Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain

Abstract Background Cleft lip and/or palate (CL/P) is a common congenital craniofacial anomaly that may negatively affect an individual’s appearance, health-related quality of life, or speech. In Spain, Colombia, and Chile the overall prevalence of CL/P ranges from 0.53 to 1.59 cases per 1000 live births. Currently, there is no patient-reported outcome (PRO) instrument that is specific for patients with CL/P. The CLEFT-Q is a new PRO instrument developed to measure outcomes of treatment in patients 8 to 29 years of age with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q for use in Colombia, Chile, and Spain. Methods The CLEFT-Q was translated from English to 3 Spanish language varieties (Colombian, Chilean, and Spanish (Spain)) and Catalan. Translation and cultural adaptation guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research were followed. Results The field- test version of the CLEFT-Q consisted of 13 scales (total 154 items) measuring appearance, health-related quality of life, and facial function. Forward translations revealed 10 (7%) items that were difficult to translate into Chilean, and back translations identified 34 (22%) and 21 (13%) items whose meaning differed from the English version in at least 1 of the 3 Spanish varieties and Catalan respectively. Twenty-one participants took part in cognitive debriefing interviews. Participants were recruited from plastic surgery centres in Bogotá, Colombia (n = 4), Santiago, Chile (n = 7), and Barcelona, Spain (n = 10). Most participants were males (n = 14, 67%) and were diagnosed with CL/P (n = 17, 81%). Participants reported difficulty understanding 1 item in the Colombian, 1 item in the Spanish (Spain), and 11 items from the Catalan version. Comparison of the 3 Spanish varieties revealed 61 (40%) of the 154 items whose wording differed across the 3 Spanish versions. Conclusion Translation and cultural adaptation processes provided evidence of transferability of the CLEFT-Q scales into 3 Spanish varieties and Catalan, as semantic, idiomatic, experiential, and conceptual equivalence of the items, instructions, and response options were achieved

Adaptation of the Quality of Life Adolescent Cleft Questionnaire for Spanish children and adolescents with cleft lip and/or palate

Background: The Quality of Life Adolescent Cleft Questionnaire is a measure of quality of life in cleft lip/palate (CL/P) including items on pre- treatment and post- treatment status. Items, however, were originally organized in a factor structure that prevents a formal pre- treatment to post- treatment comparison. Additionally, the questionnaire was tested in older patients.Aim: We aimed to explore a factor structure that allows a comparison of pre- to post- treatment status in children and adolescents with CL/P.Design: The sample comprised 60 children and adolescents with CL/P. The scale was divided into two groups of items (24 comparing pre- treatment and post- treatment sta-tus and 26 measuring current quality of life). Two different exploratory and confirm-atory analyses were conducted (one for each group of items). Sources of criterion validity were investigated with measures of self- esteem and self- efficacy.Results: The results supported a 6- factor structure for the pre- treatment and post- treatment items. In the second group of items, 9 items were removed due to inad-equate functioning and a final 4- factor solution was obtained. The criterion validity of factors was good.Conclusion: The proposed factor solution might be more useful to detect the per-ceived satisfaction in different areas and can be used in younger patients