Further construct validation of the CLEFT-Q: Ability to detect differences in outcome for four cleft-specific...

The CLEFT-Q is a patient-reported outcome measure developed for use in patients with cleft lip and/or palate. A significant indicator of the CLEFT-Q's validity relates to its ability to detect differences between the impact of specific aspects of clefting before and after surgery. This study compares relevant sub-scale scores of the CLEFT-Q for patients requiring four specific surgical treatments against those who either have had surgery or never needed surgery.

CLEFT-Q scores and clinical information regarding the past and future need for jaw surgery, lip revision, rhinoplasty, and speech surgery were obtained from the CLEFT-Q field-test data. Eight one-way analysis of variance (ANOVA) models were developed to compare mean scores of relevant CLEFT-Q scales between those who needed surgery, those who have had surgery, and those who never needed surgery. Only patients from high-income countries were included to minimize the impact of any economic confounders that could result in treatment variation. In the rhinoplasly and lip revision models, patients without a cleft lip were excluded. In the jaw surgery and speech surgery models, patients without a cleft palate or alveolus were excluded.

The CLEFT-Q field test included 1938 participants from high-income countries. Participants who needed surgery scored significantly lower (worse) than those who have had surgery in each of the eight relevant CLEFT-Q scales (p < 0.001 in each ANOVA).

The ability of the CLEFT-Q to detect differences between groups based on surgical status further supports its validity.