Core Outcome Measures in Effectiveness Trials

Development of a core outcome set reflecting patient values for orthodontic treatment for young people

General Information

Orthodontic or ‘brace’ treatment is undertaken to correct anomalies of the teeth and jaws. This treatment aims to eliminate problems that might be a threat to the dental health of young people and, by improving appearance and function, may result in a better quality of life and social well-being. Approximately one-third of children in England and Wales undergo brace treatment at significant cost to the NHS. Currently young people are eligible for NHS orthodontic treatment based only on an index (IOTN), which examines the arrangement of the teeth. This does not take into account any other aspects that might be important to either the young person or their parent, such as the impact of dento-facial anomalies on their daily lives. The results of a recent systematic review found that most previous orthodontic research has used outcomes that do not relate to values that might be of importance to patients. Moreover, there is no consensus on the outcomes to include in orthodontic trials and this has led to difficulties in comparing evidence between studies, in systematic reviews and in providing information essential for consenting to treatment. The development of a core set of outcomes is a recognised method of addressing these issues. The overall aim is to develop a core outcome set for use in clinical trials involving the orthodontic treatment of children and young people. The results will ultimately benefit decision-making by all stakeholders


Dr Padhraig Fleming (Queen Mary University of London), Dr Aliki Tsichlaki (Queen Mary University of London), Prof. Philip Benson (University of Sheffield), Dr Zoe Marshman (University of Sheffield), Dr Nicola Harman (University of Liverpool), Prof. Paula Williamson (University of Liverpool), Dr Tanya Walsh (University of Manchester), Prof. Kevin O' Brien (University of Manchester)

Further Study Information

Current Stage:
January 2016 - January 2018
Funding source(s):
Funding being sought

Health Area

Disease Category
Child health
Dentistry & oral health

Disease Name

Target Population

Age Range
10 - 18


Nature / type of Intervention


Consensus meeting
Delphi process
Semi structured discussion
Systematic review

1. Update of a recently published systematic review that has identified the primary and secondary outcome measures used in orthodontic clinical trials from January 1st, 2008 to December 31st, 2012

2. Qualitative interviews with young people who are due to have, are undergoing or have had orthodontic treatment and their parents to identify important results of treatment

3. Three-round E-Delphi surveys of these patients, parents and clinicians to identify outcome measures of most importance. This will use information collected in 1 and 2

4. Consensus conferences to prioritise the outcome measures for the final core outcome set both in relation to orthodontic treatment

Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives
Policy makers

Study Type

COS for clinical trials or clinical research

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