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Health Qual Life Outcomes. 2017 Nov 28;15(1):228. doi: 10.1186/s12955-017-0805-7.

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

Author information

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, L8S 4L8, Canada.
Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, M5G 1X8, Canada.
Fundación Operación Sonrisa Colombia, Bogotá, 110221, Colombia.
Department of Speech and Language Pathology, Fundación Dr. Alfredo Gantz Mann, Santiago, Chile.
Department of Plastic Surgery, Hospital Luis Calvo Mackenna, Santiago, Chile.
Department of Pediatric Surgery, Hospital Sant Joan de Déu, Barcelona, 08950, Barcelona, Spain.
Division of Plastic Surgery, McMaster University, Hamilton, Ontario, L8P 3A9, Canada.
Department of Pediatrics, McMaster University, Hamilton, Ontario, L8S 4K1, Canada.



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.


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.


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.


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.

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