicola L ORCID: 0000-0001-6958-6466 and Fleming, Padhraig S (2020) Development of a core outcome set for use in routine orthodontic clinical trials. AMERICAN JOURNAL OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, 158 (5). pp. 650-660.

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Abstract

<h4>Introduction</h4>A diverse range of outcomes is used in orthodontic research with a focus on measuring outcomes important to clinicians and little consistency in outcome selection and measurement. We aimed to develop a core outcome set for use in clinical trials of orthodontic treatment not involving cleft or orthognathic patient groups.<h4>Methods</h4>A list of outcomes measured in previous orthodontic research was identified through a scoping literature review. Additional outcomes of importance to patients were obtained using qualitative interviews and focus groups with adolescents aged 10-16 years. Rating of outcomes was carried out in a 2-round electronic Delphi process involving health care professionals and patients using a 9-point scale. A face-to-face meeting was subsequently held with stakeholders to discuss the results before refining the core outcome set.<h4>Results</h4>After triangulation, a final list of 34 outcomes grouped under 10 domains was obtained for rating in the e-Delphi surveys. Fifteen outcomes were voted "in" after the second Delphi round involving 274 participants with a further outcome being included after the consensus meeting. These were subsequently refined into a final set of 7 core outcomes, including the impact of self-perceived esthetics, alignment and/or occlusion, skeletal relationship, stability, patient-related adherence, breakages, and adverse effects on teeth or teeth-supporting structures.<h4>Conclusions</h4>A bespoke orthodontic core outcome set encompassing both clinician- and patient-focused outcomes was developed. Incorporating this is the first step into providing a more holistic assessment of the impact of treatment while allowing for meaningful comparisons and synthesis of results from individual trials.

Item Type:	Article
Uncontrolled Keywords:	Humans, Treatment Outcome, Esthetics, Dental, Orthodontics, Consensus, Research Design, Delphi Technique, Adolescent, Child, Clinical Trials as Topic, Outcome Assessment, Health Care
Depositing User:	Symplectic Admin
Date Deposited:	08 Oct 2020 09:15
Last Modified:	18 Jan 2023 23:29
DOI:	10.1016/j.ajodo.2020.05.010
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3103862