Reliability and Validity of the CLEFT-Q in a Chinese Context.

OBJECTIVE

To develop an appropriate Chinese version of the CLEFT-Q through translation and cultural adaptation and to evaluate its reliability and validity.

DESIGN

The English CLEFT-Q was translated into Chinese following the International Society for Pharmacoeconomics and Outcomes Research guidelines, including cognitive debriefing interviews, and its reliability and validity were assessed.

PARTICIPANTS

Patients (N = 246) were mostly in active orthodontic treatment, had a mean age of 14.7 ± 4.4 years, 29% were female, and were born with isolated cleft lip ± alveolus (12%), cleft palate (1%), or cleft lip and palate (87%).

MAIN OUTCOME MEASURES

The Chinese CLEFT-Q, including 13 subscales covering Appearance, Health-Related Quality of Life (HRQOL), and Facial Function. Criterion validity instruments included the Negative Physical Self, Satisfaction with Life Scale, and Scale of Positive and Negative Experience.

RESULTS

The wording of 67 items was adapted in the final translation. The internal consistency of the Chinese version of the CLEFT-Q was high based on Cronbach's alphas of 0.85 to 0.98 and split-half reliability of 0.85 to 0.92. Exploratory and confirmatory factor analyses yielded three factors, which demonstrated construct validity by broadly matching the structure of the original CLEFT-Q. The Appearance and HRQOL dimensions had weak to moderate correlations (r = -0.35 to 0.67) with the corresponding instruments for criterion validity.

CONCLUSIONS

The Chinese version of the CLEFT-Q is a patient-reported outcome measure that can reflect the quality of life of Chinese patients with cleft lip and/or palate with good reliability and validity.