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

ObjectiveCLEFT-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.DesignProspective observational study.SettingFive institutions in Japan.ParticipantsOne hundred and eleven individuals with cleft lip, palate, and alveolus between 8 and 17 years old.Interventionsnone.Main Outcome MeasuresCLEFT-Q scores were compared to respondents' subjective and clinicians' objective evaluations.ResultsThe 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.ConclusionsThis 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.