Abstract
Objective
CLEFT-Q is a questionnaire to assess patient-reported outcomes specific to individuals with cleft. The purpose of the present study is to evaluate the construct validity of Japanese version of CLEFT-Q by evaluating how the scores of CLEFT-Q relate to participants’ subjective and clinicians’ objective evaluations. Participants were asked to fill in CLEFT-Q and report whether they desired improvement or additional surgery for their cleft-related conditions and whether they attended/enjoyed going to schools. Objective evaluations were collected from clinicians.
Design
Prospective observational study.
Setting
Five institutions in Japan.
Participants
One hundred and eleven individuals with cleft lip, palate, and alveolus between 8 and 17 years old.
Interventions
none.
Main Outcome Measures
CLEFT-Q scores were compared to respondents’ subjective and clinicians’ objective evaluations.
Results
The CLEFT-Q face, nose, nostrils, speech, distress with speech, teeth, and eating and drinking scales were significantly lower for the individuals who desired improvement or additional surgery. CLEFT-Q school and social scales were significantly lower for individuals who did not enjoy going to school. All CLEFT-Q appearance-related scales were significantly lower for individuals who were rated as having less-favorable outcomes by clinicians. The CLEFT-Q psychological scale was associated neither with respondents’ subjective nor clinicians’ objective evaluations.
Conclusions
This study confirmed the construct validity of the Japanese version of CLEFT-Q through hypothesis testing and known group comparisons for 12 out of 13 scales, except for the psychological scale. These findings provide a scientific basis for the use of CLEFT-Q in Japan to collect and evaluate outcomes based on patients’ perspectives.
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References
Supplementary Material
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