Translation, Validation, and Cultural Adaptation of CLEFT-Q© for use in Indonesia.

ABSTRACT

OBJECTIVE: To translate and validate CLEFT-Q©, patient-reported outcome measure for patients with cleft lip and/or palate (CL and/or P), into Indonesian. CLEFT-Q© covers the domains of appearance, facial function, health-related quality of life and consists of scales describing outcomes after cleft surgery. DESIGN: The CLEFT-Q© instrument was translated according to the International Society of Pharmacoeconomics and Outcomes Research guidelines, including translation, cognitive debriefing, and field-testing. SETTING: Dr. Cipto Mangunkusumo Hospital, Indonesia; independent CL and/or P support groups. PATIENTS Patients ages 8-29 with a history of repaired CL and/or P were grouped based on age. Those unable to complete the questionnaire independently were excluded. INTERVENTIONS: The primary objective was reliable translation of the CLEFT-Q® instrument. Each scale was assessed for its internal consistency (Cronbach's alpha) and validity (inter-item correlation), and sub-group analyses were performed based on age group. RESULTS: Forward and back translation revealed 25(13.3%) and 12(6.3%) of items were difficult to translate. Cognitive debriefing revealed 10(5.3%) items were difficult to understand, with the lowest reliability on the facial appearance scale (α=0.27). Other scales demonstrated acceptable to excellent reliability (α=0.53-0.68). Field testing revealed acceptable reliability and validity of the translation (α = 0.74-0.92; 69% ideal range of inter-item correlation). Sub-group analyses revealed patients in the <11y.o. and >18y.o. groups had the lowest scores on the "cleft lip scar" scale while those 11-18y.o. had the lowest scores on the "nostrils" scale. CONCLUSION: Iterative translation and cultural adaptation of CLEFT-Q© into Indonesian demonstrated reliability and validity of the tool, supported by acceptable to excellent internal consistency and ideal inter-item correlation.