Thai CLEFT-Q: Phase 1-A Pilot Study of Translation and Cultural Adaptation in Thailand.

To translate and culturally adapt the original English version of the CLEFT-Q into Thai (Thai CLEFT-Q). A pilot study. A single tertiary referral hospital in Thailand. Patients with cleft lip or palate (CL/P) aged between 8 and 29 years. The CLEFT-Q was translated and culturally adapted from English into Thai using the good practice guidelines developed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Two forward translations and reconciliation, 1 back translation, and 2 sets of cognitive debriefing interviews with patients were performed to develop the Thai CLEFT-Q. The English version of the CLEFT-Q consists of 13 scales (119 items) assessing appearance, health-related quality of life (HRQOL), and facial function. The forward translations revealed 33.6% inconsistencies. They were related to narrow meaning (2.5%) and improper (16.8%) or incorrect (14.3%) wording or phrasing of the items. After reconciliation, the back translation showed 5 inconsistencies (4.2%) with the original version. However, no changes were needed because the reconciliation version was consistent with the source version. Sixteen participants underwent cognitive debriefing interviews, which revealed a comprehensive interpretation of the Thai CLEFT-Q. Interim reports revealed fair facial appearance scores, albeit with HRQOL and facial function outcomes. Translation and cultural adaptation of the Thai CLEFT-Q provided evidence of its transferability and equivalence with the original English version. Feasible comprehension of the Thai version was also achieved.