| dc.description.abstract | Aims:
To develop an agreed, standardised set of outcome measures for use in clinical
trials of routine orthodontic treatment for non-cleft/orthognathic patients.
Methods:
A mixed-methods approach was used. In stage I, a list of outcomes measured
in previous orthodontic research was identified through a scoping literature
review following standardised methodology. Further outcomes of importance
to patients were obtained using qualitative interviews and focus groups
involving adolescents at different stages of treatment in five centres in stage II.
Identified qualitative themes were subsequently converted into outcomes and
triangulated with those from the scoping review. In stage III, rating of outcomes
identified from stages I and II was carried out in a two-round electronic Delphi
process involving healthcare professionals and patients using a nine-point
scale. A face-to-face meeting was subsequently held with a sample of
participants from the Delphi surveys in stage IV to discuss the results of the e-
Delphi and reach consensus before refining the core outcome set.
Results:
Fifty-four outcomes were identified from the literature, with the most frequently
measured being pain, periodontal health and tooth angulation/inclination
changes. Dental aesthetics, function, social interactions, emotional well-being
and self-perception were emergent major qualitative themes, with a total of 56
themes being identified and subsequently converted into outcomes. Following
triangulation and piloting of outcomes identified from these two stages, a final
list of 34 outcomes grouped under 10 domains was obtained for scoring in the
e-Delphi surveys. Fifteen outcomes were voted “in” following the second Delphi
round involving 274 participants, with five outcomes having “no” consensus
and a further outcome being voted “in” following the consensus meeting. These
were subsequently refined into a final set of seven core outcomes, including
patient-related adherence, breakages, adverse effects on teeth or teethsupporting
structures, impact of self-perceived aesthetics, alignment and/or
occlusion, skeletal relationship and stability.
Conclusions:
A diverse range of outcomes is used in orthodontic research with a focus on
measuring outcomes important to clinicians, and little consistency among
studies in outcome selection and measurement. A bespoke, orthodontic core
outcome set encompassing both clinician- and patient- focused outcomes was
developed. It is anticipated that this will be incorporated into future orthodontic
research studies providing a more holistic assessment of the impact of
treatment while allowing for meaningful comparison and synthesis of results
from individual trials. | en_US |
