Our team first developed the CLEFT-Q for the patients with cleft lip and/or palate. In order to address noncleft craniofacial conditions, we then interviewed 84 patients aged 8 to 29 years with 28 different congenital and acquired conditions (e.g., microtia, facial paralysis, craniosynostosis, craniofacial microsomia). This qualitative study provided evidence to support the use of the original content from the CLEFT-Q with patients with noncleft craniofacial conditions. The qualitative study also identified the need for additional scales to measure constructs not covered by the CLEFT-Q. Our team used the qualitative data to design new scales measuring additional aspects of appearance, facial function and health-related quality of life.
In a combined sample of 4743 patients with cleft and noncleft conditions, psychometric analysis supported the retention of original content for 10 CLEFT-Q scales (Face, Jaws, Lips, Nose, Nostrils, Psychological, Social, School, Speech and Speech Distress), modification of the Teeth scale, and the addition of an Eating/Drinking scale. In the FACE-Q | Craniofacial field-test sample of 1495 participants, psychometric analysis supported for the additional appearance (birthmark, cheeks, chin, eyes, forehead, head shape, smile), function (breathing, facial, eyes), health-related quality of life (appearance distress), and adverse effects (eyes, face) scales and checklists.