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

Abstract

BackgroundCleft 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.MethodsThe 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.ResultsThe 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.ConclusionTranslation 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.Electronic supplementary materialThe online version of this article (10.1186/s12955-017-0805-7) contains supplementary material, which is available to authorized users.

Psychometric findings and normative values for the CLEFT-Q based on 2434 children and young adult patients with cleft lip and/or palate from 12 countries

“…22 Ideal fit residuals are between -2.5 and +2.5 with Χ 2 values nonsignificant after Bonferroni adjustment. We interpreted fit statistics together and in relation to clinical usefulness.…”

“…Cognitive interviews with 69 patients from 6 countries, and feedback from an international sample of 44 experts, provided input used to refine 13 scales and establish their content validity. 20 The scales were then translated and culturally adapted into 5 languages 21,22 following international guidelines. 23,24 The aim of this paper is to describe reliability and validity findings based on a set of statistical and graphical tests, including that of construct validity, whereby CLEFT-Q scores were hypothesized to be worse for participants who needed (v. did not need) cleft-related treatments, who were less (v. more) happy with their appearance and who had a more (v. less) severe speech problem.…”

International phase I study protocol to develop a patient-reported outcome measure for adolescents and adults receiving gender-affirming treatments (the GENDER-Q)

“…In preparation for an international field-test, the GENDER-Q will be translated into languages needed by participating sites. We will follow the methodology that was recommended for translations of PROMs in the field of plastic surgery, which we already applied to other PROMs developed by members of our team (eg, BODY-Q, 46 CLEFT-Q 47 ). This approach is in accordance with the International Society for Pharmacoeconomics and Outcomes Research 48 and the World Health Organization 49 recommendations for linguistic validations.…”

Biomaterials for Cleft Lip and Palate Regeneration

“…Orofacial cleft conditions have been estimated to have a global annual prevalence of 7.94 cases per 10,000 live births with high variances of treated patients across regions and countries (Figure 2) [11]. In some European countries, for example, the prevalence of CL/P has been reported between 0.53 to 1.59 cases per 1000 live births [12], while the countries that have reported the highest and lowest rates were Japan (19.05) and South Africa (3.13), respectively. On the other hand, in the American continent, the overall case rate is 10.49 per 10,000 live births and this figure is surpassed by some countries in South America (i.e., Bolivia with 23.7, Ecuador with 14.96, and Paraguay with 13.3).…”

“…CL/P is considered as an anatomical defect of profound aesthetic and functional impact that leads to other future alterations, and therefore may negatively impact health-related quality of life, and/or speech [12]. Individuals with clefts of the lip, palate, or alveolus often require interdisciplinary treatment into adulthood and thus they require timely and effective care.…”