CLEFT-Q Fieldtest
Research type
Research Study
Full title
An International Study to Develop a Patient-Reported Outcome Measure for Cleft Lip and/or Palate Patients: The CLEFTQ
IRAS ID
158273
Contact name
Tim Goodacre
Contact email
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Cleft lip and/or palate (CLP) is the most common congenital craniofacial anomaly. An integral component of treatment is aimed at improving appearance, speech and psychosocial well-being, outcomes best evaluated with patient input. To measure the patient perspective, a clinically meaningful patient reported outcome measure (PROM) is needed, but none currently exist. Our team has developed the CLEFT-Q from interviews with 138 patients from 6 countries (Canada, USA, UK, Kenya, India, Philippines). The CLEFT-Q is composed of 14 independently functioning scales that measure what patients think about their appearance, speech, psychological, social and physical health. We recently received funding from the Canadian Institutes for Health Research for an international study of patients aged 6 to 29 years from 6 countries, including England. Eligible patients for our study include patients with a CLP aged 8 to 22 years from the regional cleft centres located in Oxford, Salisbury, Liverpool and Birmingham. The study involves 3 phases. In Phase 1, we will recruit up to 15 patients from the Oxford site for qualitative interviews that will provide feedback on the CLEFT-Q instructions, response options and items. These data will ensure the CLEFT-Q is understandable to English patients. In Phase II, we will recruit up to 400 patients from the 4 English centres to participate in the field-test. These participants will complete the CLEFT-Q once. These data will be added to the international field-test dataset and used to reduce the size of the scales (drop items) and examine the psychometric properties (reliability and validity). In Phase III, up to 200 English patients will be asked to complete the item reduced CLEFT-Q as part of a psychometric study. A subset of 100 having jaw, nose, lip and bone graft surgery will be followed up 6 months after surgery. This is a 4 year study.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
14/LO/1910
Date of REC Opinion
17 Oct 2014
REC opinion
Favourable Opinion