Grant: Operating Grant

Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. The management of this condition is complex, beginning in infancy and often extending into adulthood. Patients undergo at least one operation, and depending on the severity of the cleft, may have more than six operations before the age of 18 years. While the goal of treatment is to improve patient's physical, psychological, and social well-being, the measurement of outcomes has typically ignored the patients' perspective to focus on objective and more readily analyzed outcomes. Our international team of experts from Canada, USA and United Kingdom has come together to develop and validate a new patient-reported outcome (PRO) instrument called the CLEFT-Q. A PRO instrument for patients with CLP needs to measure the domains of health of importance to patients (e.g., appearance, speech, psychosocial interaction) and to do this in a way that captures differences in aspects of quality of life as patients matures, as well as differences between countries. Progress to date by our team includes a literature review of health concepts in patients with CLP, interviews with 136 patients with CLP from 6 countries and the development of a conceptual framework with 4 main domains (Appearance, Physical Health, Psychological Health and Social Health). The framework was used to guide the development of 13 new CLEFT-Q scales. All scale items now need to be tested for cultural and cognitive understanding. We then plan to conduct a large scale field-test and use modern psychometric methods to choose the best possible items for inclusion in the final CLEFT-Q scales. Finally, the CLEFT-Q will be included in a psychometric evaluation study to examine validity, reliability and responsiveness. Once developed, the CLEFT-Q will be used to support patient advocacy, clinical audit for quality improvement, and local, national and international research efforts.