A Validated Cultural Adaptation and Translation of the CLEFT-Q Patient Reported Outcome Measure (PROM) from English into Italian

Abstract

Cleft lip and/or palate (CL/P) is a prevalent congenital malformation, affecting approximately 1 to 7 children per 1000 live births, with consequences impacting both appearance and functional abilities such as speech, hearing, and orodental health. These factors contribute to significant psychological challenges and reduced quality of life (QoL) in affected individuals. Treatment typically involves a multidisciplinary approach that begins during pregnancy and continues into young adulthood, ideally managed by specialized centers with dedicated cleft teams. In Italy, the Cleft Center of Milan, part of the European Reference Network (ERN CRANIO), is a leading facility providing care for CL/P. International collaboration and standardized outcome measures, like Patient-Reported Outcome Measures (PROMs), are essential in ensuring high-quality patient-centered care. The CLEFT-Q is a widely used, CL/P-specific PROM developed to assess aspects of facial appearance, psychosocial well-being, and functional abilities. Though originally developed in English, the Cleft Center of Milan, along with ERN CRANIO, undertook the translation and validation of the CLEFT-Q into Italian to enable its implementation in Italy. The translation process adhered to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines and included expert review, patient interviews, and adjustments based on participant feedback. The study confirmed the effectiveness of the CLEFT-Q in capturing relevant patient-reported outcomes in Italian-speaking populations. It also highlighted the importance of standardized PROMs in improving CL/P treatment outcomes and facilitating international research collaboration. The paper concludes with recommendations for the integration of PROMs in CL/P care and explores alternative PROMs, such as the Pediatric Quality of Life Inventory (PedsQL) and the Cleft Hearing, Appearance, and Speech Questionnaire (CHASQ), which could complement the CLEFT-Q for more comprehensive patient assessments.