Construct Validity of Japanese Version of CLEFT-Q: Cleft-Specific Patient-Reported Outcomes Questionnaire.

Area of Science:

• Cleft lip and palate research
• Patient-reported outcome measures (PROMs)
• Psychometric validation

Background:

• CLEFT-Q is a patient-reported outcome measure for individuals with clefts.
• Validating the Japanese version of CLEFT-Q is crucial for its clinical application in Japan.
• Assessing construct validity involves comparing CLEFT-Q scores with subjective and objective evaluations.

Purpose of the Study:

• To evaluate the construct validity of the Japanese version of the CLEFT-Q.
• To determine how CLEFT-Q scores correlate with patient-reported desires for improvement and school attendance/enjoyment.
• To compare CLEFT-Q scores with clinicians' objective assessments of cleft-related outcomes.

Main Methods:

• A prospective observational study was conducted across five institutions in Japan.
• 111 individuals aged 8-17 with cleft lip, palate, and alveolus participated.
• CLEFT-Q scores were compared against participants' self-reported needs and clinicians' objective evaluations.

Main Results:

• Lower CLEFT-Q scores were observed for participants desiring surgery, those not enjoying school, and those rated poorly by clinicians on appearance scales.
• The psychological scale of CLEFT-Q did not show significant associations with subjective or objective evaluations.
• Significant correlations were found for 12 out of 13 CLEFT-Q scales, supporting construct validity.

Conclusions:

• The Japanese version of CLEFT-Q demonstrates good construct validity for 12 of 13 scales, excluding the psychological scale.
• These findings validate the use of the Japanese CLEFT-Q for patient-centered outcome assessment in Japan.
• The study provides a scientific foundation for utilizing CLEFT-Q in Japanese clinical practice and research.